Devices for treating vascular abnormalities

Abstract

A device for treating aneurysms and a delivery method are described, comprising a permeable shell having an open distal end, an internal compressible mesh structure having a lumen, and an external constraint surrounding at least a portion of the internal compressible mesh structure. The external constraint may have variable stiffness. The deployed configuration of the permeable shell may be torus-shaped, with the internal compressible mesh structure disposed along the longitudinal axis of the permeable shell. The external constraint may be a coil or a hypotube. The external constraint may have a proximal portion that is stiffer than the distal portion. The stiffer proximal portion of the external constraint may attenuate hemodynamic forces at the proximal end of the permeable shell.

Description

[Technical Field]

[0001] (CROSS-REFERENCE TO RELATED APPLICATIONS) This application claims the benefit of priority to U.S. Provisional Patent Application No. 63 / 423,941, filed November 9, 2022, which is expressly incorporated herein by reference in its entirety for all purposes.

[0002] (Statement Regarding Federally Sponsored Research or Development) Not applicable

[0003] (Technical field) Embodiments of the devices and methods herein are directed to implants for treating aneurysms. [Background technology]

[0004] The mammalian circulatory system includes a heart that functions as a pump and a vascular system that transports blood to various locations in the body. The force exerted by flowing blood on blood vessels can cause various vascular abnormalities in the blood vessels. One common vascular disorder, known as an aneurysm, is the result of abnormal dilation of blood vessels. Typically, vascular aneurysms form as a result of weakening of the blood vessel wall, followed by swelling and dilation of the blood vessel wall. For example, if an aneurysm occurs in an artery in the brain and the aneurysm ruptures, causing intracranial hemorrhage, which can be fatal.

[0005] Surgical techniques used to treat cerebral aneurysms typically involve craniotomy, which involves creating an opening in the patient's skull through which the surgeon can insert surgical instruments directly into the patient's brain. Some surgical approaches require retracting the brain to expose the parent vessel in which the aneurysm originates. Once access to the aneurysm is gained, the surgeon places a clip around the neck of the aneurysm, thereby preventing arterial blood from entering the aneurysm. Once the clip is properly placed, the aneurysm is occluded within minutes. Surgical treatment can be an effective treatment for many aneurysms. Unfortunately, surgical treatments used to treat these conditions can involve highly invasive surgical procedures that are invasive to the patient and often require time under anesthesia, which carries significant risks to the patient. Therefore, patients must be in generally good health to be candidates for such procedures.

[0006] A variety of alternative, minimally invasive procedures have been used to treat cerebral aneurysms without major surgery. One approach to treating aneurysms without invasive surgery involves placing a sleeve or stent in the aneurysm-causing vessel and its surrounding area. These flow diverter devices reduce the pressure inside the aneurysm while maintaining blood flow through the vessel. Certain types of stents are expanded to the appropriate size by inflating a balloon catheter and are called balloon-expandable stents, while other stents are designed to self-expand by elastic force. Some stents are typically covered with a sleeve of polymeric material called a graft, forming a stent-graft. Stents and stent-grafts are generally delivered via a delivery catheter to a location near a preselected vascular abnormality. The use of covered stents or stent-grafts in the treatment of cerebral aneurysms is very limited due to the risk of inadvertent occlusion of small perforating vessels, which may be near the vascular abnormality being treated.

[0007] Furthermore, current uncoated stents are generally insufficient as a stand-alone treatment. Inserting a stent through a microcatheter used in the small blood vessels of the brain typically reduces the density of the stent so that there is little stent structure bridging the neck of the aneurysm when expanded. Therefore, they are unable to block blood flow sufficiently to induce clotting within the aneurysm, and are generally used in conjunction with a vaso-occlusive device such as a coil to achieve occlusion of the aneurysm.

[0008] Several procedures involve the delivery of embolic or filling materials into an aneurysm. The delivery of such vaso-occlusive devices or substances may be used to promote hemostasis or completely fill the aneurysm lumen. Vaso-occlusive devices may be placed within the body's vasculature, typically via catheter, to either block blood flow through an aneurysmal blood vessel through the formation of an embolism or to form such an embolism within an aneurysm extending from the blood vessel. Various implantable coil-type vaso-occlusive devices are known. The coils of such devices may be formed into either a secondary coil shape or a variety of more complex secondary shapes. Vaso-occlusive coils are commonly used to treat cerebral aneurysms, but they have several limitations, including low packing density, compression due to hydrodynamic pressure from blood flow, poor stability in wide-neck aneurysms, and complex and difficult placement due to the need for multiple coil placement in most aneurysm treatments using this approach. Coiling is less effective in treating certain physiological conditions such as wide-necked lumens (eg, wide-necked aneurysms) due to a greater risk of the coil becoming dislodged from the treatment site.

[0009] Numerous aneurysm neck bridging devices with a spanning portion or region have been attempted, but none of these devices have achieved significant clinical success or widespread use. A major limitation in their adoption and clinical utility is the inability to position the spanning portion to reliably cover the neck. Existing stent delivery systems that are neurovascularly compatible (i.e., deliverable via microcatheter and highly flexible) do not have the necessary rotational positioning capabilities. Another limitation of many aneurysm bridging devices described in the prior art is their poor flexibility. Cerebral blood vessels are tortuous, requiring a high degree of flexibility for effective delivery to the location of most aneurysms in the brain.

[0010] What has been needed are devices and methods for delivery to and use in small, tortuous blood vessels that can substantially block blood flow to an aneurysm, such as a cerebral aneurysm, with a low risk of inadvertent aneurysm rupture or vessel wall damage. Additionally, what has been needed are methods and devices suitable for blocking blood flow in a cerebral aneurysm for extended periods of time without significant risk of deformation, compression, or displacement.

[0011] Intra-aneurysmal occlusion devices are part of a new class of vascular occlusion devices used to treat a variety of intravascular conditions, including aneurysms. These devices are often more effective in treating these wide-neck conditions or larger treatment areas. The intra-aneurysmal device includes a structure that lies within the aneurysm and provides an occlusion effect at the neck of the aneurysm, helping to restrict blood flow to the aneurysm. The remainder of the device includes a relatively conformable structure that lies within the aneurysm and helps to occlude all or part of the aneurysm. Intra-aneurysmal devices typically conform to the shape of the treatment site. These devices also occlude a cross-section of the treatment site / aneurysm neck, thereby promoting blood clotting, thrombus formation, and closure of the aneurysm over time. In larger aneurysms, there is a risk of compression, where the intra-aneurysmal device can migrate into the aneurysm and leave the neck area.

[0012] Intraaneurysmal blood flow diversion devices may be used to treat wide-necked bifurcation aneurysms. Wide-necked bifurcation aneurysms are characterized by a parent vessel with two daughter or branch vessels at the bifurcation. These bifurcation aneurysms are observed at the internal carotid artery bifurcation, middle cerebral artery bifurcation, anterior cerebral artery bifurcation, and basilar artery bifurcation. Intracranial vascular bifurcation is characterized by the impingement of fluid forces at the bifurcation junction, which are then distributed to the two daughter vessels at the bifurcation. An intraaneurysmal blood flow diversion device implanted in the bifurcation aneurysm experiences impingement due to hemodynamic forces at its proximal end. As a result of the hydrodynamic impingement, the proximal end may experience compression.

[0013] Therefore, there is a need for an occlusion device that includes a mechanism for reducing impinging hemodynamic forces.

[0014] The following embodiments address this problem by utilizing a device with a pre-set expanded shape that can conform to and substantially fill aneurysms of many sizes. Summary of the Invention [Means for solving the problem]

[0015] Occlusion devices are described for use in treating a variety of conditions, including aneurysms and neurovascular aneurysms. In some embodiments, the occlusion devices are configured as intra-aneurysmal devices.

[0016] In many embodiments, a device for treating an aneurysm in a patient includes a permeable shell and an external constraint, the permeable shell having a proximal end, a distal end, a radially constrained elongated state configured for delivery into a catheter lumen, a deployed state, and a plurality of filaments woven together to form a mesh, each of the plurality of filaments having a first end and a second end, each of the plurality of filaments originating at the proximal end of the permeable shell, extending to the distal end of the permeable shell, and extending back to the proximal end of the permeable shell to form an internal compressible mesh structure, the first end and the second end of each of the plurality of filaments being gathered into a hub at the first end of the first permeable shell, the external constraint surrounding at least a portion of the internal compressible mesh structure and comprising a variable stiffness along a length of the external constraint.

[0017] In some embodiments, the external restraint may be a coil.

[0018] In some embodiments, the external constraint includes a proximal portion and a distal portion, and the proximal portion of the external constraint is stiffer than the distal portion of the external constraint.

[0019] In some embodiments, the external constraint comprises a coil formed from a wire, the coil comprising a proximal portion having a first pitch and a distal portion having a second pitch, the first pitch being narrower than the second pitch.

[0020] In some embodiments, the proximal portion of the coil has a first spring constant and the distal portion has a second spring constant, the first spring constant being lower than the second spring constant.

[0021] In another embodiment, the external restraint may be a hypotube having multiple openings.

[0022] In many embodiments, a method for treating an aneurysm having a lumen and a neck includes advancing an implant within a microcatheter to a region of interest in an artery, positioning the implant within a cerebral aneurysm, and withdrawing the microcatheter from the region of interest after positioning the implant, wherein during the step of advancing the implant to the region of interest in the artery, the implant includes a permeable shell and an external restraint, the permeable shell having a proximal end, a distal end, a radially constrained elongated state configured for delivery within a catheter lumen, a deployed state, and a plurality of filaments woven together to form a mesh. each of the plurality of filaments having a first end and a second end, each of the plurality of filaments originating at a proximal end of the permeable shell, extending to a distal end of the permeable shell, and extending back to the proximal end of the permeable shell to form an internal compressible mesh structure; the external constraint surrounding at least a portion of the internal compressible mesh structure, the external constraint including a variable stiffness along a length of the external constraint and a hub at the proximal end of the permeable shell; the first and second ends of each of the plurality of filaments being retained by a marker band; and during the step of placing the implant within a cerebral aneurysm, the permeable shell expands to a deployed state within the lumen of the aneurysm.

[0023] In many embodiments, a device for treating an aneurysm in a patient includes a permeable shell and a restraining means, the permeable shell having a proximal end, a distal end, a radially constrained elongated state configured for delivery within a catheter lumen, a deployed state, and a plurality of filaments woven together to form a mesh, each of the plurality of filaments having a first end and a second end, each of the plurality of filaments originating at the proximal end of the permeable shell, extending to the distal end of the permeable shell, and extending back to the proximal end of the permeable shell to form an internal compressible mesh structure, the first end and the second end of each of the plurality of filaments being gathered into a hub at the first end of the first permeable shell, and the restraining means being for positioning around at least a portion of the internal compressible mesh structure to attenuate hemodynamic forces at the proximal end of the permeable shell. [Brief explanation of the drawings]

[0024] These and other aspects, features, and advantages of possible embodiments of the present invention will become apparent from and will be explained in the following description of the embodiments, taken in conjunction with the accompanying drawings.

[0025] Various figures included within this application show occlusion devices according to one or more embodiments.

[0026] [Figure 1A] 1 illustrates an exemplary aneurysm treatment device including a reinforcing element. [Figure 1B] 1B shows a plan view of the device of FIG. 1A. [Figure 2] 1 illustrates an exemplary tubular mesh. [Figure 3A] 1 shows a heat-set tubular mesh with some small diameters. [Figure 3B] 3B shows the heat-set tubular mesh of FIG. 3A with reinforcing elements. [Figure 3C] 3C shows the heat-set tubular mesh of FIG. 3B after inversion. [Figure 4] 10 illustrates a device for treating an aneurysm that includes an alternative reinforcing element. [Figure 5A] 1 illustrates an exemplary device positioned within a vascular abnormality. [Figure 5B] 1 illustrates an exemplary device positioned within a vascular abnormality. DETAILED DESCRIPTION OF THE INVENTION

[0027] (Detailed Description of the Invention) The embodiments presented will generally relate to occlusion devices that can be used to treat aneurysms.

[0028] Intra-aneurysmal occlusion devices comprising a permeable shell formed from a woven or knitted mesh are described in U.S. Application Publication Nos. US 2016 / 0249935, US 2017 / 0095254, US 2016 / 0249934, US 2016 / 0367260, US 2016 / 0249937, US 2018 / 0000489, and US 2019 / 0223881, which are expressly incorporated by reference in their entireties for all purposes.

[0029] 1A-1B illustrate an intraaneurysmal device 110 including a permeable shell 140 having an internal compressible structure 148 with a lumen. The internal compressible structure 148 may also be referred to as an internal compressible section, an internal tubular member, or an internal permeable mesh member. The permeable shell 140 may have a proximal end 142, a distal end 150, a longitudinal axis, and may be made of a plurality of elongated elastic filaments 48. As shown in FIG. 1B, the permeable shell may have an open distal end 150 with an opening 152 that communicates with the lumen of the internal compressible structure 148. The filaments may have an interwoven structure and are secured to one another at the proximal end of the permeable shell 140 within the proximal hub 70. Each filament 48 of the plurality of filaments may originate at the proximal end 142 of the permeable shell 140, extend to the distal end 150, and then extend back to the proximal end 142. Both free ends of each of the filaments may be retained within the proximal hub 70. In some embodiments, the proximal hub 70 may be radiopaque. In some embodiments, the proximal hub 70 may be surrounded by a marker band. The permeable shell 140 of the device 110 has a radially constrained, elongated state configured for delivery within a microcatheter, with the thin, interwoven filaments extending longitudinally from the proximal end to the distal end of each radially adjacent permeable shell along the length of the filament. Relative to the radially constrained state, the permeable shell 140 has a deployed, relaxed state having a longitudinally shortened configuration. In the deployed state, the interwoven filaments form a self-expanding, resilient permeable shell 140 in a smooth, radially deployed path from the longitudinal axis of the permeable shell between the proximal and distal ends. The deployed state may be shaped like a torus or pumpkin with an inverted, open distal end 150 and an internal compressible structure 148 having a lumen extending along the longitudinal axis of the device. In some embodiments, the internal compressible structure 148 may extend along the central axis of the implant in its deployed state.The woven structure of the filaments forming the permeable shell includes a plurality of openings formed between the interwoven filaments in each permeable shell 140. The braided mesh 48 of each permeable shell 140 defines an interior lumen.

[0030] The inner compressible structure 148 can have a lumen that communicates with the open distal end 150 of the permeable shell 140. The lumen of the inner compressible structure 148 can have a portion with a constant diameter. The lumen diameter can be between about 0.01 inches and about 0.015 inches.

[0031] The internal compressible structure 148 may be surrounded or structurally reinforced by an external constraint to provide stiffness to the proximal region of the device 110. The external constraint may have variable stiffness along its longitudinal axis or length. The external constraint may have at least a proximal region and a distal region. The proximal region may be stiffer than the distal region. The external constraint may attenuate hemodynamic forces at the proximal end of the device (which is often visible under imaging during contrast injection during the implant procedure). Attenuating hemodynamic forces at the proximal end of the device may absorb pressure changes, provide a more securely implanted device, reduce device migration, improve blood flow diversion, and / or improve the rate of aneurysm size reduction over time. In some embodiments, the external constraint may surround a portion of the internal compressible structure 148 having a constant diameter.

[0032] 1A-1B, the external restraint can be a coil 154 that surrounds at least a portion of the length of the internal compressible structure 148. The coil 154 can be formed by winding a filament or wire around at least a portion of the internal compressible structure 148. The coil 154 can have a proximal portion 252 located closer to the proximal end 142 and proximal hub 70 of the permeable shell and a distal portion 254 located closer to the distal end 150 of the permeable shell 140. The pitch of the coil is the axial length of one helix. As shown in FIG. 1A, the proximal portion of the coil 252 can have a pitch (p1) that is different from the pitch (p2) of the distal portion of the coil. The proximal portion of the coil 252 can have a spring constant that is different from the spring constant of the distal portion of the coil. The winding angle or braid angle of the coil is the angle formed between the central longitudinal axis (axis 1) of the helix or coil and the braided wire or filament. The proximal portion of the coil 252 may have a different winding angle (wa1) than the winding angle (wa2) of the distal portion of the coil.

[0033] According to spring theory, the spring constant k for a coil winding is given by the following formula:

number

[0034] The spring constant k determines the stiffness of the spring during delivery. The tightly wound helical configuration in the proximal region 252 of the coil has a low spring constant k, indicating a softer implant profile during delivery. The open-gap helical configuration in the distal region 254 of the coil has a high spring constant k, indicating a slightly increased stiffness profile during delivery. The stiffer central shaft section of the implant is complemented by a softer torus braid and the absence of a marker band at the distal end of the implant 110. The tighter coil pitch reduces friction during implant delivery, but also demonstrates a high compressive modulus, i.e., resistance to compressive forces from the proximal end. In contrast, the softer central shaft section of the implant at the proximal end is complemented by the increased stiffness provided by the marker band, creating a balanced structure.

[0035] The wire diameter of the coil can range from 0.0015 inches to 0.003 inches. The pitch of the proximal portion 252 of the coil can be about 0.002 inches, alternatively about 0.01 inches, alternatively about 0.03 inches, alternatively between about 0.001 inches and 0.004 inches, alternatively between about 0.001 inches and 0.003 inches, alternatively between about 0.015 inches and 0.025 inches, alternatively between about 0.001 inches and 0.03 inches, alternatively between about 0.01 inches and 0.04 inches, alternatively between about 0.01 inches and 0.03 inches, alternatively between about 0.015 inches and 0.035 inches. The spring constant of the proximal portion 252 of the coil can be between about 0.003 and about 0.02, alternatively between about 0.004 and about 0.015, alternatively between about 0.005 and about 0.015, alternatively between about 0.005 and about 0.013, alternatively between about 0.005 and about 0.012, alternatively between about 0.006 and about 0.015, alternatively between about 0.007 and about 0.015, alternatively about 0.0060, alternatively about 0.0061, alternatively about 0.0055, alternatively about 0.005, alternatively about 0.004, alternatively about 0.003, alternatively about 0.002, alternatively about 0.015, alternatively about 0.013, alternatively about 0.011, alternatively about 0.01. When smaller diameter wire is used, the pitch may be smaller. For example, with a 0.0015 inch diameter wire, a pitch of 0.002 inch may be used. For implants using larger diameter wire, a pitch of between about 0.01 inch and about 0.03 inch may be used to provide axial resistance and constrain the internal compressible structure 148. The winding angle of the proximal portion 252 may be between about 70 degrees and about 100 degrees, alternatively between about 75 degrees and about 95 degrees, and alternatively between about 80 degrees and about 90 degrees.The proximal portion 252 of the coil may be between about 5 mm and about 20 mm in length, alternatively between about 5 mm and about 18 mm, alternatively between about 7 mm and about 18 mm, alternatively between about 10 mm and about 18 mm, alternatively between about 10 mm and about 20 mm, alternatively about 20 mm, alternatively about 18 mm, alternatively about 15 mm, alternatively about 12 mm, alternatively about 10 mm, alternatively about 7 mm, or alternatively about 5 mm. The proximal portion 252 of the coil may be less than about 50%, alternatively less than about 40%, alternatively less than about 30%, alternatively less than about 25%, or alternatively less than about 20% of the total length of the permeable shell. The proximal portion 252 of the coil may be less than about 50%, alternatively less than about 40%, alternatively less than about 30%, alternatively less than about 25%, or alternatively less than about 20% of the total length of the coil.

[0036] The pitch of the distal portion 254 of the coil can be between about 0.0075 inches and about 0.04 inches, alternatively between about 0.0075 inches and about 0.03 inches, alternatively about 0.0075 inches, alternatively about 0.009 inches, alternatively about 0.01 inches, alternatively about 0.015 inches, alternatively about 0.02 inches, or alternatively about 0.03 inches. The spring constant of the distal portion 254 of the coil can be between about 0.020 and about 0.080, alternatively between about 0.020 and about 0.075, alternatively between about 0.020 and about 0.070, alternatively about 0.020, alternatively about 0.023, alternatively about 0.027, alternatively about 0.030, alternatively about 0.033, alternatively about 0.036, alternatively about 0.040, alternatively about 0.043, alternatively about 0.046, alternatively about 0.050, alternatively about 0.053, alternatively about 0.057, alternatively about 0.060, alternatively about 0.063, alternatively about 0.067, alternatively about 0.070, alternatively about 0.075, or alternatively about 0.080. The winding angle of the distal portion 254 may be between about 80 degrees and about 40 degrees, alternatively between about 75 degrees and about 45 degrees. The distal portion 254 of the coil may be between about 5 mm and 12 mm in length, alternatively between about 5 mm and 11 mm, alternatively between about 5 mm and 10 mm, alternatively about 12 mm, alternatively about 11.8 mm, alternatively about 11.6 mm, alternatively about 11.4 mm, alternatively about 11.2 mm, alternatively about 11 mm, alternatively about 10.8 mm, alternatively about 10.6 mm, alternatively about 10.4 mm, alternatively about 10.2 mm, alternatively about 10 mm, alternatively about 9.8 mm, alternatively about 9.6 mm, alternatively about 9.4 mm, alternatively about 9.2 mm, alternatively about 9.0 mm, alternatively about 8 mm, alternatively about 7 mm, alternatively about 6 mm, alternatively about 5.8 mm, alternatively about 5.6 mm, alternatively about 5.4 mm, alternatively about 5.2 mm, or alternatively about 5 mm. The distal portion 254 of the coil may have a length that is less than about 50%, alternatively less than about 40%, alternatively less than about 30%, alternatively less than about 25%, or alternatively less than about 20% of the total length of the permeable shell.The distal portion 254 of the coil may have a length that is less than about 50%, alternatively less than about 40%, alternatively less than about 30%, alternatively less than about 25%, or alternatively less than about 20% of the total length of the coil.

[0037] As shown in Figure 4, in another embodiment, the external constraint can be a laser cut or laser etched hypotube 282 with cells or openings of different sizes in the proximal and distal portions, such that the hypotube 282 has variable stiffness along its longitudinal axis or length. As shown in Figure 4, the hypotube 282 has a stiffness of approximately 0.05 mm. 2 or about 0.3 mm 2 , alternatively about 0.059 mm 2 or about 0.27 mm 2 , alternatively about 0.1 mm 2 or about 0.26 mm 2 , alternatively about 0.1 mm 2 or about 0.3 mm 2 , alternatively about 0.1 mm 2 or about 0.4 mm 2 , alternatively about 0.1 mm 2 or about 0.5 mm 2 , alternatively about 0.1 mm 2 or about 0.6 mm 2 The distal portion 286 may have a proximal portion 284 with cells having an area of ​​about 0.10 mm 2 or about 1.0 mm 2 , alternatively about 0.15 mm 2 or about 0.9 mm 2 , alternatively about 0.17 mm 2 or about 0.88 mm 2 , alternatively about 0.28 mm 2 or about 0.58 mm 2 The hypotube may have cells with an area of ​​0.05 mm to 0.1 mm. The hypotube thickness may vary from 0.05 mm to 0.1 mm. The hypotube strut width may vary from about 0.1 mm to about 0.2 mm.

[0038] The deployed state of the permeable shell 140 may have a maximum diameter of between about 3 mm and about 12 mm, alternatively between about 3 mm and about 10 mm, alternatively about 4 mm, alternatively about 5 mm, alternatively about 6 mm, alternatively about 7 mm, alternatively about 8 mm, alternatively about 9 mm, alternatively about 10 mm, or alternatively about 11 mm. The deployed state of the permeable shell 140 may have a height or length of about 2.6 mm, about 3 mm, about 3.6 mm, about 4 mm, about 4.6 mm, about 5 mm, about 5.6 mm, about 6 mm, about 6.6 mm, about 7 mm, about 7.6 mm, about 8 mm, about 8.6 mm, about 9 mm, about 9.6 mm, or about 10 mm.

[0039] The implant's permeable shell 140 may be made of a braided tubular mesh 248, as shown in FIG. 2. The filaments that make up the mesh or braid 248 may be made from nitinol, stainless steel, drawn filled tubing (e.g., a platinum or tantalum core with a nitinol jacket), platinum, a platinum alloy such as platinum / tungsten, or a mixture thereof. The filaments may have a diameter ranging from about 0.00075 inches to about 0.003 inches and be braided onto a stainless steel mandrel, with a diameter ranging from about 3 mm to about 12 mm based on the final width of the implant design. The braid mandrel can then be heat-set to impart shape-memory properties to the wire at a predetermined mandrel diameter. FIG. 2 illustrates the primary braid wrapped onto the mandrel based on the device width before heat setting. Details of the present braiding method for forming the tubular mesh of FIG. 2 may be found in U.S. Pat. No. 8,261,648 and U.S. Pat. No. 8,826,791, both of which are expressly incorporated herein by reference in their entirety for all purposes.

[0040] After tubular braid 248 is removed from the mandrel, proximal portion 242 of the tubular braid may be folded and loaded onto a mandrel 272 having a smaller diameter than the original mandrel used to produce the tubular braid. Smaller mandrel 272 may have a diameter between about 0.01 inches and about 0.015 inches, alternatively between about 0.02 inches and about 0.025 inches. As shown in FIG. 3A , the interface between funnel-shaped distal region 262 and the folded proximal section 242 of the braid may be restrained with a restraining feature. In some embodiments, the restraining feature may be a ring fastener 244. A similar restraining feature or mechanism may be used at the proximal end of tubular mesh 248. Tubular braid 248 may undergo a second round of heat setting, as illustrated in the top section of FIG. 3A , to impart shape-memory properties to the folded structure. The proximal restraint fixture (not shown) may then be removed and the braid mandrel coiled.

[0041] In a coil embodiment, a wire or filament may be wound around the smaller heat-set proximal section 242, as shown in FIG. 3B. The wire or filament may be platinum or tungsten wire with an outer diameter between about 0.0015 inches and about 0.003 inches. For the proximal region 252 of the proximal section 242, the wire may be coiled in a closed gap configuration with the tightest possible pitch, while the distal region 254 may be about 1 / 2 to about 1 / 3 the length of the proximal section 242, or the length of the coil, and may be wound in a more open gap configuration.

[0042] As shown in FIG. 3B, proximal region 252 may have a length that is about one-third to about one-half the length of the proximal portion heat-set to a smaller diameter and may be located at the proximal end of proximal portion 242. The winding angle of the proximal portion may be about 70 degrees to about 95 degrees, alternatively about 80 degrees to about 90 degrees. The pitch of proximal portion 252 may be about 0.01 inches to about 0.03 inches. The proximal region 252 of the coil winding has a smaller pitch, or a smaller minimum gap between turns, than the distal portion 254.

[0043] The distal region 254 of the proximal portion 242 may be about one-third to about one-half the length of the smaller heat-set proximal portion 242 and may be located at the distal end of the proximal portion 242. The winding angle of the distal portion may be about 30 degrees to about 80 degrees, alternatively about 45 degrees to about 75 degrees. The pitch of the distal region 254 may be at least about 8 times, alternatively at least about 10 times, alternatively at least about 15 times the diameter of the winding wire. The pitch of the distal region 254 may be between about 0.0075 inches and about 0.03 inches.

[0044] The ends of the coil winding wire may be welded to the folded braided structure to ensure the restraint of the proximal portion 242. After the wire is wrapped at the appropriate pitch around the proximal portion 242, the mesh braid 248 may be heat set to form a funnel-shaped spring mechanism. After shape setting is complete, the mandrel may be removed.

[0045] 4, in the hypotube embodiment, a laser cut or laser etched hypotube may be advanced over the proximal section 242 that is heat set to a smaller diameter. The hypotube may be slid over the crimped mesh braid.

[0046] After the mandrel 272 is removed, the open distal end of the funnel-shaped distal region 262 may evertate toward the proximal end, such that the distal end evertates and the former inner surface of the tubular mesh in the distal region 262 becomes the outer surface of the final deployed implant. The ends of the filaments comprising the tubular mesh may be brought together at the proximal end of the implant. A torus or pumpkin-shaped fixture may be used to impart the final implant shape. The distal portion 262 of the mesh may be everted, wrapped around the torus or pumpkin-shaped fixture, temporarily restrained at the proximal end of the implant, and heat-set. The torus or pumpkin-shaped fixture may then be removed. After the fixture is removed, the ends of the mesh and the coil wrapped around the internal compressible structure may be restrained with marker bands and laser welded. An external constraint, such as a coiled or laser-cut hypotube, around the folded braid core and forming an internal compressible structure may act as a shock absorber or damper to attenuate hemodynamic forces at the proximal end. For devices with coils, a tighter pitch in the proximal region 252 minimizes compression at the proximal end of the implant. A more open winding gap in the distal region of the coil can make the distal end of the implant more flexible.

[0047] The mesh or braid 48 may be made from multiple filaments in a woven structure secured to one another at their proximal ends, e.g., at the proximal marker band 70. The multiple filaments making up the mesh or braid 48 may be made from nitinol, stainless steel, extruded and filled tubing (e.g., a platinum or tantalum core with a nitinol jacket), platinum, a platinum alloy such as platinum / tungsten, or a mixture thereof. The distal ends of the mesh or braid 48 may be secured to one another, e.g., at the distal marker band 74. The proximal ends of the mesh or braid 48 may be secured to one another at their proximal ends, e.g., at the proximal marker band 70. The wire may have a diameter of about 0.00075 inches to about 0.003 inches, alternatively about 0.001 inches to about 0.003 inches, alternatively about 0.0015 inches to about 0.0025 inches. Suitable wire materials and sizes for constructing mesh implants are described in U.S. Patent No. 2017 / 0095254, U.S. Patent Application No. 2016 / 0249934, U.S. Patent Application No. 2016 / 0367260, U.S. Patent Application No. 2016 / 0249937, and U.S. Patent Application No. 2018 / 0000489, all of which are expressly incorporated by reference in their entirety for all purposes herein.

[0048] Delivery and deployment of the device of the embodiments 110 discussed herein may be performed by first compressing the device 110 into a radially constrained, longitudinally flexible state. The device 110 may be attached to a pusher that can be advanced through a lumen of a microcatheter. The marker band of the device 110 may be removably attached to the pusher. The device 110 may then be delivered to the desired treatment site, such as an aneurysm 160, while positioned within the microcatheter, and then pushed or otherwise positioned from the distal end of the microcatheter. In other method embodiments, the microcatheter may first be navigated to the desired treatment site over a guidewire or other suitable navigation technique. The distal end of the microcatheter is oriented so that the distal port of the microcatheter faces toward or is positioned within the vascular abnormality 160 to be treated, and the guidewire is withdrawn. The device 110, secured to a suitable delivery apparatus and in a radially constrained configuration and inserted into the proximal lumen of the microcatheter, may be advanced distally through the lumen to the vascular abnormality 160.

[0049] As shown in Figures 5A-5B, once positioned within a vascular abnormality 160, such as a wide-neck aneurysm, the device 110 may be allowed to assume an expanded, relaxed state or a partially relaxed state in which the permeable shell 140 of the device spans or partially spans a portion of the vascular abnormality 160, the entire vascular abnormality 160, or both. Once the device 110 is positioned at the desired treatment site and the permeable shell 140 is detached from the delivery device, the microcatheter may be withdrawn. For example, a V-Trak (trademark) microcatheter from MicroVention, Aliso Viejo, CA, may be used. Device 110 may be detached via mechanical, chemical, or electrothermal mechanisms as described in U.S. Patent Nos. 8,182,506, 9,414,819, 9,242,070, 10,076,338, 8,192,480, 9,717,500, 9,968,358, 8,932,317, 9,561,125, 9,949,739, 9,867,622, 11,039,840, and PCT Patent Application Nos. PCT / US2022 / 0735096 and PCT / US2022 / 071230, all of which are expressly incorporated by reference in their entirety for all purposes. The external constraint may have at least a proximal region and a distal region. The proximal region may be stiffer than the distal region. The external constraint may attenuate hemodynamic forces at the proximal end of the device.

[0050] All features, elements, components, functions, and steps described with respect to any embodiment provided herein are intended to be freely combinable and interchangeable with those from any other embodiment. When a particular feature, element, component, function, or step is described with respect to only one embodiment, it should be understood that that feature, element, component, function, or step can be used with all other embodiments described herein unless expressly stated otherwise. Accordingly, this paragraph serves as antecedent and antecedent basis and written support for introducing claims that combine features, elements, components, functions, and steps from different embodiments, or that substitute features, elements, components, functions, and steps of one embodiment for those of another embodiment, even if the following description does not explicitly state that such combinations or substitutions are possible in a specific instance. It would clearly be unduly burdensome to explicitly list every possible combination and permutation, especially considering that all such combinations and permutations would be readily apparent to those skilled in the art.

[0051] As used in this specification and the appended claims, the singular forms of the terms "a," "an," and "the" include plural referents unless the context clearly dictates otherwise.

[0052] Aspects of the invention are set out in independent claims and preferred features are set out in dependent claims, the preferred features of which may be provided in combination in a single embodiment and preferred features of one aspect may be provided in conjunction with other aspects.

[0053] While the embodiments are susceptible to various modifications and alternative forms, specific examples thereof have been shown in the drawings and are described in detail herein. It should be understood, however, that these embodiments are not limited to the particular forms disclosed; on the contrary, these embodiments are intended to cover all modifications, equivalents, and alternatives falling within the spirit of the disclosure. Furthermore, any feature, function, step, or element of the embodiments, as well as negative limitations that define the scope of a claim by any feature, function, step, or element not in the scope of the claim, may be recited or added to the claims.

[0054] In the following, various aspects of the present invention are described as a review and / or supplement to the previously described embodiments, with emphasis here on the interrelationships and compatibility of the following embodiments. In other words, emphasis is placed on the fact that each feature of the embodiments can be combined with all other features unless otherwise expressly stated or logically impossible. The embodiments described herein are restated and expanded in the following paragraphs without explicit reference to figures.

[0055] In many embodiments, a device for treating an aneurysm in a patient includes a permeable shell and an external constraint, the permeable shell having a proximal end, a distal end, a radially constrained elongated state configured for intracatheter delivery, and a deployed state, and a plurality of filaments woven together to form a mesh, each of the plurality of filaments having a first end and a second end, each of the plurality of filaments originating at the proximal end of the permeable shell, extending to the distal end of the permeable shell, and extending back to the proximal end of the permeable shell to form an internal compressible mesh structure, the first end and second end of each of the plurality of filaments being gathered into a hub at the first end of the first permeable shell, the external constraint surrounding at least a portion of the internal compressible mesh structure and comprising a variable stiffness along the length of the external constraint.

[0056] In some embodiments, the external constraint includes a proximal portion and a distal portion, and the proximal portion of the external constraint is stiffer than the distal portion of the external constraint.

[0057] In some embodiments, the hub is radiopaque.

[0058] In some embodiments, the device further comprises a marker band around the hub.

[0059] In some embodiments, the external constraint comprises a coil formed from a wire, the coil comprising a proximal portion having a first pitch and a distal portion having a second pitch, the first pitch being narrower than the second pitch.

[0060] In some embodiments, the proximal portion of the coil has a first spring constant and the distal portion has a second spring constant, the first spring constant being lower than the second spring constant. In some embodiments, the proximal portion of the coil has a spring constant between about 0.005 and about 0.015. In some embodiments, the distal portion of the coil has a spring constant between about 0.02 and about 0.07.

[0061] In some embodiments, the first pitch is at least twice the second pitch. In some embodiments, the first pitch is between about 0.01 inches and about 0.03 inches. In some embodiments, the second pitch is between about 0.007 inches and about 0.03 inches.

[0062] In some embodiments, the proximal portion of the coil has a winding angle between about 80 degrees and about 90 degrees, and in some embodiments, the distal portion of the coil has a winding angle between about 45 degrees and about 75 degrees.

[0063] In some embodiments, the second pitch is at least about 10 times the diameter of the wire forming the coil.

[0064] In some embodiments, a first end of the wire is coupled to a proximal region of the internal compressible mesh structure, hi some embodiments, a second end of the wire is coupled to a distal region of the internal compressible mesh structure.

[0065] In some embodiments, the distal end of the permeable shell is everted.

[0066] In some embodiments, the permeable shell has an open end and the inner compressible mesh structure has a lumen in communication with the open end of the permeable shell. In some embodiments, the lumen has a diameter of between about 0.01 and about 0.015 inches.

[0067] In some embodiments, the internal compressible mesh structure extends along a central longitudinal axis of the permeable shell.

[0068] In some embodiments, the proximal portion of the external constraint has a length that is less than about 50% of the overall length of the permeable shell.

[0069] In some embodiments, the proximal portion of the external constraint has a length that is less than about 40% of the overall length of the permeable shell.

[0070] In some embodiments, the distal portion of the external constraint has a length that is less than 50% of the overall length of the permeable shell.

[0071] In some embodiments, the distal portion of the external constraint has a length that is less than 40% of the overall length of the permeable shell.

[0072] In some embodiments, the proximal portion of the external constraint has a length that is less than about 50% of the overall length of the external constraint.

[0073] In some embodiments, the distal portion of the external constraint has a length that is less than 50% of the overall length of the external constraint.

[0074] In some embodiments, the external constraint is a laser-cut hypotube comprising a proximal portion and a distal portion, the proximal portion comprising an opening having a first area and the distal portion comprising an opening having a second area, the first area being smaller than the second area.

[0075] In many embodiments, a method for treating a cerebral aneurysm having an internal cavity and a neck includes advancing an implant within a microcatheter to a region of interest in a cerebral artery, positioning the implant within the cerebral aneurysm, and withdrawing the microcatheter from the region of interest after positioning the implant, wherein the implant includes a permeable shell and an external restraint, the permeable shell having a proximal end, a distal end, a radially constrained elongated state configured for delivery within a catheter lumen, a deployed state, and a plurality of filaments woven together to form a mesh. each of the plurality of filaments having a first end and a second end, each of the plurality of filaments originating at a proximal end of the permeable shell, extending to a distal end of the permeable shell, and extending back to the proximal end of the permeable shell to form an internal compressible mesh structure, the external constraint being around at least a portion of the internal compressible mesh structure, the external constraint having variable stiffness along a length of the external constraint and a hub at the proximal end of the permeable shell, the first end and the second end of each of the plurality of filaments being retained by a marker band, and the permeable shell expanding to a deployed state within the lumen of the aneurysm.

[0076] In some embodiments, the external constraint comprises a proximal portion and a distal portion, and the proximal portion of the external constraint is stiffer than the distal portion of the external constraint.

[0077] In some embodiments, the hub is radiopaque.

[0078] In some embodiments, the device further comprises a marker band around the hub.

[0079] In some embodiments, the external constraint comprises a coil formed from a wire, the coil comprising a proximal portion having a first pitch and a distal portion having a second pitch, the first pitch being narrower than the second pitch.

[0080] In some embodiments, the proximal portion of the coil has a first spring constant and the distal portion has a second spring constant, the first spring constant being lower than the second spring constant. In some embodiments, the proximal portion of the coil has a spring constant between about 0.005 and about 0.015. In some embodiments, the distal portion of the coil has a spring constant between about 0.02 and about 0.07.

[0081] In some embodiments, the first pitch is at least twice the second pitch.

[0082] In some embodiments, the first pitch is between about 0.01 and about 0.03 inches.

[0083] In some embodiments, the second pitch is between about 0.007 and about 0.03 inches.

[0084] In some embodiments, the proximal portion of the coil has a winding angle between about 80 degrees and about 90 degrees.

[0085] In some embodiments, the distal portion of the coil has a winding angle between about 45 degrees and about 75 degrees.

[0086] In some embodiments, the second pitch is at least about 10 times the diameter of the wire forming the coil.

[0087] In some embodiments, a first end of the wire is coupled to a proximal region of the internal compressible mesh structure.

[0088] In some embodiments, the second end of the wire is coupled to a distal region of the inner compressible mesh structure.

[0089] In some embodiments, the distal end of the permeable shell is everted.

[0090] In some embodiments, the permeable shell has an open end and the inner compressible mesh structure has an inner lumen in communication with the open end of the permeable shell. In some embodiments, the inner lumen has a diameter of between about 0.01 and about 0.015 inches.

[0091] In some embodiments, the internal compressible mesh structure extends along a central longitudinal axis of the permeable shell.

[0092] In some embodiments, the proximal portion of the external constraint has a length that is less than about 50% of the overall length of the permeable shell.

[0093] In some embodiments, the proximal portion of the external constraint has a length that is less than about 40% of the overall length of the permeable shell.

[0094] In some embodiments, the distal portion of the external constraint has a length that is less than 50% of the overall length of the permeable shell.

[0095] In some embodiments, the distal portion of the external constraint has a length that is less than 40% of the overall length of the permeable shell.

[0096] In some embodiments, the proximal portion of the external constraint has a length that is less than about 50% of the overall length of the external constraint.

[0097] In some embodiments, the distal portion of the external constraint has a length that is less than 50% of the overall length of the external constraint.

[0098] In some embodiments, the external constraint is a laser-cut hypotube comprising a proximal portion and a distal portion, the proximal portion comprising an opening having a first area and the distal portion comprising an opening having a second area, the first area being smaller than the second area.

[0099] In many embodiments, a device for treating an aneurysm in a patient includes a permeable shell and a restraining means, the permeable shell having a proximal end, a distal end, a radially constrained elongated state configured for intracatheter delivery, a deployed state, and a plurality of filaments woven together to form a mesh, each of the plurality of filaments having a first end and a second end, each of the plurality of filaments originating at the proximal end of the permeable shell, extending to the distal end of the permeable shell, and extending back to the proximal end of the permeable shell to form an internal compressible mesh structure, the first end and second end of each of the plurality of filaments being gathered into a hub at the first end of the first permeable shell, and the restraining means being for positioning around at least a portion of the internal compressible mesh structure to attenuate hemodynamic forces at the proximal end of the permeable shell.

[0100] In some embodiments, the restraining means comprises a proximal portion and a distal portion, the proximal portion of the restraining means being stiffer than the distal portion of the external restraint.

[0101] In some embodiments, the restraining means is a coil having variable stiffness.

[0102] In some embodiments, the formed coil is formed from a wire, and the coil includes a proximal portion having a first pitch and a distal portion having a second pitch, the first pitch being narrower than the second pitch.

[0103] In some embodiments, the proximal portion of the coil has a first spring constant and the distal portion has a second spring constant, the first spring constant being lower than the second spring constant.

[0104] In some embodiments, the proximal portion of the coil has a spring constant between about 0.005 and about 0.015.

[0105] In some embodiments, the distal portion of the coil has a spring constant between about 0.02 and about 0.07.

[0106] In some embodiments, the first pitch is at least twice the second pitch.

[0107] In some embodiments, the first pitch is between about 0.01 and about 0.03 inches.

[0108] In some embodiments, the second pitch is between about 0.007 and about 0.03 inches.

[0109] In some embodiments, the proximal portion of the coil has a winding angle between about 80 and about 90 degrees.

[0110] In some embodiments, the distal portion of the coil has a winding angle of between about 45 and about 75 degrees.

[0111] In some embodiments, the restraining means is a hypotube with variable stiffness.

[0112] In some embodiments, the hypotube is laser cut to have a plurality of openings.

[0113] (Clause) Exemplary embodiments are presented in the following consecutively numbered sections:

[0114] (Section 1) 1. A device for treating an aneurysm in a patient, comprising: a permeable shell and an external restraint; the permeable shell has a proximal end, a distal end, a radially constrained elongated state configured for delivery within a catheter lumen, and a deployed state; and a plurality of filaments woven together to form a mesh, each of the plurality of filaments having a first end and a second end, each of the plurality of filaments originating at the proximal end of the permeable shell, extending to the distal end of the permeable shell, and extending back to the proximal end of the permeable shell to form an internal compressible mesh structure, the first end and the second end of each of the plurality of filaments being gathered into a hub at the first end of the first permeable shell; the external constraint is around at least a portion of the internal compressible mesh structure and includes a variable stiffness along a length of the external constraint. device.

[0115] (Section 2) Item 1. The device of item 1, wherein the external constraint includes a proximal portion and a distal portion, and the proximal portion of the external constraint is stiffer than the distal portion of the external constraint.

[0116] (Section 3) Item 1, wherein the hub is radiopaque.

[0117] (Section 4) Item 1. The device of item 1, further comprising a marker band around the hub.

[0118] (Section 5) Item 1. The device of item 1, wherein the external constraint includes a coil formed from wire, the coil including a proximal portion having a first pitch and a distal portion having a second pitch, the first pitch being narrower than the second pitch.

[0119] (Section 6) Item 6. The device of item 5, wherein the proximal portion of the coil has a first spring constant and the distal portion has a second spring constant, the first spring constant being lower than the second spring constant.

[0120] (Section 7) 7. The device of paragraph 6, wherein the proximal portion of the coil has a spring constant between about 0.005 and about 0.015.

[0121] (Section 8) 7. The device of clause 6, wherein the distal portion of the coil has a spring constant between about 0.02 and about 0.07.

[0122] (Section 9) Item 6. The device of item 5, wherein the first pitch is at least twice the second pitch.

[0123] (Section 10) Item 6. The device of item 5, wherein the first pitch is between about 0.01 and about 0.03 inches.

[0124] (Section 11) Item 6. The device of item 5, wherein the second pitch is between about 0.007 and about 0.03 inches.

[0125] (Section 12) Item 6. The device of item 5, wherein the proximal portion of the coil has a winding angle of between about 80 degrees and about 90 degrees.

[0126] (Section 13) Item 6. The device of item 5, wherein the distal portion of the coil has a winding angle of between about 45 degrees and about 75 degrees.

[0127] (Section 14) Item 6. The device of item 5, wherein the second pitch is at least 10 times the diameter of the wire forming the coil.

[0128] (Section 15) Item 6. The device of item 5, wherein a first end of the wire is coupled to a proximal region of the internal compressible mesh structure.

[0129] (Section 16) Item 6. The device of item 5, wherein the second end of the wire is coupled to a distal region of the internal compressible mesh structure.

[0130] (Section 17) Item 1. The device of item 1, wherein the distal end of the permeable shell is inverted.

[0131] (Section 18) Item 1. The device described in item 1, wherein the permeable shell has an open end and the internal compressible mesh structure has an inner lumen that communicates with the open end of the permeable shell.

[0132] (Section 19) 20. The device of paragraph 18, wherein the lumen has a diameter of between about 0.01 and about 0.015 inches.

[0133] (Section 20) Item 1. The device described in item 1, wherein the internal compressible mesh structure extends along the central longitudinal axis of the permeable shell.

[0134] (Section 21) Item 1. The device described in item 1, wherein the proximal portion of the external constraint has a length that is less than about 50% of the total length of the permeable shell.

[0135] (Section 22) Item 1. The device described in item 1, wherein the proximal portion of the external constraint has a length that is less than about 40% of the total length of the permeable shell.

[0136] (Section 23) Item 1. The device described in item 1, wherein the distal portion of the external constraint has a length that is less than 50% of the total length of the permeable shell.

[0137] (Section 24) Item 1. The device described in item 1, wherein the distal portion of the external constraint has a length that is less than 40% of the total length of the permeable shell.

[0138] (Section 25) Item 1. The device described in item 1, wherein the proximal portion of the external constraint has a length that is less than 50% of the total length of the permeable shell.

[0139] (Section 26) Item 1. The device of item 1, wherein the distal portion of the external constraint has a length that is less than 50% of the total length of the external constraint.

[0140] (Section 27) Item 1. The device of item 1, wherein the external restraint is a laser-cut hypotube, the hypotube having a proximal portion and a distal portion, the proximal portion including an opening having a first area and the distal portion including an opening having a second area, the first area being smaller than the second area.

[0141] (Section 28) 1. A method for treating a cerebral aneurysm having a lumen and a neck, comprising: advancing the implant within the microcatheter to a region of interest within a cerebral artery; placing the implant within the cerebral aneurysm; and withdrawing the microcatheter from the region of interest after placing the implant; the implant comprises a permeable shell and an external constraint; the permeable shell includes a proximal end, a distal end, a radially constrained elongated state configured for delivery within a catheter lumen, a deployed state, and a plurality of filaments interwoven together to form a mesh, each of the plurality of filaments having a first end and a second end, each of the plurality of filaments originating at the proximal end of the permeable shell, extending to the distal end of the permeable shell, and extending back to the proximal end of the permeable shell to form an internal compressible mesh structure; the external constraint is around at least a portion of the internal compressible mesh structure and includes a variable stiffness along a length of the external constraint and a hub at a proximal end of the permeable shell, and a first end and a second end of each of the plurality of filaments are retained in the marker band; The permeable shell expands to a deployed state within the lumen of the aneurysm. method.

[0142] (Section 29) 29. The method of claim 28, wherein the external constraint includes a proximal portion and a distal portion, and the proximal portion of the external constraint is stiffer than the distal portion of the external constraint.

[0143] (Section 30) 29. The method of claim 28, wherein the hub is radiopaque.

[0144] (Section 31) 29. The method of claim 28, wherein the device further comprises a marker band around the hub.

[0145] (Section 32) 29. The method of claim 28, wherein the external constraint includes a coil formed from a wire, the coil including a proximal portion having a first pitch and a distal portion having a second pitch, the first pitch being narrower than the second pitch.

[0146] (Section 33) 33. The method of claim 32, wherein a proximal portion of the coil has a first spring constant and a distal portion of the coil has a second spring constant, the first spring constant being lower than the second spring constant.

[0147] (Section 34) 34. The method of claim 33, wherein the proximal portion of the coil has a spring constant between about 0.005 and about 0.015.

[0148] (Section 35) 34. The method of claim 33, wherein the distal portion of the coil has a spring constant between about 0.02 and about 0.07.

[0149] (Section 36) 33. The method of claim 32, wherein the first pitch is at least twice the second pitch.

[0150] (Section 37) 33. The method of claim 32, wherein the first pitch is between about 0.01 and about 0.03 inches.

[0151] (Section 38) 33. The method of claim 32, wherein the second pitch is between about 0.007 and about 0.03 inches.

[0152] (Section 39) 33. The method of claim 32, wherein the proximal portion of the coil has a winding angle between about 80 degrees and about 90 degrees.

[0153] (Section 40) 33. The method of claim 32, wherein the distal portion of the coil has a winding angle between about 45 degrees and about 75 degrees.

[0154] (Section 41) 33. The method of claim 32, wherein the second pitch is at least about 10 times the diameter of the wire forming the coil.

[0155] (Section 42) 33. The method of claim 32, wherein a first end of the wire is coupled to a proximal region of the internal compressible mesh structure.

[0156] (Section 43) 33. The method of claim 32, wherein a second end of the wire is coupled to a distal region of the internal compressible mesh structure.

[0157] (Section 44) 29. The method of claim 28, wherein the distal end of the permeable shell is inverted.

[0158] (Section 45) 29. The method of claim 28, wherein the permeable shell has an open end and the internal compressible mesh structure has an internal lumen in communication with the open end of the permeable shell.

[0159] (Section 46) 46. ​​The method of claim 45, wherein the lumen has a diameter of between about 0.01 and about 0.015 inches.

[0160] (Section 47) 29. The method of claim 28, wherein the internal compressible mesh structure extends along a central longitudinal axis of the permeable shell.

[0161] (Section 48) 29. The method of claim 28, wherein the proximal portion of the external constraint is less than about 50% of the total length of the permeable shell.

[0162] (Section 49) 29. The method of claim 28, wherein the proximal portion of the external constraint has a length that is less than about 40% of the total length of the permeable shell.

[0163] (Section 50) 29. The method of claim 28, wherein the distal portion of the external constraint has a length that is less than 50% of the total length of the permeable shell.

[0164] (Section 51) 29. The method of claim 28, wherein the distal portion of the external constraint has a length that is less than 40% of the total length of the permeable shell.

[0165] (Section 52) 29. The method of claim 28, wherein the proximal portion of the external constraint has a length that is less than 50% of the total length of the external constraint.

[0166] (Section 53) 29. The method of claim 28, wherein the distal portion of the external constraint has a length that is less than 50% of the total length of the external constraint.

[0167] (Section 54) 29. The method of claim 28, wherein the external constraint is a laser-cut hypotube including a proximal portion and a distal portion, the proximal portion including an opening having a first area and the distal portion including an opening having a second area, the first area being smaller than the second area.

[0168] (Section 55) 1. A device for treating an aneurysm in a patient, comprising: a permeable shell and a restraining means; the permeable shell has a proximal end, a distal end, a radially constrained elongated state configured for delivery within a catheter lumen, and a deployed state; and a plurality of filaments woven together to form a mesh, each of the plurality of filaments having a first end and a second end, each of the plurality of filaments originating at the proximal end of the permeable shell, extending to the distal end of the permeable shell, and extending back to the proximal end of the permeable shell to form an internal compressible mesh structure, the first end and the second end of each of the plurality of filaments being gathered into a hub at the first end of the first permeable shell; the restraining means being for positioning around at least a portion of the interior compressible mesh structure for attenuating hemodynamic forces at the proximal end of the permeable shell. device.

[0169] (Section 56) 56. The device of clause 55, wherein the restraining means includes a proximal portion and a distal portion, the proximal portion of the restraining means being stiffer than the distal portion of the external restraint.

[0170] (Section 57) 56. The device of clause 55, wherein the restraining means is a coil having variable stiffness.

[0171] (Section 58) 58. The device of claim 57, wherein the formed coil is formed from wire, the coil including a proximal portion having a first pitch and a distal portion having a second pitch, the first pitch being narrower than the second pitch.

[0172] (Section 59) 59. The device of clause 58, wherein the proximal portion of the coil has a first spring constant and the distal portion has a second spring constant, the first spring constant being lower than the second spring constant.

[0173] (Section 60) 59. The device of clause 58, wherein the proximal portion of the coil has a spring constant between about 0.005 and about 0.015.

[0174] (Section 61) 59. The device of clause 58, wherein the distal portion of the coil has a spring constant between about 0.02 and about 0.07.

[0175] (Section 62) 59. The device of clause 58, wherein the first pitch is at least twice the second pitch.

[0176] (Section 63) Item 59. The device of paragraph 58, wherein the first pitch is between about 0.01 and about 0.03 inches.

[0177] (Section 64) Item 59. The device of paragraph 58, wherein the second pitch is between about 0.007 and about 0.03 inches.

[0178] (Section 65) 59. The device of paragraph 58, wherein the proximal portion of the coil has a winding angle of between about 80 and about 90 degrees.

[0179] (Section 66) 59. The device of paragraph 58, wherein the distal portion of the coil has a winding angle of between about 45 and about 75 degrees.

[0180] (Section 67) 58. The device of claim 57, wherein the restraining means is a hypotube having variable stiffness.

[0181] (Section 68) 68. The device of clause 67, wherein the hypotube is laser cut to have a plurality of openings.

Claims

1. 1. A device for treating an aneurysm in a patient, comprising: a permeable shell and an external restraint; the permeable shell has a proximal end, a distal end, a radially constrained elongated state configured for delivery within a catheter lumen, and a deployed state; and a plurality of filaments woven together to form a mesh, each of the plurality of filaments having a first end and a second end, each of the plurality of filaments originating at the proximal end of the permeable shell, extending to the distal end of the permeable shell, and extending back to the proximal end of the permeable shell to form an internal compressible mesh structure, the first end and the second end of each of the plurality of filaments being gathered into a hub at the first end of the first permeable shell; the external constraint is around at least a portion of the internal compressible mesh structure and includes a variable stiffness along a length of the external constraint. device.

2. The device of claim 1 , wherein the external constraint includes a proximal portion and a distal portion, the proximal portion of the external constraint being stiffer than the distal portion of the external constraint.

3. The device of claim 1 , wherein the hub is radiopaque.

4. The device of claim 1 further comprising a marker band around the hub.

5. 10. The device of claim 1, wherein the external constraint comprises a coil formed from wire, the coil comprising a proximal portion having a first pitch and a distal portion having a second pitch, the first pitch being narrower than the second pitch.

6. 6. The device of claim 5, wherein the proximal portion of the coil has a first spring constant and the distal portion has a second spring constant, the first spring constant being lower than the second spring constant.

7. 7. The device of claim 6, wherein the proximal portion of the coil has a spring constant between about 0.005 and about 0.

015.

8. 7. The device of claim 6, wherein the distal portion of the coil has a spring constant between about 0.02 and about 0.

07.

9. The device of claim 5 , wherein the first pitch is at least twice the second pitch.

10. 6. The device of claim 5, wherein the first pitch is between about 0.01 and about 0.03 inches.

11. 6. The device of claim 5, wherein the second pitch is between about 0.007 and about 0.03 inches.

12. 6. The device of claim 5, wherein the proximal portion of the coil has a winding angle of between about 80 degrees and about 90 degrees.

13. 6. The device of claim 5, wherein the distal portion of the coil has a winding angle of between about 45 degrees and about 75 degrees.

14. 6. The device of claim 5, wherein the second pitch is at least 10 times the diameter of the wire forming the coil.

15. The device of claim 5 , wherein a first end of the wire is coupled to a proximal region of the internal compressible mesh structure.

16. The device of claim 5 , wherein a second end of the wire is coupled to a distal region of the internal compressible mesh structure.

17. The device of claim 1 , wherein the distal end of the permeable shell is everted.

18. 10. The device of claim 1, wherein the permeable shell has an open end and the internal compressible mesh structure has an inner lumen in communication with the open end of the permeable shell.

19. 20. The device of claim 18, wherein the lumen has a diameter of between about 0.01 and about 0.015 inches.

20. The device of claim 1 , wherein the internal compressible mesh structure extends along a central longitudinal axis of the permeable shell.

21. The device of claim 1 , wherein the proximal portion of the external constraint has a length that is less than about 50% of the overall length of the permeable shell.

22. The device of claim 1 , wherein the proximal portion of the external constraint has a length that is less than about 40% of the overall length of the permeable shell.

23. The device of claim 1 , wherein the distal portion of the external constraint has a length that is less than 50% of the overall length of the permeable shell.

24. The device of claim 1 , wherein the distal portion of the external constraint has a length that is less than 40% of the overall length of the permeable shell.

25. The device of claim 1 , wherein the proximal portion of the external constraint has a length that is less than 50% of the overall length of the permeable shell.

26. The device of claim 1 , wherein the distal portion of the external constraint has a length that is less than 50% of the total length of the external constraint.

27. 2. The device of claim 1, wherein the external restraint is a laser cut hypotube, the hypotube having a proximal portion and a distal portion, the proximal portion including an opening having a first area and the distal portion including an opening having a second area, the first area being smaller than the second area.

28. 1. A method for treating a cerebral aneurysm having a lumen and a neck, comprising: advancing the implant within the microcatheter to a region of interest within a cerebral artery; placing the implant within the cerebral aneurysm; and withdrawing the microcatheter from the region of interest after placing the implant; the implant comprises a permeable shell and an external constraint; the permeable shell includes a proximal end, a distal end, a radially constrained elongated state configured for delivery within a catheter lumen, a deployed state, and a plurality of filaments interwoven together to form a mesh, each of the plurality of filaments having a first end and a second end, each of the plurality of filaments originating at the proximal end of the permeable shell, extending to the distal end of the permeable shell, and extending back to the proximal end of the permeable shell to form an internal compressible mesh structure; the external constraint is around at least a portion of the internal compressible mesh structure and includes a variable stiffness along a length of the external constraint and a hub at a proximal end of the permeable shell, and a first end and a second end of each of the plurality of filaments are retained in the marker band; The permeable shell expands to a deployed state within the lumen of the aneurysm. method.

29. 30. The method of claim 28, wherein the external constraint includes a proximal portion and a distal portion, the proximal portion of the external constraint being stiffer than the distal portion of the external constraint.

30. 30. The method of claim 28, wherein the hub is radiopaque.

31. 30. The method of claim 28, wherein the device further comprises a marker band around the hub.

32. 30. The method of claim 28, wherein the external constraint comprises a coil formed from wire, the coil comprising a proximal portion having a first pitch and a distal portion having a second pitch, the first pitch being narrower than the second pitch.

33. 33. The method of claim 32, wherein a proximal portion of the coil has a first spring constant and a distal portion of the coil has a second spring constant, the first spring constant being lower than the second spring constant.

34. 34. The method of claim 33, wherein the proximal portion of the coil has a spring constant between about 0.005 and about 0.

015.

35. 34. The method of claim 33, wherein the distal portion of the coil has a spring constant between about 0.02 and about 0.

07.

36. 33. The method of claim 32, wherein the first pitch is at least twice the second pitch.

37. 33. The method of claim 32, wherein the first pitch is between about 0.01 and about 0.03 inches.

38. 33. The method of claim 32, wherein the second pitch is between about 0.007 and about 0.03 inches.

39. 33. The method of claim 32, wherein the proximal portion of the coil has a winding angle between about 80 degrees and about 90 degrees.

40. 33. The method of claim 32, wherein the distal portion of the coil has a winding angle between about 45 degrees and about 75 degrees.

41. 33. The method of claim 32, wherein the second pitch is at least about 10 times the diameter of the wire forming the coil.

42. 33. The method of claim 32, wherein a first end of the wire is coupled to a proximal region of the internal compressible mesh structure.

43. 33. The method of claim 32, wherein a second end of the wire is coupled to a distal region of the internal compressible mesh structure.

44. 30. The method of claim 28, wherein the distal end of the permeable shell is inverted.

45. 30. The method of claim 28, wherein the permeable shell has an open end and the internal compressible mesh structure has an inner lumen in communication with the open end of the permeable shell.

46. 46. ​​The method of claim 45, wherein the lumen has a diameter of between about 0.01 and about 0.015 inches.

47. 30. The method of claim 28, wherein the internal compressible mesh structure extends along a central longitudinal axis of the permeable shell.

48. 30. The method of claim 28, wherein the proximal portion of the external constraint is less than about 50% of the total length of the permeable shell.

49. 30. The method of claim 28, wherein the proximal portion of the external constraint has a length that is less than about 40% of the overall length of the permeable shell.

50. 30. The method of claim 28, wherein the distal portion of the external constraint has a length that is less than 50% of the overall length of the permeable shell.

51. 30. The method of claim 28, wherein the distal portion of the external constraint has a length that is less than 40% of the overall length of the permeable shell.

52. 30. The method of claim 28, wherein the proximal portion of the external constraint has a length that is less than 50% of the total length of the external constraint.

53. 30. The method of claim 28, wherein the distal portion of the external constraint has a length that is less than 50% of the total length of the external constraint.

54. 29. The method of claim 28, wherein the external constraint is a laser-cut hypotube including a proximal portion and a distal portion, the proximal portion including an opening having a first area and the distal portion including an opening having a second area, the first area being smaller than the second area.

55. 1. A device for treating an aneurysm in a patient, comprising: a permeable shell and a restraining means; the permeable shell has a proximal end, a distal end, a radially constrained elongated state configured for delivery within a catheter lumen, and a deployed state; and a plurality of filaments woven together to form a mesh, each of the plurality of filaments having a first end and a second end, each of the plurality of filaments originating at the proximal end of the permeable shell, extending to the distal end of the permeable shell, and extending back to the proximal end of the permeable shell to form an internal compressible mesh structure, the first end and the second end of each of the plurality of filaments being gathered into a hub at the first end of the first permeable shell; the restraining means being for positioning around at least a portion of the interior compressible mesh structure for attenuating hemodynamic forces at the proximal end of the permeable shell. device.

56. 56. The device of claim 55, wherein the restraining means includes a proximal portion and a distal portion, the proximal portion of the restraining means being stiffer than the distal portion of the external restraint.

57. 56. The device of claim 55, wherein the restraining means is a coil having variable stiffness.

58. 58. The device of claim 57, wherein the formed coil is formed from wire, the coil including a proximal portion having a first pitch and a distal portion having a second pitch, the first pitch being narrower than the second pitch.

59. 59. The device of claim 58, wherein a proximal portion of the coil has a first spring constant and a distal portion has a second spring constant, the first spring constant being lower than the second spring constant.

60. 59. The device of claim 58, wherein the proximal portion of the coil has a spring constant of between about 0.005 and about 0.

015.

61. 59. The device of claim 58, wherein the distal portion of the coil has a spring constant of between about 0.02 and about 0.

07.

62. 60. The device of claim 58, wherein the first pitch is at least twice the second pitch.

63. 59. The device of claim 58, wherein the first pitch is between about 0.01 and about 0.03 inches.

64. 59. The device of claim 58, wherein the second pitch is between about 0.007 and about 0.03 inches.

65. 59. The device of claim 58, wherein the proximal portion of the coil has a winding angle of between about 80 and about 90 degrees.

66. 60. The device of claim 58, wherein the distal portion of the coil has a winding angle of between about 45 and about 75 degrees.

67. 58. The device of claim 57, wherein the restraining means is a hypotube having variable stiffness.

68. 68. The device of claim 67, wherein the hypotube is laser cut to have a plurality of openings.

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