Systems and methods for modifying blood flow

Abstract

Expandable metallic implant or stent devices comprise an expandable metallic implant or stent and a balloon catheter that can be implanted to modify, obstruct, or reduce flow, for example through blood vessel lacerations systems can include a balloon catheter delivery system. The deliverability of the expandable implant devices may include flexible elements to the expandable implant or stent. The fit between the expandable implant devices and the treatment site may include elements that allow the diameter of the expandable implant or stent to be enlarged to a range of diameters while maintaining a circular or substantially circular lumen or hollow region and wall after implantation. The risk of implant migration may be reduced by adding features to the expandable metallic implant or stent implants that increase sliding friction in tissue, such as flaps.

Description

AUROM.002WO PCTSYSTEMS AND METHODS FOR MODIFYING BLOOD FLOWINCORPORATION BY REFERENCE TO ANY PRIORITY APPLICATIONS

[0001] This application is an international application that claims priority to the U.S. Provisional Application 63 / 736169, filed December 19, 2024, which is incorporated by reference herein in its entirety.BACKGROUNDField

[0002] Examples of this application are directed to systems, methods, and devices for sealing or closing breaches or openings in the wall of blood vessels and other biological conduits. Examples of this application are also directed to systems, methods, and devices for increasing flow through narrowed or obstructed blood vessels.Description of the Related Art

[0003] In certain clinical situations, patients can benefit from an obstruction or reduction of flow through blood vessel lacerations and ruptures and arteriovenous fistulas, through discontinuities in endoprostheses or gaps between one endoprosthesis and another endoprosthesis or between an endoprosthesis and adjacent tissue, or from an obstruction or reduction of flow into aneurysms, pseudoaneurysms, or other blood-containing, fluid-containing, or biological spaces. Clinical settings where this is beneficial include reducing bleeding from lacerated or ruptured blood vessels, reducing the risk of rupture and bleeding from aneurysms and pseudoaneurysms, and reducing adverse local and systemic hemodynamic effects from arteriovenous fistulas, among other settings.

[0004] There remains an unmet clinical need for devices and systems that can traverse tortuous or distal blood vessel segments to reach blood vessel lacerations and ruptures, arteriovenous fistulas, discontinuities in endoprostheses or gaps between one endoprosthesis and another endoprosthesis or between an endoprosthesis and adjacent, tissue aneurysms, and pseudoaneurysms, and provide safe, effective, and reliable closure of the opening in the wall of the target vessel segment, while maintaining long-term patency of the treated segment. Devices are needed which are low profile, flexible, and deliverable, easy to use, can be quickly placed with a high degree of precision, result in immediate and closure with just one or a few devices,AUROM.002WO PCT provide durable and permanent closure with low rates of device migration, and are readily available in a range of sizes at a reasonable cost.

[0005] An aneurysm is an excessive localized enlargement of an artery or vein caused by a weakening of the artery or vein wall. Aneurysms can rupture without warning, leading to bleeding. In the brain, bleeding from a ruptured aneurysm can cause stroke and sometimes death. Outside the brain, bleeding from a ruptured aneurysm can cause hypotension and sometimes death. There are two main types of aneurysms, fusiform aneurysms and saccular aneurysms. A saccular aneurysm is a rounded or pouch-like localized enlargement that is attached by a neck to an artery or vein, or to a branching of an artery or vein. Saccular aneurysms and may occur throughout the body but are most commonly found in the arteries of the brain. A fusiform aneurysm is an outpouching of an artery or vein wall that is expanded in all directions, without a distinct neck. A pseudoaneurysm, is a condition where there is a disruption in the blood vessel wall that allows blood to collect outside the vessel but remains contained by surrounding tissue. It mimics the appearance of a true aneurysm but has a different structure. Unlike a true aneurysm, which involves all three layers of the vessel wall (intima, media, and adventitia), a pseudoaneurysm involves a breach in these layers. The blood is contained by a surrounding fibrous capsule or connective tissue. Pseudoaneurysms often occurs after trauma, surgery, or catheterization, when a blood vessel is punctured or damaged.

[0006] The rate of spontaneous rupture of aneurysms and pseudoaneurysms increases with increasing aneurysm size, and therefore large aneurysms and pseudoaneurysms that are found during a medical or surgical evaluation are often treated. Ruptured aneurysms and pseudoaneurysms are almost always treated, if possible. Aneurysms and pseudoaneurysms can be treated with surgery. During some surgical treatments of saccular aneurysms and pseudoaneurysms, a surgical clip is placed across the neck of the aneurysm or pseudoaneurysm to exclude it from blood flow. During other surgical treatments of fusiform aneurysms, a biological conduit such as a vein segment or a synthetic conduit such as an expanded polytetrafluoroethylene (PTFE) or polyester graft may be used to surgically bypass the aneurysmal segment and the aneurysmal segment is closed, usually with surgical sutures or clips.

[0007] In some cases, coil expandable bodies are used to treat saccular aneurysms and pseudoaneurysms. To treat a saccular aneurysm and pseudoaneurysm with coil expandable bodies, an operator inserts a catheter into a lumen of the vascular system and maneuvers theAUROM.002WO PCT catheter tip into the lumen or sac of the saccular aneurysm or pseudoaneurysm. With the catheter tip in position, the operator pushes individual coil expandable bodies into the lumen or sac of the saccular aneurysm and pseudoaneurysm. During and after the treatment, thrombus forms in and around the coil expandable bodies with the goal of reducing blood flow to the saccular aneurysm or pseudoaneurysms and causing thrombosis of the sac. Over time, for successful treatments, the thrombus matures into fibrous tissue, which completely seals off the saccular aneurysm or pseudoaneurysm from the adjacent vessel. Although effective, treatment of saccular aneurysms and pseudoaneurysms with coil expandable bodies has disadvantages. Coil placement is difficult to control, often resulting in coil misplacement or migration to non-target locations, sometimes resulting in occlusion of non-target vessels. In cases of coil migration, operators may be compelled to attempt retrieval of the coil expandable bodies from the non-target location. Numerous coil expandable bodies are usually required during a treatment, resulting in high costs and long treatment times. Furthermore, coil expandable bodies only partially fill the lumen or sac of the saccular aneurysm and pseudoaneurysm. Thrombus and scar tissue must accumulate to seal the saccular aneurysm or pseudoaneurysm completely, a process that can take months to years and is often incomplete. Slow saccular aneurysm and pseudoaneurysm occlusion or sealing can reduce the effectiveness of coil expandable bodies in the treatment of saccular aneurysm and pseudoaneurysm rupture. Saccular aneurysm and pseudoaneurysm occlusion or sealing after coiling is often incomplete, subjecting the patient to a persistent risk of rupture and leading to unacceptably high rates of retreatment. Even when the use of coil expandable bodies is initially effective, recanalization of the saccular aneurysms and pseudoaneurysms may occur, resulting in a return of blood flow to the saccular aneurysm or pseudoaneurysm and an increased risk of rupture. Incomplete filling, occluding, and sealing of saccular aneurysms and pseudoaneurysms with coil expandable bodies is especially common in the regions where coil density is low, and blood flow is high. Coil expandable bodies are susceptible to compaction, further exposing the saccular aneurysm or pseudoaneurysm to persistent blood flow and contributing to the high rate of recurrence and retreatment.

[0008] In some cases, specialized stents are used to treat saccular aneurysms and pseudoaneurysms. These stents are placed on delivery devices and positioned in the parent vessel adjacent to the neck of the aneurysm or pseudoaneurysm. The stents are then expanded to cover the neck of the aneurysm or pseudoaneurysm, and the delivery device is removed. The expandedAUROM.002WO PCT stents divert flow away from the aneurysm or pseudoaneurysm and promote thrombosis, reducing the risk of subsequent rupture and bleeding. In some cases, specialized stents are used to treat fusiform aneurysms. These stents are placed on delivery devices, positioned in the parent vessel and then expanded to cover the aneurysmal segment, divert flow away from the aneurysm wall, bridge to the healthy tissue proximal and distal to the aneurysm, and promote thrombosis of the fusiform aneurysm sac, reducing the risk of fusiform aneurysm rupture and bleeding.

[0009] An arteriovenous fistula is an abnormal connection or passageway between an artery and a vein. Typically, arteries carry oxygen-rich blood away from the heart to the body's tissues, while veins carry oxygen-depleted blood back to the heart. In the case of an arteriovenous fistula, there is a direct connection between an artery and a vein, bypassing the capillary system. This results in several potential issues, including increased blood flow directly from the artery into the vein, which can cause loss of blood flow to the capillary system, dilation or the artery and vein and increased flow through the arteriovenous fistula, increased blood pressure within the vein, pain, swelling, and in severe cases, tissue damage and heart failure. In some cases, covered stents can be placed in the parent vessel adjacent to the arteriovenous fistula to divert flow away from the arteriovenous fistula and promote arteriovenous fistula healing and closure. Effective treatment of arteriovenous fistulas can be challenging, especially for large and high flow arteriovenous fistulas. Attempted treatment of aneurysms, pseudoaneurysms, and arteriovenous fistulas with covered stents often ends in failure. Currently available covered stents are often long and stiff when in a crimped form for delivery to the treatment site and therefore cannot navigate tortuous vessel segments, resulting in frequent treatment failures and wasted devices. Although a shorter stent may have improved deliverability, the relatively thick walls of conventional covered stents make it problematic to overlap stents (to get full lesion coverage) without compromising the lumen of the treated vessel segment, compromising distal blood flow and increasing the risk of device and vessel thrombosis.

[0010] There remains an unmet clinical need for devices, systems, and methods for effectively and reliably treating blood vessel lacerations and ruptures, arteriovenous fistulas, aneurysms, and pseudoaneurysms. Devices and systems are needed which are low profile, flexible and deliverable, easy to use, can be quickly placed with a high degree of precision, and result in immediate, complete and lasting occlusion of blood vessel lacerations and ruptures,AUROM.002WO PCT arteriovenous fistulas, gaps and discontinuities in or adjacent to endoprostheses, and pseudoaneurysms, preserve blood flow through the treated vessel segment, have low rates of device migration, and are readily available in a wide range of sizes at a reasonable cost.

[0011] The ability of a stent device to reach a particular location in vivo (a characteristic known as “deliverability”) is dependent upon several factors. First, a stent device can be long enough to reach from the location where it is inserted (the insertion site) to the location where the treatment is desired (the treatment site). Second, a stent device can have an overall diameter or “profile” that is small enough to pass through arteries, veins, or other biological conduits and spaces that are located between device insertion site and the treatment site. Third, a stent device can not have any large or abrupt changes in outer diameter (“step-offs”) that can cause friction during device advancement or retraction, especially when encountering edges associated catheter hubs, catheter tips, vessel side branches, atherosclerotic plaques, regions of vessel wall scarring or fibrosis, or intravascular thrombus, for example. Fourth, the stent device may be flexible enough to navigate a tortuous path from the insertion site to the treatment site. For a stent device, a component of deliverability involves the flexibility of the elongate body that is used to push the implant to the target location, as well as the flexibility of the implant itself. When optimizing stent device flexibility and deliverability, there is often a trade-off wherein increasing implant flexibility increases the risk of implant collapse, compression, or compaction in vivo which could lead to a loss of lumen area and a reduction in blood flow. The deliverability of stent devices can be optimized by: 1) shortening the length of rigid device segments; 2) increasing the flexibility of flexible device segments; and 3) placing flexible junctions between rigid device segments.

[0012] The safety and tolerability of stent devices is dependent upon several factors, including the type and extent of the biological response to the stent (a characteristic known as “biocompatibility”). A biocompatible stent device is one that is well-tolerated by the body and does not cause adverse reactions, excessive local or systemic host responses or tissue damage.SUMMARY

[0013] The present application describes expandable metallic stents or implants, and expandable metallic implant or stent devices, configured to modify, obstruct, or reduce flow. Examples include the modification, obstruction or reduction of blood flow through blood vessel lacerations and ruptures and arteriovenous fistulas, through discontinuities in endoprostheses or gaps between one endoprosthesis and another endoprosthesis or between an endoprosthesis andAUROM.002WO PCT adjacent tissue, and for modifying, obstructing, or reducing flow into aneurysms, pseudoaneurysms, or other blood-containing, fluid-containing, or biological spaces using an expandable implant, and methods of their use. In some examples, the present application describes expandable metallic implant or stent devices comprising an expandable metallic implant or stent and a balloon catheter, wherein the balloon catheter comprises a balloon and an elongate body.

[0014] Examples of expandable metallic implant or stent devices are described, comprising a hollow expandable metallic implant or stent, including a hollow expandable metallic implant or stent comprising gold, with a wall that is open on the proximal end and the distal end that can be joined to a balloon of a balloon catheter by the folding and pleating together of the expandable metallic implant or stent and the balloon. The expandable metallic implant or stent can be delivered to a desired location in a human patient in a folded and pleated form using a balloon catheter, transitioned to an expanded configuration by inflation of a balloon, and separated from the balloon by deflation or collapse of the balloon, wherein the expanded expandable metallic implant or stent remains in the patient while the balloon catheter is removed from the patient.

[0015] Various examples of expandable metallic implant or stent devices are described, including devices comprising a compliant or semi-compliant balloon and an expanded expandable metallic implant or stent with one or more flaps or barbs, including flaps or barbs with a pointed end, wherein the free end of a flap or barb can be extended radially from the surface of the expanded expandable metallic implant or stent during balloon inflation as a means to reduce the risk of migration of the expanded expandable metallic implant or stent after separation from the balloon. Examples of expandable metallic implant or stent devices are also described wherein deliverability is optimized by reducing the overall diameter of the folded and pleated portion of the expandable metallic implant or stent, shortening the length of various rigid device segments, increasing the flexibility of various flexible device segments, and placing flexible junctions or segments between rigid device segments.

[0016] Methods of use of expandable implant devices and systems comprising expandable implant devices and other devices to reduce flow through blood vessel lacerations and ruptures and arteriovenous fistulas, through discontinuities in endoprostheses or gaps between one endoprosthesis and another endoprosthesis or between an endoprosthesis andAUROM.002WO PCT adjacent tissue, and for modifying, obstructing, or reducing flow into aneurysms, pseudoaneurysms, or other blood-containing, fluid-containing, or biological spaces are described, including the simultaneous placement of an expandable metallic implant or stent and one or more additional expandable implants, including one or more coil expandable implants.

[0017] Methods of manufacturing expandable metallic implant or stents, balloons, balloon catheters, and expandable implant devices are described.

[0018] In some examples, a system for modifying, obstructing, or reducing a flow of blood, for example through blood vessel lacerations and raptures and arteriovenous fistulas, through discontinuities in endoprostheses or gaps between one endoprosthesis and another endoprosthesis or between an endoprosthesis and adjacent tissue, and as further examples for modifying, obstructing, or reducing flow into aneurysms, and pseudoaneurysms can include: a balloon catheter including: an elongate body including a proximal portion and a distal portion; an inflation lumen extending from the proximal portion to the distal portion; and a balloon positioned at the distal portion of the elongate body in fluid communication with the inflation lumen; and an expandable metallic implant or stent configured to be carried by the balloon catheter to an implantation site in an artery and vein in a patient and configured to expand from an unexpanded configuration to an expanded configuration, wherein the expandable metallic implant or stent in the expanded configuration includes a wall defining a hollow shape having a proximally facing opening at a proximal end thereof and a distally facing opening at a distal end thereof; wherein the balloon and the expandable metallic implant or stent are configured to be delivered in an unexpanded configuration to the implantation site, wherein the balloon is configured to be inflated at the implantation site through the inflation lumen to expand the expandable metallic implant or stent to the expanded configuration, and wherein the balloon catheter is configured to be removed from the patient such that the expandable metallic implant or stent remains in an artery or vein in an expanded configuration at the implantation site.

[0019] In some examples, the expandable metallic implant or stent includes gold. In some examples, the expandable metallic implant or stent includes a layer of gold with a thickness of between 5 microns and 100 microns. In some examples, the expandable metallic implant or stent includes electroformed and electroplated gold. In some examples, the proximally facing opening and the distal facing opening are substantially circular. In some examples, the expandable metallic implant or stent includes one or more flaps configured to extend radially outward from aAUROM.002WO PCT surface of the expandable metallic implant or stent in the expanded configuration during inflation of the balloon. In some examples, the one or more flaps include a pointed end, and wherein the one or more flaps are configured to engage the wall of an artery or vein wall or penetrate into the wall of an artery or vein wall in the radially extended configuration and secure the expandable metallic implant or stent to an artery or vein wall. In some examples, the one or more flaps are configured to protrude from one or more holes in a surface of the expandable metallic implant or stent. In some examples, the one or more flaps are configured to protrude from a proximal end of the expandable metallic implant or stent, from a distal end of the expandable metallic implant or stent, or from a proximal end of the expandable metallic implant or stent and from a distal end of the expandable metallic implant or stent. In some examples, the balloon is semi-compliant. In some examples, the semi-compliant balloon includes a compliant polymer. In some examples, the semi-compliant balloon has a wall thickness between about 5 microns and about 30 microns. In some examples, the elongate body includes a single lumen. In some examples, the elongate body includes two lumens. Another term that describes elongate bodies is “longitudinally extending bodies”. In some examples, a length of the inflated balloon is greater than a length of the expanded expandable metallic implant or stent. In some examples, the expandable metallic implant or stent has a folded and pleated configuration when in the unexpanded configuration. In some examples, the balloon and the expandable metallic implant or stent are folded together into wings. In some examples, the proximal and distal portions of the wings include two layers of balloon. In some examples, the two layers of balloon are external layers. In some examples, the middle portion of the wings include two layers of expandable metallic implant or stent and two layers of balloon. In some examples, the two layers of balloon are internal layers, and the two layers of expandable metallic implant or stent are outer layers. In some examples, the wings are pleated around a central axis. FIG. 2A and FIG. 8A are perspective views of examples of a folded and pleated expandable metallic implant or stent device 1 with a folded and pleated expandable metallic implant or stent and folded and pleated balloon.

[0020] In some examples, a method for modifying, obstructing, or reducing a flow of blood, for example through blood vessel lacerations and ruptures and arteriovenous fistulas, through discontinuities in endoprostheses or gaps between one endoprosthesis and another endoprosthesis or between an endoprosthesis and adjacent tissue, and as further examples for modifying, obstructing, or reducing flow into aneurysms, or pseudoaneurysms of a patient usingAUROM.002WO PCT an expandable implant can include: delivering a balloon catheter carrying an expandable metallic implant or stent in an unexpanded configuration to an implantation site in an artery or vein of a patient; inflating a balloon through an inflation lumen of the balloon catheter to cause the expandable metallic implant or stent to expand to an expanded configuration that provides for an obstruction or reduction of flow of blood through blood vessel lacerations and ruptures and arteriovenous fistulas, through discontinuities in endoprostheses or gaps between one endoprosthesis and another endoprosthesis or between an endoprosthesis and adjacent tissue, or into aneurysms or pseudoaneurysms at the implantation site; and removing the balloon catheter from the patient while the expandable metallic implant or stent remains at the implantation site in the patient in an expanded configuration.

[0021] In some examples, the expandable metallic implant or stent has a folded and pleated configuration when in the unexpanded configuration. In some examples, the expandable metallic implant or stent in the expanded configuration includes a wall defining a hollow shape having a proximally facing opening at a proximal end thereof and a distally facing opening at a distal end thereof. In some examples, the expandable metallic implant or stent that engages the vessel wall or penetrates into the vessel wall of the patient includes a layer of gold with a thickness of between 5 microns and 100 microns. In some examples, inflating the balloon includes delivering between about 1 atm and about 3 atm of pressure to the balloon. In some examples, the method can include deflating the balloon such that the expandable metallic implant or stent remains in the expanded configuration and in contact with a wall of an artery or vein of the patient. In some examples, inflating the balloon causes at least one flap of the expandable metallic implant or stent to extend radially outward from a surface of the expandable metallic implant or stent. In some examples, the at least one flap protrudes radially outward from a hole in the surface of the expandable metallic implant or stent. In some examples, the at least one flap protrudes from a proximal end of the expandable metallic implant or stent, from a distal end of the expandable metallic implant or stent, or from a proximal end of the expandable metallic implant or stent and from a distal end of the expandable metallic implant or stent. In some examples, the method can include delivering the balloon catheter and the expandable metallic implant or stent to the implantation site through a guide catheter or guide sheath. In some examples, the method can include selecting the expandable metallic implant or stent from aAUROM.002WO PCT plurality of expandable metallic implant or stents of different sizes based on a vessel size at the implantation site.

[0022] The present application also describes expandable metallic stents or implants, and expandable metallic implant or stent devices configured to increase flow through narrowed or obstructed blood vessel segments, including arteries and veins, using an expandable implant, and methods of their use. In some examples, the present application describes expandable metallic implant or stent devices comprising an expandable metallic implant or stent and a balloon catheter, wherein the balloon catheter comprises a balloon and an elongate body.

[0023] In some examples, a system for placement of an expandable gold implant or stent in an artery or vein in a patient can include: a balloon catheter including: an elongate body including a proximal end and a distal end; a balloon positioned at the distal end of the elongate body; and an inflation lumen in fluid communication with the balloon, the inflation lumen extending from the proximal end to the distal end of the elongate body and configured for inflation of the balloon; and an expandable gold implant or stent configured to be earned by the balloon catheter to an implantation site in an artery or vein in a patient, the expandable gold implant or stent configured to expand from an unexpanded configuration to an expanded configuration, the expandable gold implant or stent including: a wall having an open proximal end and an open distal end; an implant or stent lumen or hollow region 11 defined by the wall, the implant or stent lumen or hollow region 11 extending from the open proximal end to the open distal end; and one or more flaps on at least one of the open proximal end or the open distal end of the wall, wherein the balloon and the expandable gold implant or stent are configured to be delivered in a folded and pleated configuration to the implantation site; wherein the balloon is configured to be inflated at the implantation site through the inflation lumen to expand the expandable gold implant or stent to the expanded configuration, and wherein, in the expanded configuration, the one or more flaps extend radially outward from the wall of the expandable gold implant or stent, such that the one or more flaps are configured to engage or penetrate into a vessel wall of the artery or vein in the patient.

[0024] In some examples, the expandable gold implant or stent includes a layer of gold with a thickness of between 3 microns and 100 microns.

[0025] In some examples, the expandable gold implant or stent includes electroformed and electroplated gold.AUROM.002WO PCT

[0026] In some examples, in the unexpanded configuration, the one or more flaps do not extend radially outward from the wall of the expandable gold implant or stent.

[0027] In some examples, the open proximal end and the open distal end of the expandable gold implant or stent are substantially circular; or wherein the lumen or hollow region 11 of the expandable gold implant or stent is substantially circular in cross-section.

[0028] In some examples, at least one flap of the one or more flaps includes a pointed end.

[0029] In some examples, the wall includes a proximal zone with one or more flaps, a distal zone with one or more flaps, and a middle zone that is located between the proximal zone and the distal zone.

[0030] In some examples, the wall includes a proximal zone with one or more flaps and a middle zone that is distal to the proximal zone.

[0031] In some examples, the wall includes a middle zone and a distal zone with one or more flaps that is distal to the middle zone.

[0032] In some examples, the wall of the middle zone is solid or continuous.

[0033] In some examples, at least a portion of the wall of the middle zone comprises openings.

[0034] In some examples, the balloon is compliant or semi-compliant.

[0035] In some examples, the balloon includes a compliant or a semi-compliant polymer.

[0036] In some examples, the balloon has a wall thickness between 5 microns and 30 microns.

[0037] In some examples, a length of the balloon is greater than a length of the expandable gold implant or stent.

[0038] In some examples, the balloon and the expandable gold implant or stent are folded together into wings and pleated around a central axis.

[0039] In some examples, the balloon catheter further includes a guidewire lumen configured to accept a guidewire.

[0040] In some examples, the guidewire lumen extends from the proximal end to the distal end of the elongate body.

[0041] In some examples, a method for placement of an expandable gold implant or stent in an artery or vein in a patient can include: providing a balloon catheter including: an elongateAUROM.002WO PCT body including a proximal end and a distal end; a balloon positioned at the distal end of the elongate body; and an inflation lumen in fluid communication with the balloon, the inflation lumen extending from the proximal end to the distal end of the elongate body; providing an expandable gold implant or stent configured to expand from a folded and pleated configuration to an expanded configuration, the expandable gold implant or stent including: a wall having an open proximal end and an open distal end; a implant or stent lumen or hollow region 11 defined by the wall, the implant or stent lumen or hollow region 11 extending from the open proximal end to the open distal end; and one or more flaps on at least one of the open proximal end or the open distal end of the wall; delivering the expandable gold implant or stent and the balloon in a folded and pleated configuration to an implantation site in an artery or vein in a patient; and inflating, via the inflation lumen, the balloon at the implantation site to expand the expandable gold implant or stent to the expanded configuration and cause the one or more flaps to extend radially outward from the wall of the expandable gold implant or stent, such that the one or more flaps engage or penetrate a vessel wall of the artery or vein in the patient; deflating the balloon and removing the balloon catheter such that the expandable gold implant or stent remains in the expanded configuration and in contact with a wall of an artery or vein.

[0042] In some examples, the wall includes a proximal zone with one or more flaps, a distal zone with one or more flaps, and a middle zone that is located between the proximal zone and the distal zone.

[0043] In some examples, the wall includes a proximal zone with one or more flaps and a middle zone that is distal to the proximal zone.

[0044] In some examples, the wall includes a middle zone and a distal zone with one or more flaps that is distal to the middle zone.

[0045] In some examples, the wall of the middle zone is solid or continuous.

[0046] In some examples, inflating the balloon includes inflating the balloon such that the balloon expands further radially outside of the expandable gold implant or stent than the balloon expands in the middle zone of the expandable gold implant or stent.

[0047] In some examples, the expandable gold implant or stent includes a layer of electroformed and electroplated gold with a thickness of between 5 microns and 100 microns.AUROM.002WO PCT

[0048] In some examples, when delivering the balloon and the expandable gold implant or stent to the implantation site, the one or more flaps do not extend radially outward from the wall of the expandable gold implant or stent.

[0049] In some examples, a pointed end of at least one flap of the one or more flaps engages the vessel wall or penetrates into the vessel wall.

[0050] In some examples, when delivering the balloon and the expandable gold implant or stent to the implantation site, the balloon and the expandable gold implant or stent are folded together into wings, and the wings are pleated around a central axis.

[0051] In some examples, delivering the balloon and the expandable gold implant or stent to the implantation site includes delivering the balloon catheter through a guide catheter or guide sheath, or over a guidewire.

[0052] In some examples, a system for placement of an expandable implant or stent in an artery or vein in a patient can include: a balloon catheter including: at least one hub on a proximal end of the balloon catheter; an elongate body including a proximal end and a distal end: a balloon positioned on a distal portion of the elongate body; and an inflation lumen in fluid communication with the balloon, the inflation lumen extending from a hub to the distal portion of the elongate body and configured for inflation of the balloon; a guidewire lumen extending from a hub to the distal end of the elongate body and configured to accept a guidewire; and an expandable implant or stent configured to be carried by the balloon catheter in a folded and pleated configuration to an implantation site in an artery or vein in a patient, the expandable implant or stent configured to expand from a folded and pleated configuration to an expanded configuration, the expandable implant or stent including: a wall having an open proximal end and an open distal end; a lumen defined by the wall, the lumen extending from the open proximal end to the open distal end; a polymer layer; a gold layer including one or more discontinuities defining at least one opening between an open proximal end and an open distal end; and wherein, at the implantation site, the folded and pleated expandable implant or stent is configured to expand to a first expanded diameter by partial or complete straightening, unfolding, or unpleating of the folded and pleated configuration of the expandable implant or stent during inflation of the balloon at the implantation site through the inflation lumen; and wherein the expandable implant or stent is configured to expand to a second, larger expanded diameter by a change in a shape of the discontinuities in the gold layer during inflation of the balloon at theAUROM.002WO PCT implantation site through the inflation lumen. In some examples, the gold layer has a wall thickness of between 3 microns and 100 microns. In some examples, the gold layer includes electroformed or electroplated gold. In some examples, the polymer layer is continuous. In some examples, the polymer layer is discontinuous. In some examples, the polymer layer extends from the open proximal end to the open distal end. In some examples, the polymer layer is compliant or semi-compliant. In some examples, the polymer layer includes a compliant or a semi- compliant polymer. In some examples, the polymer layer includes polyethylene terephthalate, a nylon, a material including block copolymers made of rigid polyamide blocks and soft polyether blocks, including Pebax, a polyurethane, including an aromatic polyether polyurethane, a polyether-block-amide, or a silicone elastomer, including a polydimethylsiloxane silicone elastomer, and combinations thereof. In some examples, the polymer layer has a wall thickness of between 3 microns and 100 microns. In some examples, the open proximal end and the open distal end of the expandable implant or stent are circular or substantially circular in cross-section; or wherein at least a portion of the lumen of the expandable implant or stent is circular or substantially circular in cross-section. In some examples, the expandable implant or stent includes one or more flaps on at least one of the open proximal end or the open distal end of the wall. In some examples, in the folded and pleated configuration, the one or more flaps do not extend radially outward from the wall of the expandable implant or stent. In some examples, the one or more flaps are configured to extend radially outward from the wall of the expandable implant or stent during inflation of the balloon and engage or penetrate into a wall of the artery or vein in the patient during implantation of the expandable implant or stent. In some examples, the wall includes a proximal zone with one or more flaps, a distal zone with one or more flaps, and a middle zone that is located between the proximal zone and the distal zone. In some examples, the balloon is compliant or semi-compliant. In some examples, the balloon includes a compliant or a semi-compliant polymer. In some examples, the balloon includes polyethylene terephthalate, a nylon, a material including block copolymers made of rigid polyamide blocks and soft poly ether blocks, including Pebax, a polyurethane, including an aromatic poly ether polyurethane, a polyether-block-amide, or a silicone elastomer, including a polydimethylsiloxane silicone elastomer, and combinations thereof. In some examples, the balloon has a wall thickness between 3 microns and 30 microns. In some examples, a length of the balloon is greater than a length of the expandable implant or stent. In some examples, the balloon and the expandableAUROM.002WO PCT implant or stent are folded together into wings and pleated around a central axis. Tn some examples, at least a portion of the inflation lumen and the guidewire lumen are the same lumen.

[0053] In some examples, a system for placement of an expandable implant or stent in an artery or vein in a patient can include: a balloon catheter including: at least one hub on a proximal end of the balloon catheter; an elongate body including a proximal end and a distal end: a balloon positioned on a distal portion of the elongate body; and an inflation lumen in fluid communication with the balloon, the inflation lumen extending from a hub to the distal portion of the elongate body and configured for inflation of the balloon; a guidewire lumen extending from a hub to the distal end of the elongate body and configured to accept a guidewire; and an expandable implant or stent configured to be carried by the balloon catheter in a folded and pleated configuration to an implantation site in an artery or vein in a patient, the expandable implant or stent configured to expand from a folded and pleated configuration to an expanded configuration, the expandable implant or stent including: a wall having an open proximal end and an open distal end; a lumen defined by the wall, the lumen extending from the open proximal end to the open distal end; a gold layer; and one or more flaps on at least one of the open proximal end or the open distal end of the wall; wherein, the expandable implant or stent is configured to be expanded at the implantation site by inflation of the balloon through the inflation lumen; and wherein the one or more flaps are configured to extend radially outward from the wall of the expandable implant or stent during balloon inflation and the one or more flaps are configured to engage or penetrate into a wall of the artery or vein in the patient during implantation of the expandable implant or stent.

[0054] In some examples, the gold layer is continuous. In some examples, the gold layer is discontinuous. In some examples, the gold layer has a wall thickness of between 3 microns and 100 microns. In some examples, the gold layer includes electroformed or electroplated gold. In some examples, the expandable implant or stent further includes a polymer layer. In some examples, the polymer layer is continuous. In some examples, the polymer layer is discontinuous. In some examples, the polymer layer extends from the open proximal end to the open distal end. In some examples, the polymer layer is compliant or semi-compliant. In some examples, the polymer layer includes a compliant or a semi-compliant polymer. In some examples, the polymer layer includes polyethylene terephthalate, a nylon, a material including block copolymers made of rigid polyamide blocks and soft polyether blocks, including Pebax, aAUROM.002WO PCT polyurethane, including an aromatic polyether polyurethane, a polyether-block-amide, or a silicone elastomer, including a polydimethylsiloxane silicone elastomer, and combinations thereof. In some examples, the polymer layer has a wall thickness of between 3 microns and 100 microns. In some examples, the open proximal end and the open distal end of the expandable implant or stent are circular or substantially circular in cross-section; or wherein at least a portion of the lumen of the expandable implant or stent is circular or substantially circular in crosssection. In some examples, in the folded and pleated configuration, the one or more flaps do not extend radially outward from the wall of the expandable implant or stent. In some examples, the one or more flaps are configured to extend radially outward from the wall of the expandable implant or stent during inflation of the balloon and engage or penetrate into a wall of the artery or vein in the patient during implantation of the expandable implant or stent. In some examples, the wall of the expandable implant or stent includes a proximal zone with one or more flaps, a distal zone with one or more flaps, and a middle zone that is located between the proximal zone and the distal zone. In some examples, the balloon is compliant or semi-compliant. In some examples, the balloon includes a compliant or a semi-compliant polymer. In some examples, the balloon includes polyethylene terephthalate, a nylon, a material including block copolymers made of rigid polyamide blocks and soft polyether blocks, including Pebax, a polyurethane, including an aromatic polyether polyurethane, a polyether-block-amide, or a silicone elastomer, including a polydimethylsiloxane silicone elastomer, and combinations thereof. In some examples, the balloon has a wall thickness between 3 microns and 30 microns. In some examples, a length of the balloon is greater than a length of the expandable implant or stent. In some examples, the balloon and the expandable implant or stent are folded together into wings and pleated around a central axis. In some examples, at least a portion of the inflation lumen and the guidewire lumen are the same lumen. In some examples, the gold layer includes a plurality of rings circumferentially disposed around the polymer layer and a plurality of pieces arranged between the rings, the plurality of pieces arranged in a pattern circumferentially around the polymer layer.

[0055] In some examples, the gold layer comprises a plurality of longitudinal segments circumferentially disposed around the polymer layer and wherein the gold layer has a wall thickness between 3 microns and 100 microns, and wherein the segments of gold layer are separated by radial gaps comprising polymer. In some examples, the segmented layers of goldAUROM.002WO PCT comprise rings or ring-like structures. In some examples, the segmented layers of gold are configured as a lattice with struts or strut elements, and cells. In some examples, the cells have an open configuration. In some examples, the cells have a closed configuration. In some examples, the cells are configured in diamond- shaped, hexagonal, Z or zigzag-shaped, serpentine, and ring and link shapes or patterns. In some examples, the rings or ring-like structures are joined by one or more struts or strut elements that cross the radial gaps. In some examples, the gold layer includes a plurality of longitudinal segments circumferentially disposed around the polymer layer, and the gold layer has a wall thickness between 3 microns and 100 microns, and the segments of gold layer are separated by radial gaps comprising polymer. In some examples, the segmented layers of gold include rings or ring-like structures. In some examples, the segmented layers of gold include rings or ring-like structures. In some examples, the segmented layers of gold include rings or ring-like structures. In some examples, the segmented layers of gold include rings or ring-like structures.BRIEF DESCRIPTION OF THE DRAWINGS

[0056] Certain features of this disclosure are described below with reference to the drawings. The illustrated implementations are intended to illustrate, but not to limit, the implementations. Various features of the different disclosed implementations can be combined to form further implementations, which are part of this disclosure.

[0057] FIG. 1A is a side perspective view of an example of a one-lumen balloon catheter with an inflated balloon shown separated from an example of an expanded expandable metallic implant or stent,.

[0058] FIG. IB is a side perspective view of an example of a one-lumen balloon catheter with an inflated balloon shown separated from an example of an expanded expandable metallic implant or stent.

[0059] FIG. 1C is a side perspective view of an example of a guidewire.

[0060] FIG. 2A is a perspective view of the distal end of an example of an expandable metallic implant or stent device with folded and pleated expandable metallic implant or stent and balloon assembly.

[0061] FIG. 2B is a perspective view of the distal end of the example of the expandable metallic implant or stent device shown in FIG. 2A after inflation of the balloon showing anAUROM.002WO PCT inflated balloon and an expanded expandable metallic implant or stent and an expanded expandable metallic implant or stent and balloon assembly. This example of an expanded expandable metallic implant or stent has a middle zone.

[0062] FIG. 2C is a perspective view of the distal end of the example of the expandable metallic implant or stent device shown in FIG. 2B after deflation or collapse of the balloon showing a deflated or collapsed balloon.

[0063] FIG. 2D is a perspective view of the distal end of the example of the expandable metallic implant or stent device shown in FIG. 2C after separation of the deflated or collapsed balloon and the expanded expandable metallic implant or stent.

[0064] FIG. 3A is a side perspective view of an example of an expanded expandable metallic implant or stent having a middle zone and not having a proximal or distal zone.

[0065] FIG. 3B is an end planar view of an example of the expanded expandable metallic implant or stent shown in FIG. 3A, wherein the observer is viewing from a distal to a proximal perspective or from a proximal to distal perspective.

[0066] FIG. 3C is an expanded end planar view of the example of an expanded expandable metallic implant or stent shown in FIG. 3B showing the exterior surface of the expandable metallic implant or stent and the interior surface of the expandable metallic implant or stent.

[0067] FIG. 3D is a planar view of an example of a pointed flap of an expanded expandable metallic implant or stent with a linear hinge region at the base of the flap.

[0068] FIG. 4 is a planar view of the distal end of a balloon catheter.

[0069] FIG. 5A is a side perspective view of an example of a two-lumen balloon catheter with an inflated balloon shown separated from an example of an expanded expandable metallic implant or stent. The proximal zone of the expanded expandable metallic implant or stent comprises one row of pointed flaps with a distal-proximal alignment and the distal zone comprises one row of pointed flaps with a proximal-distal alignment.

[0070] FIG. 5B is a side perspective view of an example of a guidewire.

[0071] FIG. 6A is a perspective view of the distal end of an example of an expandable metallic implant or stent device with folded and pleated expandable metallic implant or stent and balloon assembly.AUROM.002WO PCT

[0072] FIG. 6B is a perspective view of the distal end of the example of the expandable metallic implant or stent device shown in FIG. 6 A after inflation of the balloon showing an inflated balloon and an expanded expandable metallic implant or stent and an expanded expandable metallic implant or stent and balloon assembly. This example of an expanded expandable metallic implant or stent has a proximal zone, a middle zone, and a distal zone. The proximal zone comprises one row of pointed flaps with a distal-proximal alignment and the distal zone comprises one row of pointed flaps with a proximal-distal alignment.

[0073] FIG. 6C is a perspective view of the distal end of the example of the expandable metallic implant or stent device shown in FIG. 6B after over-inflation of the balloon showing an over-inflated balloon and flaps with free ends that are raised from the surface of the expanded expandable metallic implant or stent.

[0074] FIG. 6D is a perspective view of the distal end of the example of the expandable metallic implant or stent device shown in FIG. 6C after deflation or collapse of the balloon showing a deflated or collapsed balloon.

[0075] FIG. 6E is a perspective view of the distal end of the example of the expandable metallic implant or stent device shown in FIG. 2D after separation of the deflated or collapsed balloon and the expanded expandable metallic implant or stent.

[0076] FIG. 7A is a side perspective view of an example of an expanded expandable metallic implant or stent having a proximal, a middle zone and a distal zone. The proximal zone comprises one row of pointed flaps with a distal-proximal alignment and the distal zone comprises one row of pointed flaps with a proximal-distal alignment.

[0077] FIG. 7B is a side perspective view of an example of an expanded expandable metallic implant or stent having a proximal zone and a middle zone. The proximal zone comprises one row of pointed flaps with a distal-proximal alignment.

[0078] FIG. 7C is a side perspective view of an example of an expanded expandable metallic implant or stent having a middle zone and a distal zone. The distal zone comprises one row of pointed flaps with a proximal-distal alignment.

[0079] FIG. 8A is a side perspective view of an example of an expanded expandable metallic implant or stent having a middle zone and a proximal and distal zone. The proximal zone comprises one row of squared flaps with a distal-proximal alignment and the distal zone comprises one row of squared flaps with a proximal-distal alignment.AUROM.002WO PCT

[0080] FTG. 8B is a side perspective view of an example of an expanded expandable metallic implant or stent having a middle zone and a proximal and distal zone. The proximal zone comprises one row of rounded flaps with a distal-proximal alignment and the distal zone comprises one row of rounded flaps with a proximal-distal alignment.

[0081] FIG. 8C is a side perspective view of an example of an expanded expandable metallic implant or stent having a middle zone and a proximal and distal zone. The proximal zone comprises one row of stalk and bud flaps with a distal-proximal alignment and the distal zone comprises one row of stalk and bud flaps with a proximal-distal alignment.

[0082] FIG. 9 is a planar view of a pointed flap of an expanded expandable metallic implant or stent with a linear hinge region at the base of the flap, wherein the flap is within a square flap window.

[0083] FIG. 10A is a side perspective view of an example of an expanded expandable metallic implant or stent having a proximal, a middle zone and a distal zone. The proximal zone comprises one row of pointed internal flaps with a distal-proximal alignment and the distal zone comprises one row of pointed internal flaps with a proximal-distal alignment.

[0084] FIG. 10B is a side perspective view of an example of an expanded expandable metallic implant or stent having a proximal zone and a middle zone. The proximal zone comprises one row of pointed internal flaps with a distal-proximal alignment.

[0085] FIG. 10C is a side perspective view of an example of an expanded expandable metallic implant or stent having a middle zone and a distal zone. The distal zone comprises one row of pointed internal flaps with a proximal-distal alignment.

[0086] FIG. 10D is a side perspective view of an example of an expanded expandable metallic implant or stent having a middle zone. The middle zone comprises one row of pointed internal flaps with a distal-proximal alignment.

[0087] FIG. 10E is a side perspective view of an example of an expanded expandable metallic implant or stent having a middle zone. The middle zone comprises one row of pointed internal flaps with a proximal-distal alignment.

[0088] FIG. 10F is a side perspective view of an example of an expanded expandable metallic implant or stent having a middle zone. The middle zone comprises one row of pointed internal flaps, wherein at least one of the flaps has a distal-proximal alignment and at least one of the flaps has a proximal-distal alignment.AUROM.002WO PCT

[0089] FIG. 11 A is a planar view of a pointed flap of an expanded expandable metallic implant or stent with a square flap window.

[0090] FIG. 1 IB is a planar view of a pointed flap of an expanded expandable metallic implant or stent with a rectangular flap window that is wider than tall.

[0091] FIG. 11C is a planar view of a pointed flap of an expanded expandable metallic implant or stent with a rectangular flap window that is taller than wide.

[0092] FIG. 1 ID is a planar view of a pointed flap of an expanded expandable metallic implant or stent with a rectangular flap window that is taller than wide.

[0093] FIG. 1 IE is a planar view of a pointed flap of an expanded expandable metallic implant or stent with a triangular flap window.

[0094] FIG. 12A is an end planar view of an example of an expanded expandable metallic implant or stent having a single structural metal layer.

[0095] FIG. 12B is an end planar view of an example of an expanded expandable metallic implant or stent having a structural metal layer as an inner layer and a functional metal layer as an outer layer.

[0096] FIG. 12C is an end planar view of an example of an expanded expandable metallic implant or stent having a structural metal layer as a middle layer, a functional metal layer as an outer layer, and a functional metal layer as an inner layer.

[0097] FIG. 12D is an end planar view of an example of an expanded expandable metallic implant or stent having a structural metal layer as an inner layer and a polymer layer as an outer layer.

[0098] FIG. 12E is an end planar view of an example of an expanded expandable metallic implant or stent having a structural metal layer as a middle layer, a polymer layer as an outer layer, and a polymer layer as in inner layer.

[0099] FIG. 12F is an end planar view of an example of an expanded expandable metallic implant or stent having a structural metal layer as an outer layer, and a polymer layer as in inner layer.

[0100] FIG. 12G is an end planar view of an example of an expanded expandable metallic implant or stent having a structural metal layer as an outer layer, a polymer layer as a middle layer, and a functional metal layer as an inner layer.AUROM.002WO PCT

[0101] FIG. 13A is a planar view of an example of an expandable metallic implant or stent device with a one lumen balloon catheter and a folded and pleated expandable metallic implant or stent and balloon assembly.

[0102] FIGS. 13B-I show cross-sectional views of FIG. 13A. The individual cross sections may not be shown equivalent in scale.

[0103] FIG. 14A is a planar view of an example of an expandable metallic implant or stent device with a two-lumen balloon catheter and a folded and pleated expandable metallic implant or stent and balloon assembly.

[0104] FIGS. 14B-J show cross-sectional views of FIG. 14A. The individual cross sections may not be shown equivalent in scale.

[0105] FIG. 15 A is a cross-sectional view of a folded balloon of a balloon catheter with four balloon wings.

[0106] FIG. 15B is a cross-sectional view of a folded and pleated expandable metallic implant or stent and balloon assembly with four wings. FIG. 8B also shows a straight portion of a wing of the expandable metallic implant or stent and a curved portion of the wing of the expandable metallic implant or stent.

[0107] FIG. 16A is a planar view of a guide catheter or guide sheath and a Tuohy Borst adaptor, wherein the guide catheter or guide sheath and a Tuohy Borst adaptor are separated.

[0108] FIG. 16B is a planar view of a guide catheter or guide sheath and a Tuohy Borst adaptor, wherein the guide catheter or guide sheath and a Tuohy Borst adaptor are joined, wherein the Tuohy Borst adaptor is configured for flushing the lumen of the guide catheter or guide sheath.

[0109] FIG. 17A shows an example of a vessel with a laceration or rupture.

[0110] FIG. 17B shows an example of a balloon catheter carrying a folded and pleated expandable metallic implant or stent to the vessel of FIG. 17A,

[0111] FIG. 17C shows an example of the balloon of the balloon catheter of FIG. 17B in an expanded state such that the expanded, expandable metallic implant or stent contacts the wall of the vessel.

[0112] FIG. 17D shows an example of the balloon of the balloon catheter of FIG. 17B in an overinflated state such that flaps of the expanded, expandable metallic implant or stent engage or penetrate the wall of the vessel.AUROM.002WO PCT

[0113] FIG. 17E shows an example of the balloon of the balloon catheter of FIG. 17B in a deflated state such that flaps of the expanded, expandable metallic implant or stent remain engaged with the wall of the vessel.

[0114] FIG. 17F shows an example of the expanded, expandable metallic implant or stent of FIG. 17B with flaps engaged with the wall of the vessel after removal of the balloon catheter.

[0115] FIG. 18A is a cross-sectional view of an expanded, expandable metallic implant or stent positioned over an inflated balloon of a balloon catheter. FIG. 18B is a cross-sectional view of FIG. 18A wherein the expandable metallic implant or stent and the balloon have been folded together into three wings. FIG. 18C is a cross-sectional view of FIG. 18B wherein the folds of the expandable metallic implant or stent and the balloon have been wrapped around the inner shaft of the expandable metallic implant or stent device, thereby forming pleats.

[0116] FIG. 19A is a perspective view of a photograph of a folded expandable metallic implant or stent and balloon of a balloon catheter with three balloon wings, showing an expandable metallic implant or stent that is external to the balloon. FIG. 19B is a perspective view of a photograph of the folded expandable metallic implant or stent and balloon positioned inside the pleat head of a pleating machine.

[0117] FIG. 20A shows a folded and pleated expandable metallic implant or stent device. FIG. 20B shows inflation of the balloon in FIG. 20A and expansion the expandable metallic implant or stent and enlargement of the diameter of the lumen or hollow region 11 of the expandable metallic implant or stent. FIG. 20C shows over-inflation of the balloon in FIG. 20B and tilting or angling of the flaps on both ends of the expanded expandable metallic implant or stent. FIG. 20D shows the expanded expandable metallic implant or stent of FIG. 20C after deflation or collapse of the balloon and removal of the balloon catheter.

[0118] FIG. 21 A is a side view of an example of an over-the-guidewire expandable metallic implant or stent device with a folded and pleated expandable metallic implant or stent and balloon assembly. FIG. 21A also shows a guidewire present within the guidewire lumen of the balloon catheter of the over-the-guidewire expandable metallic implant or stent device.

[0119] FIG. 21B-K show cross-sectional views of the example of the over-the- guidewire expandable metallic implant or stent device of FIG. 21 A at various locations, as shown. The individual cross sections may not be shown equivalent in scale. FIG. 21F and FIG.AUROM.002WO PCT21 H show a folded and pleated balloon. FIG. 21 G shows a folded and pleated expandable metallic implant or stent and balloon assembly.

[0120] FIG. 22A and 22B are two perspective views of an example of an expandable metallic implant or stent having flaps with holes to enable tissue ingrowth from the wall of the vessel after implantation in a target vessel segment.

[0121] FIG. 23A and FIG. 23B show an example of an expandable metallic implant or stent with three discrete structural (outer) metal layer segments joined to a continuous flexible inner polymer layer extending from the open proximal end to the open distal end of the expandable metallic implant or stent, including the triangular flaps on both ends. FIG. 23A is a perspective view of the example and FIG. 23B is a partial cutaway showing the structural (outer) metal layer of the three segments and the flexible inner polymer layer.

[0122] FIG. 24A shows an example of an expandable metallic implant or stent with two discrete structural (outer) metal layer segments joined to a flexible inner polymer layer, where each of the structural metal layer segments are joined by a functional metal layer bridge segment comprised of a functional metal layer with a thickness less than 3 microns to facilitate electrical conductivity during plating and maintain flexibility in the region of the exposed inner polymer layer during delivery to a target vessel segment and after implantation.

[0123] FIG. 24B shows an example of an expandable metallic implant or stent with two discrete structural (outer) metal layer segments joined to a flexible inner polymer layer, where each of the structural metal layer segments are joined by a structural metal bridge segment with a thickness of greater than 3 microns to facilitate electrical conductivity during plating and transmit force and maintain hoop strength along the length of the expandable metallic implant or stent. In FIG. 24B, the structural metal bridge segments are offset.

[0124] FIG. 25A and 25B are two perspective views of an example of a slotted, variable size, expandable metallic implant or stent showing a longitudinal discontinuity in the structural metal layer such that the lumen or hollow region of the slotted, variable size, expandable metallic implant or stent can be increased to a larger diameter further after an initial expansion.

[0125] FIG. 26A is a perspective view of an example of a slotted, variable size, expandable metallic implant or stent showing a longitudinal discontinuity in the structural metal layer such that the lumen or hollow region of the slotted, variable size, expandable metallic implant or stent can be increased after an initial expansion.AUROM.002WO PCT

[0126] FTG. 26B is a perspective view of an example of a slotted, variable size, expandable metallic implant or stent showing a longitudinal discontinuity in the structural metal layer such that the lumen or hollow region of the slotted, variable size, expandable metallic implant or stent can be increased after an initial expansion.

[0127] FIG. 26C is a perspective view of an example of a slotted, variable size, expandable metallic implant or stent showing a longitudinal discontinuity in the structural metal layer such that the lumen or hollow region of the slotted, variable size, expandable metallic implant or stent can be increased after an initial expansion.

[0128] FIG. 27 is a perspective view of an example of a fenestrated, variable size, expandable metallic implant or stent showing a structural metal (outer) layer arranged in discrete, ring-shaped metal layer segments of repeating diamond-shaped strut elements such that the lumen or hollow region of the fenestrated, variable size, expandable metallic implant or stent can be expanded to a larger diameter after an initial expansion.

[0129] FIG. 28A-C are perspective views of an example of a fenestrated, variable size, expandable metallic implant or stent showing a structural metal (outer) layer arranged in discrete and independent rings of rounded diamond-shaped strut elements such that the lumen or hollow region of the fenestrated, variable size, expandable metallic implant or stent can be expanded to a larger diameter after an initial expansion.

[0130] FIG. 29A is a perspective view of an example of a fenestrated, variable size, expandable metallic implant or stent showing a structural metal (outer) layer arranged in a web, net or network pattern of diamond-shaped strut elements such that the lumen or hollow region of the fenestrated, variable size, expandable metallic implant or stent can be expanded to a larger diameter after an initial expansion.

[0131] FIG. 29B is a perspective view of an example of a longer version of the fenestrated, variable size, expandable metallic implant or stent shown in FIG. 28A.

[0132] FIGs. 30A-30E show an example of an implant and a mandrel for manufacturing the implant. FIG. 30A and FIG. 30C are perspective views of an example of a secondary folded and pleated, variable size, expandable metallic implant or stent wherein a portion of the wall of the implant or stent is folded and is pleated over itself. FIGs. 30E and 30F are perspective views of an example of a secondary folded and pleated, variable size, expandable metallic implant or stent wherein a portion of the wall of the implant or stent is formed into secondary folds, prior toAUROM.002WO PCT forming a secondary pleat. FTGs. 30B, FIG. 30D, and FIG. 30E are a perspective proximal aspect views of the mandrel that is used for the manufacture of the secondary folded and pleated, variable size, expandable metallic implants or stents of FIG. 30A, FIG. 30C, and FIG. 30D respectively.

[0133] FIG. 31A is a perspective view of a hub and the distal portion of an elongate body of an over-the-guidewire balloon catheter showing a three-layered strain relief assembly.

[0134] FIG. 3 IB is a cutaway perspective view of the hub of FIG. 20A. This example shows three layers of strain relief: an inner layer, a middle layer, and an outer layer.

[0135] FIG. 32A is a perspective view of a hub and the distal portion of an elongate body of a balloon catheter showing a three-layered strain relief assembly.

[0136] FIG. 32B is a cutaway perspective view of the hub of FIG. 20A. This example shows three layers of strain relief: an inner layer, a middle layer, and an outer layer.DETAILED DESCRIPTION

[0137] Various features and advantages of this disclosure will now be described with reference to the accompanying figures. The following description is merely illustrative in nature and is in no way intended to limit the disclosure, its application, or uses. This disclosure extends beyond the specifically disclosed implementations and / or uses and obvious modifications and equivalents thereof. Thus, it is intended that the scope of this disclosure should not be limited by any particular implementations described below. The features of the illustrated implementations can be modified, combined, removed, and / or substituted as will be apparent to those of ordinary skill in the art upon consideration of the principles disclosed herein. Furthermore, implementations disclosed herein can include several novel features, no single one of which is solely responsible for its desirable attributes, or which is essential to practicing the systems, devices, and / or methods disclosed herein.

[0138] Parts, components, features, and / or elements of the systems and devices described herein that can function the same or similarly across various implementations are identified using similar reference numerals. Differences between the various implementations are discussed herein. Reference numerals are also provided for certain elements that are described for context or related to further examples. Although these elements may not be illustrated, reference numerals are provided for convenience to identify these elements.AUROM.002WO PCT

[0139] Implementations of the present application relate to expandable metallic implant or stent devices for use in closing breaches or openings in the wall of blood vessels and other biological conduits, including for use in modifying, obstructing, or reducing flow through blood vessel lacerations and ruptures and arteriovenous fistulas, through discontinuities in endoprostheses or gaps between one endoprosthesis and another endoprosthesis or between an endoprosthesis and adjacent tissue, and for modifying, obstructing, or reducing flow into aneurysms, pseudoaneurysms, or other blood-containing, fluid-containing, or biological spaces. In some examples, the devices include two separable components: 1) an expandable metallic implant or stent 10 configured for permanent implantation in human patients; and 2) a balloon catheter 100. In some examples, the balloon catheter 100 is configured for: 1) delivering a folded and pleated expandable metallic implant or stent 10 to the treatment site a patient; 2) expanding the folded and pleated expandable metallic implant or stent 10 at the treatment site; and 3) detaching from the expanded expandable metallic implant or stent 10 and being removed from the patient, wherein the expanded expandable metallic implant or stent 10 remains in place in an expanded state after separation from the balloon catheter 100 and removal of the balloon catheter 100 from the patient’s body.

[0140] FIGS. 1A and IB are perspective views of examples of a balloon catheter 100 with an inflated balloon 110 shown separated from an example of an expanded expandable metallic implant or stent 10. FIG. 1C is a perspective view of an example of a guidewire 280 configured for use with an expandable metallic implant or stent device 1. In some examples, the balloon catheter 100 is comprised of an elongate body 160. In some examples, the elongate body 160 has one lumen (a “one lumen balloon catheter” 101) comprising a first lumen 161 with a first hub 164, as shown in FIG. 1A. In some examples, the elongate body 160 has two lumens (a “two lumen balloon catheter” 102) comprising a first lumen 161 with a first hub 164 and a second lumen 162 with a second hub 165, as shown in FIG 2 A.

[0141] For some examples of an expandable metallic implant or stent device, the expandable metallic implant or stent is folded and pleated together with the balloon 110 and configured for expansion when the folded and pleated balloon 110 is inflated and separation of the expandable metallic implant or stent in vivo when the balloon is deflated or collapsed. During expansion of a folded and pleated balloon 110, the folded and pleated expandable metallic implant or stent 10 can transition to an “expanded” configuration. After separation of anAUROM.002WO PCT expanded expandable metallic implant or stent 10 from a deflated or collapsed balloon 110, the expanded expandable metallic implant or stent 10 is configured to maintain an expanded configuration and to modify, obstruct, or reduce flow through blood vessel lacerations and ruptures and arteriovenous fistulas, through discontinuities in endoprostheses or gaps between one endoprosthesis and another endoprosthesis or between an endoprosthesis and adjacent tissue, and modify, obstruct, or reduce flow into aneurysms, pseudoaneurysms, or other bloodcontaining, fluid-containing, or biological spaces in human patients. Herein, these devices are also “expandable metallic implant or stent devices”. In some examples, the expandable metallic implant or stent 10 is provided in a “deliverable configuration” wherein some or all of the expandable metallic implant or stent 10 is folded and pleated together with a balloon 110 in a manner wherein portions of the wall 22 of the expandable metallic implant or stent 10 are squeezed or pressed together with portions of the wall 135 of a balloon 110 to facilitate passage through guide catheters or guide sheaths 200 or maneuvered into or through arteries, veins, aneurysms, biological conduits, other blood-containing and fluid-containing spaces, or biological spaces to a treatment site. As used herein, a biological space can mean a continuous area or expanse in a human patient, including a continuous area or expanse that is free, available, or unoccupied. When describing these devices, the proximal end can refer to the end that is closer to the operator, and the distal end can refer to the end that is advanced first into the patient. For individual components of devices described herein, the same proximal and distal orientation can be maintained.

[0142] Examples of the expandable metallic implant or stent 10 of the current disclosure solve several long-standing limitations of other devices intended for modifying, obstructing, or reducing flow through blood vessel lacerations and ruptures and arteriovenous fistulas, through discontinuities in endoprostheses or gaps between one endoprosthesis and another endoprosthesis or between an endoprosthesis and adjacent tissue, and for modifying, obstructing, or reducing flow into aneurysms, pseudoaneurysms, or other blood-containing, fluid-containing, or biological spaces. For example, coil expandable implants used for vascular embolization present a porous barrier to the flow of blood, often resulting in a slow or incomplete treatment effect. The present disclosure describes examples of expandable implant devices that place an expanded expandable metallic implant or stent 10 at the target location that presents a solid surface to the flow of blood or biological fluid and is capable of providingAUROM.002WO PCT immediate and complete occlusion or cessation of flow, including blood flow. FIG. 2B is a perspective view of an example of an expanded expandable metallic implant or stent 10 device 1 with an expanded expandable metallic implant or stent 10 and an inflated balloon 110.

[0143] In some examples, the expandable metallic implant or stent 10 can be configured for closing breaches or openings in the wall of blood vessels and other biological conduits and obstructing, occluding, embolizing, sealing, or reducing the flow of blood or other biological fluids through blood vessel lacerations and ruptures and arteriovenous fistulas, through discontinuities in endoprostheses or gaps between one endoprosthesis and another endoprosthesis or between an endoprosthesis and adjacent tissue, and for modifying, obstructing, or reducing flow into aneurysms, pseudoaneurysms, or other blood-containing, fluid-containing, or biological spaces. In some examples, the expandable metallic implant or stent 10 is configured to expand from a folded and pleated configuration, as shown in FIG. 2A to an expanded configuration, as shown in FIG. 2B. In some examples, the expandable metallic implant or stent 10 is configured with a wall that is open on the proximal end and the distal end and wherein the wall is continuous from the proximal end to the distal end.

[0144] In some examples, a portion of the guidewire 280 has a pre-formed shape 285 or has a portion with pre-formed shape when in an unconstrained configuration, including a distal portion, to assist in the selection of vessel branches.

[0145] As shown in FIG. 2A and FIG. 13F, an expandable metallic implant or stent 10 is a structure with a wall 22 comprising a material that can be folded and pleated together with the balloon 110 portion of a balloon catheter 100. In some examples, the balloon 110 and the expandable metallic implant or stent 10 may be folded into wings 3. The wings 3 may be compressed or pleated over around a central axis 37 of the balloon 110. The wings 3 can be formed as ridges separated by troughs. Each trough can extend longitudinally from a ridgeline. FIG. 15A is a cross-sectional view of a balloon 110 that is folded into four wings 3. FIG. 15B is a cross-sectional view of a balloon 110 and an expandable metallic implant or stent 10 that are folded together into four wings 3. FIG. 15B also shows a straight portion 40 and a curved portion 41 of a wing 3.

[0146] In some examples, the expanded expandable metallic implant or stent 10 is hollow or comprises a central hollow region 11. The expandable metallic implant or stent 10 can transition from a folded and pleated configuration to an expanded configuration, wherein theAUROM.002WO PCT wall 22 of the expandable metallic implant or stent 10 can be expanded by the inflation of the folded and pleated balloon 110 by the injection of a fluid into the interior space 115 of the balloon 110 under pressure, as shown in FIGS. 2A-D. This form of expandable metallic implant or stent 10 can be delivered to a desired location in a human patient in a folded and pleated form using the balloon catheter 100, expanded, and separated from the balloon catheter 100 in a manner that allows the expanded expandable metallic implant or stent 10 to close a breach or opening in the wall of a blood vessel or other biological conduit and obstruct, occlude, embolize, seal, or reduce the flow of blood or other biological fluids through blood vessel lacerations and ruptures and arteriovenous fistulas, through discontinuities in endoprostheses or gaps between one endoprosthesis and another endoprosthesis or between an endoprosthesis and adjacent tissue, or modify, obstruct, or reduce flow into aneurysms, pseudoaneurysms, or other blood-containing, fluid-containing, or biological spaces, and remain in the patient while the balloon catheter 100 is removed from the patient.

[0147] In some examples, the expandable metallic implant or stent 10 is comprised of a middle zone 12 only, as shown in FIG. 3 A which is a side planar view of an example of an expanded expandable metallic implant or stent 10 having a middle zone 12 with its overall geometric dimensions defined. FIG. 3B is an end planar view of an example of an expanded expandable metallic implant or stent 10 having a middle zone 12, with its overall geometric dimensions defined, wherein the observer is viewing from a distal to a proximal perspective or a proximal to a distal perspective and can see into the central hollow region 11 of an expanded expandable metallic implant or stent 10. FIG. 3C is an expanded end planar view of the example of an expanded expandable metallic implant or stent shown in FIG. 3B showing the exterior surface of the expandable metallic implant or stent and the interior surface of the expandable metallic implant or stent. The proximal and distal ends of the expanded expandable metallic implant or stent 10 may be substantially circular.

[0148] In some examples, the middle zone 12 is configured to form a circumferential seal against the vessel wall (or other biological conduit or space) and establish a solid barrier to the flow of blood or other biological fluids from the vessel (or other biological conduit or space). In some examples, the expanded expandable metallic implant or stent 10 further comprises a proximal zone 13, with a function separate and distinct from the middle zone 12, including holding the inflated balloon 110 and the expanded expandable metallic implant or stent 10AUROM.002WO PCT together or provide additional resistance to migration of the expanded expandable metallic implant or stent 10 after separation from the balloon catheter 100.

[0149] In some examples, the wall 22 of an expanded expandable metallic implant or stent 10 can have an exterior surface 34 such that, when the expandable metallic implant or stent 10 is expanded, the exterior surface 34 faces the vessel wall or other adjacent tissue and an interior surface 35 that faces the central hollow region 11. FIG. 3B is an end planar view of the example of an expanded expandable metallic implant or stent 10 shown in FIG. 3 A showing the exterior surface 34 of the wall 22 of the expanded expandable metallic implant or stent 10 and the interior surface 35 of the wall of the expanded expandable metallic implant or stent 10. In some examples, the wall 22 of the expandable metallic implant or stent 10 is formed by electroforming and electroplating. The proximal zone 13 (if present), the middle zone 12, the distal zone 14 (if present) of the expandable metallic implant or stent 10 may be made by electroforming and electroplating, including made of gold by electroforming and electroplating. The proximal zone 13 (if present), the middle zone 12, and the distal zone 14 (if present) can be configured for folding and pleating together with a balloon 110 and, through inflation of the balloon 110 are “expandable”.

[0150] In some examples, the wall 22 of the expandable metallic implant or stent 10 comprises at least one layer of metal with a thickness of at least 3 microns and wherein the wall 22 of the expandable metallic implant or stent 10 can be folded and pleated with a balloon 110 for delivery and expanded at the target location by injecting fluid into the interior space 115 of the balloon 110. In some examples, the thickness of the wall 22 of the expandable metallic implant or stent 10 is configured to enable expansion in response to the injection of fluid into the interior space 115 of the balloon 110 at a pressure of 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 10, 12, 13, 14, 15, 16, 17, 18, 19, or 20 atmospheres. In some examples, the wall 22 of the expandable metallic implant or stent 10 comprises a continuous layer of metal, excluding any proximal or distal openings.

[0151] The wall 22 of the expandable metallic implant or stent 10 may comprise at least one metal. The wall 22 of the expandable metallic implant or stent 10 may comprise gold, platinum, or combinations or alloys thereof. The wall 22 of the expandable metallic implant or stent 10 may further comprise additional metals, polymers, adhesives, and combinations thereof. Expandable metallic implant or stents 10 possess sufficient strength to maintain an expanded orAUROM.002WO PCT partially expanded configuration in vivo after separation from the balloon catheter 100, including sufficient strength to maintain an expanded or partially expanded configuration in vivo after separation from the balloon catheter 100. In some examples, the expandable metallic implant 10 comprises an outer structural metal layer 27 and an inner structural metal layer 27 nested or telescoped therewithin but not joined or bonded; and the two structural metal layers 27 are pleated and folded together with a balloon 110 of a balloon catheter 100. For these examples of expandable metallic implants or stents 10, the nested or telescoped outer structural metal layer 27 and inner structural metal layer 27 provide greater radial force and resistance to compression after expansion than either could provide alone, including after expansion in a target vessel segment.

[0152] For some examples of an expandable metallic implant or stent device 1, the expanded expandable metallic implant or stent 10 comprises a fixation region 15 to facilitate attachment or fixation of the expanded expandable metallic implant or stent 10 to the adjacent vessel wall (or other tissue) after expansion and separation from the balloon catheter 100. For some examples of an expandable metallic implant or stent device 1, the expanded expandable metallic implant or stent 10 comprises a fixation region 15 to increase sliding friction between the expanded expandable metallic implant or stent 10 and the adjacent vessel wall (or other tissue) after expansion and separation from the balloon catheter 100. For some examples of an expandable metallic implant or stent device 1. the expanded expandable metallic implant or stent 10 comprises a fixation region 15 to increase the resistance of an expanded expandable metallic implant or stent to migration after expansion and separation from the balloon catheter 100. For some examples of an expandable metallic implant or stent 10, the fixation region 15 of the expanded expandable metallic implant or stent 10 comprises one or more flaps 16. FIG. 3D is a planar view of a pointed flap 16 of an expanded expandable metallic implant or stent 10 located at either a proximal or distal end of an expanded expandable metallic implant or stent 10. For some examples of an expandable metallic implant or stent 10, the flap 16 comprises a linear hinge region 17 at the base of the flap 16. In some examples, a fixation region 15 is present in a proximal zone 13 at the proximal end of the expanded expandable metallic implant or stent 10 and a fixation region 15 is present in a distal zone 13 at the distal end of the expanded expandable metallic implant or stent 10, as shown in FIG. 5 A, 6A-E, 7 A, and 8A-C.AUROM.002WO PCT

[0153] For some examples of an expanded expandable metallic implant or stent 10, the fixation region 15 comprises one or more internal flaps 16, which are present within a flap window 18. For some examples of an expanded expandable metallic implant or stent 10, a fixation region 15 is present in a proximal zone 13 but is not present at the proximal end of the expanded expandable metallic implant or stent 10 and a fixation region 15 is present in a distal zone 14 but is not present at the distal end of the expanded expandable metallic implant or stent 10, as shown in FIG. 10A and 10D. For some examples of an expanded expandable metallic implant or stent 10, a fixation region 15 with one or more internal flaps 17 is present in a proximal zone 13 (but not at the proximal end) of an expanded expandable metallic implant or stent 10 but not in the distal zone 14 or at the distal end of the expanded expandable metallic implant or stent 10, as shown in FIG. 7B. For some examples of an expanded expandable metallic implant or stent 10, a fixation region 15 with one or more internal flaps 17 is present in a distal zone 14 (but not at the distal end) of the expanded expandable metallic implant or stent 10 but not in the proximal zone 13 or at the proximal end of the expanded expandable metallic implant or stent 10, as shown in FIG. 7C. For some examples of an expanded expandable metallic implant or stent 10, a fixation region 15 with one or more internal flaps 17 is present in the middle zone 12, as shown in FIG. 10E and 10F. A variety of shapes and sizes of the flap 16 and flap window 18 of the expanded expandable metallic implant or stent 10 are described herein, including as shown in FIG. 11A - 1 IE. For some examples of an expanded expandable metallic implant or stent 10, the tip of the flap 16 can be pointed, rounded, squared, or complex in shape, as shown in FIGS. 7 A and 8A-C.

[0154] For some examples of an expanded expandable metallic implant or stent 10, at least one flap 16 is configured such that the free end is distal to the fixed end, as shown in FIGS. 6A-E, 7A, 7C, 8A-C,10A, and 10E-F. For some examples of an expanded expandable metallic implant or stent 10, at least one flap 16 is configured such that the free end is proximal to the fixed end, as shown in FIGS. 6A-E, 7A-B, 8A-C,10A-B, 10D and 10F. For some examples of an expanded expandable metallic implant or stent 10, all of the flaps in a row are pointing in one direction, as shown in FIGS. 6A-E, 7A-C, 8A-C, and 10A-E. For some examples of an expanded expandable metallic implant or stent 10, some of the flaps in a row are pointing in one direction and other flaps 16 are pointing in the opposite direction, as shown in FIG. 10F.AUROM.002WO PCT

[0155] In some examples, one or more flaps 16 may comprise a perforation, hole or opening 43 extending from an outer surface of the flap 16 to an inner surface of the flap 16 (FIG. 24). In some examples, each flap 16 can include 1 or more perforations, holes or openings 43 therethrough. The perforations, holes or openings 43 can provide additional fixation of the expanded expandable metallic implant 11 to the vessel wall 603 as tissue ingrowth can occur through the perforations, holes or openings 43 while the flaps 16 are at least partially in contact with the vessel wall 603. The tissue ingrowth through the perforations, holes or openings 43 of the flaps 16 can provide increased adhesion of the expanded expandable metallic implant 11 and reduce the risk of migration of the expanded expandable metallic implant 11. Tissue ingrowth through the perforations, holes or openings 43 of the flaps 16 can provide increased adhesion of the expanded expandable metallic implant 11 and reduce the risk of migration of the expanded expandable metallic implant 11.

[0156] FIGS. 5A, 6A-E, and 7A include a perspective view of an example of an expanded expandable metallic implant or stent 10 having a middle zone 12, proximal zone 13, and distal zone 14 with its overall geometric dimensions defined. The proximal zone 13 and the distal zone 14 of these expanded expandable metallic implant or stent 10 comprise a fixation region 15 with pointed flaps 16 wherein the pointed flaps 16 are present at the proximal and distal ends. The pointed flaps 16 in the proximal zone 13 are configured such that the free ends are proximal to the fixed ends and the pointed flaps in the distal zone 14 are configured such that the free ends are distal to the fixed ends.

[0157] FIG. 7B is a perspective view of an example of an expanded expandable metallic implant or stent 10 having a middle zone 12 and a proximal zone 13. The proximal zone 13 of this expanded expandable metallic implant or stent 10 comprises a fixation region with pointed flaps 16 wherein the pointed flaps are present at the proximal end. The pointed flaps in the proximal zone 13 are configured such that the free ends are proximal to the fixed ends.

[0158] FIG. 7C is a perspective view of an example of an expanded expandable metallic implant or stent 10 having a middle zone 12 and a distal zone 14. The distal zone 14 of this expanded expandable metallic implant or stent 10 comprises a fixation region with pointed flaps 16 wherein the pointed flaps are present at the distal end. The pointed flaps in the distal zone 14 are configured such that the free ends are distal to the fixed ends.AUROM.002WO PCT

[0159] FIG. 8A is a perspective view of an example of an expanded expandable metallic implant or stent 10 having a middle zone 12, proximal zone 13, and distal zone 14 with its overall geometric dimensions defined. The proximal zone 13 and the distal zone 14 of these expanded expandable metallic implant or stent 10 comprise a fixation region 15 with squared flaps 16 wherein the squared flaps 16 are present at the proximal and distal ends. The squared flaps 16 in the proximal zone 13 are configured such that the free ends are proximal to the fixed ends and the pointed flaps in the distal zone 14 are configured such that the free ends are distal to the fixed ends.

[0160] FIG. 8B is a perspective view of an example of an expanded expandable metallic implant or stent 10 having a middle zone 12, proximal zone 13, and distal zone 14 with its overall geometric dimensions defined. The proximal zone 13 and the distal zone 14 of these expanded expandable metallic implant or stent 10 comprise a fixation region 15 with squared flaps 16 wherein the rounded flaps 16 are present at the proximal and distal ends. The rounded flaps 16 in the proximal zone 13 are configured such that the free ends are proximal to the fixed ends and the pointed flaps in the distal zone 14 are configured such that the free ends are distal to the fixed ends.

[0161] FIG. 8C is a perspective view of an example of an expanded expandable metallic implant or stent 10 having a middle zone 12, proximal zone 13, and distal zone 14 with its overall geometric dimensions defined. The proximal zone 13 and the distal zone 14 of these expanded expandable metallic implant or stent 10 comprise a fixation region 15 with stalk- and- bud flaps 16 wherein the stalk- and-bud flaps 16 are present at the proximal and distal ends. The stalk- and-bud flaps 16 in the proximal zone 13 are configured such that the free ends are proximal to the fixed ends and the pointed flaps in the distal zone 14 are configured such that the free ends are distal to the fixed ends.

[0162] FIG. 9 is a planar view of a pointed flap 16 of an expanded expandable metallic implant or stent with a linear hinge region 17 at the base of the flap, wherein the flap is within a square flap window 18.

[0163] FIG. 10A is a perspective view of an example of an expanded expandable metallic implant or stent 10 having a middle zone 12, proximal zone 13, and distal zone 14 with its overall geometric dimensions defined. The proximal zone 13 and the distal zone 14 of these expanded expandable metallic implant or stents 10 comprise a fixation region 15 with pointedAUROM.002WO PCT internal flaps 16 wherein the pointed internal flaps 16 are not at the proximal and distal ends. The pointed internal flaps 16 in the proximal zone 13 can be configured such that the free ends are proximal to the fixed ends and the pointed internal flaps in the distal zone 14 can be configured such that the free ends are distal to the fixed ends.

[0164] FIG. 10B is a perspective view of an example of an expanded expandable metallic implant or stent 10 having a middle zone 12 and a proximal zone 13, with its overall geometric dimensions defined. The proximal zone 13 of this expanded expandable metallic implant or stent 10 can include a fixation region 15 with pointed internal flaps 16 wherein the pointed internal flaps 16 are not at the proximal end. The pointed internal flaps 16 in the proximal zone 13 can be configured such that the free ends are proximal to the fixed ends.

[0165] FIG. 10C is a perspective view of an example of an expanded expandable metallic implant or stent 10 having a middle zone 12 and a distal zone 14, with its overall geometric dimensions defined. The distal zone 14 of this expanded expandable metallic implant or stent 10 can include a fixation region 15 with pointed internal flaps 16 wherein the pointed internal flaps 16 are not at the distal end. The pointed internal flaps 16 in the distal zone 14 can be configured such that the free ends are distal to the fixed ends.

[0166] FIG. 10D is a perspective view of an example of an expanded expandable metallic implant or stent 10 having a middle zone 12, with its overall geometric dimensions defined. The middle zone 12 of this expanded expandable metallic implant or stent 10 can include a fixation region 15 with pointed internal flaps 16. The pointed internal flaps 16 in the distal zone 14 can be configured such that the free ends are proximal to the fixed ends.

[0167] FIG. 10D is a perspective view of an example of an expanded expandable metallic implant or stent 10 having a middle zone 12, with its overall geometric dimensions defined. The middle zone 12 of this expanded expandable metallic implant or stent 10 can include a fixation region 15 with pointed internal flaps 16. The pointed internal flaps 16 in the distal zone 14 can be configured such that the free ends are distal to the fixed ends.

[0168] FIGS. 10E and 10F are perspective views of an example of an expanded expandable metallic implant or stent 10 having a middle zone 12, with its overall geometric dimensions defined. The middle zone 12 of this expanded expandable metallic implant or stent 10 can include a fixation region 15 with pointed internal flaps 16. Some of the pointed internal flaps 16 in the distal zone 14 can be configured such that the free ends are distal to the fixed endsAUROM.002WO PCT and some of the pointed internal flaps 16 in the distal zone 14 can be configured such that the free ends are proximal to the fixed ends.

[0169] In some examples, overinflating the balloon 110 can cause the over-inflated balloon 110 to protrude through the flap window 18 and cause one or more flaps 16 to protrude radially outward, as shown in FIG. 6C.

[0170] FIG. 11A is a planar view of a pointed flap 16 of an expanded expandable metallic implant or stent 10 with a square flap window 18. FIG. 1 IB is a planar view of a pointed flap 16 of an expanded expandable metallic implant or stent 10 with a rectangular flap window 18 that is wider than tall. FIG. 11C is a planar view of a pointed flap 16 of an expanded expandable metallic implant or stent 10 with a rectangular flap window 18 that is taller than wide. FIG. 1 ID is a planar view of a pointed flap 16 of an expanded expandable metallic implant or stent 10 with a rectangular flap window 18 that is taller than wide. FIG. 1 IE is a planar view of a pointed flap 16 of an expanded expandable metallic implant or stent 10 with a triangular flap window 18. The expandable metallic implant or stent 10 can include any combination of the flaps 16 and / or flap windows 24 shown in FIG. 11A-E. In some examples, the flap window 18 can be circular, ovoid, triangular, rectangular, pentagonal, hexagonal, and / or octagonal. In some examples, the pointed flap 16 can be triangular, diamond- shaped, pentagonal, hexagonal, and / or octagonal.

[0171] In some examples, at least a portion of the middle zone 12 of the expandable metallic implant or stent 10 can include fenestrations and struts so this portion can flex and bend in response to forces routinely encountered when the folded and pleated expandable metallic implant or stent device 1 is moving along a tortuous path, potentially improving deliverability of the folded and pleated expandable metallic implant or stent device 1. In some examples, the fenestrations are open. For some examples the fenestrations are closed. In some examples, the fenestrations and struts can be configured as independent ring structures that are connected to each other by connectors.

[0172] In some examples, the length of the elongate body 160 is between 20 - 200 cm. In some examples, the total length of the folded and pleated expandable metallic implant or stent device 1 is between 20.5 - 200.5 cm. In some examples, the outer diameter of the elongate body 160 is between 0.027 - 0.085 inch. In some examples, the internal or luminal diameter of the elongate body 160 is between 0.016 - 0.072 inch.AUROM.002WO PCT

[0173] In some examples, the wall 168 of the elongate body 160 is continuous from the proximal end to the distal end. In some examples, the elongate body 160 can include an outer layer 171 comprising polymer, an inner layer comprising polymer, and a middle layer comprising metal, wherein the middle layer is disposed between the outer layer 171 and the inner layer. In some examples, the inner layer, outer layer 171, or both the inner layer and outer layer 171 of the elongate body 160 can include polymer with successively decreasing durometer from the proximal to the distal end of the elongate body 160.

[0174] In some examples, a layer of the distal end of the elongate body 160 can include a material with a Shore durometer hardness of 20 - 60 D. In some examples, the distal portion of the elongate body 160 can include an aliphatic poly ether polyurethane or a polyether block amide. In some examples, the aliphatic polyether polyurethane is Tecoflex. In some examples, the middle portion of the elongate body 160 can include a polyether block amide or a nylon. In some examples, the polyether block amide is Pebax. In some examples, the range of the durometer of the polyether block amide is between Pebax 7233 and Pebax 2522 distally. In some examples, the proximal portion of the elongate body 160 can include a nylon. In some examples, the nylon is Grilamid. In some examples, a layer of the elongate body 160 can include polyimide or polytetrafluoroethylene.

[0175] In some examples, the inner layer of the wall 168 of the elongate body 160 can include a lubricious polymer. In some examples, the lubricious polymer can include polytetrafluoroethylene, polyimide, or a composite or mixture of polytetrafluoroethylene (PTFE) and polyimide. In some examples, a layer of the proximal end of the elongate body 160 can include a material with a Shore durometer hardness of 40 - 90 D. In some examples, the wall 168 of the elongate body 160 further can include a tie layer.

[0176] In some examples, the metal of the middle layer of the elongate body 160 is configured as wire. In some examples, the wire is configured in a spiral, coil, braid, woven, or straight pattern, or combinations thereof. In some examples, at least some of the metal in the middle layer of the elongate body 160 is configured as wire with a cross-sectional shape that is round, oval, square, or rectangular. In some examples, the wire can include nitinol or stainless steel. In some examples, the wire is round and has a diameter of between 0.0005 - 0.0030 inch. In some examples, the wire is configured in a coil with a pitch of between 0.0010 - 0.0060 inch. In some examples, the wire is flat and has a thickness of between 0.0005 - 0.0060 inch and aAUROM.002WO PCT width of between 0.001 - 0.030 inch. Tn some examples, the wire in the distal portion of the elongate body 160 is round, has a diameter of between 0.0005 - 0.0030 inch, and is configured in a coil pattern with a pitch of between 0.0010 - 0.0060 inch. In some examples, wherein the wire is configured in a braid, the braid has a picks per inch of length (PPI) of 50 - 300, In some examples, the metal of the middle layer of the elongate body 160 is configured as a laser cut hypotube. In some examples, the laser cut hypotube can include nitinol. In some examples, the metal or metal wire is absent from the distal portion of the elongate body 160.

[0177] For some examples of an expandable metallic implant or stent device 1, the wall 168 of the elongate body 160 can include one or more liquid crystal polymer fibers. For some examples of an expandable metallic implant or stent device 1, the one or more liquid crystal polymer fibers are oriented parallel to the first axis 38 of the elongate body 160. In some examples, the one or more liquid crystal polymer fibers are coiled around the elongate body 160.

[0178] In some examples, the polymer can include barium sulfate. In some examples, the polymer of a layer of the wall 168 of the elongate body 160 can include barium sulfate at a concentration of 10 - 30% to help visualize elongate body 160 and to visualize the separation of the expanded expandable metallic implant or stent 10 and the elongate body 160 during use during fluoroscopy, or to make it more radiopaque or conspicuous during fluoroscopy. In some examples, a marker band 134 that is radiopaque or conspicuous during fluoroscopy may be joined to the distal portion of the elongate body 160 and configured to help visualize the elongate body 160, to visualize the separation of the expanded expandable metallic implant or stent 10 and the balloon catheter 100 during use, or to make the elongate body 160 more radiopaque or conspicuous during fluoroscopy. In some examples, the radiopaque marker band 134 can include platinum, iridium, gold, silver, or alloys or combinations thereof.

[0179] In some examples, the elongate body 160 can include a lubricious or hydrophilic coating layer 172. In some examples, the lubricious or hydrophilic coating layer 172 is present on the outer surface, the inner (luminal) surface, or both the outer and inner surface of the elongate body 160. In some examples, the lubricious or hydrophilic coating layer 172 is present on the outer surface of the distal portion of the elongate body 160, on the outer surface of the middle and distal portion of the elongate body 160, or on the entire outer surface of the elongate body 160. In some examples, the lubricious coating layer 172 is present only on the distal portion of the elongate body 160 and is absent from the proximal portion of the elongate body 160.AUROM.002WO PCT

[0180] In some examples, the inner and outer diameter of the distal portion of the elongate body 160 of the expandable metallic implant or stent device 1 is larger than the inner and outer diameter of the proximal or middle portions of the elongate body 160 of the expandable metallic implant or stent device 1. In some examples, this larger diameter provides space in the first lumen 161 of the distal portion of the elongate body 160 for components that are involved in the attachment of the elongate body 160 to the proximal neck 117 of the balloon 110, components of the proximal neck assembly, or the neck bridging segment. In some examples, the inner and outer diameter of the distal portion of the elongate body 160 of the expandable metallic implant or stent device 1 is smaller than the inner and outer diameter of the proximal or middle portions of the elongate body 160 of the expandable metallic implant or stent device 1. In some examples, this smaller diameter provides space in the first lumen 161 of the distal portion of the elongate body 160 for components that are involved in the attachment of the elongate body 160 to the proximal neck 117 of the balloon 110, components of the proximal neck assembly, or the neck bridging segment. In some examples, the outer diameter of the distal portion of the elongate body 160 tapers from the larger diameter to the smaller diameter to reduce frictional forces when advancing or retracting the elongate body 160 in vivo. The proximal portion of the elongate body 160 adjacent to the first hub 164 may comprise a segment of polymer that provides strain relief to the junction between the first hub 164 and the elongate body 160.

[0181] In some examples, the elongate body 160 is straight or has no pre-formed shape or is straight or has no pre-formed shape when in an unconstrained configuration. In some examples, a portion of the elongate body 160 has a pre-formed shape or has a portion with a preformed shape when in an unconstrained configuration, including a distal portion. This preformed shape may assist operators in advancing an expandable metallic implant or stent device 1 in vivo by enabling the operator to turn the tip of the balloon catheter 100 of the expandable metallic implant or stent device 1 and to direct the tip of the balloon catheter 100 of the expandable metallic implant or stent device 1 toward various locations in vivo. In some examples, the distal portion of the elongate body 160, when in an unconstrained configuration, is angled or has an angled shape. In some examples, the angle is 10 - 70 degrees. In some examples, the outer diameter of the distal end of the elongate body 160 has a radius.AUROM.002WO PCT

[0182] The balloon 110 is joined to the distal region of the elongate body 160 and configured for pleating and folding or compression, inflation or expansion, and deflation or collapse. In some examples, the balloon 110 can include a proximal region 112, a distal region 114 generally opposite the proximal region 112, and an intermediate region 113 between the proximal region 112 and the distal region 114 configured, and a first axis 38 extending proximal to distal between the proximal region 112 and the distal region 114.

[0183] In some examples, the inflated balloon 110 is configured to have a maximum diameter of between 2 - 50 mm when measured parallel to the second axis 39. In some examples, the inflatable portion 111 of the inflated balloon 110 is configured to have a maximum length of between 3 - 100 mm when measured parallel to the first axis 38. The volume of the inflated balloon 110 may range between 0.005 mL to 65 mL. In some examples, the overall length of the inflated balloon 110 is equal to or greater than the overall length of the expanded expandable metallic implant or stent 10.

[0184] In some examples, the wall 135 of the balloon 110 can include a polyethylene terephthalate, a nylon, or a material comprising block copolymers made of rigid polyamide blocks and soft polyether blocks, including Pebax, and combinations thereof. In some examples, after expansion to the nominal diameter, the balloon 110 is compliant or semi-compliant. In some examples, after expansion to the nominal diameter, the balloon 110 is semi-compliant or compliant when the pressure inside the balloon 110 is in a range between 1 and 20 atmospheres. In some examples, after expansion to the nominal diameter, the diameter of the inflated balloon 110 increases 5 - 10%, 10 - 15%, 16 - 20%, 21 - 25%, 26 - 30%, 31 - 35%, 36 - 40%, 41 - 45%, or 46 - 50% when inflated to a pressure of 5 atmospheres. In some examples, after expansion to the nominal diameter, the diameter of the inflated balloon 110 increases 5 - 10%, 10 - 15%, 16 - 20%, 21 - 25%, 26 - 30%, 31 - 35%, 36 - 40%, 41 - 45%, or 46 - 50% when inflated to a pressure of 10 atmospheres. In some examples, after expansion to the nominal diameter, the diameter of the inflated balloon 110 increases 5 - 10%, 10 - 15%, 16 - 20%, 21 - 25%, 26 - 30%, 31 - 35%, 36 - 40%, 41 - 45%, or 46 - 50% when inflated to a pressure of 15 atmospheres. In some examples, after expansion to the nominal diameter, the diameter of the inflated balloon 110 increases 5 - 10%, 10 - 15%, 16 - 20%, 21 - 25%, 26 - 30%, 31 - 35%, 36 - 40%, 41 - 45%, or 46 - 50% when inflated to a pressure of 20 atmospheres. In some examples, the rated burst pressureAUROM.002WO PCT of the balloon 110 is between 1 - 50 atmospheres, in the range of 3 - 20 atmospheres, or in the range of 3 - 10 atmospheres.

[0185] In some examples, the wall 135 of the balloon 110 may have a thickness of 3 - 100 microns, 5 - 30 microns, or 3, 4, 5, 6, 7, 8, 9, 10, 10, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33. 34. 35, 36, 37, 38, 39 40. 41, 42, 43, 44, 45, 46, 47, 48, 49, or 50 microns. In some examples, the wall 135 of the balloon 110 can include a layer of polyethylene terephthalate with a thickness of 3 microns, 4 microns, 5 microns, 6 microns, 7 microns, 8 microns, 9 microns, 10 microns, 10 - 15 microns, or 16 - 20 microns.

[0186] In some examples, the wall 135 of the balloon 110 can include a single layer. For single layer examples of a balloon 110, the layer is a polymer layer. In some examples, the wall 135 of the balloon 110 can include two or more layers. For examples of a multiple layer balloon 110, one layer is a polymer layer, and the one or more additional layers may be a layer of polymer, metal, or adhesive.

[0187] In some examples, a balloon 110 can include a proximal neck 117 with a proximal neck opening 118 to enable fluid to pass from the elongate body 160 into the interior space 115 of the balloon 110. In some examples, the proximal neck 117 extends away from the interior space 115 of the balloon 110. In some examples, the proximal neck 117 extends into the interior space 115 of the balloon 110. The length of proximal neck 117 is between 1 mm and 20 mm, for example with a length between 2 mm and 5 mm. The proximal neck opening 118 has a diameter between 0.5 mm and 5 mm. The thickness of the wall of the proximal neck 117 may be thicker, the same as the thickness, or thinner than the wall 135 of the inflatable portion 111 of the balloon 110. In some examples, wall of the proximal neck 117 may have a thickness between 3 - 2000 microns. In some examples, at least a portion of the proximal neck 117 can include a layer of radiopaque metal that is visible under fluoroscopy, including a layer of platinum, iridium, gold, silver, or alloys or combinations thereof.

[0188] One or more ring structures, tubular structures, telescoping structures, tubular segments, catheter segments, telescoping catheter segments, or other structures may be joined to the proximal neck 117, forming a proximal neck assembly. These proximal neck ring structures, tubular structures, telescoping structures, tubular segments, catheter segments, telescoping catheter segments, or other structures may comprise metal, polymer and adhesive, and combinations thereof. These proximal neck ring structures, tubular structures, telescopingAUROM.002WO PCT structures, tubular segments, catheter segments, telescoping catheter segments, or other structures may comprise a radiopaque metal that is visible during fluoroscopy, including platinum, iridium, gold, silver, or alloys or combinations thereof. These proximal neck ring structures, tubular structures, telescoping structures, tubular segments, catheter segments, telescoping catheter segments, or other structures may comprise one piece, while in other examples they may comprise two or more pieces that are bonded together, including bonded together with a glue or adhesive. In some examples, a proximal neck joining structure 123 may be joined to the proximal neck 117 or proximal neck assembly of the balloon 110 and also joined to the elongate body 160, thereby forming a joining or sealing of the proximal neck 117 or proximal neck assembly and elongate body 160. In some examples, a distal neck joining structure may be joined to the distal neck 125 or distal neck assembly of the balloon 110 and also joined to the elongate body 160, thereby forming a joining or sealing of the distal neck 125 or distal neck assembly and elongate body 160.

[0189] The proximal neck assembly of a balloon 110 may comprise a structure, or a portion of a structure, joined to the proximal neck 117 of a balloon 110 that may be configured to provide a smooth transition from a portion of the expandable metallic implant or stent device 1 that has a larger outer diameter to a portion of the expandable metallic implant or stent device 1 that has a smaller outer diameter to reduce the risk of tissue injury or device damage when advancing or retracting the expandable metallic implant or stent device 1 in vivo, (a “proximal neck transitional structure”). In some examples, the outer diameter of the proximal portion of a proximal neck transitional structure is within 0.01 inch of the outer diameter of the adjacent portion of the distal elongate body 160 and the outer diameter of the distal portion of the proximal neck transitional structure is within 0.01 inch of the outer diameter of the folded and pleated balloon 110 or the folded and pleated expandable metallic implant or stent 10. In some examples, the outer diameter of the proximal portion of a proximal neck transitional structure is within 0.01 inch of the outer diameter of the proximal neck 117 or proximal neck assembly and the outer diameter of the distal portion of the proximal neck transitional structure is within 0.01 inch of the outer diameter of the folded and pleated balloon 110. In some examples, the proximal neck transitional structure may be conical in shape. In some examples, the proximal neck transitional structure may comprise a radiopaque metal that is visible during fluoroscopy, including platinum, iridium, gold, silver, or alloys or combinations thereof. In some examples,AUROM.002WO PCT the proximal neck transitional structure may comprise one or more polymers, including polyether ether ketone, polycarbonate, nylon, polyimide, polyethylene terephthalate, polytetrafluoroethylene, silicone, polyurethane, co-polyester polymer, thermoplastic rubber, silicone-polycarbonate copolymer, polyethylene ethyl- vinyl-acetate (PEVA)co-polymer, a biocompatible elastomer, biocompatible resilient material, or a biocompatible adhesive. In some examples, a proximal neck transitional structure may comprise one piece, while in other examples, a proximal neck transitional structure may comprise two or more pieces that are bonded together, including bonded together with a glue or adhesive. In some examples, a proximal neck transitional structure is bonded to a proximal neck 117. In some examples, a proximal neck transitional structure is bonded to a portion of a proximal neck assembly. In some examples, a proximal neck transitional structure is bonded to the proximal neck 117 and the proximal neck assembly. In some examples, a portion of the inner surface of a proximal neck transitional structure is bonded to a portion of the outer surface of a proximal neck 117 or a portion of a proximal neck assembly.

[0190] In some examples, a balloon 110 can include a distal neck 125 with a distal neck opening. In some examples, the distal neck opening is closed or sealed. In some examples, the distal neck 125 extends away from the interior space 115 of the balloon 110 and In some examples, the distal neck 125 extends into the interior space 115 of the balloon 110. The length of distal neck 125 is between 1 mm and 20 mm, for example with a length between 2 mm and 5 mm. The distal neck opening has a diameter between 0.5 mm and 5 mm. The thickness of the wall of the distal neck 125 may be thicker, the same as the thickness, or thinner than the wall 135 of the inflatable portion 111 of the balloon 110. In some examples, wall of the distal neck 125 may have a thickness between 3 - 2000 microns. In some examples, at least a portion of the distal neck 125 can include a layer of radiopaque metal that is visible under fluoroscopy, including a layer of platinum, iridium, gold, silver, or alloys or combinations thereof.

[0191] One or more ring structures, tubular structures, telescoping structures, tubular segments, catheter segments, telescoping catheter segments, or other structures may be joined to the distal neck 125, forming a distal neck assembly. These distal neck ring structures, tubular structures, telescoping structures, tubular segments, catheter segments, telescoping catheter segments, or other structures may comprise metal, polymer and adhesive, and combinations thereof. These distal neck ring structures, tubular structures, telescoping structures, tubularAUROM.002WO PCT segments, catheter segments, telescoping catheter segments, or other structures may comprise a radiopaque metal that is visible during fluoroscopy, including platinum, iridium, gold, silver, or alloys or combinations thereof. These distal neck ring structures, tubular structures, telescoping structures, tubular segments, catheter segments, telescoping catheter segments, or other structures may comprise one piece, while in other examples they may comprise two or more pieces that are bonded together, including bonded together with a glue or adhesive. In some examples, a distal neck joining structure may be joined to the distal neck 125 or distal neck assembly of the balloon 110 and also joined to the elongate body 160, thereby forming a joining or sealing of the distal neck 125 or distal neck assembly and elongate body 160. In some examples, a distal neck joining structure may be joined to the distal neck 125 or distal neck assembly of the balloon 110 and also joined to the elongate body 160, thereby forming a joining or sealing of the distal neck 125 or distal neck assembly and elongate body 160.

[0192] The distal neck assembly of a balloon 110 may comprise a structure, or a portion of a structure, joined to the distal neck 125 of a balloon 110 that may be configured to provide a smooth transition from a portion of the expandable metallic implant or stent device 1 that has a larger outer diameter to a portion of the expandable metallic implant or stent device 1 that has a smaller outer diameter to reduce the risk of tissue injury or device damage when advancing or retracting the expandable metallic implant or stent device 1 in vivo, (a “distal neck transitional structure”). In some examples, the outer diameter of the distal portion of a distal neck transitional structure is within 0.01 inch of the outer diameter of the adjacent portion of the elongate body 160 and the outer diameter of the proximal portion of the distal neck transitional structure is within 0.01 inch of the outer diameter of the folded and pleated balloon 110 or the folded and pleated expandable metallic implant or stent 10. In some examples, the outer diameter of the distal portion of a distal neck transitional structure is within 0.01 inch of the outer diameter of the distal neck 125 or distal neck assembly and the outer diameter of the proximal portion of the distal neck transitional structure is within 0.01 inch of the outer diameter of the folded and pleated balloon 110. In some examples, the distal neck transitional structure may be conical in shape. In some examples, the distal neck transitional structure may comprise a radiopaque metal that is visible during fluoroscopy, including platinum, iridium, gold, silver, or alloys or combinations thereof. In some examples, the distal neck transitional structure may comprise one or more polymers, including polyether ether ketone, polycarbonate, nylon, polyimide,AUROM.002WO PCT polyethylene terephthalate, polytetrafluoroethylene, silicone, polyurethane, co-polyester polymer, thermoplastic rubber, silicone-polycarbonate copolymer, polyethylene ethyl-vinyl- acetate (PEVA)co-polymer, a biocompatible elastomer, biocompatible resilient material, or a biocompatible adhesive. In some examples, a distal neck transitional structure may comprise one piece, while in other examples, a distal neck transitional structure may comprise two or more pieces that are bonded together, including bonded together with a glue or adhesive. In some examples, a distal neck transitional structure is bonded to a distal neck 125. In some examples, a distal neck transitional structure is bonded to a portion of a distal neck assembly. In some examples, a distal neck transitional structure is bonded to the distal neck 125 and the distal neck assembly. In some examples, a portion of the inner surface of a distal neck transitional structure is bonded to a portion of the outer surface of a distal neck 125 or a portion of a distal neck assembly.

[0193] The elongate body 160 may be joined or bonded to the inflatable portion 111 of the balloon 110, or to the proximal neck 117 and / or the distal neck 125 of the balloon 110. In another example, the elongate body 160 may be joined or bonded to one or more components of a proximal neck assembly and / or a distal neck assembly which are then joined or bonded to the balloon 110. In another example, the elongate body 160 may be joined or bonded to a neck bridging segment which is joined or bonded to the balloon 110 or may be joined or bonded to a proximal neck joining structure 123 and / or distal neck joining structure which is joined or bonded to the balloon 110, or combinations of joining or bonding thereof. In some examples, the balloon 110 can include a proximal region 112, a distal region 114 generally opposite the proximal region 112, and an intermediate region 113 between the proximal 112 and distal region 114, and a first axis 38 extending proximal to distal between the proximal region 112 and the distal region 114.

[0194] In some examples, the balloon catheter 100 can include a marker band 134 that is radiopaque or conspicuous during fluoroscopy configured for visualizing the tip region of the balloon catheter 100 during fluoroscopy, for visualizing the separation of the balloon 110 or balloon catheter 100 from the expanded expandable metallic implant or stent 10, or to make the balloon catheter 100 more radiopaque or conspicuous during fluoroscopy during use. In some examples, the balloon catheter 100 can include two marker bands 166 that are radiopaque or conspicuous during fluoroscopy configured for visualizing the proximal 112 and distal 114AUROM.002WO PCT regions of the balloon 1 10 during fluoroscopy, for visualizing the location of the balloon 110, for visualizing the separation of the balloon 110 or balloon catheter 100 from the expanded expandable metallic implant or stent 10, or to make the balloon catheter 100 more radiopaque or conspicuous during fluoroscopy during use during use. In some examples, the balloon catheter 100 can include a marker band 134 that is radiopaque or conspicuous during fluoroscopy configured for visualizing the tip region of the balloon catheter 100 during fluoroscopy and two marker bands 166 that are radiopaque or conspicuous during fluoroscopy configured for visualizing the proximal 112 and distal 114 regions of the balloon 110 during fluoroscopy. In some examples, a marker band 134 may be joined to the proximal neck 117 or proximal neck assembly of the balloon 110. In some examples, a marker band 134 may be joined to a distal neck 125 or distal neck assembly of the balloon 110.

[0195] For some examples of a one-lumen balloon catheter 101, the elongate body 160 has a first lumen 161 configured to convey fluid and assist in the dilation of a folded and pleated balloon 110, including by assisting in the conveyance of fluid from the first hub 164 to the interior space 115 of the balloon 110; and is also configured to accept a guidewire configured for use with an expandable metallic implant or stent device 1. For some examples of an expandable metallic implant or stent device with a one-lumen balloon catheter 101, a fluid can be injected into the first hub 164, through the first lumen 161 of the elongate body 160, and into the interior space 115 of the folded and pleated balloon 110 resulting in expansion of the folded and pleated balloon 110 and expandable metallic implant or stent device 10. For some examples of an expandable metallic implant or stent device with a two-lumen balloon catheter 102, a fluid can be injected into the second hub 165, through the second lumen 162 of the elongate body 160, and into the interior space 115 of the folded and pleated balloon 110 resulting in expansion of the folded and pleated balloon 110 and expandable metallic implant or stent device 10. When fluid enters the interior space 115 of a folded and pleated balloon 110 under pressure (and the folded and pleated balloon 110 and folded and pleated expandable metallic implant or stent 10 are not constrained by external forces) the folded and pleated balloon 110 can expand, which results in the expansion of the folded and pleated expandable metallic implant or stent 10. Folded and pleated expandable metallic implant or stents 10 can expand by an unfolding of the folded and pleated portion of the expandable metallic implant or stent 10.AUROM.002WO PCT

[0196] For some examples of an expandable metallic implant or stent device with a one- lumen balloon catheter 101, the first lumen 161 of the elongate body 160 extends from the first hub 164 to the distal end of the elongate body 160 and is configured to enable the passage of fluid from the first hub 164, through the first lumen 161 of the elongate body, (optionally through a joining region comprising a proximal neck 117, proximal neck assembly, neck bridging segment, or proximal neck joining structure 123, or combination thereof), and into the interior space 115 of the balloon 110 to enable inflation and deflation of the balloon 110. For some examples of a one-lumen balloon catheter 101, the elongate body 160 has a proximal end that is joined to a first hub 164 a distal portion configured for joining or fluidly coupling to the proximal neck 117, proximal neck assembly, distal neck 125, and / or distal neck assembly, of the balloon 110, or to a neck bridging segment. For some examples of a one-lumen balloon catheter 101, a balloon catheter 100 is configured so that a fluid communication can be made between the first hub 164 of the elongate body 160, the first lumen 161 of the elongate body 160, and the interior space 115 of the balloon 110.

[0197] As shown in FIG. 1A, for some examples of a one-lumen balloon catheter 101, the first hub 164 can be joined or bonded to the proximal end of the elongate body 160 of a one- lumen balloon catheter 101 and configured to couple with a syringe, inflation device, or other fluid source. The first hub 164 can be configured to couple with a first lumen 161 of elongate body 160 to allow for the passage of fluid to a balloon 110 and to allow for the passage of a guidewire 280 through the first lumen 161. The first hub 164 can be joined or bonded to the proximal end of the elongate body 160 and configured to couple with a syringe, inflation device, or other fluid source. The first hub 164 can be configured to couple with a first lumen 161 of elongate body 160 to allow for the passage of fluid to a balloon 110 and to allow for the passage of a guidewire 280 through the first lumen 161.

[0198] For some examples of a two-lumen balloon catheter 102, the elongate body 160 has a first lumen 161 configured to accept a guidewire configured for use with an expandable metallic implant or stent device 1 and a second lumen 162 configured to convey fluid and assist in the dilation of a folded and pleated balloon 110, including by assisting in the conveyance of fluid from a second hub 165 to the interior space 115 of the balloon 110. As shown in FIG. IB, for some examples of a two-lumen balloon catheter 102, the first hub 164 can be joined or bonded to the proximal end of the elongate body 160 of a one-lumen balloon catheter 101 andAUROM.002WO PCT configured to allow for the passage of a guidewire 280 through the first lumen 161 , and the first hub 164 can be joined or bonded to the proximal end of the elongate body 160 and configured to couple with a syringe other fluid source; and the second hub 165 can be joined or bonded to the proximal end of the elongate body 160 of a two-lumen balloon catheter 102 and configured to couple with a syringe, inflation device, or other fluid source and allow for the passage of fluid to a balloon 110 through a second lumen 162.

[0199] For some examples of an expandable metallic implant or stent device with a two- lumen balloon catheter 102, the second lumen 162 of the elongate body 160 extends from the second hub 165 to the distal end of the elongate body 160 and is configured to enable the passage of fluid from the second hub 165, through the second lumen 162 of the elongate body, (optionally through a joining region comprising a proximal neck 117, proximal neck assembly, neck bridging segment, or proximal neck joining structure 123, or combination thereof), and into the interior space 115 of the balloon 110 to enable inflation and deflation of the balloon 110. For some examples of a two-lumen balloon catheter 102, the elongate body 160 has a proximal portion that is joined to a first hub 164 and a second hub 165. For some examples of a two-lumen balloon catheter 102, the elongate body 160 has a distal portion configured for joining to the proximal neck 117, proximal neck assembly, distal neck 125, distal neck assembly, and / or distal neck joining structure of the balloon 110, or to a neck bridging segment, and configured to provide a fluid connection between the second hub 165, the second lumen 162 and the interior space 115 of the balloon 110.

[0200] FIG. 13A-I show views of an example of an expandable metallic implant or stent device 1 with a one-lumen balloon catheter 101 wherein the balloon 110 and the expandable metallic implant or stent 10 are folded and pleated together, with a FIG. 13A showing a perspective view and FIGS. 13B-I showing cross sectional views. The individual cross sections are not shown equivalent in scale and correspond to the section locations shown in FIG. 13 A.

[0201] FIG. 14A-J show views of an example of an expandable metallic implant or stent device 1 with a two-lumen balloon catheter 102 wherein the balloon 110 and the expandable metallic implant or stent 10 are folded and pleated together, with a FIG. 14A showing a perspective view and FIGS. 14B-J showing cross sectional views. The individual cross sections are not shown equivalent in scale and correspond to the section locations shown in FIG. 14A.AUROM.002WO PCT

[0202] A folded and pleated expandable metallic implant or stent device 1 is disclosed herein, where the flexibility and deliverability of the device is optimized. As a general approach, in order to optimize the flexibility and deliverability of the distal portion of a folded and pleated expandable metallic implant or stent device 1, the rigid segments are optimized for short length and the flexible segments are optimized for flexibility. The rigid segments of the distal portion of the folded and pleated expandable metallic implant or stent device 1 may include the folded and pleated expandable metallic implant or stent 10. The flexible segments of the distal portion of the folded and pleated expandable metallic implant or stent device 1 may include the elongate body 160, the proximal portion of the folded and pleated balloon 110 that is not covered by the folded and pleated expandable metallic implant or stent 10, and the distal portion of the folded and pleated balloon 110 that is not covered by the folded and pleated expandable metallic implant or stent 10.

[0203] Starting from the elongate body 160 and progressing distally, the following optimizations can be made to optimize the flexibility and deliverability of the folded and pleated expandable metallic implant or stent device 1. In some examples, the elongate body 160 is optimized for flexibility to enable bending, especially the distal portion and the junction between the elongate body 160 and the proximal neck 117 or proximal neck assembly, or neck bridging segment of the balloon 110, and potentially improving deliverability of the folded and pleated expandable metallic implant or stent device 1. Optimizing the flexibility of the distal portion of the elongate body 160 could include forming the distal portion of the elongate body 160 with a flexible polymer and providing a flexible metal middle layer of the elongate body 160 in this region, including in the form of a nitinol coil or braid, or a laser cut nitinol hypotube.

[0204] In some examples, the length of the proximal neck 117 of the balloon 110 is optimized for a short length, thereby reducing the overall length of this rigid segment, while still enabling a secure attachment to the balloon 110 and the elongate body 160, potentially improving deliverability of the folded and pleated expandable metallic implant or stent device 1.

[0205] In some examples, a flexible material is chosen to form the wall 135 of the balloon 110 to increase the flexibility of the folded and pleated balloon 110 and the folded and pleated expandable metallic implant or stent device 1. In some examples, a flexible material is chosen to form the wall of the neck bridging segment to increase the flexibility of the folded and pleated balloon 110 and the folded and pleated expandable metallic implant or stent device 1.AUROM.002WO PCT

[0206] The length of the folded and pleated expandable metallic implant or stent 10 is optimized for a short length, thereby reducing the overall length of this rigid portion of the folded and pleated expandable metallic implant or stent device 1. The length of the proximal zone 13 (if any), middle zone 12, and distal zone 14 can be individually and collectively optimized for the shortest possible length that still provides an effective obstruction or reduction of flow through blood vessel lacerations and ruptures and arteriovenous fistulas, through discontinuities in endoprostheses or gaps between one endoprosthesis and another endoprosthesis or between an endoprosthesis and adjacent tissue, and for obstruction or reduction of flow into aneurysms, pseudoaneurysms, or other blood-containing, fluid-containing, or biological spaces, potentially improving deliverability of the folded and pleated expandable metallic implant or stent device 1.

[0207] In some examples, the expandable metallic implant or stent 10 is comprised of a structural metal layer 27 with radial gaps or discontinuities 53 that separate the structural metal layer 27 into two or more structural metal layer 27 segments and one or more structural metal bridge segments 51 connecting structural metal layer 27 segments such that the overall stiffness of the expandable metallic implant or stent 10 is decreased and the radial gaps or discontinuities 53 provide a flexible “hinge” region, including when the expandable metallic implant 10 is folded and pleated with a balloon 110 and improve device flexibility in vivo when advanced through the body to a target vessel segment along a tortuous path, including during device advancement and retraction. In some examples, these structural metal bridge segments 51 are narrow or thin and capable of bending in response to forces routinely encountered when the folded and pleated expandable metallic implant or stent device 2 is moving along a tortuous path, thereby providing a hinge-like region, and improving deliverability of the folded and pleated expandable metallic implant or stent device 2. Radial gaps or discontinuities 53 in the structural metal layer 27 can also allow the expanded expandable metallic implant or stent 10 to better align with a tortuous target vessel segment in vivo after implantation and during movement of the patient or target vessel segment, including when the expandable metallic implant or stent 10 is expanded and implanted in the target vessel segment. As shown in the example in FIG. 23, FIG. 24, FIG. 26B, and FIG. 26C, the gaps in the structural metal layer 27 can be in the middle zone 12. This example shows three segments, but any number of segments is contemplated.AUROM.002WO PCT

[0208] For some examples of an expandable metallic implant or stent 10, some or all of the structural metal layer 27 is joined to a flexible polymer layer 29. For some examples the flexible polymer layer 29 is continuous and in other examples, the flexible polymer layer 29 is discontinuous. For some examples there is a flexible polymer layer 29 internal to the structural metal layer 27 and in other examples there is a flexible polymer layer 29 external to the structural metal layer 27.

[0209] As shown in the example in FIGS. 23 A and B, the expandable metallic implant or stent 10 can be comprised of a structural metal layer 27 deposited on a flexible polymer 29 layer such that the structural metal layer 27 is radially outside the flexible polymer layer 29. The structural metal layer 27 can include radial gaps or discontinuities 53 such that the overall stiffness of the expandable metallic implant or stent 10 is decreased and these gaps can provide a flexible “hinge” region when the expandable metallic implant or stent 10 is folded and pleated with a balloon 110 and improve device flexibility in vivo when advanced through the body to a target vessel segment along a tortuous path, including during device advancement and retraction. The radial gaps or discontinuities 53 in the structural metal layer 27 can also allow the expanded expandable metallic implant or stent 10 to better align with a tortuous target vessel segment in vivo after implantation and during movement of the patient or target vessel segment. As shown in the example in FIGS. 23 A and B, the gaps in the structural metal layer 27 can be in the middle zone 12. This example shows three segments but any number of segments is contemplated.

[0210] As shown in the example in FIG. 24A, the expandable metallic implant or stent 10 can be comprised of a structural metal layer 27 deposited on a flexible polymer 29 layer such that the structural metal layer 27 is radially outside the flexible polymer layer 29. The structural metal layer 27 can include radial gaps or discontinuities 53 such that the overall stiffness of the implant is decreased and these gaps can provide a flexible “hinge” region when the expandable metallic implant or stent 10 is folded and pleated with a balloon 110 and improve device flexibility in vivo when advanced through the body to a target vessel segment along a tortuous path, including during device advancement and retraction. The radial gaps or discontinuities 53 in the structural metal layer 27 can also allow the expanded expandable metallic implant 10 or stent to better align with a tortuous target vessel segment in vivo after implantation and during movement of the patient or target vessel segment. As shown in the example in FIG. 24A, the radial gaps or discontinuities 53 can be bridged by at least one functional metal bridge segmentAUROM.002WO PCT56 so that the individual metal layer segments are electrically connected while the function of the flexible “hinge” regions are maintained. These functional metal bridge segments 56 can be colinear, offset, or diametrically offset, or any combination thereof if multiple functional metal bridge segments 56 are used.

[0211] As shown in the example in FIG. 24B, the expandable metallic implant or stent 10 can be comprised of a structural metal layer 27 and a flexible polymer 29 layer such that the structural metal layer 27 is radially outside the flexible polymer layer 29 and the structural metal layer 27 has a radial gap, slot or discontinuity 53 such that the overall stiffness of the expandable metallic implant or stent 10 is decreased and these gaps can provide a flexible “hinge” region when the expandable metallic implant or stent 10 is folded and pleated with a balloon 110 and improve device flexibility in vivo when advanced through the body to a target vessel segment along a tortuous path, including during device advancement and retraction. The radial gaps or discontinuities 53 in the structural metal layer 27 can also allow the expanded expandable metallic implant or stent 10 to better align with a tortuous target vessel segment in vivo after implantation and during movement of the patient or target vessel segment. As shown in the example in FIG. 24B, the radial gaps or discontinuities 53 can be bridged by at least one structural metal strut 50 or structural metal bridge segment 56 so that the individual metal layer segments are connected for the transmission of force and the maintenance of hoop strength while the function of the flexible “hinge” regions is somewhat maintained. These structural metal struts 50 or structural metal bridge segments 56 can be colinear, offset, or diametrically offset, or any combination thereof. In some examples, the struts 50 or structural metal bridge segments 51 are narrow or thin so as to minimize the reduction in flexibility of segmented example expandable metallic implants or stents 10. In some examples, the structural metal layer 27 of the expandable metallic implant or stent 10 is radially outside the flexible polymer layer 29 and in other examples, the flexible polymer 29 layer is radially outside the structural metal layer 27.

[0212] Target vessel segments are variable in diameter. For some examples of expandable metallic implants or stents 10, the lumen or hollow region 11 of the expandable metallic implant or stent 10 can be expanded to a first expanded diameter by inflation of the balloon 110 of the balloon catheter 100 and then subsequently expanded to a second larger diameter by additional inflation of the balloon 110 of the balloon catheter 100. The ability of anAUROM.002WO PCT individual expandable metallic implant or stent 10 to expand to a range of diameters enables the expandable metallic implant or stent 10 to fit a wider range of target vessel segment diameters.

[0213] For some examples of expandable metallic implants or stents 10 wherein the lumen or hollow region 11 of the expandable metallic implant or stent 10 can be expanded to a first expanded diameter by inflation of the balloon 110 of the balloon catheter 100 and then subsequently expanded to a second larger diameter by additional inflation of the balloon 110 of the balloon catheter 100, the structural metal layer 27 of the expandable metallic implant or stent 10 comprises a longitudinal gap, slot or discontinuity 54. These examples are herein referred to as a “slotted, variable size” expandable metallic implants or stents 48. For these examples, the slotted, variable size, expandable metallic implant or stent 48 is folded and pleated with the balloon 110 of a balloon catheter 110 in a conventional pleating and folding operation. After delivery to a target vessel segment, the lumen or hollow region 11 of such slotted, variable size, expandable metallic implant or stent 48 can be increased by balloon 110 inflation to a first expanded diameter, wherein the folds and pleats of the are slotted, variable size, expandable metallic implant or stent 48 are partially or completely straightened, unfolded, or unpleated and the lumen or hollow region 11 of the slotted, variable size, expandable implant or stent 48 becomes circular or substantially circular in cross-section. If desired, the diameter of the lumen or hollow region 11 of the slotted, variable size, expandable metallic implant or stent 48 can be further increased by additional balloon 110 inflation to a second, larger diameter wherein the longitudinal gap, slot or discontinuity 54 widens. In some examples, a slotted, variable size, expandable metallic implant or stent 48 may have 1, 2, 3, or more longitudinal gaps or discontinuities 54 per slotted, variable size, expandable implant or stent 48.

[0214] For some examples of slotted, variable size, expandable metallic implants or stents 48 wherein the lumen or hollow region 11 of the slotted, variable size, expandable metallic implant or stent 48 can be expanded to a first expanded diameter by inflation of the balloon 110 of the balloon catheter 100 and then subsequently expanded to a second larger diameter by additional inflation of the balloon 110 of the balloon catheter 100, the slotted, variable size, expandable metallic implant or stent 48 comprises an outer structural metal layer 27 with a longitudinal gap, slot or discontinuity 54, and an inner polymer layer 29, as shown in FIG. 26 A- C. In the unexpanded configuration in which the outer metal layer and the inner polymer layer are pleated and folded together with a balloon 110. For some examples, only the structural metalAUROM.002WO PCT layer 27 comprises a longitudinal gap, slot or discontinuity 54 while polymer layer is continuous. For some examples, the edges of the longitudinal gap, slot or discontinuity 54 are be bridged or connected by strut elements 50 or structural metal bridge segments 51 of various configurations, as shown in FIGS. 26A - C. After delivery to a target vessel segment, the lumen or hollow region 11 of such slotted, variable size, expandable metallic implant or stent 48 can be increased by balloon 110 inflation to a first expanded diameter, wherein the folds and pleats of the are slotted, variable size, expandable metallic implant or stent 48 are partially or completely straightened, unfolded, or unpleated and the lumen or hollow region 11 of the slotted, variable size, expandable implant or stent 48 becomes circular or substantially circular in cross-section and the portions of the structural metal layer 27 on either side of the longitudinal gap, slot or discontinuity 54 remain in proximity, as that the slotted, variable size, expandable metallic implant or stent 48 expands to a first expanded diameter. If desired, the diameter of the lumen or hollow region 11 of the slotted, variable size, expandable metallic implant or stent 48 can be further increased by additional balloon 110 inflation to a second, larger diameter wherein the portions of the structural metal layer 27 on both sides of the longitudinal gap, slot or discontinuity 54 move apart and the polymer layer 29 stretches as the slotted, variable size, expandable metallic implant or stent 48 expands to a second expanded diameter that is larger than the first expanded diameter. In this way, longitudinal gaps or discontinuities 54 allow an operator to change the expanded diameter of the slotted, variable size, expandable metallic implant or stent 48 based on the diameter of the target vessel segment while the polymer layer 27 maintains a continuous surface to obstruct blood flow.

[0215] For some examples of slotted, variable size, expandable metallic implants or stents 48 wherein the lumen or hollow region 11 of the slotted, variable size, expandable metallic implant or stent 48 can be expanded to a first expanded diameter by inflation of the balloon 110 of the balloon catheter 100 and then subsequently expanded to a second larger diameter by additional inflation of the balloon 110 of the balloon catheter 100, the slotted, variable size, expandable metallic implant or stent 48 comprises an outer structural metal layer 27 and an inner structural metal layer 27 nested or telescoped therewithin but not joined or bonded, wherein both layers comprise a longitudinal gap, slot or discontinuity 54; and the two structural metal layers 27 are pleated and folded together with a balloon 110 of a balloon catheter 100. In some examples, the outer structural metal layer 27 comprises a longitudinal gap, slot or discontinuityAUROM.002WO PCT54 that does not overlap with the longitudinal gap, slot or discontinuity 54 of the inner structural metal layer 27 when the slotted, variable size, expandable metallic implant or stent 48 is expanded such that the solid regions of the outer structural metal layer 27 cover the longitudinal gap, slot or discontinuity 54 of the inner structural metal layer 27 and the solid regions of the inner structural metal layer 27 cover the longitudinal gap, slot or discontinuity 54 of the outer structural metal layer 27, thereby providing more complete coverage of the surface of the lumen of the target vessel segment after implantation of the slotted, variable size, expandable metallic implant or stent 48. For some examples the longitudinal gap. slot or discontinuity 54 of the outer structural metal layer 27 and the longitudinal gap, slot or discontinuity 54 of the structural inner metal layer 27 are offset, including examples wherein they are offset by 33, 45, 90, or 180 degrees. Such slotted, variable size, expandable metallic implants or stents 48 can folded and pleated with the balloon 110 of a balloon catheter 100 in a conventional pleating and folding operation wherein the outer structural metal layer 27 and the inner structural metal layer 27 are both folded and pleated together with the balloon 110. After delivery to a target vessel segment the lumen or hollow region 11 of such slotted, variable size, expandable metallic implant or stent 48, the lumen or hollow region 11 can be increased by inflation of the balloon 110 to a first expanded diameter, wherein the folds and pleats of the both the outer structural metal layer 27 and the inner structural metal layer 27 of the slotted, variable size, expandable metallic implant or stent 48 are partially or completely straightened, unfolded, or unpleated and the lumen or hollow region 11 of the slotted, variable size, expandable implant or stent 48 becomes circular or substantially circular in cross-section. If desired, the diameter of the lumen or hollow region 11 of the slotted, variable size, expandable metallic implant or stent 48 can be further increased by additional inflation of the balloon 110 to a second, larger diameter, wherein the walls of the nested or telescoped outer structural metal layer 27 and inner structural metal layer 27 slide past each other as their longitudinal gaps or discontinuities 54 widen and the lumen or hollow region 11 of the slotted, variable size, expandable metallic implant or stent 48 becomes larger by radial expansion. In this way, the overlapping structure of the outer structural metal layer 27 and the inner structural metal layer 27 with the longitudinal gaps or discontinuities 54 can allow for the operator to change the expanded diameter of the slotted, variable size, expandable metallic implant or stent 48 (and the lumen or hollow region 11) to better match the diameter of the target vessel segment, while maintaining a solid surface to cover the luminal surface of the target vesselAUROM.002WO PCT segment or obstruct blood flow. For some examples of slotted, variable size, expandable metallic implants or stents 48 wherein the lumen or hollow region 11 of the slotted, variable size, expandable metallic implant or stent 48 can be expanded to a first expanded diameter by inflation of the balloon 110 of the balloon catheter 100 and then subsequently expanded to a second larger diameter by additional inflation of the balloon 110 of the balloon catheter 100, the structural metal layer 27 of the slotted, variable size, expandable metallic implant or stent 48 comprises a longitudinal gap, slot or discontinuity 54 with structural metal bridge segments 51 or strut 50 elements designed to provide a continuous structural metal layer 27 path across the longitudinal discontinuity to maintain electrical continuity during manufacturing, limit expansion of the slotted, variable size, expandable metallic implant or stent 48 during expansion, and transmit force and maintain hoop strength of the slotted, variable size, expandable metallic implant or stent 48 after expansion and implantation. When such slotted, variable size, expandable metallic implant or stent 48 is expanded to a second expanded diameter, the shape of the structural metal bridge segments 51 or strut 50 elements are straightened and elongated in the circumferential direction, and the lumen or hollow region 11 of the slotted, variable size, expandable metallic implant or stent 48 becomes larger by radial expansion. In some examples, a slotted, variable size, expandable metallic implant or stent 48 with structural metal bridge segments 51 or strut 50 elements may have 1, 2, 3, or more longitudinal discontinuities per implant or stent and may have 1, 2, 3, or more structural metallic strut elements per discontinuity. FIG. 25A and 25B show two perspective views of an example of a slotted, variable size, expandable metallic implant or stent 48 showing the structural metal layer 27, a longitudinal gap, slot or discontinuity 54, and structural metal bridge segments 51 or strut 50 elements, as well as flaps 16 and wherein the lumen or hollow region 11 of the slotted, variable size, expandable metallic implant or stent 48 can be increased to a larger, second expanded diameter by additional balloon 110 inflation after an initial expansion for a first expanded diameter.

[0216] For some examples of slotted, variable size, expandable metallic implants or stents 48 wherein the lumen or hollow region 11 of the slotted, variable size, expandable metallic implant or stent 48 can be expanded to a first expanded diameter by inflation of the balloon 110 of the balloon catheter 100 and then subsequently expanded to a second larger diameter by additional inflation of the balloon 110 of the balloon catheter 100. the slotted, variable size, expandable metallic implant or stent 48 comprises a structural metal layer 27 and a flexible,AUROM.002WO PCT compliant, polymer layer 29 and the structural metal layer 27 of the slotted, variable size, expandable metallic implant or stent 48 comprises a longitudinal gap, slot or discontinuity 54 wherein the longitudinal gap, slot or discontinuity 54 is bridged by the polymer layer 29. In some examples, the polymer layer 29 is continuous and in other examples the flexible, compliant, polymer layer 29 is discontinuous. In some examples, a the longitudinal gap, slot or discontinuity 54 in the structural metal layer 27 is crossed by structural metal bridge segments 51 or strut 50 elements designed to provide a continuous structural metal layer 27 path across the longitudinal discontinuity to maintain electrical continuity during manufacturing, limit expansion of the slotted, variable size, expandable metallic implant or stent 48 during expansion, and transmit force and maintain hoop strength of the slotted, variable size, expandable metallic implant or stent 48 after expansion and implantation. When such slotted, variable size, expandable metallic implant or stent 48 is expanded to a second expanded diameter, the structural metal bridge segments 51 or strut 50 elements are straightened and elongated in the circumferential direction, the flexible, compliant, polymer layer 29 is stretched, and the lumen or hollow region 11 of the slotted, variable size, expandable metallic implant or stent 48 becomes larger by radial expansion. In various examples, the structural metal bridge segments 51 or strut 50 elements can be curved, zig-zag, sinusoidal, or bent in shape. In some examples, a slotted, variable size, expandable metallic implant or stent 48 with structural metal bridge segments 51 or strut 50 elements may have 1, 2, 3, or more longitudinal discontinuities per implant or stent and may have 1, 2, 3, or more structural metallic strut elements per discontinuity. FIG. 26A shows a perspective view of an example of a slotted, variable size, expandable metallic implant or stent 48 showing a structural metal layer 27, a flexible, compliant, polymer layer 29, flaps, a longitudinal gap, slot or discontinuity 54 in the structural metal layer 27 and curved, structural metal bridge segments 51 or strut 50 elements, wherein the curved, structural metal bridge segments 51 or strut 50 elements are straightened and elongated in the circumferential direction and the flexible, compliant, polymer layer 29 is stretched during balloon 110 inflation and implant expansion to the second expanded diameter. FIG. 26B shows a perspective views of an example of a slotted, variable size, expandable metallic implant or stent 48 showing a structural metal layer 27, a flexible, compliant, polymer layer 29, flaps 16, a longitudinal gap, slot or discontinuity 54 in the structural metal layer 27, and angled structural metal bridge segments 51 or strut 50 elements, wherein the angled, structural metal bridge segments 51 or strut 50 elementsAUROM.002WO PCT are straightened and elongated in the circumferential direction and the flexible, compliant, polymer layer 29 is stretched during balloon 110 inflation and implant expansion to the second expanded diameter when the longitudinal gap, slot or discontinuity 54 widens. The slotted, variable size, expandable metallic implant or stent 48 shown in FIG. 26B also comprises a structural metal layer 27 with a radial gap, slot or discontinuity 53 that separates the structural metal layer 27 into two structural metal layer 27 segments, bridged by the underlying flexible polymer layer 29 to provide a flexible “hinge” region to improve device flexibility in vivo when advanced through the body to a target vessel segment when the slotted, variable size, expandable metallic implant or stent 48 is folded and pleated with a balloon 110 and provides implant flexibility after expansion and detachment in vivo. FIG. 26C shows a perspective views of an example of a slotted, variable size, expandable metallic implant or stent 48 showing a structural metal layer 27, a flexible, compliant , compliant layer 29, flaps 16, a longitudinal gap, slot or discontinuity 54 in the structural metal layer 27, and diamond-shaped structural metal bridge segments 51 or strut 50 elements, wherein the diamond- shaped, structural metal bridge segments 51 or strut 50 elements are elongated circumferentially and foreshortened longitudinally, the longitudinal gap, slot or discontinuity 54 widens, the compliant, flexible polymer (inner) layer 29 is stretched, and the lumen or hollow region 11 of the slotted, variable size, expandable metallic implant or stent 48 becomes larger by radial expansion of the slotted, variable size, expandable metallic implant or stent 48. The slotted, variable size, expandable metallic implant or stent 48 shown in FIG. 26C also comprises a structural metal layer 27 with a radial gap, slot or discontinuity 53 that separates the structural metal layer 27 into two structural metal layer 27 segments, bridged by the underlying flexible polymer layer 29 to provide a flexible “hinge” region to improve device flexibility in vivo when advanced through the body to a target vessel segment when the slotted, variable size, expandable metallic implant or stent 48 is folded and pleated with a balloon 110 and provides implant flexibility after expansion and detachment in vivo. As shown in FIG. 26C, the diamond-shaped, structural metal bridge segments 51 or strut 50 elements of a slotted, variable size, expandable metallic implant or stent 48 can be joined together by additional curved structural metal layer 27 strut elements that can expand longitudinally as the diamond- shaped strut element foreshorten longitudinally during their circumferential expansion.AUROM.002WO PCT

[0217] As shown in FIG. 27A, for some examples of expandable metallic implants or stents 10 wherein the lumen or hollow region 11 of the expandable metallic implant or stent 10 can be expanded to a first expanded diameter by inflation of the balloon 110 of the balloon catheter 100 and then subsequently expanded to a second larger diameter by additional inflation of the balloon 110 of the balloon catheter 100, the structural metal layer 27 of the expandable metallic implant or stent 10 is arranged in discrete, ring-shaped metal layer segments of repeating diamond-shaped strut elements 50 joined to a compliant, flexible polymer layer 29. For some examples the compliant, flexible polymer layer 29 is continuous. For some examples the compliant, flexible polymer layer 29 is continuous and extends from the open proximal end to the open distal end of the fenestrated, variable size, expandable metallic implant or stent, including triangular flaps on both ends, if present. In other examples, the compliant, flexible polymer layer 29 is discontinuous. For some examples the compliant, flexible polymer layer 29 is internal to the structural metal layer 27 and in other examples the compliant, flexible polymer layer 29 is external to the structural metal layer 27. These examples are herein referred to as a “fenestrated, variable size” expandable metallic implants or stents 52. For these examples, the polymer-only gaps between the discrete and independent rings of diamond- shaped strut elements 50 provide flexibility for the fenestrated, variable size, expandable metallic implant or stent 52 both during delivery to a target vessel segment and also after implantation in the target vessel segment. For this example, the fenestrated, variable size, expandable metallic implant or stent 52 can be folded and pleated with the balloon portion of a balloon catheter in a conventional pleating and folding operation. After delivery to a target vessel segment, the lumen or hollow region 11 of such fenestrated, variable size, expandable metallic implant or stent 52 can be increased by balloon 110 inflation to a first expanded diameter, wherein the folds and pleats of the fenestrated, variable size, expandable metallic implant or stent 52 are partially or completely straightened, unfolded, or unpleated, and the lumen or hollow region 11 of the fenestrated, variable size, expandable implant or stent 52 becomes circular or substantially circular in crosssection. If desired, the diameter of the lumen or hollow region 11 of the fenestrated, variable size, expandable metallic implant or stent 52 can be further increased by additional balloon 110 inflation to a second, larger diameter, wherein the diamond-shaped strut elements 50 are elongated circumferentially and foreshortened longitudinally, the compliant, flexible polymer layer 29 is stretched, and the fenestrated, variable size, expandable metallic implant or stent 52AUROM.002WO PCT and the lumen or hollow region 1 1 of the fenestrated, variable size, expandable metallic implant or stent 52 becomes larger by radial expansion of the fenestrated, variable size, expandable metallic implant or stent 52. In other examples of a fenestrated, variable size, expandable metallic implant or stent 52, the structural metal layer 27 of the expandable metallic implant or stent 10 is arranged in discrete, ring-shaped metal layer segments of other repeating strut elements 50, such as zig-zag strut elements 50 joined to a compliant, flexible polymer layer 29, and other configurations of repeating strut elements 50. FIG. 27 shows a variation of fenestrated, variable size, expandable metallic implant or stent 52 with the structural metal (outer) layer arranged in discrete and independent rings of rounded diamond-shaped strut elements 50 wherein, when inflating the balloon 110 to a second expanded diameter, the rounded diamondshaped elements are circumferentially elongated and longitudinally foreshortened, and the diameter of the lumen or hollow region 11 of the fenestrated, variable size expandable metallic implant or stent is increased by radial expansion of the fenestrated, variable size, expandable metallic implant or stent 52. FIG. 28 shows progressively larger second expanded diameters from the smallest (FIG. 28A) to the largest (FIG. 28C) as the balloon 110 is inflated to progressively larger second expanded diameters.

[0218] For some examples of fenestrated, variable size, expandable metallic implants or stents 52 wherein the lumen or hollow region 11 of the fenestrated, variable size, expandable metallic implant or stent 52 can be expanded to a first expanded diameter by inflation of the balloon 110 of the balloon catheter 100 and then subsequently expanded to a second larger diameter by additional inflation of the balloon 110 of the balloon catheter 100, the structural metal layer 27 of the fenestrated, variable size, expandable metallic implant or stent 52 is arranged in a web, net, or network pattern of strut elements 50, including a web, net, or network pattern of diamond-shaped strut elements 50, as shown in FIG. 29. After delivery to a target vessel segment the diameter of the lumen or hollow region 11 of such fenestrated, variable size, expandable metallic implants or stents 52 can be increased by inflation of the balloon 110 to a first expanded diameter, wherein the folds and pleats of the fenestrated, variable size, expandable metallic implant or stent 52 are partially or completely straightened, unfolded, or unpleated, and the lumen or hollow region 11 of the fenestrated, variable size, expandable implant or stent 52 becomes circular or substantially circular in cross-section. If desired, the lumen or hollow region 11 diameter of the fenestrated, variable size, expandable metallic implant or stent 52 can beAUROM.002WO PCT further increased by additional balloon 110 inflation to a second, larger diameter, wherein the shape of the web, net, or network pattern of strut elements 50 is changed, the inner polymer layer is stretched, and the diameter of the lumen or hollow region 11 of the fenestrated, variable size, expandable implant or stent 52 becomes larger by radial expansion of the fenestrated, variable size, expandable implant or stent 52. The strut elements 50 in the web, net, or network can articulate at their nodes so that the fenestrated, variable size, expandable metallic implant or stent 52 can accommodate the size, diameter, length, shape and curvature of the target vessel segment after implantation. FIG. 29B is a perspective view of an example of a longer version of the fenestrated, variable size, expandable metallic implant or stent shown in FIG. 29A.

[0219] In some examples, the variable size, expandable metallic implant or stent 44 can have both one or more longitudinal gaps or discontinuities 52 to enable subsequent radial expansion, as well as one or more radial gaps or discontinuities 53 that segment the structural metal layer 27 of the variable size, expandable metallic implant or stent 44 into two or more longitudinal segments that are joined to a compliant, flexible polymer layer to enable flexibility when the variable size, expandable metallic implant or stent 44 is folded and pleated, as shown in FIG. 26B and FIG. 26C. These figures show examples of variable size, expandable metallic implants or stents 44 segmented into two rings, each of which is radially expandable to a larger size. In some examples, the structural metal layer 27 of a variable size, expandable metallic implant or stent 44 can be configured with multiple segments or rings with intervening flexible radial gaps or discontinuities 53 so as to further increase the flexibility of the folded and pleated variable size, expandable metallic implant or stent 44. In some examples, these segments or rings can take on the shape of diamond- shaped strut elements 50 that can articulate at their joints so that they expand circumferentially as they foreshorten longitudinally. In the example shown in FIG. 27 four such rings of diamond- shaped struts are affixed to the complaint, flexible polymer layer

[0220] For some examples of expandable metallic implants or stents 10 wherein the lumen or hollow region 11 of the expandable metallic implant or stent 10 can be expanded to a first expanded diameter by inflation of the balloon 110 of the balloon catheter 100 and then subsequently expanded to a second larger diameter by additional inflation of the balloon 110 of the balloon catheter 100, the expandable metallic implant or stent 10 can include one or more secondary folds and pleats along the first axis, as shown in FIG. 30A and FIG. 30C. TheseAUROM.002WO PCT examples are herein referred to as a “secondary folded and pleated” variable size expandable metallic implant implants or stents 45. Secondary folded and pleated variable size expandable metallic implants or stents 45 can have two or more secondary folds which can combine to form a pleat. For secondary folded and pleated variable size expandable metallic implants or stents 45 with two secondary folds, there is an internal secondary fold 46 that projects or faces into the lumen or hollow region 11 of the secondary folded and pleated variable size expandable metallic implant or stent 45 and an external secondary fold 47 that projects or faces externally away from the outer surface of secondary folded and pleated variable size expandable metallic implant or stent 45. For secondary folded and pleated variable size expandable metallic implants or stents 45 with three secondary folds, there is an internal secondary fold 46 that faces the lumen or hollow region 11 of the secondary folded and pleated variable size expandable metallic implant or stent 45, an external secondary fold 47 that faces externally away from the outer surface of secondary folded and pleated variable size expandable metallic implant or stent 45, and a middle fold interposed between the internal secondary fold 46 and the external secondary fold 47. For secondary folding and pleating operations, the folds project or face into the lumen or hollow region 11, while for primary folding and pleating operations, as shown in FIG.18 and FIG. 19, the folds project or face externally away from the outer surface of expandable metallic implant or stent 10.

[0221] In some examples, the secondary folded and pleated variable size expandable metallic implant or stent 45 can include 1-10 secondary pleats, each comprising 1 - 10 secondary folds. The secondary folds and pleats can be on one side of the expandable metallic implant, extending along an axis from the proximal end to the distal end of the secondary folded and pleated variable size expandable metallic implant or stent 45, or can be on more than one side. In some examples, the secondary folded and pleated variable size expandable metallic implant or stent 45 comprises two sets of secondary folds and pleats offset by 180 degrees. In some examples, the secondary folded and pleated variable size expandable metallic implant or stent 45 comprises three sets of secondary folds and pleats offset by 120 degrees. In some examples, the secondary folded and pleated variable size expandable metallic implant or stent 45 comprises four sets of secondary folds and pleats offset by 90 degrees. In some examples, the secondary folded and pleated variable size expandable metallic implant or stent 45 comprises more than four sets of secondary folds and pleats. A secondary folded and pleated variable size expandableAUROM.002WO PCT metallic implant 45 can be folded and pleated in a conventional manner, as shown in FTG. 18. Tn some examples, a secondary folded and pleated variable size expandable metallic implant or stent 45 comprises a round or substantially round cross-section prior to a conventional primary fold and pleat operation. The shape of a secondary folded and pleated variable size expandable metallic implant or stent 45 can be changed to a round or substantially round cross-section prior to a conventional primary fold and pleat operation by various methods, including by compression of the secondary folds and pleats. A secondary folded and pleated variable size expandable metallic implant or stent 45 that is subsequently be folded and pleated in a conventional manner (forming primary folds and pleats), as shown in FIG. 15, can be expanded to a first expanded diameter wherein the secondary folds and pleats remain folded and pleated. The secondary folded and pleated variable size expandable metallic implant or stent 45 can then be expanded further to a second expanded diameter by additional inflation of the balloon 110 of the balloon catheter 100 such that at least one of the secondary folds and pleats is partially or completely straightened, unfolded, or unpleated, such that the implant expands to a second expanded diameter that is larger than the first expanded diameter. A secondary folded and pleated variable size expandable metallic implant or stent 45 that is expanded to a second expanded diameter can have a round or substantially round cross-section, as the secondary pleats and folds can open to become part of a continuous round or substantially round wall 22 of the secondary folded and pleated variable size expandable metallic implant or stent 45 after the straightening, unfolding and / or unpleating of the primary and secondary folds and pleats. For some examples, the secondary folded and pleated variable size expandable metallic implant or stent 45 can be expanded to a first expanded diameter in order to secure the implant within a target vessel segment, including within a target vessel segment having a lumen diameter less than, equal to, or greater than the first expanded diameter. For some examples, the secondary folded and pleated variable size expandable metallic implant or stent 45 can then be expanded to the second, larger expanded diameter by inflation of the balloon 110 of a balloon catheter 100 in order to better secure the secondary folded and pleated variable size expandable metallic implant or stent 45 within the target vessel segment by matching the lumen diameter of the target vessel segment or enlarging the lumen diameter of target vessel segment containing the expanded secondary folded and pleated variable size expandable metallic implant or stent 45. In this way, the secondary folds and pleats can allow for an operator to change the expanded diameter of theAUROM.002WO PCT secondary folded and pleated variable size expandable metallic implant or stent 45 entirely or in sections to provide an optimal fit between the expanded secondary folded and pleated variable size expandable metallic implant or stent 45 and the lumen of the target vessel segment. In some examples, the secondary folds and pleats are formed during the formation of the expandable metallic implant or stent, while in other examples the secondary folds and pleats are formed after the formation of the expandable metallic implant or stent through a secondary folding and pleating operation, prior to the primary folding and pleating operation

[0222] The design, materials, and manufacturing methods of the various components of expandable metallic implant or stent devices 1 can provide optimal safety and efficacy for patients. In some examples, the metal(s) used to form the wall 22 of expandable metallic implant or stents 10 can be: biocompatible; malleable enough to allow for pleating and folding; and strong enough to resist compression after expansion and implantation in patients. In some examples, the material(s) used to form the wall 135 of a balloon 110 of a balloon catheter 100 can be selected to provide: acceptable biocompatibility; enough strength to enable high pressure inflation and resist puncture; and enough compliance to allow for bulging of the over-inflated balloon 110 at the proximal and distal edges of the expandable metallic implant or stent 10, and into the flap window 18 of the expanded expandable metallic implant or stent 10, so as to lift of the free edge of the one more flaps 16 of the expanded expandable metallic implant or stent 10 from the exterior surface 34 of the expanded expandable metallic implant or stent 10 with balloon over-inflation. In another example, the metal(s) used to form the wall 22 of expandable metallic implant or stents 10, the thickness of the wall 22 of expandable metallic implant or stents 10. the material(s) used to form the wall 135 of the balloon 110, and the thickness of the wall 135 of the balloon 110 can be carefully selected and balanced to provide: a balloon 110 capable of accepting a high enough pressure to expand a folded and pleated expandable metallic implant or stent 10; a balloon 110 compliant enough to allow for bulging of the over-inflated balloon 110 at the proximal and distal edges of the expanded expandable metallic implant or stent 10, and / or into the flap window 18 of the expanded expandable metallic implant or stent 10. so as to lift of the free edge of the one more flaps 16 of the expanded expandable metallic implant or stent 10 from the exterior surface 34 of the expanded expandable metallic implant or stent 10 with balloon over-inflation; and provide adequate resistance to compression of the expanded expandable metallic implant or stent 10 after separation from the balloon catheter 100AUROM.002WO PCT in a patient. Tn another example, the length (along the first axis 38) of the middle zone 12 of the expanded expandable metallic implant or stent 10 can be chosen carefully to provide: a long enough length to provide adequate sealing or closing of breaches or openings in the wall of blood vessels and other biological conduits, and modifying, obstructing, or reducing flow through blood vessel lacerations and ruptures and arteriovenous fistulas, through discontinuities in endoprostheses or gaps between one endoprosthesis and another endoprosthesis or between an endoprosthesis and adjacent tissue, and for modifying, obstructing, or reducing flow into aneurysms, pseudoaneurysms, or other blood-containing, fluid-containing, or biological spaces; and a short enough length to provide acceptability deliverability of folded and pleated expandable metallic implant or stent devices 2 to the treatment site in patients.

[0223] In some examples, the thickness of the wall 31 of a flap 16 of the expandable metallic implant or stent 10 may be made thinner than the adjacent wall 22 of the expandable metallic implant or stent 10 by adding a mask or coating to all or a portion of the wall of a flap 16 during electroforming and electroplating. In some examples, the thickness of the wall of a flap 16 of the expandable metallic implant or stent 10 may be made thinner than the adjacent wall 22 of the expandable metallic implant or stent 10 by removing metal from the wall of the flap 16 after electroforming and electroplating, including by methods wherein metal is removed with a laser. In some examples, the thickness of the wall of a region of the base of a flap 16 of the expandable metallic implant or stent 10 may be made thinner than the adjacent wall 22 of the expandable metallic implant or stent 10 by adding a mask or coating to a portion of the wall of a flap 16 during electroforming and electroplating. In some examples, the thickness of the wall of a region of the base of a flap 16 may be made thinner than the adjacent wall 22 of the expandable metallic implant or stent 10 by removing metal from a portion of the wall of a flap 16 after electroforming and electroplating, including by methods wherein metal is removed with a laser. In some examples, the expandable metallic implant or stent 10 is configured with a wall that is open on the proximal and distal ends and wherein the wall continuously from the proximal end to the distal end, except for one or more flap windows 24. In some examples, the wall 22 of an expandable metallic implant or stent 10 extends generally continuously from the proximal zone 13 (if any), through the middle zone 12, and through the distal zone 14 (if any), except for one or more flap windows 24.AUROM.002WO PCT

[0224] For some examples of an expandable metallic implant or stent device 1 comprising a compliant or semi-compliant balloon 110 and at least one flap 16, the free edge of the flap 16 of the expandable metallic implant or stent 10 can be raised from the adjacent wall 22 of the expandable metallic implant or stent 10 during over-inflation of the compliant or semi- compliant balloon 110. For some examples of an expandable metallic implant or stent device 1 comprising a compliant or semi-compliant balloon 110 and at least one flap 16, the free edge of the flap 16 of the expandable metallic implant or stent 10 can be raised from the adjacent wall 22 of the expandable metallic implant or stent 10 when the compliant or semi-compliant balloon 110 is inflated at a pressure of 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 10, 12, 13, 14, 15, 16, 17, 18, 19, or 20 atmospheres.

[0225] For some examples of an expandable metallic implant or stent device 1. the thickness of the wall of a flap 16 of an expandable metallic implant or stent 10 may be thinner than the adjacent wall 22 of the expandable metallic implant or stent 10 to facilitate the lifting of the free edge of the flap 16 from the adjacent wall 22 of the expandable metallic implant or stent 10 during over-inflation of a compliant or semi-compliant balloon 110. In some examples, the thickness of the wall of the base of the flap 16 may be thinner than the adjacent wall 22 of the expandable metallic implant or stent 10 to facilitate the lifting of the free edge of the flap 16 from the adjacent wall 22 of the expandable metallic implant or stent 10 during over- inflation of a compliant or semi-compliant balloon 110 by forming a hinge region 17 to facilitate the lifting of the flap 16. In some examples, the region of the wall of a flap 16 of the expandable metallic implant or stent 10 with the smaller thickness is linear and located at the base of the flap 16, forming a hinge region 17 to facilitate the lifting of the flap 16 by a compliant or semi-compliant balloon 110, as shown in FIG 9.

[0226] FIG. 6 A is a perspective view of the distal end of an example of a folded and pleated expandable metallic implant or stent device 1 with a folded and pleated semi-compliant balloon 110 and a folded and pleated expandable metallic implant or stent 10. FIG. 6B is a perspective view of the distal end of the example of the expandable metallic implant or stent 10 device 1 shown in FIG. 6 A after inflation of the balloon 110 showing an inflated balloon 110 and an expanded expandable metallic implant or stent 10. This example of an expanded expandable metallic implant or stent 10 has a proximal zone 13, a middle zone 12, and a distal zone 14, with its overall geometric dimensions defined. The proximal zone 13 and the distal zone 14 of theAUROM.002WO PCT expanded expandable metallic implant or stent 10 comprise a fixation region 15 with pointed flaps 16 wherein the pointed flaps 16 are present at the proximal and distal ends. The pointed flaps 16 in the proximal zone 13 can be configured such that the free ends are proximal to the fixed ends and the pointed flaps in the distal zone 14 can be configured such that the free ends are distal to the fixed ends. FIG. 6C is a perspective view of the distal end of the example of an expanded expandable metallic implant or stent 10 device 1 shown in FIG. 6B after over-inflation of the balloon 110 showing an over-inflated balloon 110 and flaps 16 with free ends that are raised from the surface of the expanded expandable metallic implant or stent 10. FIG. 6D is a perspective view of the distal end of the example of the expandable metallic implant or stent device 1 shown in FIG. 6C after deflation or collapse of the balloon 110. FIG. 6E is a perspective view of the distal end of the example of the expandable metallic implant or stent device 1 shown in FIG. 6D after separation of the deflated or collapsed balloon 110 and the expanded expandable metallic implant or stent 10.

[0227] Expandable metallic implant or stents 10 may be defined by a first axis 38 and a second axis 39, wherein the first axis 38 extends along the centerline of an expanded expandable metallic implant or stent 10 that begins at the proximal zone 13 or the middle zone 12 and ends at the middle zone 12 or the distal zone 14; and the second axis 39 is transverse to the first axis 38. Expandable metallic implant or stent devices 1 may be defined by a first axis 38 and a second axis 39. wherein the first axis 38 extends along a centerline present in the center of the first lumen 161 of the elongate body 160 that begins at the proximal end of the first hub 164 of the elongate body 160 and ends at the distal end of the elongate body 160; and the second axis 39 is transverse to the first axis 38.

[0228] The length of the middle zone 12 (see FIG. 7) of expandable metallic implant or stents 10 can affect occlusion performance. In some examples, longer middle zones 18 are generally preferred, when possible, due to the reduced leakage of blood or other fluids around an expanded expandable metallic implant or stent 10 in vivo with a long contact surface with adjacent tissues. In some examples, for treatment of arteries, veins, and other biological conduits, a longer middle zone 12 is preferred, if possible. Therefore, expandable metallic implant or stents 10 for the treatment of arteries, veins, and other biological conduits are often longer than they are wide. However, increasing the length of the middle zone 12 of an expandable metallic implant or stent 10 increases the length of the rigid folded and pleated expandable metallicAUROM.002WO PCT implant or stent 10 portion of the corresponding folded and pleated expandable metallic implant or stent device 1, potentially reducing deliverability and representing a trade-off.

[0229] As shown in FIG. 23, FIG. 24, FIG. 26B, and FIG. 26C, FIG. 27, and FIG. 28A- C, in some examples, the structural metal layer 27 of the middle zone 12 of an expandable metallic implant 10 is segmented through the formation of radial gaps or discontinuities 53 so as to increase the flexibility of the folded and pleated configuration of the expandable metallic implant 10 during advancement or retraction in vivo and to increase flexibility of the expanded configuration of the expandable metallic implant 10 during and after implantation to provide a better fit with target vessel segments, including a better fit with curved target vessel segments or target vessel segments with varying diameters. In order to connect each of these segments, the structural metal layer 27 of the various segments of the expandable metallic implant 10 are joined to polymer layer 29, including a continuous polymer layer 29.

[0230] In some examples, the middle zone 12 of the expanded expandable metallic implant or stent 10 has a length (along the first axis 38) that is greater than, equal to. or less than the largest diameter (along the first axis 46) of the middle zone 12. In some examples, the expanded expandable metallic implant or stent 10 is configured to have a maximum diameter of between 2 - 50 mm when measured parallel to the second axis 39. In some examples, middle zone 12 of the expanded expandable metallic implant or stent 10 is configured to have a maximum diameter of between 2 - 50 mm when measured parallel to the second axis 39.

[0231] In some examples, the expandable metallic implant or stent 10, when expanded, is configured to have a maximum length of between 3 - 100 mm when measured parallel to the first axis 38. In some examples, the exterior surface 34 of the expandable metallic implant or stent 10 can include a lubricous or hydrophilic coating layer. In certain instances, this lubricous or hydrophilic coating layer reduces the frictional forces between the exterior surface 34 of the expandable metallic implant or stent 10 and the adjacent tissue in vivo, thereby reducing the risk of tissue injury or device damage during placement and expansion of the expandable metallic implant or stent 10.

[0232] For some examples of an expandable metallic implant or stent device 1, the wall 22 of the expandable metallic implant or stent 10 may comprise a single metal layer with a thickness of 3 - 500 microns (a “single layered expandable metallic implant or stent”). For some examples of a single layered expandable metallic implant or stent 32, the wall 22 of theAUROM.002WO PCT expandable metallic implant or stent 10 may comprise a single metal layer with a thickness in the range of 5 - 30 microns or 3 - 100 microns. In some examples, the wall 22 of the expandable metallic implant or stent 10 can include gold with a thickness of < 5 microns, < 10 microns, < 15 microns, < 20 microns, < 25 microns, < 30 microns, < 35 microns, or < 40 microns. In some examples, the layer is a layer of gold or a gold alloy. For some examples of an expandable metallic implant or stent device 1, the wall 22 of the expandable metallic implant or stent 10 may comprise more than one layer (a “multilayered expandable metallic implant or stent”). The overall thickness of the wall 22 of a multilayered expandable metallic implant or stent 26 may range between 3 - 2000 microns.

[0233] In some examples, the wall 22 of the expandable metallic implant or stent 10 may comprise a single metal layer or multiple metal layers. In some examples, the wall 22 of the expandable metallic implant or stent 10 may be comprised of a single metal, a single metal alloy or amalgam, two different metals, two different metal alloys or amalgams, or more than two different metals, or metal alloys or amalgams. In some examples, the wall 22 of the expandable metallic implant or stent 10 may be formed by electroforming and electroplating. In some examples, the wall 22 of the expandable metallic implant or stent 10 may comprise gold, platinum, alloys thereof, and combinations thereof. In some examples, the wall 22 of the expandable metallic implant or stent 10 may have a thickness of 3 - 300 microns, or a thickness of 3, 4, 5. 6, 7, 8, 9, 10, 10, 12, 13, 14, 15, 16, 17, 18. 19. 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39 40, 41, 42, 43, 44, 45, 46, 47, 48, 49, or 50 microns. In some examples, the wall 22 of the expandable metallic implant or stent 10 may comprise a metal layer wherein the primary purpose of the metal is load bearing (a “structural metal layer”). In some examples, the structural metal layer 27 may have a thickness of 3 - 300 microns. In some examples, the structural metal layer 27 may be produced through a process of electroforming and electroplating. In some examples, the structural metal layer 27 may have a thickness of 3 - 300 microns. In some examples, the structural metal layer 27 may comprise gold or platinum, alloys thereof, and combinations thereof. In some examples, the structural metal layer 27 may have a thickness of 3 - 300 microns, or a thickness of 3, 4, 5, 6, 7, 8, 9, 10, 10, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39 40, 41, 42, 43, 44, 45, 46, 47, 48, 49, or 50 microns. For some of these examples, the expandable metallic implant or stent can include a structural metal layer 27 comprising gold with a thickness of 3 - 300 thatAUROM.002WO PCT can be folded and pleated with a balloon 1 10, advanced to a target location in a human patient with the balloon catheter 100 and expanded at the target location by expansion of the balloon 110.

[0234] In some examples, a portion of the wall 22 of the expandable metallic implant or stent 10 may also comprise a metal layer wherein the primary purpose of the metal is functional and not load bearing (a “functional metal layer”), such as for increasing fluoroscopic visualization, conducting electricity enhancing biocompatibility, and inducing a biological response in the adjacent tissue, including by stimulating the growth of an endothelial or fibrous layer on the surface of the functional metal layer 28, among other purposes. In some examples, the functional metal layer 28 may be produced through a process of electroforming and electroplating. In some examples, the functional metal layer 28 may have a thickness of less than 3 microns. In some examples, the functional metal layer 28 may be present on all, or only a portion, of the wall 22 of the expandable metallic implant or stent 10. By way of example and not limitation, the functional metal layer 28 may be present on 100% or less than 100% of the wall 22 of the expandable metallic implant or stent 10. In some examples, the functional metal layer 28 can include gold, platinum, silver, titanium, vanadium, aluminum, nickel, tantalum, zirconium, chromium, magnesium, niobium, scandium, cobalt, palladium, manganese, molybdenum, alloys thereof, and combinations thereof.

[0235] In some examples, the wall 22 of a multilayered expandable metallic implant or stent 26 may comprise a single metal layer and one or more polymer layers 36, or a more than one metal layer and one or more polymer layers 36. For some examples of a multilayered expandable metallic implant or stent 26, the wall 22 of a multilayered expandable metallic implant or stent 26 may be comprised of one or more of polyurethane, silicone, poly(p-xylylene), Parylene, or any other synthetic or natural polymer known in the art wherein the primary purpose of the polymer is functional and not load bearing (“a polymer layer”), such as for enhancing biocompatibility or inducing a biological response in the adjacent tissue, including by stimulating the growth of an endothelial or fibrous layer on the surface of the multilayered expandable metallic implant or stent 26, among other purposes. In some examples, the polymer may be formed in a layer 33. In some examples, the portion of the wall 22 of the expandable metallic implant or stent 10 with a polymer layer 29 may be formed by coating, electroplating, sputter deposition, or vapor deposition. In some examples, the portion of the wall 22 of theAUROM.002WO PCT expandable metallic implant or stent 10 with a polymer layer 29 may have a thickness of 0.0005- 2000 microns. In some examples, the wall 22 of the expandable metallic implant or stent 10 with a polymer layer 29 may have a thickness of 3, 4, 5, 6, 7, 8, 9. 10. 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39 40, 41, 42, 43, 44, 45, 46, 47, 48, 49, or 50 microns. In some examples, the polymer layer 29 may be present on all, or only a portion, of the wall 22 of the expandable metallic implant or stent 10. By way of example and not limitation, the polymer layer 29 may be present on 100% or less than 100% of the wall 22 of the expandable metallic implant or stent 10. In some examples, the polymer layer 29 may be present on between 50% and 90% of the wall 22 of the expandable metallic implant or stent 10. For some of these examples, one or more of the polymers may comprise an adhesive or glue.

[0236] In some examples, the polymer layer 29 may act as a connector between segmented sections of the structural metal layer 27 of a segmented expanded expandable metallic implant to provide greater flexibility for expandable metallic implants or stents 10, especially for longer expandable metallic implants or stents 10 with longer middle zones 12 that provide a seal with the adjacent wall of the target vessel segment. In some examples, it may be desirable for the middle zone 12 of the expanded expandable metallic implant to be twice, three times, or many times longer than what is pictured in the example shown in FIG. 3. In this instance, the middle zone 12 can be fabricated with separate structural metal layer 27 segments joined together by a polymer layer 29, including an inner polymer layer as shown in FIG. 23, FIG. 24, FIG. 26B, and FIG. 26C, FIG. 27, and FIG. 28A-C.

[0237] FIG. 12A is an end planar view of an example of an expanded expandable metallic implant or stent 10 having a single structural metal layer 27. FIG. 12B is an end planar view of an example of an expanded expandable metallic implant or stent 10 having a structural metal layer 27 as an inner layer 33 and a functional metal layer 28 as an outer layer 31. FIG. 12C is an end planar view of an example of an expanded expandable metallic implant or stent 10 having a structural metal layer 27 as a middle layer 32, a functional metal layer 28 as an outer layer 31, and a functional metal layer 28 as an inner layer 33. FIG. 12D is an end planar view of an example of an expanded expandable metallic implant or stent 10 having a structural metal layer 27 as an inner layer 33 and a polymer layer 29 as an outer layer 31. FIG. 12E is an end planar view of an example of an expanded expandable metallic implant or stent 10 having aAUROM.002WO PCT structural metal layer 27 as a middle layer 32, a polymer layer 29 as an outer layer 31 , and a polymer layer 29 as in inner layer 33.

[0238] In some examples, one or more zones, regions, or portions of the wall 22 of the expandable metallic implant or stent 10 may be thicker or thinner than one or more other zones, regions, or portions another portions of the wall 22 of the expandable metallic implant or stent 10. By way of example and not limitation, all or a portion of the wall in the proximal zone 13, middle zone 12, distal zone 14, flap 16, or flap hinge region 17 may be thicker or thinner than another zone, region, or portion of the wall 22 of the expandable metallic implant or stent 10. In some examples, the wall 22 of the expandable metallic implant or stent 10 in the flap hinge region 17 may be thinner than the wall 22 of the expandable metallic implant or stent 10 in the flap 16. In some examples, the thinner region may be linear, as shown in FIG. 9. In another example, the wall 22 of the middle zone 12 may be thicker than the wall 22 of the expandable metallic implant or stent 10 in the proximal zone 13 or distal zone 14. In another example, the wall 22 of the proximal zone 13 or distal zone 14 may be thicker than the wall 22 of the expandable metallic implant or stent 10 in the middle zone 12.

[0239] Metal is generally not considered compliant in the way some polymers are. Metals tend to be rigid, but they can exhibit some degree of compliance under certain conditions, such as when they are thin or when they undergo plastic deformation. In some examples, after expansion of an expandable metallic implant or stent 10 to its nominal diameter, the expandable portion 15 of an expanded expandable metallic implant or stent 10 of an expanded expandable metallic implant or stent 10 device 1 is non-compliant, including when the pressure inside the inflated balloon 110 or over-inflated balloon 110 is in a range between 1 - 20 atmospheres. In some examples, after expansion of an expandable metallic implant or stent 10 to its nominal diameter, the expandable portion 15 of an expanded expandable metallic implant or stent 10 of an expanded expandable metallic implant or stent 10 device 1 is semi-compliant. In some examples, after expansion of an expandable metallic implant or stent 10 to its nominal diameter, the expanded expandable metallic implant or stent 10 increases by < 2%, < 4%, < 6%, < 8%, < 10% in diameter when fluid is injected into the interior space 115 of the inflated balloon 110 or over-inflated balloon 110 at a pressure of 1, 5, 10, or 20 atmospheres.

[0240] The exterior surface 34 of expandable metallic implant or stents 10 may be formed or modified to improve biocompatibility, to promote rapid endothelialization of blood-AUROM.002WO PCT contacting surfaces, to roughen the surface texture and reduce the risk of migration of the expandable metallic implant or stent 10, or to increase the strength of the bonds that form between the expandable metallic implant or stent 10 and the surrounding tissue to increase implant anchoring after placement in vivo. Surface modifications may include surface roughening or smoothing, changes in surface chemistry, attachment of molecules or biomolecules, or various combinations of these methods.

[0241] In some examples, at least a portion of the exterior surface 34 of an expandable metallic implant or stent 10 may comprise a rounded, pebbled, granular, or textured surface, wherein the pebbles or granules have a surface height of 0.0001 - 10 microns or the distance between the highest and the lowest portions is 0.0001 - 10 microns. In some examples, the exterior surface 34 of an expandable metallic implant or stent 10 can include surface structures 36. In certain instances, the rounded, pebbled, or granular surface, and the surface structures 36 can increase surface roughness and increase frictional forces between the exterior surface 34 of an expandable metallic implant or stent 10 and the adjacent tissue, including the internal surface of an artery, vein, aneurysm, parent vessel of a saccular aneurysm, paravalvular leak pathway, biological conduit, or other blood-containing, fluid-containing, or biological space, thereby reducing the risk of movement or migration of the expanded expandable metallic implant or stent 10 after placement in vivo. At least a portion of the wall 22 of the expandable metallic implant or stent 10 may be formed by electroforming and electroplating, a process that can produce a rounded, pebbled, or granular surface. In some examples, the exterior surface 34 of the expandable metallic implant or stent 10 can include a lubricous or hydrophilic coating layer. In certain instances, this lubricous or hydrophilic coating layer reduces the frictional forces between the exterior surface 34 of the multilayered expandable metallic implant or stent 26 and the adjacent tissue in vivo, thereby reducing the risk of tissue injury or device damage during placement and expansion of the multilayered expandable metallic implant or stent 26.

[0242] When using expandable metallic implant devices 1, it may be useful for an operator to have an expandable metallic implant 10 wherein the expandable metallic implant 10 can be expanded to a range of diameter and still maintain a circular or substantially circular lumen or hollow region 11 or wall 22 to provide a good fit with a range of target vessel diameters or adjust the size or shape of the expandable metallic implant 10 to the unique anatomy of individual patients when placing the implant. In some instances, it may be difficult toAUROM.002WO PCT choose the appropriate size of expandable metallic implant 10 prior to implantation, including choosing the appropriate diameter, length, and shape. In accordance with this need, some examples of the expandable metallic implant 10 are fabricated in a manner that makes them adjustable in diameter during implantation. For some examples, the expandable metallic implant 10 comprises one or more longitudinal gaps or discontinuities 54 to enable a range of diameters, including examples with strut elements 50 and structural metal bridge segments 51. For some examples, the expandable metallic implant 10 comprises one or more localized discontinuities or fenestrations 55 to enable a range of diameters, including examples with various forms and shapes of strut elements 50 or structural metal bridge segments 51. For some examples, the expandable metallic implant 10 comprises one or more secondary folds and pleats to enable a range of diameters. For some of these secondary folded and pleated variable size expandable metallic implants 45, the secondary folds and pleats are formed when the structural metal layer 27 is fabricated, as shown in FIG. 30 wherein the structural metal layer 27 is formed over a sacrificial mandrel pre-formed with the secondary folds and pleats. For some of these examples, the secondary folds and pleats are formed after the structural metal layer 27 is fabricated through a secondary fold and pleat process. Either way, the secondary folds and pleats are formed before the primary folding and pleating procedure wherein the secondary folded and pleated variable size expandable metallic implant 45 and the balloon 110 are pleated and folded together.

[0243] For some examples wherein the structural metal layer 27 of a secondary folded and pleated variable size expandable metallic implant 45 is formed over a sacrificial mandrel pre-formed with the secondary folds and pleats 383, once the metal is deposited atop the sacrificial mandrel (FIG. 30B and D), it takes the shape of a secondary folded and pleated variable size expandable metallic implant 45 with secondary folds and pleats (FIG. 30A and C). After a removal of the sacrificial mandrel, the lumen or hollow region 11 and the wall 22 of the secondary folded and pleated variable size expandable metallic implant 45 can be made into a circular or substantially circular shape through various means, including mechanical means. For some examples, a secondary folded and pleated variable size expandable metallic implant 45 can be placed inside a rigid, constraining mold in a desired size and shape and a balloon or mandrel can be fitted inside the lumen or hollow region 11 of the secondary folded and pleated variable size expandable metallic implant 45 and used to press the secondary folds and pleats together to form a circular or substantially lumen or hollow region 11 and wall 22. Following this, theAUROM.002WO PCT circular or substantially circular secondary folded and pleated variable size expandable metallic implant 45 can be fitted over a balloon 110 of a balloon catheter 100 and the secondary folded and pleated variable size expandable metallic implant 45 can be folded and pleated together with the balloon 110 for delivery to a target vessel segment.

[0244] When using expandable implant devices, operators often remove air from the devices before inserting them into patients, a process sometimes known as “de-airing”. De-airing can be accomplished by injecting fluid into the devices to expel air and replace it with fluid. De- airing can also be accomplished by aspirating fluid into the devices to remove air. Incorporating one or more small openings (“flush openings”) in the elongate body 160 of the balloon catheter, balloon 110, proximal neck 117 of the balloon 110, or distal neck 125 of the balloon 110 would allow the injection or aspiration of fluid and the removal of air from the interior space 115 of the balloon 110 and the first lumen 161 of the elongate body 160. The diameter of the flush opening(s) may need to be large enough to allow for de-airing in a reasonable amount of time and small enough to allow for inflation of the balloon 110 and the expandable metallic implant or stent 10 at the treatment site.

[0245] FIG. 22A and 22B are two perspective views of an example of an expandable metallic implant or stent having flaps with holes to enable tissue ingrowth from the wall of the vessel after implantation in a target vessel segment. The ingrowth of tissue through the flap holes may help anchor the expanded expandable metallic implant or stent to the vessel wall and help resist migration of the expanded expandable metallic implant or stent from the target vessel segment.

[0246] FIG. 23A and FIG. 23B show an example of an expandable metallic implant or stent with three discrete structural (outer) metal layer segments joined to a continuous flexible inner polymer layer extending from the open proximal end to the open distal end of the expandable metallic implant or stent, including the triangular flaps on both ends. FIG. 23A is a perspective view of the example and FIG. 23B is a partial cutaway showing the structural (outer) metal layer of the three segments and the flexible inner polymer layer. The polymer-only gaps between three discrete structural (outer) metal layer segments provide flexibility for the expandable metallic implant or stent both during delivery to a target vessel segment and also after implantation in the target vessel segment, including providing flexibility in response to vessel movement after implantation.AUROM.002WO PCT

[0247] FTG. 24A and shows an example of an expandable metallic implant or stent with two discrete structural (outer) metal layer segments joined to a flexible inner polymer layer, where each of the structural metal layer segments are joined by a functional metal layer bridge segment 56 comprised of a functional metal layer 28 with a thickness less than 3 microns to facilitate electrical conductivity during plating and maintain flexibility in the region of the exposed inner polymer layer during delivery to a target vessel segment and after implantation. In FIG. 24A, the functional metal layer bridge segments are colinear.

[0248] FIG. FIG. 24B shows an example of an expandable metallic implant or stent with two discrete structural (outer) metal layer segments joined to a flexible inner polymer layer, where each of the structural metal layer segments are joined by a structural metal bridge segment 51 with a thickness of greater than 3 microns to facilitate electrical conductivity during plating and transmit force and maintain hoop strength along the length of the expandable metallic implant or stent 10. In FIG. 24B, the structural metal bridge segments 51 are offset.

[0249] FIG. 25A and 25B are two perspective views of an example of a slotted, variable size, expandable metallic implant or stent showing a longitudinal discontinuity in the structural metal layer such that the lumen or hollow region 11 of the slotted, variable size, expandable metallic implant or stent can be increased to a larger diameter further after an initial expansion. The longitudinal discontinuity is crossed by curved strut elements comprised of a structural metal layer 27 that are designed to provide a continuous structural metal layer 27 path across the longitudinal discontinuity to maintain electrical continuity during manufacturing, limit expansion of the slotted metallic implant or stent during expansion, and transmit force and maintain hoop strength of the slotted, variable size, expandable metallic implant or stent after implantation. For this example, the slotted, variable size, expandable metallic implant or stent is folded and pleated with the balloon portion of a balloon catheter in a conventional pleating and folding operation. After delivery to a target vessel segment the lumen or hollow region 11 of such slotted, variable size, expandable metallic implant or stent can be increased by balloon inflation to a first expanded diameter, wherein the folds and pleats of the are slotted, variable size, expandable metallic implant or stent are partially or completely straightened, unfolded, or unpleated and the lumen or hollow region 11 of the slotted, variable size, expandable implant or stent becomes circular or substantially circular in cross-section. If desired, the diameter of the lumen or hollow region 11 of the slotted, variable size, expandable metallic implant or stent can be furtherAUROM.002WO PCT increased by additional balloon inflation to a second, larger diameter, wherein the curved metallic strut elements are straightened and elongated in the circumferential direction, and the lumen or hollow region 11 of the expandable implant or stent becomes larger by radial expansion of the metallic implant or stent. In some examples, a slotted, variable size, expandable metallic implant or stent may have 1, 2, 3, or more longitudinal discontinuities per implant or stent and may have 1, 2, 3, or more structural metallic strut elements per discontinuity.

[0250] FIG. 26A is a perspective view of an example of a slotted, variable size, expandable metallic implant or stent showing a longitudinal discontinuity in the structural metal layer such that the lumen or hollow region 11 of the slotted, variable size, expandable metallic implant or stent can be increased after an initial expansion. The longitudinal discontinuity is bridged by curved metallic strut elements that are designed to provide a continuous structural metal path across the longitudinal discontinuity to maintain electrical continuity during manufacturing, limit expansion of the slotted metallic implant or stent during expansion, and transmit force and maintain hoop strength of the slotted, variable size, expandable metallic implant or stent after implantation. For this example, a structural metal (outer) layer is joined to a continuous flexible polymer (inner) layer extending from the open proximal end to the open distal end of the expandable metallic implant or stent, including the triangular flaps on both ends. For this example, the slotted, variable size, expandable metallic implant or stent can be folded and pleated with the balloon portion of a balloon catheter in a conventional pleating and folding operation. After delivery to a target vessel segment, the lumen or hollow region 11 of such slotted, variable size, expandable metallic implant or stent can be expanded by balloon inflation to a first expanded diameter, wherein the folds and pleats of the slotted, variable size, expandable metallic implant or stent are partially or completely straightened, unfolded, or unpleated and the lumen or hollow region 11 of the of such slotted, variable size, expandable metallic implant or stent becomes circular or substantially circular in cross-section. If desired, the diameter of the lumen or hollow region 11 of the slotted, variable size, expandable metallic implant or stent can be further increased by additional balloon inflation to a second, larger diameter, wherein the curved structural metallic strut elements are straightened and elongated circumferentially, the flexible polymer (inner) layer is stretched, and the lumen or hollow region 11 of the expandable implant or stent becomes larger by radial expansion of the metallic implant or stent. In some examples, the slotted, variable size, expandable metallic implant or stent may have 1, 2, 3, orAUROM.002WO PCT more longitudinal discontinuities per implant or stent and may have 1 , 2, 3, or more structural metallic strut elements per discontinuity.

[0251] FIG. 26B is a perspective view of an example of a slotted, variable size, expandable metallic implant or stent showing a longitudinal discontinuity in the structural metal layer such that the lumen or hollow region 11 of the slotted, variable size, expandable metallic implant or stent can be increased after an initial expansion. The longitudinal discontinuity is bridged by angled metallic strut elements that are designed to provide a continuous structural metal path across the longitudinal discontinuity to maintain electrical continuity during manufacturing, limit expansion of the slotted metallic implant or stent during expansion, and transmit force and maintain hoop strength of the slotted, variable size, expandable metallic implant or stent after implantation. For this example, a structural metal (outer) layer is joined to a continuous flexible polymer (inner) layer extending from the open proximal end to the open distal end of the expandable metallic implant or stent, including the triangular flaps on both ends. For this example, there are two discrete structural (outer) metal layer segments joined to the flexible inner polymer layer. The polymer-only gaps between two discrete structural (outer) metal layer segments provide flexibility for the expandable metallic implant or stent both during delivery to a target vessel segment and also after implantation in the target vessel segment. For this example, the slotted, variable size, expandable metallic implant or stent can be folded and pleated with the balloon portion of a balloon catheter in a conventional pleating and folding operation. After delivery to a target vessel segment, the lumen or hollow region 11 of such slotted, variable size, expandable metallic implant or stent can be expanded by balloon inflation to a first expanded diameter, wherein the folds and pleats of the slotted, variable size, expandable metallic implant or stent are partially or completely straightened, unfolded, or unpleated and the lumen or hollow region 11 of the of such slotted, variable size, expandable metallic implant or stent becomes circular or substantially circular in cross-section. If desired, the diameter of the lumen or hollow region 11 of the slotted, variable size, expandable metallic implant or stent can be further increased by additional balloon inflation to a second, larger diameter, wherein the angled structural metallic strut elements are straightened and elongated circumferentially, the flexible polymer (inner) layer is stretched, and the lumen or hollow region 11 of the expandable implant or stent becomes larger by radial expansion of the metallic implant or stent. In some examples, the slotted, variable size, expandable metallic implant or stent may have 1, 2, 3, orAUROM.002WO PCT more longitudinal discontinuities per implant or stent and may have 1 , 2, 3, or more structural metallic strut elements per discontinuity.

[0252] FIG. 26C is a perspective view of an example of a slotted, variable size, expandable metallic implant or stent showing a longitudinal discontinuity in the structural metal layer such that the lumen or hollow region 11 of the slotted, variable size, expandable metallic implant or stent can be increased after an initial expansion. The longitudinal discontinuity is bridged by diamond- shaped strut elements that are designed to provide a continuous structural metal path across the longitudinal discontinuity to maintain electrical continuity during manufacturing, limit expansion of the slotted metallic implant or stent during expansion, and transmit force and maintain hoop strength of the slotted, variable size, expandable metallic implant or stent after implantation. For this example, a structural metal (outer) layer is joined to a continuous flexible polymer (inner) layer extending from the open proximal end to the open distal end of the expandable metallic implant or stent, including the triangular flaps on both ends. For this example, there are two discrete structural (outer) metal layer segments joined to the flexible inner polymer layer. The polymer-only gaps between two discrete structural (outer) metal layer segments provide flexibility for the expandable metallic implant or stent both during delivery to a target vessel segment and also after implantation in the target vessel segment. For this example, the slotted, variable size, expandable metallic implant or stent can be folded and pleated with the balloon portion of a balloon catheter in a conventional pleating and folding operation. After delivery to a target vessel segment, the lumen or hollow region 11 of such slotted, variable size, expandable metallic implant or stent can be expanded by balloon inflation to a first expanded diameter, wherein the folds and pleats of the slotted, variable size, expandable metallic implant or stent are partially or completely straightened, unfolded, or unpleated and the lumen or hollow region 11 of the of such slotted, variable size, expandable metallic implant or stent becomes circular or substantially circular in cross-section. If desired, the diameter of the lumen or hollow region 11 of the slotted, variable size, expandable metallic implant or stent can be further increased by additional balloon inflation to a second, larger diameter, wherein the diamond-shaped strut elements are elongated circumferentially and foreshortened longitudinally, the flexible polymer (inner) layer is stretched, and the lumen or hollow region 11 of the expandable implant or stent becomes larger by radial expansion of the metallic implant or stent. In some examples, the slotted, variable size, expandable metallic implant or stent may have 1, 2,AUROM.002WO PCT3, or more longitudinal discontinuities per implant or stent and may have 1 , 2, 3, or more structural metallic strut elements per discontinuity.

[0253] FIG. 27 is a perspective view of an example of a fenestrated, variable size, expandable metallic implant or stent 52 showing a structural metal (outer) layer arranged in discrete, ring-shaped metal layer segments of repeating diamond- shaped strut elements such that the lumen or hollow region 11 of the fenestrated, variable size, expandable metallic implant or stent can be expanded to a larger diameter after an initial expansion.

[0254] In some examples, rings of diamond-shaped strut elements 29 / 55 are joined to a continuous flexible inner polymer layer 50 that extends from the open proximal end to the open distal end of the fenestrated, variable size, expandable metallic implant or stent, including the triangular flaps 16 on both ends. For this example, the polymer-only gaps between the discrete and independent rings of diamond-shaped strut elements provide flexibility for the fenestrated, variable size, expandable metallic implant or stent both during delivery to a target vessel segment and also after implantation in the target vessel segment. For this example, the fenestrated, variable size, expandable metallic implant or stent can be folded and pleated with the balloon portion of a balloon catheter in a conventional pleating and folding operation. After delivery to a target vessel segment the lumen or hollow region 11 of such fenestrated, variable size, expandable metallic implant or stent can be increased by balloon inflation to a first expanded diameter, wherein the folds and pleats of the fenestrated, variable size, expandable metallic implant or stent are partially or completely straightened, unfolded, or unpleated, and the lumen or hollow region 11 of the fenestrated, variable size, expandable implant or stent becomes circular or substantially circular in cross-section. If desired, the lumen or hollow region 11 diameter of the fenestrated, variable size, expandable metallic implant or stent can be further increased by additional balloon inflation to a second, larger diameter, wherein the diamondshaped strut elements are elongated circumferentially and foreshortened longitudinally, the inner polymer layer is stretched, and the lumen or hollow region 11 of the expandable implant or stent becomes larger by radial expansion of the metallic implant or stent.

[0255] In some examples, the inner polymer layer 50 can be an ultra-thin layer of polyurethane. The polymer layer 50 can be compliant and can stretch and still maintain barrier integrity with secondary expansion. The polymer layer 50 may be surrounded by alternating gold structures disposed radially or circumferentially around the polymer layer 50. The polymer layerAUROM.002WO PCT50 may be surrounded by columns of diamond-shaped struts 29 / 55, or pieces. Tn some examples, the polymer layer 50 may be surrounded by 4 columns of diamond-shaped struts 29 / 55 extending circumferentially around the polymer layer 50. In some examples, the polymer layer 50 may be surrounded by 1-10 columns of diamond-shaped struts 29 / 55 extending circumferentially around the polymer layer 50. The polymer layer 50 may be surrounded by columns of zig-zag elements 29 / 53, or rings. In some examples, the polymer layer 50 may be surrounded by 3 columns of zigzag elements 29 / 53 extending circumferentially around the polymer layer 50. In some examples, the polymer layer 50 may be surrounded by 1-10 columns of zig-zag elements 29 / 53 extending circumferentially around the polymer layer 50. In some examples, the diamond-shaped struts 29 / 55 and zig-zag elements 29 / 53 can be formed of electroformed gold or another suitable metal. In some examples, the diamond- shaped struts 29 / 55 and zig-zag elements 29 / 53 can be interspersed between each other. In some examples, the distalmost and / or proximalmost metal structure of the outer layer of the stent 52 can be the diamond-shaped struts 29 / 55. In some examples, the gold layer can include discontinuities or gaps between the diamond-shaped struts 29 / 55 and zig-zag elements 29 / 53. In some examples, the ring pattern can resemble what a crimped, balloon expandable stent would look like with crowded struts. In some examples, the ring pattern can resemble what a fully expanded stent would look like with elongate, open cells. In some examples, the diameter gain can be increased by unfolding the pleated and folded stent and expanding the ring structure further. The ring structure can include the diamond- shaped struts 29 / 55 and zig-zag elements 29 / 53. In some examples, the flaps 16 can have rounded tips. In some examples, the flaps 16 can be made of polymer. In some examples, the stent can include a thin layer of gold, for example less than 1 micron, on the inner surface of the polyurethane. In some examples, an inner layer of gold can speed up endothelialization, which can get patients off anticoagulants sooner. In some examples, the stent 52 can be used with a thin walled (for example 8 - 14 micron single-wall thickness) balloon made of Pebax or PET that is moderately compliant on an over-the-wire catheter system with a single hub with both the guidewire port and the inflation port. In some examples, the stent 52 can accommodate a low profile, for example a 0.14” platform due to the thinner balloon and implant wall. In some examples, the structure of the implant 52 with the gold struts arranged circumferentially around the polymer layer can improve flexibility and deliverability. In some examples, the stent 52 can have increased fluoroscopic conspicuity and minimal foreshortening to provide good landing zoneAUROM.002WO PCT accuracy. Tn some examples, the gold rings and the gold pieces can be completely separated in the expanded configuration. In some examples, the gold rings and the gold pieces can be connected by flexible metal struts, for example gold struts, in the expanded configuration.

[0256] FIG. 28A-C are perspective views of an example of a fenestrated, variable size, expandable metallic implant or stent showing a structural metal (outer) layer arranged in discrete and independent rings of rounded diamond-shaped strut elements such that the lumen or hollow region 11 of the fenestrated, variable size, expandable metallic implant or stent can be expanded to a larger diameter after an initial expansion. The rings of rounded diamond- shaped strut elements are joined to a continuous flexible inner polymer layer that extends from the open proximal end to the open distal end of the expandable metallic implant or stent, including the triangular flaps on both ends. For this example, the polymer-only gaps between the discrete and independent rings of rounded diamond- shaped strut elements provide flexibility for the expandable metallic implant or stent both during delivery to a target vessel segment and also after implantation in the target vessel segment. For this example, the fenestrated, variable size, expandable metallic implant or stent can be folded and pleated with the balloon portion of a balloon catheter in a conventional pleating and folding operation. After delivery to a target vessel segment, the lumen or hollow region 11 of such variable size expandable metallic implant or stent can be increased by balloon inflation to a first expanded diameter, wherein the folds and pleats of the fenestrated, variable size, expandable metallic implant or stent are partially or completely straightened, unfolded, or unpleated, and the lumen or hollow region 11 of the fenestrated, variable size, expandable implant or stent becomes circular or substantially circular in cross-section. If desired, the lumen or hollow region 11 diameter of the fenestrated, variable size expandable metallic implant or stent can be further increased by additional balloon inflation to a second, larger diameter, wherein the rounded diamond- shaped elements are circumferentially elongated and longitudinally foreshortened, and the lumen or hollow region 11 of the expandable implant or stent becomes larger by radial expansion of the metallic implant or stent. FIG. 28A-C show progressively larger second expanded diameters from the smallest (FIG. 28A) to the largest (FIG. 28C).

[0257] FIG. 29A is a perspective view of an example of a fenestrated, variable size, expandable metallic implant or stent showing a structural metal (outer) layer arranged in a web, net or network pattern of diamond-shaped strut elements such that the lumen or hollow region 11AUROM.002WO PCT of the fenestrated, variable size, expandable metallic implant or stent can be expanded to a larger diameter after an initial expansion. For this example, the struts can articulate at nodes so that the variable size expandable implant or stent can accurately accommodate the size, diameter, length, shape and curvature of the underlying vascular structure after implantation. The rings of diamond-shaped strut elements are joined to a continuous flexible inner polymer layer that extends from the open proximal end to the open distal end of the fenestrated, variable size, expandable metallic implant or stent, including the triangular flaps on both ends. For this example, the fenestrated, variable size, expandable metallic implant or stent can be folded and pleated with the balloon portion of a balloon catheter in a conventional pleating and folding operation. After delivery to a target vessel segment the lumen or hollow region 11 of such fenestrated, variable size, expandable metallic implant or stent can be increased by balloon inflation to a first expanded diameter, wherein the folds and pleats of the fenestrated, variable size, expandable metallic implant or stent are partially or completely straightened, unfolded, or unpleated, and the lumen or hollow region 11 of the fenestrated, variable size, expandable implant or stent becomes circular or substantially circular in cross-section. If desired, the lumen or hollow region 11 diameter of the fenestrated, variable size, expandable metallic implant or stent can be further increased by additional balloon inflation to a second, larger diameter, wherein the diamond-shaped strut elements are elongated circumferentially and foreshortened longitudinally, the inner polymer layer is stretched, and the lumen or hollow region 11 of the expandable implant or stent becomes larger by radial expansion of the metallic implant or stent.

[0258] FIG. 29B is a perspective view of an example of a longer version of the fenestrated, variable size, expandable metallic implant or stent shown in FIG. 28A.

[0259] FIG. 30A, FIG. 30C are perspective views of an example of a secondary folded and pleated, variable size, expandable metallic implant or stent wherein a portion of the wall of the implant or stent is folded and is pleated over itself. FIG. 30E is a perspective view of an example of a secondary folded and pleated, variable size, expandable metallic implant or stent wherein a portion of the wall of the implant or stent is formed into a secondary fold, prior to forming a secondary pleat. For these examples, the secondary folds and pleats are formed first and then the primary pleats and folds are formed after that. In some examples, the secondary folds and pleats are formed during the formation of the secondary folded and pleated, variable size, expandable metallic implant or stent; and in other examples, the secondary folds and pleatsAUROM.002WO PCT are formed in a separate operation after the formation of the secondary folded and pleated, variable size, expandable metallic implant or stent. After the formation of secondary folds and pleats, the secondary folded, variable size, expandable metallic implant or stent is subsequently folded and pleated together with the balloon portion of a balloon catheter in a conventional pleating and folding operation. After delivery to a target vessel segment, the diameter of the lumen or hollow region 11 of such secondary folded and pleated, variable size, expandable metallic implant or stent can be increased by balloon inflation to a first expanded diameter, wherein the primary folds and pleats of the secondary folded and pleated, variable size, expandable metallic implant or stent are partially or completely straightened, unfolded, or unpleated and the lumen or hollow region 11 of the secondary folded and pleated, variable size, expandable implant or stent becomes circular or substantially circular in cross-section. If desired, the lumen or hollow region 11 diameter of the secondary folded and pleated, variable size expandable metallic implant or stent can be further increased by additional balloon inflation to a second, larger diameter, wherein the secondary folds and pleats of the secondary folded and pleated, variable size expandable metallic implant or stent are partially or completely straightened, unfolded, or unpleated, and the lumen or hollow region 11 of the expandable implant or stent becomes larger by radial expansion of the metallic implant or stent.

[0260] As shown in FIG. 23A and B, FIG. 27, and FIG. 28A-C, a structural metal layer 27 of an expandable metallic implant 10 may comprise a plurality of longitudinal segments circumferentially disposed around a polymer layer 29 wherein the structural metal layer segments are separated by radial gaps or discontinuities 53 comprising polymer. As shown in FIG. 23A and B, FIG. 27, and FIG. 28A-C, the structural metal layer 27 segments may comprise rings or ring-like structures. As shown in FIG. 27, and FIG. 28A-C, the structural metal layer 27 segments may be configured as a lattice with struts or strut elements, and cells. As shown in FIG. 27, FIG. 28A-C, and FIG. 29. the structural metal layer 27 can comprise cells with a closed configuration. As shown in FIG. 27, FIG. 28A-C, and FIG. 29, the cells can have a diamondshaped or modified (rounded) diamond-shaped configuration. In other examples, the cells can have hexagonal, Z or zigzag-shaped, serpentine, and ring and link shapes or patterns. As shown in FIG. 24A and FIG. 24A, the rings or ring-like structures can be joined by one or more struts or strut elements that cross the radial gaps. In some examples, the struts or strut elements that crossAUROM.002WO PCT the radial gaps can have a straight, angled, diamond-shaped, hexagonal, Z or zigzag-shaped, or serpentine shape.Guide Catheters and Methods of Use

[0261] FIG. 16A is a planar view of a guide catheter or guide sheath 200 and a Tuohy Borst adaptor 406, wherein the guide catheter or guide sheath 200 and a Tuohy Borst adaptor 406 are separated. FIG. 16B is a planar view of a guide catheter or guide sheath 200 and a Tuohy Borst adaptor 406, wherein the guide catheter or guide sheath 200 and a Tuohy Borst adaptor 406 are joined, wherein the Tuohy Borst adaptor 406 is configured for flushing the lumen of the guide catheter or guide sheath 200.

[0262] In some examples, guide catheter and guide sheath devices 200 may include an elongate body 201, a hub 203 joined or bonded to the proximal end the elongate body 201, and a lumen extending from the proximal to the distal end, wherein the guide catheter and guide sheath can be configured for use in selecting, delivering, and detaching various examples of expandable metallic implant or stents 10 of expandable metallic implant or stent devices 1. and methods of use thereof. The guide catheter or guide sheaths 200 have a proximal end, a distal end that is open, and a lumen configured to accept an expandable metallic implant or stent 10 configured for delivery (including a folded and pleated expandable metallic implant or stent 10) and the associated elongate body 160. In some examples, the guide catheter or guide sheath 200 is also configured for detaching various examples of the expanded expandable implants 10 from the elongate body 160 after deflation or collapse of the balloon 110. In some examples, the lumen of the guide catheter or guide sheath 200 is configured for the injection of fluids, including water, saline, radiographic contrast, solutions comprising therapeutic agents or drugs, and mixtures therein.

[0263] In some examples, the length of the elongate body 201 is between 20 - 200 cm. In some examples, the total length of the guide catheter or guide sheath 200 is between 20.5 - 200.5 cm. In some examples, the outer diameter of the elongate body 201 is between 0.067 - 0.140 inch. In some examples, the internal or luminal diameter of the elongate body 201 is between 0.055 - 0.126 inch.

[0264] In some examples, the wall 211 of the elongate body 201 is continuous from the proximal end to the distal end. In some examples, the elongate body 201 can include: 1) an outer layer comprising polymer; 2) an inner layer comprising polymer; and a middle layer comprisingAUROM.002WO PCT metal; wherein the middle layer is disposed between the outer layer and an inner layer. Tn some examples, the inner layer, outer layer, or both the inner layer and outer layer of the elongate body 201 can include polymer with successively decreasing durometer from the proximal to the distal end of the elongate body 201.

[0265] In some examples, the distal segment of the outer layer of the wall 211 of the elongate body 201 can include an aliphatic polyether polyurethane or a polyether block amide. In some examples, the aliphatic polyether polyurethane is Tecoflex. In some examples, a distal segment of the outer layer of the of the wall 211 of the elongate body 201 can include a material with a Shore durometer hardness of 20 - 60 D. In some examples, the middle segment of the outer layer of the wall 211 of the elongate body 201 can include a polyether block amide or a nylon. In some examples, the polyether block amide is Pebax. In some examples, the range of the durometer of the polyether block amide is between Pebax 7233 and Pebax 2522 distally. In some examples, the proximal segment of the wall 211 of the outer layer of the elongate body 201 can include a nylon. In some examples, the nylon is Grilamid. In some examples, a proximal segment of the outer layer of the wall 211 of the elongate body 201 can include a material with a Shore durometer hardness of 40 - 90 D. In some examples, the outer layer of at least a portion of the elongate body 201 can include polyimide.

[0266] In some examples, the inner layer of the wall 211 of the elongate body 201 can include a lubricious polymer. In some examples, the lubricious polymer can include polytetrafluoroethylene, polyimide, or a composite or mixture of polytetrafluoroethylene (PTFE) and polyimide.

[0267] In some examples, the metal of the middle layer of the elongate body 201 is configured as wire. In some examples, the wire is configured in a spiral, coil, braid, woven, or straight pattern, or combinations thereof. In some examples, at least some of the metal in the middle layer of the elongate body 201 is configured as wire with a cross-sectional shape that is round, oval, square, or rectangular. In some examples, the wire can include nitinol or stainless steel. In some examples, the wire is round and has a diameter between 0.0005 - 0.0030 inch. In some examples, the wire is configured in a coil with a pitch of between 0.0010 - 0.0060 inch. In some examples, the wire is flat and has a thickness of between 0.0005 - 0.0060 inch and a width of between 0.001 - 0.030 inch. In some examples, wherein the wire is configured in a braid, the braid has a picks per inch of length (PPI) of between 50 - 300. In some examples, the metal ofAUROM.002WO PCT the middle layer of the elongate body 201 is configured as a laser cut hypotube. In some examples, the laser cut hypotube can include nitinol. In some examples, the metal or metal wire is absent from the distal segment of the elongate body 201.

[0268] In some examples, the wall of the elongate body 201 of the guide catheter or guide sheath 200 further can include a tie layer. In some examples, the wall of the elongate body 201 can include one or more liquid crystal polymer fibers. In some examples, the liquid crystal polymer fibers are oriented parallel to the first axis 38 of the elongate body 201. In some examples, the one or more liquid crystal polymer fibers are coiled around the elongate body 201. In some examples, one or more polymers of the wall of the elongate body 201 can include barium sulfate. In some examples, the polymer can include barium sulfate at a concentration of 10 - 30%.

[0269] In some examples, the elongate body 201 can include one or more marker bands 209 that are radiopaque or conspicuous during fluoroscopy. In some examples, the elongate body 201 can include a single marker band 209 that is conspicuous during fluoroscopy configured for identifying the tip region of the guide catheter or guide sheath 200 during fluoroscopy or a single marker band 209 that is radiopaque or conspicuous during fluoroscopy at a location < 10 mm proximal to the distal end of the elongate body 201. In some examples, the elongate body 201 can include 2 - 5 marker bands 209 that are radiopaque or conspicuous during fluoroscopy and configured for making measurements of the diameter of blood-containing structures during angiography, or 2 - 5 marker bands 209 that are radiopaque or conspicuous during fluoroscopy at a location > 10 mm proximal to the distal end of the elongate body 201. In some examples, the elongate body 201 can include a single marker band 209 that is radiopaque or conspicuous during fluoroscopy configured for identifying the tip region of the guide catheter or guide sheath 200 during fluoroscopy, and two or three additional marker bands 209 that are radiopaque or conspicuous during fluoroscopy and configured for making measurements of the diameter of blood-containing structures during angiography. In some examples, the elongate body 201 can include a single marker band 209 that is radiopaque or conspicuous during fluoroscopy at a location < 10 mm proximal to the distal end of the elongate body 201 and two or three additional marker bands 209 that are radiopaque or conspicuous during fluoroscopy at a location > 10 mm proximal to the distal end of the elongate body 201. In some examples, the 2 - 5 marker bands 209 are located on a straight portion of the elongate body 201.AUROM.002WO PCT

[0270] Tn some examples, the proximal portion of the elongate body 201 adjacent to the hub 203 can include a segment of polymer that provides strain relief 204 to the junction between the hub 203 and the elongate body 201. In some examples, the outer diameter of the distal end of the elongate body 201 has a radius.

[0271] In some examples, the elongate body 201 can include a lubricious or hydrophilic coating layer. In some examples, the lubricious or hydrophilic coating layer is present on the inner surface, the outer surface, or both the inner and outer surface of the elongate body 201. In some examples, the lubricious or hydrophilic coating layer is present on the outer surface of the distal portion of the elongate body 201, on the outer surface of the middle and distal portion of the elongate body 201, or on the entire outer surface of the elongate body 201.

[0272] In some examples, the outer diameter of the distal end of the elongate body 201 has a radius. In some examples, the elongate body 201 is straight or is straight when in an unconstrained configuration. In some examples, a portion of the elongate body 201 has a portion with a pre-formed shape 211 or has a portion with a pre-formed shape 211 when in an unconstrained configuration, including a distal portion. In some examples, the pre-formed shape portion 211 can include an Angled, Multi-Purpose, Berenstein, Vertebral, Hockey Stick, Simmons 1, Simmons 2, Simmons 3, Cobra 1, Cobra 2, Headhunter, JB 1, JB2, and Renal Double Curve shape, or any other shape needed to facilitate advancement.

[0273] In some examples, the guide catheter or guide sheath 200 is provided with an obturator or dilator to provide a smooth transition from a guidewire 280 to the tip of the guide catheter or guide sheath 200 during insertion. In some examples, the obturator or dilator can include: a lumen configured to accept a guidewire 280; an outer diameter that is between 0.001 - 0.006 inch smaller than the inner (luminal diameter) of the guide catheter or guide sheath 200; a longer elongate body than the guide catheter or guide sheath 200 so that it can pass through the lumen of the guide catheter or guide sheath 200 and exit the tip of the guide catheter or guide sheath 200; and a hub that can reversibly couple with the hub 203 of the guide catheter or guide sheath 200. In some examples, the obturator or dilator can include a lubricious or hydrophilic coating layer. In some examples, the lubricious or hydrophilic coating layer is present on the inner surface, the outer surface, or both the inner and outer surface of the obturator or dilator. In some examples, the lubricious or hydrophilic coating layer is present on the distal portion of the outer surface of the obturator or dilator, on the middle and distal portion of the outer surface ofAUROM.002WO PCT the obturator or dilator, or on the entire outer surface of the obturator or dilator. Tn some examples, the lumen of the obturator or dilator is configured to accept a 0.010, 0.014, 0.018, 0.025, 0.035. or 0.038 inch guidewire 280.

[0274] In some examples, the system can include a guide catheter or guide sheath 200 and an expandable metallic implant or stent device 1 is used to obstruct, occlude, embolize, or reduce flow in arteries, veins, aneurysms, parent vessels of saccular aneurysms, paravalvular leak pathways, biological conduits, or other blood-containing, fluid-containing, or biological spaces, the inner (luminal) diameter of a guide catheter or guide sheath 200 is larger than the outer diameter of elongate body 160. If the expandable metallic implant or stent device 1 is inserted directly into the guide catheter or guide sheath 200, blood will enter the lumen of the guide catheter or guide sheath 200 and leak around the elongate body 160 and out of the patient at the hub 203 of the guide catheter or guide sheath 200. Therefore, operators will sometimes join a Tuohy Borst adaptor 406 with a rotating hemostatic valve 407 or a rotating hemostatic valve without a side arm to the hub 203 of the guide catheter or guide sheath 200 and then insert the expandable metallic implant or stent device 1 through the Tuohy Borst adaptor 406 into the lumen of the guide catheter or guide sheath 200 and use the valve on the Tuohy Borst adaptor 406 to prevent the leading of blood. The present disclosure includes systems comprising a guide catheter or guide sheath 200, an expandable metallic implant or stent device 1, and a Tuohy Borst adaptor 406. Opening and closing of a Tuohy Borst adaptor 406 can introduce air into the Tuohy Borst adaptor 406 and the lumen of the guide catheter or guide sheath 200. A Tuohy Borst adaptor 406 can include a side arm 408 that can be used to aspirate air from the Tuohy Borst adaptor 406 and to flush the Tuohy Borst adaptor 406. A rotating hemostatic valve can include a valve but not a side arm for flushing.Coiling or Delivery Catheter Medical Devices and Methods of Use

[0275] Coil expandable implants can be delivered to the treatment site through a thin, flexible specialty catheter developed for the implantation of coil expandable implants (a “coiling catheter”), or through another type of catheter. A coiling catheter is advanced into the body and once the desired position is reached, one more coil expandable implants are pushed through the lumen of the coiling catheter and placed at the treatment site.

[0276] Further implementations of this disclosure relate to coiling catheters 260 comprising an elongate body, a hub joined or bonded to the proximal end the elongate body, andAUROM.002WO PCT a single lumen extending from the proximal to the distal end, wherein the coiling catheters 260 can be configured for facilitating the placement of coil expandable implant devices, and methods of use thereof. The coiling catheters 260 have a proximal end, a distal end that is open, and a lumen configured to accept a guidewire 280, deliver coil expandable implant devices, and for the injection of fluids, including water, saline, radiographic contrast, solutions comprising therapeutic agents or drugs, and mixtures therein.

[0277] In some examples, the length of the elongate body is between 21 - 201 cm. In some examples, the total length of the coiling catheter is between 21.5 - 201.5 cm. In some examples, the outer diameter of the elongate body is between 0.033 - 0.041 inch. In some examples, the internal or luminal diameter of the elongate body is between 0.021 - 0.029 inch.

[0278] In some examples, the wall of the elongate body is continuous from the proximal end to the distal end. In some examples, the elongate body can include: 1) an outer layer comprising polymer; 2) an inner layer comprising polymer; and a middle layer comprising metal; wherein the middle layer is disposed between the outer layer and an inner layer. In some examples, the inner layer, outer layer, or both the inner layer and outer layer of the elongate body can include polymer with successively decreasing durometer from the proximal to the distal end of the elongate body.

[0279] In some examples, the distal segment of the outer layer of the wall of the elongate body can include an aliphatic polyether polyurethane or a polyether block amide. In some examples, the aliphatic polyether polyurethane is Tecoflex. In some examples, a distal segment of the outer layer of the wall of the elongate body can include a material with a Shore durometer hardness of 20 - 60 D. In some examples, the middle segment of the outer layer of the wall of the elongate body can include a polyether block amide or a nylon. In some examples, the polyether block amide is Pebax. In some examples, the range of the durometer of the polyether block amide is between Pebax 7233 and Pebax 2522 distally. In some examples, the proximal segment of the outer layer of the wall of the elongate body can include a nylon. In some examples, the nylon is Grilamid. In some examples, a proximal segment of the outer layer of the wall of the elongate body can include a material with a Shore durometer hardness of 40 - 90 D. In some examples, the outer layer of at least a portion of the wall of the elongate body can include polyimide.AUROM.002WO PCT

[0280] In some examples, the metal of the middle layer of the elongate body is configured as wire. In some examples, the wire is configured in a spiral, coil, braid, woven, or straight pattern, or combinations thereof. In some examples, at least some of the metal in the middle layer of the elongate body is configured as wire with a cross-sectional shape that is round, oval, square, or rectangular. In some examples, the wire can include nitinol or stainless steel. In some examples, the wire is round and has a diameter of between 0.0005 - 0.0030 inch. In some examples, the wire is configured in a coil with a pitch of between 0.0010 - 0.0060 inch. In some examples, the wire is flat and has a thickness of between 0.0005 - 0.0060 inch and a width of between 0.001 - 0.030 inch. In some examples, wherein the wire is configured in a braid, the braid has a picks per inch of length (PPI) of between 50 - 300. In some examples, the metal of the middle layer of the elongate body is configured as a laser cut hypotube. In some examples, the laser cut hypotube can include nitinol. In some examples, the metal or metal wire is absent from the distal segment of the elongate body.

[0281] In some examples, the inner layer of the wall of the elongate body can include a lubricious polymer. In some examples, the lubricious polymer can include polytetrafluoroethylene, polyimide, or a composite or mixture of polytetrafluoroethylene (PTFE) and polyimide. In some examples, a layer of the proximal end of the elongate body can include a material with a Shore durometer hardness of 40 - 90 D. In some examples, a layer of the distal end of the elongate body can include a material with a Shore durometer hardness of 20 - 60 D.

[0282] In some examples, the wall of the elongate body of the coiling catheter further can include a tie layer. In some examples, the wall of the elongate body can include one or more liquid crystal polymer fibers. In some examples, the liquid crystal polymer fibers are oriented parallel to the first axis 38 of the elongate body. In some examples, the one or more liquid crystal polymer fibers are coiled around the elongate body. In some examples, one or more polymers of the wall of the elongate body can include barium sulfate. In some examples, the polymer can include barium sulfate at a concentration of 10 - 30%.

[0283] In some examples, the elongate body can include one or more marker bands that are radiopaque or conspicuous during fluoroscopy. In some examples, the elongate body can include a marker band that is radiopaque or conspicuous during fluoroscopy configured for identifying the tip region of the coiling catheter during fluoroscopy or a marker band that is radiopaque or conspicuous during fluoroscopy at a location < 10 mm proximal to the distal endAUROM.002WO PCT of the elongate body. Tn some examples, the elongate body can include two marker bands that are radiopaque or conspicuous during fluoroscopy and configured for assisting the detachment of coil expandable implants or two marker bands that are radiopaque or conspicuous during fluoroscopy and are located on a straight portion of the elongate body at a location > 10 mm proximal to the distal end of the elongate body. In some examples, the elongate body can include a single marker band that is radiopaque or conspicuous during fluoroscopy and configured for identifying the tip region of the coiling catheter during fluoroscopy and two additional marker bands that are radiopaque or conspicuous during fluoroscopy and configured for assisting the detachment of coil expandable implants. In some examples, the elongate body can include a single marker band that is radiopaque or conspicuous during fluoroscopy at a location < 10 mm proximal to the distal end of the elongate body and two additional marker bands that are radiopaque or conspicuous during fluoroscopy and are located on a straight portion of the elongate body at a location > 10 mm proximal to the distal end of the elongate body.

[0284] In some examples, the proximal portion of the elongate body adjacent to the hub can include a segment of polymer that provides strain relief to the junction between the hub and the elongate body. In some examples, the outer diameter of the distal end of the elongate body has a radius. In some examples, the outer diameter of the distal end of the elongate body has a radius.

[0285] As shown in FIGs. 21B-21K, FIGs. 31A-31B, and FIGs. 32A-32B, in some examples, the strain relief and / or implant can be fabricated with multiple layers. The layers may include an inner layer 181. The inner layer 181 may be positioned radially around an elongate body 179 or an outer shaft 180 of the balloon catheter 100 . The layers may include an outer layer 180. The hub 185 may include a first outlet 198 and a second outlet 199. The first outlet 198 may have a first lumen 184. The second outlet 199 may have a second lumen 163. The hub 197 may include an outlet with a single lumen 161 / 162. In some examples, the various layers of strain relief can have different lengths so that there is a progression of strain relief lengths distally from the hub so as to effect a progressive reduction of stiffness from the hub to the shaft of the elongate body.

[0286] In some examples, the elongate body can include a lubricious or hydrophilic coating layer. In some examples, the lubricious or hydrophilic coating layer is present on the inner surface, the outer surface, or both the inner and outer surface of the elongate body. In someAUROM.002WO PCT examples, the lubricious or hydrophilic coating layer is present on the outer surface of the distal portion of the elongate body, on the outer surface of the middle and distal portion of the elongate body, or on the entire outer surface of the elongate body.

[0287] In some examples, the distal portion of the elongate body of the coiling catheter is straight or is straight when in an unconstrained configuration. In some examples, a portion of the elongate body of the coiling catheter has a pre-formed shape or has a portion with a preformed shape when in an unconstrained configuration, including a distal portion.Coil Expandable Implants

[0288] Further implementations of this disclosure include the use of coil expandable implants. Coil expandable implants (not shown) can be complex, flexible, elongated metallic structures with a pre-formed shape configured for permanent implantation in a patient. In some examples, coil expandable implants can be configured for use in modifying, obstructing, or reducing the flow of blood or other biological fluids in a human patient after being placed in the lumen or space where the blood or other biological fluids are flowing. In some examples, coil expandable implant devices comprise a coil expandable implant and an elongate body reversibly joined to the coil expandable implant and configured to advance or retract the coil expandable implant in a human patient.

[0289] In some examples, coil expandable implants can be configured as a wire assembly comprising a core wire surrounded by an outer coiled or externally wound wire. The core wire has a distal end, a middle portion, and a proximal end. The middle portion of the core wire may have a diameter that is greater than the diameter of the distal end, the proximal end, or both the distal and proximal end. In some examples, the core wire is tapered at the distal end, the proximal end, or both the distal and proximal end. The outer wound or coiled wire can be wound in a right-hand manner or a left-hand manner around the core wire. The outer wound or coiled wire may be securely attached to the core wire at the distal end, the proximal end, or both the distal end and the proximal end with a cap. In some examples, the coil expandable implant can include a lubricious coating layer or covering.

[0290] In some examples, the core wire can include stainless steel or nitinol, or combinations thereof. In some examples, outer wound or coiled wire may comprise platinum or platinum alloys, such as platinum-tungsten or platinum-iridium, or gold. In some examples.AUROM.002WO PCT platinum is a preferred material due to its radiopacity (ability to be visualized under X-ray), conspicuity under fluoroscopy, flexibility, and biocompatibility.

[0291] The design of coil expandable implants can vary depending on factors such as the size and shape of the region being treated. Coil expandable implants may have a coating layer or adherent threads or fibers or other material to promote thrombosis (clotting). The coating layer or adherent threads or fibers or other material encourages the formation of a stable blood clot or thrombus around the coil expandable implants, effectively sealing off the treated area. Coil expandable implants are designed to be detached from the elongate body when they are properly positioned in vivo. This detachment can be achieved through mechanical, electrolytic, or thermal detachment, or other various types of detachment mechanisms. Coil expandable implants are radiopaque, meaning they are visible under X-ray fluoroscopy. This allows the operator to monitor the placement of the coil expandable implants in real-time during the procedure. Coil expandable implants are designed to be biocompatible, meaning they are well- tolerated by the body and does not cause adverse reactions, excessive local or systemic host responses or tissue damage.

[0292] The primary structure of a coil expandable implant is the “stock” wire, which is fabricated in linear form with a diameter (DI) of any range. Most stock wires used for coil expandable implant manufacturing are between 0.00122 to 0.003 inch. The stock wire diameter, DI, is the central factor in determining coil “stiffness.” The stock wire is wound around a mandrel, also of varying diameter, to produce the secondary structure of the coil expandable implant. The diameter (D2) of the secondary structure, in conjunction with the number of turns per unit of length around the mandrel, represents two additional factors that impact product stiffness. The secondary diameter, D2, dictates the historic coil expandable implant grouping, in which coil expandable implants deemed “10” coils are typically wound to approximately 0.010 inch and coils deemed “18” coils are typically wound to approximately 0.015 inch. The secondary structure can be shaped into any number of tertiary configurations (including helical, complex, and spherical), which also are developed with a specific diameter (D3) and length (L), parameters that serve as measurements shown on package labeling and serve as factors in the selection of expandable implants during interventional procedures. For instance, coils are typically packaged as “3 mm x 4 cm,” where the millimeter measurement is that of the tertiary diameter, D3, and the centimeter measurement is that of L.AUROM.002WO PCT

[0293] Tn some examples, coil expandable implants are joined to an elongate body by a bond or joint that can be separated after placement of the coil expandable implant into an artery, vein, aneurysm, parent vessel of a saccular aneurysm, paravalvular leak pathway, biological conduit, or other blood-containing, fluid-containing, or biological space, or the interior space 115 of the balloon 110 so that the elongate body can be removed from the patient while the coil expandable implant remains in the patient. In some examples, the coil expandable implants can be configured to stimulate thrombus formation and fibrosis in vivo, including by the addition of coatings, coverings, threads or fibers, including those comprised of polymers like polyesters, nylon, and polyvinyl alcohols or natural materials such as wool.

[0294] Coil expandable implants may be made from wire, polymer, and other flexible materials, and combinations therein. Coil expandable implants may be formed from selfexpanding materials or generally formed in a manner that renders the coil expandable implant self-expanding. Coil expandable implants may be formed from materials that are not selfexpanding or generally formed in a manner wherein the coil expandable implant is not selfexpanding. Examples of coil expandable implants include coils, metallic coils, metallic coils, polymer coils, coils comprising metal and polymer, coiled wires, coiled metallic wires, coiled metallic wires, coiled wires comprising metal and polymer, strands, polymer strands, metallic strands, metallic strands, strands comprising polymer and metal, vascular coils, assemblies of wires, assemblies of metallic wires, assemblies of metallic wires, assemblies of polymer strands, assemblies of wires or strands comprising metal and polymer, assemblies of coiled wires, assemblies of coiled metallic wires, assemblies of coiled metallic wires, assemblies of coiled polymer strands, assemblies of coiled structures comprising metal and wire, assemblies of strands, assemblies of polymer strands, assemblies of metallic strands, assemblies of metallic strands, and assemblies of strands comprising polymer and metal, and combinations thereof.

[0295] For some examples of coil expandable implants, the coils, metallic coils, metallic coils, polymer coils, coils comprising metal and polymer, coiled wires, coiled metallic wires, coiled metallic wires, coiled wires comprising metal and polymer, polymer strands, metallic strands, metallic strands, strands comprising polymer and metal, vascular coils, assemblies of wires, assemblies of metallic wires, assemblies of metallic wires, assemblies of polymer strands, assemblies of wires or strands comprising metal and polymer, assemblies of coiled wires, assemblies of coiled metallic wires, assemblies of coiled metallic wires, assemblies of coiledAUROM.002WO PCT polymer strands, assemblies of coiled structures comprising metal and wire, assemblies of polymer strands, assemblies of metallic strands, assemblies of metallic strands, and / or assemblies of strands comprising polymer and metal are self-expanding. In some examples, the coils, metallic coils, metallic coils, coils comprising metal and polymer, coiled wires, coiled metallic wires, coiled metallic wires, coiled wires comprising metal and polymer, metallic strands, metallic strands, strands comprising polymer and metal, vascular coils, assemblies of wires, assemblies of metallic wires, assemblies of metallic wires, assemblies of wires or strands comprising metal and polymer, assemblies of coiled wires, assemblies of coiled metallic wires, assemblies of coiled metallic wires, assemblies of coiled structures comprising metal and wire, assemblies of metallic strands, assemblies of metallic strands, and / or assemblies of strands comprising polymer and metal comprise nitinol.

[0296] In some examples, the coil expandable implant is a vascular coil. In some examples, the coil expandable implant can include platinum, iridium, nickel, tungsten, or combinations thereof.

[0297] In some examples, coil expandable implant may comprise a primary wire having a diameter of between 0.00122 - 0.003 inch. In some examples, coil expandable implants may comprise a primary wire having a diameter of between 0.005 - 0.050 inch. This primary wire may be wound against itself to provide an overall or secondary diameter of the coil expandable implant that is between 0.010 - 0.040 inch in diameter. Furthermore, this secondary shape of the coil expandable implants may be formed into tertiary shapes having a diameter of approximately 2 to 100 mm. The secondary diameter of coil expandable implants are generally similar to the standard diameters for guidewires 280 (0.010. 0.014, 0.018, 0.025, 0.035, and 0.038 inch) given that the same catheters are often used to place guidewires 280 and coil expandable implants.

[0298] Coil expandable implants come in various shapes and sizes. In some examples, at least a portion of a coil expandable implant has a looped, coiled, helical, spherical, or complex tertiary structure. In some examples, at least a portion of a coil expandable implant is configured to form a coiled, helical, or complex tertiary shape when relaxed. In some examples, the coil expandable implant has a tertiary diameter of the looped, coiled, or formed portion with a tertiary diameter between 2 - 100 mm.

[0299] In various examples, the coil expandable implants have a tertiary structure without pre-formed loops or shapes when relaxed (“unformed coil expandable implants”). InAUROM.002WO PCT some examples, unformed coil expandable implants can be configured to form a straight or unformed tertiary shape when relaxed. In various examples, these coil expandable implants are elongated and generally straight, and have a length between 10 cm - 500 cm. The unformed coil expandable implants may be deployed within an artery, vein, aneurysm, parent vessel of a saccular aneurysm, paravalvular leak pathway, biological conduit, or other blood-containing, fluid-containing, or biological space, or the central hollow region 11 of an expanded expandable metallic implant or stent 10. The unformed coil expandable implants may be used with various expandable metallic implant or stents 10 of any size and shape. In one aspect, unformed coil expandable implants are formed into a secondary shape when placed within the central hollow region 11 of an expanded expandable metallic implant or stent 10. The expanded expandable metallic implant or stent 10 can give the unformed coil expandable implants an advantageous secondary shape by constraining them inside the expanded expandable metallic implant or stent 10. Unformed coil expandable implants are desirable as they reduce friction during passage through coiling catheters 260. The unformed coil expandable implants also permits the use of fewer unformed coil expandable implants and reduces overall treatment times.

[0300] In some examples, unformed coil expandable implants may be manufactured to include one or more proximal or distal loops. The loops may be deformed under tension for delivery through catheters and then return to their pre-formed loop shape after they exit the catheter. The loops on the unformed coil expandable implants may reduce the risk of tissue injury during placement that could occur when using unformed coil expandable implants lacking loops. The loops on the unformed coil expandable implants may present a flatter surface to the adjacent tissue as the unformed coil expandable implant is pushed forward, reducing the risk of tissue injury. In some examples, the distal portion of a coil expandable implant can include 1, 2, 3 or 4 loops of tertiary structure and the remainder of the coil expandable implant can include a tertiary structure without pre-formed loops or shapes when relaxed. In some examples, the distal portion of a coil expandable implant can include 1, 2, 3 or 4 or more than 4 loops of tertiary structure and the remainder of the coil expandable implant can include a tertiary structure configured to form a straight or unformed tertiary shape when relaxed. The tertiary diameter of the looped, coiled, formed, or tertiary portion of the coil expandable implant is between 2 - 100 mm.AUROM.002WO PCT

[0301] In some methods, the elongate body of a coil expandable implant device is a wire, laser cut nitinol tube, or catheter.

[0302] In some methods, the operator can push all or a portion of a coil expandable implant out of a coiling catheter and use fluoroscopy or angiography to evaluate the placement of the coil expandable implant and the degree of obstruction or reduction in flow, before detaching the coil expandable implant from the elongate body. If the placement of the coil expandable implant or the degree of obstruction or reduction in flow is not appropriate then the coil expandable implant can be repositioned and detached, the coil expandable implant can be removed, the expandable metallic implant or stent 10 can be deflated and repositioned (if possible), the expandable metallic implant or stent 10 can be removed and replaced (if possible), an additional expandable metallic implant or stent 10 can be placed, or additional coil expandable implants can be placed.

[0303] In some examples, at least a portion of a coil expandable implant is configured to contact the exterior surface 34 of an expanded expandable metallic implant or stent 10.Guidewires and Methods of Use

[0304] A guidewire 280 can be a form of elongate body that is configured for use in guiding and advancing a guide catheter or guide sheath 200, intermediate catheter, selective catheter, or coiling catheter in a human patient. Guidewires 280 generally have a secondary diameter between 0.010 - 0.038 inch, including guidewires 280 with diameters of 0.010, 0.011, 0.012, 0.013, 0.014, 0.015, 0.016, 0.017, 0.018, 0.033, 0.034, 0.035, 0.036, 0.037, or 0.038 inch. Guidewires 280 generally have a length between 45 - 500 cm. The lumen of a guide catheter or guide sheath 200, intermediate catheter, selective catheter, or coiling catheter can be configured to accept guidewires 280 of various diameters and lengths.

[0305] FIG. 13B, 131, 14B, and 14J are cross sectional views of an example of a guide wire 280.

[0306] In some examples, guidewires 280 can be configured as a wire assembly comprising a core wire 281 surrounded by an outer coiled or externally wound wire. The core wire 281 has a distal end, a middle portion, and a proximal end. The middle portion of the core wire 281 may have a diameter that is greater than the diameter of the distal end, the proximal end. or both the distal and proximal end. In some examples, the core wire 281 is tapered at the distal end, the proximal end, or both the distal and proximal end. The outer wound or coiled wireAUROM.002WO PCT282 can be wound in a right-hand manner or a left-hand manner around the core wire 281 . The outer wound or coiled wire 281 may be securely attached to the core wire 281 at the distal end, the proximal end, or both the distal end and the proximal end with a cap.

[0307] In some examples, the core wire 281 can include stainless steel, nitinol, or combinations thereof. In some examples, the outer coiled or externally wound wire 282 can include platinum, gold, or combinations thereof. In some examples, the guidewire 280 can include a lubricious coating layer or covering. In some examples, a portion of the guidewire 280 has a pre-formed shape 285 or has a portion with pre-formed shape when in an unconstrained configuration, including a distal portion, to assist in the selection of vessel branches.Systems Comprising Expandable Implant Medical Devices, Guide Catheters or Guide Sheaths, and Coil Expandable Implants, and Methods of Use

[0308] The present disclosure describes devices, systems, and methods for sealing or closing breaches or openings in the wall of blood vessels and other biological conduits, and modifying, obstructing, or reducing flow through blood vessel lacerations and ruptures and arteriovenous fistulas, through discontinuities in endoprostheses or gaps between one endoprosthesis and another endoprosthesis or between an endoprosthesis and adjacent tissue, and for modifying, obstructing, or reducing flow into aneurysms, pseudoaneurysms, or other bloodcontaining, fluid-containing, or biological spaces using one or more expandable metallic implant or stent devices 1, or one or more expandable metallic implant or stent devices 1 and coil expandable implants.

[0309] In some examples, the present disclosure relates to devices, systems, and methods for delivering and positioning various examples of coil expandable implants before, during, and after expansion of an expandable metallic implant or stent 10 and wherein the expandable metallic implant or stents 10 and coil expandable implants are dimensioned and configured to seal or close breaches or openings in the wall of blood vessels and other biological conduits, and modify, obstruct, or reduce flow through blood vessel lacerations and ruptures and arteriovenous fistulas, through discontinuities in endoprostheses or gaps between one endoprosthesis and another endoprosthesis or between an endoprosthesis and adjacent tissue, and modify, obstruct, or reduce flow into aneurysms, pseudoaneurysms, or other blood-containing, fluid-containing, or biological spaces, and wherein the expandable metallic implant or stents 10 and coil expandable implants remain in place in an expanded or elongated state. In someAUROM.002WO PCT examples, one or more coil expandable implants are placed adjacent to an expandable metallic implant or stent 10 to increase the rate or completeness of the seal, closure, obstruction, or flow reduction.

[0310] In some examples, an expandable metallic implant or stent 10 in or folded and pleated form is advanced through the lumen of a guide catheter or guide sheath 200 and positioned in an artery or vein, and partially or fully expanded but, prior to separation of the expandable metallic implant or stent 10 and the guide catheter, a coiling catheter is advanced through the lumen of the guide catheter or guide sheath 200 alongside the elongate body 160 and one or more coil expandable implants are advanced through the lumen of the coiling catheter and placed adjacent to the expandable metallic implant or stent 10 in the blood vessel laceration or rupture, endoprosthesis discontinuity, arteriovenous fistula, aneurysm, pseudoaneurysm, or other blood-containing space.

[0311] In some examples, the expandable metallic implant or stent 10 is expanded by the injection of fluid through the first lumen 161 of the elongate body 160 and into the interior space 115 of the balloon 110. In some examples, expandable metallic implant or stent devices with larger diameter expandable metallic implant or stents 10 and balloons 110 require injection of larger amounts of fluid to achieve full expansion of the expandable metallic implant or stents 10 and balloons 110. The rate of fluid injection into the interior space 115 of the balloon 110 is dependent on several factors, including the pressure of the injection, the resistance to the flow of fluid in the first lumen 161 of the elongate body 160, the resistance to the flow of fluid through the proximal neck 117 of the balloon 110, the resistance to expansion of the folded and pleated balloon 110, and the resistance to expansion of the folded and pleated expandable metallic implant or stent 10. The resistance to the flow of fluid in the first lumen 161 of the elongate body 160 is reduced when the first lumen 161 diameter increases. In certain examples, expandable metallic implant or stent devices 1 with a larger diameter expanded expandable metallic implant or stent 10 also have an elongate body 160 with a larger lumen 161 diameter in order to keep expansion times low or relatively similar between the various device sizes. In certain examples, systems comprising an expandable metallic implant or stent device 1, a guide catheter or guide sheath 200, and a coiling catheter can be configured so that the devices can work together to seal or close breaches or openings in the wall of blood vessels and other biological conduits, and modify, obstruct, or reduce flow through blood vessel lacerations and ruptures and arteriovenousAUROM.002WO PCT fistulas, through discontinuities in endoprostheses or gaps between one endoprosthesis and another endoprosthesis or between an endoprosthesis and adjacent tissue, and modify, obstruct, or reduce flow into aneurysms, pseudoaneurysms, or other blood-containing, fluid-containing, or biological spaces. In such system examples, the lumen of the guide catheter or guide sheath 200 can be large enough to allow the folded and pleated expandable metallic implant or stent 10 and the elongate body 160 of the folded and pleated expandable metallic implant or stent device 1 to pass through the lumen of the guide catheter or guide sheath 200 and to the target location in the patient. In some examples, the inner diameter of the guide catheter or guide sheath 200 (the diameter of the lumen) and the outer diameter of the elongate body 160 of the folded and pleated expandable metallic implant or stent device 1 can be configured such that a coiling catheter for placing coil expandable implants can be advanced through the lumen of the guide catheter or guide sheath 200 while the elongate body 160 is also present in the lumen of the guide catheter or guide sheath 200, so that coil expandable implants can be placed adjacent to the expandable metallic implant or stent 10, including prior to or after expansion of the expandable metallic implant or stent 10. In some examples, the coiling catheter is configured to accept both guidewires 280 and coil expandable implants, or similar types of implants. In some examples, the system is designed so that the coiling or delivery catheter can be moved forward or backward while the expandable metallic implant or stent device 1 and the guide catheter or guide sheath 200 remain fixed in position. In some examples, the system is designed so that the expandable metallic implant or stent device 1 can be moved forward or backward while the coiling catheter and the guide catheter or guide sheath 200 remain fixed in position. In some examples, the system is designed so that the guide catheter or guide sheath 200 can be moved forward or backward while the expandable metallic implant or stent device 1 and coiling catheter remain fixed in position. In some examples, the system is designed so that coil expandable implants can be moved forward or backward while the coiling catheter, expandable metallic implant or stent device 1, and guide catheter or guide sheath 200 and remain fixed in position. In some examples, coil expandable implants can be placed at the target location while the expandable metallic implant or stent 10 is folded and pleated, partially expanded, or fully expanded. These types of systems wherein expandable metallic implant or stents 10 or coil expandable implants are used together allows operators to modify, obstruct, or reduce flow through blood vessel lacerations and ruptures and arteriovenous fistulas, through discontinuities in endoprostheses or gapsAUROM.002WO PCT between one endoprosthesis and another endoprosthesis or between an endoprosthesis and adjacent tissue, and modify, obstruct, or reduce flow into aneurysms, pseudoaneurysms, or other blood-containing, fluid-containing, or biological spaces in less time, to a greater degree, and to a greater extent than can be achieved by using the expandable metallic implant or stent 10 alone. These types of systems wherein expandable metallic implant or stents 10 and coil expandable implants are used together allows operators to reduce the risk of migration of the expanded expandable metallic implant or stent 10 and the coil expandable implants. In some examples, a system of one or more expandable metallic implant or stents 10 and one or more coil expandable implants is assembled in vivo to modify, obstruct, or reduce flow through blood vessel lacerations and ruptures, arteriovenous fistulas, and endoprosthesis discontinuities, and modify, obstruct, or reduce flow into aneurysms, pseudoaneurysms, or other blood-containing, fluidcontaining, or biological spaces. In some examples, a system of one or more expandable metallic implant or stents 10 and one or more coil expandable implants is assembled in vivo to reduce the risk of migration of both the expanded expandable metallic implant or stent 10 and the coil expandable implants.

[0312] Coil expandable implants can be configured for use with the expandable metallic implant or stent devices 1 , including by incorporating a design wherein the coil expandable implants are straight or mostly straight, enabling the adjunctive use of one or a few long, straight, or mostly straight, coil expandable implants for use in various clinical situations and thereby potentially reducing procedure time and cost.Systems Comprising Expandable metallic implant or stent Devices and Guide Sheaths or Guide Catheters, Coiling Catheters, and Coil Expandable Implant Devices, and Methods of Use

[0313] Further implementations of this disclosure relate to systems comprising an expandable metallic implant or stent device 1 and a guide catheter or guide sheath 200 device, wherein the guide catheter or guide sheath 200 can include an elongate body 201 and a hub 203, wherein the diameter and length of the lumen of the guide catheter or guide sheath 200 is configured so that the folded and pleated expandable metallic implant or stent 10 and elongate body 160 of a folded and pleated expandable metallic implant or stent device 1 can be passed through the lumen of the guide catheter or guide sheath 200 and positioned at the target location in vivo. For some examples of a system comprising an expandable metallic implant or stentAUROM.002WO PCT device 1 and a guide catheter or guide sheath 200, the system may comprise one or more of the following: a system wherein the difference between the diameter of the lumen of the guide catheter or guide sheath 200 and the outer diameter of the elongate body 160 is > 0.020 inch, including a system wherein the elongate body 160 passes through the lumen of the guide catheter or guide sheath 200; a system wherein the elongate body 160 passes through the lumen of the guide catheter or guide sheath 200; a system wherein the elongate body 160 is at least 5 mm longer than the overall length of the guide catheter or guide sheath 200; a system wherein the lumen of the guide catheter or guide sheath 200 is configured to allow for the passage of the folded and pleated portion of the folded and pleated expandable metallic implant or stent device 1 through the guide catheter or guide sheath 200 and into the body of the patient distal to the guide catheter or guide sheath 200; a system wherein the guide catheter or guide sheath 200 can be moved forward or backward while the expandable metallic implant or stent device 1 remains fixed in position; a system wherein the folded and pleated expandable metallic implant or stent device 1 can be moved forward or backward while the guide catheter or guide sheath 200 remains fixed in position; a system further comprising a Tuohy Borst adaptor 406 operably and reversibly coupled to the hub 203 of the guide catheter or guide sheath 200, the Tuohy Borst adaptor 406 comprising a side arm 408 configured for the injection of fluids, including water, saline, radiographic contrast, solutions comprising therapeutic agents or drugs, and mixtures therein.

[0314] In some examples, the distal end of the guide catheter or guide sheath 200 is configured for use in assisting the separation of the expanded expandable metallic implant or stent 10 and the balloon catheter 100. The present disclosure also relates to the use of systems comprising an expandable metallic implant or stent device 1 and a guide catheter or guide sheath 200, including using the distal end of the guide catheter or guide sheath 200 to separate or detach an expanded expandable metallic implant or stent 10 from a balloon catheter 100. For some examples of the system comprising an expandable metallic implant or stent device 1 and a guide catheter or guide sheath 200, a Tuohy Borst adaptor 406 with a side arm 408 for injection of fluids is joined to the hub 203 of the guide catheter or guide sheath 200 to enable the injection of radiographic contrast material through the lumen of the guide catheter or guide sheath 200 and into patients using the Tuohy Borst adaptor 406, including: after positioning the expandable metallic implant or stent 10 in a patient but before the expansion of the expandable metallicAUROM.002WO PCT implant or stent to evaluate the position of the expandable metallic implant or stent; after expansion of the expandable metallic implant or stent 10 to evaluate the shape and position of the expandable metallic implant or stent 10 and the obstruction or reduction in the rate of flow at the target location; and after removal of the balloon catheter 100 from the patient to evaluate the shape and position of the expanded expandable metallic implant or stent 10 and the obstruction or reduction in the rate of flow at the target location.

[0315] The present disclosure can also relate to systems comprising an expandable metallic implant or stent device 1 and a guide catheter or guide sheath 200 device, further comprising a coiling catheter, and one or more coil expandable implant devices. For some examples of a system comprising an expandable metallic implant or stent device 1, a guide catheter or guide sheath 200, a coiling catheter, and one or more coil expandable implant devices, the system may comprise one or more of the following: a system wherein the difference between the diameter of the lumen of the guide catheter or guide sheath 200 and the sum of the outer diameter of the elongate body 160 of the balloon catheter 100 and the elongate body of the coiling catheter is > 0.020 inch, including a system wherein the elongate body 160 of the balloon catheter 100 and the elongate body of the coiling catheter pass through the lumen of the guide catheter or guide sheath 200; a system wherein the lumen of the guide catheter or guide sheath 200 is configured to allow for the simultaneous passage of the elongate body 160 of the balloon catheter 100 and the elongate body of the coiling catheter through the lumen of the guide catheter or guide sheath 200; a system wherein, when the elongate body 160 of the balloon catheter 100 passes through the lumen of the guide catheter or guide sheath 200 and the proximal end of the balloon 110 is distal to the distal end of the guide catheter or guide sheath 200. the elongate body of the a coiling catheter can be passed through the lumen of the guide catheter or guide sheath 200; a system wherein the elongate body of the coiling catheter is at least 5 mm longer than the overall length of the expandable metallic implant or stent device 1, including examples where the expandable metallic implant or stent is folded and pleated or expanded; a system wherein the coiling catheter can be moved forward or backward while the guide catheter or guide sheath 200 and the folded and pleated expandable metallic implant or stent device 1 remain fixed in position; a system wherein the folded and pleated expandable metallic implant or stent device 1 can be moved forward or backward while the guide catheter or guide sheath 200 and the coiling catheter remain fixed in position; a system wherein the guide catheter or guide sheath 200 can beAUROM.002WO PCT moved forward or backward while the folded and pleated expandable metallic implant or stent device 1 and the coiling catheter remain fixed in position; or a system wherein the coil expandable implant device can be moved forward or backward while the guide catheter or guide sheath 200, the folded and pleated expandable metallic implant or stent device 1, and the coiling catheter remain fixed in position.Manufacturing of Expandable Metallic Implant or Stents

[0316] Various configurations of expandable metallic implant or stents 10 are described, along with the associated methods of manufacturing and use. In one example, the expandable metallic implant or stent 10 portion of an expandable metallic implant or stent device 1 is configured in a folded and pleated form and configured for permanent implantation in the lumen of an artery or vein in a human patient. Alternatively, the expandable metallic implant or stent 10 of an expandable metallic implant or stent device 1 is folded and pleated (or wrapped or compressed) together with a balloon 110, in a manner wherein portions of the wall 22 of the expandable metallic implant or stent 10 and the balloon 110 are squeezed, pressed, or wrapped together into a condensed space to facilitate passage through guide catheters or guide sheaths 200 or maneuvering into or through arteries, veins, aneurysms, chambers of the heart, biological conduits, biological spaces, and other blood-containing and fluid-containing spaces to a treatment or target site.

[0317] Metal layers of expandable metallic implant or stents 10 and multilayered expandable metallic implant or stents 26 may be formed by various methods. In some examples, a structural metal layer 27 can be formed by electroforming and electroplating and functional metal layer 28 can be formed by. In some examples, an expandable metallic implant or stent 10 may be manufactured by electroforming or electroplating, methods wherein a metal such as gold is deposited over a sacrificial conductive mandrel made from an electrically conductive material such as aluminum. The sacrificial conductive mandrel may then be removed from the single layered expandable metallic implant or stent 25 or multilayered expandable metallic implant or stent 26 structure by processes such as drilling and acid etching. By creating conductive mandrels of various sizes and shapes and then applying one or more layers of metal by electroforming or electroplating techniques, expandable metallic implant or stents 10 can be made of various sizes and shapes. The expandable metallic implant or stent 10 may further undergo an annealing process to improve the flexibility and ductility of the wall 22 of theAUROM.002WO PCT expandable metallic implant or stent 10, including before and after pleating and folding. 10. Tn some examples, a functional metal layer 28 can be formed by sputter deposition, wherein material is eroded from a target and is then deposited onto a substrate, such as a sacrificial conductive mandrel or an expandable metallic implant or stent 10, forming a thin layer on the substrate. In some examples, a functional metal layer 28 is formed by vapor deposition, wherein vapors from one or metals or metal alloys are condensed upon a substrate, such as a sacrificial conductive mandrel or an expandable metallic implant or stent 10.

[0318] In some examples, various zones or regions of an expandable metallic implant or stent 10 may have different compositions or thickness. In some examples, the different composition or thickness is produced by masking portions or regions of a mandrel or an expandable metallic implant or stent 10 prior to adding metal. In some examples, the additional metal may be applied to all or portions of the expandable metallic implant or stent 10 by electroforming, electroplating, vapor deposition, or sputter deposition. In some examples, regions of the exterior surface 34 or interior surface 35 of an expandable metallic implant or stent 10 may be masked or covered prior to adding additional metal layers or adding additional material to an existing metal layer, including when additional metal layers or additional metal is added by electroforming, electroplating, vapor deposition, and sputter deposition. In some of these examples, the additional metal layer or additional metal may be applied to a zone, region, or other portion of an expandable metallic implant or stent 10 that has not been masked or covered prior to electroforming, electroplating, vapor deposition, or sputter deposition.

[0319] The thickness of a metal layer in any zone, region, or other portion of an expandable metallic implant or stent 10 can be modified by varying process time or conditions, or by adding additional processes or conditions. In some examples, a thicker structural metal layer 27 can be formed by increasing the time of electroforming. In some examples, a thicker functional metal layer 28 can be formed by increasing the time of electroplating, vapor deposition or sputter deposition.

[0320] In some examples, structural metal layers 27 or functional metal layers 28 of expandable implants may be formed in various patterns. For example, one or more masks or coverings may be applied to the exterior surface of a sacrificial conductive mandrel or an expandable metallic implant or stent 10. In some examples, after one or more masks or coverings are applied, a functional metal layer 28 is added to the unmasked or uncovered regions byAUROM.002WO PCT electroplating, sputter deposition or vapor deposition, and the one or more masks or coverings are removed. In some examples, various zones, regions, or other portions of an expandable metallic implant or stent 10 may have one or more structural metal layers 27. In some examples, various portions of an expandable metallic implant or stent 10 may have one or more structural metal layers 27 and one or more functional metal layers 28. Structural metal layers 27 are generally applied as continuous layers. Functional metal layers 28 may be applied as continuous layers or in discontinuous layers in a wide range of patterns.

[0321] Polymer layers 36 of multilayered expandable metallic implant or stents 26 may be formed by various methods. In some examples, a polymer layer 29 can be formed by electroplating, vapor deposition, sputter deposition, or by applying a coating. In some examples, a polymer layer 29 may be applied to modify the mechanical, electrical, biocompatibility, or surface texture characteristics of an expandable metallic implant or stent 10. The polymer coating may comprise Parylene, polyurethane, PTFE, silicone, or other biocompatible polymers. In some examples, the additional coating may include an exterior coating of a polyurethane- containing solution. The coating may be applied by dipping, spinning, spraying, or other deposition processes specialized for the specific polymer. The coating may be applied to the entire exterior of the expandable metallic implant or stent 10 or to only selected zone, region, or other portion by masking. In various examples, all or a portion of the exterior surface 34 or interior surface 35 of expandable metallic implant or stents 10 may be coated with a variety of materials having properties ranging from hydrophobic to hydrophilic, polyurethanes, metals, or combinations thereof.

[0322] In some examples, a polymer layer 29 can be formed by sputter deposition, wherein material is eroded from a target and is then deposited onto a substrate, such as an expandable metallic implant or stent 10, forming a thin layer on the substrate. In some examples, a polymer layer 29 is formed by vapor deposition, wherein vapors from one or polymers are condensed upon a substrate such as an expandable metallic implant or stent 10.

[0323] In some examples, various polymer regions or layers 29 of a multilayered expandable metallic implant or stent 26 may have different compositions or thickness. In some examples, the different composition or thickness is produced by masking portions or regions of an expandable metallic implant or stent 10, prior to adding polymer. Polymer layers 29 may be applied as continuous layers or in discontinuous layers in a wide range of patterns. In someAUROM.002WO PCT examples, polymer may be applied to all or portions or regions of the expandable metallic implant or stent 10 by electroplating, vapor deposition, sputter deposition, or by applying a coating. In some examples, regions of the exterior surface 34 or interior surface 35 of an expandable metallic implant or stent 10, may be masked or covered prior to adding polymer, including when polymer is added by electroplating, vapor deposition, sputter deposition, or applying a coating. In some of these examples, the polymer may be applied to the portions of an expandable metallic implant or stent 10 that have not been masked or covered prior to electroplating, vapor deposition, sputter deposition, or coating.

[0324] The thickness of a polymer layer 29 in any portion of an expandable metallic implant or stent 10, can be modified by varying process time or conditions, or by adding additional processes or conditions. In some examples, a thicker structural metal layer 27 can be formed by increasing the time of electroforming. In some examples, a thicker functional metal layer 28 can be formed by increasing the time of electroplating, vapor deposition or sputter deposition. In some examples, a thicker polymer layer 29 can be formed by increasing the time of electroplating, vapor deposition or sputter deposition. In some examples, a thicker polymer layer 29 can be formed by applying more polymer material to the exterior surface 34 or interior surface 35 of the expandable metallic implant or stent 10.

[0325] In some examples, a polymer layer 29 of a multilayered expandable metallic implant or stent 26 may be formed in various patterns. For example, one or more masks or coverings may be applied to the exterior surface 34 or interior surface 35 of an expandable metallic implant or stent 10 and a polymer layer 29 added to the unmasked or uncovered regions by electroplating, vapor deposition, sputter deposition, or by applying a coating, after which the one or more masks or coverings are removed. In some examples, various portions of an expandable metallic implant or stent 10 may have one or more ...

Claims

AUROM.002WO PCTClaimsWHAT IS CLAIMED IS:

1. A system for placement of an expandable implant or stent in an artery or vein in a patient, the system comprising: a balloon catheter comprising: at least one hub on a proximal end of the balloon catheter; an elongate body comprising a proximal end and a distal end; a balloon positioned on a distal portion of the elongate body; an inflation lumen in fluid communication with the balloon, the inflation lumen extending from a hub to the distal portion of the elongate body and configured for inflation of the balloon; and a guidewire lumen extending from a hub to the distal end of the elongate body and configured to accept a guidewire; and an expandable implant or stent configured to be carried by the balloon catheter in a folded and pleated configuration to an implantation site in an artery or vein in a patient, the expandable implant or stent configured to expand from a folded and pleated configuration to an expanded configuration, the expandable implant or stent comprising: a wall having an open proximal end and an open distal end; a lumen defined by the wall, the lumen extending from the open proximal end to the open distal end; a polymer layer; and a gold layer comprising one or more discontinuities defining at least one opening between an open proximal end and an open distal end, wherein, at the implantation site, the folded and pleated expandable implant or stent is configured to expand to a first expanded diameter by partial or complete straightening, unfolding, or unpleating of the folded and pleated configuration of the expandable implant or stent during inflation of the balloon at the implantation site through the inflation lumen, andAUROM.002WO PCT wherein the expandable implant or stent is configured to expand to a second, larger expanded diameter by a change in a shape of the discontinuities in the gold layer during inflation of the balloon at the implantation site through the inflation lumen.

2. The system of claim 1, wherein the gold layer has a wall thickness of between 3 microns and 100 microns.

3. The system of any one of claims 1 or 2, wherein the gold layer comprises electroformed or electroplated gold.

4. The system of any one of claims 1-3, wherein the polymer layer is continuous.

5. The system of any one of claims 1 -4, wherein the polymer layer is discontinuous.

6. The system of any one of claims 1-5, wherein the polymer layer extends from the open proximal end to the open distal end.

7. The system of any one of claims 1-6, wherein the polymer layer is compliant or semi- compliant.

8. The system of any one of claims 1-7, wherein the polymer layer comprises a compliant or a semi-compliant polymer.

9. The system of any one of claims 1-8, wherein the polymer layer comprises polyethylene terephthalate, a nylon, a material comprising block copolymers made of rigid polyamide blocks and soft polyether blocks, including Pebax, a polyurethane, including an aromatic polyether polyurethane, a polyether-block-amide, or a silicone elastomer, including a polydimethylsiloxane silicone elastomer, and combinations thereof.

10. The system of any one of claims 1-9. wherein the polymer layer has a wall thickness of between 3 microns and 100 microns.

11. The system of any one of claims 1-10, wherein the open proximal end and the open distal end of the expandable implant or stent are circular or substantially circular in crosssection; or wherein at least a portion of the lumen of the expandable implant or stent is circular or substantially circular in cross-section.

12. The system of any one of claims 1-11. wherein the gold layer comprises a plurality of longitudinal segments circumferentially disposed around the polymer layer and whereinAUROM.002WO PCT the gold layer has a wall thickness between 3 microns and 100 microns, and wherein the segments of gold layer are separated by radial gaps comprising polymer.

13. The system of claim 12, wherein the segmented layers of gold comprise rings or ring-like structures.

14. The system of any one of claims 12-13, wherein the segmented layers of gold are configured as a lattice with struts or strut elements, and cells.

15. The system of claims 14, wherein the cells have an open configuration.

16. The system of claims 14, wherein the cells have a closed configuration.

17. The system of any one of claims 14-16, wherein the cells are configured in diamondshaped. hexagonal, Z or zigzag-shaped, serpentine, and ring and link shapes or patterns.

18. The system of any one of claims 13 - 17, wherein the rings or ring-like structures are joined by one or more struts or strut elements that cross the radial gaps.

19. The system of any one of claims 1-18, wherein the expandable implant or stent comprises one or more flaps on at least one of the open proximal end or the open distal end of the wall.

20. The system of claim 19, wherein, in the folded and pleated configuration, the one or more flaps do not extend radially outward from the wall of the expandable implant or stent.

21. The system of claim 19. wherein the one or more flaps are configured to extend radially outward from the wall of the expandable implant or stent during inflation of the balloon and engage or penetrate into a wall of the artery or vein in the patient during implantation of the expandable implant or stent.

22. The system of claim 19, wherein the wall comprises a proximal zone with one or more flaps, a distal zone with one or more flaps, and a middle zone that is located between the proximal zone and the distal zone.

23. The system of any one of claims 1-22, wherein the balloon is compliant or semi-compliant.

24. The system of any one of claims 1-23, wherein the balloon comprises a compliant or a semi-compliant polymer.AUROM.002WO PCT25. The system of any one of claims 1-24, wherein the balloon comprises polyethylene terephthalate, a nylon, a material comprising block copolymers made of rigid polyamide blocks and soft polyether blocks, including Pebax, a polyurethane, including an aromatic polyether polyurethane, a polyether-block-amide, or a silicone elastomer, including a polydimethylsiloxane silicone elastomer, and combinations thereof.

26. The system of any one of claims 1-25. wherein the balloon has a wall thickness between 3 microns and 30 microns.

27. The system of any one of claims 1-26, wherein a length of the balloon is greater than a length of the expandable implant or stent.

28. The system of any one of claims 1-27. wherein the balloon and the expandable implant or stent are folded together into wings and pleated around a central axis.

29. The system of any one of claims 1-28, wherein at least a portion of the inflation lumen and the guidewire lumen are the same lumen.

30. A system for placement of an expandable implant or stent in an artery or vein in a patient, the system comprising: a balloon catheter comprising: at least one hub on a proximal end of the balloon catheter; an elongate body comprising a proximal end and a distal end; a balloon positioned on a distal portion of the elongate body; an inflation lumen in fluid communication with the balloon, the inflation lumen extending from a hub to the distal portion of the elongate body and configured for inflation of the balloon; and a guidewire lumen extending from a hub to the distal end of the elongate body and configured to accept a guidewire; and an expandable implant or stent configured to be carried by the balloon catheter in a folded and pleated configuration to an implantation site in an artery or vein in a patient, the expandable implant or stent configured to expand from a folded and pleated configuration to an expanded configuration, the expandable implant or stent comprising:AUROM.002WO PCT a wall having an open proximal end and an open distal end; a lumen defined by the wall, the lumen extending from the open proximal end to the open distal end; a gold layer; and one or more flaps on at least one of the open proximal end or the open distal end of the wall, wherein, the expandable implant or stent is configured to be expanded at the implantation site by inflation of the balloon through the inflation lumen, and wherein the one or more flaps are configured to extend radially outward from the wall of the expandable implant or stent during balloon inflation and the one or more flaps are configured to engage or penetrate into a wall of the artery or vein in the patient during implantation of the expandable implant or stent.

31. The system of claim 30. wherein the gold layer is continuous.

32. The system of claim 30. wherein the gold layer is discontinuous.

33. The system of any one of claims 30-32, wherein the gold layer has a wall thickness of between 3 microns and 100 microns.

34. The system of any one of claims 30-33, wherein the gold layer comprises electroformed or electroplated gold.

35. The system of any one of claims 30-34, wherein the expandable implant or stent further comprises a polymer layer.

36. The system of claim 35, wherein the polymer layer is continuous.

37. The system of claim 35, wherein the polymer layer is discontinuous.

38. The system of claim 35. wherein the polymer layer extends from the open proximal end to the open distal end.

39. The system of claim 35, wherein the polymer layer is compliant or semi-compliant.

40. The system of claim 35, wherein the polymer layer comprises a compliant or a semi- compliant polymer.AUROM.002WO PCT41 . The system of claim 35, wherein the polymer layer comprises polyethylene terephthalate, a nylon, a material comprising block copolymers made of rigid polyamide blocks and soft polyether blocks, including Pebax, a polyurethane, including an aromatic polyether polyurethane, a polyether-block-amide, or a silicone elastomer, including a polydimethylsiloxane silicone elastomer, and combinations thereof.

42. The system of any one of claims 35-41, wherein the polymer layer has a wall thickness of between 3 microns and 100 microns.

43. The system of any one of claims 35-42, wherein the open proximal end and the open distal end of the expandable implant or stent are circular or substantially circular in crosssection; or wherein at least a portion of the lumen of the expandable implant or stent is circular or substantially circular in cross-section.

44. The system of any one of claims 35-43, wherein, in the folded and pleated configuration, the one or more flaps do not extend radially outward from the wall of the expandable implant or stent.

45. The system of any one of claims 35-44, wherein the one or more flaps are configured to extend radially outward from the wall of the expandable implant or stent during inflation of the balloon and engage or penetrate into a wall of the artery or vein in the patient during implantation of the expandable implant or stent.

46. The system of any one of claims 35-45, wherein the wall of the expandable implant or stent comprises a proximal zone with one or more flaps, a distal zone with one or more flaps, and a middle zone that is located between the proximal zone and the distal zone.

47. The system of any one of claims 35-46, wherein the balloon is compliant or semi- compliant.

48. The system of any one of claims 35-46, wherein the balloon comprises a compliant or a semi-compliant polymer.

49. The system of any one of claims 35-46, wherein the balloon comprises polyethylene terephthalate, a nylon, a material comprising block copolymers made of rigid polyamide blocks and soft polyether blocks, including Pebax, a polyurethane, including an aromatic polyether polyurethane, a polyether-block-amide, or a silicone elastomer, including a polydimethylsiloxane silicone elastomer, and combinations thereof.AUROM.002WO PCT50. The system of any one of claims 35-49, wherein the balloon has a wall thickness between 3 microns and 30 microns.

51. The system of any one of claims 35-50, wherein a length of the balloon is greater than a length of the expandable implant or stent.

52. The system of any one of claims 35-51, wherein the balloon and the expandable implant or stent are folded together into wings and pleated around a central axis.

53. The system of any one of claims 35-52, wherein at least a portion of the inflation lumen and the guidewire lumen are the same lumen.

54. The system of any one of claims 35-53, wherein the gold layer comprises a plurality of longitudinal segments circumferentially disposed around the polymer layer, and wherein the gold layer has a wall thickness between 3 microns and 100 microns, and wherein the segments of gold layer are separated by radial gaps comprising polymer.

55. The system of claim 54, wherein the segmented layers of gold comprise rings or ring-like structures.

56. The system of any one of claims 54 or 55, wherein the segmented layers of gold are configured as a lattice with struts or strut elements, and cells.

57. The system of claims 56, wherein the cells have an open configuration.

58. The system of claims 56, wherein the cells have a closed configuration.

59. The system of any one of claims 56-58. wherein the cells are configured in diamondshaped, hexagonal, Z or zigzag-shaped, serpentine, and ring and link shapes or patterns.

60. The system of any one of claims 55-59, wherein the rings or ring-like structures are joined by one or more struts or strut elements that cross the radial gaps.

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