EXPANDABLE BODY DEVICE AND METHOD OF USE

Abstract

Devices, designs, methods of manufacture and medical devices are provided, including expandable bodies for treating saccular vascular aneurysms and occluding segments of blood vessels and other biological conduits. [Solution] An exemplary expandable body includes a hollow gold structure that can be folded, rolled, and compressed, coupled to a delivery device, advanced to a location within a patient's body requiring treatment, expanded by injection of fluid into a central cavity, and detached from the delivery device to remain in place in an open, expanded configuration without additional support structure for the central cavity. Other expandable bodies include coiled wires that are loaded into a delivery catheter and removed from the delivery catheter using a pushing device. Further disclosed herein are multiple medical devices and methods of using expandable bodies, where multiple expandable bodies are positioned adjacent to one another to occlude saccular aneurysms.

Description

[Technical field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims priority to U.S. Provisional Patent Application No. 64 / 051,873, entitled "Expandable Body Device and Method of Use," filed Sep. 17, 2014, the entire contents of which are incorporated herein by reference.

[0002] The present disclosure relates to medical devices and systems including an expandable body and one or more uses of a medical apparatus or system including an expandable body for the treatment of saccular aneurysms of the vasculature, where the one or more expandable bodies ultimately remain in the aneurysm in an expanded state. The present disclosure further relates to methods and systems for delivering and deploying various embodiments of an expandable body that are sized and configured to fill and / or seal at least a portion of a saccular aneurysm such that the expandable body remains in place in an expanded state. The present disclosure further relates to medical devices and systems including shapes of expandable bodies including hollow metallic or metal-containing balloons and delivery catheters for use therewith. The present disclosure further relates to devices, systems, and methods for saccular aneurysm treatment, where different shapes of expandable bodies may be deployed in combination. For example, an expandable body in the form of a hollow metallic balloon may be placed within the aneurysm sac and expanded, after which one or more expandable bodies in the form of coiled wires may be placed within the aneurysm sac such that the coiled wires contact both the aneurysm wall and the wall of an expanded hollow metallic balloon positioned near the aneurysm neck and apply a force to the expanded hollow metallic balloon to seal off the aneurysm neck.

[0003] The present disclosure further relates to medical devices and systems including an expandable body and including the use of one or more of the medical devices or systems including the expandable body for occlusion of a blood vessel segment or other biological conduit, where the expandable body ultimately remains in an expanded state in the blood vessel segment or biological conduit segment. The present disclosure further relates to methods and systems for delivering and deploying various embodiments of the expandable body that are sized and configured to fill and / or occlude at least a portion of the blood vessel segment or biological conduit segment such that the expandable body remains in place in the expanded state. The present disclosure further relates to medical devices and systems including shapes of expandable bodies including hollow metallic or metal-containing balloons and delivery catheters for use therewith. The present disclosure further relates to devices, systems, and methods for occlusion of a blood vessel segment or other biological conduit, where different shapes of expandable bodies may be deployed in combination.

[0004] The present disclosure further relates to the manufacture of an expandable body, where a stainless steel ring is coupled to a proximal end of a mandrel, depositing a metal layer on the mandrel and on at least a portion of the stainless steel ring or tube, and optionally removing the mandrel, forming the metal layer into the shape of a mandrel-shaped hollow body, which may become the expandable body. This embodiment of the manufacturing method includes a method of depositing metal using electroforming, where the metal deposited is gold. The stainless steel ring is thus joined and extends from a proximal region of the hollow body to form a neck. Forming the neck includes forming a proximal neck. The stainless steel ring may further be attached to the neck or main body of the expandable body by welding a split segment, the main body being defined as including a proximal region, a distal region, and optionally an intermediate region. In a particular embodiment, the stainless steel ring or tube is coupled to a delivery device and configured such that the ring or tube can be separated by electrolysis. [Background technology]

[0005] Aneurysms are abnormal external bulges of blood vessels that can occur anywhere in the body. These bulges weaken the vessel walls and make them more susceptible to rupture, which can lead to bleeding and blood loss. Aneurysms are common in the arterial circulation of the brain, where they are known as cerebral or intracranial aneurysms. When a cerebral aneurysm ruptures, it often causes hemorrhagic stroke, brain damage, and sometimes death. Cerebral aneurysms are common, affecting an estimated 2% of the adult population. Approximately 90% of cerebral aneurysms are saccular, shaped like a round, sac, or pouch. Invasive surgery is the traditional method of treatment, which involves surgery to open the skull and place small surgical clips on the outside of the neck or body of the aneurysm to seal off the aneurysm, thereby restricting blood flow to the aneurysm sac.

[0006] Alternatively, less invasive, catheter-based endovascular treatments have been used in which a series of small metallic coiled wires (coils) are used to fill the aneurysm sac, blood vessel segment, or biological conduit segment to create an occlusion. To occlude an aneurysm or blood vessel with coils, the physician inserts a catheter into the lumen of the vasculature and navigates the tip of the catheter to the location where occlusion is desired. With the tip of the catheter in place, the physician passes a coil through the catheter and into the lumen or interior cavity of the aneurysm, blood vessel segment, or biological conduit segment.

[0007] Although effective, coiling of saccular cerebral aneurysms has drawbacks. First, coil placement is difficult to control, often resulting in coil protrusion into the parent vessel or coil migration to unintended locations. Second, coils only partially fill and occlude the aneurysm sac. Accumulation of thrombus and fibrous tissue is necessary to seal the aneurysm, a process that often takes weeks to months to occur and can sometimes be incomplete, reducing the effectiveness of coils in treating acute aneurysm rupture associated with subarachnoid hemorrhage. Even if the use of coils is initially effective, recanalization of the aneurysm, blood vessel, or biological conduit is common, allowing blood flow back into the aneurysm, increasing the risk of rupture over time. Incomplete filling of the aneurysm sac with coils is especially common in the neck region of the aneurysm sac, where coil density is lower and blood flow velocity may be higher. Third, many coils are usually required to treat the aneurysm, resulting in high costs and long treatment times. Fourth, coils are prone to compression, further exposing the aneurysm neck, thereby contributing to a high aneurysm recurrence rate.

[0008] Recently, conventional tubular stents have been suitable for treating cerebral aneurysms. These stents are placed into a catheter delivery device and placed in the parent vessel adjacent to the aneurysm. These stents are then expanded in the parent vessel along with the delivery device, which is subsequently removed. The expanded metallic stents act to reduce blood flow to the aneurysm sac and promote aneurysm thrombus formation. Although effective, there are drawbacks to the use of these "diverting" stents. First, the stents may cover and divert blood from the main arterial branches adjacent to the aneurysm, sometimes resulting in ischemia and stroke, a problem particularly seen in the treatment of bifurcation aneurysms. Second, these stents may be a source of thrombus and intimal hyperplasia in the parent vessel, resulting in stenosis of the parent vessel lumen, ischemia, and stroke.

[0009] More recently, wire mesh expandable bodies have been applied to the treatment of cerebral aneurysms. These wire mesh expandable bodies are deployed using a pushing device, including a pushing wire, pushing catheter, or pushing system, through a catheter delivery device and placed into the aneurysm sac. These wire mesh expandable bodies are then expanded within the aneurysm sac and detached from the pushing device. The wire mesh expandable bodies act to reduce blood flow to the aneurysm sac and promote aneurysm thrombus formation.

[0010] There remains a need for medical devices, systems, and methods for treating saccular aneurysms, including cerebral aneurysms, that result in a more rapid, effective, and complete reduction in blood flow to the saccular aneurysm, that is more effective at sealing the neck, and that is more permanent and lasting. Medical devices, systems, and methods that seal the aneurysm neck more quickly are further desired. Finally, there is a need for medical devices, systems, and methods for treating saccular aneurysms that are easier, shorter in duration, and have a lower risk of complications and lower cost when compared to existing treatments.

[0011] In other clinical situations, patients may benefit from occlusion of specific arterial or venous segments. Clinical situations in which occlusion of intravascular vessels may be beneficial include reducing bleeding from damaged vessels, reducing blood flow to tumors, and rerouting blood in the vascular system for other purposes such as reducing blood flow to vascular anomalies and malformations. Minimally invasive, catheter-based endovascular treatments have been developed to occlude vessel segments. Intravascular medical devices for occlusion of vessels include balloon catheters, where the balloon can be inflated to fill the lumen of the vessel segment and can be detached from the catheter. There are two major drawbacks to using detachable balloon catheters for occlusion of vessels. First, balloons are typically made from polymers that are resistant to tissue uptake. This limits fixation of the placed device and increases the risk of migration. Second, balloons are composed of elastic walls that expand under pressure and valves designed to maintain that pressure after detachment. Unfortunately, there is a significant rate of balloon and valve failure, resulting in deflation. If tissue uptake does not occur, balloon deflation may result in recanalization of the vessel or biological conduit or balloon migration and occlusion of the unintended vessel segment.

[0012] More recently, intravascular medical devices for vascular occlusion, including wire mesh structures in the form of an expandable body, have been used to fill a portion of the lumen of a vessel segment, inducing thrombus formation and occlusion of the vessel segment. Although only a single wire mesh expandable body is usually required to occlude a vessel segment, and the devices are usually easy to control, these devices only fill a portion of the vessel, and require thrombus accumulation and fibrous tissue to occlude the vessel. As with coils, this process can take weeks to occur and is sometimes incomplete, often resulting in incomplete occlusion or recanalization and failed treatment.

[0013] There remains a need for catheter-based medical devices, systems, and methods for occluding blood vessel segments and segments of other biological conduits that are easy to perform, provide more rapid, controlled and complete occlusion, have low risk of recanalization, balloon migration, or other complications, and are affordable at a reasonable cost. Summary of the Invention

[0014] Disclosed herein are medical systems and devices for the treatment of saccular aneurysms with an expandable body, including an expandable body with a hollow metallic balloon or a hollow metal-containing balloon, or one or more expandable bodies in combination to occlude saccular aneurysms. Disclosed further are medical systems and devices for occlusion or sealing of blood vessel segments, including arteries, veins, other vascular conduits, and other biological conduits, with an expandable body, including an expandable body with a hollow metallic balloon or a hollow metal-containing balloon, or one or more expandable bodies in combination.

[0015] Broadly speaking, an expandable body can be delivered from outside the body in a compressed, folded, pleated, bent, coiled, bundled, stretched, or other unexpanded configuration and placed inside the body where it expands at the treatment site to fill a space or apply a force to adjacent structures. One example of an expandable body is a hollow gold structure that can be pleated, coiled, or compressed, delivered to the treatment location and expanded by injecting a liquid into the central void of the hollow gold structure. Another example of an expandable body is a nitinol, platinum, or stainless steel wire that can be formed into a coil and then stretched or bundled in the lumen of a catheter, delivered to the treatment location in this configuration, and then withdrawn from the catheter where it can expand into a coil. Yet another example of an expandable body is a single wire mesh device comprising Nitinol that can be compressed, stretched, and bundled within the lumen of the catheter, delivered in this configuration to the treatment location, and then withdrawn from the catheter where it can be re-expanded to the expanded state.

[0016] As used herein, the terms "expandable body," "expanded body," "expanded expandable body," "expandable structure," "expandable balloon," "hollow metallic structure," "hollow metallic expandable body," "hollow metallic expandable body," "metallic balloon," "ballstent," and "blockstent" refer to an expandable body that may be first introduced into a patient in an unexpanded state, optionally with a delivery device, second passed in an unexpanded state through one or more biological conduits of the patient to a desired treatment site (i.e., implantation site), third expanded to an expanded state at the desired treatment site, and fourth separated from the delivery device to remain within the patient in the expanded configuration at the desired or treatment site.

[0017] In certain embodiments, the expandable body may be configured for use as a hollow metallic structure that can be inflated or expanded by injecting a liquid into a central cavity. In describing this particular embodiment, in this context the terms "expandable body", "expandable structure", "expandable balloon", "hollow metallic structure", "hollow metallic expandable structure", "hollow metallic expandable body", "metallic balloon", "ballstent", and "blockstent" are used as described herein. In some embodiments, the expandable body in this context may have a single or multi-walled structure with a generally solid surface and no overall openings or perforations.

[0018] The medical systems disclosed herein may be used to fill a biological space in a patient. Such a medical system may include a single lobed metallic expandable body and a delivery device. Such a medical system may further include one or more additional expandable bodies, each of which may be referred to as a "coiled wire expandable body" and may include a coiled wire that may be placed directly adjacent to the single lobed expandable body. Filling the biological space includes occlusion of at least a portion of a ruptured lumen, or the lumen of an unruptured saccular aneurysm, or the lumen of a blood vessel segment. The lumen of a blood vessel segment may include an artery and a vein, or other type of biological conduit lumen.

[0019] The single lobed hollow metallic expandable body includes a distal region, a proximal region generally opposite the distal region, and optionally an intermediate region transitioning from the distal region to the proximal region. A central axis extends proximally-distally between the proximal and distal regions of the single lobed metallic expandable body. In one embodiment, the expandable body wall extends generally continuously from the proximal region, optionally through the intermediate region, to the distal region, and defines an outer surface of the expandable body and an inner surface of the expandable body. The inner surface defines an interior volume of the expandable body. The expandable body is configured to expand from a deliverable (i.e., collapsed or unexpanded) configuration to an expanded configuration. In another embodiment, the expandable body wall comprises a single wire mesh device with gaps, perforations, or openings between the wire components.

[0020] In various embodiments, the single lobed hollow metallic expandable body includes a proximal region and a distal region separated by a middle region that forms a unitary structure of the expandable body. The single lobed metallic expandable body may be further defined by a first axis and a second axis transverse to the first axis. The first axis extends between the proximal and distal necks of the expandable body, or in other words, extends from the middle of the proximal face to the middle of the distal face. In one aspect, the shape of the middle region may be described and defined by an arc parallel to the first axis. In various embodiments, the width or length of the expandable body along the second axis is greater than the height or length of the expandable body along the first axis. In some embodiments, when expanded, the maximum radius of the distal region parallel to the second axis is less than or equal to the maximum radius of the proximal region parallel to the second axis. In some embodiments, when expanded, the maximum radius of the distal region parallel to the first axis is less than or equal to the maximum radius of the proximal region parallel to the first axis.

[0021] In various other embodiments, the single lobed hollow metallic expandable body may be further defined and described as having a generally hemispherical proximal region attached to a generally hemispherical distal region. The hemisphere formed by each region may be further defined by a semimajor axis and a semiminor axis aligned with a first axis or a second axis. In some embodiments, each region may have a corresponding neck and individually define an oblate hemisphere, a prolate hemisphere, or a hemisphere.

[0022] In one embodiment, the single lobed hollow metallic expandable body and its delivery device features an internal catheter shaft (i.e., guidewire shaft) that functions as a guidewire lumen. Under distal vision, the guidewire is inserted into the artery and advanced to the intended treatment site. The delivery device is then delivered over the guidewire with the unexpanded expandable body at its distal end to the intended treatment site. In some embodiments, the guidewire is removed following delivery, expansion, and detachment of the expandable body. In other embodiments, the expandable body is delivered and expanded, and the guidewire is removed prior to detachment. In other embodiments, the expandable body is delivered, and then the guidewire is removed prior to expansion and detachment of the expandable body.

[0023] The delivery device has a longitudinally extending body including a proximal end and a distal end generally opposite the proximal end. The distal end of the delivery device is operably coupled to a proximal neck of a single lobed hollow metallic expandable body. In some embodiments, the distal end of the delivery device is further operably coupled to a distal neck of the expandable body. In one embodiment, when the expandable body is in a deliverable configuration, the wall is in a pleated configuration having a plurality of pleats folded clockwise about a first or central axis, or alternatively, counterclockwise about a first or central axis, which is considered to form a folded region of the expandable body. Conversely, when the expandable body is in an expanded configuration, the plurality of pleats are not folded and the pleated configuration is substantially eliminated.

[0024] In related embodiments, the distal end of the single lobed hollow metallic expandable body further comprises a unique tubular structure referred to as a "bridge segment." In some embodiments, the bridge segment is a two-part telescopic bridge segment, comprising a rigid metal or polymer tube ("telescope") that slides over the distal end of the catheter or catheter shaft ("bridge catheter"). In other embodiments, the bridge segment is a one-part flexible bridge segment, comprising a polymer tube, with or without braid reinforcement. In some embodiments, the bridge segment is connected to the body portion of the expandable body with an adhesive, glue, or weld. Upon expansion of the expandable body, the bridge segment allows the body portion of the expandable body to freely contract axially. The bridge segment may then be positioned to maximize the distance between the distal end of the expanded hollow metallic expandable body and the aneurysm dome, reducing the risk of the coiled wire expandable body perforating the aneurysm dome. Additionally, the bridge segment reduces leakage of injected liquid media from the expandable body, which in turn reduces the applied pressure required for expansion.

[0025] Various methods may be used to separate the expanded hollow metallic expandable body from the delivery device. In one embodiment, the system or medical system includes a detachment system partially supported on the delivery device and having an electrical circuit configured to electrolytically detach the expandable body from the distal end of the delivery apparatus. In another embodiment, detachment may be performed by an electrothermal process whereby the electrical circuit melts a thermoplastic link between the delivery device and the neck segment of the expanded hollow metallic expandable body. In another embodiment, mechanical means of detachment may employ a threaded connection that is detached by twisting the delivery device, or a slip-fit ​​connection that is detached by removing the delivery device from a sleeve, valve, or valves disposed on or in the expandable body, or the like. In the case of mechanical detachment, a detachment catheter may be employed to prevent axial movement of the expandable body while the delivery device is removed.

[0026] Methods of filling at least a portion of a patient's biological space are also described herein. One method includes providing a single lobed hollow metallic expandable body configured to expand from a deliverable configuration to an expanded configuration. The expandable body is introduced in a deliverable configuration to the patient's biological space via a delivery device having a distal end that operably engages a proximal neck, a proximal region, or a distal neck of the expandable body. A liquid medium can be delivered to an interior volume of the expandable body via the delivery device to inflate or expand the expandable body to the expanded configuration. After expansion, the expandable body is detached from the delivery device. In some embodiments, the method includes using a detachment system having an electrical circuit partially supported on the delivery device to electrolytically disconnect the expandable body from the distal end of the delivery apparatus. Here, a portion of the delivery device including a portion of the proximal neck is subjected to electrolysis prior to detachment. In certain embodiments, the portion of the proximal neck that is subjected to electrolysis is ring-shaped.

[0027] Methods of manufacturing a device or system for filling at least a portion of a patient's biological space are also described herein. One method includes manufacturing a single lobed hollow metallic expandable body having a distal region, a proximal region generally opposite the distal region, and an optional intermediate region transitioning from the distal region to the proximal region. A central or first axis extends between the proximal and distal necks of the single lobed metallic expandable body. The walls of the expandable body extend generally continuously from the proximal region through the intermediate region to the proximal region, defining an outer surface of the expandable body and an inner surface of the expandable body. The inner surface defines an interior volume of the expandable body. The method further includes welding or connecting all or a portion of the proximal or distal neck segment to the expandable body, or both the proximal and distal neck segments. In other embodiments, the proximal neck segment, the distal neck segment, or both the proximal and distal neck segments may be connected during an electroforming process to form the expandable body.

[0028] The method further includes manufacturing a delivery device having a longitudinally extending body including a proximal end and a distal end generally opposite the proximal end. The delivery device operably couples the delivery device distal end to a hollow metallic expandable body. The expandable body includes a proximal neck or region of the expandable body. The manufacturing method further includes forming a wall of the expandable body into a pleated configuration. The pleated configuration has a plurality of pleats folded clockwise about a first or central axis, or alternatively, counterclockwise about the first or central axis, to form a folded region of the expandable body.

[0029] The method further includes fabricating a hollow metallic expandable body, where fabricating the body includes coupling a stainless steel ring to a proximal end of a sacrificial mandrel, such as an aluminum mandrel, depositing a metal layer on at least a portion of the sacrificial mandrel and the stainless steel ring or tube, and removing the sacrificial mandrel leaving the metal layer in the shape of the hollow body in the shape of the sacrificial mandrel to form the expandable body. This embodiment of the method includes depositing the metal using electroforming, where the metal deposited is gold. The stainless steel ring is thus connected to the proximal region of the hollow body and extends therefrom to form a neck, including forming a proximal neck. The stainless steel ring is further attached by welding a split segment to the neck or main body of the expandable body, where the main body is defined as including a proximal region, a distal region, and optionally an intermediate region. In a particular embodiment, the stainless steel ring or tube is coupled to a delivery device and configured such that the ring or tube can be separated by electrolysis.

[0030] The method further includes fabricating a hollow metallic expandable body, where fabricating the body includes coupling a stainless steel ring to a proximal end of a hollow non-sacrificial mandrel, such as a PET balloon, depositing a metal layer on at least a portion of the non-sacrificial mandrel and the stainless steel ring or tube, and leaving the non-sacrificial mandrel in place as an inner layer, resulting in a hollow bi-layered expandable body in the shape of the non-sacrificial mandrel to form the expandable body. This embodiment of the method of fabrication includes a method of depositing metal using sputter coating or electroforming, sputter coating followed by electroforming, or electroforming followed by sputter coating, where the metal deposited is gold. Sputter coating may include sputter deposition.

[0031] In the aforementioned process, the stainless steel ring is thus connected to the proximal region of the hollow metal body and extends therefrom to form a neck including forming a proximal neck. The stainless steel ring is further attached to the neck or main body of the expandable body by welding a split segment, the main body being defined as including a proximal region, a distal region, and optionally an intermediate region. In certain embodiments, the stainless steel ring or tube is coupled to a delivery device and configured such that the ring or tube can be separated by electrolysis. In certain embodiments, the gold-covered stainless steel region can be etched to expose the underlying stainless steel, the region being susceptible to galvanic corrosion, and the etched region can be cut by electrolysis. In certain embodiments, the etching is performed by a laser.

[0032] The method may include applying a metallic coating or electrically insulating material to all or a portion of an exterior or interior surface of the hollow metallic expandable body and the exterior or interior surface of the stainless steel ring, and leaving a portion of the exterior surface of the neck region of the stainless steel ring free of the metallic coating or electrically insulating material to create an anode. The method may further include coupling at least a portion of the stainless steel ring to a distal end of a delivery device and electrically coupling an electrolytic system to the stainless steel ring to form an electrical potential anode through a conductive pathway traveling through the delivery device.

[0033] The method also includes attaching one or more end caps or nose cones to the neck of the hollow metallic expandable body or the distal end of the delivery catheter. The end caps or nose cones may comprise a polymeric material. Additionally, a polymeric sheath or coating may be applied to the expandable body and the end caps or nose cones, the polymeric sheath encapsulating the expandable body when the expandable body is in a folded, rolled, or compressed delivery configuration.

[0034] In various embodiments of the aforementioned devices, systems, and methods, the walls of the hollow metallic expandable body may include at least one metal layer having a thickness of approximately 5-50 μm. In one example, the metal layers in the proximal, intermediate, and distal regions may include gold or platinum, or alloys thereof. The walls of the expandable body may further include an inner layer of a non-metallic coating extending on the inner surface of the metal layer and / or an outer layer of a non-metallic coating extending on the outer surface of the metal layer. The non-metallic "coating" may be a hollow, non-sacrificial mandrel used during manufacture, or may be an additional layer of electrically insulating material, including, for example, PET or parylene. In one embodiment, there may be an inner layer of PET or parylene and an outer layer of gold. In another example, there may be an inner and outer layer of parylene covering a central layer of gold or platinum. The surface of the metal layer may include a circular, pebbly, or granular surface structure having a surface height of approximately 0.001-0.01 μm, approximately 0.001-0.1 μm, approximately 0.001-1 μm, or approximately 0.001-10 μm. The outer surface of the metal layer may include generally tubular protrusions. In one embodiment, some of the generally tubular protrusions are branched. In another embodiment, some of the generally tubular protrusions are tethered at both ends to the metal layer to form loops.

[0035] The metal layer of the hollow metallic expandable body may be produced by electroforming on a mandrel, optionally with all or a portion of the mandrel being sacrificial. The sacrificial mandrel may be removed from within the electroform by processes such as drilling and acid etching. A portion of the mandrel may include a sacrificial aluminum component and a non-sacrificial component made of other metals such as stainless steel, zinc, magnesium, or copper. In other embodiments, all or a portion of the non-sacrificial mandrel may be hollow and may include a non-sacrificial component made of stainless steel (for the neck) and a polymer such as PET and parylene. The non-sacrificial stainless steel mandrel component may include a surface layer of gold or platinum extending over at least a portion of one of the interior or exterior surfaces of the non-sacrificial mandrel component.

[0036] Mandrels are 1 to 30μ inches R a (i.e., a calculated average of the absolute values). The surface roughness of the mandrel may be selected to optimize the final surface roughness of the hollow metallic expandable body.

[0037] Alternatively, the mandrel may have a pleated outer surface that generally replicates the pleated configuration of the hollow metallic expandable body in an intermediate shape between the deliverable configuration and the expanded configuration.

[0038] In one embodiment, the mandrel may comprise a water-soluble polymer sputter coated with gold, which may reduce the time to both replicate and etch the mandrel. In one embodiment, the mandrel may be injection molded from polyethylene glycol (PEG) or polyethylene oxide (PEO) that is sputter coated with a layer of gold approximately 10-50 nm thick. The gold may be sputter coated using a line-of-sight process with a rotating sample stage to create a surface that can conduct electricity. The sputter coated polymer mandrel may then be further coated by an electroforming process, after which the water-soluble polymer mandrel may be immersed in warm water upon completion of the electroforming process.

[0039] In various embodiments, the hollow metallic expandable body may undergo one or more annealing processes. The expandable body may be annealed before or after being collapsed into a deliverable configuration. Additionally, the expandable body may undergo an annealing process while including a non-metallic coating.

[0040] In some embodiments, the walls of the hollow metallic expandable body may include holes or perforations that may extend completely through the thickness of the wall from the inner surface to the outer surface. The holes may be fine, ranging from 0.1 to 500 μm in diameter, or fine, ranging from 500 μm to 3 mm in diameter. One example of a perforated expandable body is a self-expanding wire mesh structure with fine holes, including structures made from Nitinol wire. Another example of a perforated expandable body is a hollow metallic structure with mostly continuous walls and fine holes. Thus, the expandable body may be inflated by a fluid supply device in fluid communication with the interior volume of the expandable body via a delivery device. The fluid supply device is configured to supply a supply fluid flow rate that exceeds the leakage fluid flow rate at a flow rate delivery pressure from the plurality of holes to the interior volume. In one embodiment, upon expansion of the expandable body, the holes are filled with a biodegradable or bioerodible material such that the holes remain open for a period of time after expansion in vivo.

[0041] One method of making a hollow metallic expandable body includes a) providing a sacrificial mandrel, b) depositing a metal layer onto the sacrificial mandrel, c) removing the sacrificial mandrel leaving the metal layer in the shape of the hollow metallic body, and d) folding the hollow metallic body, where the folding includes folding a plurality of pleats in a clockwise direction about a central axis of the hollow metallic pleated body or in a counterclockwise direction about a central axis of the hollow metallic pleated body. Prior to folding, the hollow pleated body may be filled with a biocompatible and hemocompatible lubricating fluid to reduce friction, reduce the risk of the expandable body being damaged during folding, and minimize the compressed device profile.

[0042] Another method of manufacturing a hollow metallic expandable body includes a) providing a hollow non-sacrificial mandrel, b) depositing a metal layer onto the hollow non-sacrificial mandrel, and c) folding the multi-layered hollow metallic body, where the folding includes folding a plurality of pleats in a clockwise direction about a central axis of the hollow metallic pleated body or in a counter-clockwise direction about a central axis of the hollow metallic pleated body. Prior to folding, the hollow pleated body may be filled with a biocompatible and hemocompatible lubricating fluid to reduce friction, reduce the risk of the expandable body being damaged during folding, and minimize the compressed device profile.

[0043] When in a delivery or deliverable configuration, the folded or compressed regions of the hollow metallic expandable body may define a wire receiving channel. In one embodiment, a portion of the delivery device or delivery catheter is not within the folded or compressed regions of the expandable body. In another embodiment, a portion of the delivery device or delivery catheter is within the folded or compressed regions of the expandable body. For pleated embodiments, each pleat includes a ridge extending proximally-distally and radially away from the central axis, and each pleat is separated from an immediately adjacent pleat by an intervening groove extending proximally-distally, such that the pleated configuration has an alternating ridge-groove arrangement. When folded, each pleat folds over an immediately adjacent pleat in a clockwise direction about the first or central axis or in a counterclockwise direction about the first or central axis. In one embodiment, a portion of the delivery device is not within the folded or compressed regions of the expandable body. In other embodiments, the folded or compressed region of the expandable body defines a channel for receiving a guidewire, hi other embodiments, a portion of the delivery device or delivery catheter is within the folded or compressed region of the expandable body.

[0044] In various embodiments, the hollow metallic expandable body is inflated or expanded to reach the expanded configuration. The expandable body is inflated or expanded via delivery of a liquid medium to an interior volume of the expandable body. The liquid medium typically comprises a liquid or a gas. In various embodiments, the pressure within the expandable body during expansion is 6 atmospheres (atm) or less. Other suitable pressures include 5 atm or less, 4 atm or less, 3 atm or less, 2 atm or less, and 1 atm or less.

[0045] During expansion or inflation, the pleated configuration and the plurality of pleats of the hollow metallic expandable body present in the deliverable configuration substantially disappear. When expanded, the expandable body has sufficient strength to maintain itself in the expanded configuration within the biological space after being separated or detached from the delivery device, including having sufficient strength when the expanded expandable body is not sealed and when the pressure inside the space of the expanded expandable body is the same as or close to the pressure outside the expanded expandable body.

[0046] In some embodiments, the hollow metallic expandable body and delivery device are configured such that the interior volume of the expandable body can optionally be at least partially filled with a solid or semi-solid support structure, including metallic or polymeric coils or wires, metallic or polymeric expandable structures, beads, balls, microparticles, bioabsorbable or bioerodible materials, or combinations thereof. In one embodiment, no non-patient derived solid or semi-solid materials or members are required in the interior volume of the expandable body to allow the expandable body to assume or maintain an expanded configuration following separation of the expandable body and the delivery device.

[0047] When in the expanded configuration, the hollow metallic expandable body may have an overall shape that is spherical, spheroidal, or ellipsoidal. In one embodiment, the shape may be a flattened spheroidal surface on a disk. In various embodiments, the expandable body is selected to be smaller than the biological space to be filled. In various embodiments, when expanded, the expandable body has a maximum width, length, or diameter parallel to the second axis that is greater than the width of the entrance or opening to the biological space, such that the expanded shape of the expandable body may reduce the flow of biological fluids to the biological space or seal the entrance, neck, or opening to the biological space. For example, the expandable body may be used to seal the opening or neck to a saccular aneurysm or at least reduce blood flow to a saccular aneurysm.

[0048] The hollow metallic expandable body may be placed in combination with one or more additional expandable bodies to maintain contact with the aneurysm entrance, neck, or opening. In one embodiment, one or more coiled wire expandable bodies are placed in the aneurysm sac adjacent to the expanded hollow metallic expandable body, whereby the one or more coiled wires fill a portion of the remaining space in the biological space and exert a force on the surface of the expanded hollow metallic expandable body to maintain position in the space and maintain continuous contact with the aneurysm entrance, neck, or opening. In a particular embodiment, the coiled wire expandable body comprises Nitinol or other self-expanding material. In other embodiments, the coiled wire expandable body comprises platinum or stainless steel. In a special embodiment, one or more coiled wire expandable bodies (referred to as "auxiliary coils") are placed in the aneurysm cavity between the expanded hollow metallic expandable body (referred to as "ballstent") and the aneurysm wall facing the entrance, neck, or opening from the parent vessel to the aneurysm lumen or sac. As used herein, a parent vessel is the vessel in which the aneurysm forms.

[0049] The size of the expanded hollow metallic expandable body is selected so that the expanded hollow metallic expandable body is larger or wider than the aneurysm entrance, neck, or opening, and does not push or pull out of the aneurysm and occludes 50% or more of the parent vessel's luminal cross-sectional area into the parent vessel. In this context, one or more auxiliary coils are positioned to contact both i) the aneurysm wall opposite the aneurysm entrance, neck, or opening, and ii) the expanded hollow metallic expandable body, the auxiliary coil(s) applying a force to press or hold the expanded hollow metallic expandable body against the aneurysm entrance, neck, or opening. In one embodiment, the auxiliary coil may be made of a method and material that gives the coil self-expanding properties. For example, the auxiliary coil may be a spherical coil comprising Nitinol. In other embodiments, the auxiliary coil may be a variety of other shapes, including but not limited to spherical, spheroidal, ellipsoidal, or cylindrical configurations. In other embodiments, the auxiliary coil may be coated with a polymeric material such as PTFE to soften the coil and increase the lubricity of the coil in a manner that can reduce trauma to the aneurysm wall and reduce the force required to push the coil through and out of the coil delivery catheter. In various aspects, the auxiliary coil may have a diameter in the range of approximately 0.002 to 0.0035 inches. Preferably, the auxiliary coil has a diameter between approximately 0.004 to 0.008 inches, which is smaller than aneurysms and cerebral aneurysms, and between approximately 0.008 to 0.038 inches, which is larger than aneurysms and peripheral aneurysms. Similarly, in various aspects, the polymeric coating on the auxiliary coil may have a thickness in the range of approximately 0.001 to 0.004 inches. Preferably, the polymeric coating may have a thickness in the range of approximately 0.0015 to 0.002 inches.

[0050] The auxiliary coil may be delivered to a biological space, such as the lumen of an aneurysm, without the use of a separate and segmented delivery catheter. For example, the auxiliary coil may be inserted into a guidewire lumen of a medical device comprising a single lobed metallic expandable body and a delivery catheter, and advanced into the aneurysm sac, including using a pushing device. The auxiliary coil is then released from the pushing device, including a method of creating an electric field in the connection region between the pushing device and the auxiliary coil.

[0051] The auxiliary coil may be delivered to a biological space, such as the lumen of an aneurysm, using a separate and segmented delivery catheter. For example, the auxiliary coil may be loaded into the lumen of an "auxiliary coil delivery catheter" and the auxiliary coil / auxiliary coil delivery catheter assembly may be inserted into the guidewire lumen of a medical device comprising a single lobed metallic expandable body and delivery catheter, and the auxiliary coil / auxiliary coil delivery catheter assembly may be advanced into the aneurysm sac. The auxiliary coil is then withdrawn from the auxiliary coil delivery catheter using a pushing device, which includes a method of providing an electric field in the connection region between the pushing device and the auxiliary coil, and the auxiliary coil is then released from the pushing device. The auxiliary coil delivery catheter is then removed from the patient.

[0052] The auxiliary coil delivery catheter may have an outer diameter in the range of approximately 0.010 to 0.050 inches, preferably in the range of approximately 0.016 to 0.020 inches. Similarly, the auxiliary coil delivery catheter may have an inner diameter in the range of approximately 0.006 to 0.044 inches, preferably in the range of approximately 0.010 to 0.014 inches.

[0053] The auxiliary coil may be either of the pushable type or of the detachable type. In the case of the detachable type, an exemplary method of removing the coil from its delivery catheter includes the use of an electrolytic or electrothermal system. To enhance visibility under fluoroscopy, the auxiliary coil and / or the tip of the delivery catheter may be electroplated with a radiopaque metal such as gold or may be fitted with a radiopaque marker, including a marker band or wire segment. Such radiopaque markers include markers containing platinum, stainless steel, and platinum-iridium. Alternatively, the auxiliary coil may be coated with a polymer containing radiopaque liquid or powder. In various embodiments, the first expandable body (including a single lobed hollow metallic expandable body) and the second expandable body (including one or more coiled wire expandable bodies or auxiliary coils) may be used in combination with other minimally invasive, catheter-based intravascular devices, such as framing coils or vascular stents. Stents include stents designed to hold a coil within the aneurysm sac for occlusion and "shunt" stents designed to occlude the aneurysm without a coil.

[0054] In certain embodiments, the hollow metallic expandable body may include a proximal neck and a distal neck, each extending away from the expandable body. In one embodiment, both the expandable body and the neck are formed entirely from a malleable metal, such as gold or platinum. In another embodiment, a portion of at least one neck comprises stainless steel, which may then be cut via electrolysis. The stainless steel comprises a stainless steel ring. In yet another embodiment, the proximal neck or the proximal body of the expandable body is coated with a hydrogel to enhance occlusion of the aneurysm neck.

[0055] The delivery device includes a longitudinally extending body that may have the shape and function of a catheter and may have a hydrophilic or lubricious coating. This coating may be present on the expandable body as well. A distal segment of the longitudinally extending body is operably coupled to the expandable body. The expandable body includes a proximal neck and a proximal region. The distal segment of the longitudinally extending body may further be operably coupled to the distal neck. For example, the distal end of the longitudinally extending body may be received at a neck at the proximal region of the expandable body such that an outer surface of the distal segment of the longitudinally extending body abuts an inner surface of the proximal neck of the expandable body. In other embodiments, the distal segment of the longitudinally extending body terminates near a proximal end of an exposed metal ring-shaped region at the neck of the expandable body. In other embodiments, the distal segment of the longitudinally extending body extends through the expandable body and abuts an inner surface of the distal neck of the expandable body. In other embodiments, a longitudinally extending distal segment of the body extends through the expandable body and through a distal neck of the expandable body.

[0056] Various systems and methods may include or use an electrolytic system configured to deliver electrical current to the hollow metallic expandable body, where the electrical current is delivered to an exposed metallic surface on the proximal or distal neck of the hollow metallic expandable body.Various systems and methods may further include or use an electrolytic system configured to deliver electrical current to the coiled wire expandable body, where the electrical current is delivered to an exposed metallic surface on the connection area between the coiled wire expandable body and the pushing device.Various systems and methods may further include or use an electrolytic system configured to deliver electrical current to the wire mesh expandable body, where the electrical current is delivered to an exposed metallic surface on the connection area between the wire mesh expandable body and the pushing device.

[0057] In various embodiments, the current includes constant current, low voltage, or square wave voltage. In particular embodiments, the current includes 2 mA direct current and constant 2 mA direct current. When the longitudinally extending body or delivery catheter is coupled to the expandable body, delivery of the current can result in separation or removal of the delivery catheter from the expandable body. Separation can occur at a circumferential or ring-shaped uncoated or exposed metal surface area of ​​the neck formed of gold coated or plated stainless steel, the circumferential or ring-shaped uncoated or exposed metal surface area being a surface of the stainless steel exposed by etching, e.g., laser etching. During electrolysis, the circumferential uncoated or exposed metal surface area of ​​the neck acts as an anode. When delivering a square wave voltage, the voltage of the anode is adjusted based on a comparison between the voltage of the anode and the voltage of a reference electrode present on the outside of the delivery device, such as a needle or electrode pad supported on the delivery device or attached to the inside or outside of the patient, or an electrode present on the body of the delivery catheter.

[0058] The portion of the electrolytic system supported on the delivery device includes one or more conductors incorporated on or in the delivery catheter wall that act as electrical conductors for the electrical system. These conductors may also simultaneously provide structural reinforcement to the wall of the delivery catheter. The conductors are wires, cables, or other electrical conductors that may be routed through or through the catheter or catheter wall in various configurations, including helical, braided, or linear configurations. In some embodiments, one of the conductors is in electrical communication with a portion of the expandable body that can function as an anode, such as at or near the circumferential area of ​​the neck that has an exposed metal surface, while the other conductor is in electrical communication with a structure supported on the delivery device that can function as a cathode, such as a platinum metal electrode or ring. In other embodiments, one of the conductors is in electrical communication with a portion of the expandable body that can function as an anode, such as at or near the connection area between the coiled wire and the pushing device, while the other conductor is in electrical communication with a structure supported on the delivery device that can function as a cathode, such as a platinum metal electrode or ring. In other embodiments, the third conductor is in electrical communication with a structure supported on the delivery device that can function as a reference electrode.

[0059] When in the expanded configuration, the expandable body may have an overall shape that is cylindrical. In various embodiments, the ends of the expandable body may have a hemispherical or conical shape. Such an expandable body may be optimized for occlusion of an arterial or venous segment. In various embodiments, the proximal or distal nosecone of the expandable body may include one or more valves that block blood flow through the central cavity of the expanded expandable body to facilitate occlusion of the target vessel segment.

[0060] This application is related to PTC International Patent Application No. PTC / US14 / 30869, filed March 14, 2014, entitled "Expandable Body Devices and Methods of Use Thereof," PCT International Patent Application No. PTC / US12 / 47072, filed July 17, 2012, entitled "Expandable Body Devices and Methods of Use Thereof," PCT International Patent Application No. PTC / US12 / 21620, filed January 17, 2012, entitled "Separable Metal Balloon Delivery Devices and Methods Thereof," and PCT International Patent Application No. PTC / US12 / 21620, filed January 17, 2012, entitled "Separable Metal Balloon Delivery Devices and Methods Thereof." PCT International Patent Application No. PTC / US12 / 21621, filed Jan. 17, 2012, entitled "Ballstent Devices and Methods of Use Thereof," PCT International Patent Application No. PTC / US12 / 00030, filed Jan. 17, 2012, entitled "Blockstent Devices and Methods of Use Thereof," and U.S. Provisional Patent Application No. 61 / 433,305, filed Jan. 17, 2011 (the '305 application), entitled "Separable Metal Balloon Delivery Device and Method." Each of the above-listed patent applications is co-owned and co-owned by the same inventors at the time of filing, and is hereby incorporated by reference in its entirety. [Brief description of the drawings]

[0061] [Figure 1A-1D] FIG. 1A is a plan view of an embodiment of an expandable body; FIG. 1B is a plan view of an embodiment of an expandable body; FIG. 1C is a plan view of an embodiment of an expandable body; and FIG. 1D is a plan view of an embodiment of an expandable body. [Figures 2A-2E] FIG. 2A is a perspective view of an embodiment of an expandable body. FIG. 2B is a partial internal view of the embodiment of the expandable body of FIG. 2A. FIG. 2C is a cross-sectional view of the embodiment of the expandable body of FIG. 2A. FIG. 2D is a perspective view of an embodiment of an expandable body. FIG. 2E is a cross-sectional view of an embodiment of an expandable body. [Fig. 2F-2I] (FIG. 2F) A plan view of an embodiment of an expandable body. (FIG. 2G) A partial internal view of the embodiment of the expandable body of FIG. 2F. (FIG. 2H) An enlarged plan view of the embodiment of the expandable body of FIG. 2F. (FIG. 2I) An enlarged cross-sectional view of the embodiment of the expandable body of FIG. 2F. [Fig. 2J-2M]FIG. 2J is an enlarged cross-sectional view of the expandable body embodiment of FIG. 2F; FIG. 2K is an enlarged cross-sectional view of the expandable body embodiment of FIG. 2F; FIG. 2L is a perspective view of the expandable body embodiment; and FIG. 2M is a top view of the expandable body embodiment of FIG. 2L. [Fig. 2N-2Q] (FIG. 2N) A cross-sectional view of an embodiment of the expandable body of FIG. 2L. (FIG. 2O) An enlarged cross-sectional view of an embodiment of the expandable body of FIG. 2L. (FIG. 2P) A cross-sectional view illustrating a delivery device and coil traversing the interior of the expandable body of FIG. 2L. (FIG. 2Q) A partial internal view illustrating a delivery device traversing the interior of the expandable body of FIG. 2L. [Figures 3A-3I] FIG. 3A is a cross-sectional view of an embodiment of an expandable body. FIG. 3B is a close-up cross-sectional view of an embodiment of an expandable body. FIG. 3C is a perspective view of an expandable body with a bridging catheter having a radiopaque marker at its distal end. FIG. 3D is a perspective view of an expandable body with a bridging catheter having a radiopaque marker at its distal end. FIG. 3E is a cross-sectional view of an embodiment of a rigid telescoping bridge segment within an expandable body. FIG. 3F is a cross-sectional view of an embodiment of a rigid telescoping bridge segment within an expandable body. FIG. 3G is a cross-sectional view of an embodiment of a rigid telescoping bridge segment within an expandable body. FIG. 3H is a cross-sectional view of an embodiment of a flexible bridge segment within an expandable body. FIG. 3I is a cross-sectional view of an embodiment of a flexible bridge segment within an expandable body. [Figure 4A-5B] FIG. 4A is a plan view of an embodiment of an expandable body. FIG. 4B is an enlarged cross-sectional view of an embodiment of an expandable body. FIG. 5A is a plan view of an electrolytic neck segment for an embodiment of an expandable body. FIG. 5B is an enlarged cross-sectional view of an electrolytic neck segment for an embodiment of an expandable body. [Figures 6A-6D] FIG. 6A is a cross-sectional view of an embodiment of an expandable body and a delivery device; FIG. 6B is a cross-sectional view of an embodiment of an expandable body and a delivery device; FIG. 6C is a perspective view of an embodiment of an expandable body; and FIG. 6D is a cross-sectional view of an embodiment of an expandable body. [Fig. 6E-8G](Figure 6E) A plan view of an embodiment of an expandable body having a cylindrical shape with a conical end. (Figure 7) A perspective view of an embodiment of a dual catheter delivery device. (Figure 8A) A plan view of a configuration of an embodiment of an expandable body. (Figure 8B) A plan view of a configuration for an embodiment of an expandable body. (Figure 8C) A plan view of a configuration for an embodiment of an expandable body. (Figure 8D) A plan view of a configuration for an embodiment of an expandable body. (Figure 8E) A plan view of a configuration for an embodiment of an expandable body. (Figure 8F) A plan view of a configuration for an embodiment of an expandable body. (Figure 8G) A perspective view of a configuration for an embodiment of an expandable body. [Fig. 8H-8K] FIG. 8H is a perspective view of a configuration for an embodiment of an expandable body; FIG. 8I is a plan view of a configuration for an embodiment of an expandable body; FIG. 8J is a plan view of a configuration for an embodiment of an expandable body; and FIG. 8K is a cross-sectional view of a configuration for an embodiment of an expandable body. [Fig. 8L-8O] FIG. 8L is a cross-sectional view of a configuration for an embodiment of an expandable body; FIG. 8M is a cross-sectional view of a configuration for an embodiment of an expandable body; FIG. 8N is a cross-sectional view of a configuration for an embodiment of an expandable body; and FIG. 8O is a cross-sectional view of a configuration for an embodiment of an expandable body. [Fig. 8P-8T] (FIG. 8P) A plan view of a configuration for an embodiment of an expandable body. (FIG. 8Q) A plan view of a configuration for an embodiment of an expandable body. (FIG. 8R) A cross-sectional view of a configuration for an embodiment of an expandable body. (FIG. 8S) A cross-sectional view of a configuration for an embodiment of an expandable body. (FIG. 8T) A cross-sectional view of a configuration for an embodiment of an expandable body. [Fig. 8U-9C](Figure 8U) Cross-sectional view of a configuration for an embodiment of an expandable body. (Figure 8V) Cross-sectional view of a configuration for an embodiment of an expandable body. (Figure 8W) Top view of an embodiment of an expandable body having a flattened spheroid shape on a disk. (Figure 8X) Top perspective view of an embodiment of an expandable body having a flattened spheroid shape on a disk. (Figure 9A) Longitudinal cross-sectional view of an expandable body incorporating valves in the distal and proximal nose cones. (Figure 9B) Longitudinal cross-sectional view of an expandable body incorporating valves in the distal and proximal nose cones. (Figure 9C) Longitudinal cross-sectional view of an expandable body incorporating valves in the distal and proximal nose cones. [Fig. 9D-9G] (FIG. 9D) A longitudinal cross-sectional view of an expandable body incorporating valves in the distal and proximal nosecones. (FIG. 9E) A perspective view of a central piercing configuration for a valve embodiment used in the distal and / or proximal nosecones. (FIG. 9F) A perspective view of a central piercing configuration for a valve embodiment used in the distal and / or proximal nosecones. (FIG. 9G) A perspective view of a central piercing configuration for a valve embodiment used in the distal and / or proximal nosecones. [Fig. 9H-10A] (FIG. 9H) A cross-sectional view of an embodiment using multiple valves in the distal and / or proximal nosecone. (FIG. 9I) A cross-sectional view of an embodiment using multiple valves in the distal and / or proximal nosecone. (FIG. 10A) A top view of an embodiment of a medical device. [Fig. 10B-11C] (Figure 10B) A plan view of an embodiment of a medical device. (Figure 10C) A plan view of an embodiment of a medical device. (Figure 11A) A schematic diagram of an embodiment of a medical device illustrating the sequence of steps involved in delivering and positioning an expandable body into an aneurysm. (Figure 11B) A schematic diagram of an embodiment of a medical device illustrating the sequence of steps involved in delivering and positioning an expandable body into an aneurysm. (Figure 11C) A schematic diagram of an embodiment of a medical device illustrating the sequence of steps involved in delivering and positioning an expandable body into an aneurysm. [Fig. 11D-11K]FIG. 11D is a schematic diagram of an embodiment of a medical device illustrating the sequence of steps involved in delivering and positioning an expandable body into an aneurysm. FIG. 11E is a schematic diagram of an embodiment of a medical device illustrating the sequence of steps involved in delivering and positioning an expandable body into an aneurysm. FIG. 11F is a schematic diagram of an embodiment of a medical device illustrating the sequence of steps involved in delivering and positioning an expandable body into an aneurysm. FIG. 11G is a schematic diagram of an embodiment of a medical device illustrating the sequence of steps involved in positioning an expandable body in a vessel segment. FIG. 11H is a schematic diagram of an embodiment of a medical device illustrating the sequence of steps involved in positioning an expandable body in a vessel segment. FIG. 11I is a schematic diagram of an embodiment of a medical device illustrating the sequence of steps involved in positioning an expandable body in a vessel segment. FIG. 11J is a schematic diagram of an embodiment of a medical device illustrating the sequence of steps involved in positioning an expandable body in a vessel segment. FIG. 11K is a schematic diagram of an embodiment of a medical device illustrating the sequence of steps involved in positioning an expandable body in a vessel segment. [Figure 12A-13] (Figure 12A) A perspective view of an embodiment of an auxiliary coil. (Figure 12B) A perspective view of an embodiment of an auxiliary coil. (Figure 12C) A perspective view of an embodiment of an auxiliary coil having functions to increase its smoothness and visibility under fluoroscopy. (Figure 12D) A cross-sectional view of an embodiment of an auxiliary coil having functions to increase its smoothness and visibility under fluoroscopy. (Figure 12E) A cross-sectional view of an embodiment of an auxiliary coil having functions to increase its smoothness and visibility under fluoroscopy. (Figure 13) A plan view of an embodiment of a medical device. [Figures 14A-15C](FIG. 14A) is a plan view of an embodiment of a medical device. (FIG. 14B) is a plan view of an embodiment of a medical device. (FIG. 15A) is a schematic view of an embodiment of a medical device illustrating the sequence of steps involved in placing an expandable body in an aneurysm. (FIG. 15B) is a schematic view of an embodiment of a medical device illustrating the sequence of steps involved in placing an expandable body in an aneurysm. (FIG. 15C) is a schematic view of an embodiment of a medical device illustrating the sequence of steps involved in placing an expandable body in an aneurysm. [Fig. 15D-15K] (FIG. 15D) is a schematic diagram of an embodiment of a medical device illustrating the sequence of steps involved in positioning an expandable body in an aneurysm. (FIG. 15E) is a schematic diagram of an embodiment of a medical device illustrating the sequence of steps involved in positioning an expandable body in an aneurysm. (FIG. 15F) is a schematic diagram of an embodiment of a medical device illustrating the sequence of steps involved in positioning an expandable body in an aneurysm. (FIG. 15G) is a schematic diagram of an embodiment of a medical device illustrating the sequence of steps involved in positioning an expandable body in a vessel segment. (FIG. 15H) is a schematic diagram of an embodiment of a medical device illustrating the sequence of steps involved in positioning an expandable body in a vessel segment. (FIG. 15I) is a schematic diagram of an embodiment of a medical device illustrating the sequence of steps involved in positioning an expandable body in a vessel segment. (FIG. 15J) is a schematic diagram of an embodiment of a medical device illustrating the sequence of steps involved in positioning an expandable body in a vessel segment. (FIG. 15K) is a schematic diagram of an embodiment of a medical device illustrating the sequence of steps involved in positioning an expandable body in a vessel segment. [Figures 16A-16D] (FIG. 16A) A hemispherical cross-section taken through the diameter of an embodiment of an expandable body. (FIG. 16B) A hemispherical cross-section taken through the diameter of an embodiment of an expandable body. (FIG. 16C) A hemispherical cross-section taken through the diameter of an embodiment of an expandable body. (FIG. 16D) A hemispherical cross-section taken through the diameter of an embodiment of an expandable body. [Fig. 16E-17B](FIG. 16E) A longitudinal cross-section of an expandable body supported on the distal end of a delivery catheter, the expandable body being spherical and may be employed as an embodiment of a ballstent. (FIG. 16F) A partial cross-section through the ballstent wall of FIG. 16E. (FIG. 16G) A longitudinal cross-section of an expandable body supported on the distal end of a delivery catheter, the expandable body being cylindrical with hemispherical ends and may be employed as an embodiment of a ballstent or blockstent. (FIG. 16H) A partial cross-section through the wall of the expandable body of FIG. 16G. (FIG. 16I) A longitudinal cross-section of an expandable body supported on the distal end of a delivery catheter, the expandable body being spherical and may be employed as an embodiment of a ballstent. (FIG. 16J) A partial cross-section through the ballstent wall of FIG. 16I. (FIG. 16K) A longitudinal cross-sectional view of an expandable body supported on the distal end of a delivery catheter, the expandable body being cylindrical in shape with hemispherical ends and may be employed as a ballstent or blockstent embodiment. (FIG. 16L) A partial cross-sectional view through the wall of the expandable body of FIG. 16K. (FIG. 17A) A plan view of an expandable body positioned within a bifurcation aneurysm with an auxiliary coil according to one embodiment. (FIG. 17B) A plan view of an expandable body positioned within a bifurcation aneurysm with an auxiliary coil according to one embodiment. [Fig. 17C-17F] (Figure 17C) Plan view of an expandable body positioned within a bifurcation aneurysm after insertion of an auxiliary coil positioned both within the expandable body and within the biospace. (Figure 17D) Plan view of an expandable body positioned within a bifurcation aneurysm after insertion of a magnetic internal support structure and an external magnetic coil. (Figure 17E) Plan view of an expandable body after insertion of an internal support structure. (Figure 17F) Plan view of an embodiment of an expandable body where the shape of the expandable body is changed by application of an external force using a balloon catheter. [Fig. 17G-17K](FIG. 17G) A plan view of an embodiment of an expandable body after insertion into a bifurcation aneurysm. (FIG. 17H) A cross-sectional view of a wide neck aneurysm depicting the effect of treatment with a medical device on the aneurysm aspect ratio. (FIG. 17I) A cross-sectional view of a wide neck aneurysm depicting the effect of treatment with a medical device on the aneurysm aspect ratio. (FIG. 17J) A cross-sectional view of a wide neck aneurysm depicting the effect of treatment with a medical device on the aneurysm aspect ratio. (FIG. 17K) Provides a cross-sectional view showing steps for using a medical device along with a framing coil to occlude an aneurysm. [Fig. 17L-17O] (FIG. 17L) A cross-sectional view of an embodiment of a medical device used along with a vascular stent to occlude an aneurysm. (FIG. 17M) A flow diagram detailing the steps for using a medical device along with a vascular stent to occlude an aneurysm. (FIG. 17N) A flow diagram detailing the steps for using a medical device along with a vascular stent to occlude an aneurysm. (FIG. 17O) A perspective view of an auxiliary coil delivery catheter having a radiopaque marker at its distal end. [Fig. 17P-18B] (FIG. 17P) provides a plan view showing a sequence of operations of a typical electrothermal separation system suitable for use with an auxiliary coil embodiment. (FIG. 17Q) provides a perspective view showing a sequence of operations of a typical electrothermal separation system suitable for use with an auxiliary coil embodiment. (FIG. 18A) provides a partial cross-sectional view of an embodiment of an expandable body having a perforated surface layer that promotes tissue ingrowth within an aneurysm. (FIG. 18B) provides a partial cross-sectional view of an embodiment of an expandable body having a perforated surface layer that promotes tissue ingrowth within an aneurysm. [Fig. 18C-18F] (FIG. 18C) A partial cross-sectional view of an embodiment of an expandable body having a perforated surface layer that promotes tissue ingrowth within an aneurysm. (FIG. 18D) A partial cross-sectional view of an embodiment of an expandable body having a perforated surface layer that promotes tissue ingrowth within an aneurysm. (FIG. 18E) A partial cross-sectional view of an embodiment of an expandable body having a perforated surface layer that promotes tissue ingrowth within an aneurysm. (FIG. 18F) A plan view of the expandable body after insertion of an auxiliary coil that contacts and secures thrombus within the bifurcation aneurysm. [Fig. 18G-19B](FIG. 18G) A plan view of an embodiment of an expandable body having external protrusions for anchoring the expandable body to surrounding tissue. (FIG. 18H) A plan view of an embodiment of an expandable body having external protrusions for anchoring the expandable body to surrounding tissue. (FIG. 18I) A cross-sectional view of an embodiment of an expandable body with a proximally localized hydrogel surface layer that promotes tissue ingrowth within the aneurysm. (FIG. 19A) A perspective view of an embodiment of an expandable body as compressed against a delivery device. (FIG. 19B) An end view of an embodiment of a compressed expandable body. [Fig. 19C-20D] (Figure 19C) An end view of an embodiment of a compressed expandable body defining an eccentric channel. (Figure 19D) An end view of an embodiment of a compressed expandable body. (Figure 20A) A cross-sectional view of an embodiment of a delivery catheter of a medical device having multiple lumens. (Figure 20B) A cross-sectional view of an embodiment of a delivery catheter of a medical device having multiple lumens. (Figure 20C) A cross-sectional view of an embodiment of a delivery catheter of a medical device having multiple lumens. (Figure 20D) A cross-sectional view of an embodiment of a delivery catheter of a medical device having multiple lumens. [Figures 21A-21D] (FIG. 21A) A plan view of a medical embodiment having an internal lumen configured to receive a guide catheter rather than a guidewire. (FIG. 21B) A cross-sectional view of the device taken along line AA of FIG. 21A. (FIG. 21C) An enlarged plan view of an embodiment of a mechanical detachment system incorporating an elastomeric sleeve at the proximal neck of the expandable body. (FIG. 21D) A partial cross-sectional view of an embodiment of a mechanical detachment system incorporating an elastomeric sleeve at the proximal neck of the expandable body. [Fig. 21E-21H] (Figure 21E) A partial cross-sectional view of an embodiment of a mechanical detachment system incorporating an elastomeric sleeve at the proximal neck of the expandable body. (Figure 21F) A perspective view of an embodiment of a mechanical detachment system incorporating an elastomeric sleeve at the proximal neck of the expandable body. (Figure 21G) A cross-sectional view of an embodiment of a mechanical detachment system incorporating a detachment catheter. (Figure 21H) A cross-sectional view of an embodiment of a mechanical detachment system incorporating a detachment catheter. [Fig. 21I-23B] (FIG. 21I) A plan view in a perspective view of an embodiment of a mechanical detachment system incorporating a detachment catheter. (FIG. 21J) A partial internal view in a perspective view of an embodiment of a mechanical detachment system incorporating a detachment catheter. (FIG. 22) A perspective view of an arrangement for expanding or contracting an expandable body. (FIG. 23A) A plan view of an embodiment of a medical device in which an expandable body is attached to a delivery catheter with an adhesive and detached from the delivery catheter by electrolysis at a portion of the neck of the expandable body. (FIG. 23B) A cross-sectional view of a delivery catheter. [Fig. 23C-24A] (Figure 23C) Plan view of the delivery catheter. (Figure 23D) Cross-sectional view of the delivery catheter. (Figure 23E) Plan view of the delivery catheter. (Figure 23F) Plan view of the delivery catheter. (Figure 23G) Photograph of the catheter supporting two electrode rings. (Figure 23H) Partial cross-sectional view of the expandable body attached to a delivery device. (Figure 23I) Perspective view of the expandable body attached to a delivery device. (Figure 24A) Various views of an expandable body with a cylindrical middle section and hemispherical ends. [Figure 24B-26] (Figure 24B) A longitudinal cross-sectional view illustrating the neck region of the expandable body. (Figure 24C) A longitudinal cross-sectional view illustrating the neck region of the expandable body. (Figure 25A) A partial cross-sectional view depicting the sequence for electroforming an expandable body on a mandrel. (Figure 25B) A partial cross-sectional view depicting the sequence for electroforming an expandable body on a mandrel. (Figure 25C) A perspective view depicting the sequence for electroforming an expandable body on a mandrel. (Figure 26) A perspective view depicting an embodiment of a mandrel for electroforming a metallic expandable body. [Figure 27-30A]FIG. 27 is a longitudinal cross-sectional view depicting another embodiment of a mandrel for electroforming a metallic expandable body. FIG. 28 is a partial cross-sectional view of a metallic expandable body produced by electroforming. FIG. 29A is a photograph of an embodiment of a mandrel and a metallic expandable body formed thereon. FIG. 29B is a photograph of an embodiment of a mandrel and a metallic expandable body formed thereon. FIG. 29C is a photograph of an embodiment of a mandrel and a metallic expandable body formed thereon. FIG. 29D is a photograph of an embodiment of a mandrel and a metallic expandable body formed thereon. FIG. 29E is a scanning electron micrograph showing the exterior surface of a metallic expandable body according to one embodiment. FIG. 30A is a plan view depicting coatings on the exterior and interior surfaces of a spherical embodiment of an expandable body. [Fig. 30B-31A] (FIG. 30B) A cross-sectional view depicting a coating on the exterior and interior surfaces of a spherical embodiment of the expandable body. (FIG. 30C) A top view depicting an area of ​​exposed metal surface where the metallic expanded body separates from the delivery device by electrolysis. (FIG. 30D) A cross-sectional view depicting an area of ​​exposed metal surface where the metallic expanded body separates from the delivery device by electrolysis. (FIG. 30E) A top view depicting an area of ​​exposed metal surface where the metallic expanded body separates from the delivery device by electrolysis. (FIG. 30F) A cross-sectional view depicting an area of ​​exposed metal surface where the metallic expanded body separates from the delivery device by electrolysis. (FIG. 31A) A perspective view of an embodiment of a medical device for delivering an embodiment of an expandable body. [Fig. 31B-32F]FIG. 31B is a perspective view of an embodiment of a medical device for delivering an embodiment of an expandable body. FIG. 32A is a cross-sectional view of a hub for use with a medical device, where electrolytic detachment of the expanded body is achieved by passing an electric current through the medical device. FIG. 32B is a partial perspective view of a hub for use with a medical device. FIG. 32C is a partial perspective view of a hub for use with a medical device. FIG. 32D is a perspective partial internal view of an embodiment of a dual locking hub for use with a medical device, where mechanical detachment of the expanded body is achieved. FIG. 32E is a perspective partial internal view of an embodiment of a dual locking hub for use with a medical device, where mechanical detachment of the expanded body is achieved. FIG. 32F is a perspective partial internal view of an embodiment of a dual locking hub for use with a medical device, where mechanical detachment of the expanded body is achieved. [Fig. 32G-35] (FIG. 32G) A perspective view of the proximal end of a delivery catheter shaft according to one embodiment. (FIG. 33) Top and side views of a handheld controller for use with a medical device, where detachment of the expanded body is achieved by passing an electric current through the medical device. (FIG. 34) A flow diagram illustrating steps for manufacturing a medical kit including an expandable body, a delivery catheter, and a medical device. (FIG. 35) A flow diagram illustrating steps for manufacturing a medical kit including an expandable body, a delivery catheter, and a medical device. [Figure 36-37D](FIG. 36) A flow diagram illustrating steps for the manufacture of a medical kit including an expandable body, a delivery catheter, and a medical device. (FIG. 37A) A process for surgically constructing a saccular aneurysm on a terminal branch of a newly created carotid artery as performed during non-clinical testing of an embodiment of the expandable body. (FIG. 37B) A process for surgically constructing a saccular aneurysm on a terminal branch of a newly created carotid artery as performed during non-clinical testing of an embodiment of the expandable body. (FIG. 37C) A process for surgically constructing a saccular aneurysm on a terminal branch of a newly created carotid artery as performed during non-clinical testing of an embodiment of the expandable body. (FIG. 37D) A process for surgically constructing a saccular aneurysm on a terminal branch of a newly created carotid artery as performed during non-clinical testing of an embodiment of the expandable body. [Figure 38-40A] (FIG. 38) An angiogram of a saccular aneurysm obtained during non-clinical testing of an embodiment of the expandable body. (FIG. 39A) An angiogram of an occluded saccular aneurysm obtained during non-clinical testing of an embodiment of the expandable body. (FIG. 39B) An angiogram of an occluded saccular aneurysm obtained during non-clinical testing of an embodiment of the expandable body. (FIG. 40A) Photomicrographs of saccular aneurysm tissue samples collected during non-clinical testing of an embodiment of the expandable body. [Fig. 40B-43A] (FIG. 40B) Angiogram of an occluded saccular aneurysm obtained during a non-clinical trial of a conventional neurovascular coil. (FIG. 40C) Photomicrograph of a saccular aneurysm tissue sample collected during a non-clinical trial of a conventional neurovascular coil. (FIG. 41) Depicts angiogram results of a treated artery performed during a non-clinical trial of an embodiment of an expandable body. (FIG. 42A) Photomicrograph of a treated arterial tissue sample collected during a non-clinical trial of an embodiment of an expandable body. (FIG. 42B) Photomicrograph of a treated arterial tissue sample collected during a non-clinical trial of an embodiment of a conventional vascular plug. (FIG. 43A) A perspective view of an embodiment of an unexpanded expandable body positioned over a guidewire to occlude an artery. [Fig. 43B-43K](FIG. 43B) A plan view of an embodiment of an unexpanded expandable body placed over a guidewire to occlude an artery. (FIG. 43C) A cross-sectional view of an embodiment of an unexpanded expandable body placed over a guidewire to occlude an artery. (FIG. 43D) A partial cross-sectional view of an embodiment of an unexpanded expandable body placed over a guidewire to occlude an artery. (FIG. 43E) A plan view of an embodiment of an expanded expandable body placed over a guidewire to occlude an artery. (FIG. 43F) A cross-sectional view of an embodiment of an expanded expandable body placed over a guidewire to occlude an artery. (FIG. 43G) A detailed cross-sectional view of a distal portion of an embodiment of an expanded expandable body placed over a guidewire to occlude an artery. (FIG. 43H) A detailed cross-sectional view of a proximal portion of an embodiment of an expanded expandable body placed over a guidewire to occlude an artery. (FIG. 43I) A plan view of an embodiment of an expanded and detached expandable body placed over a guidewire to occlude an artery. (FIG. 43J) A cross-sectional view of an embodiment of an expanded and detached expandable body placed over a guidewire to occlude an artery. (FIG. 43K) Partial cross-sectional view showing an embodiment of an unexpanded expandable body positioned over a guidewire to occlude an artery. [Fig. 43L-44H]FIG. 43L is a cross-sectional view (along line AA shown in FIG. 43K) of an embodiment of an unexpanded expandable body placed over a guidewire to occlude an artery, showing dual lumens for 1) inflation and 2) guidewire insertion or X-ray contrast injection. FIG. 43M is a cross-sectional view (along line BB shown in FIG. 43K) of an embodiment of an unexpanded expandable body placed over a guidewire to occlude an artery, showing lumens for guidewire insertion or X-ray contrast injection. FIG. 44A is a perspective view of an embodiment of an unexpanded expandable body placed over a guidewire to occlude an artery or vein. FIG. 44B is a perspective view of an embodiment of an expanded expandable body placed over a guidewire to occlude an artery or vein. FIG. 44C is a cross-sectional view of an embodiment of an expanded expandable body placed over a guidewire to occlude an artery or vein. FIG. 44D is a perspective view of an embodiment of an expanded expandable body placed over a guidewire to occlude an artery or vein during separation. (FIG. 44E) A perspective view of an embodiment of an expandable body, expanded and separated, during separation, placed over a guidewire to occlude an artery or vein. (FIG. 44F) A cross-sectional view showing lumens for inflation and x-ray contrast in an embodiment of an unexpanded expandable body placed over a guidewire to occlude an artery or vein. (FIG. 44G) A cross-sectional view (along line AA shown in FIG. 44F) of an embodiment of an unexpanded expandable body placed over a guidewire to occlude an artery, showing triple lumens for 1) inflation, 2) guidewire insertion, and 3) x-ray contrast injection. (FIG. 44H) A cross-sectional view (along line BB shown in FIG. 43K) of an embodiment of an unexpanded expandable body placed over a guidewire to occlude an artery, showing lumens for guidewire insertion or x-ray contrast injection. [Fig. 45A-47A]FIG. 45A is a cross-sectional view of a low-profile embodiment of an unexpanded expandable body placed over a guidewire to occlude an artery or vein. FIG. 45B is a perspective view of a low-profile embodiment of an expanded expandable body placed over a guidewire to occlude an artery or vein. FIG. 45C is a cross-sectional view of a low-profile embodiment of an expanded expandable body placed over a guidewire to occlude an artery or vein. FIG. 46A is a perspective view of a mandrel used in heat treating a Nitinol framing coil. FIG. 46B is a plan view of a framing coil placed over an expanded expandable body. FIG. 46C is a continuation of the plan view from FIG. 46B of a framing coil placed over an expanded expandable body. FIG. 46D is a continuation of the plan view from FIG. 46C of a framing coil placed over an expanded expandable body. FIG. 47A is a plan view of one embodiment of an expandable body. [Fig. 47B-49A] (FIG. 47B) A perspective view of one embodiment of an expandable body. (FIG. 47C) A cross-sectional view of one embodiment of an expandable body. (FIG. 48) A plan view of an embodiment of a medical device in which a hollow metallic expandable body and a wire coil expandable body are individually separated from the delivery device by electrolysis using a common power source and cathode. (FIG. 49A) A perspective view of an auxiliary coil catheter and expandable body according to one embodiment. [Fig. 49B-49E] (FIG. 49B) A plan view of an auxiliary coil catheter and expandable body according to one embodiment; (FIG. 49C) A plan view of an auxiliary coil and expandable body withdrawn from an auxiliary coil catheter according to one embodiment; (FIG. 49D) A plan view of an auxiliary coil and expandable body withdrawn from an auxiliary coil catheter according to one embodiment; (FIG. 49E) A perspective view of an auxiliary coil and expandable body withdrawn from an auxiliary coil catheter according to one embodiment. [Fig. 50A-50E]FIG. 50A is a plan view of an auxiliary coil delivery system according to one embodiment; FIG. 50B is a perspective view of an auxiliary coil delivery system according to one embodiment; FIG. 50C is a plan view of an auxiliary coil delivery system according to one embodiment; FIG. 50D is a perspective view of an auxiliary coil delivery system according to one embodiment; and FIG. 50E is a perspective view of an auxiliary coil being extracted from an auxiliary coil system according to one embodiment. [Fig. 51A-52A] FIG. 51A is a perspective view of an electrolytically detachable auxiliary coil according to one embodiment; FIG. 51B is a plan view of an electrolytically detachable auxiliary coil according to one embodiment; FIG. 51C is a perspective view of an electrolytically detachable auxiliary coil according to one embodiment; and FIG. 52A is a perspective view of an auxiliary coil and marker wire according to one embodiment. [Fig. 52B-53C] (FIG. 52B) A cross-sectional view of an auxiliary coil and marker wire according to one embodiment; (FIG. 53A) A plan view of an auxiliary coil and marker band according to one embodiment; (FIG. 53B) A perspective view of an auxiliary coil and marker band according to one embodiment; (FIG. 53C) A cross-sectional view of an auxiliary coil and marker band according to one embodiment. [Figure 54A] FIG. 1 is a cross-sectional view of a guidewire catheter shaft according to one embodiment.

[0062] Corresponding reference symbols indicate corresponding elements in the various views of the drawings. Headings used in the figures are not to be construed as limiting the scope of the claims. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0063] The present disclosure relates to medical devices and systems, including an expandable body and the use of one or more medical apparatus or systems including the expandable body for the treatment of saccular aneurysms in the vasculature, where the expandable body ultimately resides within the aneurysm at the site of dilation. Additionally, the present disclosure relates to methods and systems for delivering and deploying various embodiments of the expandable body, where the expandable body is sized and configured to fill and / or seal at least a portion of the saccular aneurysm to remain in place in an expanded state.

[0064] The present disclosure further relates to medical devices and systems including hollow metallic expandable body shapes, including metallic or metal-containing balloons, and delivery catheters, and uses thereof. This expandable body shape is a thin-walled, hollow metallic structure. It can be compressed and then expanded to a semi-rigid shape. It remains within the body while expanded, and can withstand compression without a rigid or semi-rigid material in the central cavity of the expandable body, and can withstand compression without a seal when the pressure in the central cavity of the expanded expandable body is the same as or close to the pressure outside the expanded expandable body.

[0065] The present disclosure further relates to devices, systems, and methods for treating saccular aneurysms, where different shapes of expandable bodies may be deployed in combination, for example, a hollow metallic form of the expandable body may be placed within the aneurysm sac and expanded, and then one or more coiled wire form of the expandable body may be placed within the aneurysm sac, whereby the coiled wire contacts both the aneurysm wall and the wall of an expanded metallic balloon placed near the aneurysm neck and exerts a force on the expanded metallic balloon to seal off the aneurysm neck.

[0066] The present disclosure further relates to medical devices and systems including hollow metallic expandable bodies. This includes the use of one or more medical devices or systems including expandable bodies for occlusion of blood vessel segments or other biological conduits, where the expandable body ultimately remains in an expanded state in the blood vessel segment or biological conduit segment. The present disclosure further relates to methods and systems for delivering and deploying various embodiments of the expandable body. The expandable body is sized and configured to fill and / or occlude at least a portion of the blood vessel segment or biological conduit segment so as to remain in place in an expanded state. The present disclosure further relates to medical devices and systems including expandable body shapes including metallic or metal-containing balloons and delivery catheters, and their uses. The present disclosure further relates to devices, systems, and methods for occlusion of blood vessel segments or other biological conduits, where different shapes of expandable bodies may be deployed in combination.

[0067] As described herein, the terms "expandable body," "expanded body," "expanded expandable body," "expandable structure," "expandable balloon," "hollow metallic structure," "hollow metallic expandable body," "hollow metallic expandable body," "metallic balloon," "ballstent," and "blockstent" are described herein for use in an expandable body to fill a biological space, where the expandable body is first introduced into a patient, optionally with a delivery device, in an unexpanded state, second passed through one or more biological conduits of the patient to a desired treatment site (i.e., implantation site) in an unexpanded state, third expanded to an expanded state at the desired treatment site, and fourth separated from the delivery device to remain within the patient in the expanded configuration at the desired or treatment site.

[0068] In certain embodiments, the expandable body may be configured for use as a hollow metallic structure that can be inflated or expanded by injecting a liquid into a central cavity. In this context, when describing this particular embodiment, the terms "expandable body", "expandable structure", "expandable balloon", "hollow metallic structure", "hollow metallic expandable body", "hollow metallic expandable body", "metallic balloon", "ballstent", and "blockstent" as used herein refer to a single- or multi-layered walled expandable body with a generally solid surface without any overall openings or perforations.

[0069] In one embodiment, the term "ballstent" is sometimes used to describe a generally circular hollow metallic expandable body and may be used to treat saccular cerebral aneurysms. In another embodiment, the term "blockstent" is sometimes used to describe a generally rectangular or cylindrical configuration of a hollow metallic expandable body and may be used to fill a portion of the lumen of an arterial or vein segment, or a portion of the lumen of an otherwise configured segment of a biological conduit. Specifically, ballstents are configured for use in filling and occluding saccular aneurysms of blood vessels, particularly saccular cerebral aneurysms and ruptured aneurysms. Specifically, blockstents are configured for use in blocking or occluding the lumen of segments of arteries, veins, and other biological conduits.

[0070] The ballstent may be delivered to the saccular aneurysm using a delivery device. The delivery device further provides a pathway through the hollow cylindrical member or lumen of the cylindrical member for liquid medium to move into the void of the ballstent to expand the ballstent and fill at least a portion of the volume of the aneurysmal sac. The delivery device further provides a pathway for a guidewire through the hollow cylindrical member or lumen of the cylindrical member. The delivery device may further be configured to deliver other structures to the aneurysm, such as a second expandable body or a coiled wire or wire mesh expandable body, by providing a pathway through the hollow cylindrical member or lumen of the cylindrical member for passing the coiled wire or wire mesh expandable body from outside the patient's body to the lumen or cavity of the aneurysm. In some embodiments, the pathway for the guidewire and the pathway for the coiled wire or wire mesh expandable body are the same pathway. In some embodiments, the pathway for the guidewire and the pathway for the coiled wire or wire mesh expandable body are different pathways.

[0071] The blockstent can be delivered to a target region of an artery, vein, or biological conduit using a delivery device that further provides a hollow cylindrical member or a pathway through the lumen of the cylindrical member for fluid to travel to a central cavity of the blockstent to expand the blockstent and fill at least a portion of the lumen of the blood vessel segment.

[0072] The hollow metallic expandable body can be folded into a deliverable configuration for introduction into an aneurysm, an arterial or venous segment, or other shaped segment of a biological conduit. When folded into a deliverable configuration, the expandable body can be formed into a pleated configuration having a plurality of pleats that can be wound clockwise or counterclockwise around a central axis of the expandable body.

[0073] When used to fill an artery, the catheter delivery device and attached ballstent are advanced into the lumen or cavity of the saccular aneurysm. Similarly, when used to occlude a blood vessel or other biological conduit, the delivery device and attached blockstent are advanced into the lumen or space of the blood vessel or biological conduit. The delivery device can further deliver fluids, solids, or combinations thereof into the interior space of the expandable body to expand the body in the lumen of the aneurysmal sac and to assist in maintaining the expansion of the expanded body. The expanded body may be separated from the delivery device by one or more of a variety of arrangements and methods, including mechanical, electrolytic, electrothermal, chemical, hydraulic, or ultrasonic devices, systems, arrangements, and methods.

[0074] The medical device may be used as part of various systems, methods, and medical kits that may be used to treat saccular aneurysms, such as saccular cerebral aneurysms, and to occlude segments of arteries or veins or other biological conduits, such as the ductus arteriosus, bronchus, pancreatic duct, bile duct, ureter, or fallopian tube, etc. These systems, methods, and medical kits may be used to treat a variety of medical conditions.

[0075] Expandable body In various embodiments, the expandable body configured for occlusion of saccular cerebral aneurysms is commonly referred to as a ballstent and can be of many shapes, including spherical, spheroidal, ellipsoidal, or cardioidal. In various other embodiments, the expandable body may be configured as a blockstent for occluding the lumen of biological conduits, including arterial and venous segments, and can be of many shapes, including generally rectangular or generally cylindrical, including cylindrical with both flattened and rounded ends.

[0076] Generally, spherical ballstents 100 and 150 are shown in Figures 1A-D and 2A-4B. In particular, spherical ballstent 100 is shown in an expanded state in Figures 1A-4A. Ballstents 100 and 150 have a proximal neck 116 that projects away from the ballstent and defines an opening 112 for the passage of fluids, liquids, gases, gels, or solids into or through the space of the ballstent. In the ballstent 100 shown in Figure 1B, the neck 116 projects into the space to define an opening 112 for the passage of fluids, liquids, gases, gels, or solids into the ballstent 100.

[0077] Another spherical embodiment of the ballstent 100 is shown in an expanded state in FIG. 1C. This embodiment includes a proximal neck 116 that defines an opening 112 through which fluids, liquids, gases, gels, or solids enter or pass through the ballstent. The ballstent 100 further includes a distal neck 118 that projects away from the ballstent and defines an opening 114 for passage of a guidewire 302 or coil 162 through the ballstent or from the interior of the ballstent to the exterior of the ballstent, as shown in FIGS. 2A-B and 3A-B. The ballstent includes a distal to distal neck. A similar another spherical embodiment of the ballstent 100 is shown in an expanded state in FIG. 1D. This embodiment includes a proximal neck 116 defining an opening 112 and a distal neck 118 defining an opening 114, both of which project into the interior of the ballstent 100 for the passage of fluids, liquids, gases, gels, or solids, including a guidewire 302 or coil 162, into or through the interior of the ballstent.

[0078] Finally, the metallic expandable body disclosed herein may have any of a variety of configurations and configurations that can be employed for a variety of uses, including occlusion of aneurysms, including saccular aneurysms, and segments of biological conduits, including arteries and veins. Generally speaking, some configurations may lend themselves more quickly or effectively to one application or another. For example, the spherical expandable body 100 of Figures 1A-D may be particularly advantageous when functioning as a ball stent to fill the lumen (or space or cavity) of a saccular aneurysm. Similarly, as described further below, the spherical expandable bodies 100 and 150 of Figures 1A-D and 2A-4B and the expandable bodies 140 and 170A-F of Figures 6A-D, 8A-S, 16G, and 16K may be used with a coil or auxiliary coil 162, for example, to fill at least a portion of the lumen (or space or cavity) of a saccular aneurysm and reduce or block blood flow from a parent vessel through an opening into the aneurysm lumen or reduce or block blood flow through the neck of the saccular aneurysm into the body of the aneurysmal lumen (or space or cavity). In various embodiments, the coil or auxiliary coil 162 comprises a self-expanding material, such as Nitinol wire.

[0079] In some embodiments, as shown in Figures 8A-G and 8U, the expandable body 170A-H may be characterized as including a proximal region 174A-G, an intermediate region 173A-G, and a distal region 172A-G, where the proximal and distal regions are generally opposed to one another. Each body 170A-H, the proximal region 174A-G, the intermediate region 173A-G, and the distal region 172A-G form a unitary structure of the expandable body. Because of this feature, the proximal region, the intermediate region, and the distal region together form the "main body" of the expandable body, which does not include the neck. The expandable body 170A-H may be further defined by a first axis 176 and a second axis 178 that transverses the first axis. In one aspect, the first axis 176 extends between the necks 116 and 118.

[0080] In one embodiment, the shape of intermediate regions 173A-G of expandable bodies 170A-H may be defined by rotation about first axis 176 of a variable radius arc formed along the first axis, with a maximum radius of the variable arc equal to either maximum radius 181 of distal region 172 or maximum radius 180 of proximal region 174 as measured along second axis 178. In some embodiments, expanded expandable bodies 170A-H have an overall length 179 along first axis 176 that is less than or equal to a maximum diameter 182 of the expanded expandable body along second axis 178.

[0081] In some embodiments without an intermediate region, as shown in FIGS. 8A-G and 8U, the expandable body 170A-H may be characterized as including a proximal region 174 and a distal region 172, where the proximal and distal regions are generally opposed to one another. Each body 170A-H, the proximal region 174 and the distal region 172 form a unitary structure of the expandable body. Because of this feature, the proximal and distal regions together form the "main body" of the expandable body. It does not include the neck. The expandable body 170A-H may be further defined by a first axis 176 and a second axis 178 transverse to the first axis. In one aspect, the first axis 176 extends between the necks 116 and 118. In some embodiments, the expanded expandable body 170A-H has an overall length 179 along the first axis 176 that is greater than or equal to the maximum diameter 182 of the expanded expandable body along the second axis 178.

[0082] In various other embodiments, the expandable body may be defined and described by a proximal region 174 and a distal region 172, each of which is generally hemispherical. The hemispherical body formed by each of the regions 172 and 174 is further defined by a major axis and a semiminor axis that may be parallel to the first axis 176 or the second axis 178, based on the length of each axis. In various embodiments, the hemispherical body of the proximal region 174 has a major axis and a semiminor axis that are different from those of the distal region 172. In other embodiments, the hemispherical body of the proximal region 174 has a major axis and a semiminor axis that are the same as those of the distal region 176. Similarly, for each of the distal region 172 and the proximal region 174, the major axis and the semiminor axis may be different or consistent with one another, such that the corresponding regions may have the general shape of an oblate hemispheroid, an oblate hemispheroid, or a hemisphere. As shown, the expandable bodies 170A-H may also be assembled in various other configurations that have a generally spheroidal or ellipsoidal shape. The expandable bodies 170A-H may further include a proximal neck 116 and a distal neck 118.

[0083] In some embodiments, the expanded expandable bodies 170A-H have a length 179 from the proximal neck 116 to the distal neck 118 that is approximately 4-16 mm or more and a maximum diameter 182 that is approximately 4-16 mm or more. As shown in Figures 8A-F and 8U, the maximum radial lengths of the proximal and distal regions 174A-G and 172A-G are equal such that the expandable bodies 170A-H may have a generally circular cross-section when viewed in cross-section along the first axis 176. As shown in Figures 8A-E and 8U, the radial lengths at any equivalent location of the proximal and distal regions 174A-G and 172A-G may not be equal such that the expandable bodies 170A-H may not have a generally circular cross-section when viewed in cross-section along the second axis 176. As shown in FIG. 8F, in other embodiments, the radial lengths at any equivalent location of the proximal and distal regions 174A-G, 172A-G can be equal such that the expandable bodies 170A-H can have a generally circular cross-section when viewed in cross-section along the second axis 176.

[0084] In one embodiment, the different configurations of expandable bodies 170A-H may be obtained by separately varying the maximum length ("height") along first axis 176 of proximal regions 174A-G and distal regions 172A-G. For example, as shown in Figures 8A, C, and E, height 183 of proximal region 174A may be less than height 184 of distal region 172A. In other embodiments, height 183 of proximal region 174A may be equal to height 184 of distal region 172A, as shown in Figures 8B, D, and F. In other embodiments, height 183 of proximal region 174A may be greater than height 184 of distal region 172A. While both expandable bodies 170A and 170B have the same maximum diameter, the heights of the proximal and distal regions of each expandable body result in different overall shapes for the expandable body. As shown, expandable body 170A is generally cardiac shaped, while expandable body 170B is spheroid shaped.

[0085] In another embodiment shown in Figures 8A-F and 8U, the heights 183 and 184 of the proximal and distal portions 174A-F, 173A-F, respectively, may be varied separately to obtain a wide range of configurations of the expandable bodies 170A-H. The height 183 of the proximal region 174C may be approximately 2 mm, while the height of the distal region 172C is approximately 4 mm. Similarly, the height 183 of the proximal region 174D may be approximately 3 mm, while the height of the distal region 172D is also approximately 3 mm. In the expandable body 170E, the height 183 of the proximal region 174E may be approximately 2 mm, while the height 184 of the distal region 172E is approximately 3.5 mm, while in the expandable body 170F, the height 183 of the proximal region 174F may be approximately 3 mm, while the height 184 of the distal region 172F is approximately 4 mm. As shown, the expandable bodies 170A-H can have a number of configurations, which can be generally spheroidal, generally spherical, or generally cardiac shaped.

[0086] In another embodiment shown in Figures 8W-X, the expandable body 170H may be in the shape of a flattened sphere on a disk. The proximal region 174 may resemble a cylinder whose diameter is greater than its length, while the distal region 172 may resemble an oblate spheroid. The shape of the proximal region may be optimized to occlude the opening of the saccular aneurysm 700.

[0087] In another embodiment shown in Fig. 6E, the expandable body 140 is cylindrical in shape, but with ends that are conical rather than hemispherical as previously shown in Figs. 6A-D. Such an expandable body may be optimized for occlusion of an arterial or venous segment. Metallic expandable bodies, such as the expanded spherical ballstents 100 and 150 of Figs. 1A-D and 2A-4B, and the expanded expandable bodies 140 of Figs. 8A-U, 16G, and 16K, may have a wall 102 made of a single continuous layer 122, as shown in Fig. 16A. The wall 102 is made of a metal, preferably a metal that is biocompatible and ductile, capable of being formed into thin walls, and capable of being formed into various shapes after expansion. By way of example and not limitation, the metal may be selected from the group consisting of gold, platinum, silver, nickel, titanium, vanadium, aluminum, tantalum, zirconium, chromium, silver, magnesium, niobium, scandium, cobalt, palladium, manganese, molybdenum, alloys thereof, and combinations thereof. Preferred metals include gold, platinum, and silver, alloys thereof, and combinations thereof. The expandable body may also be made from alternative materials that are rigid or semi-rigid enough to withstand compression and expansion and can be formed into a thin-walled structure capable of maintaining an expanded state within the body. Alternative materials include polymers or plastics reinforced with metal coils or braids, and materials with similar properties. The materials forming the wall 102 and the wall thickness are selected so that the expandable body 100, 140, 150, or 170A-H has sufficient rigidity to remain in an expanded state within the body under normal physiological conditions after expansion and separation from the delivery catheter, both when the internal and external pressures of the central void or space 108 are the same or close to each other and when the external pressure is higher than the internal pressure.

[0088] Additionally, it is desirable for the material used to form and support the expandable body 100, 140, 150, or 170A-H to have sufficient mechanical properties of ductility, malleability, and plasticity to be compressed or folded without tearing and to not break after expansion. Generally, ductility is the degree of a material's ability to deform without breaking, while malleability of a material determines whether a metal is susceptible to deformation without breaking when subjected to pressure or force. The ductility and malleability of a material consider the plasticity of the material, which generally refers to the property of a material being able to withstand a permanent change in shape without bursting or collapsing. Thus, the expandable body may be constructed of any biocompatible material that has sufficient ductility, malleability, and plasticity to withstand one or more of the compression, folding process, and expansion.

[0089] The central layer 122 of the wall 102 has an inner surface 106 and an outer surface 124 that define a wall thickness 120. With particular reference to Figures 16A and 16B, the distance between the inner surface 106 and the outer surface 124 is the overall wall thickness 120 of the wall 102. Preferably, the central layer 122 of the wall 102 has a thickness 120 of about 3 μm to about 50 μm, preferably approximately 10 μm thick. The wall thickness 120 can be uniform. For example, the wall 102 has a uniform thickness of 3 μm, 5 μm, 10 μm, 15 μm, 20 μm, 30 μm, 40 μm, or 50 μm. For example, the thickness 120 of the wall 102 may be selected so that the expandable body is strong enough to withstand pressure from pulsating blood, yet weak enough to collapse and fold during healing and shrinkage of a treated saccular aneurysm or occluded segment of an artery, vein, or other shaped biological conduit.

[0090] Alternatively, the thickness of the wall 102 at different locations may vary in thickness. Alternatively, the expandable body 100, 140, 150, or 170A-H may be comprised of a single perforated layer or wall 122 with holes or microperforations 1300, as shown in FIG. 16B, where at least some or all of the microperforations extend widely from the inner surface 106 to the outer surface 124. For this embodiment, the wall 102 may be of uniform thickness or of varying thickness. During expansion of the ballstent 100 in this embodiment, the liquid medium may move under pressure from the voids or spaces 108 through the wall 102 and exit the ballstent at the outer surface 124. For this embodiment, the diameter of the microperforations 1300 may range from 1 to 500 μm. Other exemplary microperforation diameter ranges are 0.01 to 50 μm.

[0091] The expandable body 100, 140, 150, or 170A-H includes a central wall or layer 122, optionally with an outer wall or layer 104, and optionally with an inner wall or layer 214, as shown in FIG 16D. As stated, the composition of the central wall or layer 122 and layers 104 and 214 can be uniform, porous, or a combination thereof. In one embodiment of a ballstent 100 used to treat saccular aneurysms, the wall 102 includes a plurality of microperforations 1300 that extend through the thickness 120 of the wall 102.

[0092] In one configuration, the central layer or wall 122 is continuous and formed of gold. Optionally, this preferred configuration may include the addition of an outer layer 104 formed of porous gold. Optionally, there may be an inner layer 214 formed of parylene. Optionally, there may be an outer layer 104 formed of parylene. In certain embodiments where an electrolysis is used to separate the expanded expandable body 100, 140, 150, or 170A-H from the delivery catheter, the ballstent or certain portions of the expanded expandable body (such as the neck or body) are coated with an insulator or polymer, such as parylene. In certain embodiments where an electrolysis is used to separate the expanded expandable body 100, 140, 150, or 170A-H from the delivery catheter, the ballstent or certain portions of the expanded expandable body (such as the neck or body) are coated with a relatively electrolysis resistant metal, such as gold or platinum. These portions include the exterior surface, the interior surface, or both the interior and exterior surfaces, while a portion of the cervix or body remains uncoated or uninsulated. In this case, the uncoated or uninsulated portions of the wall are electrolytically dissolved (i.e., corroded) by passing an electric current from the exposed metal of the wall to the surrounding electrolyte (i.e., blood or serous fluid). In certain embodiments, the uncoated or uninsulated portions of the wall are created by masking during the coating process. In other embodiments, the coating or insulation is removed from the uncoated or uninsulated portions of the wall or cervix through etching or ablation, such as laser etching or laser ablation.

[0093] One embodiment of a generally spherical ballstent 150 is shown in Figures 1A-4B. The generally spherical ballstent 100 or 150 includes a wall 102 that forms a spheroid when expanded. In one aspect, a distal region 152 of the wall 102 includes one or more annular portions 154A-B. The annular portions 154A-B have a larger radius of curvature than the remainder of the wall 102 such that the distal region presents a flatter surface than the remainder of the wall. The generally spheroidal ballstent 150 further includes a proximal neck 116 and a distal neck 118 that project away from the distal region 152. In other embodiments, the distal necks can project into the interior void of the expanded expandable body.

[0094] 2B-C and 2E, in various embodiments, the bridge segment 160 extends through the proximal neck 116, through the void of the expanded expandable body to the distal neck 118. In one aspect, the bridge segment 160 is an elongated tubular member component of a delivery catheter that provides structural support to the ballstent 150. In one embodiment, the bridge segment 160 has an outer inner diameter in the range of approximately 0.5 to 2.0 mm and an inner diameter in the range of approximately 0.4 to 1.9 mm. In some embodiments, the bridge catheter is a component of or operably coupled to the delivery catheter.

[0095] In other embodiments, the bridging catheter 160 provides a pathway for delivery of a solid material such as a guidewire 302 or coil 162 through the interior space 108 via the distal neck 118 to the exterior of the ballstent, as shown in Figures 2B-C, 2E, 2G, 2N-P, 8H, 8J-O, and 8R-S. The bridging catheter 160 further includes one or more openings 164 for passing a fluid, liquid, gas, gel, or even solid into the interior 108 of the ballstent 150. Thus, as will be described more fully below, the bridging catheter 160 may be used to inflate or expand the expandable body, but may also pass a guidewire 302 or coil 162 to or through the interior 108 of the ballstent 150 and exterior of the distal region 152.

[0096] In various embodiments, the opening 164 in the bridging catheter 160 may have a diameter ranging from approximately 200 μm to 1 mm. As shown in Figures 3A-3B, the bridging catheter 160 may be sized to receive a coil or auxiliary coil 162. The coil or auxiliary coil 162 may be delivered directly through the lumen of the bridging catheter 160 or delivered through a second catheter 352B ("coil delivery catheter") that passes through the bridging catheter 160 as shown in Figure 7, in this manner providing a dual catheter delivery system suitable for use with a ballstent expandable body.

[0097] In other embodiments, the bridging catheter 160 may further pass a coil delivery catheter 352B through the interior of the expandable body 100, 140, 150, or 170A-H to deliver a coil or auxiliary coil 162 to the lumen, cavity, or void 701 of the saccular aneurysm 700. As shown in Figures 2L-Q, the coil delivery catheter 352B may be delivered through the expandable body, and the auxiliary coil 162 may be delivered simultaneously or sequentially through the coil delivery catheter 352B.

[0098] In another embodiment, the bridging catheter 160 includes a radiopaque spot or marker 165 at its distal end, as shown in Figures 3C-D. The marker 165 is for enhancing the relative position of the expandable body 150 and fluoroscopic visibility of the tip of the bridging catheter 160 during the separation process. The marker includes various radiopaque materials including barium, or metals such as gold, platinum, iridium, tantalum, or stainless steel. The shape of the marker may be configured as a band, spot, or line. In one aspect, the radiopaque material may be in the form of a radiopaque liquid or particulates mixed into the polymer melt during extrusion of the bridging catheter 160.

[0099] In various embodiments, including those shown in Figures 3E-F, a telescoping component, referred to herein as telescope 630 or 640, may slide over a bridge catheter 160 that couples to a proximal hub 362A in the distal end of the expandable body 150 and forms an assembly 642 that functions as a rigid telescoping bridge segment. Depending on its length compared to the length of the expandable body 150, the telescope may be referred to as either a short telescope 630 or a long telescope 640. Upon expansion, the telescoping bridge segment 642 allows the expandable body 150 to freely contract in the axial direction 644, further reducing leakage of the injected fluid media. The net effect is a reduction in the applied pressure required to expand the expandable body 150.

[0100] In one embodiment, telescope 630 or 640 may be a piece of metal tubing including gold, platinum, iridium, tantalum, or stainless steel and may function as a radiopaque marker as well. In one aspect, telescope 630 or 640 enhances visibility of expandable body 150 during fluoroscopic imaging.

[0101] In various embodiments, the telescoping bridge segment 642 separates into its constituent components when the expandable body 150 separates from the delivery catheter 306. In particular, the bridge catheter 160 is removed from the expandable body 150, leaving behind the telescope 630 or 640, as can be seen in FIG.

[0102] In various other embodiments illustrated in Figures 3H-I, the flexible bridge segment 643 allows the expandable body 150 to freely contract in the axial direction 644, reducing leakage of the injected liquid medium. As shown in Figure 3H, the flexible bridge segment 643 may be a piece of braid-reinforced polymer tubing (i.e., braided extrusion) including a flattened braid of stainless steel or nitinol within an extrusion sheet of polyimide or polyurethane. As shown in Figure 3I, in other embodiments, the flexible bridge segment 643 may be configured as a metal including the following: stainless steel, nitinol, or combinations thereof. Aspects of these alternative embodiments may increase the flexibility and compliance of the expandable body 150. Upon separation of the expandable body 150 from the delivery catheter 306, the flexible bridge segment 643 is removed along with the delivery catheter 306.

[0103] 47A-C illustrate another embodiment of the expandable body 190. In this embodiment, the expandable body 190 includes a distal region 202 that engages the distal neck 362A. Adjacent to the distal region 202 is a distal transition region 203 that is located between the distal region and the intermediate region 206. A proximal transition region 205 is located adjacent to the intermediate region 206 and opposite the distal transition region 203. The proximal transition region 205 connects the intermediate region 206 with a proximal region 208 that further engages the proximal neck 362B. The expandable body 190 is in the form of a single lobed metallic expandable body. FIG. 47C is a cross-sectional view of the expandable body 190 taken along line BB.

[0104] In one embodiment, the distal region 202 and the proximal region 208 are semi-ellipsoids of the expandable body 190 defined by radii 191 and 192, respectively, from a center 193 of the expandable body 190, such that 191 and 192 are shorter than radius 194 from a central longitudinal axis of the intermediate region 206. Additionally, the radius 195 of the distal transition region is equal to the radius 194 adjacent the intermediate region 206 and decreases to the radius 191 where the expandable body 190 transitions to the distal region 202, thereby increasing the curvature of the distal transition region as it reaches the distal region. Similarly, the radius 196 of the proximal transition region is equal to the radius 194 adjacent the intermediate region 206 and decreases to the radius 191 where the expandable body 190 transitions to the proximal region 208, thereby increasing the curvature of the proximal transition region as it reaches the proximal region. As a result, the embodiment of the expandable body 190 appears as if the distal and proximal regions 202 and 208 are compressed or flattened inwardly toward the intermediate region 206 .

[0105] Expandable exterior of the body As discussed, the expandable body 100, 140, 150, or 170A-H may have one or more additional coatings or layer(s) 104 on the outer surface 124 of the central layer 122, as shown in Figures 16C-D. The wall 102 and any additional outer layers define an outer surface 110 that contacts the inner wall of the aneurysm or blood vessel when expanded. The outer layer 104 may be of uniform or varying thickness, preferably between about 1 μm and about 59 μm. In one embodiment, the outer layer 124 has a thickness between 0.1 and 10 μm. In a particular embodiment, the outer layer 124 has a thickness between about 1 μm.

[0106] The outer layer 124 may be formed of a polymer, latex, elastomer, or metal. The outer layer 124 may be an electrical insulator, and in a preferred embodiment, the outer layer 124 is formed of a parylene coating. The outer layer 124 may be a metallic or non-metallic material that is not susceptible to galvanic or galvanic corrosion, such as a precious metal, and in a preferred embodiment, is gold or platinum. The outer coating or layer 104 of the expandable body 100, 140, 150, or 170A-H may be porous and include a plurality of pores 200, as shown in Figures 16C and 16D. Alternatively, the outer layer 104 may be smooth, with limited porosity or protrusions. For example, the outer layer 104 may be a polished metal surface. In one embodiment, portions of the outer layer 104 may be smooth, while other portions may be porous or include protrusions. In one embodiment, the surface alterations may include a pattern. Figure 29E depicts the structure of the outer surface 110 after electroforming and parylene coating. As shown, the outer surface 110 of the wall 102 may have a circular, pebbled, or granular structure. In various embodiments, the circular, pebbled, or granular surface structure has a height of approximately 0.1 to 10 μm.

[0107] When configured as a porous or spongy layer, the outer layer 104 may contain (or be configured to contain) a solution containing a pharmaceutical drug, pharmacologically active molecule, or pharmaceutical composition within the pores 200. In this manner, a solution such as a pharmaceutical drug, pharmacologically active molecule, or pharmaceutical composition may be delivered to a treatment location. Drugs, pharmacologically active molecules, or pharmaceutical compositions that promote thrombus formation, stimulate cell proliferation or extracellular matrix production, or tissue growth are examples of substances that may be placed in the pores 200 of the outer layer 104. The pharmaceutical drug, pharmacologically active molecule, or pharmaceutical composition is incorporated into the wall or pores 200 of the outer layer 104 before the expandable body 100, 140, 150, or 170A-H is placed at a desired location. The pharmaceutical composition may be delivered to the pores 200 by capillary or wicking action. The diameter of the pores 200 ranges from about 0.01 μm to about 500 μm. The pore diameter of each expandable body may vary according to the particular drug, pharmacologically active molecule, or pharmaceutical composition incorporated and the desired release rate into the body. By way of example and not limitation, expandable bodies 100, 140, 150, or 170A-H may have a porous outer layer 104 with pore diameters that average from about 0.01 μm to about 0.05 μm, from about 0.05 μm to about 0.5 μm, from 0.5 μm to about 5 μm, from about 5 μm to about 25 μm, from about 25 μm to about 500 μm, from about 0.05 μm to about 500 μm, or from about 0.01 μm to about 500 μm.

[0108] The pharmaceutical drug, pharmacologically active molecule, or pharmaceutical composition may include thrombin, platelet derived growth factor, Ethiodol®, Sotradecol®, or combinations thereof. Other pharmaceutical compounds and compositions that promote clot formation, stimulate cell proliferation, extracellular matrix production, or tissue growth into the porous outer wall of the expandable body 100, 140, 150, or 170A-H may be used as well. Such drugs or pharmaceutical compositions may include molecules for promoting cell proliferation, extracellular matrix production, or tissue growth, which may result in the expanded expandable body 100, 140, 150, or 170A-H being more firmly attached to the tissue at the treatment location. The dosage and manner in which the pharmaceutical drug, pharmacologically active molecule, or pharmaceutical composition is incorporated into the wall 102 or outer layer 104 may be selected depending on the treatment being performed. Other compounds may be used to promote blood clotting or clot formation around the expandable body. In various aspects, the pores 200 may be filled with a biodegradable or bioerodible material, so that the amount of material in the pores gradually decreases and the pores open up in place in the body over time following deployment of the expandable body. In embodiments of the expandable body 100, 140, 150, or 170A-H having a porous layer 104, the ballstent, blockstent, or expandable body will remain expanded over time and the expandable body will eventually attach to the surrounding tissue.

[0109] As can be seen from FIGS. 18G-H, the outer surface 110 of the expandable body 100, 140, 150, or 170A-H may further include one or more protrusions or projections 1800 (which may be generally tubular or of other configurations) that can increase the strength of attachment of the expandable body to adjacent tissue, thereby reducing the risk of movement or migration. The protrusions have lengths ranging from about 0.01 μm to about 167 μm. Some protrusions may be branched structures, while others may be joined at both ends to the outer surface 110 to form loops. In some embodiments, the protrusions are rigid or semi-rigid. In other embodiments, the protrusions are flexible and hair-like, and may even include bulbous ends similar to the protrusions on the plantar surface of a lizard. The protrusions may be attached to the expandable body 100, 140, 150, or 170A-H after formation. Additionally or alternatively, the protrusions may be incorporated into the expandable body during electroforming.

[0110] In other embodiments, the ballstent 100 may include a porous outer layer or wall 104 or a wall with external protrusions 1800 to promote thrombus formation on the outer surface 110 or within the holes 200 and to promote cell proliferation, extracellular matrix production, or tissue growth on or around the wall 102 of the ballstent 100, thereby gradually causing the ballstent 100 to become more firmly attached to tissue in the adjacent aneurysm wall.

[0111] As shown in Figures 18A-D, the central layer 122 and porous outer layer 104 of the ballstent 100 placed into the saccular aneurysm 700 may be configured to promote the formation of a thrombus 1206 on the outer layer. The thrombus may be comprised of red blood cells 1208, platelets 1210, and fibrin 1212. Over time, the thrombus 1206 may dissolve to some extent into the outer layer 104, and new endothelial cells 1214 may form over the thrombus. The new endothelial cells may form a connective tissue seal across the opening of the saccular aneurysm 700. In addition to sealing the opening of the saccular aneurysm 700, connective tissue 1216 from the wall 704 of the aneurysm may grow into the porous outer layer 104 of the ballstent 100 to attach the ballstent to the wall of the aneurysm, as shown in Figure 18E. In other embodiments, the protrusions or projections 1800 may be configured as generally tubular, straight, curved, hooked, or pigtail hooks, as shown in Figures 18G-H. In a microscopic form, the projections may be constructed from Nitinol or other suitable biocompatible materials.

[0112] FIG. 18H depicts an expanded ballstent 100 anchored to the wall 704 of a saccular aneurysm 700. The size and shape of the protrusions may be selected depending on the condition being treated and may be designed and dimensioned to provide sufficient anchoring support without undue damage to the aneurysm wall or surrounding tissue. Alternatively, fine protrusions or filaments may be used to anchor the ballstent. In some embodiments, these fine protrusions range in length from 0.01 μm to about 57 μm and may be straight or branched. In various embodiments, both ends of one or more protrusions may be connected to the outer surface 110 of the ballstent 100 and / or the outer surface 216 of the wall 102 to form a loop.

[0113] In other embodiments, a layer of hydrogel 720 may be applied to the exterior surface 110 of the proximal region 208 of the expandable body 100 after deployment, as depicted in Figures 16E-F and 18I. This layer is to promote thrombus formation at the opening 703 of the saccular aneurysm 700 and stimulate cell proliferation, extracellular matrix production, or tissue growth. Various methods may be used to attach the layer of hydrogel 720 to the desired location. A polymerized hydrogel layer may be attached with an adhesive. Alternatively, a viscous liquid hydrogel prepolymer may be applied and then polymerized using ultraviolet light to form the hydrogel layer.

[0114] The ballstent or expandable body 100, 140, 150, or 170A-H may also be used to contain or capture thrombi, such as mural thrombi, formed within an aneurysm or other biological space. As shown in FIG. 18F, the expandable body 170G may be placed within a saccular aneurysm 700 having one or more thrombi. This includes a mural thrombus 707 within the cavity 701 or dome of the aneurysm. In one embodiment, an expandable body 170G is selected that has an expanded volume that is smaller than the volume of the aneurysm cavity. The expandable body is delivered to the aneurysm inflated or expanded form as described above, and contacted by insertion of the auxiliary coil 162. In this embodiment, the auxiliary coil 162 contacts the expandable body 170G, the thrombus 707, and the wall of the aneurysm simultaneously. The expandable body 170G in conjunction with the auxiliary coil 162 acts to capture the thrombus 707 within the aneurysm and hold it in place until it is absorbed by the patient.

[0115] In various embodiments, an expandable body that does not completely fill the cavity 701 of the saccular aneurysm 700, which may contain a blood clot, is preferred. Thus, a larger expandable body that more completely fills the cavity 701 is not preferred because it may cause blood clots within the saccular aneurysm 700 to be expelled into the parent vessel 1202 or 1203, where the blood clots may cause an occlusion, travel through the vasculature, and cause a stroke.

[0116] In various embodiments, the expandable body 100 may include a thin polymer sheath that surrounds the entire circumference of the expandable body during delivery or when in a deliverable configuration. The sheath may be added to the exterior of the expandable body 100 during assembly of the expandable body. The sheath may be attached to the proximal nosecone 362B, the distal nosecone 360, or 362A, or both, such as those shown in FIGS. 2A-Q. The polymer sheath improves the compliance of the expandable body 100 as it is delivered through the vasculature and reduces friction with the intima of the blood vessel. During inflation or expansion of the expandable body 100, the polymer sheath opens up while remaining attached to the expandable body, the delivery catheter, the proximal nosecone 362B, or the distal nosecone 360 ​​or 362A. In one embodiment, the sheath may be perforated or partially slit prior to deployment to facilitate expansion of the expandable body 100.

[0117] Expandable body interior In some embodiments, the expandable body 100, 140, 150, or 170A-H may include one or more additional layers or liners 214 on the inner surface 106 of the central layer 122, as shown in Figures 16D, 16F, 16H, 16J, and 16L. The inner layer may be made of the same material as the central layer or may be made of a different material. The inner layer may be formed of gold, platinum, silver, alloys thereof, or combinations thereof. The additional layer 214 on the inner surface 106 of the central layer 122 of the expandable body 100, 140, 150, or 170A-H may further be formed of a polymer, plastic, latex, rubber, woven or knitted fiber material, metal, or other material, or combinations thereof. Preferably, the inner layer 214 is an elastomeric coating applied to the inner surface 106 of the central layer 122. The inner layer 214 may be of various thicknesses, preferably ranging from about 0.1 μm to about 59 μm. In one embodiment, the inner layer 214 has a thickness between about 0.1 μm and about 10 μm. Whether the wall includes one, two, three, or more layers, the total thickness of the wall 102, including the central layer 122, the outer layer 104, and the inner layer 214, is preferably between about 2 μm and about 50 μm. The inner layer 214 may include a polymer, latex, or elastomer. In a preferred embodiment, the inner layer 214 includes parylene. The inner layer 214 further adds mechanical properties (such as strength) to the wall 102. Additionally, the inner layer 214 may optionally form a seal to prevent leakage of a liquid medium from the expandable body 100, 140, 150, or 170A-H, and the central layer 122 may include defects or imperfections. The central layer 122 and any additional layers define an inner surface 106 or 218, respectively, which defines a central void or space 108 when the ballstent or expandable body is expanded with a fluid, liquid, gas, or solid. The distance between the inner surface 218 and the outer surface 110 is the overall wall thickness 120 of the wall 102, as shown in FIG.

[0118] Expandable body neck(s) and opening(s) In certain embodiments, the hollow metallic expandable body includes two necks located at opposite ends of the expandable body. In some embodiments, one neck may be located at the proximal end of the expandable body and the other neck may be located at the distal end of the expandable body. Optionally, at least one neck may comprise a metal susceptible to galvanic corrosion, such as stainless steel, and may be cut off by electrolysis after placement of the expandable body in the biological space. In some embodiments, a stainless steel ring may be connected to the neck of the expandable body, and in other embodiments, the stainless steel ring may be connected to the main body of the expandable body, such as with an adhesive, glue, or welding. In this case, the remainder of the expandable body may comprise a material that is not susceptible to galvanic or galvanic corrosion, such as a noble metal, including but not limited to gold, while the neck or a portion of the neck may comprise a less noble material that is more susceptible to galvanic or galvanic corrosion, such as stainless steel.

[0119] In other embodiments, the body and neck of the hollow metallic expandable body may comprise materials with similar characteristics that are susceptible to electrolysis or galvanic corrosion, and the body and optionally a portion of the neck may be coated with a material that acts as an electrical insulator to limit electrolysis or galvanic corrosion to the neck or coated portions of the neck during electrolysis. Such electrical insulators may include parylene.

[0120] In yet other embodiments, the neck of the hollow metallic expandable body may comprise a less noble material that is more susceptible to electrolysis or galvanic corrosion, such as stainless steel, and portions of this material that is more susceptible to electrolysis or galvanic corrosion may be coated with an additional material that is less susceptible to electrolysis or galvanic corrosion, such as a noble metal, including but not limited to gold, such that the electric field is concentrated in portions of the neck where the less noble material that is more susceptible to electrolysis or galvanic corrosion, such as stainless steel, is exposed or not coated with.

[0121] Each neck of the hollow metallic expandable body may include a tip or nose cone to enhance the dynamic profile of the device to reduce resistance while advancing the device back and forth within the artery, vein, or other biological conduit. In this manner, the tip or nose cone may reduce the risk of injuring the wall of the artery, vein, or other biological conduit. The tip or nose cone may comprise a polymer, metallic, or other material, including a biodegradable or bioerodible material. The presence of the tip or nose cone on the expandable body may reduce friction, reduce trauma from the proximal or distal ends of the body, and improve compliance during placement and repositioning of the device. This is particularly relevant when placing the expandable body within an aneurysm, as the dome of the aneurysm is fragile and susceptible to wall rupture when probing with a sharp or fine-tipped device. The tip or nose cone may also provide an attachment point to a polymer wrap that surrounds the folded, rolled, or compressed expandable body when the body is in place within the patient. The polymer wrap further increases compliance and reduces friction of the expandable body as it is delivered through the vasculature. A tip or nose cone may also be placed on the distal portion of the delivery catheter where it may serve a similar purpose.

[0122] 1A-D, 2A-4B, 8A-S, 8U, 16A-D, 16G, and 16K, the expandable body 140, 150, or 170A-H has one or more openings 112 and 114 defined by the wall 102 or by the proximal neck 116 or the distal neck 118. In various embodiments, the ballstent, blockstent, or expandable body has one or more openings 112 and 114 defined by the necks 116 or 118, respectively. In all embodiments, a liquid medium can enter the openings 112 and migrate into the central void or space 108 defined by the inner surface 106 or 218, thereby expanding or expanding the expandable body. In various embodiments, as shown in Figures 1A, 1C, 2A-4B, 8A-S, 8U, 16G and 16K, one or both of the necks 116 and 118 may extend outwardly from the respective end regions (proximal or distal regions) of the expandable body 100, 140, 150 or 170A-H. Additionally, as shown in Figures 1A and 1D, one or both of the necks 116 and 118 may extend inwardly from the respective end regions into the interior space 108. The proximal neck 116 may be used to attach the expandable body 100, 140, 150 or 170A-H to a delivery catheter and may function to separate the ballstent or expandable body from the delivery catheter. In various embodiments, the necks 116 and 118 and the wall 102 or main body portion may be formed of different metals. For example, in one embodiment, the neck(s) 116 and 118 and the wall 102 or main body may be formed of gold. In other embodiments, the necks 116 and 118 may comprise stainless steel, including but not limited to 304 series or 316L series stainless steel, and the wall 102 or main body may be formed of gold, platinum, or other malleable metals. The necks 116 and 118 may comprise multiple metals, such as stainless steel and other metals, such as gold or platinum.This includes embodiments where various regions of expandable body 100, 140, 150, or 170A-H differ in their metal content, and where different metals are formed in layers in various regions, including embodiments where the neck comprises an inner layer of stainless steel with an outer layer of gold, and embodiments where the neck comprises a central layer of stainless steel with inner and outer layers of gold, including embodiments where at least a portion of the surface of the outer layer is stainless steel, and where a portion of the outer layer of gold is removed by masking or etching, including laser etching.

[0123] Additionally, the necks 116 and 118 can be designed and dimensioned such that the openings 112 or 114, preferably the proximal opening 112, can be closed or partially closed before, during, or after the expandable body is separated from the delivery catheter. One or more openings 112 or 114 may remain open. Optionally, the necks 116 and 118 may be folded, crimped, or closed to form a seal before, during, or after separation. The necks 116 and 118, or alternatively the stainless steel ring 250, may have a length N1, as shown in Figures 24A and 30C, ranging from about 0.5 mm to about 20 mm, preferably between about 0.5 mm and about 5 mm. In one embodiment, the neck length N1 is approximately 1.27 mm ± 0.08 mm.

[0124] In various embodiments, at least one of the necks 116 and 118 and the stainless steel ring 250 have an outer diameter N2 and an inner diameter N3 that define the openings 112 and 114, respectively, as shown in Figures 2A-E, 24A, and 30D. The outer diameter N2 ranges from about 0.25 mm to about 2 mm, and the inner diameter N3 ranges from about 0.24 mm to about 1.95 mm. In one embodiment, the neck outer diameter N2 is approximately 0.99 ± 0.01 mm, and the neck inner diameter N3 is approximately 0.89 ± 0.01 mm.

[0125] The wall thickness of either or both of the necks 116 and 118 may be the same as the wall of the main body of the ballstent, blockstent, or expandable body, or may be thinner or thicker than the wall of the main body. Preferably, either or both of the necks 116 and 118 have a wall thickness N4 between about 3 μm and about 60 μm, as shown in FIGS. 24B-C, 30D, and 30F. In one particular embodiment, the necks have a thickness of approximately between 50 μm. In one embodiment of the ballstent 100 in which the neck(s) 116 and 118 extend into the central void space 108, as shown in FIGS. 1B and 1D, the outer surface 110 of the expanded ballstent retains a more curved surface profile, improving the strength of the expanded ballstent and reducing the risk of damage to the aneurysm wall or adjacent tissue during deployment.

[0126] One or both of the necks 116 or 118 may be coated or insulated on the inner wall, the outer wall, or both. The coatings may include metals such as gold or platinum and polymers such as parylene. Additionally, the necks 116 and 118 may include one or more caps or nose cones 360 as shown in FIGS. 2A-C and 4A-B, or nose cones 362A-B as shown in FIGS. 2D-Q, to improve the compliance of the expandable body 100 during delivery and deployment. In addition to improving the compliance of the expandable body 100 during deployment, the nose cones 360 or 362A-B may also serve to protect the necks 116 and 118 during deployment, further reducing the risk of damage to the wall or intima of any blood vessels or conduits that the expandable body 100 traverses during deployment. In some embodiments, a nose cone attached to the distal portion of the delivery catheter may serve the same purpose.

[0127] As shown in Figures 2C and 4B, the nose cone 360 ​​or 362A-B includes a central channel 364 that surrounds and engages the necks 116 and 118. In one embodiment, the nose cone 360 ​​is generally cylindrical, as shown in Figures 2A-C and 4A-B, while in other embodiments, the nose cones 362A-B may be frusto-conical or "bullet-shaped" configurations, as shown in Figures 2D-Q. The nose cones 360 or 362A-B may be constructed of any biocompatible material, including polymers and metals. In one embodiment, the nose cones 360 or 362A-B are constructed of PTFE. In various embodiments, the nose cones 360 or 362A-B have an outer diameter in the range of approximately 0.75 to 2.5 mm, an inner diameter in the range of approximately 0.25 to 2 mm, and a length in the range of approximately 1 to 4 mm.

[0128] In various embodiments, such as those shown in FIGS. 9A-D, the nosecones 360 or 362A-B may each be formed from two parts, each including a valve 560A-B that blocks blood flow through the lumen of the inner catheter shaft of the expanded expandable body 150 (i.e., the guidewire lumen) and facilitates occlusion of the targeted vessel segment. In one aspect, the valves 560A-B may be disks made of one or more elastomeric polymers, such as, but not limited to, silicone rubber, with diametric slits. Alternatively, the valves 560A-B may be assembled from adhesive injected into the nosecones 362A-B, each with a diametric slit or opening. The valves 560A-B may be incorporated into either or both of the nosecones 362A-B. When incorporated into the distal nosecone 362A, the valve 560A is secured between the outer distal nosecone 575 and the inner distal nosecone 580. When assembled to the proximal nosecone 362B, the valve 560B is secured between the outer proximal nosecone 585 and the inner proximal nosecone 590. As can be seen in Figures 9A-B, when the expandable body 150 is attached to the delivery catheter 306, the valve 560A or 560B seals against the bridge catheter 160. After separation, the valve 560A or 560B seals against itself, as shown in Figures 9C-D. In addition to providing hemostasis within the expandable body 150, the valves 560A and / or 560B may, in some embodiments, provide the only method of attachment to the delivery catheter 306.

[0129] In various embodiments shown in Figures 9E-G, the valves 560A-B may comprise disks approximately between 0.010 and 0.020 inches thick. The central opening 565 through the entire thickness of the valve may be a slit resembling a plus or minus sign, or may be a circular hole. As shown in Figures 9A-D and 9H-K, the nosecones 262A-B may include a single valve or multiple valves arranged in series in various combinations of central hole shapes. In a preferred embodiment, during assembly of the medical device, only the distal nosecone 362A includes the valve or valves, and the guidewire shaft 160 is attached from distal to proximal to the distal nosecone 362A. In other preferred embodiments, a single distal valve 560A is used, comprising a silicone rubber disk of a durometer range of about 40 Shore A to about 90 Shore A with a thickness of 0.010 inches and a central opening of a circular hole.

[0130] In various embodiments, the necks 116 and 118 are further modified to provide a separation point for separating the expandable body 100, 140, 150, or 170A-H from the delivery catheter. For example, uncoated or uninsulated portions of necks, welds, brazes, or other fastening points, or pieces of conductive material including portions of ballstents, blockstents, or the expandable body itself, are left exposed, uncoated, or uninsulated, or are subsequently exposed after coating. This includes exposed, uncoated, or uninsulated areas that are circumferential or ring-shaped exposed surfaces of metal or conductive material that can be subjected to an electric field to achieve separation between the expanded expandable body and the distal end of the delivery device. A stainless steel ring is preferably attached to the expandable body wall 102 or main body portion, since stainless steel is highly susceptible to galvanic corrosion or electrolysis. For example, as can be seen in Figs. 16E, 16G, 16I, 16K, 28, and 30A-B, in one embodiment, at least a portion of the inner surface of the metallic expandable body neck metal layer is electrically insulated by having the outer surface of the distal portion of the delivery device extend along the inner surface of the metallic expandable body neck metal layer. In some embodiments, on the inner surface of the proximal neck 116, the proximal boundary of the ring-shaped exposed metal surface may be defined by the distal boundary of the delivery device at the neck region, and the distal boundary of the ring-shaped exposed metal surface may be defined by the boundary of the inner insulating layer at the neck region. With respect to the outer surface of the proximal neck 116, both the proximal and distal boundaries of the ring-shaped exposed metal surface may be defined by the boundary of the outer insulating layer at the neck region. In such an embodiment, the distal end of the delivery catheter 300 or 400 may terminate distally near the proximal edge of the neck ring-shaped exposed metal surface. As shown in FIG. 23A, the conductor wire can be engaged in electrical contact with the uncoated or uninsulated portions of the neck or welds or brazes between the neck and the delivery catheter or on the expandable body 100, 140, 150, or 170A-H such that the uncoated or uninsulated portions are dissolved (corroded) or removed via electrolysis.

[0131] In other embodiments, one or both of necks 116 and 118 may be attached with a metallic ring 250 and then cut using electrolysis, as shown in Figures 2A, 2B, 5A, and 5B. Metallic ring 250 may be constructed of stainless steel and may undergo one or more heat treatments, as described below, to make the steel susceptible to galvanic corrosion, thereby allowing it to be separated or cut more quickly via electrolysis.

[0132] Expandable body shape and dimensions 16E-F and 16I-J illustrate a ballstent 100 and a delivery catheter 220 that may be used to deliver the ballstent. In one aspect, the ballstent 100 includes a distal region 202 that includes the distal end 204 of the ballstent. Adjacent to the distal region 202 is an intermediate region 206 that transitions the ballstent from the distal region 202 to a proximal region 208 that includes the proximal end 210 of the ballstent. The proximal region 208 is generally opposed to the distal region 202. A central axis 212 extends proximally-distally between the proximal region 208 and the distal region 202. The ballstent wall 102 extends generally continuously from the proximal region 208 to the distal region 202 through the intermediate region 206, and the ballstent 100 is in the form of a single lobed metallic expandable body. In other features, the ballstent 100 includes a proximal region 222 that connects directly to a proximal region 228 that is generally opposite the distal region 222. A central axis 212 extends proximally-distally between the proximal region 208 and the distal region 202. The ballstent wall 102 extends generally continuously from the proximal region 208 to the distal region 202, and the ballstent 100 is in the form of a single lobed metallic expandable body.

[0133] In one embodiment, when the ballstent 100 expands, the intermediate region 206, the proximal region 208, and the distal region 202 combine to form a generally spherical shape. In various embodiments, the dimensions of the ballstent 100 are selected based on the size and shape of the saccular aneurysm to be treated. Suitable shapes of the ballstent 100 include circular, elliptical, and distorted shapes. The diameter of the circular expanded ballstent 100 ranges from about 2 mm to about 30 mm, with a preferred expanded diameter ranging from about 2 mm to about 20 mm. The expanded length of the elliptical ballstent or blockstent preferably ranges from about 2 mm to about 30 mm. The ballstent 100 may have an expanded volume ranging from about 0.001 mL to about 65 mL. In a preferred embodiment, the expanded diameter of the spheroid ballstent 100 ranges from about 2 mm to about 10 mm, with a preferred expanded volume ranging from about 0.004 mL to about 40 mL. In a preferred embodiment, the expanded length of the oval ballstent or blockstent 100 ranges from about 2 mm to about 30 mm.

[0134] 16G-H and 16K-L illustrate an expandable body 140 and a catheter 220 that may be used to deliver the expandable body. In some embodiments, as shown in FIG. 16G, the expandable body 140 can include a generally cylindrical intermediate region 206 (where the longitudinal axis of the cylindrical portion is perpendicular to the central axis 212), a generally spherical distal region 208, and a generally conical distal region 208. In other embodiments, as shown in FIG. 24A, the expandable body 140 can include a generally cylindrical intermediate region 206 (where the longitudinal axis of the cylindrical portion is aligned with the longitudinal axis of the neck 116), a generally spherical distal region 208, and a generally conical distal region 208. The intermediate region 206 can have a radius R1 equal to the radius R2 of both the proximal and distal regions 208, as shown in FIG. 24A. In various embodiments, the delivery catheter 220 is normally engaged with the proximal neck 116 or proximal region 208 of the expandable body.

[0135] In other embodiments, one or more portions of the expandable body wall 102 may be thicker than the remainder of the wall. By way of example and not limitation, the wall in the middle of the main body portion or the middle region of the expandable body may be thinner or thicker than the wall in the proximal and distal regions or portions of the expandable body, or the wall in the neck portion may be thicker or thinner than the main body portion of the expandable body. In various embodiments, as shown in Figures 16A-D, the wall thickness 120 may be measured relative to the overall diameter of the expandable body to avoid undesirable wall stresses with increasing diameter. In various embodiments of the expandable body 100, 140, 150, or 170A-H, a balance can be struck between a wall thickness 120 that is thin enough to allow for various small compressed shapes in the delivery configuration, allowing expansion of the expandable body at low pressures, and a wall thickness that is thick enough to maintain structural integrity and resist compression after delivery and detachment. Thus, the average wall thickness 120 is preferably in the range of about 10 μm to about 50 μm. By way of example and not limitation, the wall thickness 120 for an expandable body 100, 140, 150, or 170A-H having an expanded diameter of about 4 mm may be about 10 μm, while the wall thickness for an expandable body having an expanded diameter of about 10 mm may be about 25 μm. In a preferred embodiment, the blockstent expandable body 150 may have an average wall thickness of 12.5 μm for a 4 mm expanded diameter device and 20 μm for a 6 mm expanded diameter device. In another preferred embodiment, the ballstent expandable body 150 may have an average wall thickness of 20 μm for a device with an expanded diameter of 8 mm and an expanded length of 6 mm.

[0136] As shown in FIG. 24A, the expanded body 140 may be generally cylindrical with curved or hemispherical ends (where the longitudinal axis of the cylinder is aligned with the longitudinal axis of the neck 116) such that the overall length L1 of the main body portion of the expandable body parallel to the first axis is greater than the overall width of the expandable body parallel to the second axis (i.e., twice the radial distance R1). In other embodiments, the expandable body 140 may be generally cylindrical with flattened or flat ends as shown in FIGs. 16G and 16K such that the overall length of the main body portion of the expandable body along the central axis 212 is less than the overall width of the expandable body perpendicular to the central axis. The expandable body 140 is in the form of a single lobed metallic expandable body.

[0137] In various embodiments, the expandable body 140 has an expanded diameter (along but perpendicular to the central axis 212) that ranges from about 2 mm to about 30 mm. Assuming no change in wall thickness 120, the stress in the wall of the expandable body 140 increases as the radius R1 (see FIG. 24A) of the intermediate region 206 increases. Thus, in some embodiments, the diameter of the expandable body 140 is limited by the ultimate tensile strength of the material (e.g., gold) used to form the expandable body and by the pressure required to expand the compressed expandable body. As can be seen in FIG. 24A, the expandable body 140 may have an expanded length L1 between about 2 mm and about 120 mm, including the proximal, intermediate, and distal regions. Preferably, the length is between about 5 mm and about 60 mm, and in a particular embodiment, the expanded length L1 is approximately 40±0.03 mm, and the length of the intermediate region 206 may be approximately 24±0.03 mm, such length L2 including only the intermediate region.

[0138] The stress concentration between the neck 116 and the proximal region or end 208 of the expandable body 100, 140, 150, or 170A-H can be reduced or offset by increasing the radius R4 between the neck and the proximal region, as shown in FIG. 24B-C. For example, the stress experienced by the wall 102 with radius R4 in FIG. 24B is greater than the stress experienced by the wall with radius R4' in FIG. 24C, where R4' is greater than R4. Additionally, stress may be concentrated at the point where the neck 116 transitions the wall of the proximal region 208 of the expandable body 100, 140, 150, or 170A-H due to a metallic ring that is incorporated into the neck 116 during formation of the expandable body. This stress concentration can be reduced by reducing the overall wall thickness N4 of the neck 116. By way of example and not by way of limitation, the neck 116 shown in FIG. 24B may have a wall thickness N4 of approximately 25 μm, while the neck shown in FIG. 24C may have a wall thickness N4' of approximately 12.5 μm. Method for forming an expandable body

[0139] The hollow metallic expandable body can be formed by depositing a metal layer on a mandrel using an electroforming process. During the electroforming process, a metal ring or structure can be incorporated into the metal layer to create the neck of the expandable body. The ring or structure can include a region of stainless steel, zinc, copper or gold, or other material susceptible to galvanic corrosion. Alternatively, the ring or structure can include a region including a polymer suitable for electrothermal isolation. The mandrel can be removed from the expandable body after electroforming to leave a hollow metallic structure, or it can be a sacrificial mandrel that can be formed into the expandable body. All or a portion of the mandrel can remain with the expandable body after electroforming, and in some embodiments, it can be a hollow non-sacrificial mandrel that results in a multi-layer hollow metallic structure that can be formed into the expandable body.

[0140] In one embodiment, the hollow metallic expandable body is manufactured using a process in which a stainless steel ring is coupled to a proximal end of a mandrel, a metal layer is deposited over the mandrel and over at least a portion of the stainless steel ring or tube, and optionally the mandrel is removed and the metal layer is formed into the shape of the mandrel-shaped hollow body, which can become the expandable body. This embodiment includes a method of depositing metal using electroforming, where the metal deposited is gold. The stainless steel ring is thus joined and extends from the proximal region of the hollow body to form a neck, which includes forming a proximal neck. The stainless steel ring is further attached to the neck or main body of the expandable body by welding a split segment, the main body being defined as including a proximal region, a distal region, and optionally an intermediate region. In a particular embodiment, the stainless steel ring or tube is coupled to a delivery device and configured such that the ring or tube can be separated by electrolysis.

[0141] In an exemplary method of forming the expandable body 100, 140, 150, or 170A-H, the central layer 122 of the wall 102 may be formed by deposition in which vapor from one or more polymers, pure metals, alloys, or layers thereof condenses onto a substrate or form (e.g., a mandrel). The form may be removed to provide a hollow shell formed of the pure metal or alloy.

[0142] In a preferred embodiment, the central layer 122 of the wall 102 is formed by electroforming or electroplating a metallic shell over a removable form or mold (e.g., a mandrel). For example, as shown in Figures 25A-C, a multi-piece mandrel 3200 for electroforming the expandable bodies 100, 140, 150, or 170A-H is shown in partial cross-section. The mandrel 3200 includes a steel base 3202 and a forming member 3204 that is removable from the base. Preferably, the forming member 3204 is constructed of a rigid material, including, but not limited to, aluminum or stainless steel. Although shown as a sphere, other embodiments of the forming member 3204 may be other shapes, including but not limited to partially pleated or partially folded body 3204 shapes, such as the partially pleated mandrel 3204 depicted in FIG. 26, which results in an expandable body 100, 140, 150, or 170A-H in a configuration that is intermediate between a deliverable (i.e., fully folded or pleated and folded) configuration and a fully expanded configuration. Additionally, the protrusions 1800 shown in FIGS. 18G-H may be molded onto the forming member 3204 such that the protrusions 1800 are formed during an electroforming or electroplating process. The forming member 3204 may be spherical as shown in FIGS. 25A-B and 27 to form a spherical expandable body 100, or 150. Similarly, the forming member 3204 may be an ellipse, a cylindrical shape with hemispherical ends, or any other shape for forming the expandable bodies 140 and 170A-H. In various embodiments, the mandrel 3200, or at least the removable shape 3204, is sacrificial so as to be consumed during the forming process of the expandable bodies 100, 140, 150, or 170A-H.

[0143] To form the metallic expandable body, the forming member 3204 is removed from the base 3202. A portion of the forming member 3204 may be threaded to engage a threaded spindle 3206 extending from the base 3202. After the forming member 3204 is separated from the base 3202, the metallic ring 3208 is placed onto the threaded spindle 3206. In one embodiment shown in FIG. 27, the threaded spindle 3206 includes a shoulder 3212 with a diameter larger than the diameter of the threaded spindle 3206 to accommodate the metallic ring 3208 in a desired position.

[0144] The metallic ring 3208 is a non-sacrificial component of the mandrel 3200. In one embodiment, the metallic ring 3208 may be any biocompatible metal that responds to electrolysis. For example, the metallic ring 3208 may be comprised of gold, 316L stainless steel, or 304 stainless steel. The metallic ring preferably comprises 304 stainless steel, as it has a lower nickel content than 316L stainless steel, minimizing the risk of cytotoxicity during electrolysis. In some embodiments, 304 stainless steel is preferred, as it has a lower pitting potential (approximately 0.18-0.38 V vs. reference electrode) than the hydrolysis potential of water (approximately 0.82 V). Thus, electrolysis with 304 stainless steel may be performed under more controlled conditions and with more reproducible results than electrolysis performed with 316L stainless steel or gold, whose pitting potentials (approximately 0.98-1.18 V and approximately 0.7-0.9 V, respectively) exceed the hydrolysis potential of water.

[0145] In various embodiments, the metallic ring 3208 is between approximately 0.025-0.150 inches long and has a wall thickness between approximately 25.4-254 μm. In one embodiment, the metallic ring 3208 is 0.05 inches long. A gold plating or coating may be optionally applied to at least a portion 3210 of the metallic ring 3208 to promote the deposition of gold used to form the gold expandable body. Similarly, platings or coatings composed of other metals, including but not limited to platinum, may be used to promote the deposition of other metals. In this manner, the metallic ring 3208 is incorporated into the expandable body 100, 140, 150, or 170A-H and forms all or a portion of the neck 116 or 118 of the expandable body. A non-conductive polymeric joint may be placed between the neck 116 or 118 of the expandable body 100 and the curved body portion. This joint provides additional flexibility to the expandable body 100 while at the same time further insulating the expandable body from electrolytic currents that are used to separate the expandable bodies of the various embodiments.

[0146] Once the metallic ring 3208 and forming member 3204 are positioned on the threaded spindle 3206, the mandrel 3200 is placed in an electrolyte bath (not shown) containing metallic ions such as gold, where the gold ions are deposited on the forming member and on at least a portion of the metallic ring 3208. In particular, the mandrel 3200 is positioned such that the expandable body 100, 140, 150, or 170A-H is electroformed over the forming member 3204 and a portion of the metallic ring 3208 with a gold flash, thereby bonding the metallic ring to the expandable body. In some embodiments, a portion of the metallic ring 3208 is not coated with gold, which includes using a masking method prior to electroforming.

[0147] In various embodiments, and as can be seen from FIGS. 16A-D, the thickness 120 of the ballstent wall 102 can be controlled by modifying the electroforming process. For example, by adjusting the duration of the electroforming process, a wall of greater or lesser thickness can be formed. Similarly, the wall thickness 120 can be altered at specific locations by applying one or more masks to the mandrel 3200. Additionally, the position of the mandrel 3200 relative to the anode in the solution bath will affect the wall thickness as well. For example, the internal feature at the neck of the expandable body 100, 140, 150, or 170A-H may have a thinner wall than the curved bulbous portion of the expandable body. The expandable body 100, 140, 150, or 170A-H can be intentionally formed thinner and therefore more fragile in the neck region so that the neck region can be cut to separate the expandable body from the neck 116, including the neck containing the metallic ring 3208. Additionally or alternatively, stress concentration rings in the form of wires or strips may be defined in the neck or proximal portion 208 of the expandable body 100, 140, 150, or 170A-H, particularly in the ring-shaped region of exposed metal (e.g., the stainless steel portion of the ring 3208 or the gold portion of the neck 116) to aid in separation of the delivery device or catheter from the expanded expandable body at the ring-shaped region of exposed metal. Such stress concentration lines may be formed in the ring-shaped region of exposed metal in a variety of ways, including laser etching, various mechanical operations such as cutting, machining or grinding, chemical forming, electro-discharge machining, or electrolysis. In various methods of manufacture, the wall thickness and tolerance of the neck may be precisely controlled. For example, the neck portion may be formed by extrusion of a tubular structure. Alternatively, the neck portion may be formed by centerless grinding.

[0148] After formation, the expandable body 100, 140, 150, or 170A-H and forming member 3204 are removed from the mandrel base 3202. Here, the forming member is removed leaving only the metallic ring 3208 which may form the body portion and all or part of the proximal neck and remainder of the expandable body which may optionally include a distal neck as shown in partial cross section in FIG. 28. In one embodiment, the aluminum forming member 3204 is removed through the neck 116 by chemical and / or thermal leaching or etching. In another embodiment, holes are drilled through the neck 116 into the aluminum forming member 3204 by mechanical operations such as, but not limited to, drilling with an auger bit. The holes may be used to facilitate and control the chemical etching process to remove the aluminum forming member 3204 from the expandable body 100, 140, 150, or 170A-H. A combination of mechanical, chemical, and thermal methods are preferably used to ensure that all of the constituents of the forming member 3204 are removed. It may be desirable to completely remove the forming member 3204 from the expandable body 100, 140, 150, or 170A-H to ensure sufficient plasticity or malleability of the expandable body and to minimize any toxic effects after implantation, particularly if the expandable body contains residual aluminum.

[0149] To reduce the presence of stress concentration areas or surface variations in the expandable body 100, 140, 150, or 170A-H, and to eliminate the transfer of concentric machine marks from the forming member 3204, the mandrel 3200, and particularly the forming member, may be polished or honed prior to electroforming of the expandable body. An unpolished forming member 3204 and the resulting gold expandable body 100, 140, 150, or 170A-H are shown in Figures 29A and 29B, respectively. Conversely, a polished and honed forming member 3204 and the resulting gold expandable body 100, 140, 150, or 170A-H are shown in Figures 29C and 29D, respectively. In one embodiment, the forming member 3204 is polished to obtain a surface finish of 16μ inches Ra.

[0150] Once the forming member 3204 is removed from the expandable body 100, 140, 150, or 170A-H, the expandable body may undergo an annealing process to improve the flexibility of the expandable body. In one embodiment, the expandable body is heated to approximately 300° C. for approximately one hour and then immediately quenched in a room temperature distilled water bath. In other embodiments, the expandable body 100, 140, 150, or 170A-H is folded or deformed after the initial annealing process and then undergoes one or more additional annealing processes. In further embodiments, the expandable body 100, 140, 150, or 170A-H is coated on the exterior surface, including coating with a polymer such as parylene, and then undergoes one or more additional annealing processes.

[0151] The interior and exterior surfaces of the expandable body 100, 140, 150, or 170A-H may be cleaned to remove any remaining contaminants from the product. For example, in one embodiment, the expandable body 100, 140, 150, or 170A-H is placed in an ultrasonic cleaner containing an isopropyl alcohol bath for approximately 10 minutes. The expandable body 100, 140, 150, or 170A-H is then removed from the bath and injected with distilled water to remove any remaining contaminants within the interior of the expandable body. Optionally, the expandable body 100, 140, 150, or 170A-H may be dried in a vacuum oven maintained at approximately 90° C. In various embodiments, the exterior surface of the expandable body, and optionally the interior surface, may be plated with platinum to reduce the possibility of causing an undesirable reaction in the patient during deployment. This includes reducing the possibility of electrolysis on the surface of the main body portion or distal neck of the expanded expandable body.

[0152] As shown in Figures 16D, 30A, and 30B, the outer surface 106, the inner surface 106, or both of the ballstent 100 can be coated with a polymer, such as parylene or an acrylic polymer. The polymer can be applied by vapor deposition or by otherwise incorporating a preformed material into the desired orientation. In some embodiments, at least a portion of the neck 116 or the inner surface 3304 of the metallic ring 3208 is not coated. In one embodiment, the ballstent 100 may be annealed at least once as described above after the non-metallic coating is applied.

[0153] In embodiments of expandable body 100, 140, 150, or 170A-H, wall 102 is constructed of a material that is highly unreactive during electrolysis, such as platinum, and the interior and exterior of neck 116 or 118 are coated while the remaining surfaces are uncoated. Similarly, in some embodiments in which expandable body 100, 140, 150, or 170A-H is separated by an operation other than electrolysis, only interior surface 106 may be coated with a non-metallic coating.

[0154] In some embodiments, after coating, a portion of the polymer coating is removed from the outer surface 3300 to expose the metal surface in the form of a strip or ring, as shown in FIG. 30C-F. In other embodiments, the exposed metal surface may be formed by masking this area prior to coating, and then the masking material is removed. An electrolysis can be used to separate the expanded expandable body from the remainder of the neck 3300 and the delivery catheter in the area including the exposed metal surface. The width W of the separation location (i.e., the exposed metal surface in the form of a strip or ring) 3302 can range between about 0.1 mm and about 0.4 mm. The separation location 3302 can be located anywhere along the length N1 of the neck 116. In some embodiments W can be located within the area of ​​the neck formed by the metallic ring 3208. In one particular embodiment, the exposed strip at the separation location 3302 has a width W of 0.25 mm±0.03 mm and is located at a length N5 of approximately 0.51 mm±0.03 mm from the end of the neck 116. The metal strip may be exposed in any suitable manner, including but not limited to laser etching or laser cutting. In other embodiments, the metal strip at the separation location 3302 may be exposed before or after folding or compressing the expandable body 100, 140, 150, or 170A-H. By way of example and not limitation, in one embodiment, the exposed metal at the region 3302 is gold, while in other embodiments the exposed metal is stainless steel. In other embodiments, the separation location 3302 may be formed by laser etching a gold plated portion of stainless steel that will ultimately form the neck of the expandable body prior to electroforming of the expandable body. In a preferred embodiment, the neck 316 has an average wall thickness of 23 μm±5 μm and the laser etched separation location 3302 has an average wall thickness of about 15 μm, a width of about 125 μm, and is located about 1 mm from the end of the neck 116. In this embodiment, the laser etched portion is subsequently masked off during the electroforming process.

[0155] In various embodiments, the wall 102 of the expandable body 100, 140, 150, or 170A-H is perforated to create a plurality of microperforations 1300, as shown in FIG. 16B. By way of non-limiting example, the microperforations 1300 may be created by laser drilling the wall 102. The microperforations 1300 or holes may be approximately in the range of 1-500 μm in diameter and may extend through the thickness of the wall 1022 from the interior void 108 to the exterior surface 110. Alternatively, the microperforated expandable body 100, 140, 150, or 170A-H may be formed during an electroforming process, such as by using a masking pattern.

[0156] After perforation, the expandable body surfaces 110 and 106 may be coated with a polymer that does not completely cover the microperforations 1300, thereby leaving channels between the inner and outer surfaces. Alternatively, the expandable body 100, 140, 150, or 170A-H may be laser perforated after coating. The microperforations 1300 allow for fluid exchange between the interior void 108 of the expandable body 100, 140, 150, or 170A-H and the environment external to the expandable body.

[0157] 16C-D, in various embodiments, the outer layer 104 may be formed on the outside of the central layer 122 of the expandable body 100, 140, 150, or 170A-H by further electroplating or electroforming, vapor deposition, or sputter deposition, where a material is etched from the object (e.g., a metal or alloy) and then deposited onto a substrate (e.g., a mandrel or form) to form a thin layer on the substrate. Similarly, the inner layer 214 may be formed on the inside of the central layer 122 of the expandable body 100, 140, 150, or 170A-H by further electroplating or electroforming, vapor deposition, or sputter deposition.

[0158] In various embodiments, an additional polymer coating is applied to the expandable body 100, 140, 150, or 170A-H to modify the strength and flexibility properties of the wall 102. For example, the polymer may be applied via dip, spin, or spray coating, or through a deposition process specific to the particular polymer, to provide additional strength or flexibility to the wall. The additional coating may be parylene, biocompatible polyurethane, PTFE, and silicone, among others. In one embodiment, the coating may be limited to the neck 116 or 118 of the expandable body 100, 140, 150, or 170A-H by using mechanical or chemical templates. In various embodiments, detailed shapes and designs may be laser etched into the reinforced coating to further optimize the wall properties with the folded shape. Additionally, removal of the reinforced coating in areas not needed will further remove unnecessary material from the final diameter of the folded and rolled expandable body 100, 140, 150, or 170A-H.

[0159] The wall 102 of the main body portion of the expandable body 100, 140, 150, or 170A-H may be formed in a different manner than the neck 116. As shown in FIG. 16C-D, the central layer 122 of the expandable body 100, 140, 150, or 170A-H may be formed in a different manner than the outer layer or coating 104 or the inner layer or coating 214. In various embodiments, the expandable body 100, 140, 150, or 170A-H may be formed by manipulating and fastening one or more metal sheets in a desired configuration to form the wall 102 and / or the outer layer 104. These two-dimensional sheets may further include rubber, plastic, polymer, woven or knitted fiber material, or other materials, or combinations thereof. By way of example and not limitation, one or more two-dimensional sheets of metal may be folded into the shape of the expandable body and welded, brazed, glued, or bonded together. Similarly, two-dimensional sheets of material may be manipulated and fixed to form the outer layer 104 or the inner layer 214 .

[0160] In other embodiments, as shown in Figures 2A, 2B, 5A, and 5B, a stainless steel (SST) ring 250 is attached to the proximal neck 116 by welding after formation of the expandable body 100, 140, 150, or 170A-H. In other embodiments, the entire neck 116 may be stainless steel and may be combined either during formation of the expandable body or following welding to the body. The SST ring 250 or SST neck 116 may be constructed from a biocompatible stainless steel alloy, including, but not limited to, 300 series stainless steel or 400 series stainless steel, and preferably 304, 316, 316L, or 316LVM stainless steel.

[0161] The SST ring 250 may be subjected to one or more heat treatment processes to make the SST ring more susceptible to galvanic corrosion caused by electrolysis. The heat treatment process thus allows the SST ring 250 to be more easily cut, thereby reducing the time required to separate the expandable body from the delivery catheter. In one embodiment, the SST ring is heated by laser etching a surface of the SST ring. The SST ring 250 is similarly heated by a welding process to attach the ring to the proximal neck 116. It is believed that the heat treatment of welding or laser etching can make the SST ring 250 susceptible to galvanic corrosion caused by electrolysis.

[0162] In one embodiment, the SST ring 250 may be included in an elongated electrolysis segment 260, as shown in Figures 2A-B, 2D-I, 2K-N, 2P-Q, 6A-D, 8G-K, 8P, 10C, and 14B. In this embodiment, the electrolysis segment 260 is a coil segment, similar to a catheter or guidewire, attached to the distal portion of a delivery catheter 400 that has been modified to include a cathode ring 262 and at least a portion of the SST ring 250 that serves as an anode for electrolysis. Similar to the thermosetting polymer segment 1020 described below in connection with Figures 23H-I, the electrolysis segment 260 includes an insulating coating 264 that separates the ring cathode electrode 262 and the SST ring anode 250. In other embodiments, the electrolysis segment 260 may be fabricated independently and then secured to the delivery catheter 400 using any suitable method. By way of example and not limitation, methods for securing the electrolysis segment 260 to the delivery catheter 400 may include welding, solder bonding, or adhesive bonding.

[0163] The hollow metallic expandable body may undergo one or more annealing processes. The annealing process may occur before or after the neck segment and includes welding or bonding stainless steel to the expandable body. The annealing process may occur before or after folding, rolling, or compression. The inner and outer surfaces of the metallic expandable body may be coated with metallic or non-metallic materials that are electrically insulating materials, including polymers such as parylene. The inner and outer surfaces of the metallic expandable body may be coated or partially coated with metallic or non-metallic materials that are less susceptible to galvanic or galvanic corrosion, such as precious metals, including but not limited to gold. The metallic body may be annealed before or after a coating is applied, including a coating of an electrically insulating material. The metallic expandable body may be annealed before or after the metallic expandable body is considered to be in a deliverable (i.e., compressed, folded, pleated, folded, rolled, bundled, stretched, or unexpanded) configuration.

[0164] Single Lumen Catheter as an Expandable Body Delivery Device FIG 10A depicts a longitudinal view and FIG 20A depicts a cross-sectional view of the single lumen catheter of the delivery catheter portion 400 of the medical device 500. As shown in FIG 11A-F, for the single lumen embodiment, the delivery catheter 400 travels through the lumen of the guide catheter 800 to deliver the compressed ballstent 100 to the lumen 701 of the saccular aneurysm 700. For this single lumen embodiment, the delivery catheter 400 does not include a hollow cylindrical member defining a lumen sized to accommodate the passage of a guidance member or guidewire.

[0165] The sizing of the delivery catheter 300, 352A-B, or 400 is a matter of design choice based on the size of the aneurysm to be treated and the location of the aneurysm in the vasculature. The distance between the aneurysm to be treated and the location of the insertion of the medical device into the vasculature determines, in part, the length of the delivery catheter 300, 352A-B, or 400. The delivery catheters range in length from about 5 cm to about 300 cm, with a preferred range of about 75 cm to about 225 cm. The smallest diameter vessel segment in the path between the location of the insertion of the medical device into the vasculature and the aneurysm to be treated determines, in part, the diameter of the delivery catheter 300, 352A-B, or 400. The delivery catheters range in diameter between 2 Fr and 7 Fr, with a preferred range of 2 Fr to 5 Fr.

[0166] Figures 10B-C depict longitudinal views of a single lumen embodiment of the delivery catheter portion 400 of the medical device 500. Figure 10B depicts a longitudinal view of a single lumen embodiment of the medical device 500 with the ballstent 100 in a compressed configuration. Figure 10C depicts a longitudinal view of a single lumen embodiment of the medical device 500 with the ballstent 100 in an expanded configuration.

[0167] In some embodiments, as shown in Figures 10B-C, the proximal end of the delivery catheter 400 is configured with a hub 3408 that may facilitate a luer lock or luer slip connection for connecting a liquid media source, such as a syringe 314 (not shown) or a pump (e.g., Endoflator® by Karl Storz, not shown) to the lumen 312 of a hollow cylindrical member configured to pump liquid media from the proximal end of the delivery catheter to the central void or space of the expandable body 100, 140, 150, or 170A-H. As shown in Figure 22, the lumen 312 of the delivery catheter 400 is connected to a liquid media source, such as a syringe 314, through a female luer fitting 2802. A stopcock 2804 or flow switch may be placed between the liquid media source and the delivery catheter 400 to allow for better control over the movement of liquid media into and out of the delivery catheter.

[0168] As shown in FIG. 17E, in one embodiment, a single lumen delivery catheter can be used to place the ballstent 100 within the lumen 701 of the aneurysm 700. For this embodiment, the optional detachable wire or occluder 404 is removed from the delivery catheter. The detachable wire or occluder 404 may include a handle 408 or other device to facilitate insertion and removal. A source of liquid media, such as a syringe 314 (not shown) or a pump (e.g., Endoflator® by Karl Storz, not shown), can then be connected to the hub 3408 and liquid media can be pressure-moved from the syringe 314 into the central void or space 108 of the ballstent 100, causing the ballstent to expand or dilate within the lumen 701 of the aneurysm 700 and substantially fill all or a portion of the aneurysmal sac. A liquid medium such as water (including pure water), saline, a solution of an x-ray contrast agent, or a solution of a drug such as thrombin can be used to expand the compressed ballstent 100. After the ballstent 100 is expanded or expanded, a coil, auxiliary coil, expansion wire, or expandable structure 1204 can be placed into the central cavity of the ballstent 100, as shown in FIG.

[0169] Various methods and devices can be used to separate the delivery catheter 400 from the ballstent, blockstent, or expandable body. As shown in Figures 9, 10B-C, and 23A, in one embodiment, the delivery catheter 300 or 400 includes one or more electrolysis wire(s) 320 or insulated conductor wire(s). For this embodiment, after expansion of the ballstent 100, a current is applied to the electrolysis wire(s) 320 or insulated conductor wire(s) to dissolve a portion of the proximal neck of the ballstent 100 (including the stainless steel portion) by electrolysis. In alternative embodiments, a current may be applied to dissolve a portion of the stainless steel ring 250 between the ballstent 100 and the delivery catheter 300 or 400, or to dissolve a portion of the proximal region of the ballstent by electrolysis. In any of these embodiments, a direct current (DC) may be used. Once a portion of the proximal neck, stainless steel ring 250, or proximal region of ballstent 100 has degraded or eroded, the delivery catheter 300 or 400 is separated from the expanded ballstent and delivery catheter, and the guide catheter 800 is removed.

[0170] As illustrated in Figures 23B-C, in various embodiments, a single lumen catheter 1000 has a coil-reinforced wall 1002 comprised of one, two, or three electrical conductors (e.g., wires or cables) to provide a conductive path(s) for performing electrolysis as described more fully below. In one embodiment, the exterior surface 1004 of the wall 1002 is comprised of polyimide and has a hydrophilic or lubricious coating, while the conductive path(s) include a 0.001 inch by 0.003 inch flat stainless steel coil 1006. The conductor coil(s) 1006 can be configured in one, two, or three conductor arrangements 1008 as shown in Figures 23B-F and described below with respect to performing electrolysis. The conductor of the coil 1006, and any other conductors, may be straight, braided, or coiled. The conductive path defined by conductor coil 1006 is coated with an insulating polymer such as parylene, while lumen 1012 may be lined with PTFE, including PTFE composites such as polyimide / PTFE.

[0171] In certain embodiments, the modified infusion wire with a removable core can be used as a single lumen delivery catheter. The infusion wire is a modified guidewire, and the solid metal core can be removed to leave a lumen that can be used to inject a liquid medium. The infusion wire with a removable core can be modified such that an expandable body 100, 140, 150, or 170A-H can be attached to the distal end and expanded through the wire lumen after removal of the core wire.

[0172] In some embodiments, all or a portion of the interior or exterior surface of the delivery device can be further coated with a hydrophilic or lubricious coating, hi other embodiments, all or a portion of the expandable body 100, 140, 150, or 170A-H can be similarly coated with a hydrophilic or lubricious coating.

[0173] Multi-lumen catheter as an expandable body delivery device - Patents.com As shown in Figures 13 and 20B, the delivery catheter 300 may include an additional hollow cylindrical member defining a second lumen 324 for receiving a guidance member such as a guidewire 302 to assist in guiding the ballstent 100 component of the medical device to a desired location, as can be seen in Figures 14A-B and 15A-F. This second lumen 324 is generally adjacent and parallel to the first lumen 312. As shown in Figures 13 and 20B, the delivery catheter 300 may be a dual lumen catheter with one lumen 312 configured to allow passage of a liquid medium from a source of liquid medium at the proximal end of the delivery catheter to the central void or space 108 of the ballstent at the distal end of the delivery catheter, and the other lumen 324 configured to receive a guidance member such as a guidewire 302 to facilitate advancement and placement of the medical device in the vasculature. In certain embodiments, the distal end of lumen 324 configured to receive a guidance member may be defined by a bridge catheter, similar to bridge catheter 160 as shown in Figures 2B-C, 2E, 2G, 2L-N, 2O-P, 8H, 8J-O, and 8R-S, either as part of the delivery catheter passing from the proximal hub to the distal end of the delivery catheter, or as a separate element coupled or joined to the distal end of the delivery catheter. As previously described, this guidance catheter may be operatively coupled through the proximal neck, through the void of the expandable body, and to the distal neck so that a guidewire, guidance member, coil, auxiliary coil, or auxiliary coil catheter may pass through the hub of the delivery catheter and exit the distal end of the medical device, including placement of a guidewire or guidance member within an artery, vein, or other biological conduit, and further including placement of a coil or auxiliary coil within the lumen of a saccular aneurysm.

[0174] As shown in FIG. 20B, the delivery catheter 300 includes two hollow cylindrical members, each with a lumen, the hollow cylindrical members 304 or 306 having a wall thickness ranging from about 0.05 mm to about 0.25 mm. Preferably, the wall thickness of the hollow cylindrical members 304 or 306 ranges from about 0.1 mm to about 0.2 mm. The lumen defined by the hollow cylindrical member 304 for receiving the guidewire 302 has a diameter ranging from about 0.25 mm to about 0.5 mm. The diameter of the lumen for passing a liquid medium to the ballstent 100 and the diameter of the lumen for receiving the guidance member 324 may be of similar dimensions. Alternatively, the diameter of the lumen for passing a liquid medium to the ballstent, blockstent, or expandable member may be larger or smaller than the diameter of the lumen for receiving a guidance member such as the guidewire 302 or for receiving a coil, auxiliary coil, or auxiliary coil catheter.

[0175] For a delivery catheter with two lumens, the first and second hollow cylindrical members may be of similar dimensions. Alternatively, the second hollow cylindrical member may have a larger or smaller diameter to receive a guidewire, guidance member, coil, auxiliary coil, or auxiliary coil catheter. The proximal end of the second hollow cylindrical member 304 is engaged to a hub 3408. The hub 3408 facilitates the insertion of the guidewire 302, guidance member, coil, auxiliary coil, or auxiliary coil catheter into the second hollow cylindrical member 304. As can be seen from FIGS. 13, 14A-B, 15A-F, and 20B, in some embodiments, the guidewire 302, guidance member, coil, auxiliary coil, or auxiliary coil catheter can be fed through the second hollow cylindrical member 304 and extend out the distal end of the delivery catheter 300 and exit the distal end of the medical device as well. In other embodiments, including those lacking a bridge catheter component, a coil, auxiliary coil, or auxiliary coil catheter can be delivered through the second hollow cylindrical member 304 and positioned within the central cavity of the ballstent, blockstent, or expandable body. In some embodiments using a dual lumen delivery catheter, the delivery catheter 300 is advanced over the guidewire 302 until the compressed ballstent 140 is positioned within the lumen of the saccular aneurysm. Once the compressed ballstent 140 is in the desired location, the ballstent 140 is expanded by a liquid medium delivered to the first hollow cylindrical member 306 by a syringe 314 (not shown) or pump (e.g., Endoflator® by Karl Storz, not shown) connected to the ballstent expansion portion 3408. A liquid medium such as water, saline, a solution of x-ray contrast, or a solution of a drug such as thrombin can be used to expand the compressed ballstent. Guidewire 302 is preferably an angiography wire that is long enough for the distal tip of the guidewire to reach the aneurysm and the proximal end to extend away from the point where it enters the vascular system.In some embodiments, the guidewire 302 has a straight or angled distal tip, while in other embodiments, the guidewire 302 has a curved J-shaped distal tip, typically made from a shape memory alloy or braided metal, such that the tip can return to the J-shape after removal of applied stress. The material and size of the guidewire 302 may be selected based on the diameter, length, and tortuosity of the vessel to be traversed. Generally, the guidewire 302 may be constructed from any suitable biocompatible material and have an outer diameter in the range of about 0.012 to 0.035 inches. In one embodiment for placement of a compressed expandable body 100, 140, 150, or 170A-H for general use, the guidewire diameter may be 0.018 or 0.035 inches. In other embodiments for treatment of peripheral or tortuous vasculature requiring particularly small devices, the guidewire diameter may be 0.012 or 0.014 inches.

[0176] In another embodiment of the dual lumen catheter depicted in FIG. 20C, the delivery catheter 300 may function as two independent concentric catheter shafts. The outer catheter shaft 306 (i.e., the delivery shaft) connects to the expandable body 100 for placement and delivery purposes. The inner catheter shaft 160 (i.e., the guidewire shaft or bridge catheter) slides into the expandable body 100 for the purposes of sealing the necks 116 and 118 of the expandable body 100 and facilitating the passage of the guidewire 302 through the delivery catheter 300 and the expandable body 100. The annular gap between these two catheter shafts functions as the inflation lumen 312, while the interior of the inner catheter shaft 160 functions as the guidewire lumen 324. In the absence of a guidewire 302, the guidewire lumen 324 may be used to inject an X-ray contrast agent. In various embodiments, the minimum clearance between the inner diameter of the outer catheter shaft 306 and the outer diameter of the inner catheter shaft 160 or the inner diameter of the inner catheter shaft 160 and the guidewire 302 is approximately 0.004 inches.

[0177] In a related embodiment, a triple lumen catheter is depicted in FIG. 20D. The delivery catheter 300 may have the functionality of three independent concentric catheter shafts. In addition to the functionality previously described and in FIG. 20C, there is a separation catheter shaft 610 that surrounds the delivery catheter shaft 306. The annular gap between these two catheter shafts functions as an X-ray contrast lumen 760. In various embodiments, the minimum gap between the inner diameter of the separation catheter shaft 610 and the outer diameter of the delivery catheter shaft 160 is approximately 0.004 inches. The separation catheter shaft 610 may be used to deliver axial force to the mechanical separation mechanism. After separation, the separation catheter shaft 610 can be used for diagnostic or therapeutic procedures.

[0178] In another embodiment, shown in Fig. 54A, the guidewire catheter shaft 160 has a lamellar design. The outer layer 160A includes a polymer such as polyimide for added axial stiffness. The middle layer 160B includes a metal braid, such as a flat stainless steel braid, for added torsional and bending stiffness. The inner layer 160C includes a lubricious polymer, such as PTFE or a polyimide / PTFE composite (e.g., PD-Slick™ by International Wire Group), to reduce friction between the guidewire catheter shaft 160 and the guidewire 302. In some embodiments, all or a portion of the inner or outer surface of the guidewire catheter shaft 160 can be further coated with a hydrophilic or lubricious coating.

[0179] 14A-B depict longitudinal views of a dual lumen catheter of the delivery catheter portion 300 of the medical device 500. FIG. 14A depicts a longitudinal view of a dual lumen embodiment of the medical device 500 with the expandable body 140 in a compressed configuration, while FIG. 14B depicts a longitudinal view of a dual lumen embodiment of the medical device 500 with the ballstent 140 in an expanded configuration. The delivery catheter 300 is used to advance the ballstent 140 over the guidewire 302 and into the lumen of the aneurysm sac. The delivery catheter 300 is also used to deliver a fluid, liquid, gas, solid, or combination thereof to expand the ballstent 140 within the lumen 701 of the aneurysm 700. In some embodiments, the delivery catheter 300 or 400 includes one or more electrolysis wire(s) 320 or insulated conductor wire(s). For these embodiments, after expansion of the ballstent 100, a current is applied to the electrolysis wire(s) 320 or insulated conductor wire(s) to dissolve a portion of the proximal neck of the ballstent 100 (including the stainless steel portion) by electrolysis. In alternative embodiments, a current may be applied to dissolve a portion of the stainless steel ring 250 between the ballstent 100 and the delivery catheter 300 or 400, or to dissolve a portion of the proximal region of the ballstent by electrolysis. In any of these embodiments, a direct current (DC) may be used. Once the portion of the proximal neck, the stainless steel ring 250, or the proximal region of the ballstent 100 has been dissolved or corroded, the delivery catheter 300 or 400 is separated from the expanded ballstent and the delivery catheter, and the guide catheter 800 is removed.

[0180] In one embodiment, the electrolysis wire 320 or insulated conductor wire is connected or electrically coupled to a portion of the proximal neck of the ballstent, including the exposed metal surface 3302. In other embodiments, the electrolysis wire 320 or insulated conductor wire is connected or electrically coupled to a portion of the proximal neck of the ballstent, including the exposed metal surface 3302. In other embodiments, the electrolysis wire 320 or insulated conductor wire is connected or electrically coupled to another portion of the ballstent 140, including the exposed metal surface 3302.

[0181] In various embodiments of the "over the wire" ballstent medical device 500 as described below in connection with Figures 10B-C, 13, 14A-B, 15A-F, and 17O, the expandable body 100 or 140 is used to occlude a saccular aneurysm 700. First, a guidewire 302 is positioned so that its distal tip is located within the aneurysmal sac, lumen, or cavity 701 as shown in Figure 15A. Next, a delivery catheter 300 or 400 is advanced with the attached and compressed expandable body 100 or 140 over the guidewire 302 and through the aneurysm neck or entrance 703 as shown in Figure 15B.

[0182] Once the compressed ballstent 100 or 140 is positioned within the lumen 701 of the saccular aneurysm 700, it is then removed as shown in Figure 15C. At this point, x-ray contrast may be injected through the guidewire lumen of the delivery catheter 300 or 400 so that the position of the compressed expandable body 100 or 140 can be assessed using fluoroscopy.

[0183] Once proper placement of the expandable body 100 within the lumen 701 of the saccular aneurysm 700 has been achieved and confirmed, the medical device 500 then expands as shown in Figure 15D. A source of liquid medium, such as a syringe 314 (not shown) or a pump (not shown), such as, for example, the Endoflator® by Karl Storz, is connected to the hub 3408 and liquid medium is injected into the central void or space 108 of the ballstent 100 or 140, causing expansion of the ballstent until it fills at least a portion of the aneurysm lumen.

[0184] After inflation or expansion, the delivery catheter 300 or 400 is pulled back within the aneurysm sac 701 to pull the expanded expandable body 100 or 140 toward the opening 703 between the parent vessel and the aneurysm, as shown as 702 in FIG. 15D. This includes toward the neck or ostium, bringing the expanded expandable body 100 or 140 into contact with the aneurysm wall 704 near or adjacent the neck or ostium 703 of the saccular aneurysm 700, as shown in FIG. 15E. At this point, x-ray contrast may be injected through the guidewire lumen of the delivery catheter 300 or 400 so that the position of the expanded expandable body 100 or 140 can be assessed using fluoroscopy. A coil or auxiliary coil 162 is then fed through the catheter 300 or 400 and delivered through the interior of the expandable body 100 or 140 into the aneurysm lumen 701, as shown in FIG. 15E. This involves threading a coil or auxiliary coil through the guidewire lumen. The auxiliary coil 162 is inserted until it contacts both the aneurysm wall 704 opposite the entrance 703 and the exterior surface of the expandable body 100 or 140 where the auxiliary coil applies a continuous force on the expandable body causing the expandable body to seal the aneurysm entrance. At this point, x-ray contrast may again be injected through the guidewire lumen of the delivery catheter 300 or 400 so that the final position of the auxiliary coil 162 and expanded expandable body 100 or 140 can be assessed using fluoroscopy.

[0185] The expanded expandable body 100 or 140 is then separated from the delivery catheter 300 or 400, and the delivery catheter is removed as shown in Figure 15F. The ballstent expanded body is left within the lumen 701 of the saccular aneurysm 700 in a location that seals the aneurysm entrance 703. Similarly, an auxiliary coil is left within the aneurysm lumen behind the expanded body in a location that serves to hold the ballstent in place.

[0186] The over-the-wire embodiment may be particularly well suited for treating cerebral aneurysms in vasculature that is both distal and tortuous. When faced with this structure, the tip of an elongated guidewire 302 can be placed directly into the lumen 701 of a cerebral aneurysm 700, as shown in FIG. 15A. The guidewire 302 may feature a pre-shaped (e.g., curved J-shape) distal end to aid in passing through the aneurysm entrance 703, as shown in FIG. 15A.

[0187] As can be seen from the process depicted in Figures 15G-K, various embodiments of the over-the-wire blockstent medical device 500 may be used to occlude a blood vessel 802. First, the guidewire 302 is positioned so that its distal tip is located just distal to the targeted area of ​​the blood vessel lumen 804 to be occluded, as shown in Figure 15G. Next, the delivery catheter 300 advances the attached and compressed expandable body 100 over the guidewire 302, as shown in Figure 15H, and into the targeted area of ​​the blood vessel lumen 804, as shown in Figure 15I. At this point, x-ray contrast may be injected through the lumen of the separation catheter 610 so that the location of the compressed expandable body 100 can be assessed using fluoroscopy.

[0188] Once proper placement of the expandable body 100 within the vessel lumen 804 has been achieved and confirmed, the medical device 500 then expands, as shown in FIG. 15J. A source of liquid media, such as a syringe 314 (not shown) or a pump (e.g., an Endoflator® by Karl Storz (not shown)) is connected to the hub 3408 and liquid media is injected into the central void or space 108 of the blockstent 100, filling the target area of ​​the lumen and causing the blockstent to expand until it abuts the luminal surface 806 of the vessel. The vessel 802 is now occluded. At this point, an x-ray contrast agent may be injected through the lumen of the isolation catheter 610 so that the final position of the compressed expandable body 100 and the degree of vessel occlusion can be assessed using fluoroscopy.

[0189] The process of detachment is then performed as shown in Figures 15J-K and illustrated by Figures 3F and 9A-D. Leaving the guidewire 302 in place, the delivery catheter 300 is removed and the bridge catheter 160 is withdrawn out of the distal valve 560A and the delivery catheter 300 out of the proximal valve 560B while simultaneously holding the distal end of the detachment catheter 610 against the proximal nosecone 362B. A radiopaque marker band 620 at the distal end of the detachment catheter 610 enhances fluoroscopic visibility during the detachment process. Finally, the detachment catheter 610 and guidewire 302 are removed. The blockstent expanded body 100 is left within the lumen 804 of the blood vessel 802 in place to maintain a permanent occlusion.

[0190] Various methods and devices can be used to separate the delivery catheter 300 or 400 from the ballstent, blockstent, or expandable body 100 or 140. As shown in Figures 10A-C and 23A, in one embodiment, the delivery catheter 300 or 400 includes one or more electrolysis wire(s) 320 or insulated conductor wire(s). For this embodiment, after expansion of the ballstent 100, an electric current is applied to the electrolysis wire(s) 320 or insulated conductor wire(s) to dissolve a portion of the proximal neck of the ballstent 100 (including the stainless steel portion) by electrolysis. In alternative embodiments, an electric current may be applied to dissolve a portion of the stainless steel ring 250 between the ballstent 100 and the delivery catheter 300 or 400, or to dissolve a portion of the proximal region of the ballstent 100 by electrolysis. In any of these embodiments, a direct current (DC) may be used. Once a portion of the proximal neck, stainless steel ring 250, or proximal region of ballstent 100 has degraded or eroded, the delivery catheter 300 or 400 is separated from the expanded ballstent and delivery catheter, and the guide catheter 800 is removed.

[0191] The dual lumen catheter has a coil-reinforced wall comprised of one, two, or three electrical conductors (e.g., wires or cables) to provide a conductive path(s) for conducting electrolysis as described more fully below. In one embodiment, the exterior surface of the wall is comprised of polyimide and has a hydrophilic or lubricious coating, while the conductive path(s) comprise a 0.001 inch by 0.003 inch flat stainless steel or copper coil. The conductor coil 1006 can be configured in a one, two, or three conductor arrangement, as described below with respect to conducting electrolysis. The coil conductor and any other conductors may be straight, braided, or coiled. The conductive path defined by the conductor coil is coated with an insulating polymer such as parylene, while the lumen may be lined with PTFE, including PTFE composites such as polyimide / PTFE.

[0192] In some embodiments, all or a portion of the interior or exterior surface of the delivery device or catheter can be further coated with a hydrophilic or lubricious coating, hi other embodiments, all or a portion of the expandable body 100, 140, 150, or 170A-H can be similarly coated with a hydrophilic or lubricious coating.

[0193] Medical device including an expandable body and a delivery device for the expandable body - Patents.com The expandable body 100, 140, 150, or 170A-H is advanced and positioned within the human body by an elongated portion of a medical device known as a "delivery device" or "delivery catheter," with the delivery catheter being particularly used when the elongated portion of the medical device is flexible. In one embodiment, the delivery device is an elongated medical device that defines at least one lumen, or potential lumen. The delivery device has a proximal end and a distal end and is dimensioned to deliver a liquid medium from a source of liquid medium at the proximal end of the device to a central void or space 108 of the expandable body 100, 140, 150, or 170A-H that is attached or coupled to the distal end of the delivery device. Furthermore, any medical device or component of a medical device that can position the expandable body 100, 140, 150, or 170A-H at a desired location in the vasculature, such as the lumen of a saccular aneurysm or the lumen of a target blood vessel, and that facilitates expansion of the expandable body and subsequent detachment of the expandable body from the delivery device, is generally accepted as a delivery device. Generally, the delivery device is a flexible catheter ("delivery catheter"). Preferably, the delivery catheter may be any flexible catheter, hollow wire, removable core wire, or combination thereof suitable for accessing a location in the vasculature, including delivery catheters 300, 352A-B, and 400 shown in Figures 7, 9, and 13. The delivery device may also be any other type of catheter, hollow wire, or removable core wire, or alternatively a needle or trocar, stylet, or combination thereof suitable for accessing a location in the vasculature or other biological conduit. In various embodiments, the delivery device is a catheter 300, 352A-B, or 400 that can carry the attached and compressed expandable body 100, 140, 150, or 170A-H into the lumen of a saccular aneurysm, or into the lumen of an artery or vein, or other form of biological conduit.

[0194] A catheter is a flexible, tubular, elongated medical device configured for insertion into a portion of the body, including a blood vessel, to allow for the infusion or withdrawal of fluids. Catheters are often formed of polymers or plastics, and optionally further include metals such as coils or braided configurations for reinforcement. The catheter can be configured to be attached to an expandable body 100, 140, 150, or 170A-H, to facilitate delivery of the compressed expandable body to the lumen of an aneurysm sac or the lumen of a target blood vessel or other biological conduit, to facilitate expansion or dilation of the compressed expandable body, and to detach from the expanded expandable body. In some embodiments, the delivery catheter 300, 352A-B, or 400 can be configured to pass through the vasculature with the attached expandable body 100, 140, 150, or 170A-H in a compressed configuration, as shown in FIGS. 10B and 17A. After expansion, expandable body 100, 140, 150, or 170A-H is detached from delivery catheter 300, 352A-B, or 400, thereby allowing the expanded expandable body to remain in place while the delivery catheter is removed from the body. In this manner, the delivery catheter is similar to an angioplasty balloon catheter configured to facilitate delivery of a mounted and compressed conventional tubular stent into the lumen of a particular segment of a blood vessel or other biological conduit, to allow expansion of the compressed conventional tubular stent, and to be attachable to a conventional rigid tubular stent for detachment from the expanded conventional tubular stent.

[0195] The delivery catheter 300, 352A-B, or 400 is constructed from a biocompatible material. By way of example and not limitation, the delivery catheter 300, 352A-B, or 400 and various components thereof may be formed from silicone rubber, natural rubber, polyvinyl chloride, polyurethane, copolyester polymers, thermoplastic rubber, silicone polycarbonate copolymers, polyethylene ethyl-vinyl-acetate copolymers, woven polyester fibers, or combinations thereof. In one embodiment, to improve control of the delivery catheter during use and reduce kinking, the walls of the delivery catheter 300, 352A-B, or 400 may be reinforced with a metal such as coiled or braided stainless steel or nitinol. Suitable metals for reinforcing the delivery catheter include stainless steel and nitinol.

[0196] 7, 9, 10B-C, 13, 14A-B, and 23A-B, the delivery catheter 300, 352A-B, or 400 has a hollow, or potentially hollow, cylindrical member that defines a lumen for passing a liquid medium from the proximal end of the delivery catheter to the distal end of the delivery catheter and into the central cavity 108 of the expandable body. The delivery catheters 352A-B are designed and dimensioned for insertion into the body to deliver the compressed expandable body 100, 140, 150, or 170A-H to a desired location, to facilitate expansion or expansion of the expandable body, and to facilitate detachment of the expanded expandable body from the delivery catheter. When a single lumen catheter 300, 352A-B, or 400 is used, the compressed expandable body may be deployed into the lumen of the saccular aneurysm or the lumen of the target vessel after being advanced through a separate larger catheter, guide catheter, or guide sheath that is placed at its distal end inside or near the aneurysm or at a target location within the target vessel. Once in the lumen of the aneurysmal sac or the lumen of the target vessel and out of the guide catheter, the compressed expandable body 100, 140, 150, or 170A-H can be expanded, after which the expanded expandable body and delivery catheter 300, 352A-B, or 400 can be separated and the delivery catheter and guide catheter can be removed from the body while the expanded expandable body remains in place. The hollow or potentially hollow cylindrical member 306 of the delivery catheter 300, 352A-B, or 400 has a wall thickness in the range of about 0.05 mm to about 0.25 mm. Preferably, the wall thickness of hollow cylindrical member 306 ranges from about 0.1 mm to about 0.2 mm. A lumen 312 defined by hollow cylindrical member 306 for permitting the passage of a liquid medium to a central void or space of expandable body 108 has a diameter ranging from about 0.4 mm to about 1 mm. The proximal end of hollow cylindrical member 306 includes a port or hub 3408 that communicates with a source of pressurized liquid medium, such as a syringe 314 or pump (e.g., Endoflator® by Karl Storz) containing water, saline, or x-ray contrast solution.A fluid medium for expanding the expandable body is received into the delivery catheter 300 , 352 AB, or 400 through a hub or port 3408 .

[0197] Medical device including an expandable body - Patents.com 31A depicts an embodiment of an expandable body medical device that can be used as a ballstent catheter 3400A. As shown, the ballstent catheter medical device 3400A includes a delivery catheter 3402 configured at a distal end 3404 to engage the ballstent 100. The proximal end 3406 of the delivery catheter 3402 is engaged to a hub 3408 that allows electrical and fluid communication with the ballstent 100 through the catheter. A syringe 314 or pump (e.g., Endoflator® by Karl Storz, not shown) may be used to deliver a liquid medium to the ballstent 100. The device 3400A further includes an electrical connector or port 3422 for establishing electrical communication from a handheld controller 3418 to the ballstent 100.

[0198] 31B depicts an embodiment of an expandable body medical device that can be used as a blockstent medical device 3400B. As shown, the medical device 3400B includes a delivery catheter 3402 configured at a distal end 3404 to engage the expandable body 100. The proximal end 3406 of the delivery catheter 3402 is engaged to a hub that allows electrical and fluid communication with the expandable body 150 through the catheter. A syringe 314 may be used to deliver a liquid medium to the expandable body 150. The device 3400B further includes an electrical connector or port 3422 for establishing electrical communication from a power source (not shown) to the expandable body 150 through an electrolysis wire or conductor present in the wall of the delivery catheter.

[0199] A cross-sectional view of a hub 3408 for a medical device with a single lumen delivery catheter where the temporary method of separation is electrolysis is shown in FIG. 32A. The hub 3408 includes a first connection port 3410 configured with a luer hub or taper that may facilitate a luer lock or luer slip type connection for connecting a source of liquid media, such as a syringe 314 (not shown) or a pump (e.g., Endoflator® by Karl Storz, not shown) to the lumen 312 of the hollow cylindrical member of the delivery catheter 3402 configured to deliver liquid media from the proximal end of the delivery catheter to the central void or space 108 of the expandable body 100, 140, 150, or 170A-H. Optionally, the first connection port 3410 may further receive a guidewire or guidance member. The hub 3408 is further configured with a second connection port 3422 configured to enable electrical communication with the catheter 3402. For example, one or more electrolysis wire(s) 320 in electrical communication with the catheter 3402 and / or ballstent, blockstent, or expandable member 100 may extend through the channel 3416 of the hub 3408 to the second connection port 3422. Alternatively, one or more resistive wires may extend through the channel 3416 of the hub 3408 to the second connection port 3422. A power source or power supply, such as the handheld controller 3418 shown in FIGS. 31A and 33, may communicate with the wires 320 to perform various functions, such as, but not limited to, electrolysis or heating of a thermally sensitive material, and such communication occurs through a connection between an electrical connector portion 3424 of the handheld controller and the communication port 3422 of the hub 3408.

[0200] A diagram of a hub 3408 for a medical device with a dual lumen delivery catheter where the temporary method of separation is electrolysis is shown in FIG. The hub 3408 includes a first connection port 3410 configured with a luer hub or taper that may facilitate a luer lock or luer slip type connection for connecting a source of liquid medium, such as a syringe 314, to the lumen 312 of the hollow cylindrical member of the delivery catheter 3402 configured to deliver liquid medium from the proximal end of the delivery catheter to the central void or space 108 of the expandable body 100, 140, 150, or 170A-H. The hub 3408 is further configured with a second communication port 3422 configured to permit electrical communication with the catheter 3402. For example, one or more electrolysis wire(s) 320 in electrical communication with the catheter 3402 and / or the ballstent, blockstent, or expandable member 100 may extend through a channel 3416 of the hub 3408 to the second connection port 3422. Alternatively, one or more resistive wires may extend through the channel 3416 of the hub 3408 to the second connection port 3422. A power source or power supply, such as the handheld controller 3418 shown in Figures 31A and 33, may communicate with the wires 320 to perform various functions, such as, but not limited to, electrolysis or heating of thermally sensitive materials, and such communication occurs through a connection between the electrical connector portion 3424 of the handheld controller 3418 and the communication port 3422 portion of the hub 3408. The third communication port 3410 is further configured to receive and engage the guidewire 302 or obturator wire 404.

[0201] A diagram of a hub 3408 for a medical device with a dual lumen delivery catheter where the temporary method of separation is mechanical is shown in FIG. The hub 3408 includes a first connection port 3410 configured with a luer hub or taper that may facilitate a luer lock or luer slip type connection for connecting a source of liquid media, such as a syringe 314 (not shown) or a pump (e.g., Endoflator® by Karl Storz, not shown) to the lumen 312 of the hollow cylindrical member of the delivery catheter 3402 configured to deliver liquid media from the proximal end of the delivery catheter to the central void or space 108 of the expandable body 100, 140, 150, or 170A-H. The second communication port 3410 is further configured to receive and engage the guidewire 302 or obturator wire 404.

[0202] An alternative design of a hub 3408 for a medical device with a dual lumen delivery catheter, where the temporary method of separation is mechanical, is shown in Figures 32D-F. The hub 3408 is of the dual lock type, combining a Y-shaped delivery catheter hub 670 with a Y-shaped separation catheter hub 650 that lock together via male and female Luer fittings 695 and 675 after the delivery catheter 306 is inserted into the separation catheter 610. Figure 32D shows the assembled configuration of the hub 3408, while Figures 32E-F show the disassembled configuration leaving only the separation catheter hub 650. The hub 3408 is further suitable for use with a blockstent expandable body. According to various embodiments, the components of the hub 3408, including the hubs 650 and 670, may be colored to aid in identification and access of the components. Preferably, red is avoided to prevent confusion with blood entering the hub 3408.

[0203] The delivery catheter hub 670 attaches to the delivery catheter 306 (i.e., outer shaft) and the bridge catheter 160 (i.e., inner shaft) with an annular gap between the two catheter shafts serving as an inflation lumen. The base of the delivery catheter hub 670 features a male luer spinlock 695 for connecting to the separate catheter hub 650. One arm of the delivery catheter hub 670 includes a male luer lock fitting 680 for connecting a source of fluid medium such as a syringe 314 or a pump (not shown) (e.g., Endoflator® by Karl Storz) that is used to inflate the expandable body 150 (not shown). This arm also includes a pressure relief valve 685 to protect the expandable body 150 from over-inflation. The other arm of the delivery catheter hub 670 houses a tapered female luer lock fitting 680 that serves as a lumen for the insertion of a guidewire 302, including a hemostasis method. Alternatively, this arm may be used for injection of X-ray contrast media from a syringe or other suitable dispensing tool (not shown) having a male Luer lock fitting.

[0204] The separation catheter hub 650 attaches to the separation catheter 610 via a pressure relief 615. The annular gap between the delivery catheter 306 and the separation catheter 610 serves as a lumen for receiving X-ray contrast media. One arm 663 of the separation catheter hub 650 includes a female luer lock fitting 675 for connecting to a delivery catheter hub 670, or alternatively, houses a hemostasis valve 665 for use after separation of the expandable body 150 and removal of the delivery catheter hub 670. The other arm of the separation catheter hub includes a side port 655 attached to a tubing and stopcock 660 used to inject X-ray contrast media.

[0205] 32A, in a preferred embodiment, the second connection port 3414 is coupled to a threaded nut 3420 such that an electrical terminal 3422 may be secured to the nut and hub 3408. The electrical terminal 3422 is in electrical communication with one or more conductor wires and is configured to receive an electrical connector from an external power source, such as a handheld controller 3418. By way of non-limiting example, the electrical connector 3424 may be a 3.5 mm audio jack. Other electrical connectors may be used as well.

[0206] As shown in Figure 33, the handheld controller 3418 can be connected to electrical terminals 3422 through a jack 3424 for delivering electrical current through the catheter 3402 to separate expandable bodies 100, 140, 150, or 170A-H. For example, in one embodiment, the catheter 3402 includes a conductor coil 1006 that can be arranged in one, two, or three conductor arrangements 1007, 1008, and 1010 as shown in Figures 23C, 23E, and 23F, respectively. The various conductor arrangements 1008 and 1010 can provide both strength reinforcement and a conductor path along the length of the catheter 3402. The handheld controller 3418 supplies electrical current or potential to the electrodes 1014, 1016, and optionally 1026 extending through the catheter 3402 to separate the expandable bodies 100, 140, 150, or 170A-H by electrolytic or thermal separation as described below. In one embodiment, the handheld controller 3418 includes a body 3426, a power source such as a battery, one or more activation buttons 3428, and one or more gauges 3430 that indicate the status of the controller, the separation of the expandable bodies 100, 140, 150, or 170A-H, and the status of the power source such as a battery.

[0207] 50A-50F illustrate one embodiment of an auxiliary coil delivery system (ACDS) 900. As shown, the auxiliary coil delivery system (ACDS) includes an auxiliary coil catheter 902 preloaded with an auxiliary coil 162 and a pusher wire 950. As shown, the proximal end of the auxiliary coil catheter is received within an outer hypotube 906 and is further engaged to a female luer lock connector 908. The luer lock connector 908 further engages a Y-adapter hub 970 that provides access to the auxiliary coil catheter shaft 910 and the expandable body 190 through various ports 912-914. As shown, one port 912 is configured to receive the pusher wire 950 and an inner hypotube 916 that receives the pusher wire. In one aspect, the inner hypotube provides stiffness to the pusher wire 950 to minimize tangential torque on the pusher wire as it advances through the hub 970.

[0208] In one embodiment, the push wire 950 may be fitted with a handle 918 that provides a grip for the user to advance the push wire. In conjunction with the Y-adapter hub 970, which also functions as a torque handle during deployment, the push handle 918 provides the user with better control. As the user applies force to the push wire 950 to advance it through the hub 970, the push wire and inner hypotube advance through the hub 970, into the auxiliary coil catheter shaft 910 and into the outer hypotube 906. As the push wire 950 advances through the auxiliary coil catheter shaft 910 to eject the auxiliary coil 162, the inner and outer hypotubes fit together in a telescoping manner to provide stiffness during advancement of the push wire.

[0209] Radiopaque marker for medical device including an expandable body - Patents.com According to any method in which the expandable body 100, 140, 150, or 170A-H is detached or separated from the delivery catheter, one or more radiopaque markers may be incorporated into appropriate portions of the expandable body or delivery catheter in addition to the nosecone 360 ​​or 362A-B to aid in positioning the expandable body, expansion of the expandable body, detachment or detachment of the expanded expandable body from the delivery catheter, and removal of the delivery catheter after detachment or detachment. For example, a radiopaque marker band or spot may be incorporated into the medical device to identify the location where detachment is deemed or designed to occur. In addition, a radiopaque material may be incorporated into the expandable body 100, 140, 150, or 170A-H. In addition, a radiopaque spot or marker band may be incorporated into the distal end of the delivery catheter so that the tip of the delivery catheter can be visualized under fluoroscopy while the delivery catheter is being withdrawn from the expandable body 100, 140, 150, or 170A-H. Radiopaque spots or marker bands may also be placed on the separation components as needed. Radiopaque markers may comprise a variety of radiopaque materials, including but not limited to metal bands, metal spots or lines, or barium spots or lines. Radiopaque materials may include radiopaque liquids or particles mixed into a polymer extrusion or coating.

[0210] In various embodiments, the saccular aneurysm 700 or blood vessel may be visualized using a radiopaque dye, which may be injected prior to introduction of the expandable body 100, 140, 150, or 170A-H and can be used to ascertain the approximate size and location of the compressed or expanded body.

[0211] 52A-B illustrate a marker wire 930 that may be incorporated into either the guidewire 302, the auxiliary coil 162, or the pusher wire 950. According to one embodiment, the marker wire 930 comprises a radiopaque material such as platinum, iridium, barium, gold, tantalum, stainless steel, and alloys thereof. In one example, the marker wire 930 comprises platinum and is approximately 0.004-0.005 inches in diameter and 0.075 inches in length.

[0212] The marker wire 930 is coaxially aligned with the guidewire 302, auxiliary coil 162, or pusher wire 950. For example, FIG. 52B is a cross-sectional view of an exemplary auxiliary coil 162 with a marker wire 930 as disposed within an embodiment of the ACDS 900 and viewed along line CC. The marker wire 930 is held in place at least in part by a PTFE sheath 932 applied along the length of the marker wire and the guidewire 302, auxiliary coil 162, or pusher wire 950. In one aspect, the PTFE sheath 932 is a shrink film that is heated and shrinks to conform to the marker wire 930 and associated coil or wire.

[0213] 53A-53C illustrate a marker band 920 that may engage any of the wires, catheters, or deployment systems disclosed herein, including but not limited to, the delivery catheter 220, or the auxiliary coil 162. According to one embodiment, the marker band 920 comprises a radiopaque material such as platinum, iridium, barium, gold, tantalum, stainless steel, and alloys thereof. The marker band 920 is engaged to the exterior of either the wire, catheter, or deployment system. For example, FIG. 53C is a cross-sectional view of an exemplary auxiliary coil 162 with a marker band 920 as disposed within an embodiment of the ACDS 900 and viewed along line DD. In one example, the marker band 920 comprises a platinum-iridium alloy and is approximately 0.006 inches in diameter, 0.010 inches thick, and approximately 0.068 inches in length.

[0214] The marker band 920 is held in place at least in part by a PTFE shrink wrap sheath 932. In other embodiments, the marker band 920 may be defined by a tubular configuration that receives and engages an exterior surface of a wire, catheter, or deployment system.

[0215] Placing the expandable body into a deliverable configuration To facilitate advancement of the expandable body through the vasculature, the expandable body 100, 140, 150, or 170A-H can be compressed into various shapes and sizes. Optionally, this compression can include various shapes and patterns of folding or pleating. For example, one or more pleats can be made in the expandable body 100, 140, 150, or 170A-H, and the pleats can then be rolled into a cylindrical shape. Alternatively, the expandable body 100, 140, 150, or 170A-H can be flattened into a plane and then rolled into a cylindrical shape. Alternatively, the expandable body 100, 140, 150, or 170A-H can be compressed into a compact spherical shape. Additionally, a portion of the expandable body 100, 140, 150, or 170A-H can be twisted during compression. In certain embodiments, the expandable body may be compressed around a delivery catheter 300 as in FIG. 14A. In other examples, the expandable body may be compressed around an occluder 404 as in FIG. 10B. In other embodiments, the expandable body may be compressed around a guidewire, including embodiments of medical devices having a single lumen delivery catheter, where the single lumen is used both to deliver fluid to the central cavity of the expandable body for inflation or expansion, and to receive a guidewire or guidance member. In other embodiments, the expandable body 100, 140, 150, or 170A-H may be compressed on itself without a central catheter, occluder, or guidewire.

[0216] In another embodiment shown in Figure 32G, the delivery catheter shaft 3402 may have a pressure relief 3403 at its proximal end in communication with a hub 3408. This pressure relief prevents kinking of the delivery catheter shaft 3402, as well as the guidewire catheter shaft 160 inserted therein, at their proximal ends. This arrangement is suitable for use with a variety of delivery catheter embodiments including single, dual, and triple lumen designs and a variety of methods of separation including mechanical and electrolytic.

[0217] In FIG. 19A, the expandable body 100, 140, 150, or 170A-H is pleated, folded, and wrapped around a cylindrical member 304 of a delivery catheter 300. Such a hollow cylindrical member may include a bridging catheter similar to bridging catheter 160. Such an embodiment may further include compression of the folded and wrapped expandable body against a delivery catheter. In FIG. 19B, the expandable body 100, 140, 150, or 170A-H is pleated and wrapped without being wrapped around a hollow cylindrical member or a delivery catheter. In other embodiments, the expandable body 100, 140, 150, or 170A-H is folded into pleats and then the pleats of the folded expandable body are wrapped around an obturator, removable wire, guidewire, or guidance member 304 as shown in FIG. 19C. Such embodiments may further include compression of the folded and rolled expandable body against the obturator, removable wire, guidewire, or guidance member 304. In other embodiments, the expandable body 100, 140, 150, or 170A-H is folded into pleats and then the pleated folds are rolled into a generally cylindrical shape without a removable wire, obturator, guidewire, guidance member, or catheter acting as a central fixation point, as shown in FIG.

[0218] In various embodiments, the expandable body 100, 140, 150, or 170A-H is attached to the delivery catheter 300, 400, then the pleats are formed, and then the pleated folds are rolled and compressed onto the delivery catheter 300, occluder 404, or guidewire. In other embodiments, the expandable body 100, 140, 150, or 170A-H is first folded to form pleats, then attached to the delivery catheter 300, 400, and then the pleated folds are rolled and compressed onto the outer surface of the delivery catheter 300, occluder 404, or guidewire. In other embodiments, the expandable body 100, 140, 150, or 170A-H may be folded and compressed into various shapes in a manner similar to the Japanese art of origami.

[0219] Expandable body 100, 140, 150, or 170A-H may be folded to form one or more pleats that may be further folded, rolled, and compressed similar to the folding of a non-compliant angioplasty expandable body. In various other embodiments, the pleated expandable body is folded and compressed to fit over the end of a flexible guidewire and travel within a hollow cylindrical member of an independent catheter. Expandable body 100, 140, 150, or 170A-H may be folded and compressed using any suitable arrangement and method. When in the delivery configuration, it is desirable for the surface of expandable body 100, 140, 150, or 170A-H to be smooth. In certain embodiments, it is desirable for the folding of expandable body 100, 140, 150, or 170A-H to result in a uniform fold.

[0220] In various embodiments, the expandable body 100, 140, 150, or 170A-H may be filled with a lubricating fluid prior to folding, rolling, and compressing to reduce friction, reduce the risk of damage to the body and surrounding tissue, and minimize the profile of the compressed device. The lubricating fluid is preferably biocompatible and hemocompatible.

[0221] Expandable body extension To expand or inflate the expandable body 100, 140, 150, or 170A-H, the central void or space 108 of the expandable body 100, 140, 150, or 170A-H may be filled with a fluid or gel, or a combination thereof, or a solid (i.e., a solid, a lattice, granular particles, or a combination thereof). The terms expand, inflate, and their shapes may be used interchangeably to refer to the action of changing the expandable body from a delivery or deliverable configuration to an expanded or at least partially expanded configuration. A liquid medium is a substance with particles that move easily without separating the mass and change their relative positions. Liquid media that may be used to expand the expandable body 100, 140, 150, or 170A-H include liquids, gases, gels, and combinations thereof. By way of non-limiting example, the liquid medium may be water, a saline solution, an x-ray contrast solution, or a mixture thereof. In one embodiment, the liquid medium may further comprise a solution or suspension of a drug, a pharmacologically active molecule, or a pharmaceutical formulation.

[0222] In various embodiments, the shape and structure of the expandable body 100, 140, 150, or 170A-H, including the multi-layer structure, allows the expandable body to maintain an expanded or expanded configuration without the use of any support structures not derived from the patient. For example, the liquid medium used to expand the expandable body 100, 140, 150, or 170A-H, and optionally blood from the patient, fills the interior void 108 and maintains the ballstent, blockstent, or expandable body in the expanded configuration. In addition, patient-derived support structures, including but not limited to thrombus and tissue ingrowth, may support and maintain the structural integrity of the expandable body 100, 140, 150, or 170A-H during expansion.

[0223] 17A-B, in one embodiment, expandable body 100, 140, 150, or 170A-H may be used to seal a saccular aneurysm 700 located near the junction of blood vessels 1202 and 1203. As shown, expandable body 100, 140, 150, or 170A-H may be positioned and inflated by delivery catheter 352A with a coil or auxiliary coil introduced through delivery catheter 352A and into the aneurysm by way of a path through the expanded expandable body to seal the opening 703 of the saccular aneurysm 700. Coil or auxiliary coil 162 abuts the walls of saccular aneurysm 700 (including the walls facing the openings from parent vessels 1202 and 1203 to the aneurysm 703) as well as the exterior of expandable body 100, 140, 150, or 170A-H. Here, the coil 162 exerts a force on the expandable body towards the opening 703 to press the expandable body against the opening as shown by 705. As a result, the expandable body 100, 140, 150, or 170A-H prevents blood flow into the aneurysm as shown at 706. In one embodiment, the expandable body 100, 140, 150, or 170A-H may be fully expanded prior to the introduction of the auxiliary coil 162. In other embodiments, the auxiliary coil 162 may be at least partially introduced prior to the expansion of the expandable body 100, 140, 150, or 170A-H. In still other embodiments, the expansion of the expandable body 100, 140, 150, or 170A-H and the introduction of the auxiliary coil 162 may occur simultaneously or in an alternative incremental manner. In certain embodiments, after inflation or expansion of the expandable body 100, 140, 150, or 170A-H and insertion of the coil or auxiliary coil 162, the expandable body 100, 140, 150, or 170A-H is separated from the delivery catheter 352A by an electrolysis that corrodes a portion of the proximal neck 250, including the exposed stainless steel ring-shaped region.

[0224] In one embodiment, multiple coils or auxiliary coil(s) 162 may be disposed within the saccular aneurysm 700. As shown in FIG. 17C, in one embodiment, one or more coils or auxiliary coils 162 are disposed within the lumen, void, or cavity of the aneurysm, while other portions of the coils are disposed within the voids of the expandable body 100, 140, 150, or 170A-H. For example, after inflation or expansion of the expandable body, the auxiliary coil delivery catheter 352B may be inserted completely through the delivery catheter 352A, through the expandable body 100, 140, 150, or 170A-H, into the lumen of the saccular aneurysm 700, and the auxiliary coil 162 may be inserted into the unfilled portion of the saccular aneurysm 700. The coil delivery catheter 352B is then removed so that its distal end is located within the expandable body 100, 140, 150, or 170A-H, and the auxiliary coil 162 or other auxiliary coil remnants are placed with the expandable body. The placement of the auxiliary coil 162 both internal and external to the expandable body 100, 140, 150, or 170A-H may serve to stabilize and maintain a portion of the expandable body within the saccular aneurysm 700.

[0225] In other embodiments, the auxiliary coil 162 may be magnetic such that multiple ferromagnetic auxiliary coils may be positioned to stabilize the expandable body 100, 140, 150, or 170A-H within the aneurysm with the magnetic force of the coils. For example, as shown in FIG. 17D, a first magnetic auxiliary coil 162A may be positioned within the expanded expandable body 100, 140, 150, or 170A-H as previously described. The magnetic coil may include a nitinol or stainless steel coil coated with magnetic nanoparticles (MNPs) or the magnetic coil may be a polymer coil with MNPs incorporated therein. The MNPs may include ions, nickel, or cobalt coated with arginine-glycine-asparagine (RGD) peptide, fibronectin, or dextran, or combinations thereof. One or more other ferromagnetic auxiliary coils 162B are then positioned within the neck or opening 703 of the saccular aneurysm 700. The ferromagnetic coils may include magnetic stainless steel alloys, including 410 series, 416 series, 420 series, and 440 series stainless steel. The auxiliary coils 162B fill and occlude any remaining space in the neck or opening 703 after deployment of the expandable body 100, 140, 150, or 170A-H. In one embodiment, the auxiliary coils 162A-B are attracted to and contact the exterior surface of the expandable body 100, 140, 150, or 170A-H. In other embodiments, the auxiliary coils 162A-B are attracted to each other through the walls of the expandable body 100, 140, 150, or 170A-H. The design of the magnetic and ferromagnetic coils may be optimized for safety and compatibility with a magnetic resonance (MR) environment.

[0226] Various methods and devices can be used to deliver the auxiliary coil 162. The auxiliary coil can be either a pushable or detachable type. When the auxiliary coil 162 is a pushable type, in one embodiment, it is removed from the auxiliary coil delivery catheter 352B by injecting a fluid. As shown in FIG. 17O, one embodiment of the auxiliary coil delivery catheter 352B features a radiopaque spot or marker 355 at its distal end as shown. The marker 355 is for enhancing fluoroscopic visibility of the catheter tip during coil placement. The marker includes various radiopaque materials including barium, or metals such as gold, platinum, iridium, tantalum, or stainless steel. The shape of the marker can be configured as a band, spot, or line. In one aspect, the radiopaque material can be in the form of a radiopaque liquid or particulates mixed into the polymer melt upon extrusion of the delivery catheter 352B.

[0227] If the auxiliary coil 162 is of a detachable type, it is inserted into the distal end of the auxiliary coil delivery catheter 352B and detached by way of an electrolysis system 3419 (as shown in FIG. 17P) or an electric heating system 3421 (as shown in FIG. 17Q). The electric heating system 3421 incorporates an electrical heating circuit 550 that melts a thermoplastic link 530 between the auxiliary coil delivery catheter 352B and a ring 540 on the proximal end of the auxiliary coil 162.

[0228] In various other embodiments, the shape of the expanded expandable body 100, 140, 150, or 170A-H is maintained by placing a solid material or support structure into the central void or cavity 108. Examples of this solid material include metallic or polymeric coils or wires, metallic or polymeric solid support structures, bioabsorbable materials, radially expandable materials, beads, particles, granules, spheres, microspheres, or sponges. In certain embodiments, these solid materials can be further used to aid in the expansion of the expandable body 100, 140, 150, or 170A-H. In other embodiments, these solid materials are added after expansion. As shown in FIG. 17E, in one embodiment, a saccular aneurysm 700 in a patient's blood vessel 1202 is filled with a ballstent 100 comprising at least one coil or expansion wire 1204. In one aspect, the expandable body 100, 140, 150, or 170A-H may be expanded only by the coil or expansion coil 1204. In other aspects, the expandable body 100, 140, 150, or 170A-H may be expanded by a liquid medium, or conversely, a solid material may be added later to provide support to maintain the expanded shape of the expandable body. Other suitable biocompatible solid materials may be used as well. The solid filler member may act as a lattice to ensure the structural integrity of the expandable body 100, 140, 150, or 170A-H. For example, the coil 1204 may promote the structural integrity of the expandable body 100, 140, 150, or 170A-H and reduce compression of the expandable body. In one embodiment, the solid material may be designed and manufactured to match a particular size or shape of the expandable body 100, 140, 150, or 170A-H and may be encapsulated as part of a medical device for use with the encapsulated expandable body.

[0229] Detaching the expandable body from the delivery device using mechanical methods The expandable body 100, 140, 150, or 170A-H may be attached or engaged to the delivery catheter 306 or 1000 by a friction fit, by bonding of components, or by application of pressure from a valve, clamp, ring, elastomeric sleeve or wrap, or compression balloon. Various methods and devices may be used to detach the expanded expandable body 100, 140, 150, or 170A-H from the delivery catheter 306 or 1000.

[0230] In various embodiments of mechanically attaching the expandable body 150 to the delivery catheter 306, a soft, thin-walled elastomeric sleeve 710 may be used, as shown in FIGS. 21C-E. The elastomeric sleeve connects the proximal nosecone 362B to the distal portion of the delivery catheter 306. At its distal end, the elastomeric sleeve is compressed between the outer proximal nosecone 585 and the proximal neck 116 of the expandable body. At its proximal end, the elastomeric sleeve slides over the delivery catheter with a friction fit. Upon application of axial tension to the delivery catheter, the expandable body separates from the delivery catheter as the elastomeric sleeve slides freely. The elastomeric sleeve may be coupled either to the proximal neck (which remains with the expandable body after separation) or to the delivery catheter (which remains with the delivery catheter after separation).

[0231] In various embodiments, the elastomeric sleeve 710 may comprise polyurethane having a wall thickness of about 0.005-0.015 inches and a durometer ranging from about Shore 80A to about Shore 72D. The inner diameter of the elastomeric sleeve may be reduced for higher separation force requirements or enlarged for lower separation force requirements. The elastomeric sleeve may include longitudinal reinforcement on the exterior surface to increase strength and prevent axial stretching during separation.

[0232] In the case of mechanical detachment, a separate detachment catheter 610 may be employed to prevent axial movement of the expandable body 100, 140, 150, or 170A-H while the delivery catheter 306 or 1000 is removed, as shown in Figures 3F, 9B, and 21F. The detachment catheter 610 is a rigid hollow shaft adjacent to the proximal nosecone 362B and sized to slide over the annular gap between the two catheters which serves as a lumen for the delivery catheter 306 or 1000 and the injection of X-ray contrast media.

[0233] In various embodiments shown in FIGS. 21G-H, the separation catheter 610 is optimized for high lateral flexibility (enabling placement through tortuous vasculature) and high axial stiffness (enabling transmission of axial forces for mechanical separation of the expandable body 150 from the delivery catheter 306). The wall thickness of the catheter may taper from its proximal to distal end. Lamellar designs may be used including extruded polymers and metal reinforcement. The outer layer 610A comprises a polymer such as Pebax with a durometer ranging from about 55 Shore D to about 72 Shore D to add axial stiffness, with a preferred embodiment using Pebax with a 72 Shore D durometer. The middle layer 610B comprises a flattened braid or stainless steel or Nitinol round coil wire to add torsional and bending stiffness. The inner layer 160C comprises a lubricious polymer such as PTFE or a polyimide / PTFE composite (e.g., PD-Slick™ by International Wire Group) to reduce friction between the separation catheter and the delivery catheter 306. A fourth layer 610D comprises a polymer, such as polyimide, located between the inner and middle layers that may also be used to provide additional axial stiffness. In some embodiments, all or a portion of the inner and outer surfaces of the detachment catheter 610 may be further coated with a hydrophilic or lubricious coating.

[0234] 21I-J, the distal portion of the separation catheter 610 may include a flared end 615 with or without a radiopaque marker band 620. The flared end is sized to abut the proximal hub 362B without abutting the wall 102 of the expandable body 150. The radiopaque marker band is believed to enhance fluoroscopic visibility during the separation process.

[0235] In other embodiments, an electrothermal process can be used to separate the ballstent, blockstent, or expandable body 100 or 140. As can be seen from the configuration shown in FIG. 17Q, the electrical circuit 550 melts the thermoplastic link 530 between the two portions. In this application, the device delivery catheter 400 may take the place of the auxiliary coil delivery catheter 352B, and the proximal hub 362B may take the place of the auxiliary coil 162.

[0236] Electrochemical Detachment of Expandable Body and Delivery Device The expandable body 100, 140, 150, or 170A-H may be attached or engaged to the delivery catheter 306 or 1000 using adhesives or glues, by welding or brazing, by connecting or bonding components, or by application of pressure from clamps, rings, elastomeric sleeves or wraps, or compression balloons. Various methods and devices may be used to detach the expanded expandable body 100, 140, 150, or 170A-H from the delivery catheter 306 or 1000.

[0237] The expandable body 100, 140, 150, or 170A-H may be separated or decoupled from the delivery catheter 306 or 1000 by electrolysis. When electrolysis is used, a constant current, a constant voltage, or a square wave potential may be used. Detachment of the expandable body 100, 140, 150, or 170A-H from the delivery catheter may be performed using a medical device or system with one, two, or three electrical conductors as shown in FIG. 23B-F. In one embodiment, the conductor arrangement 1010 includes three conductors incorporated into or carried by the delivery catheter 1000. In an alternative embodiment of the three conductor arrangement, two conductors are incorporated into or carried by the delivery catheter 1000, and the third conductor is configured to make electrical contact with the patient in other ways, such as with an electrode patch or electrode needle. Similarly, one conductor may be incorporated into or carried by the delivery catheter 1000 and two conductors configured to make electrical contact with the patient in other ways, such as with an electrode patch such as patch 3106 shown in FIG. 23A or an electrode needle. In a two conductor arrangement 1008, two conductors are incorporated into or carried by the delivery catheter 1000. Alternatively, one conductor may be incorporated into or carried by the delivery catheter 1000 and one conductor configured to make electrical contact with the patient in other ways, such as with an electrode patch 3106 or an electrode needle as shown in FIG. 23A. As shown in FIG. 23F, another conductor arrangement 1007 includes a single conductor arrangement in which a single conductor is incorporated into or carried by the delivery catheter 1000.

[0238] The medical device or system may further comprise a termination such as an electrode at the distal end of the conductor, including a termination that is a tubular or ring-shaped cathode ring 1028. In other embodiments, the termination is an exposed stainless steel ring-shaped segment at the proximal neck of the expandable body, such segment functioning as an anode.

[0239] A two conductor arrangement may be used to perform galvanostatic electrolysis, with one conductor electrically connected to the anode and one conductor electrically connected to the cathode, as shown in FIG. 23G. A variety of three conductor arrangements may be used to perform potentiostatic electrolysis or electrolysis using a square wave potential, with one conductor electrically connected to the anode, one conductor electrically connected to the cathode, and a third conductor electrically connected to a reference electrode. In any of these arrangements, the electrical conductors or electrodes may be constructed from any biocompatible conductive material, including platinum, stainless steel, gold, or silver, and alloys thereof. In one embodiment, the electrical conductors or electrodes may include a platinum-iridium alloy.

[0240] When using the two electrical conductor arrangement 1008 to perform galvanostatic electrolysis, there is little control over the potential at the anode or working electrode 1014. Thus, the potential at the working electrode 1014 and anode site or portion 3102 is increased until the potential or current to the working electrode, or anode, is sufficient to cause oxidation of ions in the bloodstream near the working electrode or anode. For example, the current may break down H2O molecules in the bloodstream to create H+ ions and negative O2 molecules. In one embodiment, the O2 molecules can then bind to the exposed gold at the working electrode, or anode, of the gold expandable body 100, 140, 150, or 170A-H, breaking down the exposed gold strips, thereby allowing separation of the expandable body and the delivery catheter.

[0241] In one embodiment, the polymer coating on the expandable body 100, 140, 150, or 170A-H may be an electrical insulator or dielectric material that prevents or impedes H+ ions and O2 molecules from reacting with the coated portion of the expandable body. In another embodiment, electrolysis may occur at the exposed stainless steel ring strip of the anode portion 3102, resulting in dissolution of the exposed stainless steel at the neck of the expandable body where the main body portion comprises gold, thereby allowing separation of the expandable body and the delivery catheter. In one embodiment, the polymer coating on the expandable body 100, 140, 150, or 170A-H may be an electrical insulator or dielectric material that prevents or impedes electrolysis of the coated portion of the expandable body, enhancing the effect of electrolysis at the stainless steel anode portion 3102. One such polymer coating may comprise a thiol that binds to the gold surface via a strong sulfur-gold interaction, which renders the surface hydrophobic and blocks electron transfer. Alternatively, a hydrophilic surface may be obtained by modifying thiol molecules with carboxyl groups at their termini. This coating may be applied by immersion in an alkaline thiol solution containing long (e.g. C18) alkyl chains that form self-assembled monolayers (SAMs) on the gold surface. Alternatively, thiol-containing proteins such as serum albumin may spontaneously form SAMs on the gold surface during electrolysis.

[0242] In one embodiment, a biocompatible gel coating may be applied to the anode 3102 or 3302, or to both the anode and cathode 1028 or 3106, as may be depicted in Figures 23A, 23G, 30A, and 30C-F. The gel prevents contamination of the anode and cathode by protein deposition, thus improving the effectiveness of the electrolysis. Aqueous gels such as polyethylene glycol (PEG) (e.g., Dow Carbowax 600NF) or gelatin (>20% w / v) may be used.

[0243] In one embodiment, a constant current of approximately 0.01-5.0 mA is provided between the anode site 3102 or working electrode and the cathode or ground electrode 3106 which electrically engages an electrode patch 3106 on the patient's skin or a needle within the patient which serves as the cathode for the electrolysis system or process. In another embodiment, the cathode or ground electrode is mounted on the delivery catheter 300 as shown by 1028 in FIG. 23G, which comprises the shape of a conductive cathode ring or tube. Another embodiment of a two electrical conductor arrangement is shown in FIG. 23H-I. In this embodiment, the proximal end 1018 of the thermosetting polymer segment 1020 is bonded to the distal end 1022 of the catheter 1000, while the distal end 1024 of the thermosetting polymer segment is bonded to a metallic ring 3208 formed in the neck 116 or 3208 of the expandable body 100, 140, 150, or 170A-H. The anode region 3102 is present at the neck 116 of the expandable body 100, 140, 150, or 170A-H. As shown in FIG. 23H, the conductor wire 1014 is embedded within the polymer segment 1020 and is bonded to the neck 116 or 3208 of the expandable body 100, 140, 150, or 170A-H, providing an electrical connection to the ring-shaped anode region 3102 via the working electrode 1014. In one embodiment, the conductor wire may be bonded directly to the anode region 3102. In some embodiments, the conductor wire 1014 may be bonded to the neck 116 or 3208 of the expandable body 100, 140, 150, or 170A-H using silver glue or any other suitable glue. In other embodiments, the conductor wire 1014 may be welded to the neck 116 or 3208 of the expandable body 100, 140, 150, or 170A-H, including by laser welding.

[0244] 23H, a cathode, ground electrode 1028 is mounted on the delivery catheter 1000. In addition, a conductor wire 1016 is embedded within the wall of the delivery catheter and coupled to the cathode or ground electrode 1028, providing an electrical connection to the ring-shaped cathode or ground electrode 1028. In one embodiment, the conductor wire may be directly coupled to the cathode ring 1028. In some embodiments, the conductor wire 1016 may be coupled to the cathode ring 1028 using silver glue or any other suitable adhesive. In other embodiments, the conductor wire 1016 may be welded to the cathode ring 1028, including laser welding.

[0245] In other embodiments, a three electrical conductor arrangement may be used to provide better control and selectivity in the potential of the anode site 3102. In addition to the working electrode 1014 and ground electrode 1016, the three electrical conductor arrangement includes a reference electrode (not shown) and a potentiostat (not shown) that are used to monitor and control the potential of the working electrode 1014 relative to the reference electrode. In various embodiments, the reference electrode is preferably made from platinum, silver, or silver chloride. By way of example and not limitation, the three electrical conductor arrangement may be used to isolate the expandable body 100, 140, 150, or 170A-H using a constant current, a constant voltage, or an alternating square wave potential voltage. The working electrode 1014 is adjusted based on a comparison of the voltage of the anode site 3102 and the voltage of the reference electrode via the voltage of the working electrode 1014. The reference electrode may be supported on a delivery catheter in some embodiments, and may be configured to make electrical contact with the patient in other ways, such as with an electrode patch or electrode needle in other embodiments. In one embodiment, the potentiostat is configured to provide a voltage in the range of approximately +0.5 to +1.5 V at the working electrode 1014 relative to the reference electrode.

[0246] In various embodiments, the electrical current flows from a cathode ring 1028 supported on the delivery catheter 1000 to a location external to the patient's body by a conductor wire 1016 embedded within the wall of the delivery catheter. The conductor wire 1016 can also simultaneously provide structural reinforcement to the wall of the delivery catheter 1000.

[0247] In other embodiments, the expandable body 100, 140, 150, or 170A-H and the delivery catheter 300 may be connected by one or more non-insulated welds 316, brazing, or bonding 318 as shown in FIG. 23A, including embodiments in which the connection is between the proximal neck 116 and the distal end of the delivery catheter 304 or 306. An electrical conductor 320, which may be in the form of a wire or cable that relies on the electrically insulating material surrounding the catheter wall and / or a dedicated electrically insulating jacket of the electrical conductor for electrical insulation, extends along the length of the delivery catheter from the proximal end of the delivery catheter 300 to the distal end of the delivery catheter. The proximal end of the electrical conductor 320 electrically couples to a power source or current supply 3100 outside the patient's body. The power source 3100 is further in electrical communication with a needle or electrode patch 3106 on the patient's skin that serves as the cathode for the electrolysis process. The distal end of the electrical conductor 320 is coupled to a proximal portion of the expandable body 100, 140, 150, or 170A-H, which further couples to a distal portion of the delivery catheter. In this embodiment, the neck of the expandable body 100, 140, 150, or 170A-H serves as the anode site 3102 for electrolysis. In this embodiment, the electrolysis electrical conductor 320 is not electrically insulating and electrically couples with the portion 3102 of the expandable body that is not coupled to the delivery catheter (i.e., the anode site). In various embodiments, the electrolysis electrical conductor 320 can be within the wall of the delivery catheter 300, along the exterior surface of the delivery catheter, or within the lumen of the delivery catheter, as shown in FIG. 23A.

[0248] In some embodiments, the electrical conductor 320 is insulated as shown in FIG 23A, and the proximal anodic portion 3102 of the expandable body 100, 140, 150, or 170A-H, including the portion of the proximal neck similar to the separation site 3302 as shown in FIG 30A-F, is not insulated. In some embodiments, the remainder of the expandable body 100, 140, 150, or 170A-H and 116, including the electrical conductor 320 and the remainder of the neck, is insulated, while the proximal anodic portion 3102 of the expandable body, including the portion of the proximal neck in some embodiments, is not insulated. In some embodiments, the neck 116 of the expandable body 100, 140, 150, or 170A-H is made of a metal that can be readily subjected to electrolysis (such as stainless steel) and the remainder of the expandable body is made of a metal that cannot be readily subjected to electrolysis, such as gold or platinum. For this embodiment, the gold or platinum portions of expandable body 100, 140, 150, or 170A-H may not need to be insulated. A current or charge is applied to electrical conductor 320 after expandable body 100, 140, 150, or 170A-H is expanded. The current is applied in an amount and for a time sufficient to degrade at least a portion of non-insulated anode portion 3102 of expandable body 100, 140, 150, or 170A-H, allowing the delivery catheter to be detached from the expandable body, leaving the expanded expandable body in place at the desired location while delivery catheter 300 is removed.

[0249] In other embodiments, electrical current is applied to electrical conductor 320 after expandable body 100, 140, 150, or 170A-H has expanded. The electrical current is applied in an amount and for a time sufficient to break down at least a portion of the weld or braze between expandable body 100, 140, 150, or 170A-H and delivery catheter 300, and the delivery catheter can be detached from the expandable body, leaving the expanded expandable body in place at the desired location while delivery catheter 300 is removed. In other embodiments, electrical current is applied in an amount and for a time sufficient to break down at least a portion of the main body portion of the expandable body, and the delivery catheter can be detached from the expandable body, leaving the expanded expandable body in place at the desired location while delivery catheter 300 is removed. In one embodiment, the electrical current is direct current (DC), while in other embodiments, the electrical current is alternating current (AC).

[0250] Generally, during galvanostatic electrolysis, gas bubbles formed as a by-product of electrolysis serve to form an insulating barrier at the separation site. The gas bubble barrier in combination with the collection of non-ionic blood components (especially lipids, proteins, and amino acids) at the separation site tends to increase the impedance at the separation site as the rate of electrolysis decreases, and increase the time required for separation. Similarly, blood may begin to clot at the separation site 3302, further impeding the separation process.

[0251] Electrolysis is preferably performed when the expandable body 100, 140, 150, or 170A-H is positioned such that the detachment site 3302 shown in Figures 30A-F is in a constant flow of ionic blood constituents. For example, when the ballstent 100 is positioned to fill an aneurysm, the detachment site 3302 can be positioned such that it protrudes into or near the adjacent parent vessel. While in or near the adjacent parent vessel, the detachment site 3302 is exposed to a constant flow of ionic blood constituents which aids in the electrolysis process to detach the ballstent 100. The constant flow of blood further minimizes the occurrence of blood clotting at the detachment site 3302 during electrolysis, thereby potentially reducing the time required for detachment of the expandable body 100, 140, 150, or 170A-H and delivery catheter, reducing the risk of thromboembolism and stroke when a cerebral aneurysm is treated.

[0252] In another embodiment, the voltage-controlled electrolysis is performed using an alternating square wave potential voltage. By way of example and not limitation, the potential at the anode site 3102 or working electrode 1014 varies from approximately +0.5 to +0.8 V relative to the reference electrode, with a frequency ranging from 0.1 Hz to 10 Hz, as shown in Figures 23H-I. In one aspect, the rate at which the potential at the anode site 3102 or working electrode 1014 is varied may be configured to allow for the removal of oxides that form on the surface of the anode or working electrode and any protein aggregates that may have formed. In this embodiment, the oxides are removed during a low voltage "depassivation" period, while the clumped proteins are removed during a high voltage "passivation or hydrolysis" period. The removal of both oxides and clumped proteins is facilitated by voltage cycling. Thus, the use of an alternating square wave potential voltage or the use of square wave voltage pulses may allow for shorter and more consistent separation times.

[0253] In various embodiments, the voltage range used to perform voltage controlled electrolysis may vary depending on the composition of materials at the separation site 3302 (e.g., anode site 3102) and the reference electrode. For example, if the separation site 3302 is constructed of gold and the reference electrode 1026 is constructed of platinum, then the voltage at the gold anode may vary from approximately +0.6 to +1.4 V versus the reference electrode at approximately 1 Hz. Conversely, the potential at a separation site 3302 constructed of 304 stainless steel may vary from approximately +0.1 to +0.4 V versus the platinum reference electrode at approximately 1 Hz. In one embodiment, the separation site 3302 functioning as the anode site 3102 is 316L stainless steel. In this embodiment, the electrolysis is performed such that the potential at the 316L stainless steel anode varies from approximately +0.7 to +1.2 V versus the platinum reference electrode at approximately 1 Hz. In various embodiments, it is desirable for the lower voltage of the alternating square wave voltage potential to be below the hydrolysis potential of water.

[0254] 51A-C depict another embodiment of an auxiliary coil delivery system (ACDS) 900. In particular, this embodiment of the auxiliary coil delivery system (ACDS) 900 includes an auxiliary coil 162 engaged to a pusher wire 950 by a non-insulated stainless steel segment 922. The stainless steel segment serves as an anode for electrolytic detachment of the auxiliary coil 162. During deployment, the auxiliary coil 162 is advanced through the auxiliary coil catheter 902 as previously described and positioned at the desired location. The pusher wire 950 is advanced until the anode segment 922 is withdrawn from the auxiliary coil catheter 902. Marker bands 920 on the auxiliary coil 162 and the pusher wire 950, respectively, aid in visualization of the anode segment 922 during deployment. In one embodiment, the anode segment 922 is disassembled using the same electrolytic controller and power supply used to detach the expandable bodies 100, 140, 150, or 170A-H. In other embodiments, a decoupling controller and power supply may be coupled to the ACDS 900 to decouple the auxiliary coil 162.

[0255] As shown in FIG. 48, and with reference to FIGS. 23A, 23G-I, 30C-F, and 51A-C, in a preferred embodiment, the same power source 3100 may be used independently to initially control the electrolytic detachment of the hollow metallic expandable body (i.e., ballstent) 100 and the wire coil expandable body (i.e., auxiliary coil) 162. Each expandable body has its own anode; a detachment site 3302 on the outer surface 3302 of the laser etched gold plated stainless steel proximal neck for the ballstent, and a segment of uninsulated stainless steel 922 that connects to a pusher wire 950 for the auxiliary coil. The same cathode is used during the detachment of each expandable body, i.e., the cathode ring 1028 attached to the distal end of the ballstent delivery catheter 1000. This embodiment eliminates the need for an electrode patch 3106 or electrode needle to contact the patient's skin, as is typically required for conventional electrolytic detachment embolic coils, as shown in FIG. 23A.

[0256] In another embodiment, the electrolytic detachment system described above is used in conjunction with a substantially cylindrical blockstent expandable body 150 designed to treat occluded cerebral arteries and veins.

[0257] Detaching the expandable body from the delivery device using other methods By way of non-limiting example, methods of detachment of the expanded expandable body from the delivery device may be broadly categorized as physical, or mechanical, electrical, thermal, chemical, hydraulic, and sonic methods.

[0258] In one embodiment, an electrothermal process can be used to separate the ballstent, blockstent, or expandable body 100 or 140. As can be seen from the configuration shown in Figure 17Q, an electrical circuit 550 melts the thermoplastic link 530 between the two portions.

[0259] Sealing of expandable body after separation from delivery device In one embodiment, the openings 112 and / or 114 of the expanded expandable body 100, 140, 150, or 170A-H, including the openings at the proximal or distal neck, remain open at the end of the procedure. In another embodiment, the openings 112 and / or 114 of the expanded expandable body 100, 140, 150, or 170A-H are closed prior to the end of the procedure. By way of example and not limitation, the openings 112 may be sealed by applying an external force associated with the inflation of the balloon portion 1102 of the balloon catheter 1100 adjacent the expanded expandable body 100, 140, 150, or 170A-H, as shown in FIG. 17E. Alternatively, the openings may be sealed by drawing a loop of flexible material around the exterior of the neck of the expandable body 100, 140, 150, or 170A-H prior to separation of the expanded expandable body and the delivery catheter. In this method, the loop of material may comprise a wire, polymeric thread, filament, string, thread, or snare.

[0260] In various embodiments, one or both of the necks 116 and 118 of the expandable bodies 100, 140, 150, or 170A-H are plugged or sealed after expansion. For example, the necks 116 and 118 may be plugged by expansion of a solid structure sized to be rigidly secured within the neck. This material may be a sponge, coil, or metal cap placed over or within the necks 116 and 118.

[0261] Collapsing and Retracting the Expandable Body In the event that the expandable body 100, 140, 150, or 170A-H is not properly sized or dimensioned for the desired treatment, the expandable body may be intentionally folded and recaptured. In one embodiment where the expandable body 100, 140, 150, or 170A-H is still attached to the delivery device, negative pressure may be generated within the delivery catheter to assist in collapsing the expandable body. In this embodiment, the expandable body 100, 140, 150, or 170A-H may be recollapsed by vacuum pressure alone.

[0262] In other embodiments, additional force is required to collapse expandable body 100, 140, 150, or 170A-H after deployment according to the expandable body's inherently stable shape. Additionally, structural features may be incorporated into expandable body 100, 140, 150, or 170A-H to facilitate the intended collapse. For example, a series of longitudinal grooves may be created in expandable body 100, 140, 150, or 170A-H during the electroforming process to create geometric stress concentrations that facilitate collapse under sufficient vacuum pressure. In other embodiments, the exterior surface of expandable body 100, 140, 150, or 170A-H is coated with a polymer (including thick film polymer), and then the polymer coating is etched (including laser etching) to leave a series of "helpers," channels, or grooves along the exterior surface 110 of the expandable body. The grooves may be formed transversely or longitudinally around the periphery of the expandable body 100, 140, 150, or 170A-H.

[0263] In other embodiments, one or more tools designed to collapse the expandable body 100, 140, 150, or 170A-H may be used. In one example, an elongated tubular folding tool may be used with multiple "fingers" that are outwardly biased or flared. The fingers are folded inward when the folding tool is inserted into the patient. When the folding tool is actuated, the fingers extend radially outward to encircle the expanded expandable body 100, 140, 150, or 170A-H. The folding tool is then removed such that the fingers engage, compress, and contract the expanded expandable body 100, 140, 150, or 170A-H. Negative pressure may also be applied throughout the process to encourage the collapse of the expandable body 100, 140, 150, or 170A-H.

[0264] In one embodiment where expandable body 100, 140, 150, or 170A-H is no longer attached to the delivery catheter, a dedicated retrieval catheter may be used to collapse and capture expandable body 100, 140, 150, or 170A-H.

[0265] Guidance member for use in a medical device with an expandable body - Patents.com As shown in Figs. 15A-F, for an embodiment using a dual lumen catheter, a delivery catheter 300 travels over a guidance member or guidewire 302 to deliver a compressed ballstent 140 into the lumen 701 of a saccular aneurysm 700. Examples of guidance members include a flexible guidewire. The guidewire 302 can comprise metal in the form of a flexible thread, coil, or elongated rod. For example, a basic angiography guidewire consists of a fixed solid metal core covered by a metal spring coil. In other situations, the delivery catheter is advanced over a needle or trocar. The guidewire 302 occupies a lumen within the delivery catheter, which lumen is defined by the tubular portion of the delivery catheter. Once in place, the guidewire 302 can be removed for injection of a fluid medium or for withdrawal.

[0266] As shown in Figures 21A-B, in other embodiments, the delivery catheter of the medical device can be configured with a lumen that can receive a guide catheter 800 as a guidance member. In this configuration, the medical device can be advanced in a triaxial configuration, with the medical device 500 advanced over the guide catheter 800, which is advanced over the guidewire. In certain embodiments, the proximal hub on the guide catheter can be eliminated such that the lumen of the hollow cylindrical member 304 of the delivery catheter 300 of the medical device 500 can receive the guide catheter 800. In certain cases, this embodiment of the medical device can provide better control in the delivery of the compressed expandable body to the aneurysm or target vessel lumen, and better trackability of the expandable body 100, 140, 150, or 170A-H as it is advanced to the desired location. As shown, in one embodiment, the hollow cylindrical member 304 of the delivery catheter 300 is annular and may completely surround the guidance catheter 800, while in other embodiments, the delivery catheter may engage 60%, 70%, 80%, 90% or more of the circumference of the guidance catheter.

[0267] Use of a medical device including an expandable body Advantageously, as illustrated in FIG. 17F, the ballstent 100 may be delivered into the lumen, cavity, or dome 701 of the aneurysm 700, expanded, and then detached from the delivery catheter 300 such that the delivery catheter may be removed while the expanded ballstent remains in place filling a portion, substantially all, or all of the aneurysm lumen in an expanded state. The expanded ballstent 100 generally conforms to the shape of the saccular aneurysm cavity 701 in which it is deployed. The expanded ballstent 100 may further be formed by an external force, such as a physical force applied by an inflated balloon portion 1102 of an adjacent balloon catheter 1100, as shown in FIG. 17F. The ballstent 100 may be deployed with precise placement and formation such that the saccular aneurysm cavity 701 is completely or substantially filled and further sealed with no or a minimal number of ballstents. Here, the ballstent extends into the lumen of the parent vessel 1202 in which the saccular aneurysm is formed.

[0268] In treating saccular aneurysms of various shapes, numerous expanded ballstent shapes are acceptable, including circular, elliptical, and irregular, so long as the shape is generally curved and the expanded ballstent includes a single lobe. Regardless of the configured shape, when the ballstent expands within the cavity 701 of the aneurysm 700, in one embodiment, the ballstent is designed to at least partially conform to the shape of the cavity.

[0269] In one embodiment, the expandable body may be used to treat bifurcation aneurysms located at the intersection of two or more blood vessels. As shown in FIG. 17G, bifurcation aneurysm 600 has a neck or opening 603 that forms a substantially right angle with blood vessels 1202 and 1203. In one aspect, bifurcation aneurysm 600 may be treated with expandable body 170G as shown in FIG. 8T-V, which is a view of the expandable body as proximal region 174G is viewed along first axis 176, as indicated by 185. Expandable body 170G includes proximal region 174G having a generally frustoconical configuration, and distal region 172G having a configuration similar to any one of distal regions 172A-G of expandable body 170A-H shown in FIG. 8A-F and 8U. Expandable body 170G further includes proximal and distal necks 116 and 118, respectively. 17G, the frustoconical configuration of the expandable body 170G allows the expandable body to contact and seal with the vertical surfaces of the blood vessels 1202 and 1203 at the opening 603 of the bifurcation aneurysm 600. The placement of coil or auxiliary coil(s) 162 within and / or outside the expandable body 170G may also function to stabilize and maintain the position of the expandable body 170G within the bifurcation aneurysm 600.

[0270] Research suggests that in certain clinical situations, the presence of intact endothelial cells correlates with the expansion of the lumen of blood vessels and aneurysms. In these circumstances, endothelial cells sense changes in the lumen of the blood vessel or aneurysm and stimulate biological processes that cause changes in extracellular and cellular components in the wall of the blood vessel segment or aneurysm and increased cellular and enzymatic activity associated with the expansion or hypertrophy of the lumen. Research has further found that endothelial cells require blood flow to their luminal surface to remain healthy and capable of growth. Thus, a medical device, system, or method that may reduce or eliminate blood flow to the luminal surface of endothelial cells lining an aneurysm or blood vessel segment, thereby reducing the growth capacity of the endothelial cells, reducing the biochemical signaling from the endothelial cells, and reducing the enzyme activation associated with the expansion or hypertrophy of the blood vessel or aneurysm. This is an important goal in the prevention or treatment of aneurysms. Thus, in certain embodiments, the ballstent 100 fully expands to treat a saccular aneurysm. In addition to the physical nature of the filling and blocking effect of the expanded ballstent within the aneurysm sac, this treatment also reduces the endothelial growth potential in the aneurysm sac. In other embodiments, the ballstent 100 need not be fully expanded to treat a saccular aneurysm, but may successfully seal or partially expand the aneurysm while reducing the endothelial growth potential. In all embodiments, the ballstent remains in an expanded state (partially or fully) after separation from the delivery catheter. Expanded state refers to at least partial expansion of the ballstent 100, such as at least 20%, 50%, 75%, or 90% and up to 100% of the ballstent maximum capacity. In various aspects, the size of the biological space may be determined in any suitable manner. The size and configuration of the expandable body 100, 140, 150, or 170A-H is then selected to optimally fill the space or the desired portion of the space.

[0271] In various embodiments of the "over-the-wire" ballstent medical device 500 as described below in connection with Figures 10B-C and 11A-F, an expandable body 100 or 140 is used to occlude a saccular aneurysm, as shown in Figure 11A. First, a microcatheter 805 and a guide catheter or guide sheath 800 are positioned so that their distal tip is within the opening 703 of the aneurysm, as shown in Figure 11B. The expandable body 100 or 140 on the delivery catheter 400 is then positioned within the aneurysmal sac, lumen, or cavity 701 through the guide catheter 800, as shown in Figure 11C. As shown in Figure 11D, the expandable body is configured as described, but not limited to, in Karl et al. It is expanded to an expanded state using a syringe (not shown) or pump (not shown), such as the Endoflator® by Storz, thereby "arresting" the microcatheter 805 against the aneurysm wall 704. In this embodiment, the expandable body 100 or 140 is sized to have an expanded width or diameter (as measured across an axis extending from the proximal nosecone 362B to the distal nosecone 362A) that is greater than the width of the aneurysm opening 703 from the parent vessel 1202.

[0272] After inflation or expansion, the expandable body 100 or 140 is removed toward the opening 703 of the saccular aneurysm 700, as shown as 702 in FIG. 11E. An X-ray contrast agent may be injected through the guide catheter or guide sheath 800 so that the position of the expanded expandable body 100 or 140 can be assessed using fluoroscopy. A coil or auxiliary coil 162 is then delivered through the incarcerated microcatheter 805 and positioned within the aneurysm sac, lumen, or cavity in the region of the dome 701, as shown in FIG. 11E. The auxiliary coil 162 contacts both the inner surface 704 of the aneurysm wall and the outer surface of the expandable body 100 or 140, including the distal surface of the expandable body. The auxiliary coil 162 exerts a force against the expandable body 100 or 140 to push the expandable body against the opening 703 of the aneurysm. At this point, x-ray contrast may again be injected through the guide catheter 800 so that the position of the auxiliary coil 162 and the expanded expandable body 100 or 140 can be assessed using fluoroscopy.

[0273] The expandable body 100 or 140 is then separated from the delivery catheter 400, and the delivery catheter, guide catheter 800, and microcatheter 805 are removed, as shown in FIGURE 11F. The ballstent expanded body 100 or 140 is left behind within the lumen 701 of the saccular aneurysm 700 in a location that seals the aneurysm entrance 703. Similarly, the auxiliary coil 162 is left behind within the aneurysm lumen in a location that serves to hold the ballstent in place.

[0274] The no-wire embodiment may be particularly well suited for treating peripheral aneurysms in vasculature that is neither peripheral nor tortuous. In either peripheral or tortuous vasculature, the distal tip of the guide catheter 800 may be placed away from, but as close as possible to, the opening 703 of the saccular aneurysm 700. The guidewire 800 may feature a pre-formed distal end to facilitate delivery of the expandable body 100 or 140 through the entrance 703 of the aneurysm, as shown in FIG. 11B.

[0275] As can be seen from the process shown in Figures 11G-K, various embodiments of the over-wire blockstent medical device 500 may be used to occlude a blood vessel 802 depicted in Figure 11G.

[0276] First, the guide catheter or guide sheath 800 is positioned so that its distal tip is just proximal to the targeted area of ​​the vascular lumen to be occluded, as shown in FIGURE 11H. The compressed expandable body 100 on the delivery catheter 400 is then advanced through the guide catheter to the targeted area of ​​the vascular lumen, as shown in FIGURE 11I. At this point, x-ray contrast may be injected through the guide catheter 800 so that the position of the compressed expandable body 100 can be assessed using fluoroscopy.

[0277] Once proper placement of the expandable body 100 within the vessel lumen 804 has been achieved and confirmed, the medical device 500 is then expanded to an expanded state using a syringe (not shown) or a pump (not shown), such as, but not limited to, an Endoflator® by Karl Storz, as shown in Figures 11I-J. The expandable body 100 fills the target area of ​​the lumen and abuts the luminal surface 806 of the vessel. The vessel 802 is now occluded. At this point, an x-ray contrast agent may be injected through the lumen of the guide catheter 800 so that the final position of the expanded expandable body 100 and the extent of vessel occlusion can be assessed using fluoroscopy.

[0278] The process of separation is then performed as shown in Figures 11J-K and 21C. The delivery catheter 300 is removed, leaving the guide catheter 800 in place, while simultaneously holding the distal end of the guide catheter 800 against the proximal nosecone 362B which operates to pull the delivery catheter 300 out of the elastomeric sleeve 710 on the proximal nosecone 362B. Finally, the guide catheter 800 is removed. The blockstent expanded body 100 is left within the lumen 804 of the blood vessel 802 in place to maintain a permanent occlusion.

[0279] As illustrated in Figures 17H-J, the use of ballstent expandable body 150 in conjunction with auxiliary coils 162 follows a different paradigm than typical coiling techniques for occlusion of "wide-neck" saccular aneurysms 700. In one embodiment, the shape of the saccular aneurysm 700 is defined by a neck width (N), a dome height (H), and a dome diameter (D), as shown in Figure 17H. In conventional coiling treatments, wide-neck aneurysms are defined to have a dome height to neck width (H / N) ratio <2. As depicted in Figure 17I, the H / N ratio does not change significantly when comparing an untreated aneurysm 700A to a post-coil treatment aneurysm 700B, as the coils tend to push outward evenly on both the apex 708 and the sidewalls 704 of the aneurysm 700. Furthermore, because the arterial blood pressure has already moved the walls of the aneurysm 704 to their maximum level of expansion, the aneurysmal walls have little elasticity to allow for further expansion. With the ballstent expandable body treatment described herein, a wide-neck aneurysm is defined as having a dome diameter to neck width (D / N) ratio <2. As depicted in FIG. 17J, this ratio changes significantly when comparing an untreated aneurysm 700A to a post-ballstent treated aneurysm 700C because the expanded ballstent acts to push only the sidewalls of the aneurysm 704 outward, thereby pulling the apex of the aneurysm dome 708 downward, i.e., the narrow aneurysm becomes shorter and wider. The ballstent expandable body increases the D / N ratio, thereby improving its fit within the treated wide-neck aneurysm 700C and preventing the device from exiting through the aneurysm neck 703.

[0280] In various embodiments, the auxiliary coil 162 is constructed of Nitinol. In one aspect, the auxiliary coil 162 may be formed from a wire having a diameter in the range of approximately 0.05-0.20 mm. To enhance their lubricity, the Nitinol wires may be further coated with a polymer 161, including but not limited to PTFE, as shown in FIG. 3B. Methods of polymer coating include, but are not limited to, dipping, painting, or application of heat shrink tubing.

[0281] In one embodiment, the coated nitinol wire or fiber of the auxiliary coil 162 may include end caps 163, including polymer end caps, to minimize the possibility of damaging the aneurysmal surface or other blood vessels that the coil traverses, as shown in Figure 3 A. The coating and end caps may also reduce friction when the coil is inserted with an auxiliary coil delivery catheter 352B, as shown in Figure 7.

[0282] In various embodiments, the auxiliary coil 162 may have a diameter in the range of between approximately 0.002-0.012 inches. Preferably, the auxiliary coil 162 may have a diameter in the range of between approximately 0.004-0.008 inches. Similarly, the polymer coating 161 on the auxiliary coil 162 may have a thickness in the range of between approximately 0.001-0.003 inches. Preferably, the polymer coating may have a thickness in the range of between approximately 0.0015-0.002 inches. The coil delivery catheter 352B may have an outer diameter in the range of between approximately 0.014-0.022 inches, preferably an outer diameter in the range of between approximately 0.016-0.020 inches. Similarly, the coil delivery catheter 352B may have an inner diameter in the range of between approximately 0.008-0.016 inches, preferably an inner diameter in the range of between approximately 0.010-0.014 inches.

[0283] As shown in Figures 12C-E, in various embodiments, the auxiliary coil 162 may include structures and features to enhance visibility under fluoroscopic imaging. This is advantageous with respect to embodiments including an auxiliary coil 162 constructed from Nitinol. In one aspect, gold or platinum plating is applied to all or a portion of the auxiliary coil 162. In a second aspect, as shown in Figure 12D, a marker band 510 comprising gold, platinum, iridium, tantalum, or stainless steel is applied near the end of the auxiliary coil 162 and / or to a section along the length of the auxiliary coil 162. In a third aspect, a marker bullet 520 is applied at or near the end of the auxiliary coil 162, as shown in Figure 12E. The marker band 510 or bullet 520 may be secured by adhesive or polymer heat shrink tubing such as PTFE. In another aspect (not shown), the auxiliary coil is formed of a polymer with a radiopaque material mixed into the polymer during manufacture.

[0284] In one embodiment, the auxiliary coil can be delivered to the aneurysm to fill the void within the aneurysm not occupied by the expandable body. In another embodiment, the auxiliary coil is preformed into a sphere having dimensions X1×Y1 as shown in FIG. 12A or into an oval having dimensions X1×Y1 or X2×Y2 as shown in FIG. 12B. As an example, the auxiliary coil 162 may be formed into a ball having a diameter of approximately 8 mm or a spheroid having dimensions of approximately 8 mm×4 mm. In another example, the auxiliary coil may be configured into a three-dimensional structure having a volume between approximately 50 mm3 and 300 mm3.

[0285] 49A-E illustrate an embodiment of an expandable body 190 with one embodiment of an auxiliary coil catheter 902 extending therethrough for placement of an auxiliary coil 162. For purposes of illustration, the expandable body 190 is shown in an expanded configuration. The auxiliary coil catheter 902 may, however, be advanced and placed through an unexpanded, and optionally folded or pleated, expandable body 100.

[0286] After delivery of the expandable body 190 and auxiliary coil catheter 902 to the desired placement site, the auxiliary coil 162 is pulled out of the auxiliary coil catheter 902 by a push wire 950 that is inserted into the proximal end of the auxiliary coil catheter. The push wire 950 contacts the proximal end of the auxiliary coil 162 and pushes the auxiliary coil out of the auxiliary coil catheter 902, as shown in Figures 49D-E. In one embodiment, the push wire 950 is stainless steel coated with PTFE. In other embodiments, any suitable combination of biocompatible metals and coatings may be used.

[0287] According to one embodiment, as shown, the distal end 904 of the auxiliary coil catheter 902 includes a marker band 920 to aid in visualization during placement of the auxiliary coil. In various aspects, the marker band 920 may be composed of a radiopaque material, including but not limited to platinum, iridium, barium, gold, tantalum, stainless steel, and alloys thereof. In one particular example, the marker band 920 is a platinum-iridium alloy. The marker band 920 may be incorporated into the shaft of the auxiliary coil catheter 902 or may be engaged to the distal end of the auxiliary coil catheter.

[0288] In other embodiments, the auxiliary coil 162 may include an incorporated radiopaque marker wire 930, as shown in and described in conjunction with Figures 52A-B. The marker may include a variety of radiopaque materials, including metals such as platinum, iridium, barium, gold, tantalum, stainless steel, and alloys thereof.

[0289] Medical device with expandable body and use for treating saccular aneurysms in human patients - Patents.com Ballstent expandable body embodiments suitable for use in aneurysm occlusion have been designed for deployment over both 0.014 and 0.018 inch guidewire platforms, as shown in Figures 43A-J. The design features for each embodiment are similar with shapes scaled to match the diameter of the guidewire.

[0290] The unexpanded configuration of the ballstent device is shown in Figures 43A-D. The distal nosecone 362A is attached to the expandable body 150 at its distal neck 118. The proximal nosecone 362B is attached to the unexpanded expandable body 150 at its proximal neck 116. In one embodiment, the electrolysis segment 260 comprises a ring 250 of 302 or 304 series stainless steel that serves as the anode with a laser etched separation site 3302 125 μm wide and 18 μm thick. An insulating coating 264 separates the cathode ring 262 from the anode ring 250. The expandable body 150 is attached onto the delivery catheter 1000 via a bridge catheter 160 constructed of polyimide and a rigid telescopic bridge segment 642 that includes a long telescope 640 constructed of 90% platinum a...

Claims

1. an expandable body configured for permanent implantation within an artery or vein of a patient, a wall defining an exterior surface of the expandable body and an interior surface of the expandable body defining a central cavity of the expandable body; an expandable body including a distal region, a proximal region opposite the distal region, an intermediate region transitioning from the distal region to the proximal region, and a central axis extending proximally to distally between the proximal region and the distal region; 1. A multi-lumen catheter assembly comprising: a delivery catheter having a distal end and a proximal end opposite the distal end, the delivery catheter being coupled to the expandable body so as to be separable from the expandable body and delivering the expandable body; and a separation catheter having a distal end and a proximal end opposite the distal end and disposed outside the delivery catheter, a distal end of the delivery catheter is detachably coupled to a proximal region of the expandable body during delivery of the expandable body, and an inner wall of the delivery catheter defines at least one inner lumen providing fluid communication between the proximal end of the delivery catheter and a central cavity of the expandable body; a multi-lumen catheter assembly, wherein an outer wall of the delivery catheter and an inner wall of the separation catheter define an outer lumen that provides fluid communication between a proximal end of the separation catheter and a region of an artery or vein adjacent the expandable body; Equipped with the expandable body is configured to expand from a deliverable configuration to an expanded configuration; After delivery of the expandable body, the expandable body can be separated from the delivery catheter by retracting the delivery catheter through the separation catheter while holding the separation catheter against the expandable body. Medical systems.

2. The medical system of claim 1 , wherein the expandable body comprises a proximal neck, or a distal neck, or a proximal and a distal neck, protruding from the expandable body.

3. The medical system of claim 2 , wherein the distal end of the delivery catheter is inserted into the proximal neck of the expandable body.

4. The medical system of any one of claims 1 to 3, wherein the expandable body is attached to the delivery catheter by a valve, a clamp, a ring, an elastomeric sleeve, or a wrap.

5. 5. The medical system of claim 1, wherein after the expandable body is expanded to an expanded configuration and the expandable body and the delivery catheter are separated, the pressure inside the expandable body is equal to or less than the pressure outside the expandable body.

6. the expandable body being made of metal; 5. The medical system of claim 1, wherein the expandable body has sufficient strength to expand to an expanded configuration and to maintain itself in the expanded or partially expanded configuration after separation of the expandable body and the delivery catheter within the artery or vein.

7. 7. The medical system of claim 6, wherein the central cavity of the expandable body does not require a support structure comprised of non-patient derived solid or semi-solid materials or components to maintain the expanded or partially expanded configuration after separation of the expandable body and the delivery catheter.

8. 7. The medical system of claim 6, wherein the expandable body retains at least 20% of its maximum volume when in the expanded configuration.

9. 2. The medical system of claim 1, wherein the expandable body is operable to expand from the deliverable configuration to the expanded configuration by injecting a liquid medium into the central cavity of the expandable body at a pressure of up to 6 atmospheres.

10. 2. The medical system of claim 1, wherein the expandable body has a spherical, spheroidal, ellipsoidal, or cardioidal cross-sectional shape along a central axis of the expandable body when in the expanded configuration.

11. The medical system of claim 1 , wherein the wall of the expandable body comprises gold.

12. The medical system of claim 1 , wherein the wall of the expandable body comprises a continuous layer of gold.

13. The medical system of claim 1 , wherein a distal end of the detachment catheter is adapted to contact the proximal region of the expandable body upon detachment of the delivery catheter from the expandable body.

14. the expandable body comprising one or more elastomeric valves; each of the one or more elastomeric valves is incorporated into a nose cone attached to a neck defining an opening in the wall of the expandable body; The medical system of claim 1 .

15. 15. The medical system of claim 14, wherein the one or more elastomeric valves comprise a polymer disc.

16. 15. The medical system of claim 14, wherein the one or more elastomeric valves are comprised of silicone or polyurethane.

17. 15. The medical system of claim 14, wherein the one or more elastomeric valves comprise a disk with a central orifice, the central orifice comprising a circular hole, a slit along a diameter of the disk, or two orthogonal slits along a diameter of the disk.

18. 15. The medical system of claim 14, wherein the one or more elastomeric valves are configured to contact an outer wall of the delivery catheter when the expandable body and the delivery catheter are coupled.

19. 15. The medical system of claim 14, wherein when the expandable body and the delivery catheter are coupled, the one or more elastomeric valves form a seal against the delivery catheter to allow for injection of a liquid medium under pressure into the central cavity of the expandable body.

20. 15. The medical system of claim 14, wherein the one or more elastomeric valves are configured to close the neck of the nosecone in which the one or more elastomeric valves are incorporated when the expandable body is separated from the delivery catheter.

21. The medical system of claim 1, wherein the wall of the expandable body has a wall thickness in the range of 3 to 50 μm.

22. 10. The medical system of claim 1, wherein the wall of the expandable body comprises at least two layers, and at least one of the at least two layers is a metallic layer.

23. 23. The medical system of claim 22, wherein the metal layer comprises gold.

24. The medical system of claim 1 , wherein the expandable body is a hollow structure when the expandable body is in the expanded configuration.

25. 10. The medical system of claim 1, wherein the expandable body includes an overall shape that has a rectangular cross-sectional shape along a central axis of the expandable body when the expandable body is in an expanded configuration.

26. The medical system of claim 1 , wherein the intermediate region of the expandable body comprises an overall shape that is cylindrical when the expandable body is in an expanded configuration.

27. 27. The medical system of claim 25 or 26, wherein the proximal and distal regions of the expandable body are hemispherical or conical in shape when the expandable body is in an expanded configuration.

28. The medical system of claim 1 , wherein the expandable body has an expanded length in the range of 2 mm to 60 mm when the expandable body is in the expanded configuration.

29. 10. The medical system of claim 1, incorporating a radiopaque marker band to identify the location where separation of the expandable body and the delivery catheter is designed to occur.

30. the delivery catheter is capable of delivering a solid or semi-solid material to the central cavity of the expandable body via the inner lumen; 30. The medical system of claim 29, wherein the solid or semi-solid material comprises a metal coil.

31. the delivery catheter is capable of delivering a solid or semi-solid material to the central cavity of the expandable body via the inner lumen; 31. The medical system of claim 29 or 30, wherein the solid or semi-solid material is a second expandable body configured to pass through the inner lumen in a compressed, folded, bundled, or elongated configuration.

32. 32. The medical system of claim 31, wherein the second expandable body comprises a wire.

33. 33. The medical system of claim 32, wherein the wire comprises a Nitinol wire having shape memory properties.

34. 33. The medical system of claim 32, wherein at least a portion of the wires are formed into a mesh.

35. 33. The medical system of claim 32, wherein at least a portion of the wire comprises platinum or gold.

36. 33. The medical system of claim 32, wherein at least a portion of the wire is coated with a lubricious polymer.

37. 37. The medical system of claim 36, wherein the lubricious polymer is PTFE.

38. The medical system of any one of claims 31 to 37, wherein the second expandable body has one or more markers visible under fluoroscopy.

39. 33. The medical system of claim 32, wherein a portion of the wire is a pusher wire.

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