Systems and methods for treating aneurysms

Abstract

The invention relates to systems and methods for treating aneurysms. Specifically, the present invention relates to a device for treating an aneurysm, comprising an occlusion element configured to be releasably coupled to an elongate delivery shaft and having a distal end, a proximal end, and a longitudinal axis extending between the distal end and the proximal end, the occlusive element is configured to be delivered in a contracted configuration and further configured to be expanded to an expanded configuration, the occlusive element comprising a flipping mesh tube having an outer layer and an inner layer, the outer layer transitioning to the inner layer at a flipping fold at or adjacent a distal end of the occlusive element, the flipping fold defining an inner diameter, the occluding element further includes a maximum outer diameter wherein the inner diameter is between about 35% and about 85% of the maximum outer diameter, and wherein the outer diameter of the occluding element increases along the longitudinal axis to the maximum outer diameter.

Description

[0001] This application is a divisional application of Chinese patent application No. 202080045996.1, entitled “System and Method for Treating Aneurysms”, filed on May 25, 2020. Background of the Invention Technical Field

[0003] The field of the invention generally relates to embolic devices for filling spaces in vascular systems, including cerebral aneurysms or left atrial appendages. In some cases, the embolic devices can be used to embolize native blood vessels. Background Art

[0004] Embolization devices may be used as stand-alone devices for occlusions and aneurysms, or may be used with auxiliary devices or materials. Summary of the invention

[0005] In one embodiment of the present disclosure, a device for treating an aneurysm in a blood vessel includes an occlusion element (occlusion element, blocking element, occlusion element), which is constructed to be releasably coupled to an elongate delivery shaft (elongated delivery shaft) and has a distal end, a proximal end and a longitudinal axis (longitudinal axis) extending between the distal end and the proximal end, the occlusion element includes an inverted mesh tube having an outer layer and an inner layer, the outer layer transitions to the inner layer at an inverted fold, the inverted fold defines a first inner diameter, the inner layer defines a maximum inner diameter, and the outer layer defines a maximum outer diameter, the maximum inner diameter and the maximum outer diameter are both located in a first plane transverse to the longitudinal axis, and the first inner diameter is located in a second plane transverse to the longitudinal axis.

[0006] In another embodiment of the present disclosure, a device for treating an aneurysm in a blood vessel includes an occluding element configured to be releasably coupled to an elongated delivery shaft and having a distal end, a proximal end, and a longitudinal axis extending between the distal end and the proximal end, the occluding element configured to be delivered in a collapsed configuration through a lumen of a delivery catheter, the lumen having a proximal end and a distal end, the occluding element further configured to expand into an expanded configuration when advanced out of the distal end of the lumen of the delivery catheter and into the aneurysm, the occluding element comprising an everted mesh tube having an outer layer and an inner layer, the outer layer transitioning to the inner layer at an everted fold located at or adjacent to the distal end of the occluding element, the everted fold defining an inner diameter, the occluding element further comprising a maximum outer diameter, wherein the inner diameter is between about 35% and about 85% of the maximum outer diameter, and wherein the outer diameter of the occluding element increases along the longitudinal axis to the maximum outer diameter.

[0007] In another embodiment of the present disclosure, a device for treating an aneurysm in a blood vessel includes an occlusive element configured to be releasably coupled to an elongated delivery shaft, the occlusive element including a cap having a mesh material and configured to be delivered in a collapsed configuration through a lumen of a delivery catheter, the lumen having a proximal end and a distal end, the cap further configured to expand to an expanded configuration when advanced out of the distal end of the lumen of the delivery catheter and into the aneurysm, wherein the cap includes a diameter greater than a diameter or a maximum transverse dimension of a neck of the aneurysm, and wherein the cap includes a distal concave surface configured to face away from the neck of the aneurysm; and a first tubular mesh having a first end, a second end, a wall, and a cavity, the first end and the second end of the first tubular mesh being coupled to a central portion (central portion) of the cap. The invention relates to a first tubular mesh having a first tubular mesh and a first and second tubular mesh having a first and second ends, wherein the first tubular mesh has a first and second ends, such that the middle portion of the first tubular mesh between the first end and the second end includes a substantially 180 degree turn, the middle portion of the first tubular mesh extending from the distal concave surface of the cap, wherein the middle portion of the first tubular mesh has a contracted structure configured to be delivered through the lumen of a delivery catheter, and wherein the middle portion of the first tubular mesh is configured to expand to an expanded structure when advanced out of the distal end of the lumen of the delivery catheter and into the aneurysm.

[0008] In another embodiment of the present disclosure, a device for treating an aneurysm in a blood vessel includes an occlusive element configured to be releasably coupled to an elongated delivery shaft, the occlusive element including a cap having a mesh material and configured to be delivered in a contracted configuration through a lumen of a delivery catheter, the lumen having a proximal end and a distal end, the cap further configured to expand to an expanded configuration when advanced out of the distal end of the lumen of the delivery catheter and into the aneurysm, wherein the cap includes a diameter greater than a diameter or a maximum transverse dimension of a neck of the aneurysm; a first tubular mesh having a first end, a second end, a wall, and a cavity, the first end and the second end of the first tubular mesh being coupled to a central portion of the cap such that a midsection between the first end and the second end of the first tubular mesh includes a substantially 180 degree turn, the midsection of the first tubular mesh being recessed from the distal end of the cap. The invention relates to a cap comprising a first tubular mesh extending from a concave surface of the cap, wherein a middle portion of the first tubular mesh has a contracted structure configured to be delivered through an inner cavity of a delivery catheter, and wherein the middle portion of the first tubular mesh is configured to expand to an expanded structure when it advances out of the distal end of the inner cavity of the delivery catheter and into the aneurysm; and a second tubular mesh having a first end, a second end, a wall and a cavity, the first end and the second end of the second tubular mesh being coupled to the central portion of the cap so that the middle portion of the second tubular mesh between the first end and the second end includes a substantially 180 degree turn, the middle portion of the second tubular mesh extending from the distal concave surface of the cap, wherein the middle portion of the second tubular mesh has a contracted structure configured to be delivered through an inner cavity of a delivery catheter, and wherein the middle portion of the second tubular mesh is configured to expand to an expanded structure when it advances out of the distal end of the inner cavity of the delivery catheter and into the aneurysm.

[0009] In another embodiment of the present disclosure, a device for treating an aneurysm in a blood vessel includes an occlusive element configured to be releasably coupled to an elongated delivery shaft, the occlusive element including a cover having a mesh material and configured to be delivered in a contracted structure through an inner cavity of a delivery catheter, the inner cavity having a proximal end and a distal end, the cover further configured to expand to an expanded structure when advancing out of the distal end of the inner cavity of the delivery catheter and into the aneurysm, wherein the cover in the expanded structure has a transverse dimension greater than the maximum transverse dimension of the neck of the aneurysm; and a first tubular mesh having a first end, a second end, a wall and a cavity, the first end and the second end of the first tubular mesh being coupled to a central portion of the cover so that a middle portion of the first tubular mesh between the first end and the second end includes a substantially 180 degree turn, the middle portion of the first tubular mesh extending from the central portion of the cover to the distal end, wherein the middle portion of the first tubular mesh has a contracted structure configured to be delivered through the inner cavity of the delivery catheter, and wherein the middle portion of the first tubular mesh is configured to expand to an expanded structure when advancing out of the distal end of the inner cavity of the delivery catheter and into the aneurysm.

[0010] In another embodiment of the present disclosure, a device for treating an aneurysm in a blood vessel includes an occluding element configured to be releasably coupled to an elongated delivery shaft, the occluding element comprising a first tubular mesh having a first end, a second end, a wall, and a cavity, the first end and the second end of the first tubular mesh being coupled together at a proximal end of the occluding element such that a middle portion of the first tubular mesh between the first end and the second end comprises a substantially 180 degree turn, the middle portion of the first tubular mesh extending from the proximal end to the distal end of the occluding element, wherein the middle portion of the first tubular mesh has a contracted structure configured to be delivered through an inner lumen of a delivery catheter, and wherein the middle portion of the first tubular mesh is configured to expand to an expanded structure when advanced out of the distal end of the inner lumen of the delivery catheter and into the aneurysm. In some embodiments, the device also includes a second tubular mesh having a first end, a second end, a wall and a cavity, the first end and the second end of the second tubular mesh being coupled to the proximal end of the occluding element such that a middle portion of the second tubular mesh between the first end and the second end includes a substantially 180 degree turn, the middle portion of the second tubular mesh extending from the proximal end to the distal end of the occluding element, wherein the middle portion of the second tubular mesh has a contracted structure configured to be delivered through the lumen of a delivery catheter, and wherein the middle portion of the second tubular mesh is configured to expand to an expanded structure when advanced out of the distal end of the lumen of the delivery catheter and into the aneurysm.

[0011] In another embodiment of the present disclosure, a device for treating an aneurysm in a blood vessel includes an occluding element constructed to be releasably coupled to an elongated delivery shaft, the occluding element including a mesh body constructed to be delivered in a contracted structure through an inner cavity of a delivery catheter, the inner cavity having a proximal end and a distal end, the body further constructed to expand to an expanded structure when advancing out of the distal end of the inner cavity of the delivery catheter and into the aneurysm, wherein the body includes a proximal portion having a proximal maximum transverse dimension A and a distal maximum transverse dimension B and a truncated conical portion extending between the proximal maximum transverse dimension A and the distal maximum transverse dimension B, and wherein the body further includes a distal portion having a maximum transverse dimension C and a waist located between the proximal portion and the distal portion, and wherein dimension A is between about 50% and about 100% of dimension B.

[0012] In another embodiment of the present disclosure, a device for treating an aneurysm in a blood vessel includes an occluding element configured to be releasably coupled to an elongated delivery shaft, the occluding element comprising an everted mesh tube having an outer layer and an inner layer, the outer layer transitioning to the inner layer at an everted fold, wherein at least the outer layer forms an expanded shape having a proximal portion having a first diameter, a distal portion having a second diameter, and a waist having a third diameter, wherein the third diameter is smaller than the first diameter and the third diameter is smaller than the second diameter.

[0013] In yet another embodiment of the present disclosure, a device for treating an aneurysm in a blood vessel comprises an occluding element constructed to be releasably coupled to an elongated delivery shaft, the occluding element comprising an everted mesh tube having an outer layer and an inner layer, the outer layer transitioning to the inner layer at an everted fold, wherein at least the outer layer forms an expanded shape having a proximal portion having a first diameter, a distal portion having a second diameter and a first waist having a third diameter, a middle section having a fourth diameter and a second waist having a fifth diameter, wherein the first diameter, the second diameter and the fourth diameter are each larger than the third diameter, and wherein the first diameter, the second diameter and the fourth diameter are each larger than the fifth diameter.

[0014] In yet another embodiment of the present disclosure, a method of forming a device for treating an aneurysm in a blood vessel includes forming a mesh tube, flipping the mesh tube to form an outer layer and an inner layer, the outer layer transitioning to the inner layer at a flip fold, forming at least the outer layer into an expanded shape having a proximal portion having a first diameter and a distal portion having a second diameter, and etching the distal portion to reduce its stiffness.

[0015] In yet another embodiment of the present disclosure, a device for treating an aneurysm in a blood vessel includes an occluding element configured to be releasably coupled to an elongated delivery shaft, the occluding element including an everted mesh tube having an outer layer and an inner layer, the outer layer transitioning to the inner layer at an everted fold, the occluding element being configured to be delivered in a contracted configuration through an inner lumen of a delivery catheter, the inner lumen having a proximal end and a distal end, the occluding element being further configured to expand to an expanded configuration when advanced out of the distal end of the inner lumen of the delivery catheter and into the aneurysm, wherein in the expanded configuration, at least the outer layer of the everted mesh tube forms an expanded shape, the expanded shape including a proximal segment having a first transverse dimension, a distal segment having a second transverse dimension, and a waist having a third transverse dimension, wherein the third transverse dimension is smaller than the first transverse dimension, and the third transverse dimension is smaller than the second transverse dimension, and wherein in the expanded configuration, the waist is configured to be deformed by an externally applied force so that the distance between the distal segment and the proximal segment is reduced.

[0016] In another embodiment of the present disclosure, a vascular occlusion system configured for embolizing an aneurysm having a neck and a sac, the system comprising an elongated pusher configured to be slidably disposed within a delivery catheter having a proximal end, a distal end, and a delivery lumen extending therebetween, an implantable vascular occlusion device coupled to the distal end of the pusher, the vascular occlusion device configured to be implanted in the aneurysm sac and having a delivery structure that collapses when confined within the delivery lumen of the delivery catheter and collapses after being delivered out of the delivery lumen of the delivery catheter and into the aneurysm sac. An expanded deployed configuration wherein the vascular occlusive device includes a proximal face configured to abut an inferior wall portion of the aneurysm sac, against the aneurysm neck, and a concave face opposite the proximal face and having a perimeter extending into the sac and away from the aneurysm neck, the concave face being arranged about the longitudinal axis, and wherein the vascular occlusive device is configured to releasably couple to a distal end of a pusher at a releasable joint, the distal end of the pusher extending from the releasable joint at an angle of about 30 degrees to about 120 degrees with the central longitudinal axis.

[0017] In another embodiment of the present disclosure, a vascular occlusion system is constructed for embolizing an aneurysm having a neck and a sac, the system comprising an elongated pusher constructed to be slidably disposed within a delivery catheter having a proximal end, a distal end and a delivery lumen extending therebetween, an implantable vascular occlusive device coupled to the distal end of the pusher, the vascular occlusive device being constructed to be implanted into the aneurysm sac and having a contracted delivery structure when confined within the delivery lumen of the delivery catheter, and an expanded deployment structure after being delivered out of the delivery lumen of the delivery catheter and into the aneurysm sac, wherein the vascular occlusive device comprises a proximal face constructed to abut against a lower wall portion of the aneurysm sac and against the aneurysm neck, and a concave face, the concave face being opposite to the proximal face and having a circumference extending into the sac and away from the aneurysm neck, the concave face being arranged around a longitudinal axis, and wherein the vascular occlusive device is constructed to be releasably coupled to the distal end of the pusher at a releasable joint, and wherein the releasable joint is coupled at a position on the proximal face of the vascular occlusive device that is radially offset from the central longitudinal axis.

[0018] In yet another embodiment of the present disclosure, a vascular occlusion system configured for embolizing an aneurysm having a neck and a sac, the system comprising an elongated pusher configured to be slidably disposed within a delivery catheter having a proximal end, a distal end, and a delivery lumen extending therebetween, an implantable vascular occlusive device coupled to the distal end of the pusher, the vascular occlusive device configured to be implanted in the aneurysm sac and having a collapsed delivery configuration when confined within the delivery lumen of the delivery catheter, and an expanded deployed configuration after being delivered out of the delivery lumen of the delivery catheter and into the aneurysm sac, wherein the vascular occlusive device comprises a proximal face, the proximal face of the vascular occlusive device comprising a proximal face. The invention relates to a vascular occluding device configured to abut an inferior wall portion of an aneurysm sac, abut an aneurysm neck, and a concave surface opposite the proximal surface and having a perimeter extending into the sac and away from the aneurysm neck, the concave surface being arranged about the longitudinal axis, and wherein the vascular occluding device is configured to be releasably coupled to a distal end of a pusher at a releasable joint, and wherein the releasable joint has a characteristic selected from the list consisting of: (1) the distal end of the pusher extends from the releasable joint at an angle of about 30 degrees to about 120 degrees to the central longitudinal axis, and (2) the releasable joint is coupled to the proximal surface of the vascular occluding device at a position radially offset from the central longitudinal axis.

[0019] In yet another embodiment of the present disclosure, a system for embolizing an aneurysm includes an expandable implant constructed for placement within the aneurysm, the implant having a collapsed structure and an expanded structure, the expanded structure having an asymmetric shape relative to a longitudinal axis, and a delivery catheter having a proximal end and a distal end and a cavity extending from the proximal end to the distal end, the cavity having a non-circular cross-section at least in a distal region adjacent to the distal end of the delivery catheter, wherein the expandable implant in its collapsed structure is constructed to be keyed into the cavity in the distal region so that the expandable implant is deliverable from the cavity at the distal end of the delivery catheter in a specific rotational position relative to the longitudinal axis.

[0020] In yet another embodiment of the present disclosure, a method for inserting an expandable implant includes providing an introducer having a proximal end and a distal end and an introducer lumen extending between the introducer proximal end and the introducer distal end, the introducer lumen being configured to maintain the expandable implant in its contracted configuration while introducing the expandable implant at its proximal end into a lumen of a delivery catheter, wherein the lumen of the delivery catheter has a non-circular shape, and wherein the expandable implant in the contracted configuration has a substantially non-circular shape, pushing the expandable implant out of the introducer lumen and into the lumen of the delivery catheter so that the substantially non-circular shape of the expandable implant in the contracted configuration is oriented in a manner that is keyed to the non-circular shape of the delivery catheter lumen, and advancing the expandable implant so that it is completely within the lumen of the delivery catheter.

[0021] In yet another embodiment of the present disclosure, a vascular occlusion system configured for embolizing an aneurysm having a neck and a sac, the system comprising an elongated pusher configured to be slidably disposed within a delivery catheter having a proximal end, a distal end, and a delivery lumen extending therebetween, an implantable vascular occlusive device coupled to the distal end of the pusher, the vascular occlusive device configured for implantation in the aneurysm sac and having a collapsed delivery configuration when confined within the delivery lumen of the delivery catheter, and an expanded deployed configuration after delivery from the delivery lumen of the delivery catheter and into the aneurysm sac, wherein the vascular occlusion device is implanted in the aneurysm sac and has a collapsed delivery configuration when confined within .... The occlusive device includes a proximal end configured to abut an aneurysm proximal to the aneurysm neck, a distal end configured to extend in a sac and away from the aneurysm neck, and a central longitudinal axis, and wherein the vascular occlusive device is configured to releasably couple to the distal end of a pusher at a releasable joint, wherein the releasable joint includes one or both of the following configurations: (1) the distal end of the pusher extends from the releasable joint at an angle of about 30 degrees to about 120 degrees to the central longitudinal axis, and (2) the releasable joint is coupled at a location on the proximal end of the vascular occlusive device that is radially offset from the central longitudinal axis. BRIEF DESCRIPTION OF THE DRAWINGS

[0022] Figure 1is a cross-sectional view of an occluding device according to an embodiment of the present disclosure.

[0023] Figure 2 is a perspective view of an occluder device according to an embodiment of the present disclosure.

[0024] Figure 3 yes Figure 2 Perspective view of an occlusion device.

[0025] Figure 4 yes Figure 2 Perspective view of an occlusion device.

[0026] Figure 5 yes Figure 1 Perspective view of an occlusion device.

[0027] Figure 6 is delivered to the terminal aneurysm Figure 2 A partial cross-sectional view of an occlusion device.

[0028] Figure 7 An occlusive device delivered into a terminal aneurysm is shown in accordance with an embodiment of the present disclosure.

[0029] Figure 8 is a perspective view of an occluder device according to an embodiment of the present disclosure.

[0030] Fig. 9 is a perspective view of an occluder device according to an embodiment of the present disclosure.

[0031] Fig. 10A is a perspective view of an occluder device according to an embodiment of the present disclosure.

[0032] Fig. 10B According to the embodiment of the present disclosure Fig. 10A Detailed view of an alternative distal end of an occlusion device.

[0033] Fig. 10C According to the embodiment of the present disclosure Fig. 10A Detailed view of an alternative distal end of an occlusion device.

[0034] Fig. 10D According to the embodiment of the present disclosure Fig. 10A Detailed view of an alternative distal end of an occlusion device.

[0035] Fig.10E According to the embodiment of the present disclosure Fig. 10A Detailed view of an alternative distal end of an occlusion device.

[0036] Fig.11A yes Fig. 10A Side view of the occlusion device.

[0037] Fig. 11B yes Fig. 10A Detailed view of the detachment portion of the occluding device prior to detachment.

[0038] Fig. 11C yes Fig. 10A Detailed view of the detachment portion of the occluding device during the detachment process.

[0039] Fig.12 is a perspective view of an occluder device according to an embodiment of the present disclosure.

[0040] Fig.13 is delivered into the aneurysm Fig.12 Perspective view of an occlusion device.

[0041] Fig.14 is a perspective view of an occluding device delivered into an aneurysm according to an embodiment of the present disclosure.

[0042] Fig.15 yes Fig.14 Perspective view of an occlusion device.

[0043] Fig.16 is a perspective view of an occluder device according to an embodiment of the present disclosure.

[0044] Fig.17 is a perspective view of an occluder device according to an embodiment of the present disclosure.

[0045] Fig.18 is a perspective view of an occluder device according to an embodiment of the present disclosure.

[0046] Fig.19 It is in the delivery catheter Fig.18 Cross-sectional view of an occlusion device.

[0047] Fig. 20 It is intercepted by line 20-20 Fig.18 A cross-sectional view of an occluding device.

[0048] Fig.21 is a cross-sectional view of an alternative embodiment of the present disclosure.

[0049] Fig. 22 It is intercepted by line 22-22 Fig.18 Cross-sectional view of an occlusion device.

[0050] Figure 23-Figure 26 Shows Fig.18 Implantation of an occlusive device in an aneurysm of a patient's blood vessel.

[0051] Fig. 27 is a perspective view of an occluder device according to an alternative embodiment of the present disclosure.

[0052] Fig.28 It is in the delivery catheter Fig. 27 Cross-sectional view of an occlusion device.

[0053] Fig.29 It is intercepted by line 29-29 Fig. 27 Cross-sectional view of an occlusion device.

[0054] Fig.30 It is intercepted by line 30-30 Fig. 27 Cross-sectional view of an occlusion device.

[0055] Figure 31-Figure 32 Shows Fig. 27 Implantation of an occlusive device in an aneurysm of a patient's blood vessel.

[0056] Fig.33 is a perspective view of an occluder device according to an alternative embodiment of the present disclosure.

[0057] Fig.34 is a perspective view of an occluder device according to an alternative embodiment of the present disclosure.

[0058] Fig.35 is a perspective view of an occluder device according to an alternative embodiment of the present disclosure.

[0059] Fig.36 is a perspective view of an occluder device according to an alternative embodiment of the present disclosure.

[0060] Fig.37 is a perspective view of an occluder device according to an alternative embodiment of the present disclosure.

[0061] Fig.38 is a longitudinal cross-sectional view of an occluder device according to an alternative embodiment of the present disclosure.

[0062] Fig.39 is a view of an occluding device implanted within an aneurysm according to an embodiment of the present disclosure.

[0063] Fig.40 is a view of an occluding device implanted within an aneurysm according to an embodiment of the present disclosure.

[0064] Fig.41 is a perspective view of an occluder device according to an embodiment of the present disclosure.

[0065] Fig.42 yes Fig.41 Cross-sectional view of an occlusion device.

[0066] Fig.43 is a cross-sectional view of an alternative occlusive device according to an embodiment of the present disclosure.

[0067] Fig.44 is a cross-sectional view of an alternative occlusive device according to an embodiment of the present disclosure.

[0068] Fig.45 is a cross-sectional view of an alternative occlusive device according to an embodiment of the present disclosure.

[0069] Figure 46-Figure 49 Shows Fig.41 Implantation of an occlusive device in an aneurysm of a patient's blood vessel.

[0070] Fig.50 is a cross-sectional view of an alternative occlusive device according to an embodiment of the present disclosure.

[0071] Fig.51 is a cross-sectional view of an alternative occlusive device according to an embodiment of the present disclosure.

[0072] Fig.52 is a cross-sectional view of an alternative occlusive device according to an embodiment of the present disclosure.

[0073] Fig.53 is a cross-sectional view of an alternative occlusive device according to an embodiment of the present disclosure.

[0074] Fig.54 An occlusive device according to an embodiment of the present disclosure is implanted within an aneurysm.

[0075] Fig.55 An occlusive device according to an embodiment of the present disclosure is implanted within an aneurysm.

[0076] Fig.56 An occlusive device according to an embodiment of the present disclosure is shown implanted within an aneurysm.

[0077] Fig.57 An occlusive device according to an embodiment of the present disclosure is shown implanted within an aneurysm.

[0078] Fig.58 An occlusive device according to an embodiment of the present disclosure is shown.

[0079] Fig.59 is a cross-sectional view of an unrestricted occlusive device according to an embodiment of the present disclosure.

[0080] Fig.60 is confined within the delivery catheter Fig.59 occluding device.

[0081] Fig.61 The delivery is confined to the aneurysm. Fig.59 occluding device.

[0082] Fig.62 is a cross-sectional view of an occluding device according to an embodiment of the present disclosure.

[0083] Fig.63 is a side view of an occluder device according to an embodiment of the present disclosure.

[0084] Fig.64 is a plan view of an occlusive device according to an embodiment of the present disclosure.

[0085] Fig.65 is releasably coupled to the thruster according to an embodiment of the present disclosure Fig.64 A plan view of the occlusion device.

[0086] Fig.66 According to the embodiment of the present disclosure, the Fig.64 Perspective view of an occlusion device.

[0087] Fig.67 According to the embodiment of the present disclosure, the Fig.64 Perspective view of an occlusion device.

[0088] Fig.68 is a cross-sectional view of an alternative occlusive device according to an embodiment of the present disclosure.

[0089] Fig.69 is a perspective view of an occluder device according to an embodiment of the present disclosure.

[0090] Fig.70 is a cross-sectional view of an occluding device according to an embodiment of the present disclosure.

[0091] Fig.71 Delivered via a microcatheter Fig.70 Cross-sectional view of an occlusion device.

[0092] Fig.72 It comes from the deployment of the microcatheter Fig.70 Cross-sectional view of an occlusion device.

[0093] Fig.73 yes Fig.70 Detailed cross-sectional view of the distal end of the occlusion device.

[0094] Figure 74A-Figure 74C is a cross-sectional view of delivering an occluding device of an occluding system into an aneurysm according to an embodiment of the present disclosure.

[0095] Figure 75A-Figure 75C is a cross-sectional view of delivering an occluding device of an occluding system into an aneurysm according to an embodiment of the present disclosure.

[0096] Figure 76A-76C is a cross-sectional view of delivering an occluding device of an occluding system into an aneurysm according to an embodiment of the present disclosure.

[0097] Fig.77 is a plan view of an occlusive device according to an embodiment of the present disclosure.

[0098] Fig.78 is a plan view of an occlusive device according to an embodiment of the present disclosure.

[0099] Fig.79 is a perspective view of delivering an occluding device of an occluding system into an aneurysm according to an embodiment of the present disclosure.

[0100] Fig.80 is a perspective view of delivering an occluding device of an occluding system into an aneurysm according to an embodiment of the present disclosure.

[0101] Fig.81 is a perspective view of delivering an occluding device of an occluding system into an aneurysm according to an embodiment of the present disclosure.

[0102] Fig.82 is a perspective view of delivering an occluding device of an occluding system into an aneurysm according to an embodiment of the present disclosure.

[0103] Fig.83 is a perspective view of delivering an occluding device of an occluding system into an aneurysm according to an embodiment of the present disclosure.

[0104] Fig.84 is a perspective view of delivering an occluding device of an occluding system into an aneurysm according to an embodiment of the present disclosure.

[0105] Fig.85 is a top view of a delivery catheter according to an embodiment of the present disclosure.

[0106] Fig.86 yes Fig.85 Side view of the delivery catheter.

[0107] Fig.87 is along Fig.86 An enlarged cross-sectional view taken along line 87.

[0108] Fig.88 is a top view of a delivery catheter according to an embodiment of the present disclosure.

[0109] Fig.89 yes Fig.88 Side view of the delivery catheter.

[0110] Fig.90 is along Fig.89 An enlarged cross-sectional view taken along line 90.

[0111] Fig.91 is a perspective view of a loading sheath according to an embodiment of the present disclosure.

[0112] Fig.92 yes Fig.91 Perspective view of a loading sheath with the occluding device constrained in its collapsed configuration.

[0113] Fig.93 It is changed to another structure Fig.91 A perspective view of the loading sheath.

[0114] Fig.94 is used to load the occluding device into the proximal end of the delivery catheter Fig.91 A perspective view of the loading sheath.

[0115] Figure 95A-Figure 95E is an alternative configuration of the lumen of a delivery catheter according to an embodiment of the present disclosure.

[0116] Fig.96A is a perspective view of an occluder device according to an embodiment of the present disclosure.

[0117] Fig.96B According to the embodiment of the present disclosure Fig.96A Detailed view of an alternative distal end of an occlusion device.

[0118] Fig.96C According to the embodiment of the present disclosure Fig.96A Detailed view of an alternative distal end of an occlusion device.

[0119] Fig.96D According to the embodiment of the present disclosure Fig.96A Detailed view of an alternative distal end of an occlusion device.

[0120] Fig.96E According to the embodiment of the present disclosure Fig.96A Detailed view of an alternative distal end of an occlusion device.

[0121] Fig.97A yes Fig.96A Side view of the occlusion device.

[0122] Fig.97B yes Fig.96A Detailed view of the detachment portion of the occluding device prior to detachment.

[0123] Fig.97C yes Fig.96A Detailed view of the detachment portion of the occluding device during the detachment process. DETAILED DESCRIPTION

[0124] An aneurysm is an abnormal dilation or weakening of a blood vessel, usually an artery, and can have many complications. The dilation of the blood vessel can damage or exert pressure on surrounding tissue. Brain aneurysms can lead to a variety of side effects, such as impaired vision, impaired speech, impaired balance, etc. In addition, the volume created by the aneurysm is not along the main flow path of blood through the blood vessels. Therefore, it can serve as a location for blood to stagnate and, due to eddy currents, can promote the formation of thromboemboli. If an aneurysm ruptures, it can cause severe internal bleeding, which is often fatal in the cerebral arteries.

[0125] Aneurysms can be treated externally through open surgery. Such surgery typically involves closing the entrance or "neck" of the aneurysm using devices such as vascular clips, clamps, or ligatures. However, such open surgical procedures can be highly invasive and may cause trauma to adjacent tissues and other side effects.

[0126] Aneurysms can also be treated by endovascular surgery. In one procedure, a detachable length of wire (e.g., a coil) is inserted into the internal volume of the aneurysm using a catheter. The coil is intended to fill the volume of the aneurysm to reduce the blood flow into the aneurysm, induce blood flow stagnation and stimulate coagulation within the aneurysm. In the case of cerebral aneurysms, filling the aneurysm with multiple coils can lead to a mass effect, which may cause brain swelling and become an independent cause of new symptoms. In another procedure, for aneurysms with relatively large necks, the auxiliary use of stents helps to keep the coils within the aneurysm. Due to the need for additional antithrombotic drugs, this method may be contraindicated for use in the treatment of ruptured aneurysms. In another procedure, a temporary balloon inflated in a blood vessel is used to keep the coils in the volume of the aneurysm. Once the mass of the coil is fixed, the balloon is deflated and removed. In yet another procedure, a stent device is placed in an artery to promote blood flow through the aneurysm. This leads to blood stagnation within the aneurysm and thrombosis within the aneurysm volume. However, the side branches of the aorta in which the stent device is placed may become trapped or "imprisoned," which can hinder access to the side branches. In other cases, the side branches may clot, potentially leading to a stroke. In addition, such procedures often require the use of additional anti-thrombotic medications, which limits the use of such devices to situations where a ruptured aneurysm is being treated. Stent devices are typically formed with a relatively tight braid. While the tight braid increases the effectiveness of the stent device in diverting blood flow, it also hinders or blocks access to the volume of the aneurysm or imprisoned artery. In situations where the aneurysm cannot clot, the occlusion of the aneurysm by the stent device prevents the possibility of placing an embolic device within the aneurysm. Additional procedures, such as placement of additional stents or open surgery, may then be required to treat the remnant.

[0127] Surgeries involving filling the volume of an aneurysm may encounter several common disadvantages. First, it may require many wire coils to fill the volume of the aneurysm, which is time consuming and increases the time required to complete the procedure. In addition, the coils can become compacted over time to occupy a smaller percentage of the total volume of the aneurysm. Enough coil compaction can be considered a recurrence of the aneurysm and may require further treatment.

[0128] Figure 1 and Figure 5 An occluding device 420 having a double layer of mesh is shown, and includes a single D-shaped element 422 having a D-shaped longitudinal cross-section. The occluding device 420 is constructed of an everted mesh tube 424 having a first end 426, a second end 428, and a wall 429. The everted mesh tube 424 extends on the outer layer 430 from the second end 428 through the proximal end 432 of the D-shaped element 422 and along the hemispherical shape 434 to a maximum diameter portion 436 having an acute angle 438. From the maximum diameter portion 436, the outer layer 430 extends radially inward along a substantially flat portion 440 that substantially covers a transverse plane to an everted fold 442 from the outer layer 430 to an inner layer 444 that follows the contour of the outer layer 430 from the distal orifice 446 to the first end 426. The occluding device 420 is manufactured as an everted mesh tube 424 having a simple straight elongated configuration, and is subsequently formed into Figure 1 and Figure 5The shape shown in the figure is then heat-set into this shape. For example, the inverted mesh tube 424 can be constructed as a single-layer mesh tube formed by at least some nickel-titanium alloy wires and then inverted on itself. The inverted mesh tube 424 can then be placed in a die or mold containing one or more components to keep it in the shape of the D-shaped element 422. The D-shaped element 422 can then be subjected to an elevated temperature and then cooled to lock the shape, producing a D-shaped element 422 with at least some superelastic properties. The occluding device 420, as all occluding devices described herein, is configured to be delivered through the lumen of the delivery catheter in a compressed structure and out of the distal end of the lumen and into the aneurysm. When the occluding device 420 is released from the constraint of the lumen, it self-expands into an expanded structure within the aneurysm. The marker band 448 holds the first end 426 and the second end 428 together, and can contain a radiopaque material such as platinum or a platinum alloy, such as 90% platinum and 10% iridium, or 80% platinum and 20% iridium, or 75% platinum and 25% iridium. The D-shaped element 422 is configured to cover the neck of the aneurysm. The maximum diameter portion 436 can be configured to engage the wall of the aneurysm to hold the occluding device 420 in place. For example, the diameter of the maximum diameter portion 436 can be oversized relative to the target aneurysm diameter, such as 10% larger, 20% larger, etc. In some embodiments, the occluding device 420 in its expanded configuration has a generally isosceles trapezoidal cross-section in a plane containing the longitudinal axis. In some embodiments, the occluding device 420 in its expanded configuration has a generally triangular cross-section in a plane containing the longitudinal axis.

[0129] The size of the distal orifice 446 can be designed to control the overall width of the substantially flat portion 440. The smaller the distal orifice 446, the thicker the width in the substantially flat portion 440 (on each side of the orifice 446). The thicker the width of this portion, the greater the radial force (aneurysm clamping force) that the maximum diameter portion 436 can exert on the aneurysm wall. In some embodiments, the inner diameter of the orifice 446 is between about 35% and about 85% of the diameter of the maximum outer diameter portion 463. In some embodiments, the inner diameter of the orifice 446 is between about 45% and about 75% of the diameter of the maximum outer diameter portion 463. In some embodiments, the inner diameter of the orifice 446 is between about 50% and about 70% of the diameter of the maximum outer diameter portion 463. In some embodiments, the inner diameter of the orifice 446 is between about 55% and about 65% of the diameter of the maximum outer diameter portion 463. In some embodiments, the orifice 446 is on the same plane as the maximum outer diameter portion 463. In other embodiments, the orifice 446 is located in a plane that is generally distal to the plane bearing the largest outer diameter portion 463. In other embodiments, the orifice 446 is located in a plane that is generally proximal to the plane bearing the largest outer diameter portion 463.

[0130] Figure 2-Figure 4 A bowl-shaped occlusion device 801 is shown, which is constructed of an inverted mesh tube 803 and has a concavity 805 at its distal end 807. The laser cut conical coil 809 can be constructed of nickel titanium sheet or nickel titanium tube. The inverted mesh tube 803 is not in the Figure 2-Figure 4 , to show the details of coil 809. Figure 6, the everted mesh tube 803 is shown covered with a coil 809, and the occluding device 801 is deployed in the terminal aneurysm 471. In some embodiments, the coil 809 is between the outer layer 461 and the inner layer 463 of the everted mesh tube 803, and exerts an outward radial force on the outer layer 461 and thereby the aneurysm 471. In other embodiments, the coil 809 is within both the outer layer 461 and the inner layer 463 of the everted mesh tube 803, and exerts an outward radial force on the inner layer 463 and the outer layer 461 together, and thereby exerts an outward radial force on the aneurysm 471. The coil 809 has a small diameter end 811 and a large diameter end 813, and the diameter between the two ends 811, 813 gradually tapers or changes to match the bowl shape of the occluding device 801. In some embodiments, the coil 809 at least partially forces the bowl shape into the outer layer 461, or into the inner layer 463 and the outer layer 461. In some embodiments, the coil 809 may even be outside both the inner layer 463 and the outer layer 461, and may be coupled to one or both of the inner layer 463 or the outer layer 461 by adhesive bonding, epoxy bonding, heat staking, tying, sewing, braiding, forging, welding, stapling, soldering, or other means. Thus, the outward radial force applied by the coil 809 pulls the outer layer 461 and or the inner layer 463 outward. The maximum diameter of the occluding device 801 (e.g., at the large diameter end 813) may be configured to engage the wall 491 of the aneurysm 471 to hold the occluding device 801 in place. For example, the maximum diameter may be larger relative to the target aneurysm diameter, such as 10% larger, 20% larger, etc. In some embodiments, the occluding device 801 in its expanded configuration has a generally isosceles trapezoidal cross-section in a plane containing the longitudinal axis. In some embodiments, the occluding device 801 in its expanded configuration has a generally triangular cross-section in a plane containing the longitudinal axis.

[0131] The occluding device 801 is coupled to the pusher wire 481 and delivered through the microcatheter 485, which is placed through the aorta 495. After being deployed at the desired location, the occluding device 801 is released from the pusher wire 481 by detachment at the detachable joint 489. The detachable joint 489 may include one of a variety of detachment systems, including but not limited to pressurized detachment, electrolytic detachment mechanism, hydraulic detachment mechanism, mechanical or interlocking detachment mechanism, chemical detachment mechanism, heat-activated detachment system, or friction detachment system. During delivery, the pusher wire 481 is held by the user at its proximal end (not shown) and pushed forward longitudinally so as to advance the occluding device 801 to the distal end 493 of the delivery catheter (microcatheter) 485.

[0132] Figure 7An occlusive device 815 is shown deployed within an aneurysm and having a plurality of wire forms 817 (three are shown) that are looped back at each of their ends (first end 475, second end 477) and attached to a proximal end 819 of the occlusive device 815. The loop portion 479 of the wire form 817 is configured to clamp within the aneurysm 829 by interfacing with the aneurysm wall 483. The proximal mesh 821 includes a circumferentially extending recessed portion 823 that is configured to divert or direct blood flow toward the side arteries 825, 827 as indicated by the curved arrows. The occlusive device 815 is shown in FIG. Figure 7 , within the terminal aneurysm 829 (e.g., the basilar tip or other terminal aneurysm). The occluding device 815 is delivered through a microcatheter 485, which is placed through the basilar artery 487, and after the occluding device is deployed in the desired position, it is released from the pusher wire 481 by detachment at the detachable joint 489. The detachable joint 489 may include one of a variety of detachment systems, including but not limited to pressurized detachment, electrolytic detachment mechanism, hydraulic detachment mechanism, mechanical or interlocking detachment mechanism, chemical detachment mechanism, heat-activated detachment system, or friction detachment system. During delivery, the pusher wire 481 is held by the user at its proximal end (not shown) and pushed forward longitudinally to advance the occluding device 815 to the distal end 493 of the delivery catheter (microcatheter) 485.

[0133] Figure 8 is a perspective view of a basket occluder device 831 having Figure 7 The occluding device 815 has the general structure of the occluding device 815, but has a rounded wire form 833 that is configured to conform to the dome of the aneurysm and also force the proximal mesh portion 835 against the neck of the aneurysm.

[0134] Fig. 9 An occluding device 550 is shown having a double layer of mesh and includes a disc-shaped element 552 having a disc-shaped longitudinal cross-section. The occluding device 550 is constructed of an everted mesh tube 554 having a first end 556, a second end 558, and a wall 560. The everted mesh tube 554 extends on the outer layer 562 from the second end 558 through the proximal end 564 of the disc-shaped element 552 and along the hemispherical shape 566 to a maximum diameter portion 568. From the maximum diameter portion 568, the outer layer 562 extends radially inward and distally along the frustoconical portion 570 and along and adjacent to the rounded portion 572 to an everted fold 574 from the outer layer 562 to an inner layer 576 that follows the contour of the outer layer 562 from the distal orifice 578 to the first end 556. The occluding device 550 is manufactured as an everted mesh tube 554 having a simple straight elongated configuration and is subsequently formed into a Fig. 9The shape shown in the figure is formed into a shape and heat-set into this shape. For example, the inverted mesh tube 554 can be constructed as a single-layer mesh tube formed by at least some nickel-titanium alloy wires and then inverted on itself. The inverted mesh tube 554 can then be placed in a die or mold including one or more parts to keep it in the shape of the disc-shaped element 552. The disc-shaped element 552 can then be subjected to an elevated temperature and then cooled to lock the shape, resulting in the disc-shaped element 552 having at least some superelastic properties. The inner marker band 580 is attached to the first end 556 and the second end 558 at its proximal end 582, and can include a radiopaque material, such as platinum or a platinum alloy, such as 90% platinum and 10% iridium, or 80% platinum and 20% iridium, or 75% platinum and 25% iridium. The inner marker band 580 has a distal end 584 and a hollow cavity 586. The pusher wire 588 is inserted through the cavity 586 of the inner marker band 580 and has a distal end 590 with a radially extending protrusion 592. The disc-shaped element 552 is configured to cover the neck of the aneurysm. The maximum diameter portion 568 can be configured to engage the wall of the aneurysm to hold the occlusion device 550 in place. For example, the diameter of the maximum diameter portion 568 can be larger relative to the target aneurysm diameter, such as 10% larger, 20% larger, etc.

[0135] Fig. 10A and Figures 11A-11CAn occluder device 1040 is shown comprising a mesh cover 1042 including a distal concave surface 1044. An inner tube 1046 having a lumen 1048 and an outer wall 1050 is secured within the mesh cover 1042 such that its proximal end 1052 is flush with or closely adjacent to the proximal end 1054 of the mesh cover 1042. A pusher 1056 comprises a wire having a distal end 1058 including a plurality of radially extending fingers 1060 extending from the distal end 1058. The fingers 1060 are configured to be meltable, detachable, inflexible, frangible, ablative, deformable, or otherwise changeable. Prior to detachment, the radially extending fingers 1060 create a maximum diameter that is greater than the diameter of the lumen 1048 of the inner tube 1046, so that the traction on the wire of the pusher 1056 causes the fingers 1060 to pull the distal end of the outer wall 1050 of the inner tube 1046, and thereby pull the entire occluding device 1040. For example, the occluding device 1040 can be advanced into an aneurysm, and if the user does not believe that the fit or configuration of the occluding device 1040 within the aneurysm is desired, the user can pull the pusher 1056 to pull the occluding device 1040 out of the aneurysm and into the lumen of the delivery catheter. However, then the occluding device 1040 has been delivered into the aneurysm in an acceptable manner, and the user can detach by any detachment means (deforming, damaging or destroying the fingers 1060), by methods including but not limited to pressurized detachment, electrolytic detachment mechanisms, hydraulic detachment mechanisms, mechanical or interlocking detachment mechanisms, chemical detachment mechanisms, heat-activated detachment systems, or friction detachment systems. In one embodiment, mechanical disengagement is achieved by placing the distal end of the microcatheter against the proximal end 1054 of the mesh cover 1042 while pulling the pusher 1056, thereby bending the fingers 1060 and removing the pusher 1056 from the occlusion device 1040. The inner tube 1046 provides a smooth proximal end 1054 of the mesh cover 1042, so there are no residual wires protruding toward the proximal end. Residual protruding wires may cause thrombosis, which may cause embolic stroke. In some embodiments, for example, if the distal end 1058 includes a stainless steel wire, the distal end 1058 of the pusher 1056 can be tapered to as small as 0.001 inches or 0.002 inches. The inner tube 1046 can include a polyimide tube and can have an inner diameter as small as 0.002 inches to 0.010 inches and an outer diameter between about 0.003 inches and about 0.014 inches. In some embodiments, there may be two fingers 1060, or three fingers 1060, or four fingers 1060, or five fingers 1060, or six fingers 1060 or more.

[0136] The flush or adjacent relationship of the proximal end 1052 of the inner tube 1046 to the proximal end 1054 of the mesh cover 1042 ensures that no detached remnants extend substantially proximal to the proximal end 1054 of the mesh cover 1042 (and into the parent artery). Thus, any potentially associated thromboembolic events, where such remnants would be a risk, can be avoided. In some embodiments, the minimum outer diameter of the mesh cover 1042 is between about 70% and about 90% of the maximum outer diameter of the mesh cover 1042. Fig. 10B An alternative distal end 1058b is shown including a ball 1062 having a spherical or bulbous shape. Disengagement may occur at the ball 1062, or at a portion 1064 of the distal end 1058b proximate the ball 1062, or at both. The ball 1064 may be attached to the pusher 1056 by epoxy, adhesive, swaging, brazing or welding, or may be formed from the material of the distal end 1058b by swaging. Fig. 10C An alternative distal end 1058c is shown including a disc 1066 having a flat circular shape. Disengagement may occur at the disc 1066, or at a portion 1068 near the distal end 1058c of the disc 1066, or at both. The disc 1066 may be attached to the pusher 1056 by epoxy, adhesive, forging, brazing or welding, or may be formed from the material of the distal end 1058c by forging. Fig. 10D An alternative distal end 1058d is shown including a tip 1070 having a frustoconical shape. Detachment may occur at the tip 1070, or at a portion 1072 of the distal end 1058d near the tip 1070, or both. The tip 1070 may be attached to the pusher 1056 by epoxy, adhesive, swaging, brazing, or welding, or may be formed from the material of the distal end 1058d by swaging. Fig.10E An alternative distal end 1058e is shown, which includes a tip 1076 having a flattened reverse spear shape. Disengagement can occur at the tip 1076, or at a portion 1078 of the distal end 1058e near the tip 1076, or at both. The tip 1076 can be attached to the pusher 1056 by epoxy, adhesive, forging, brazing or welding, or can be formed from the material of the distal end 1058e by forging, or can be a flattened portion of the pusher 1056 wire, such as by rolling or pressing. In each alternative embodiment, the diameter (or maximum transverse dimension) of the ball 1062, the disk 1066, the proximal end 1074 of the tip 1070, or the distal end 1080 of the tip 1076 is greater than the diameter of the lumen 1048 of the inner tube 1046, thereby allowing the occluding device 1040 to be removably locked to the pusher 1056.

[0137] Fig.12An occlusive device 600 is shown having a double layer mesh and including a single bowl-shaped element 602 having a trapezoidal longitudinal cross-section. The occlusive device 600 is constructed of an inverted mesh tube 604 having a first end and a second end (not shown), both of which are inserted (in a collapsed state) and bonded within a marker band 606. The inverted mesh tube 604 extends on an outer layer 608 from the second end of the inverted mesh tube 604 through the proximal end 610 of the bowl-shaped element 602 and along a first substantially flat portion 612 that substantially covers the transverse plane to a maximum diameter portion 614 having an acute angle 616. From the maximum diameter portion 614, the outer layer 608 extends radially inwardly distally along a frustoconical portion 618, to an obtuse angle 620, to a second substantially flat portion 622, to an inverted fold 624 from the outer layer 608 to an inner layer 626, which follows the contour of the outer layer 608 from a distal orifice 628 to the first end of the inverted mesh tube 604. The occluder device 600 is manufactured as an inverted mesh tube 604 having a simple straight elongated configuration and is subsequently formed into Fig.12 The shape shown is heat-set into this shape. For example, the inverted mesh tube 604 can be constructed as a single-layer mesh tube formed by at least some nickel-titanium alloy wires and then inverted on itself. The inverted mesh tube 604 can then be placed into a die or mold including one or more parts to hold it in the shape of the bowl-shaped element 602. The bowl-shaped element 602 can then be subjected to an elevated temperature and then cooled to lock the shape, resulting in the bowl-shaped element 602 having at least some superelastic properties. The marker band 606 holds the first and second ends of the inverted mesh tube 604 together and can include a radiopaque material, such as platinum or a platinum alloy, such as 90% platinum and 10% iridium, or 80% platinum and 20% iridium, or 75% platinum and 25% iridium.

[0138] The bowl-shaped element 602 is configured to cover the neck of the aneurysm. The maximum diameter portion 614 can be configured to engage the wall of the aneurysm to hold the occlusion device 600 in place. For example, the diameter of the maximum diameter portion 614 can be larger relative to the target aneurysm diameter, such as 10% larger, 20% larger, etc. Fig.13 As shown, the maximum diameter portion 614 engages the aneurysm 630 at a proximal end portion 632 just distal to the neck 634 of the aneurysm 630. Because the maximum diameter portion 614 is larger in diameter relative to the proximal end portion 632 of the aneurysm 630, and because the maximum diameter portion 614 is at the proximal end of the bowl-shaped element 602, the second substantially flat portion 622 and / or the frustoconical portion 618 can be deformed as desired so that the bowl-shaped element 602 adjusts its shape to the shape of the aneurysm 630. The occluding device 600 is removably coupled to a pusher wire 636, which is a removable joint 638. In some embodiments, the minimum outer diameter of the bowl-shaped element 602 is between about 70% and about 90% of the maximum outer diameter of the bowl-shaped element 602.

[0139] Figure 14-15 An occluding device 837 constructed from an everted mesh tube 839 and having a proximal end 715 and a concave surface 841 at a distal end 845 thereof is shown. Fig.14 An occlusive device 837 is shown implanted within an aneurysm 847 using a microcatheter 714 and a pusher 716, the aneurysm 847 having a neck 710 and a dome 712, as previously taught herein. The inverted mesh tube 839 includes a support stent 718 secured between an outer layer 720 and an inner layer 722 of the inverted mesh tube 839. The stent 718 is configured to apply a supplemental radial force to the wall 724 of the aneurysm 847 to increase the grip of the occlusive device 837 within the aneurysm 847 near the neck 710. The stent 718 allows for greater radial force and a better fit than an inverted mesh tube 839 without a stent. The stent 718 may comprise a nickel-titanium alloy and may be laser machined from a nickel-titanium alloy tubing. The tube may be machined by other techniques that allow a slot pattern to be formed in the wall. After machining, the stent 718 may be thermoformed to produce an expanded diameter having superelastic properties. Although Figure 14-15 A "zigzag" shape 726 is shown in FIG. 7 , alternatively, the stent 718 may include modular sections with an open or closed cell design. In some embodiments, the stent 718 may include a braided ring. In other embodiments, the stent may include a coil. In alternative embodiments, the stent is fixed within the outer layer 720 and the inner layer 722 and is used to force the two layers toward a larger diameter. In some embodiments, the stent 718 may even be fixed to the outside of both the outer layer 720 and the inner layer 722 and serve to "pull" the two layers toward an increased outer diameter. The stent 718 may be fixed to either of the outer layer 720 and the inner layer 722 by tying, braiding, weaving, welding, forging, brazing, adhesives, epoxy resins or other types of bonding or attachment. In some embodiments, the stent is captured within the outer layer 720 and the inner layer 722 without being directly fixed to any mesh or any layer.

[0140] Fig.16An occluder device 730 is shown that includes a single or double layer mesh cover 732 and has a radiopaque wire loop 734 having a first end 736 and a second end 738, both of which are fixed at the proximal end 740 of the occluder device 730. The radiopaque wire loop 734 surrounds the middle portion 742 at the distal end 744 of the occluder device 730. The mesh cover 732 can contain nickel titanium alloy and / or DFT and / or platinum wire / wire. The mesh cover 732 does not need to contain DFT, platinum or other radiopaque materials because the radiopaque wire loop 734 contains radiopaque materials and, due to its shape, it represents the general size and shape of the occluder device 730. In some embodiments, the radiopaque wire loop 734 contains platinum flat wire, which has sufficient mass to be clearly visible in fluoroscopy or x-ray examination, but when folded down in a smaller size, its profile is low when the occluder device is collapsed to be placed through the lumen of the microcatheter. In other embodiments, the radiopaque wire loop 734 may comprise a braided rope of radiopaque strands having a flat shape.

[0141] Fig.17 An alternative version of an occluding device 849 is shown, similar to the occluding device 730, but having a first radiopaque wire loop 851 and a second radiopaque wire loop 853. Fig.17 As shown, the two radiopaque wire loops 851, 853 may be substantially orthogonal to each other. Fig.16 The occluder device 730 is secured in a similar manner to the single or double layer mesh cover 855. The two radiopaque wire loops 851, 853 are constructed to represent the general size and shape of the occluder device 849 in multiple axes, for example, if biplane fluoroscopy is not used, or to add additional precision in biplane fluoroscopy. Fig.16 and Fig.17 The occluder device 730, 849 can also be constructed using some of the wires in the mesh cover 732, 855 containing DFT wire. A proximal marker band (not shown) can also be added to increase radiopacity.

[0142] In some embodiments, the braided element may subsequently be etched (chemically, photochemically) to reduce the bus diameter and reduce stiffness.

[0143] Fig.18An occlusive device 100 configured for placement within an aneurysm is shown. The occlusive device 100 includes a cap 102 having an outer diameter D. In some embodiments, the cap 102 is circular, having substantially the same diameter D at any transverse measurement around the perimeter. In other embodiments, the cap 102 is non-circular, and may include an elliptical, oval, polygonal, or other shape. In non-circular embodiments, the cap 102 includes a minimum transverse dimension and a maximum transverse dimension. In the particular case of an elliptical or oval shape, the cap 102 includes a major diameter and a minor diameter. The minor diameter or minimum transverse dimension is configured to be larger than the maximum transverse dimension of the opening into the aneurysm (neck). Thus, the cap 102 is configured to completely cover the neck, thereby causing blood stagnation within the aneurysm, resulting in occlusion. The cap 102 is constructed of a mesh (braided) nitinol (nickel-titanium alloy) tube 105 that is inverted on itself. The mesh tube 105 has a first end 104 and a second end 106 (see Fig. 20 ). The second end 106 is folded back on the outer diameter of the first end 104, thereby providing an outwardly facing surface 108 and an inwardly facing surface 110. The mesh tube 105 is thermoformed so that the cover 102 includes an expanded portion and the first end 104 and the second end 106 include an unexpanded (or partially expanded) portion. A smooth fold 112 extends around the periphery 114 of the cover 102 and represents a transition between the outwardly facing surface 108 and the inwardly facing surface 110. The fold 112 avoids any sharp edges that may present a risk of rupture of the aneurysm wall or other anatomical damage. The cover 102 includes a concave surface 116 facing the distal end 118 of the occluding device 100 and away from the proximal end 120 of the occluding device 100. The cover 102 is manufactured as an inverted mesh tube 105 having a simple straight elongated configuration and is subsequently formed into Fig.18 The shape shown is heat-set into this shape. For example, the inverted mesh tube 105 can be constructed as a single layer mesh tube formed from at least some nickel-titanium alloy wires and then inverted on itself. The inverted mesh tube 105 can then be placed into a die or mold including one or more components to hold it in the shape of the cover 102. The cover 102 can then be subjected to an elevated temperature and then cooled to lock the shape, causing the cover 102 to have at least some superelastic properties. The cover 102 includes a lower portion 107 opposite the fold 112. The lower portion 170 is substantially flat, typically defining a plane, but can have a more truncated conical or hemispherical shape in other embodiments.

[0144] When formed (e.g., thermoformed), the cover 102 has an expanded structure (e.g., Fig.18 ) and contraction structures, such as Fig.19As shown. The cover 102 includes two mesh layers, provided by the surface 108 facing outward and the surface 110 facing inward. In some embodiments, the cover 102 may include some nickel titanium alloy wires and some radiopaque elements, including platinum, gold, tantalum or alloys of any one of these or other radiopaque materials. In some embodiments, the wire may include a stretch-filled tube (DFT), such as those including a nickel-titanium alloy outer wall and a platinum core. The radiopaque material allows the cover 102 to be visible in radiographs or fluoroscopy. The occluding device 100 can be configured by controlling how much radiopaque material is used, by the ratio of radiopaque wire to non-radiopaque wire, or by stretching the amount of platinum core in the filling tube. In this way, the cover 102 can be selectively made to be visible enough, but not excessively visible, such as too bright, so that other objects are obscured. In some embodiments, whether any wire includes radiopaque material, the marker band can be attached to the proximal end 120 of the occluding device 100 by adhesive or epoxy bonding, or forging, welding or other mechanical attachment.

[0145] Extending from the concave surface 116 is a bi-fold or looped tubular mesh 122 having a smooth apex 124, which is configured to securely contact the inner wall of the aneurysm. The tubular mesh 122 has a first end 126 and a second end 128, and a middle portion 130 extending between the first end 126 and the second end 128. Fig.18 In the illustrated embodiment, the first end 126 and the second end 128 are substantially unexpanded and inserted into the cavity 132 in the inverted mesh tube 105 forming the cover 102, particularly at the first end 104 and the second end 106 of the mesh tube 105 forming the cover 102 ( Fig. 20 ). The first end 126 and the second end 128 of the tubular mesh 122 can be bonded to the cavity 132 with an adhesive 134 or alternatively with epoxy, or welded or bonded with any other fixing technique. The first end 126 and the second end 128 can each be compressed or deformed into an oval, elliptical or D-shape so that they can more effectively fit into the circular cross-section of the cavity 132. Fig.21 An alternative configuration is shown in which the first end 126 includes a cutout 142 in its wall 144 that allows the second end 128 to be inserted into the interior space 146 at the first end 126. Thus, the second end 128 is retained within the first end 126, and the first and second ends 126, 128 are secured within the cavity 132, for example, by adhesive, epoxy, welding, or other securing techniques. The tubular mesh 122 is constructed of a mesh (braided) nitinol (nickel titanium alloy) tube, and may also include wires of platinum or other radiopaque material as well as nickel titanium wire. A drawn filling tube may also be used.

[0146] The tubular mesh 122 intermediate portion 130 further includes a first leg 136 and a second leg 138 extending therefrom between the apex 124 and the first and second ends 126, 128 of the intermediate portion 130. Each of the first leg 136 and the second leg 138 includes a different portion of the tubular mesh 122. Thus, the tubular mesh 122 is a single-layer mesh (braided) tube extending from its first end 126 through the first leg 136 and around the apex 124, and then through the second leg 138 to the second end 128. Fig.18 In the illustrated embodiment, the first leg 136 and the second leg 138 are shown in their substantially unconstrained expanded states, and in this embodiment, the first leg 136 and the second leg 138 each have a sufficiently large diameter such that they contact each other at the central axis 140. Fig. 22 It will be appreciated that the first leg 136 and the second leg 138 each form a more oval or elliptical cross-sectional shape rather than a circle because they are opposite to each other at the central axis 140. Moreover, the first leg 136 and the second leg 138 together form a first transverse dimension TD X and the second transverse dimension TD Y In this embodiment, the first transverse dimension TD X Greater than the second transverse dimension TD Y In other embodiments, the first transverse dimension TD X Smaller than the second transverse dimension TD Y In some embodiments, the first transverse dimension TD X Equal to the second transverse dimension TD Y In some cases, the first transverse dimension TD X is configured to contact the inner wall of the aneurysm to stabilize the occlusion device 100 within the aneurysm, and the second transverse dimension TD Y In some cases, the second transverse dimension TD Y is configured to contact the inner wall of the aneurysm to stabilize the occlusion device 100 within the aneurysm, and the first transverse dimension TD X In some cases, the occlusion device 100 may be placed into a non-circular aneurysm, and in these cases, the first transverse dimension TD X and the second transverse dimension TD Y Each may be configured to contact the inner wall of the aneurysm at different peripheral locations, as the aneurysm may be more oval or elliptical in cross-section, or other non-circular shapes.

[0147] Back to Fig.19, the occluding device 100 is shown with the cap 102 and tubular mesh 122 in a collapsed or compacted configuration while it is placed into the lumen 148 of a delivery catheter 150 having a distal end 162 and a proximal end 164. The delivery catheter 150 can be a microcatheter having a lumen diameter of 0.017 inches or 0.021 inches, 0.025 inches or 0.028 inches or other sizes. An elongated pusher 152 having a distal end 154 and a proximal end 156 can include a wire, a hypotube, or another elongated structure with a column support, and is detachably coupled to the proximal end 120 of the occluding device 100 at its distal end 154. The detachable joint 158 ​​can include one of a variety of detachment systems, including but not limited to a pressurized detachment, an electrolytic detachment mechanism, a hydraulic detachment mechanism, a mechanical or interlocking detachment mechanism, a chemical detachment mechanism, a heat-activated detachment system, or a friction detachment system. During delivery, the pusher 152 is grasped by a user at its proximal end 156 and pushed in a longitudinal forward direction 160 to advance the occluding device 100 to the distal end 162 of the delivery catheter 150 .

[0148] exist Figure 23-Figure 26 , an aneurysm 10 having a neck 16 is shown. The occlusive device 100 is shown being implanted in the aneurysm 10 by a user (e.g., a physician) via a delivery catheter 150 in use to interrupt or stop blood flow between the blood vessel 12 and the interior volume 14 of the aneurysm 10, thereby reducing the likelihood of rupture of the aneurysm 10. Alternatively, in the event that the aneurysm 10 has already ruptured, the occlusive device 100 is being implanted to help heal the rupture and / or prevent re-rupture. The occlusive device 100 is constructed as a low-profile device that minimizes disruption to the surrounding body, such as the side branches 18 of the blood vessel 12. The blood vessel 12 has a vessel wall 13 and the aneurysm 10 has an aneurysm wall 11. In Fig.23 In the embodiment of the present invention, the delivery catheter 150 is advanced through a puncture or incision in a peripheral blood vessel (e.g., a femoral artery, a brachial artery, or a radial artery) through a sheath and / or a guide catheter (not shown). The distal end 162 of the delivery catheter 150 can be curved as shown by the manufacturer or by the user prior to surgery to allow for improved backup support when delivering the occluding device 100, as well as the ability to aid delivery into the aneurysm 10. The distal end 162 of the delivery catheter 150 is placed proximate to the neck 16 of the aneurysm 10. The delivery catheter 150 can first be advanced over a guide wire (not shown) passing through the lumen 148. The guide wire can then be removed, leaving the lumen 148 as a delivery conduit and the delivery catheter 150 as a support column.

[0149] exist Fig.24, as described, the occluding device 100 is advanced through the lumen 148 of the delivery catheter 150, and the distal end 118 of the occluding device 100 having the smooth apex 124 (of the curve in the tubular mesh 122) is advanced out of the lumen 148 and into the interior volume 14 of the aneurysm 10. The smooth apex 124 is the first portion of the occluding device 100 to exit the lumen 148 and, therefore, is the first portion of the occluding device to enter the aneurysm 10. The smooth apex 124, due to the curved and contoured surface and its flexible mesh wall, is a blunt, soft, and atraumatic element that is configured to first contact the inner surface 15 of the aneurysm 10. The smooth apex 124 can contact the inner surface 15 and slide around the inner surface 15 less traumatically than most devices that are configured to be implanted in aneurysms, such as small diameter detachable coils. The atraumatic nature of the smooth apex 124 makes it fully deployable not only in unruptured cerebral aneurysms, but also in ruptured cerebral aneurysms where certain other devices may be contraindicated. In Fig.25 , the occlusive device 100 is shown in a substantially expanded configuration within the interior volume 14 of the aneurysm 10. The cap 102 is expanded against the interior surface 15 of the aneurysm 10 and covers the neck 16 of the aneurysm. The tubular mesh 122 is expanded against the interior surface 15 of the aneurysm 10 at least in one or more portions and serves to anchor or stabilize the cap 102 in the aneurysm 10 and adjacent the neck 16.

[0150] In addition, Fig.25 In the embodiment, the removable joint 158 ​​has been detached, so the free end 154 of the pusher 152 can be pulled into the lumen 148 of the delivery catheter 150. In some embodiments, the delivery catheter 150 remains on the removable joint 158 ​​during the detachment process to further protect the aneurysm 10. Fig.26 In the embodiment of the present invention, the delivery catheter 150 is removed and the deployed occluding device 100 is in place to begin occluding the interior volume 14 of the aneurysm 10. The expanded tubular mesh 122 also serves to force the cap 102 against the neck 16 and / or against the inner surface 15, see Fig.26 The straight arrow in the figure. The double-layer mesh in the cover 102 at the lower part 107 ( Fig.18 and Fig.26 ) helps to interrupt blood flow into the aneurysm 10, thereby causing thrombosis to form to isolate the interior volume 14 of the aneurysm 10 from blood flow through the blood vessel 12. The force (straight arrows) holding the cap 102 in place further ensures this process and also prevents undesirable compaction of the occluding device 100 over time, whether in the longitudinal direction or in the transverse or radial directions.

[0151] Fig. 27 An occlusive device 500 is shown that is configured for placement within an aneurysm. The occlusive device 500 is Fig.18An alternative construction of the occlusion device 100 includes a cover 502 having an outer diameter DD. In some embodiments, the cover 502 is circular, having substantially the same diameter DD at any measurement around the perimeter of each transverse plane. In other embodiments, the cover 502 is non-circular and may include a cross-section having an elliptical, oval, polygonal, or other shape. In non-circular embodiments, the cover 502 includes a minimum transverse dimension and a maximum transverse dimension. In the specific case of an elliptical or oval shape, the cover 502 includes a major diameter and a minor diameter. The minor diameter or minimum transverse dimension is configured to be larger than the maximum transverse dimension of the opening into the aneurysm (neck). Therefore, the cover 502 is configured to completely cover the neck, thereby causing blood stagnation within the aneurysm, resulting in occlusion. The cover 502 is constructed of a mesh (braided) nitinol (nickel-titanium alloy) tube 505 that is inverted on itself. The mesh tube 505 has a first end 504 and a second end 506 ( Fig.28 ), similar to Fig. 20 The first end 104 and the second end 106. The second end 506 is folded back on the outer diameter of the first end 504 to provide an outwardly facing surface 508 and an inwardly facing surface 510 ( Fig.30 ). The mesh tube 505 is thermoformed so that the cap 502 includes an expanded portion and the first end 504 and the second end 506 include an unexpanded (or partially expanded) portion. Thermoforming can be as described with respect to Fig.18 The occluder device 100 is described as described above. The cap 502 has a generally disc shape defined by an outwardly facing surface 508. In some embodiments, the cap 502 can include an annular, partially annular shape. The occluder device 500 includes a distal end 518 and a proximal end 520. When formed (e.g., thermoformed), the cap 502 has an expanded configuration (e.g., Fig. 27 ) and contraction structures, such as Fig.28 As shown. The cover 502 comprises two mesh layers, provided by an outwardly facing surface 508 and an inwardly facing surface 510. In some embodiments, the cover 502 may comprise some nickel-titanium wires and some radiopaque elements, comprising an alloy of platinum, gold, tantalum or any of these or other radiopaque materials. In some embodiments, the wire may comprise a stretched filling tube (DFT), such as those comprising a nickel-titanium alloy outer wall and a platinum core. The radiopaque material allows the cover 502 to be visible in radiographs or fluoroscopy. The occluding device 500 can be configured by controlling how much radiopaque material is used, by the ratio of radiopaque wire to non-radiopaque wire, or by the amount of platinum core in the stretched filling tube. In this way, the cover 502 can be selectively made to be visible enough, but not too visible, such as too bright, so that other objects are obscured. In some embodiments, whether or not any of the filaments include a radiopaque material, the marker band 521 can be attached to the proximal end 520 of the occluder device 500 by adhesive or epoxy bonding, or swaging, welding, or other mechanical attachment.

[0152] Extending from the opening 503 in the distal end 519 of the cap 502 is a first bifold or annular tubular mesh 522 and a second bifold or annular tubular mesh 523. The first annular tubular mesh 522 has a smooth apex 524 configured to securely contact the inner wall of the aneurysm. The second annular tubular mesh 523 has an apex 525 configured to fit within the central axis 540 of the first tubular mesh 522. The first tubular mesh 522 and the second tubular mesh 523 are oriented in planes that are not parallel to each other. Fig.29 As shown, in one embodiment, the first tubular net 522 and the second tubular net 523 are orthogonal to each other and substantially follow orthogonal planes or planes at right angles to each other. The first tubular net 522 has a first end 526 and a second end 528, and a middle portion 530 extending between the first end 526 and the second end 528. Fig. 27 In the illustrated embodiment, the first end 526 and the second end 528 are substantially unexpanded and are aligned with the Fig. 20 The first end 104 and the second end 106 are inserted into a cavity (not shown) in the inverted mesh tube 505 forming the cover 502 in a similar manner. Similarly, the second tubular mesh 523 has a first end 527 and a second end 529, and a middle portion 531 extending between the first end 527 and the second end 529. Fig. 27 In the illustrated embodiment, the first end 527 and the second end 529 are substantially unexpanded and inserted into a cavity (not shown) within the inverted mesh tube 505 forming the cap 502. The first ends 526, 527 and the second ends 528, 529 of the first tubular mesh 522, 523 can be bonded into the cavity with an adhesive, or alternatively bonded with epoxy, or welded or bonded with any other fixing technique. The first ends 526, 527 and the second ends 528, 529 can each be compressed or deformed into an oval, elliptical or D-shape so that they can more effectively fit the circular cross-section of the cavity. Alternatively, the first ends 526, 527 and the second ends 528, 529 can ... Fig.21 The first tubular mesh 522 and the second tubular mesh 523 can both be constructed from mesh (braided) Nitinol (nickel-titanium alloy) tubes, and can also include wires of platinum or other radiopaque materials, as well as nickel-titanium wires. A stretch fill tube can also be used.

[0153] The middle portion 530 of the tubular mesh 522 further includes a first leg 536 and a second leg 538 extending therefrom between the apex 524 and the first and second ends 526, 528 of the middle portion 530. The middle portion 531 of the tubular mesh 523 further includes a first leg 537 and a second leg 539 extending therefrom between the apex 525 and the first and second ends 527, 528 of the middle portion 531. Fig. 27 In the illustrated embodiment, the first legs 536, 537 and the second legs 538, 539 are shown in their expanded states. Fig.29 , it can be understood that the spacing between the first leg 536, the first leg 537, the second leg 538 and the second leg 539. Each leg 536, 537, 538, 539 can form a circular cross-sectional shape when expanded, or can form a more oval or elliptical cross-sectional shape as they face or intersect each other. Each leg pair 536 / 538, 537 / 539 can form a first transverse dimension TD X and the second transverse dimension TD Y (See Fig.29 ). For example, in some embodiments, the first transverse dimension TD X may be larger than the second transverse dimension TD Y In some embodiments, the first transverse dimension TD X may be smaller than the second transverse dimension TD Y In some embodiments, the first transverse dimension TD X is configured to contact the inner wall of the aneurysm to stabilize the occlusion device 500 within the aneurysm, and the second transverse dimension TD Y In some embodiments, the second transverse dimension TD Y is configured to contact the inner wall of the aneurysm, and the first transverse dimension TD X In some embodiments, the first transverse dimension TD X and the second transverse dimension TD Y The cover 502 may alternatively have a distal concave surface, such as Fig.18 The cover 102 of the closure device 100. In addition, Fig.18 The cover 102 of the occluding device 100 may be a cover 502 without a distal concave surface but with an opening 503, such as Fig. 27 The occluding device 500.

[0154] Go to Fig.28, the occluding device 500 is shown with the cap 502 and tubular meshes 522, 523 in their collapsed or compacted configuration when placed into the lumen 148 of a delivery catheter 150 having a distal end 162 and a proximal end 164. The delivery catheter 150 can be a microcatheter having a lumen diameter of 0.017 inches or 0.021 inches, 0.025 inches or 0.028 inches or other sizes. An elongated pusher 857 having a distal end 859 and a proximal end 861 can include a wire, a hypotube, or another elongated structure having a column support and is removably coupled to the proximal end 520 of the occluding device 500 at its distal end 859. The removable joint 863 can include one of a variety of detachment systems, including but not limited to a pressurized detachment, an electrolytic detachment mechanism, a hydraulic detachment mechanism, a mechanical or interlocking detachment mechanism, a chemical detachment mechanism, a heat-activated detachment system, or a friction detachment system. During delivery, the pusher 857 is grasped by the user at its proximal end 861 and pushed in the longitudinal forward direction 160 in order to advance the occluding device 500 to the distal end 162 of the delivery catheter 150 .

[0155] exist Fig.31 , the occlusive device 500 is shown as being within the interior volume 14 of the aneurysm 10 (see Fig.23 ) is in a substantially expanded configuration. The cap 502 expands against the inner surface 15 of the aneurysm 10 and covers the neck 16 of the aneurysm. One or both of the first tubular mesh 522 and the second tubular mesh 523 expand against the inner surface 15 of the aneurysm 10 (see Fig.23 ), and is used to anchor or stabilize the cap 502 in the aneurysm 10 and near the neck 16. In addition, Fig.31 In the embodiment, the detachable joint 863 has been detached, so the free end 859 of the pusher 857 can be pulled into the lumen 148 of the delivery catheter 150. In some embodiments, the delivery catheter 150 is retained on the detachable joint 863 during the detachment process to further protect the aneurysm 10. Fig.32 In the embodiment, the delivery catheter 150 is removed and the deployed occluding device 500 is in place to begin occluding the interior volume 14 of the aneurysm 10. The expanded first tubular mesh 522 and the expanded second tubular mesh 523 are also used to force the cap 502 against the neck 16 and / or against the inner surface 15, see Fig.32 The double layer of mesh in the cap 502 at the lower portion 507 helps interrupt blood flow into the aneurysm 10, thereby causing thrombosis to form to isolate the interior volume 14 of the aneurysm 10 from blood flow through the blood vessel 12. The force holding the cap 502 in place (straight arrow) further ensures this process and also prevents undesirable compaction of the occluding device 500 over time.

[0156] Fig.33An occluding device 865 is shown, which includes a first bifold or looped tubular mesh 867 and a second bifold or looped tubular mesh 203. The occluding device 865 is similar to Fig. 27 The occlusive device 500 of the present invention is provided with a first tubular mesh 867, but without a cover (e.g., cover 502). The first tubular mesh 867 includes a first end 869 and a second end 871, and the second tubular mesh has a first end 873 and a second end 875. All four ends 869, 871, 873, 875 are retained within a cylindrical marker band 877 in a collapsed or constrained configuration of the tubular mesh 867, 203. The marker band 877 can comprise stainless steel or a radiopaque material such as platinum, and the ends 869, 871, 873, 875 can be bonded within the lumen of the marker band 877 with an adhesive or epoxy, or can be brazed, soldered, or welded. The first annular tubular mesh 867 has a middle portion 211 having a smooth apex 879 configured to securely contact the inner wall of the aneurysm. The second annular tubular net 203 has a middle portion 213 having an apex 881 configured to fit within a central axis 883 of the first tubular net 867. The first tubular net 867 and the second tubular net 203 are oriented in planes that are not parallel to each other. Fig.33 As shown, the first tubular mesh 867 and the second tubular mesh 203 are substantially orthogonal to each other and substantially follow orthogonal planes or planes at right angles to each other. Because there is no cap, the first proximal end 885 and the second proximal end 887 of the first tubular mesh 867, and the first proximal end 889 and the second proximal end 891 of the second tubular mesh 203 are shaped and configured for placement (such as the cap 502) against the proximal end of the aneurysm, adjacent to the neck of the aneurysm, to substantially provide occlusion of the neck.

[0157] Fig.34An occlusive device 893 is shown, comprising a bifolded or looped tubular mesh 895 and a cap 897. The cap 897 comprises a single layer mesh tube 900 that is thermoformed as described herein. The cap 897 comprises a proximal end 899 (incorporated within a marker band 901) and a flared distal end 902 that allows for free expansion. The tubular mesh 895 comprises a first end 903 and a second end 904 that are also incorporated within the marker band 901, and a middle portion 905 having a smooth apex 906. The inner surface 907 of the first leg 251 of the tubular mesh 895 can be configured to contact the inner surface 908 of the second leg 253 of the tubular mesh 895 when the tubular mesh 895 is in its expanded configuration. In other embodiments, the size and configuration of the tubular mesh can be designed such that the inner surfaces 907, 908 are generally not in contact with each other while the tubular mesh is in its expanded configuration. The proximal face 909 of the cap 897 is configured to be disposed against the proximal portion of the aneurysm, adjacent the neck of the aneurysm, to substantially provide occlusion of the neck. The maximum diameter portion 910 of the cap 897 can be configured to engage with a wall surface on the aneurysm. In addition, the maximum transverse dimension portion 258 of the intermediate portion 905 of the mesh tube 895 is configured to engage the wall of the aneurysm.

[0158] Fig.35 An occluder device 300 is shown that includes a cap 302 that includes a concave surface 304 facing a distal end 306 of the cap 302 and away from a proximal end 308 of the cap 302. The cap 302 is fabricated as an inverted mesh tube 310 that has a simple straight elongated structure that is subsequently formed. Fig.35 The occluder device 300 is shaped as shown and heat set into such shape as previously described herein. The smooth fold 316 extends around the distal end 306 of the cover 302 and represents the transition between the outwardly facing surface 318 and the inwardly facing surface 320. The occluder device 300 is similar to Fig.18 The occlusive device 100 of the present invention is provided, however, the orifice 312 leading to the concave surface 304 is smaller than the maximum diameter 314 of the cap 302. The diameter of the orifice 312 is between about 35% and about 85%, or between about 45% and about 75%, or between about 50% and about 70%, or between about 55% and about 65% of the maximum diameter 314. Extending from the concave surface 304 is a bifold or annular tubular mesh 322 having a smooth apex 324, which is configured to safely contact the inner wall of the aneurysm. The tubular mesh 322 has a first end 326 and a second end 328, and a middle portion 330 extending between the first end 326 and the second end 328. The cap 302 and the tubular mesh 322 can have different characteristics from each other to optimize the performance characteristics of each. In certain embodiments, the cap 302 may include 36 to 144 wires, each having a diameter between about 0.00075 and 0.001 inches. In a particular embodiment, the cap 302 may include 72 nickel titanium wires, each having a diameter of 0.00085 inches.

[0159] In certain embodiments, the tubular mesh 322 may include 18 to 36 wires, each having a diameter between about 0.00075 and 0.00125 inches. In a specific embodiment described with respect to the cap 302, the tubular mesh is composed of 24 nickel-titanium wires, each having a diameter of 0.00093 inches. The specific diameters of 0.00085 and 0.00093 inches can be achieved by manufacturing wires having such diameters, or can be achieved by etching wires having a slightly larger diameter (e.g., 0.001 inches) until the desired diameter is reached. In a specific embodiment, the cap 302 has a maximum diameter 314 (in the expanded state) between about 4 mm and about 8 mm, or between about 5 mm and about 7 mm, or about 6 mm. The diameter of the tubular mesh 322 (in the expanded state) is between about 2 mm and 3 mm, or about 2.5 mm. In some embodiments, some or all of the wires may comprise a stretched fill tube (DFT) having a radiopaque cross-sectional fill area ratio of between about 10% to about 70% or between about 51% to about 70%. The fill material may be platinum, gold, tantalum, or an alloy of any of these. The particular embodiments described have excellent compression, compressing into a small diameter for delivery through a small catheter lumen, and having safety features when expanded and delivered into an aneurysm.

[0160] Fig.36 An occluding device 332 is shown, which includes Fig.35 The cover 334 of the occluding device 300 is similar to the cover 302. However, there are three folded or annular tubular nets 336, 338, 340, each having a smooth vertex 342, 344, 346, respectively. The three folded or annular tubular nets 336, 338, 340 are arranged adjacent to each other, like books on a bookshelf. Because the diameter of their middle parts 337, 339, 341 in the expanded configuration is greater than the diameter of their ends, the three folded or annular tubular nets 336, 338, 340 are fanned out. In some embodiments, the three folded or annular tubular nets 336, 338, 340 together form a fan angle α, which is between about 15° and about 90°, or between about 20° and about 75°, or between about 30° and about 60°. In an alternative embodiment, the three folded or looped tubular webs 336 , 338 , 340 lie in three substantially parallel planes that are not coplanar with one another, so that the three folded or looped tubular webs 336 , 338 , 340 are linearly arranged in a transverse dimension to the longitudinal axis 348 of the cover 334 .

[0161] Fig.37 An occluding device 350 is shown, which includes a cover 352 having a concave surface 351, and the cover 352 is similar to Fig.35The cover 302 of the occluding device 300 is shown. However, there are three bifold or annular tubular webs 354, 356, 358, each having a smooth vertex 360, 362, 364, respectively. The three bifold or annular tubular webs 354, 356, 358 are arranged adjacent to each other, like the ribs of an open folding hand fan. In some embodiments, all three annular tubular webs 354, 356, 358 together approximate a single plane. In other embodiments, the annular tubular webs 354, 356, 358 each approximate a different plane, together approximate an open triptych. In some embodiments, the annular tubular meshes 354, 356, 358 together form a fan angle β between the centerline 355 of the first outer tubular mesh 354 and the centerline 357 of the second outer tubular mesh 358, that is, between about 15° and about 120°, or between about 20° and about 90°, or between about 25° and about 75°, or between about 30° and about 60°. In some embodiments, the annular tubular meshes 354, 356, 358 together form a fan angle γ between the overall outer contour line 359 of the first outer tubular mesh 354 and the overall outer contour line 361 of the second outer tubular mesh 358, that is, between about 20° and about 150°, or between about 30° and about 120°, or between about 30° and about 90°. The outer contour lines 359, 361 extend between the attachments 366 at the first and second ends of the tubular meshes and the points of maximum lateral extension 368, 369. The maximum transverse dimension T is formed by three annular tubular meshes 354, 356, 358 and is configured to contact the inner surface of the aneurysm on both sides to stabilize the occlusion device 350 within the aneurysm. The cap 352 is configured to seal or occlude the aneurysm adjacent the neck, as in other caps presented herein.

[0162] Fig.38 An occluder device 370 is shown that includes an outer cover 372 and an inner cover 374. The outer cover 372 includes a concave surface 376 facing a distal end 378 of the outer cover 372 and away from a proximal end 380 of the outer cover 372. The inner cover 374 is disposed within the concave surface 376 of the outer cover 372 and includes a concave surface 386 facing a distal end 388 of the inner cover 374 and away from a proximal end 390 of the outer cover 374. The outer cover 372 has a distal flare 392, and the inner cover 374 has a maximum diameter 394 and a reduced diameter distal orifice 396. The covers 372, 374 are each manufactured as an inverted mesh tube 382, ​​384 having a simple straight elongated configuration and are subsequently formed into Fig.38The shapes shown in the figure are heat set to these shapes as described above. Any of the covers 372, 374 can have the material or dimensional characteristics of any other cover described herein. The overlapping dimension Do has an increased weaving density because it is basically the weaving density (e.g., number of picks per inch) of the two covers 372, 374 combined. Therefore, a large amount of blood flow stagnation can be achieved at the neck of the aneurysm to form a thrombus and occlude the aneurysm. Extending from the concave surface 386 is a folded or annular tubular mesh 398 with a smooth vertex 399, which is constructed to safely contact the inner wall of the aneurysm. The tubular mesh 398 has a first end 397 and a second end 395, and an intermediate portion 393 extending between the first end 397 and the second end 395. The outer cover 372, the inner cover 374 and the tubular mesh 398 can each have different characteristics from each other to optimize their respective performance characteristics. In one embodiment, the inner cover 374 has a first weaving density and the outer cover 372 has a second weaving density greater than the first weaving density. The tubular mesh 398 has a third braid density that is less than the first braid density. In some embodiments, the second braid density is between 110% and 200% of the first braid density. In some embodiments, the first braid density is between 110% and 200% of the third braid density. In certain embodiments, the outer cover 372 may include 24 to 48 wires, the inner cover 374 may include 12 to 36 wires, and the tubular mesh 398 may include 6 to 24 wires. The diameter of each wire may be between about 0.0006 to about 0.0015 inches, or between about 0.00075 to about 0.00125 inches. In a specific embodiment, the outer cover 372 may include 36 wires, the inner cover 374 may include 24 wires, and the tubular mesh 398 may include 12 wires. The wire may include nickel titanium alloy, or DFT wire, or a combination thereof. The inner cover 374 may be additionally used to stabilize the tubular mesh 398 so that its loop remains substantially upright. The outer cover 372 is configured to clamp the inner wall of the aneurysm at its distal flare 392. As in all occluding devices, a marker band 379 may be carried at the end of the occluding device 370 and is configured to retain the ends 395, 397 and serve as a radiopaque indicator of the proximal end of the occluding device 370 under x-ray or fluoroscopy.

[0163] In any of the embodiments presented herein, the bifurcated or looped tubular mesh may be configured to engage a portion of the inner wall of the aneurysm, up to and including a majority of the wall of the entire aneurysm sac. In any of the embodiments presented herein that include a cover, the cover may be configured to engage the inner wall of the aneurysm at or adjacent to the neck of the aneurysm. The engagement may include radial forces. In some embodiments, the cover may be configured to cover the neck of the aneurysm without significantly engaging the aneurysm wall using radial forces.

[0164] Additional material may be carried on the proximal end of the cap or any portion of the occlusive device adjacent the aneurysm neck to promote healing of the aneurysm neck. Fig.39 An occlusive device 301 is shown comprising a cover 303 coupled to a bifolded or looped tubular mesh 305 having a first leg 307 and a second leg 309. The cover 303 comprises a biolayer 311 configured to promote growth. In some embodiments, the biolayer 311 may comprise antibodies to accelerate the formation of an endothelial layer, such as by attracting endothelial progenitor cells (EPCs). In some embodiments, the biolayer 311 may comprise a natural membrane or structure, such as a membrane, such as from an ear, or a cornea, or an ultrathin sheet of ligament, or even a sheet of a blood vessel wall.

[0165] Fig.40 An occlusive device 313 is shown comprising a cover 315 coupled to a bifolded or looped tubular mesh 317 having a first leg 319 and a second leg 321. The cover 315 comprises a polymer layer 323 configured to act as a simulated arterial wall. In some embodiments, the polymer layer 323 may comprise polytetrafluoroethylene, such as expanded polytetrafluoroethylene (ePTFE), such as polytetrafluoroethylene for implantation.

[0166] The following items include examples of the disclosed apparatus.

[0167] Item 1: In one example, an apparatus for treating an aneurysm in a blood vessel includes an occlusive element configured to be releasably coupled to an elongated delivery shaft, the occlusive element including a cap comprising a mesh material and configured to be delivered in a collapsed configuration through a lumen of a delivery catheter having a proximal end and a distal end, the cap further configured to expand to an expanded configuration when advanced out of the distal end of the lumen of the delivery catheter and into the aneurysm, wherein the cap includes a diameter greater than a diameter or a maximum transverse dimension of a neck of the aneurysm, and wherein the cap includes a distal concave surface configured to extend beyond the distal end of the lumen of the delivery catheter and into the aneurysm. The invention relates to a first tubular mesh having a first end, a second end, a wall and a cavity, wherein the first end and the second end of the first tubular mesh are coupled to the central portion of the cap so that the middle portion of the first tubular mesh between the first end and the second end includes a substantially 180 degree turn, the middle portion of the first tubular mesh extending from the distal concave surface of the cap, wherein the middle portion of the first tubular mesh has a contracted structure configured to be delivered through the inner cavity of a delivery catheter, and wherein the middle portion of the first tubular mesh is configured to expand to an expanded structure when advancing out of the distal end of the inner cavity of the delivery catheter into the aneurysm.

[0168] Item 2: In some examples, the apparatus includes Item 1, wherein the occlusive element is configured such that the intermediate portion of the first tubular mesh is the first portion delivered from the distal end of the delivery catheter lumen.

[0169] Item 3: In some examples, the apparatus includes item 2, wherein the intermediate portion of the first tubular mesh, when in its expanded configuration, includes a first leg and a second leg, the first leg being configured to contact the second leg.

[0170] Item 4: In some examples, the apparatus includes any of items 1-3, wherein the cover is formed of a tube having a cover cavity, and wherein the first end and the second end of the first tubular mesh are configured to be inserted into the cover cavity.

[0171] Item 5: In some examples, the apparatus includes Item 4, wherein the first end and the second end of the first tubular mesh are configured to be secured adjacent to each other in a collapsed state within the cap cavity.

[0172] Item 6: In some examples, the device includes Item 4, further comprising a cutout in the wall of the first tubular mesh at the first end, wherein the second end in a contracted state is retained within the first end, and wherein the first end and the second end are secured within the cover cavity.

[0173] Item 7: In some examples, the device includes any of Items 5 or 6, wherein the first end and the second end of the first tubular mesh are fixed within the cap cavity at a position proximal to the distal concave surface of the cap.

[0174] Item 8: In some examples, the device includes item 7, further comprising a pusher having a proximal end and a distal end, wherein the occluding element is configured to releasably couple to the distal end of the pusher at a releasable joint.

[0175] Item 9: In some examples, the device includes item 8, wherein the releasable joint is located within the cover cavity at a proximal location adjacent to the distal concave surface of the cover.

[0176] Item 10: In some examples, the apparatus includes any of items 1-3, wherein the intermediate portion of the first tubular mesh has a maximum transverse dimension that is greater than a diameter of the cap when in its expanded configuration.

[0177] Item 11: In some examples, the device includes any of items 1-10, wherein the cover is circular.

[0178] Item 12: In some examples, the device includes any of items 1-10, wherein the cover is elliptical or oval, and wherein the cover has a minor diameter or minimum transverse dimension that is greater than a diameter or maximum transverse dimension of the aneurysm neck.

[0179] Item 13: In some examples, the apparatus includes any of items 1-12, wherein the cover includes two layers of mesh.

[0180] Item 14: In some examples, the device includes item 13, wherein the cover is constructed of an inverted mesh tube.

[0181] Item 15: In some examples, the device includes any of items 1-14, wherein the cover includes a nickel-titanium alloy.

[0182] Item 16: In some examples, the apparatus includes any of items 1-15, wherein the first tubular mesh includes a nickel-titanium alloy.

[0183] Item 17: In some examples, the device includes any of items 1-16, wherein the occluding element includes a radiopaque material.

[0184] Item 18: In some examples, the device includes any of items 1-17, wherein the radiopaque material includes a marker band.

[0185] Item 19: In some examples, the apparatus includes any of items 1-18, wherein the marker band is coupled to the first end and the second end of the first tubular mesh.

[0186] Item 20: In some examples, the device includes any of items 18 or 19, wherein the marker band is coupled to the proximal end of the cover.

[0187] Item 21: In some examples, the device includes any of items 1 or 2, wherein the occluding element further includes a second tubular mesh having a first end, a second end, a wall, and a cavity, the first end and the second end of the second tubular mesh being coupled to a central portion of the cover such that a middle portion of the second tubular mesh between the first end and the second end includes a substantially 180 degree turn, the middle portion of the second tubular mesh extending from a distal concave surface of the cover, wherein the middle portion of the second tubular mesh has a contracted structure configured to be delivered through an inner cavity of a delivery catheter, and wherein the middle portion of the second tubular mesh is configured to expand to an expanded structure when advancing out of the distal end of the inner cavity of the delivery catheter and into the aneurysm.

[0188] Item 22: In some examples, the apparatus includes item 21, wherein the intermediate portion of the first tubular mesh, when in its expanded configuration, includes first and second legs, and wherein the second tubular mesh passes between the first and second legs of the first tubular mesh.

[0189] Item 23: In some examples, the apparatus includes item 22, wherein a substantially 180 degree turn of the first tubular mesh generally defines a first plane, and wherein a substantially 180 degree turn of the second tubular mesh generally defines a second plane that is not parallel to the first plane.

[0190] Item 24: In some examples, the apparatus includes item 23, wherein the second plane is generally perpendicular to the first plane.

[0191] Item 25: In another example, a device for treating an aneurysm in a blood vessel includes an occlusive element configured to be releasably coupled to an elongated delivery shaft, the occlusive element including a cover comprising a mesh material and configured to be delivered in a contracted configuration through a lumen of a delivery catheter having a proximal end and a distal end, the cover further configured to expand to an expanded configuration when advanced out of the distal end of the lumen of the delivery catheter and into the aneurysm, wherein the cover includes a diameter greater than a diameter or maximum transverse dimension of a neck of the aneurysm; a first tubular mesh having a first end, a second end, a wall, and a cavity, the first end and the second end of the first tubular mesh being coupled to a central portion of the cover such that a mid-portion of the first tubular mesh between the first end and the second end includes a substantially 180 degree turn, the mid-portion of the first tubular mesh extending from the distal end of the cover. The cover is a cap having a first end, a second end, a wall and a cavity, the first end and the second end of the second tubular mesh being coupled to the central portion of the cover so that the middle portion of the second tubular mesh between the first end and the second end includes a substantially 180 degree turn, the middle portion of the second tubular mesh extending from the distal concave surface of the cover, wherein the middle portion of the second tubular mesh has a contracted structure configured to be delivered through the inner cavity of the delivery catheter, and wherein the middle portion of the second tubular mesh is configured to expand to an expanded structure when advancing out of the distal end of the inner cavity of the delivery catheter and into the aneurysm.

[0192] Item 26: In some examples, the apparatus includes item 25, wherein the intermediate portion of the first tubular mesh, when in its expanded configuration, includes a first leg and a second leg, wherein the second tubular mesh passes between the first leg and the second leg of the first tubular mesh.

[0193] Item 27: In some examples, the apparatus includes item 25, wherein the wall of the first tubular mesh has a first opening and a second opening, wherein the second tubular mesh enters the first opening and exits the second opening.

[0194] Item 28: In some examples, the apparatus includes any of items 25-27, wherein the cover includes an aperture in the mesh material and wherein the first tubular mesh and the second tubular mesh pass through the aperture.

[0195] Item 29: In another example, a device for treating an aneurysm in a blood vessel includes an occlusive element configured to be releasably coupled to an elongated delivery shaft, the occlusive element including a cover comprising a mesh material and configured to be delivered in a contracted configuration through an inner cavity of a delivery catheter, the inner cavity having a proximal end and a distal end, the cover further configured to expand to an expanded configuration when advanced out of the distal end of the inner cavity of the delivery catheter and into the aneurysm, wherein the cover in the expanded configuration has a transverse dimension greater than a maximum transverse dimension of a neck of the aneurysm; and a first tubular mesh having a first end, a second end, a wall, and a cavity, the first end and the second end of the first tubular mesh being coupled to a central portion of the cover such that a middle portion of the first tubular mesh between the first end and the second end includes a substantially 180 degree turn, the middle portion of the first tubular mesh extending distally from the central portion of the cover, wherein the middle portion of the first tubular mesh has a contracted configuration configured to be delivered through the inner cavity of the delivery catheter, and wherein the middle portion of the first tubular mesh is configured to expand to an expanded configuration when advanced out of the distal end of the inner cavity of the delivery catheter and into the aneurysm.

[0196] Item 30: In some examples, the device includes item 29, wherein the occlusive element is configured such that the intermediate portion of the first tubular mesh is configured to begin exiting the distal end of the lumen of the delivery catheter prior to the cap.

[0197] Item 31: In some examples, the apparatus includes item 30, wherein the intermediate portion of the first tubular mesh, when in its expanded configuration, includes a first leg and a second leg, the first leg being configured to contact the second leg.

[0198] Item 32: In some examples, the apparatus includes item 29, wherein the cover is formed of a tube having a cover cavity, and wherein the first end and the second end of the first tubular mesh are configured to be inserted into the cover cavity.

[0199] Item 33: In some examples, the apparatus includes item 32, wherein the first end and the second end of the first tubular mesh are configured to be secured adjacent to each other in a collapsed state within the cap cavity.

[0200] Item 34: In some examples, the device includes item 33, wherein the cap includes a distal concave surface configured to face away from the neck of the aneurysm.

[0201] Item 35: In some examples, the device includes item 34, wherein the first end and the second end of the first tubular mesh are fixed within the cap cavity at a location proximal to the distal concave surface of the cap.

[0202] Item 36: In some examples, the device includes item 32, further comprising an at least partially longitudinally extending cut in the wall at the first end of the first tubular mesh, wherein the second end in a contracted state is surrounded by the first end, and wherein the first end and the second end are fixed within the cover cavity.

[0203] Item 37: In some examples, the device includes item 29, further comprising a pusher having a proximal end and a distal end, wherein the occluding element is releasably coupled to the distal end of the pusher at a releasable joint.

[0204] Item 38: In some examples, the apparatus includes item 29, wherein the intermediate portion of the first tubular mesh, when in its expanded configuration, has a maximum transverse dimension that is greater than a maximum transverse dimension of the cap.

[0205] Item 39: In some examples, the device includes item 29, wherein the cover includes two layers of mesh.

[0206] Item 40: In some examples, the device includes item 39, wherein the cover is constructed of an inverted mesh tube.

[0207] Item 41: In some examples, the device includes item 29, wherein the occluding element further includes a second tubular mesh having a first end, a second end, a wall, and a cavity, the first end and the second end of the second tubular mesh being coupled to a central portion of the cover such that a middle portion of the second tubular mesh between the first end and the second end includes a substantially 180 degree turn, the middle portion of the second tubular mesh extending from the central portion of the cover, wherein the middle portion of the second tubular mesh has a contracted structure configured to be delivered through an inner cavity of a delivery catheter, and wherein the middle portion of the second tubular mesh is configured to expand to an expanded structure when advanced out of the distal end of the inner cavity of the delivery catheter and into the aneurysm.

[0208] Item 42: In some examples, the apparatus includes item 41, wherein the intermediate portion of the first tubular mesh, when in its expanded configuration, includes first and second legs, and wherein the second tubular mesh passes between the first and second legs of the first tubular mesh.

[0209] Item 43: In some examples, the apparatus includes item 42, wherein the substantially 180 degree turn of the first tubular mesh generally defines a first plane, and wherein the substantially 180 degree turn of the second tubular mesh generally defines a second plane, the second plane being non-parallel to the first plane.

[0210] Item 44: In some examples, the apparatus includes item 43, wherein the second plane is generally perpendicular to the first plane.

[0211] Item 45: In some examples, the apparatus includes item 41, wherein the wall of the first tubular mesh has a first opening and a second opening, wherein the second tubular mesh enters the first opening and exits the second opening.

[0212] Item 46: In some examples, the apparatus includes item 45, wherein the first opening comprises a first cutout in a wall of a first tubular mesh and wherein the second opening comprises a second cutout in the wall of the tubular mesh.

[0213] Item 47: In some examples, the device includes Item 41, wherein the middle portion of the first tubular mesh in its expanded structure has a maximum transverse dimension, and the middle portion of the second tubular mesh in its expanded structure has a maximum transverse dimension, and the maximum transverse dimension of the middle portion of the first tubular member is greater than the maximum transverse dimension of the middle portion of the second tubular member.

[0214] Item 48: In some examples, the apparatus includes item 47, wherein the maximum transverse dimension of the middle portion of the first tubular mesh and the maximum transverse dimension of the middle portion of the second tubular mesh are both different than the maximum transverse dimension of the cover.

[0215] Item 49: In some examples, the device includes item 41, wherein the cover includes a hole in the mesh material at the distal end of the cover, and wherein the intermediate portion of the first tubular mesh and the intermediate portion of the second tubular mesh pass through the hole.

[0216] Item 50: In some examples, the device includes item 41, wherein when in its expanded structure, the middle portion of the first tubular mesh includes a first leg and a second leg, and wherein the second tubular mesh includes a first leg and a second leg when in its expanded structure, the first leg of the first tubular mesh is adjacent to and on a first side of the first leg of the second tubular mesh, and the second leg of the first tubular mesh is adjacent to and on the first side of the second leg of the second tubular mesh.

[0217] Item 51: In some examples, the apparatus includes item 29, wherein the cover includes an aperture in the mesh material and wherein the middle portion of the first tubular mesh passes through the aperture.

[0218] Item 52: In some examples, the device includes item 29, wherein the cover has a circular outer shape.

[0219] Item 53: In some examples, the apparatus includes item 29, wherein the cover has a longitudinal cross-section that is generally trapezoidal in shape.

[0220] Item 54: In some examples, the device includes item 29, wherein at least the mesh of the cover comprises a stretched fill tube having a radiopaque core and a nickel-titanium alloy.

[0221] Item 55: In some examples, the apparatus includes item 54, wherein the radiopaque core of each of at least some of the stretched fill tubes has a cross-sectional area between about 51% and about 70% of the total cross-sectional area of ​​each of at least some of the stretched fill tubes.

[0222] Item 56: In some examples, the device includes item 29, wherein the mesh of the cover is woven from wire, and wherein between about 50% and about 100% of the wire comprises stretched fill tubes.

[0223] Item 57: In another example, a device for treating an aneurysm in a blood vessel includes an occluding element configured to be releasably coupled to an elongated delivery shaft, the occluding element comprising a first tubular mesh having a first end, a second end, a wall, and a cavity, the first end and the second end of the first tubular mesh being coupled together at a proximal end of the occluding element such that a middle portion of the first tubular mesh between the first end and the second end comprises a substantially 180 degree turn, the middle portion of the first tubular mesh extending from the proximal end to the distal end of the occluding element, wherein the middle portion of the first tubular mesh has a contracted structure configured to be delivered through an inner cavity of a delivery catheter, and wherein the middle portion of the first tubular mesh is configured to expand to an expanded structure when advanced out of the distal end of the inner cavity of the delivery catheter and into the aneurysm.

[0224] Item 58: In some examples, the device includes item 57, wherein the occluding element further includes a second tubular mesh having a first end, a second end, a wall, and a cavity, the first end and the second end of the second tubular mesh being coupled to the proximal end of the occluding element such that a middle portion of the second tubular mesh between the first end and the second end includes a substantially 180 degree turn, the middle portion of the second tubular mesh extending from the proximal end to the distal end of the occluding element, wherein the middle portion of the second tubular mesh has a contracted structure configured to be delivered through an inner cavity of a delivery catheter, and wherein the middle portion of the second tubular mesh is configured to expand to an expanded structure when advanced out of the distal end of the inner cavity of the delivery catheter and into the aneurysm.

[0225] Fig.41 An occlusive device 200 configured for placement within an aneurysm is shown. The occlusive device 200 comprises a proximal segment 202 and a distal segment 204, each comprised of a single continuous double-layer mesh. Fig.42, the occluding device 200 is constructed of an everted mesh tube 206 having a first end 208, a second end 210, and a wall 209. The everted mesh tube 206 extends on an outer layer 212 from the second end 210 through the proximal end 214 of the proximal segment 202 and along a proximal hemispherical shape 216 to a maximum diameter portion 218 having an acute angle 219. From the maximum diameter portion 218, the outer layer 212 extends radially inward along a substantially flat portion 220 to a central waist 222. The outer layer 212 then extends radially outward along a substantially flat portion 224 of the distal segment 204 to a maximum diameter portion 226 having an acute angle 227, to a distal hemispherical shape 228, to a distal end 230 of the occluding device 200. The hemispherical shape 228 is configured to contact at least a portion of the dome of the aneurysm. The diameter of the maximum diameter portion 226 is approximately equal to the diameter of the maximum diameter portion 218, but in other embodiments, they may be different. The occluder device 200 is substantially cylindrically symmetrical about the central axis Z. However, in alternative embodiments, there may be certain asymmetric portions, such as one or more indented or extended features at specific locations of the perimeter. At the distal end 230, the wall 209 is inverted inwardly at the inversion fold 232, which creates a distal orifice 234 and an internal volume 236. The wall 209 transitions from the outer layer 212 to the inner layer 238 at the inversion fold 232, and the inner layer 238 follows the contour of the outer layer 212 from the distal orifice 234 to the first end 208. The inner layer 238 follows the hemispherical shape 240, the maximum diameter portion 242 with an acute angle 244, the substantially flat portion 246 of the distal segment 204, the central waist 248, the substantially flat portion 250 of the proximal segment 202, the maximum diameter portion 252 with an acute angle 254, and the hemispherical shape 256. The occluder device 200 is manufactured as an inverted mesh tube 206 having a simple straight elongated configuration and is subsequently formed into Fig.41 and Fig.42 The shape shown in the figure is formed and heat-set into such shape. For example, the occluding device 200 can be constructed as a single-layer mesh tube formed by at least some nickel-titanium alloy wires and then turned over on itself. The turned mesh tube 206 can then be placed into a die or mold containing one or more components to keep it in the shape of the occluding device 200. The occluding device 200 can then be subjected to an elevated temperature and then cooled to lock the shape, resulting in the occluding device 200 having at least some superelastic properties. Each of the proximal segment 202 and the distal segment 204 is constructed to be compressed or compacted within the cavity 148 of the delivery catheter 150 (e.g., a microcatheter).

[0226] In some embodiments, one or both of the proximal section 202 or the distal section 204 may include some nickel-titanium alloy wires and some radiopaque elements, including platinum, gold, tantalum or alloys of any of these or other radiopaque materials. In some embodiments, the wire may include a stretched filling tube, such as those including a nickel-titanium alloy outer wall and a platinum core. The radiopaque material allows the occluding device 200 to be visible in radiographs or fluoroscopy. The occluding device 200 can be constructed by controlling how much radiopaque material is used, by the ratio of radiopaque wire to non-radiopaque wire, or by stretching the amount of platinum core in the filling tube. In this way, the occluding device 200 can be selectively made to be visible enough, but not overly visible, such as too bright, so that other objects are obscured. In some embodiments, whether any wire includes radiopaque material, the marker band can be attached to the proximal end 214 of the proximal section 202 by adhesive or epoxy resin bonding, or forging, welding or other mechanical attachment.

[0227] Fig.43 An occluder device 260 is shown that also includes an inverted mesh tube 262 and has an outer layer 264, an inner layer 266, and an inverted fold 268, which creates a distal orifice 270 and serves as a transition between the outer layer 264 and the outer layer 266. The inverted mesh tube 262 has a first end 284 and a second end 286. The occluder device 260 includes a proximal segment 272 and a distal segment 274. The proximal segment 272 and the distal segment 274 have generally flat portions 276, 278, and the distal segment 274 has a distal hemispherical shape 280 that is configured to contact the dome of the aneurysm. There is a waist 281 between the generally flat portions 276, 278. The diameter of the maximum diameter portion 279 is approximately equal to the diameter of the maximum diameter portion 277, but in other embodiments, they may be different. The proximal section 272 includes a concave tapered shape 282 or a circumferentially extending concave surface that can be configured to direct blood flow, particularly when the occluding device 260 is implanted within a bifurcated aneurysm or a terminal aneurysm, wherein blood flow is directed along the path of arrow 288 or arrow 290. The occluding device 260 can comprise any material and be made with any of the processes described with respect to the occluding device 200.

[0228] Fig.44An occluding device 911 is shown that also includes an inverted mesh tube 913 and has an outer layer 914, an inner layer 915, and an inverted fold 916, which creates a distal orifice 917 and serves as a transition between the outer layer 914 and the outer layer 915. The inverted mesh tube 913 has a first end 918 and a second end 919. The occluding device 911 includes a proximal segment 920 and a distal segment 921. The proximal segment 920 and the distal segment 921 have substantially flat portions 922, 923, and the distal segment 921 has a distal hemispherical shape 924 that is configured to contact the dome of the aneurysm. There is a waist 912 between the substantially flat portions 922, 923. The diameter of the maximum diameter portion 926 on the distal segment 921 is greater than the diameter of the maximum diameter portion 925 on the proximal segment 920, so the occluding device 911 is configured to be implanted in an aneurysm having a larger dome (distal) portion of the aneurysm sac and a smaller proximal portion. The proximal segment 920 of the occluding device 911 includes a partially convex, partially concave shape 927, which can be configured to direct blood flow along the concave portion 928, and is also configured to interface with the proximal portion of the aneurysm at the convex portion 929. The concave portion 928 and the convex portion 929 face substantially proximally. The occluding device 911 can include any material and be made with any process described with respect to the occluding device 200.

[0229] Fig.45 An occluding device 931 is shown that also includes an inverted mesh tube 932 and has an outer layer 933, an inner layer 934, and an inverted fold 935, the inverted fold 935 creating a distal orifice 936 and serving as a transition between the outer layer 933 and the inner layer 934. The inverted mesh tube 932 has a first end 937 and a second end 938. The occluding device 931 includes a proximal segment 939 and a distal segment 940. The proximal segment 939 and the distal segment 940 have curved portions 941, 942 facing each other, and the proximal segment 939 has a hemispherical shape 943 that is configured to contact the proximal wall of the aneurysm. The diameter of the maximum diameter portion 945 of the distal segment 940 is smaller than the diameter of the maximum diameter portion 944 of the proximal segment 939, and thus, the occluding device 931 is configured to be implanted in an aneurysm having a smaller dome (distal) portion of the aneurysm sac and a larger proximal portion. The distal section 940 includes a smaller hemispherical shape 946. The occluder device 931 can comprise any material and be made using any of the processes described with respect to the occluder device 200.

[0230] exist Figure 46-Figure 49, an aneurysm 10 having a neck 16 is shown. The occluding device 200 shown is implanted in the aneurysm 10 by a user (e.g., a physician) via a delivery catheter 150 in use to interrupt or stop blood flow between the blood vessel 12 and the aneurysm's interior volume 14, thereby reducing the likelihood of rupture of the aneurysm 10 (or if previously ruptured, reducing the likelihood of re-rupture). The occluding device 200 is constructed as a low-profile device that minimizes damage to the surrounding body, such as the side branches 18 of the blood vessel 12. The blood vessel 12 has a vessel wall 13 and the aneurysm 10 has an aneurysm wall 11. In Fig.46 In the embodiment of the present invention, the delivery catheter 150 is advanced through a puncture or incision in a peripheral blood vessel (e.g., a femoral artery, a brachial artery, or a radial artery) through a sheath and / or a guide catheter (not shown). The distal end 162 of the delivery catheter 150 can be formed by the manufacturer or by the user prior to surgery into a curve as shown to provide improved backup support when delivering the occlusion device 200. The distal end 162 of the delivery catheter 150 is placed near the neck 16 of the aneurysm 10. The delivery catheter 150 can be advanced over a guide wire (not shown) passing through the lumen 148. The guide wire can then be removed, leaving the lumen 148 as a delivery conduit and the delivery catheter 150 as a support column.

[0231] exist Fig.47 , as described, the occluding device 200 is advanced through the lumen 148 of the delivery catheter 150, and the distal segment 204 of the occluding device 200 is advanced out of the lumen 148 and into the interior volume 14 of the aneurysm 10. The distal end 230 is the first portion of the occluding device 200 to exit the lumen 148, and is therefore the first portion of the occluding device to enter the aneurysm 10. The distal end 230 is blunt, soft, and atraumatic, and is configured to first contact the inner surface 15 of the aneurysm 10. Fig.48 , the occlusive device 200 is shown in a substantially expanded configuration within the interior volume 14 of the aneurysm 10. The proximal segment 202 is expanded against the interior surface 15 of the aneurysm 10 and covers the neck 16 of the aneurysm. The distal segment 204 is expanded against the interior surface 15 of the aneurysm 10 and serves to anchor or stabilize the proximal segment 202 in the aneurysm 10 and adjacent the neck 16.

[0232] In addition, Fig.48 In the embodiment, the removable connector 158 (see Fig.47 ) has been detached, so the free end 154 of the pusher 152 can be pulled into the lumen 148 of the delivery catheter 150. In some embodiments, during the detachment process, the delivery catheter 150 remains on the detachable connector 158 to further protect the aneurysm 10. Fig.49In the embodiment, the delivery catheter 150 is removed and the deployed occluding device 200 is in place to begin occluding the interior volume 14 of the aneurysm. The distal segment 204 is also used to force the proximal segment 202 against the neck 16 and / or against the inner surface 15, see Fig.49 The straight arrow in the figure. Fig.42 and Fig.49 ) helps interrupt blood flow into the aneurysm 10, thereby causing thrombosis to isolate the interior volume 14 of the aneurysm 10 from blood flow through the blood vessel 12. The waist 222 helps the distal segment 204 transfer forces to the proximal segment 202, although the maximum diameter portions 218, 226 are also configured to transfer forces to the substantially flat portions 220, 224, or to each other as the waist 222 is longitudinally compressed. The forces (straight arrows) holding the proximal segment 202 in place further ensure this process and also prevent unwanted compaction of the occluding device 200 over time. The double layer of mesh in the distal segment 204 can help with the healing of the dome. In an unruptured aneurysm, contact with the dome can lead to healing, which can thicken the dome in this portion, where the dome is typically in its thinnest, most stretched state. In a ruptured aneurysm, contact with the dome can act as a bandage, speeding up or augmenting the healing process to further avoid another rupture.

[0233] Figure 43-Figure 45 The occluding devices 260, 911, 931 are related to Figure 46-Figure 49 The occlusive device 200 is implanted into the aneurysm 10 in a manner similar to that described in the implantation procedure. Figure 50-Figure 53 Shows Figure 41-45 The invention provides an alternative embodiment of the occlusion device 200, 260, 911, 931. The occlusion devices 947, 950, 954, 958 are each similar to the occlusion devices 200, 260, 911, 931, respectively, except that the inner layer 948, 951, 955, 959 does not follow the contour of the outer layer 949, 952, 956, 960, but is essentially a straight tubular column. These columns can be the diameter of the original tubular mesh (when braided) or the diameter after expansion (when thermoformed). The inner layer 948, 951, 955, 959 can each provide additional column strength and longitudinal support, which can help to apply force to the aneurysm neck 16 with the proximal section 391, 953, 957, 961.

[0234] Fig.54The occlusive device 400 is shown implanted into an angled sidewall aneurysm 19 having a dome 21 that is off-axis from the neck 16. This can be approximated by the angle A. The occlusive device 400 is similar to the occlusive device 200 and has a proximal segment 402 separated from a distal segment 404 by an elongated flexible extension 406. The flexible extension 406 can be similar to the central waist 222 of the occlusive device 200, but can vary in diameter and length to vary its flexibility characteristics and vary the overall amount of angles possible between the proximal segment 402 and the distal segment 404. The configuration of the occlusive device 400 can be similar to that of the occlusive device 200. Figure 42-Figure 45 and Figure 50-Figure 53 The occluding device 400 is the same as any of the embodiments described above for the occluding devices 200, 260, 911, 931, 947, 950, 954, 958. However, the longer, more flexible extension 406 allows the distal segment 404 to be more easily angled relative to the proximal segment 402. It also allows for a greater amount of angle between the proximal segment 402 and the distal segment 404 because there is a greater amount of space between them (e.g., due to the increased longitudinal distance). Thus, the occluding device 400 is able to conform to a large number of different aneurysm shapes or aneurysm angle take-off angles or general angles. The occluding device 400 can be configured to allow for an angle A between 90° and 180° or between about 135° and about 180°. Thus, the angle A can be varied to a minimum angle between about 90 degrees and about 135 degrees. If the elongated flexible extension 406 is long enough, angulations of less than 90° may even be possible, which may occur in some very oddly shaped aneurysms. The substantially flat portion can have a slight angle or taper, such as Figure 42-Figure 43 The substantially flat portions 220, 224, 276, 278 of Figure 50-Figure 51 As the longitudinal space increases toward the outer diameter, the angle A ( Fig.54 ) even further decline. The total longitudinal length of the flexible extension 406 can be between about 0.5mm and about 30mm, or between about 0.5mm and about 25mm, or between about 1mm and about 10mm, or between about 1mm and about 6mm, or between about 1mm and about 3mm. For cerebral aneurysms, the occluding device 400 can be configured so that the shapes of the proximal section 402 and the distal section 404 are both substantially hemispherical, but the flexible extension provides an elongated, rotated oval profile when in a straight line. For example, the proximal section 402 and the distal section 404 both have a hemispherical shape with a diameter of about 6mm, and the 1mm long flexible extension 406 produces an implant of 7mm length by 6mm diameter. The 2mm long flexible extension 406 produces an implant of 8mm length by 6mm diameter. The 3mm long flexible extension 406 produces an implant of 9mm length by 6mm diameter. A wide range of sizes are possible, and the diameter of the proximal section 402 may be different than the diameter of the distal section 404, or they may be substantially the same as one another.

[0235] Fig.55 An occlusive device 410 is shown implanted into an angled sidewall aneurysm 19 via a delivery catheter 417. The occlusive device 410 is similar to Fig.54 The occluding device 400 of the present invention is different in that the elongated extension 416 extending between the proximal section 412 and the distal section 414 has a bellows structure that further contributes to its bendability. Both the inner layer and the outer layer of the mesh tube may include bellows-type features, or only the outer layer may include such features. In alternative embodiments, the flexible section 406 or the elongated extension 416 (e.g., including bellows-type features) may have an outer diameter that varies along its longitudinal axis. For example, the outer diameter tapers in the center and gradually increases at the ends, thereby having a concave cylindrical shape or an hourglass shape. Alternatively, the outer diameter may gradually increase in the center and gradually decrease at the ends, thereby having a convex cylindrical shape or an American football shape. Fig.56 An occlusive device 450 is shown implanted within an aneurysm 452. The aneurysm 452 is the terminal end of the aorta 454 and several connecting arteries 456, 458, 460, 462. Fig.56 The occluding device 450 has a proximal segment 464 and a distal segment 466 separated by an elongated flexible extension 468. The proximal segment 464 includes a hemispherical proximal end 470 and a concave surface 472 distally opposite the proximal end 470. The distal segment 466 includes a hemispherical distal end 474 and a concave surface 476 proximally opposite the distal end 474. The distal segment 466 and the proximal segment 464 are each capable of pivoting (away from the longitudinal axis) relative to the elongated flexible extension 468, which allows the occluding device 450 to conform to the internal contour shape of the aneurysm 452 when delivered into the aneurysm 452, thereby more closely fitting the aneurysm 452. As shown in FIG. Fig.56 As shown, the apex 478 of the distal segment 466 of the occluding device 450 is slightly pivoted rearward and to the right. The proximal segment 464 is slightly pivoted forward. The maximum diameter of the proximal segment 464 is greater than the diameter or transverse dimension of the aneurysm neck 480. The maximum diameter of the proximal segment 464 can also be configured to be oversized relative to the aneurysm sac in order to apply a clamping radial force. The same is true for the distal segment 466. Once in the preferred position within the aneurysm 452, the occluding device 450 is then disengaged from the pusher 415.

[0236] Fig.57 An occlusive device 482 is shown implanted within an aneurysm 484. Fig.57 The occluding device 482 is similar to Figure 41-424. The occlusion device 482 is similar to the occlusion device 200 of FIG. 4, but with slightly different dimensions. When the occlusion device 482 is implanted within an aneurysm, the distal segment 486 and the proximal segment 488 are longitudinally compressed together. The waist 490 can be slightly deformed (e.g., shortened and widened) to allow dynamic shaping of the occlusion device 482 when implanted in the aneurysm 484. The proximal segment 488 is forced (straight arrow) against the neck 492. The substantially flat portion 494 of the proximal segment 488 and the substantially flat portion 496 of the distal segment 486 can both bend to form an annular recess. The bend acts as a spring to maintain the force of the proximal segment 488 against the neck 492. Fig.58 The illustrated occluder device 401 has a relatively wide waist 403 and a relatively long flexible extension 405 between its proximal section 407 and distal section 409 . Fig.58 The waist 403 of the occluding device has a circumferentially extending concave surface (hourglass shape) and includes a hemispherical proximal surface 411 and a hemispherical distal surface 413. Figure 56-Figure 58 The occluding device is still shown as being coupled to the pusher 415 and delivered through the delivery catheter 417. Figure 59-Figure 61 Three different configurations of the occluding device 962 are shown. Fig.59 In the embodiment of the present invention, the occluding device 962 is in a fully unconstrained expanded configuration when thermoformed. Fig.60 In the embodiment of the present invention, the occluding device 962 is confined within the microcatheter lumen 980. Fig.61 , occluding device 962 has been delivered into aneurysm 748.

[0237] Fig.59 An occluder device 962 is shown comprising a proximal section 963 and a distal section 964 and a waist 971, all of which are constructed from a single continuous double-layer mesh. The occluder device 962 is constructed from an inverted mesh tube 965 having a first end, a second end, and a wall (e.g., Figure 41-42The inverted mesh tube 965 extends over the outer layer 966 through the proximal end 967 of the proximal segment 963 and along the hemispherical shape 968 to a maximum diameter portion 969 having an acute angle 719. From the maximum diameter portion 969, the outer layer 966 extends radially inward along a substantially flat portion 970 to a central waist 971. The outer layer 966 then extends radially outward along a substantially flat portion 972 of the distal segment 964 to a maximum diameter portion 973 having an acute angle 727, to a hemispherical shape 728, to a distal end 974 of the occluding device 962. The hemispherical shape 728 is configured to contact at least a portion of the dome of the aneurysm. The diameter of the maximum diameter portion 973 is approximately equal to the diameter of the maximum diameter portion 969, but in other embodiments, they may be different. At the distal end 974, the wall 709 is inverted inward at an inverted fold 975, which creates a distal orifice 976 and an internal volume 977. The wall 709 transitions from the outer layer 966 to the inner layer 978 at the inversion fold 975, and the inner layer 978 follows the contour of the outer layer 966 from the distal orifice 976 to the first end. The occluding device 962 is shown coupled to the elongated pusher 701 and the marker band 705.

[0238] exist Fig.59 In the embodiment of the present invention, the occlusive device 962 is shown as unconstrained. Therefore, if the mesh tube 965 is formed by braiding together at least some nickel-titanium or shape memory alloy wires, as described herein, it can be thermoformed. Fig.59 As shown in Fig.60 The occluding device 962 is shown in its compressed configuration inserted through a lumen 980 of a delivery catheter 979 having a distal end 981 and a proximal end 746 . Fig.61 The occluding device 962 is shown within the aneurysm 748, which has a neck 982 and a dome 983. Both the proximal segment 963 and the distal segment 964 are deformed by contact with the aneurysm wall 984, thereby adjoining the aneurysm wall 984 in a tight manner. Due to the longitudinal compressive force F exerted in turn by the aneurysm wall 984, the total length L2 of the occluding device 962 becomes less than the original length L1 ( Fig.59 ).therefore, Fig.61 The overall shape of the occluding device within the aneurysm 748 is similar to Fig.59 The proximal end 967 and the marker band 705 are located at or adjacent to the neck 982 of the aneurysm 748, while the distal segment 964 is adjacent to the dome 983. Fig.61 Also shown is a remnant 703 of the pusher 701 after detachment has occurred. In some embodiments, no remnant of the pusher 701 remains after detachment. The occluding device 962 is highly conformable to different aneurysm shapes and sizes. To this end, the occluding device 962 can also be adapted to a variety of aneurysm shapes and sizes. Fig.61The aneurysm 748 is longitudinally longer and narrower in diameter. It can also be adapted to aneurysms with a significantly asymmetric shape.

[0239] Go to Fig.62 , the occluder device 985 is constructed from an inverted mesh tube 986 having a first end 987, a second end 988, and a wall 989. The inverted mesh tube 986 extends from the second end 988 through the proximal end 991 of the proximal section 992 and along the lower mushroom shape 993 on the outer layer 990 to the maximum diameter portion 994. From the maximum diameter portion 994, the outer layer 990 extends radially inward along the mushroom shape 988 to the first central waist 995. The outer layer 990 then extends radially outward along the bulbous portion 996 having the maximum diameter portion 997 and then reaches the second central waist 998. Although the bulbous portion 996 of the occluder device 985 is relatively short and wide, in other embodiments, the opposite may be true, and the bulbous portion 996 has a more American football shape. In other embodiments, the bulbous portion 996 may have a generally spherical shape. The outer layer 990 is then formed into an upper mushroom shape 999 having a maximum diameter 640 to the distal end 641 of the occluding device 985. The hemispherical shape 642 of the upper mushroom shape 999 is configured to contact the dome of the aneurysm. The maximum diameter 640 is approximately equal to the maximum diameter 997, but in other embodiments, they may be different. The occluding device 985 is generally cylindrically symmetrical about the central axis Z. However, in alternative embodiments, there may be certain asymmetric portions, such as one or more indented or extended features at specific locations in the perimeter. At the distal end 641, the wall 989 is inverted inwardly at the inversion fold 643, which creates a distal orifice 644 and an internal volume 645. The wall 989 transitions from the outer layer 990 to the inner layer 646 at the inversion fold 643, and the inner layer 646 follows the contour of the outer layer 990 from the distal orifice 644 to the first end 987. The occluder device 985 is manufactured as an inverted mesh tube 986 having a simple straight elongated configuration and is subsequently formed into Fig.62 Each of the three segments, the proximal segment 594, the central segment 596 and the distal segment 598, is shown in its expanded configuration. Fig.62 The proximal end 991 below the proximal segment 594 has a flat surface 599 or a substantially flat surface and is configured to engage and even grasp the neck of the aneurysm inside the aneurysm. Engaging the neck of the aneurysm by the flat surface 599 or a substantially flat surface can help seal the aneurysm and help prevent endoleaks. The bulb 996 / central segment 596 is configured to allow angulation between the proximal segment 594 and the distal segment 598 while providing some solid or stop / limitation between them.

[0240] In some embodiments, one or more of the proximal section 594, the central section 596, or the distal section 598 may include some nickel-titanium alloy wires and some radiopaque elements, including platinum, gold, tantalum, or alloys of any of these or other radiopaque materials. In some embodiments, the wire may include a stretched filling tube, such as those including a nickel-titanium alloy outer wall and a platinum core. The radiopaque material allows the occluding device 985 to be visible in radiographs or fluoroscopy. The occluding device 985 can be constructed by controlling how much radiopaque material is used, by the ratio of radiopaque wire to non-radiopaque wire, or by the amount of platinum core in the stretched filling tube. In this way, the occluding device 985 can be selectively made to be visible enough, but not too visible, such as too bright, so that other objects are blocked. In some embodiments, regardless of whether any of the filaments comprise radiopaque material, the marker band may be attached to the first end 987 and / or second end 988 of the everted mesh tube 986 by adhesive or epoxy bonding, or swaging, welding, or other mechanical attachment.

[0241] Fig.63An occluder device 647 is shown having an inverted mushroom-shaped proximal segment 648, a bulbous central segment 649, and a mushroom-shaped distal segment 650 having a distal apex 81. Each of the segments 648, 649, 650 is separated by a central waist 651, 653. The segments 648, 649 are separated by the central waist 651, and the segments 649, 650 are separated by the central waist 653. Each of the segments 648, 649, 650 is formed of a braided mesh 607 having different stiffness characteristics from one another. Although the segments 648, 649, 650 are fully braided, for simplicity, the braiding is only shown in the windows 654, 655, 656. The proximal segment 648 is braided to make it stiffer than the central segment 649 or the distal segment 650. The proximal segment 648 can be braided with a larger diameter wire, and / or can be braided with a larger braiding angle to achieve increased stiffness. The increased stiffness is configured to firmly wedge or set against the neck of the aneurysm, for example, to achieve better closure or interruption at the entrance of the aneurysm. The distal segment 650 is braided so that it is less hard / more flexible than the central segment 649 or the proximal segment 648. The distal segment 650 can be braided with a smaller diameter wire, and / or can be braided with a smaller braiding angle to achieve reduced stiffness. The reduced stiffness is configured to be gently set against the aneurysm dome. This is particularly helpful for avoiding rupture of aneurysms (e.g., high-risk aneurysms). High-risk aneurysms can have a relatively large diameter, or have a relatively thin wall at the dome. Another high-risk aneurysm may be a previously ruptured aneurysm that has at least partially healed but may be prone to rupture again. The central segment 649 can be braided by wire, and / or can be braided with a braid angle, which achieves intermediate stiffness to the proximal segment 648 and the distal segment 650. After the braided mesh 607 is formed by a single set of wires, changes in wire / wire diameter can be produced by adjusting or rearranging the braiding crossover. In some embodiments, the distal segment 650 can then be etched (chemically etched, photochemically etched) to reduce the bus diameter and reduce stiffness. In some embodiments, the distal segment 650 and the central segment 649 are etched in a first etching operation. Then, only the distal segment 650 is etched in a second etching operation. This is the same as originally formed, the proximal segment 659, the central segment 649, and the distal segment 650 are formed by wires with the same diameter, but after two etching operations, the distal segment 650 has a wire with a smaller diameter than the central segment 649, and the central segment 649 has a wire with a smaller diameter than the proximal segment 648. Thus, in some embodiments, the distal segment 650 can be made more flexible than the proximal segment 648 simply by etching.

[0242] Fig.64An occluding device 1000 having a proximal end 1002 and a distal end 1004 and configured for placement within an aneurysm is shown. The occluding device 1000 comprises a lower portion 1006 having a proximal outer diameter A and a distal outer diameter B and a tapered frustoconical segment 1008 extending between diameter A and diameter B. In some embodiments, the lower portion 1006 is circular, having substantially the same diameter in any transverse slice (around the perimeter). In other embodiments, the lower portion 1006 is non-circular and may comprise an elliptical, oval, polygonal, or other shape. The tapered frustoconical segment 1008 is configured to be larger than the maximum transverse dimension of the opening into the aneurysm (neck) at least in some portions between A and B. In some embodiments, the diameter A is configured to be larger than the maximum transverse dimension of the opening into the aneurysm (neck). Thus, the lower portion 1006 is configured to completely cover the neck, thereby causing blood stagnation within the aneurysm, resulting in occlusion. The occlusive device 1000 is constructed of a mesh (braided) Nitinol (nickel-titanium alloy) tube 1005 that is turned over on itself. The mesh tube 1005 has a first end and a second end. The second end is folded back over the outer diameter of the first end, thereby providing an outwardly facing surface 1003 and an inwardly facing surface (at Fig.64 The mesh tube 1005 is thermoformed so that the occlusive device 1000 comprises several expansion sections: a lower section 1006, an upper section 1010 and a middle waist 1012. The upper section 1010 has a length L, a maximum diameter C MAX and minimum diameter C MIN The waist 1012 has a diameter D and a length g.

[0243] It has been found that the specific size ratios of the occluding device 1000 can effectively create a simple, easy-to-form structure (body) that is particularly suitable for placement in an aneurysm that may have at least one elongated dimension. For example, a deep and narrow aneurysm, or a wide and short aneurysm. The length L of the upper portion 1010 can be in the range of about 1 mm to about 25 mm. The diameter C can be in the range of about 1 mm and about 25 mm. The diameter B can be in the range of about 1 mm and about 25 mm. The diameter A can be in the range of about 1 mm and about 24 mm. Generally speaking, the diameter C is between about 50% and about 100% of the diameter B. In addition, generally speaking, the diameter A is between about 50% and about 100% of the diameter B. In some embodiments, the diameter A is between about 70% and about 90% of the diameter B.

[0244] When formed (e.g., thermoformed), the occlusive device 1000 has an expanded configuration (e.g., Fig.641000 is a device that can be used to deliver a device through a delivery catheter (e.g., a microcatheter) and a contracted structure. The device can be configured to deliver a device through a cavity of a delivery catheter (e.g., a microcatheter). The occluding device 1000 includes two mesh layers, provided by an outwardly facing surface 1003 and an inwardly facing surface. In some embodiments, the occluding device 1000 may include some nickel-titanium alloy wires and some radiopaque elements, including an alloy of any one of platinum, gold, tantalum, or these or other radiopaque materials. In some embodiments, the wire may include a stretch-filled tube (DFT), such as those including a nickel-titanium alloy outer wall and a platinum core. The radiopaque material allows the occluding device 1000 to be visible in radiographs or fluoroscopy. The occluding device 1000 can be constructed by controlling how much radiopaque material is used, by the ratio of radiopaque wire to non-radiopaque wire, or by the amount of platinum core in the stretch-filled tube. In this way, the occluding device 1000 can be selectively made to be visible enough, but not too visible, such as too bright, so that other objects are blocked. In some embodiments, whether or not any of the wires contain radiopaque material, the marker band can be attached to the proximal end 1002 of the occlusion device 1000 by adhesive or epoxy bonding, or swaging, welding, or other mechanical attachment. The drawn filling tubes (DFT) can each have a platinum core having a cross-sectional area between about 10% and about 70% of the total cross-sectional area of ​​the DFT. In some embodiments, all (100%) of the wires can contain DFT. In other embodiments, between 50% and 100% of the wires can include DFT, with the remainder of the wires only comprising nickel-titanium alloy.

[0245] Go to Fig.65 , the occluding device 1000 can be coupled to a pusher 152 having a distal end 154 and a proximal end 156 at or near its proximal end 1002. The pusher 152 may include a wire, a hypotube, or another elongated structure having a column support, which is detachably coupled to the proximal end 1002 of the occluding device 1000 at its distal end 154. The detachable joint 158 ​​may include one of a variety of detachment systems, including but not limited to pressurized detachment, electrolytic detachment mechanisms, hydraulic detachment mechanisms, mechanical or interlocking detachment mechanisms, chemical detachment mechanisms, heat-activated detachment systems, or friction detachment systems. During delivery, the pusher 152 is held by the user at its proximal end 156 and pushed forward in the longitudinal direction to advance the occluding device 1000 to the distal end of a delivery catheter (e.g., a microcatheter) having a delivery cavity. The delivery catheter may also include a proximal hub, such as a Luer connector.

[0246] Fig.66 A first view of the occlusive device 1000 delivered into a first aneurysm configuration 1020 is shown, comprising an aneurysm 1022 , a neck 1024 , a first parent vessel limb 1026 , a second parent vessel limb 1028 , and an additional connecting vessel 1030 . Fig.67The waist 1012 allows some flexion between the upper portion 1010 and the lower portion 1006 so that the upper portion 1010 can be slightly compressed into the lower portion 1006, as shown. Fig.66 and Fig.67 Thus, the lower portion 1006 protects and covers the neck 1024 of the aneurysm 1022, while the upper portion 1010 allows the occluding device 1000 to adapt to the shape of the aneurysm 1022 to fit with a secure fit. The waist 1012 also acts as a shock absorber.

[0247] Fig.68 An occlusive device 800 is shown that also includes an inverted mesh tube 802 and has an outer layer 804, an inner layer 806, and an inverted fold 808, which creates a distal orifice 810 and serves as a transition between the outer layer 804 and the inner layer 806. The inverted mesh tube 802 has a first end 812 and a second end 814. The occlusive device 800 includes a proximal segment 816, a distal segment 818, and an intermediate segment 820. The proximal segment 816 has a substantially flat portion 822, and the distal segment 818 has a spherical shape 824 that is configured to contact the dome of the aneurysm. The intermediate segment 820 also has a spherical shape 826. There is a waist 828 between the proximal segment 816 and the intermediate segment 820, and there is a circumferentially extending concave surface 830 between the distal segment 818 and the intermediate segment 820. The proximal segment 816 includes a proximal concave surface 832 concave surface, which is configured as a clear marker band 834. The proximal segment 816 has a maximum diameter 836, which is configured to clamp the inner wall of the aneurysm. The occlusion device 800 includes a cover 838, which is configured to be installed adjacent to the neck of the aneurysm. In some embodiments, the cover 838 is circular and has substantially the same diameter at any transverse measurement around the perimeter. In other embodiments, the cover 838 is non-circular and may include an ellipse, an oval, a polygon or other shapes. In a non-circular embodiment, the cover 838 includes a minimum transverse dimension and a maximum transverse dimension. In the specific case of an ellipse or an oval, the cover 838 includes a major diameter and a minor diameter. The minor diameter or minimum transverse dimension is configured to be greater than the maximum transverse dimension of the opening into the aneurysm (neck). Therefore, the cover 838 is configured to completely cover the neck, thereby causing blood stagnation within the aneurysm, resulting in occlusion. The cap 838 is constructed of a mesh (braided) nitinol (nickel-titanium alloy) tube 840 that is turned over on itself. The mesh tube 840 has a first end 842 and a second end 844. The second end 844 is folded back on the outer diameter of the first end 842. The mesh tube 840 is thermoformed so that the cap 838 includes an expanded portion 843 and the first end 842 and the second end 844 include unexpanded (or partially expanded) portions. The cap 838 is manufactured as an inverted mesh tube 840 having a simple straight elongated configuration and is subsequently formed into Fig.68The shape shown in FIG. 8 is formed by heating the mesh tube 840 to the shape shown in FIG. 8 and heat setting it into this shape. For example, the inverted mesh tube 840 can be constructed as a single layer mesh tube formed of at least some nickel-titanium alloy wires and then inverted on itself. The inverted mesh tube 840 can then be placed into a die or mold including one or more components to hold it in the shape of the cap 838. The cap 838 can then be subjected to an elevated temperature and then cooled to lock in the shape, resulting in the cap 838 having at least some superelastic properties.

[0248] The occluder device 800 may comprise any material and be made with the processes described with respect to the occluder device 200 or any other occluder device described herein. The occluder device 800 is configured to have bending or articulation capabilities at the waist 828 and the circumferentially extending concave surface 830, thereby allowing the proximal section 816, the distal section 818, and the intermediate section 820 to bend and conform to complex and irregularly shaped aneurysms. The maximum diameter 836 is configured to apply radial force to the aneurysm wall to hold the occluder device 800 in place, while the cap 838 promotes thrombosis and closure of the aneurysm at the neck.

[0249] Although the foregoing is directed to embodiments of the present disclosure, other and further embodiments may be designed without departing from the basic scope thereof. The filament diameter of the filaments comprising any mesh material described herein (e.g., mesh tubes, including flip mesh tubes) may be between about 0.0004 inches and about 0.003 inches, or between about 0.0005 inches and about 0.002 inches, or between about 0.0006 inches and about 0.002 inches, or between about 0.0006 inches and about 0.0015 inches. The stretch-fill tube (DFT) may be 0% to 100% of the total strands / filaments in any braided tube / mesh tube. In some embodiments, the stretch-fill tube (DFT) comprises about 50% to about 100% of the total filaments of the cover and about 50% to about 100% of the total filaments of each of the folded or looped tubular nets. The radiopaque core of each of at least some of the drawn fill tubes has a cross-sectional area between about 10% and about 70% of the total cross-sectional area of ​​each of at least some of the stretched fill tubes, or between about 51% and about 70% of the total cross-sectional area of ​​each of at least some of the stretched fill tubes. In some embodiments, NiTi #1- produced by Fort Wayne Metals Research Products Corp. (Fort Wayne, USA) can be used. The silk can be woven with a pattern of silk crossing with any one or more of the following silk ratios: 1x1, 1x2, 2x1, 2x2, 2x3, 3x2, 3x3, etc. (e.g., warp and weft). Any low, medium, or high weft count can be used, such as between about 15 wefts per inch to about 300 wefts per inch, or between about 20 wefts per inch to about 160 wefts per inch. Any part of any silk or occlusion device can be coated with a compound that enhances endothelialization, thereby improving the healing process when implanted in an aneurysm and optimizing occlusion. The thruster and occlusion device configurations proposed herein can also be used for other types of implantable devices, such as stents, shunt devices, filters, and occlusion devices for structural heart defects.

[0250] In some embodiments, the braided element may subsequently be etched (chemically, photochemically) to reduce the bus diameter and reduce stiffness.

[0251] Additional material can be carried on the cover of the occluding device or any other proximal end of the occluding device, and is configured to face the aneurysm neck. In some embodiments, the material on the occluding device may include a biological layer, which is configured to promote growth. In some embodiments, the biological layer may include antibodies, to accelerate the formation of the endothelial layer, such as by attracting endothelial progenitor cells (EPC). In some embodiments, the biological layer may include a natural membrane or structure, such as a membrane, such as a membrane from an ear, or a cornea, or an ultra-thin ligament sheet, or even a piece of vascular wall. In some embodiments, the material on the occluding device may include a polymer layer, which is configured to serve as a simulated arterial wall. In some embodiments, the polymer layer may include polytetrafluoroethylene, such as expanded polytetrafluoroethylene (ePTFE), such as those used for transplantation. Occluding devices as described herein can be blended with biological layers or polymer layers.

[0252] The following items include examples of devices of the present disclosure.

[0253] Item 101: In one example, a device for treating an aneurysm in a blood vessel includes an occluding element constructed to be releasably coupled to an elongated delivery shaft, the occluding element including a mesh body constructed to be delivered in a contracted configuration through an inner lumen of a delivery catheter, the inner lumen having a proximal end and a distal end, the body further constructed to expand to an expanded configuration when advanced out of the distal end of the inner lumen of the delivery catheter and into the aneurysm, wherein the body includes a proximal portion having a proximal maximum transverse dimension A and a distal maximum transverse dimension B and a truncated conical portion extending between the proximal maximum transverse dimension A and the distal maximum transverse dimension B, and wherein the body further includes a distal portion having a maximum transverse dimension C and a waist between the proximal portion and the distal portion, and wherein dimension A is between approximately 50% and approximately 100% of dimension B.

[0254] Item 102 : In some examples, a device includes item 101 , wherein dimension A is between about 70% and about 90% of dimension B.

[0255] Item 103 : In some examples, the apparatus includes item 101 , wherein dimension C is between about 50% and about 100% of dimension B.

[0256] Item 104: In another example, a device for treating an aneurysm in a blood vessel includes an occlusive element constructed to be releasably coupled to an elongated delivery shaft, the occlusive element comprising an everted mesh tube having an outer layer and an inner layer, the outer layer transitioning to the inner layer at an everted fold, wherein at least the outer layer is formed into an expanded shape having a proximal segment having a first diameter, a distal segment having a second diameter, and a waist having a third diameter, wherein the third diameter is smaller than the first diameter and the third diameter is smaller than the second diameter.

[0257] Item 105: In some examples, the device includes item 104, wherein the inner layer has an expanded shape that conforms to the expanded shape of the outer layer.

[0258] Item 106: In some examples, the apparatus includes any of items 104 or 105, wherein the first diameter is approximately equal to the second diameter.

[0259] Item 107: In some examples, the device includes any of items 104 or 105, wherein the first diameter is greater than the second diameter.

[0260] Item 108: In some examples, the device includes any of items 104 or 105, wherein the first diameter is smaller than the second diameter.

[0261] Item 109: In some examples, the device includes any of items 104-108, wherein the distal segment has a generally hemispherical shape.

[0262] Item 110: In some examples, the device includes any of items 104-109, wherein the proximal segment has a generally hemispherical shape.

[0263] Item 111: In some examples, the device includes any of items 104-109, wherein the proximal segment includes a proximal end portion having a concave conical shape.

[0264] Item 112: In some examples, the device includes any of items 104-111, wherein the inversion fold is a circular shape surrounding an orifice in communication with the interior volume of the occlusive element.

[0265] Item 113: In some examples, the device includes item 111, wherein the concave cone shape is configured to direct blood flow within a native vessel adjacent to the aneurysm when the occlusive element is implanted substantially within the aneurysm.

[0266] Item 114: In some examples, the device includes any of items 104-113, wherein the proximal segment and the distal segment are configured to bend relative to each other such that they do not share the same longitudinal axis.

[0267] Item 115: In some examples, the device includes item 114, wherein the waist is provided by an elongated tubular section.

[0268] Item 116: In some examples, the device includes any of items 114 or 115, wherein the waist is provided by a bellows-shaped element.

[0269] Item 117: In some examples, the device includes any of items 114-116, wherein the longitudinal axis of the proximal segment and the longitudinal axis of the distal segment are configured to be movable between 90° and 180°.

[0270] Item 118: In some examples, the device includes item 117, wherein the longitudinal axis of the proximal segment and the longitudinal axis of the distal segment are configured to be movable between 135° and 180°.

[0271] Item 119: In some examples, the device includes item 115, wherein the length of the tubular segment is between about 1 mm and about 10 mm.

[0272] Item 120: In some examples, the device includes item 115, wherein the length of the tubular segment is between about 1 mm and about 6 mm.

[0273] Item 121: In some examples, the device includes item 115, wherein the length of the tubular segment is between about 1 mm and about 3 mm.

[0274] Item 122: In some examples, the device includes any of items 104-121, wherein the occlusive element includes a nickel-titanium alloy.

[0275] Item 123: In some examples, the device includes any of items 104-122, wherein the occluding element includes a radiopaque material.

[0276] Item 124: In some examples, the device includes item 123, wherein the radiopaque material includes a marker band.

[0277] Item 125: In some examples, the apparatus includes item 124, wherein the marker band is coupled to the proximal segment.

[0278] Item 126: In another example, a device for treating an aneurysm in a blood vessel includes an occluding element constructed to be releasably coupled to an elongated delivery shaft, the occluding element comprising an everted mesh tube having an outer layer and an inner layer, the outer layer transitioning to the inner layer at an everted fold, wherein at least the outer layer is formed into an expanded shape having a proximal segment having a first diameter, a distal segment having a second diameter, and a first waist having a third diameter, a middle segment having a fourth diameter, and a second waist having a fifth diameter, wherein the first diameter, the second diameter, and the fourth diameter are each larger than the third diameter, and wherein the first diameter, the second diameter, and the fourth diameter are each larger than the fifth diameter.

[0279] Item 127: In some examples, the device includes item 126, wherein the proximal segment has a first stiffness and the distal segment has a second stiffness, the first stiffness being greater than the second stiffness.

[0280] Item 128: In some examples, the apparatus includes item 127, wherein the intermediate section has a third stiffness, the third stiffness is greater than the second stiffness, and wherein the first stiffness is greater than the third stiffness.

[0281] Item 129: In some examples, the device includes any of items 126-128, wherein the proximal segment includes a set of wires, each wire having a diameter greater than a diameter of the wires in the distal segment.

[0282] Item 130: In another example, a method of forming a device for treating an aneurysm in a blood vessel includes forming a mesh tube, flipping the mesh tube to form an outer layer and an inner layer, the outer layer transitioning to the inner layer at a flip fold, forming at least the outer layer into an expanded shape having a proximal segment having a first diameter and a distal segment having a second diameter, and etching the distal segment to reduce its stiffness.

[0283] Item 131: In some examples, the method includes item 130, wherein after the etching step, the stiffness of the distal segment is less than the stiffness of the proximal segment.

[0284] Item 132: In another example, a device for treating an aneurysm in a blood vessel includes an occlusive element constructed to be releasably coupled to an elongated delivery shaft, the occlusive element including an inverted mesh tube having an outer layer and an inner layer, the outer layer transitioning to the inner layer at an inverted fold, the occlusive element being constructed to be delivered in a contracted configuration through an inner lumen of a delivery catheter, the inner lumen having a proximal end and a distal end, the occlusive element being further constructed to expand to an expanded configuration as it advances out of the distal end of the inner lumen of the delivery catheter and into the aneurysm, wherein in the expanded configuration, at least the outer layer of the inverted mesh tube is formed into an expanded shape, the expanded shape including a proximal segment having a first transverse dimension, a distal segment having a second transverse dimension, and a waist having a third transverse dimension, wherein the third transverse dimension is smaller than the first transverse dimension, and the third transverse dimension is smaller than the second transverse dimension, and wherein in the expanded configuration, the waist is constructed to be deformed by an externally applied force so that the distance between the distal segment and the proximal segment is reduced.

[0285] Item 133: In some examples, the device includes item 132, wherein the waist has a longitudinal length of between about 0.05 mm and about 25 mm in the substantially undeformed state.

[0286] Item 134: In some examples, the device includes item 132, wherein the length of the distal segment is between about 1 mm and about 25 mm.

[0287] Item 135: In some examples, the device includes item 132, wherein the distal segment has a first longitudinal axis and the proximal segment has a second longitudinal axis, and wherein in the expanded structure, the waist is configured to be deformed by an externally applied torque such that the angle between the first longitudinal axis and the second longitudinal axis changes.

[0288] Item 136: In some examples, the device includes item 135, wherein the angle between the first longitudinal axis and the second longitudinal axis is changeable to a minimum angle between about 90 degrees and about 135 degrees.

[0289] Item 137: In some examples, the apparatus includes item 132, wherein the waist includes a bellows shape.

[0290] Item 138: In some examples, the apparatus includes item 132, wherein the waist includes a circumferential concavity.

[0291] Item 139: In some examples, the device includes item 132, wherein the proximal portion includes a proximal diameter A and a distal diameter B, and wherein the distal portion includes a diameter C, and wherein diameter A is between about 50% and about 100% of diameter B.

[0292] Item 140: In some examples, the apparatus includes item 139, further comprising a frustoconical portion extending between diameter A and diameter B.

[0293] Item 141 : In some examples, the apparatus includes item 139 , wherein diameter A is between about 70% and about 90% of diameter B.

[0294] Item 142: In some examples, the apparatus includes item 139, wherein diameter C is between about 50% and about 100% of diameter B.

[0295] Item 143: In some examples, the device includes item 132, wherein the inner layer has an expanded shape that conforms to the expanded shape of the outer layer.

[0296] Item 144: In some examples, a device includes item 132, wherein the first lateral dimension is approximately equal to the second lateral dimension.

[0297] Item 145: In some examples, a device includes item 132, wherein the first lateral dimension is greater than the second lateral dimension.

[0298] Item 146: In some examples, the device includes item 132, wherein the distal segment has a generally hemispherical shape.

[0299] Item 147: In some examples, the device includes item 132, wherein the proximal section has a generally hemispherical shape.

[0300] Item 148: In some examples, the device includes item 147, wherein the distal segment has a generally hemispherical shape.

[0301] Item 149: In some examples, the device includes item 132, wherein the inversion fold is a circular shape surrounding an orifice in communication with the interior volume of the occlusive element.

[0302] Item 150: In some examples, the device includes item 132, wherein the distal segment has a generally cylindrical shape and a blunt distal end.

[0303] Item 151 : In some examples, the device includes item 132, wherein the length of the distal segment is greater than the second transverse dimension.

[0304] Item 152: In some examples, the apparatus includes item 132, wherein the everted mesh tube is formed from a plurality of filaments.

[0305] Item 153: In some examples, the device includes item 152, wherein at least some of the plurality of filaments at the outer layer of the distal segment have an etched surface.

[0306] Item 154: In some examples, the apparatus includes item 152, wherein about 50% to about 100% of the plurality of filaments comprises a stretched fill tube.

[0307] Item 155: In some examples, the apparatus includes item 154, wherein at least some of the stretched fill tubes include a radiopaque core having a cross-sectional area between about 51% and about 70% of the total cross-sectional area.

[0308] Item 156: In some examples, the device includes item 132, further comprising a pusher having a proximal end and a distal end, wherein the occluding element is configured to releasably couple to the distal end of the pusher at a releasable joint.

[0309] Item 157: In some examples, the device includes item 156, further comprising a connecting tube having a proximal end substantially flush with the proximal end of the occluding element, a distal end extending within the occluding element, and a cavity, wherein the distal end of the pusher extends through the cavity of the connecting tube and includes a plurality of radially extending protrusions located distal to the distal end of the connecting tube, wherein a maximum lateral dimension formed by the plurality of radially extending protrusions is greater than a maximum diameter of the cavity of the connecting tube.

[0310] Item 158: In some examples, the device includes item 157, further comprising an activator configured to modify the plurality of radially extending protrusions so that the distal end of the pusher can be completely removed from the lumen of the connecting tube.

[0311] Item 159: In some examples, the device includes item 158, wherein the activator is configured to produce an effect on the radially extending protrusions selected from the list consisting of: melting, detaching, straightening, fracturing, ablating, and deforming.

[0312] Item 160: In some examples, the device includes item 132, wherein the waist includes a circumferential convexity.

[0313] Item 161: In some examples, the apparatus includes item 160, further comprising a first circumferential concave surface adjacent to the first end of the circumferential convex surface and a second circumferential concave surface adjacent to the second end of the circumferential convex surface.

[0314] Aneurysms are often non-spherical in shape and may also or alternatively have slight to severe angles at which they bulge or protrude relative to one or more blood vessels. This can make it technically and physically challenging to deliver and use one or more aneurysm embolization devices to an aneurysm. The system proposed herein can address difficulties that may arise.

[0315] Fig.69An occluding device 660 configured for placement within an aneurysm is shown. The occluding device 660 includes a cap 663 having an outer diameter D. In some embodiments, the cap 663 is circular, having substantially the same diameter D at any transverse measurement around the perimeter. In other embodiments, the cap 663 is non-circular and may include an ellipse, an oval, a polygon, or other shapes. In non-circular embodiments, the cap 663 includes a minimum transverse dimension and a maximum transverse dimension. In the specific case of an ellipse or an oval, the cap 663 includes a major diameter and a minor diameter. The minor diameter or minimum transverse dimension is configured to be larger than the maximum transverse dimension of the opening into the aneurysm (neck). Thus, the cap 663 is configured to completely cover the neck, thereby causing blood stagnation within the aneurysm, resulting in occlusion. The cap 663 is constructed of a mesh (braided) nitinol (nickel-titanium alloy) tube 665 that is turned over on itself, thereby providing an outward-facing surface 664 and an inward-facing surface 661. The mesh tube 665 is thermoformed so that the cap 663 includes an expansion portion and the tube 665 ( Figure 2 ) each includes an unexpanded (or partially expanded) portion at the first end 675 and the second end 674 of the cap 663. A smooth fold 662 extends around the periphery 659 of the cap 663 and represents a transition between the outwardly facing surface 664 and the inwardly facing surface 661. The fold 662 avoids any sharp edges that could risk rupture of the aneurysm wall or other anatomical damage. The cap 663 includes a concave surface 657 arranged about a longitudinal axis 668. The cap 663 is manufactured as an inverted mesh tube 665 having a simple straight elongated configuration and is subsequently formed into Fig.69 The shape shown in FIG. 664 is formed by heating the cap 663 and heat setting the cap 663 into the shape shown in FIG. 664. For example, the inverted mesh tube 665 can be constructed as a single layer mesh tube formed by at least some nickel-titanium alloy wires and then inverted on itself. The inverted mesh tube 665 can then be placed into a die or mold containing one or more components to hold it in the shape of the cap 663. The cap 663 can then be subjected to an elevated temperature and then cooled to lock in the shape, resulting in the cap 663 having at least some superelastic properties.

[0316] When formed (e.g., thermoformed), the cover 663 has an expanded configuration (e.g., Fig.69 ) and contraction structures, such as Fig.71 The cover 663 comprises two mesh layers, provided by an outwardly facing surface 664 and an inwardly facing surface 661 .

[0317] In some embodiments, the cover 663 can include some nickel-titanium alloy wires and some radiopaque elements, including platinum, gold, tantalum or an alloy of any one of these or other radiopaque materials. In some embodiments, the wire can include a stretch filling tube (DFT), such as those including a nickel-titanium alloy outer wall and a platinum core. The radiopaque material allows the cover 663 to be visible in radiographs or fluoroscopy. The occluding device 660 can be constructed by controlling how much radiopaque material is used, by the ratio of radiopaque wire to non-radiopaque wire, or by stretching the amount of the platinum core in the filling tube. In this way, the cover 663 can be selectively manufactured to be visible enough, but not excessively visible, such as too bright, so that other objects are obscured. In some embodiments, no matter whether any one of the wires includes radiopaque material, the marker band 119 can be attached to the proximal end 672 of the occluding device 660 by adhesive or epoxy resin bonding, or die forging, welding or other mechanical attachment.

[0318] The pusher 669 having a distal end 673 and a proximal end 667 may comprise a wire, a hypotube, or another elongated structure having a column support, which is removably coupled to the proximal end 672 of the occluding device 660 at its distal end 673. The removable joint 670 may comprise one of a variety of release systems, including but not limited to a pressurized release, an electrolytic release mechanism, a hydraulic release mechanism, a mechanical or interlocking release mechanism, a chemical release mechanism, a heat-activated release system, or a friction release system. During delivery, the pusher 669 is held by the user at its proximal end 667 and moved in a longitudinal forward direction 676 ( Figure 71-Figure 72 ) to advance the occluding device 660 to the distal end 679 of a delivery catheter 677 (e.g., a microcatheter) having a delivery lumen 678. The delivery catheter 677 may also include a proximal hub 137, such as a Luer connector.

[0319] exist Fig.70 In an embodiment, the pusher 669 includes an outer tube 153 and an inner wire 151 coupled to each other. Conductors (e.g., wires) 147, 149 are electrically coupled to the inner wire 151 and the outer tube 153 (e.g., if a metal tube) at the distal end, and electrically coupled to first and second circumferential contacts 143, 145 carried on a hub 141, which is attached to the proximal end 667 of the pusher 669. The hub 141 has a cavity 671 into which the proximal end 667 of the pusher 669 is inserted and coupled. The hub 141 and its circumferential contacts 143, 145 are reversibly coupleable to a connector (not shown) of a disengagement controller (not shown), such as those known in the art. Disengagement of the occluding device 660 from the pusher 669 can be achieved by using a disengagement controller of any disengagement system, including but not limited to a pressurized disengagement, an electrolytic disengagement mechanism, a hydraulic disengagement mechanism, a mechanical or interlocking disengagement mechanism, a chemical disengagement mechanism, a heat-activated disengagement system, or a friction disengagement system.

[0320] Go to Fig.73 , the cover 663 of the occluding device 660 in its expanded configuration includes a concave surface 657 arranged generally about the longitudinal axis 668. This does not require that the longitudinal axis 668 be a complete axis of symmetry, as the cover may or may be elliptical, or another non-circular shape. The pusher 669 extends from the removable joint 670 along its own longitudinal axis 135, which is not colinear with the longitudinal axis 668. A non-zero angle θ is therefore formed between the two longitudinal axes 668, 135. The angle θ may be between about 15 degrees and about 120 degrees, or between about 30 degrees and about 120 degrees, or between about 40 degrees and about 100 degrees, or between about 45 degrees and about 90 degrees, or between about 75 degrees and about 90 degrees. This angling facilitates delivery of the occluding device 660 to an aneurysm having an angled take-off and / or positioned along a tortuous artery or an artery having sharp bends, such as Figure 74A-Figure 76C shown.

[0321] In addition, the outwardly facing surface 664 has a general center point 133 at the longitudinal axis 668. The center point 133 (and the longitudinal axis 668) are separated from the removable joint 670 by a non-zero distance r. Thus, the removable joint 670 is radially offset from the longitudinal axis 668. The maximum radius r of the cover 663 is MAX The distance r is the maximum radius measured from the longitudinal axis 668 to the periphery 131, for example, at any point on the periphery 131 on a generally circular cap, or at a point on the periphery 131 (or circumference in general) along the major axis as in an ellipse. The phrase "radial deviation" as used herein should be interpreted as referring to a radial deviation of at least about 5%. In some embodiments, the distance r is the maximum radius r MAX At least about 10% of the maximum radius r MAX at least about 25% of the maximum radius, or at least about 50% of the maximum radius, or the maximum radius r MAX The deviation (distance r) facilitates delivery of the occluding device 660 to an aneurysm having an angled takeoff and / or positioned along a tortuous artery or an artery having a sharp bend, such as Figure 74A-Figure 76C as shown in .

[0322] Although in Fig.73 In other embodiments, there is a non-zero angle θ and a non-zero distance r. In other embodiments, there may be a non-zero angle θ but a substantially zero distance r, such as Fig.78 In other embodiments, there may be a non-zero distance r and a substantially zero angle θ, such as Fig.77 The occluding device 1109.

[0323] Figure 74A-Figure 76CArteries 681, 802, 902 with sidewall aneurysms 680, 800, 900 are shown. When placing a single occluding device, the approach through a catheter (e.g., a delivery catheter / microcatheter 685) in a sidewall aneurysm is often challenging. The distal end 686 of the delivery catheter 685 can be provided as a pre-formed with a specific curve, or can be steam formed or otherwise formed by the user to form a preferred curve before inserting the delivery catheter 685 into the patient's vasculature, so that the delivery angle of the occluding device 687, 692, 698 into the aneurysm 680, 800, 900 allows delivery along an axis that is substantially or slightly parallel to the longitudinal axis of the neck 683, 806, 906 of the aneurysm 680, 800, 900, or substantially or slightly parallel to the longitudinal axis of the sac of the aneurysm 680, 800, 900 itself. However, the curvature of the artery 681, 802, 902 or the small diameter of the artery 681, 802, 902 may make it difficult for the curved tip of the delivery catheter 685 to fit into the artery 681, 802, 902 adjacent to the neck 683, 806, 906. In other cases, the curved tip may not provide adequate backup support for delivering the implant (occlusion device). The occlusion devices 687, 692, 698 according to the embodiments disclosed herein improve the efficacy of embolization performed under these anatomical conditions by allowing the user to select specific device parameters that match the anatomy.

[0324] exist Fig.74A In FIG. 6 , an occluding device 687 including a cap 688 removably coupled to a pusher 691 at a removable joint 1103 is delivered through a delivery catheter 685 to an aneurysm 680 extending from an artery 681. Aneurysm 680 includes a dome 682 and a neck 683. Occluding device 687 is similar to occluding device 660, but has a different angle θ and offset distance r, as shown in FIG. Fig.74A The attending physician can select a specific occlusion device 687 (e.g., size, specification, model) to fit the aneurysm 680, specifically selecting the angle θ and the offset distance r to facilitate delivery through the artery 681 and into the aneurysm 680, and to optimize the geometry of the system (e.g., delivery catheter 685 and occlusion device 687) during detachment. The cap 688 has a concave surface 690 and an outer perimeter 1104 or circumference ( Fig.74C ).exist Fig.74B In the embodiment of the present invention, the cap 688 is detached from the pusher 691 via the removable joint 1103 in any of the ways described with respect to the occlusion device 660. The pusher 691 and the delivery catheter 685 are then removed from the patient, leaving the occlusion device 687 deployed within the aneurysm 680, as shown in FIG. Fig.74CThe outwardly facing surface 689 of the cap 688 abuts the lower wall portion 708 of the aneurysm 680 sac, abutting the neck 683 of the aneurysm 680. The periphery 1104 extends into the sac, at least at some portions thereof, and in a direction substantially away from the neck 683 of the aneurysm 680.

[0325] exist Fig.75A In FIG. 6 , an occluding device 692 including a cap 693 removably coupled to a pusher 696 at a removable joint 695 is delivered through a delivery catheter 685 to an aneurysm 800 extending from an artery 802. Aneurysm 800 includes a dome 804 and a neck 806. Occluding device 692 is similar to occluding device 660, but has a different angle θ and offset distance r, as shown in FIG. Fig.75A As shown. The attending physician can select a particular occlusion device 692 (e.g., size, specification, model) to fit the aneurysm 800, specifically selecting the angle θ and the offset distance r to facilitate delivery through the artery 802 and into the aneurysm 800, and to optimize the geometry of the system (e.g., delivery catheter 685 and occlusion device 692) during detachment. The cap 693 has a concave surface 697 and an outer perimeter 1106 or circumference ( Fig.75C ).exist Fig.75B In the embodiment of the present invention, the cover 693 is detached from the pusher 696 via the removable joint 695 in any of the ways described with respect to the occlusion device 660. The pusher 696 and the delivery catheter 685 are then removed from the patient, leaving the occlusion device 692 deployed within the aneurysm 800, as shown in FIG. Fig.75C The outwardly facing surface 694 of the cap 693 abuts against the lower wall portion 808 of the aneurysm 800 sac, abutting the neck 806 of the aneurysm 800. The periphery 1106 extends into the sac, at least at some portions thereof, and in a direction substantially away from the neck 806 of the aneurysm 800.

[0326] exist Fig.76A In the embodiment of the present invention, an occluding device 698 including a cap 699 removably coupled to a pusher 1101 at a removable joint 1102 is delivered through a delivery catheter 685 to an aneurysm 900 extending from an artery 902. Aneurysm 900 includes a dome 904 and a neck 906. Occluding device 698 is similar to occluding device 660, but has a different angle θ and offset distance r, as shown in FIG. Fig.76A. The specific occlusion device 698 (e.g., size, specification, model) can be selected by the attending physician to fit the aneurysm 900, and the angle θ and the offset distance r can be specifically selected to facilitate delivery through the artery 902 and into the aneurysm 900, and to optimize the geometry of the system (e.g., delivery catheter 685 and occlusion device 698) during detachment. The cap 699 has a concave surface 1100 and an outer perimeter 1108 or circumference ( Fig.76C ).exist Fig.76B In the embodiment of the present invention, the cap 699 is detached from the pusher 1101 via the removable joint 1102 in any of the ways described with respect to the occlusion device 660. The pusher 1101 and the delivery catheter 685 are then removed from the patient, leaving the occlusion device 698 deployed within the aneurysm 900, as shown in FIG. Fig.76C The outwardly facing surface 408 of the cap 699 abuts the lower wall portion 908 of the aneurysm 900 sac, abutting the neck 906 of the aneurysm 900. The periphery 1108 extends into the sac, at least at some portions thereof, and in a direction substantially away from the neck 906 of the aneurysm 900.

[0327] As in Figure 74A-Figure 76C It can be seen that a particular angle θ and / or offset distance r enables optimized delivery and deployment of the occluding devices 687, 692, 698 within the aneurysm 680, 800, 900. Fig.74A and Fig.75A , the delivery catheter 685 is shown as having little or no curve formed on its distal end 686. However, in Fig.76A , the distal end 686 has a pre-formed or physician-formed curve 163 to aid in delivering the occluding device 698 into the aneurysm 900. The curve 163 is oriented more or less in the plane of the page, with one or more radii or curvatures being substantially perpendicular to the page (i.e., extending perpendicularly from the page). However, because the occluding device 698 has a concave shape arranged about the longitudinal axis 418, and because the occluding device 698 and the pusher 1101 together form a structure that is asymmetric with respect to the longitudinal axis 418, it may be desirable to selectively control the orientation rotation of the occluding device 698 relative to its longitudinal axis 418, which will thus further control the overall orientation of the occluding device 698 relative to the aneurysm 900.

[0328] Back to Fig.69 , the cover 663 can be braided such that the braid, mesh, etc. is arranged somewhat symmetrically about the longitudinal axis 668. However, in alternative embodiments, it may also be desirable to form the braid asymmetrically about the longitudinal axis 668 so that when the cover 663 is compressed into its collapsed configuration, it is actually more preferably biased (via structure and sliding dynamics) to form a more linear structure that is more oriented along the longitudinal axis 135 ( Fig.73). Thus, when compressed within the lumen 678 of the delivery catheter 677, the longitudinal axis 668 and the "pseudo" longitudinal axis 135 (because the cover 663 is now temporarily deformed) are now forced into an angle θ (relative to each other) of approximately 90 degrees. That is, until the cover 663 is delivered from the lumen 678 of the delivery catheter 677, it is allowed to assume its expanded configuration and, through the memory of the braided material, conform to its true angle θ. Asymmetric braiding can be achieved by using a braiding process or an automatic braiding machine that changes the braiding angle in an oscillating or sinusoidal manner. For example, at a particular clock position around the periphery 659 of the cover 663 (e.g., 6 o'clock), the braiding angle can be equal to a first value X, and at another clock position around the periphery 659 of the cover 663 (e.g., 9 o'clock), the braiding angle can be equal to a second value 0.8X. In some embodiments, the second value can be between about 40% and about 95% of the first value, or between about 50% and about 90% of the first value, or between about 60% and about 85% of the first value.

[0329] Fig.77 An occluder device 1109 is shown comprising a cap 1110 removably coupled to a pusher 1113 at a removable joint 1112. The cap 1110 has an outer periphery 514. A longitudinal axis 1111 of the cap 1110 is radially offset by a non-zero distance r from a longitudinal axis 535 of the pusher 1113. There is an angle of substantially zero between the longitudinal axis 1111 of the cap and the longitudinal axis 535 of the pusher 1113.

[0330] Fig.78 An occluder device 1114 is shown that includes a cap 1115 removably coupled to the pusher 652 at a removable joint 658. The cap 1115 has an outer periphery 1116. A longitudinal axis 1117 of the cap 1115 is at a non-zero angle θ with the longitudinal axis 635 of the pusher 652. There is a distance r between the longitudinal axis 1117 of the cap 1115 and the longitudinal axis 635 of the pusher 652 that is substantially zero.

[0331] Although the occlusion devices 660, 687, 692, 698, 1109, 1114 described in accordance with the embodiments disclosed herein are shown as generally having a proximal convex surface and a distal concave surface, and are configured to be placed primarily in the lower (near the neck) portion of an aneurysm, any other configuration for an aneurysm occlusion device is contemplated for use in combination with the attachment / detachment geometries taught in the disclosed embodiments. This includes devices configured as the only device implanted in an aneurysm, as well as devices configured as one or more devices implanted in an aneurysm. Figure 79-Figure 84Six different occlusion systems 770, 772, 774, 776, 778, 780 are shown being used to deliver a braided shell 758 into an aneurysm 750 having a dome 752 and a neck 768. The braided shell 758 has a longitudinal axis 756 and is configured to fill a majority of the aneurysm 750 or in some cases substantially all of the aneurysm 750 sac. The braided shell 758 is braided or woven from a wire 760 and has a proximal end 751, a distal end 753, and a middle portion 782. The aneurysm 750 has the geometry of a sidewall aneurysm associated with the left extended artery 762 and the right extended artery 764. Alternatively, the aneurysm 750 has the geometry of a terminal aneurysm associated with the artery 754. Additional blood vessels 766 may also be present. It may be desirable to avoid embolization of this blood vessel 766 during embolization of the aneurysm 750.

[0332] exist Fig.79 In the embodiment of the present invention, the occlusion system 770 includes a pusher 784 removably coupled to the proximal end 751 of the braided shell 758 at a removable joint 785. The pusher 784 extends from the removable joint 785 at a non-zero angle relative to the longitudinal axis 756 of the braided shell 758. The removable joint 785 is dimensionally offset from the longitudinal axis 756 of the braided shell 758 by a non-zero distance. The offset side is the same as the side from which the pusher 784 extends. The occlusion system 770 is Fig.79 762, although it may also be delivered from one or more other arteries.

[0333] exist Fig.80 In the embodiment of the present invention, the occlusion system 772 includes a pusher 786 removably coupled to the proximal end 751 of the braided shell 758 at a removable joint 787. The pusher 786 extends from the removable joint 787 at a non-zero angle relative to the longitudinal axis 756 of the braided shell 758. The removable joint 787 is dimensionally offset from the longitudinal axis 756 of the braided shell 758 by a non-zero distance, and the braided shell 758 is located on the side of the longitudinal axis opposite to the side from which the pusher 784 extends. The occlusion system 772 is Fig.80 762, although it may also be delivered from one or more other arteries.

[0334] exist Fig.81 In the embodiment of the present invention, the occlusion system 774 includes a pusher 788 removably coupled to the proximal end 751 of the braided shell 758 at a removable joint 789. The pusher 788 extends from the removable joint 789 at a non-zero angle relative to the longitudinal axis 756 of the braided shell 758. The removable joint 789 is generally not offset from the longitudinal axis 756 of the braided shell 758, but is substantially coupled at the longitudinal axis 756. The occlusion system 774 is Fig.81 762, although it may also be delivered from one or more other arteries.

[0335] exist Fig.82 In the embodiment of the present invention, the occlusion system 776 includes a pusher 790 removably coupled to the proximal end 751 of the braided shell 758 at a removable joint 791. The pusher 790 extends from the removable joint 791 at a substantially zero angle relative to the longitudinal axis 756 of the braided shell 758. The removable joint 791 is dimensionally offset from the longitudinal axis 756 of the braided shell 758 by a non-zero distance. Fig.82 754, although it may also be delivered from one or more other arteries.

[0336] exist Fig.83 In the embodiment of the present invention, the occlusion system 778 includes a pusher 792 removably coupled to the proximal end 751 of the braided shell 758 at a removable joint 793. The pusher 792 extends from the removable joint 793 at a non-zero angle relative to the longitudinal axis 756 of the braided shell 758. The removable joint 793 is dimensionally offset from the longitudinal axis 756 of the braided shell 758 by a non-zero distance. The offset side is opposite to the side from which the pusher 792 extends. The occlusion system 778 is Fig.83 754, although it may also be delivered from one or more other arteries.

[0337] exist Fig.84 In the embodiment of the present invention, the occlusion system 780 includes a pusher 794 that is detachably coupled to the proximal end 751 of the braided shell 758 at a detachable joint 795. The pusher 794 extends from the detachable joint 795 at a non-zero angle relative to the longitudinal axis 756 of the braided shell 758. The detachable joint 795 does not deviate from the longitudinal axis 756 of the braided shell 758, but is substantially coupled at the longitudinal axis 756. The occlusion system 780 is Fig.84 754, although it may also be delivered from one or more other arteries.

[0338] As in Figure 79-Figure 84 As can be seen in FIG. 7 , the angle θ and / or the offset distance r enable optimized delivery and deployment of the occluding device (braided shell 758 ) within the aneurysm 750 .

[0339] Fig.85 and Fig.86 A delivery catheter 85 is shown that includes a shaft 87 having a proximal end 89, a distal end 93 having a bend 97, and a non-circular lumen 99. A Luer hub 91 is coupled to the proximal end 89 of the shaft 87. In some embodiments, the non-circular lumen 99 can extend through the entire shaft 87, but at a distal end 93 having a bend 97. Fig.85 and Fig.86 In the embodiment, the non-circular cavity 99 is deformed into a circular cavity 83 at the proximal end 89 ( Fig.87). In some embodiments, the shaft 87 may be extruded with a circular cavity 83 throughout its entire length, and then a mandrel of non-circular cross-section may be placed in the cavity 83 at the distal end 93, and heat may be applied to reform the cavity 83 at the distal end 93 to have a non-circular cavity 99 shape. In other embodiments, the first tubular portion 22 having a circular cavity 83 may be heat fused to the second tubular portion 24 having a non-circular cavity 99. The mandrel may be placed from the proximal end and have a smooth transition between the circular outer cross-section and the non-circular outer cross-section to form a transition zone 26 that includes a continuous smooth cavity wall surface transition between the circular cavity 83 and the non-circular cavity 99. The non-circular cavity 99 at Fig.85 , but may alternately be oval, or any type of non-circular cross-sectional shape. For example, a polygon, dog bone, guitar, or U-shape. Optionally, to further aid in visualization on fluoroscopy (e.g., biplane fluoroscopy), a radiopaque strip 28 may be extruded or otherwise placed on one side of the wall 30 of the shaft 87. Thus, the physician delivering the delivery catheter 85 is better able to judge the orientation (rotational clock position) of the bend 97 relative to the aneurysm. The non-circular cavity 99 allows a compressed or constrained profile that is roughly oval or elliptical or other non-circular occluding device to be selectively rotated, such as so that it can only be placed at 0°, or at 180°, or at other rotational angles. The marker 95 on the Luer hub 91 can be used to assist in the insertion of the occluding device by serving as a comparative visual aid so that it is oriented in a specific one of the 0° or 180° orientations. In some embodiments, longitudinal strips may be placed on shaft 87 near distal end 93 to allow steam forming of bend 97 (if not pre-formed), or re-forming of bend 97 along a desired plane. In some embodiments, steam forming may be performed by placing a bendable mandrel within non-circular cavity 99 to further or alternatively assist in forming or re-forming bend 97 along a desired plane. In some embodiments, the bendable mandrel has a cross-sectional shape similar to non-circular cavity 99 such that it substantially fills non-circular cavity 99.

[0340] Fig.88 and Fig.89 A delivery catheter 32 is shown that includes a shaft 34 having a proximal end 36, a distal end 38 having a bend 40, and a non-circular lumen 42. A Luer hub 44 is coupled to the proximal end 36 of the shaft 34. In this particular embodiment, the non-circular lumen 42 extends through the entire shaft 34. The non-circular lumen 42 is disposed at a distal end 38 having a bend 40. Fig.8834 and 35. The occluding device 34 is shown as a guitar shape having a first smaller leaf 46 and a second larger leaf 48 connected together by a waist 50. Thus, the guitar shape creates a key that allows only one specific rotational position of the occluding device when it exits the cavity 42 at the distal end 38 of the shaft 34 and thus enters the aneurysm. In some embodiments, the size of the non-circular cavity 42 may taper near the distal end 38 of the shaft 34. Thus, the occluding device is essentially tightly held near the distal end 38 of the shaft 34, but there is more space over most of the length of the cavity 42 to minimize axial friction. Any other type of "keyed" shape may alternatively be used for the non-circular cavity 42. Optionally, to further aid visualization on fluoroscopy (e.g., biplane fluoroscopy), a longitudinal opaque line band 52 may be extruded or otherwise placed on one side of the wall 54 of the shaft 34.

[0341] Go to Figure 91-94 The loading sheath (or guide sheath or insertion sheath) 56 is configured to assist in inserting the asymmetric occluding device 58 (or asymmetric occluding device 58 / pusher 59 / detachable joint 61 system) into the non-circular lumen 60 of the delivery catheter 62 ( Fig.94 The non-circular lumen 60 may extend only within the shaft 64 of the catheter 62, or the Luer hub 66 itself may have a non-circular lumen 60 (e.g., Fig.94 ). The removable funnel 68 has a proximal end 70 attached to the distal end 72 of the loading sheath 56. The funnel 68 has a proximal inner diameter 74 ( Fig.93 The funnel 68 tapers smoothly to an increased inner diameter 78 at the distal end 80. In use, the occluding device 58 may be packaged within the lumen 82 of the loading sheath 56 or may be packaged to extend from the loading sheath 56. Prior to insertion into the non-circular lumen 60 of the delivery catheter 62, the occluding device 58 may be filled or flushed into the lumen 82 of the loading sheath 56 ( Fig.91 ) to prepare. The occluding device 58 can be inspected or flushed in saline or saline and heparin outside the loading sheath 56, such as Fig.91 . The user then carefully applies traction (pulling) to the pusher 59 to load the occluding device 58 into the cavity 82 of the loading sheath 56 in the preferred compressed configuration. For example, the folds are oriented in a minimal profile manner, or the preferred distal extensions are configured so that they will exit the cavity 82 first. The internal profile of the funnel 68 optimizes the ability to preferentially load the occluding device 58 into the cavity 82. For example, preferential loading can be performed in a certain manner to obtain the smallest possible compressed or contracted diameter. The loaded occluding device 58 is shown in Fig.92 , completely within the cavity 82 of the loading sheath 56. Fig.93As shown, the funnel 68 can then be broken off, unscrewed, or otherwise removed from the loading sheath 56. The funnel 68 can then be removed and discarded. In some embodiments, the funnel 68 can be reattached to the loading sheath 56. Fig.94 , the distal end 72 of the loading sheath 56 is placed near the entrance of the non-circular cavity 60, so that, for example, the larger profile leaf 84 of the compressed occluding device 58 can match to enter the larger leaf 86 of the non-circular cavity 60, and the smaller profile leaf 88 of the occluding device 58 can match to enter the smaller leaf 90 of the non-circular cavity 60. Then, the pusher 59 is pushed by the user to load the occluding device 58 in the non-circular cavity 60 and advance the occluding device 58 toward the distal end (not shown) of the delivery catheter 62. The loading sheath 56 can be peeled off, or can be simply pulled back to the proximal end of the pusher 59. The occluding device 58 can now be reliably delivered to the aneurysm in a selected orientation. For example, the correct side is facing up, not upside down. In some embodiments, the loading sheath may have external longitudinal stripes on the loading tube to help the user apply the desired rotational orientation when inserting the occluding device 58.

[0342] Alternative lumen shapes and compressed shapes of the occlusion device are shown in Figure 95A-Figure 95E .exist Fig.95A In an embodiment, the distal end 852 of the delivery catheter 850 has a pentagonal non-circular lumen 854. The occluding device 856 in a compressed configuration facilitates a generally pentagonal shape that is matable with the shape of the non-circular lumen 854. Fig.95B In an embodiment, the distal end 858 of the delivery catheter 860 has a diamond-shaped non-circular lumen 862. The occluding device 864 in a compressed configuration facilitates a substantially diamond-shaped shape that is matable with the shape of the non-circular lumen 862. Fig.95C In an embodiment, the distal end 866 of the delivery catheter 868 has a U-shaped non-circular lumen 870. The occluding device 872 in a compressed configuration facilitates a substantially U-shaped shape that is matable with the shape of the non-circular lumen 870. Fig.95D In the embodiment of the present invention, the distal end 874 of the delivery catheter 876 has an oval non-circular lumen 878. The occluding device 880 in the compressed configuration facilitates a substantially oval shape that is matable with the shape of the non-circular lumen 878. Fig.95E In an embodiment, the distal end 882 of the delivery catheter 884 has a guitar-shaped non-circular lumen 886. The occluding device 888 in a compressed configuration facilitates a basic guitar shape that is keyable to the shape of the non-circular lumen 886.

[0343] Fig.96A and Figure 97A-Figure 97CAn occluder device 2040 is shown that includes a mesh cover 2042 that includes a distal concave surface 2044. A radially offset inner tube 2046 having a lumen 2048 and an outer wall 2050 is secured within the mesh cover 2042 such that its proximal end 2052 is flush with or closely adjacent to the proximal end 2054 of the mesh cover 2042. The pusher 2056 includes a wire having a distal end 2058 that includes a plurality of radially extending fingers 2060 extending from the distal end 2058. The fingers 2060 are configured to be meltable, detachable, inflexible, frangible, ablative, deformable, or otherwise changeable. Prior to detachment, the radially extending fingers 2060 create a maximum diameter that is greater than the diameter of the lumen 2048 of the inner tube 2046, so that the traction on the wire of the pusher 2056 causes the fingers 2060 to pull the distal end of the outer wall 2050 of the inner tube 2046, and thereby pull the entire occluding device 2040. For example, the occluding device 2040 can be advanced into an aneurysm, and if the user does not believe that the fit or configuration of the occluding device 2040 within the aneurysm is desirable, the user can pull the pusher 2056 to pull the occluding device 2040 out of the aneurysm and into the lumen of the delivery catheter. However, then the occluding device 2040 has been delivered into the aneurysm in an acceptable manner, and the user can detach by any detachment means (deformation, damage or destruction of the fingers 2060), by means including but not limited to pressurized detachment, electrolytic detachment mechanisms, hydraulic detachment mechanisms, mechanical or interlocking detachment mechanisms, chemical detachment mechanisms, heat-activated detachment systems, or friction detachment systems. In one embodiment, mechanical disengagement is achieved by pushing the distal end of the microcatheter against the proximal end 2054 of the mesh cover 2042 while pulling the pusher 2056, thereby bending the finger 2060 and removing the pusher 2056 from the occlusion device 2040. The inner tube 2046 provides a smooth proximal end 2054 of the mesh cover 2042, so there are no residual protruding wires to the proximal end. Residual protruding wires may cause thrombosis, which may cause embolic stroke. In some embodiments, for example, if the distal end 2058 includes a stainless steel wire, the distal end 2058 of the pusher 2056 may taper to as small as 0.001 inches or 0.002 inches. The inner tube 2046 may include a polyimide tube and may have an inner diameter as small as 0.002 inches to 0.010 inches and an outer diameter between about 0.003 inches and about 0.014 inches. In some embodiments, there may be two fingers 2060, or three fingers 2060, or four fingers 2060, or five fingers 2060, or six fingers 2060 or more.

[0344] The flush or adjacent relationship of the proximal end 2052 of the inner tube 2046 to the proximal end 2054 of the mesh cover 2042 ensures that no detached remnants extend substantially proximal to the proximal end 2054 of the mesh cover 2042 (and into the parent artery). Thus, any potentially associated thromboembolic events, where such remnants would be a risk, can be avoided. Fig.96B An alternative distal end 2058b is shown including a ball 2062 having a spherical or spherical shape. Disengagement may occur at the ball 2062, or at a portion 2064 of the distal end 2058b proximal to the ball 2062, or at both. The ball 2064 may be attached to the pusher 2056 by epoxy, adhesive, forging, brazing or welding, or may be formed from the material of the distal end 2058b by welding. Fig.96C An alternative distal end 2058c is shown including a disc 2066 having a flat circular shape. Disengagement may occur at the disc 2066, or at a portion 2068 near the distal end 2058c of the disc 2066, or at both. The disc 2066 may be attached to the pusher 2056 by epoxy, adhesive, forging, brazing or welding, or may be formed from the material of the distal end 2058c by welding. Fig.96D An alternative distal end 2058d is shown including a tip 2070 having a frustoconical shape. Detachment may occur at the tip 2070, or at a portion 2072 of the distal end 2058d proximal to the tip 2070, or both. The tip 2070 may be attached to the pusher 2056 by epoxy, adhesive, forging, brazing or welding, or may be formed from the material of the distal end 2058d by welding. Fig.96E An alternative distal end 2058e is shown that includes a tip 2076 having a flattened reverse spear shape. Disengagement may occur at the tip 2076, or at a portion 2078 of the distal end 2058e proximal to the tip 2076, or both. The tip 2076 may be attached to the pusher 2056 by epoxy, adhesive, forging, brazing or welding, or may be formed from the material of the distal end 2058e by welding, or may be a flattened portion of the pusher 2056 wire formed, for example, by rolling or pressing. In each alternative embodiment, the diameter (or maximum transverse dimension) of the ball 2062, disk 2066, proximal end 2074 of the tip 2070, or distal end 2080 of the tip 2076 is greater than the diameter of the lumen 2048 of the inner tube 2046, thereby allowing the occluding device 2040 to be removably locked to the pusher 2056. Shown in Figures 10A-10E and Figure 96A-Figure 96E Any of the tip configurations may be incorporated into a variety of different occluding devices, including any occluding device disclosed herein.

[0345] The following items include examples of devices of the present disclosure.

[0346] Item 201: In one example, a vascular occlusion system constructed for embolizing an aneurysm having a neck and a sac, comprising an elongated pusher constructed to be slidably disposed within a delivery catheter having a proximal end, a distal end, and a delivery lumen extending therebetween, an implantable vascular occlusive device coupled to the distal end of the pusher, the vascular occlusive device being constructed for implantation in the aneurysm sac and having a contracted delivery structure when confined within the delivery lumen of the delivery catheter, and an expanded, deployed structure after being delivered from the delivery lumen of the delivery catheter and into the aneurysm sac, wherein the vascular occlusive device includes a proximal face and a concave face opposite the proximal face, the proximal face being constructed to abut a lower wall portion of the aneurysm sac, abut the aneurysm neck, the concave face having a circumference extending into the sac and away from the aneurysm neck, the concave face being arranged around a longitudinal axis, and wherein the vascular occlusive device is constructed to be releasably coupled to the distal end of the pusher at a releasable joint, the distal end of the pusher extending from the releasable joint at an angle of about 30 degrees to about 120 degrees with the central longitudinal axis.

[0347] Item 202: In some examples, the system includes item 201, wherein the pusher extends from the releasable joint at an angle of about 40 degrees to about 100 degrees to the central longitudinal axis.

[0348] Item 203: In some examples, the system includes item 201, wherein the pusher extends from the releasable joint at an angle of about 45 degrees to about 90 degrees to the central longitudinal axis.

[0349] Item 204: In some examples, the system includes item 201, wherein the pusher extends from the releasable joint at an angle of about 75 degrees to about 90 degrees to the central longitudinal axis.

[0350] Item 205: In some examples, a system includes any of items 201-204, wherein the releasable connector is coupled to a proximal face of the vaso-occlusive device.

[0351] Item 206: In some examples, the system includes item 205, wherein the releasable connector is coupled to the proximal face of the vaso-occlusive device at a location radially offset from the central longitudinal axis.

[0352] Item 207: In some examples, the system includes item 206, wherein the vaso-occlusive device in its expanded, deployed configuration has a maximum radius, and wherein the location on the proximal face deviates from the maximum radius by at least 50%.

[0353] Item 208: In some examples, the system includes item 206, wherein the vaso-occlusive device in its expanded, deployed configuration has a maximum radius, and wherein the location on the proximal face deviates from the maximum radius by at least 75%.

[0354] Item 209: In some examples, the system includes item 206, wherein the vaso-occlusive device in its expanded, deployed configuration has a maximum radius, and wherein the location on the proximal face is at a radial edge.

[0355] Item 210: In another example, a vascular occlusion system configured for embolizing an aneurysm having a neck and a sac, comprising an elongated pusher configured to be slidably disposed within a delivery catheter having a proximal end, a distal end, and a delivery lumen extending therebetween, an implantable vascular occlusive device coupled to the distal end of the pusher, the vascular occlusive device configured to be implanted in the aneurysm sac and having a collapsed delivery configuration when confined within the delivery lumen of the delivery catheter, and a delivery configuration configured to be delivered from the delivery lumen of the delivery catheter and into the delivery lumen of the delivery catheter. The invention relates to an expanded, deployed configuration after the aneurysm sac is expanded, wherein the vascular occlusive device includes a proximal face and a concave face opposite the proximal face, wherein the proximal face is configured to abut against a lower wall portion of the aneurysm sac, abut against the aneurysm neck, and the concave face has a perimeter extending into the sac and away from the aneurysm neck, the concave face is arranged around the longitudinal axis, and wherein the vascular occlusive device is configured to be releasably coupled to the distal end of the pusher at a releasable joint, and wherein the releasable joint is coupled to the proximal face of the vascular occlusive device at a position that is radially offset from the central longitudinal axis.

[0356] Item 211: In some examples, the system includes item 210, wherein the vaso-occlusive device in its expanded, deployed configuration has a maximum radius, and wherein the location on the proximal face deviates from the maximum radius by at least 50%.

[0357] Item 212: In some examples, the system includes item 210, wherein the vaso-occlusive device in its expanded, deployed configuration has a maximum radius, and wherein the location on the proximal face deviates from the maximum radius by at least 75%.

[0358] Item 213: In some examples, the system includes item 210, wherein the vaso-occlusive device in its expanded, deployed configuration has a maximum radius, and wherein the location on the proximal face is at a radial edge.

[0359] Item 214: In some examples, a system includes any of items 201-213, wherein the vaso-occlusive device comprises a cap having a first side and a second side, wherein the proximal surface comprises the first side of the cap and the concave surface comprises the second side of the cap.

[0360] Item 215: In some examples, the system includes any of items 201-214, wherein the vaso-occlusive device is formed of a mesh material.

[0361] Item 216: In some examples, the system includes item 215, wherein the mesh material includes a plurality of filaments.

[0362] Item 217: In some examples, the system includes item 216, wherein the plurality of wires include wires comprising a nickel-titanium alloy.

[0363] Item 218: In some examples, the system includes item 216, wherein the plurality of wires includes wires comprising a radiopaque material.

[0364] Item 219: In some examples, the system includes item 216, wherein the plurality of wires includes a wire comprising a stretched fill tube.

[0365] Item 220: In some examples, the system includes any of items 217-219, wherein the plurality of filaments include filaments comprising platinum.

[0366] Item 221: In another example, a vascular occlusion system configured for embolizing an aneurysm having a neck and a sac, comprising an elongated pusher configured to be slidably disposed within a delivery catheter having a proximal end, a distal end, and a delivery lumen extending therebetween, an implantable vascular occlusive device coupled to the distal end of the pusher, the vascular occlusive device configured to be implanted in the aneurysm sac and having a contracted delivery structure when confined within the delivery lumen of the delivery catheter, and an expanded, deployed structure after being delivered out of the delivery lumen of the delivery catheter and into the aneurysm sac, wherein the vascular occlusive device includes a proximal face and a distal face that is adjacent to the proximal face. The concave surface of the pair of pushers is configured to abut against an inferior wall portion of the aneurysm sac, against the aneurysm neck, and has a perimeter extending into the sac and away from the aneurysm neck, the concave surface is arranged about the longitudinal axis, and wherein the vascular occluding device is configured to be releasably coupled to the distal end of the pusher at a releasable joint, and wherein the releasable joint has a characteristic selected from the list consisting of: (1) the distal end of the pusher extends from the releasable joint at an angle of about 30 degrees to about 120 degrees to the central longitudinal axis, and (2) the releasable joint is coupled to the proximal surface of the vascular occluding device at a position that is radially offset from the central longitudinal axis.

[0367] Item 222: In another example, a system for embolizing an aneurysm includes an expandable implant constructed for placement within the aneurysm, the implant having a collapsed structure and an expanded structure, the expanded structure having an asymmetric shape about a longitudinal axis, and a delivery catheter having a proximal end and a distal end and a cavity extending from the proximal end to the distal end, the cavity having a non-circular cross-section at least in a distal region adjacent to the distal end of the delivery catheter, wherein the expandable implant in its collapsed structure is constructed to fit into the cavity in the distal region in a keyed manner so that the expandable implant can be delivered from the cavity at the distal end of the delivery catheter in a specific rotational position relative to the longitudinal axis.

[0368] Item 223: In some examples, the system includes item 222, further comprising an elongated pusher having a distal end that is releasably coupled to the expandable implant.

[0369] Item 224: In some examples, the system includes any of items 222 or 223, wherein the non-circular cross-section of the cavity includes an oval shape.

[0370] Item 225: In some examples, the system includes any of items 222 or 223, wherein the non-circular cross-section of the cavity includes an elliptical shape.

[0371] Item 226: In some examples, the system includes any of items 222 or 223, wherein the non-circular cross-section of the cavity includes a dog-bone shape.

[0372] Item 227: In some examples, the system includes any of items 222 or 223, wherein the non-circular cross-section of the cavity comprises a guitar shape.

[0373] Item 228: In some examples, the system includes any of items 222 or 223, wherein the non-circular cross-section includes a polygonal shape.

[0374] Item 229: In some examples, the system includes any of items 222 or 227, wherein the lumen of the delivery catheter has a circular cross-section at its proximal end.

[0375] Item 230: In some examples, the system includes item 229, wherein the circular cross-section extends from a proximal end of the delivery catheter to a proximal end of the distal region.

[0376] Item 231: In some examples, the system includes any of items 222-230, wherein the expandable implant in its contracted configuration has a first transverse axis relative to the longitudinal axis and a second transverse axis relative to the longitudinal axis, the first transverse axis being orthogonal to the second transverse axis, wherein a first transverse dimension along the first transverse axis is different from a second transverse dimension along the second transverse axis.

[0377] Item 232: In some examples, the system includes any of items 222-231, further comprising an introducer having a proximal end and a distal end and an introducer lumen extending between the introducer proximal end and the introducer distal end, the introducer lumen being constructed to maintain the expandable implant in its contracted configuration while the expandable implant is introduced at its proximal end into the lumen of the delivery catheter.

[0378] Item 233: In some examples, the system includes item 232, wherein the introducer includes an outwardly extending loop adjacent a distal end thereof.

[0379] Item 234: In some examples, the system includes item 233, wherein the loop has a proximal end coupled to the distal end of the introducer, and a distal end, wherein the loop has a first internal transverse dimension at its proximal end that is approximately the same as a transverse dimension of the introducer cavity at the distal end of the introducer.

[0380] Item 235: In some examples, the system includes item 234, wherein the loop has a second inner transverse dimension at a distal end thereof, the second inner transverse dimension being greater than the first inner transverse dimension.

[0381] Item 236: In some examples, the system includes item 235, wherein there is a gradual increase along the collar between the first inner lateral dimension and the second inner lateral dimension.

[0382] Item 237: In some examples, the system includes any of items 233-236, wherein the loop is removable from the introducer.

[0383] Item 238: In some examples, the system includes any of items 229 or 230, further comprising a continuous smooth transition region between the circular cross-section and the non-circular cross-section.

[0384] Item 239: In another example, a method for inserting an expandable implant includes providing an introducer having a proximal end and a distal end and an introducer lumen extending between the introducer proximal end and the introducer distal end, the introducer lumen being configured to hold the expandable implant in its contracted configuration while introducing the expandable implant at its proximal end into a lumen of a delivery catheter, wherein the lumen of the delivery catheter has a non-circular shape and wherein the expandable implant has a substantially non-circular shape in its contracted configuration, pushing the expandable implant out of the introducer lumen and into the lumen of the delivery catheter so that the substantially non-circular shape of the expandable implant in its contracted configuration is oriented in a keyed manner with the non-circular shape of the delivery catheter lumen, and advancing the expandable implant so that it is completely within the lumen of the delivery catheter.

[0385] Item 240: In another example, a vascular occlusion system configured for embolizing an aneurysm having a neck and a sac, comprising an elongated pusher configured to be slidably disposed within a delivery catheter having a proximal end, a distal end, and a delivery lumen extending therebetween, an implantable vascular occlusive device coupled to the distal end of the pusher, the vascular occlusive device being configured to be implanted in the aneurysm sac and having a contracted delivery configuration when confined within the delivery lumen of the delivery catheter, and an expanded, deployed configuration after being delivered from the delivery lumen of the delivery catheter and into the aneurysm sac, wherein the vascular occlusive device comprises The vascular occlusive device comprises a proximal end configured to abut the aneurysm adjacent to the neck of the aneurysm, a distal end configured to extend in the sac and away from the neck of the aneurysm, and a central longitudinal axis, and wherein the vascular occlusive device is configured to releasably couple to the distal end of the pusher at a releasable joint, wherein the releasable joint includes one or both of the following configurations: (1) the distal end of the pusher extends from the releasable joint at an angle of about 30 degrees to about 120 degrees to the central longitudinal axis, and (2) the releasable joint is coupled at a location on the proximal end of the vascular occlusive device that is radially offset from the central longitudinal axis.

[0386] Item 241: In some examples, the system includes item 240, wherein the distal end of the pusher extends from the releasable joint at an angle of about 40 degrees to about 100 degrees to the central longitudinal axis.

[0387] Item 242: In some examples, the system includes item 240, wherein the distal end of the pusher extends from the releasable joint at an angle of about 45 degrees to about 90 degrees to the central longitudinal axis.

[0388] Item 243: In some examples, the system includes item 240, wherein the distal end of the pusher extends from the releasable joint at an angle of about 75 degrees to about 90 degrees to the central longitudinal axis.

[0389] Item 244: In some examples, the system includes item 240, wherein the releasable connector is directly attached to the proximal end of the vaso-occlusive device.

[0390] Item 245: In some examples, the system includes item 240, wherein the vaso-occlusive device in its expanded, deployed configuration has a maximum radius, and wherein a location on the proximal end of the vaso-occlusive device is radially offset from the central longitudinal axis by at least 10% of the maximum radius.

[0391] Item 246: In some examples, the system includes item 240, wherein the vaso-occlusive device in the expanded, deployed configuration has a maximum radius, and wherein the location on the proximal end of the vaso-occlusive device is radially offset from the central longitudinal axis by at least 50% of the maximum radius.

[0392] Item 247: In some examples, the system includes item 240, wherein the vaso-occlusive device in the expanded, deployed configuration has a maximum radius, and wherein the location on the proximal end of the vaso-occlusive device is radially offset from the central longitudinal axis by at least 75% of the maximum radius.

[0393] Item 248: In some examples, the system includes item 240, wherein the vaso-occlusive device is in an expanded state, wherein the location on the proximal end of the vaso-occlusive device is at a radial edge of the vaso-occlusive device.

[0394] Item 249: In some examples, a system includes item 240, wherein the vaso-occlusive device includes a cap, and wherein the proximal end of the vaso-occlusive device includes a proximal surface of the cap, the cap further including a concave surface opposite and distal to the proximal surface.

[0395] Item 250: In some examples, the system includes item 249, wherein the concave surface is arranged generally about the central longitudinal axis.

[0396] Item 251: In some examples, the system includes item 249, wherein the cover has a generally circular outer shape.

[0397] Item 252: In some examples, the system includes item 240, wherein the vaso-occlusive device is formed of a mesh material.

[0398] Item 253: In some examples, a system includes item 252, wherein the mesh material includes a plurality of filaments.

[0399] Item 254: In some examples, the system includes item 253, wherein the plurality of wires includes wires comprising a nickel-titanium alloy.

[0400] Item 255: In some examples, the system includes item 253, wherein the plurality of wires includes a wire comprising a radiopaque material.

[0401] Item 256: In some examples, the system includes item 253, wherein the plurality of wires includes a wire comprising a stretched fill tube.

[0402] Item 257: In some examples, a system includes item 252, wherein the mesh material comprises an everted mesh tube having an outer layer and an inner layer, the outer layer transitioning to the inner layer at an everted fold.

[0403] Item 258: In some examples, the system includes item 240, further comprising a selectively oriented catheter having a proximal end, a distal end, and a lumen extending from the proximal end to the distal end, wherein the lumen of the selectively oriented catheter includes a non-circular cross-section at least in a distal region adjacent to the distal end of the selectively oriented catheter, wherein a vascular occlusive device in a collapsed delivery configuration has a substantially non-circular cross-section configured to at least keyably fit into the distal region of the lumen of the selectively oriented catheter such that the vascular occlusive device is deliverable from the lumen of the selectively oriented catheter at a particular rotational position.

[0404] Item 259: In some examples, the system includes item 258, wherein the non-circular cross-section of the lumen of the selectively-orientable catheter comprises an oval shape.

[0405] Item 260: In some examples, the system includes item 258, wherein the non-circular cross-section of the lumen of the selective orientation catheter comprises an elliptical shape.

[0406] Item 261: In some examples, the system includes item 258, wherein the non-circular cross-section of the lumen of the selectively-orientable catheter comprises a shape selected from the list consisting of: a dog-bone shape, a guitar shape, and a polygonal shape.

[0407] Item 262: In some examples, the system includes item 258, wherein the lumen of the selectively-orientable catheter has a circular cross-section at least at its proximal end.

[0408] Item 263: In some examples, a system includes item 262, wherein the circular cross-section of the lumen of the selectively orientable catheter includes a circular cross-sectional region extending from a proximal end of the selectively orientable catheter toward a distal end of the distal region.

[0409] Item 264: In some examples, the system includes item 263, further comprising a continuous smooth transition region matching the circular cross-sectional region and the distal region.

[0410] Item 265: In some examples, the system includes item 258, wherein the vascular occlusive device in its contracted delivery configuration has a first transverse axis and a second transverse axis, the first transverse axis being orthogonal to the second transverse axis, wherein a first transverse dimension along the first transverse axis is different from a second transverse dimension along the second transverse axis.

[0411] Item 266: In some examples, the system includes item 258, further comprising an introducer having a proximal end, a distal end, and an introducer lumen extending between the proximal end of the introducer and the distal end of the introducer, the introducer lumen being configured to maintain the expandable implant in its contracted configuration while introducing the expandable implant at its proximal end into the lumen of a delivery catheter, wherein the introducer includes a loop adjacent its distal end, the loop having an internal transverse dimension that increases from a proximal loop end to a distal loop end, the loop being configured to facilitate transition of the vascular occlusive device from its expanded, deployed configuration to its contracted delivery configuration when a user applies traction on the elongated pusher.

[0412] Item 267: In some examples, the system includes item 266, wherein the collar is removable from the introducer by a user after the vaso-occlusive device has been placed within the introducer lumen of the introducer in its collapsed delivery configuration.

[0413] Item 268: In some examples, the system includes item 240, further comprising a connecting tube having a proximal end substantially flush with the proximal end of the vascular occluding device, a distal end extending within the vascular occluding device, and a lumen, wherein the distal end of the pusher extends through the lumen of the connecting tube and includes a plurality of radially extending protrusions located distal to the distal end of the connecting tube, the plurality of radially extending protrusions forming a maximum transverse dimension that is greater than a maximum diameter of the connecting tube lumen.

[0414] Item 269: In some examples, the system includes item 258, further comprising an activator configured to modify the plurality of radially extending protrusions such that the distal end of the pusher can be completely removed from the lumen of the connecting tube.

[0415] The range disclosed herein also encompasses any and all overlaps, sub-ranges, and combinations thereof. Languages ​​such as "up to," "at least," "greater than," "less than," "between..." include the numbers listed. As used herein, the numbers preceded by terms such as "approximately," "about," and "substantially" include the numbers listed (e.g., about 10%=10%), and also represent an amount close to the stated amount that still performs the desired function or achieves the desired result. For example, the terms "approximately," "about," and "substantially" may refer to an amount within less than 10%, less than 5%, less than 1%, less than 0.1%, and less than 0.01% of the stated amount.

[0416] For purposes of this disclosure and the appended claims, the conjunction “or” shall be construed as inclusive (e.g., “apple or orange” shall be construed as “apple, or orange, or both”; e.g., “apple, orange or avocado” shall be construed as “apple, or orange, or avocado, or any two, or all three”) unless: (i) otherwise expressly indicated, such as by use of “either…or,” “only one of…,” or similar language; or (ii) two or more of the listed alternatives are mutually exclusive in the particular context, in which case “or” shall encompass only those combinations involving the non-mutually exclusive alternatives. For purposes of this disclosure and the appended claims, the words “comprises,” “including,” “having,” and variations thereof, wherever they appear, shall be construed as open-ended terms, having the same meaning as if each instance thereof were followed by the phrase “at least.”

Claims

1. A device for treating an aneurysm in a blood vessel, comprising: An occlusive element configured to be releasably coupled to an elongated delivery shaft and having a distal end, a proximal end, and a longitudinal axis extending therebetween, the occlusive element configured to be delivered in a contracted configuration through a lumen of a delivery catheter, the lumen having a proximal end and a distal end, the occlusive element further configured to expand to an expanded configuration when advanced out of the distal end of the lumen of the delivery catheter and into an aneurysm, the occlusive element comprising an everted mesh tube having an outer layer and an inner layer, the outer layer transitioning to the inner layer at an everted fold, the everted fold being located at or adjacent the distal end of the occlusive element, the everted fold defining an inner diameter, the occlusive element further comprising a maximum outer diameter, wherein the inner diameter is between about 35% and about 85% of the maximum outer diameter, and wherein the outer diameter of the occlusive element increases along the longitudinal axis to the maximum outer diameter.

2. The device according to claim 1, wherein: The maximum outer diameter of the occlusive element is located at or adjacent to the distal end of the occlusive element.

3. The device according to claim 1, wherein: The largest outer diameter of the occlusive element is located at or adjacent to the proximal end of the occlusive element.

4. The device according to claim 1, wherein: The everted mesh tube includes a first end and a second end coupled together at a proximal end of the occlusive element.

5. The device according to claim 1, wherein: The occlusive element in its expanded configuration has a generally D-shaped cross-section in a plane containing the longitudinal axis.

6. The device according to claim 1, wherein: The occlusive element in its expanded configuration has a generally triangular cross-section in a plane containing the longitudinal axis.

7. The device according to claim 1, wherein: The occlusive element in its expanded configuration has a generally isosceles trapezoidal cross-section in a plane containing the longitudinal axis.

8. The apparatus of claim 1, further comprising a frustoconical outer surface extending between a maximum outer diameter of the occluding element and one of a distal end or a proximal end of the occluding element.

9. The device according to claim 8, wherein: The frustoconical surface has a minimum outer diameter that is between about 70% and about 90% of a maximum outer diameter of the occlusive element.

10. The device of claim 1, further comprising a convex surface extending between a maximum outer diameter of the occluding element and one of a distal end or a proximal end of the occluding element.

11. The device according to claim 10, wherein: The convex surface has a minimum outer diameter that is between about 70% and about 90% of a maximum outer diameter of the occlusive element.

12. The device according to claim 1, wherein: The distal end includes a substantially planar face.

13. The apparatus according to claim 1, wherein: The proximal end includes a substantially flat face.

14. The apparatus according to claim 1, wherein: The everted mesh tube includes a set of wires comprising a nickel-titanium alloy.

15. The device according to claim 14, wherein: At least some of the filaments further comprise a radiopaque material.

16. The apparatus according to claim 1, wherein: When the occlusive element is in its expanded configuration, the inner layer of the everted mesh tube substantially follows the contour of the outer layer of the everted mesh tube.

17. The apparatus of claim 1, further comprising a pusher having a proximal end and a distal end, wherein: The occlusive element is configured to releasably couple to the distal end of the pusher at a releasable joint.

18. The apparatus of claim 17, further comprising a connecting tube having a proximal end substantially flush with the proximal end of the occluding element, a distal end extending within the occluding element, and a lumen, wherein The distal end of the pusher extends through the lumen of the connecting tube and includes a plurality of radially extending protrusions located distal to the distal end of the connecting tube, the plurality of radially extending protrusions forming a maximum transverse dimension greater than a maximum diameter of the lumen of the connecting tube.

19. The apparatus of claim 18, further comprising an activator configured to modify the plurality of radially extending projections such that the distal end of the pusher can be completely removed from the lumen of the connecting tube.

20. The apparatus of claim 19, wherein: The activator is configured to produce an effect on the radially extending protrusions selected from the list consisting of: melting, detaching, straightening, fracturing, ablating, and deforming.

21. The apparatus of claim 18, wherein: The connecting tube includes a radiopaque marker.

22. The apparatus of claim 18, wherein: The connecting tube comprises polyimide.

23. The apparatus of claim 18, wherein: The connecting tube has a length of about 1.5 mm or less.

24. The apparatus of claim 1, wherein: The occlusive element is configured to engage a wall of the aneurysm at the maximum outer diameter.

25. The apparatus of claim 1, wherein: The inner diameter is between about 45% and about 75% of the maximum outer diameter.

26. The apparatus of claim 1, wherein: The occlusive element has a proximal diameter at its proximal end and a distal diameter at its distal end, the proximal diameter being between about 50% and about 120% of the distal diameter.

27. The apparatus of claim 1, wherein: The occlusive element is heat set into an expanded configuration.

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