Ballstent device and methods of use

BALLSTENT DEVICE AND METHOD OF USE

FIELD OF THE PRESENT DISCLOSURE [0001] The present disclosure relates to a medical device comprising a ballstent and a delivery catheter for the treatment of saccular aneurysms of the vascular system. The present disclosure also relates to various forms of ballstents and delivery catheters, and methods of their manufacture. The present disclosure further relates to methods of treating saccular aneurysms using the various medical devices, whereby the ballstent ultimately remains in the saccular aneurysm. Ballstents are rounded, thin-walled expandable metal structures comprised of a single lobe and designed to fill the lumen of a saccular aneurysm. Ballstents are configured for attachment to delivery catheters, compression, advancement through the vascular system, expansion within lumen of saccular aneurysms, and then separation from delivery catheters. Delivery catheters of various sizes, shapes, materials, and configurations can be used to position a compressed ballstent in a saccular aneurysm and expand the ballstent in the aneurysm by the passage of fluids or solids through the delivery catheter and into the central void or space of the ballstent. Further, the invention relates to components for, and methods of, attaching the ballstent to the delivery catheter, as well as components for, and methods of, separating the expanded ballstent from the delivery catheter, such that the ballstent remains in place in an expanded state within the aneurysm sac while the delivery catheter is removed from the body.

BACKGROUND OF THE PRESENT DISCLOSURE [0002] An aneurysm is an abnormal outward bulging of a blood vessel that can occur anywhere in the body. This bulge weakens the blood vessel wall, making it susceptible to rupture, which results in bleeding or hemorrhage. Aneurysms are common in the arterial circulation of the brain, where they are known as cerebral aneurysms. When cerebral aneurysms rupture, this often leads to a hemorrhagic stroke, and sometimes brain damage and death. Cerebral aneurysms are a common condition, affecting an estimated 2% of the adult population. Approximately 90% of cerebral aneurysms are saccular with a rounded, pouch-like shape. Invasive surgery remains a mainstay in their treatment, with the

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227440/3 surgery involving opening the skull and sealing the aneurysms by placing a small surgical clip on the outside of the neck, thereby limiting blood flow into the aneurysm sac.

[0003] Alternatively, minimally invasive, catheter-based, endovascular treatments have been developed wherein a series of small metal coils are used to fill the aneurysm sac, effectively stabilizing it. In order to treat a blood vessel or aneurysm with coils, a physician inserts a catheter into a lumen of the vascular system and maneuvers the catheter tip into the aneurysm sac. With the catheter tip in position, the physician passes small coils through the catheter into the lumen of the vessel or the cavity of the aneurysm. 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 non-target locations. Second, coils only partially fill the aneurysm sac. The accumulation of thrombus and scar tissue is required to seal the aneurysm, a process that takes weeks to occur and is sometimes incomplete, often resulting in aneurysm recanalization and rupture. Incomplete filling of saccular aneurysms with coils is especially common in the neck region of saccular aneurysms, where coil density can be low and blood flow rates high. Third, numerous coils are usually required to fill the aneurysm, resulting in high costs and long treatment times.

[0004] More recently, traditional tubular stents have been adapted for the treatment of cerebral aneurysms. These stents are placed on delivery devices and positioned in the parent vessel adjacent to the aneurysm. These stents are then expanded in the parent vessel with the delivery device, followed by removal of the delivery device. The expanded metal stent acts to seal the neck of the aneurysm and keep blood flow out of the aneurysm sac in order to promote aneurysm thrombosis. Although effective, the use of these “flow diverting” stents has drawbacks. First, the stents may cover and divert blood flow away from important arterial branches adjacent to the aneurysm, sometimes resulting in ischemia and stroke. Second, the stents are a source of thrombus and intimal hyperplasia formation in the parent vessel, which can result in narrowing in the parent vessel lumen, ischemia, and stroke.

[0005] Therefore, there remains a need for medical devices, systems, and methods for treating saccular aneurysms, including cerebral aneurysms, which result in a more effective and complete sealing of saccular aneurysms that is more durable and permanent. It is further desired to have medical devices, systems, and methods that seal aneurysm sacs more quickly. Finally, it is desired to have medical devices, systems, and

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227440/3 methods that can be performed more easily and in less time, with a lower risk of complications, and at a lower cost, when compared with existing treatments.

[0006] US 2008/0281350 discloses an implantable occlusion device forbridging the neck of an aneurysm comprises a biocompatible matrix. The device is movable between a compressed position prior to implantation and a generally concave or cup-shaped position following implantation. The device may comprise a frame having a plurality of elements. The frame elements have a first pre-deployment position generally parallel to a major axis of the delivery lumen, and a second post-deployment position spread radially from the major axis of the delivery lumen. The biocompatible matrix and/or the frame elements may also form or be manipulated to form a generally concave or cupped shape. The matrix can be porous or semiporous, such as a foam or a reticulated matrix. The occlusion device can be folded, twisted and/or stretched to adopt a narrow profile for loading into a coaxial delivery device and expand in place as it adopts its original shape on release. The device may be released or manipulated to a desired shape to occlude an aneurysm.

SUMMARY OF THE PRESENT DISCLOSURE [0007] The present invention relates to medical devices for the treatment of saccular aneurysms of the vascular system. The medical devices comprise a ballstent, a delivery catheter for delivering and expanding the ballstent, and a component for separating the expanded ballstent and the delivery catheter. The ballstent is a stent-like device with a ball shape. The invention further relates to an expanded ballstent left in the lumen of a saccular aneurysm. Additionally, the invention includes various forms of ballstents, delivery catheters, and components for separation. Further, the invention includes systems and methods relating to the use of the medical devices, as well as kits comprising medical devices and instructions for use. The invention also includes methods of manufacturing ballstents, delivery catheters, and components for separation.

[0008] The walls of ballstents can be formed from a variety of expandable, rigid materials, preferably metals. The metal used to make the wall of a ballstent can be selected from the group consisting of gold, platinum, silver, titanium, vanadium, aluminum, nickel, tantalum, zirconium, chromium, magnesium, niobium, scandium, cobalt, palladium, manganese, molybdenum, alloys thereof, and combinations thereof. Other metals can be used so long as they are safe to use as an implanted medical device, can be formed into thin

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227440/3 walls, and can be expanded from a compressed state and remain expanded in the body, holding their shape under typical conditions. Preferably, the ballstent is made of a ductile metal such as gold, platinum, silver, alloys thereof, and combinations thereof. In a fully expanded form, the ballstent can be configured in a variety of sizes and shapes, depending on the size and shape of the aneurysm to be treated. With a generally rounded form to the metal ballstent, the medical device can be used to treat focal, eccentric, rounded aneurysmal dilations of blood vessels, a condition also known as saccular aneurysms. Available shapes include, but are not limited to, round, oblong, and irregular. Preferably, the round ballstent can have an expanded diameter ranging from about 2 mm to about 20 mm. The oblong ballstent can have an expanded length of between about 2 mm to about 30 mm. The ballstent wall has a width, or thickness ranging from about 3 pm to about 60 pm. Such width allows for compression into a small volume and facilitates passage through blood vessels and catheters. For example, ballstents can be folded and compressed to a diameter small enough to pass through 3Fr, 4Fr, and 5Fr guide catheters or maneuvered through cerebral arteries.

[0009] The expanded shape of the ballstent is designed to completely fill the lumen of a saccular aneurysm. As such, the preferred shape is round, or generally rounded. Also, the expanded ballstent comprises a single lobe to maximize the wall contact between the expanded ballstent and the luminal surface of the aneurysm sac so as to reduce the risk of ballstent migration and reduce the amount of blood that flows between the exterior surface of the ballstent and the inner lining of the saccular aneurysm. For this reason, forms with multiple attached, not proximal, lobes are not preferred. Also for this reason, collapse of an expanded ballstent resulting in decreased wall contact with the inner lining of the aneurysm or decreased filling of the lumen of the aneurysm sac is not preferred.

[0010] The wall of the ballstent can be uniform or variable, with the thickness changing at different locations on the ballstent. In some ballstent embodiments, the wall of the region near the attachment to the delivery catheter is thicker than the main body of the ballstent, while in other embodiments this region is thinner.

[0011] In other embodiments, the wall of the ballstent is porous. This porosity can be uniformly distributed or can be applied only in certain regions, or in a pattern on the surface. In certain embodiments, a ballstent can have a plurality of pores extending through the entire wall.

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227440/3 [0012] In other embodiments, the external surface of the wall of the ballstent contains projections, which in certain instances act to reduce ballstent migration after expansion. These projections may be macroscopic, such as with the hooks or barbs seen on other implanted cardiovascular medical devices such as caval filters. For example, a plurality of projections, such as barbs and hooks, can be located on the exterior layer to anchor the ballstent to the surrounding tissue. In a further embodiment, these projections comprise an expansile metal, such as nitinol. For some embodiments, these projections are microscopic, ranging in length from 0.01 pm to about 57 pm. In other embodiments, these projections are branching and can be made of nitinol or fibers.

[0013] The surface of the ballstent wall can be configured to increase local thrombus formation and tissue growth into the ballstent wall in order to secure the ballstent in place and reduce the risk of ballstent migration. The wall of the ballstent can further be configured to release solutions that can include drugs, pharmacologically active molecules, or pharmacologic compositions, such as those that would increase the formation of local thrombus, stimulate cell proliferation or the production of extracellular matrix, or increase the rate or extent of tissue growth, such as tissue growth into pores, or around projections, of the wall of the ballstent.

[0014] In one embodiment, the ballstent has an exterior layer located on the exterior surface of the wall. The exterior layer may be made from the same materials as the central layer or wall, or can be made of different materials. The exterior layer may be comprised gold, platinum, silver, alloys thereof, or combinations thereof. The exterior layer may also be comprised of polymer, plastic, latex, rubber, an elastomer, fiber material, and combinations thereof. The exterior layer can have a thickness ranging between about 1 pm to about 59 pm.

[0015] In one embodiment, the exterior layer has a porous construction. For embodiments with a porous exterior layer, the exterior layer of the ballstent wall can have a plurality of pores ranging in diameter from about 0.01 pm to about 100 pm. The pores allow tissue to grow into the wall of the ballstent. The pores can be uniformly distributed, or can be applied only in certain regions, or in a pattern on the surface. In another embodiment the exterior layer comprises a plurality of projections. These projections can range in length from about 0.01 pm to about 57 pm. In other embodiments, these projections are branching. The projections allow tissue to grow around portions of the wall

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227440/3 of the ballstent. The projections can be uniformly distributed, or can be applied only in certain regions, or in a pattern on the surface.

[0016] In one embodiment, the porous exterior layer can be configured to release solutions such as drugs, pharmacologically active molecules, pharmacologic compositions, or other compositions that increase the local formation of thrombus, stimulate cell proliferation or extracellular matrix formation, or tissue growth into pores, or around projections, of the ballstent wall. Examples of such substances include thrombin, plateletderived growth factor, Ethiodol®, Sotradecol®, and combinations thereof, and can include both solutions and suspensions. The porous exterior layer can be comprised of any other porous material, including metal, that can hold fluid or solid material, including drugs, pharmacologically active molecules, or pharmacologic compositions, or any material that promotes thrombosis, cell proliferation, extracellular matrix productions or tissue growth.

[0017] Alternatively, the exterior layer can be more smooth, with limited porosity or projections, such as with a polished metal surface. In one embodiment, portions of the exterior layer can be smooth, while other portions can be porous or contain projections. In one embodiment, this surface variation can have a pattern.

[0018] In one embodiment, the ballstent has an interior layer located on the interior surface of the central layer or wall. The interior layer may be made from the same materials as the central layer, or can be made of different materials. The interior layer may be comprised gold, platinum, silver, alloys thereof, or combinations thereof. The interior layer may also be comprised of polymer, plastic, latex, rubber, an elastomer, fiber material, and combinations thereof. The interior layer can have a thickness ranging between about 0.1 pm to about 59 pm. Preferably, the interior layer may be an elastomeric coating that strengthens the wall, reduces the leaking of fluid from the ballstent during expansion, or facilitates folding, compression, or expansion of the ballstent.

[0019] In another embodiment, the ballstent wall may include two or more metal regions joined by a flexible polymer and/or elastomer joint. The joint allows for better maneuverability and increased trackability as the ballstent is advanced to the desired location. In other embodiments, the ballstent may include three or more metallic regions that are joined through two or more flexible joints [0020] The ballstent wall defines an opening that allows for the passage of fluid. An attachment between the ballstent and delivery device is formed whereby the the void of the ballstent defined by the inner surface of the wall can be joined in fluid communication

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227440/3 with the lumen of a hollow cylindrical member of the delivery device which is configured to allow for the proximal end of the lumen to accept a fluid source and for fluid to pass from the fluid source, through the lumen of the hollow cylindrical member of the delivery device, and into the void of the compressed ballstent, resulting in expansion of the ballstent.

[0021] In one embodiment, the fluid used to expand the ballstent is water or a saline solution. In another embodiment, the fluid is a solutions of radiopaque contrast material. In another embodiment, solids can be used to expand the ballstent, including solids used in combination with fluids. In one embodiment, the solids used to expand the ballstent, or to reduce subsequent compression of the expanded ballstent, are selected from the group of metallic or polymeric coils or wires, metallic or polymeric expansile structures, beads, balls, microspheres, radially expansive materials, support structures, or combinations thereof. In another embodiment, the fluid that is used to expand the ballstent can contain drugs or pharmacologically active molecules, such as those that catalyze the formation of thrombus, including thrombin. Fluid, as defined, can be a gas, liquid, or combination thereof.

[0022] The opening defined by the wall of the ballstent can have a diameter ranging between about 0.25 mm and about 5 mm. Optionally, the ballstent has a neck integral with the wall, whereby the neck defines an opening that can extend away from the main body of the ballstent, such as with an external neck, or may extend into the void of the ballstent, such as with an internal neck. The neck of the ballstent may be configured to remain open at the end of the procedure, or may be configured to be sealed prior to the end of the procedure.

[0023] The present invention also includes a delivery device for positioning and expanding the ballstent. Various configurations of delivery device can be used to advance the ballstent to the desired location and expand the ballstent. Preferably, the delivery device is a delivery catheter. The delivery catheter includes one or more hollow cylindrical members that define one or more lumens. The delivery catheter can be constructed as a single-lumen catheter, wherein the single hollow cylindrical member is dimensioned to deliver the ballstent to a desired location and deliver fluid from a fluid source at the proximal end into the void of the ballstent at the distal end. When a single hollow cylindrical member with a single lumen is used, generally the medical device is advanced into position through the lumen of a separate guide catheter, which acts to guide the ballstent portion of the medical device to the desired location in the lumen of the aneurysm.

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227440/3

Once at the desired location, the ballstent can be expanded and separated from the delivery catheter so that it can remain in the aneurysm sac while the catheter is removed. For this single lumen embodiment, the catheter does not include a hollow cylindrical member that defines a lumen that is dimensioned to allow for the passage of a guidance member, or guide wire. The wall of the delivery catheter can be comprised of standard catheter materials including a plastic or polymer material such as polyurethane. Further, the wall of the delivery catheter can be additionally comprised of metal reinforcement, such as metal reinforcement that is wound in a coil or braid, or some combination of these materials, as described.

[0024] In one embodiment, the delivery device comprises a single lumen delivery catheter wherein the distal end of the delivery catheter is configured to enable a fluid connection between a lumen of the delivery catheter and the void of the ballstent. When the ballstent is compressed, this delivery catheter can advance the compressed ballstent through a guide catheter and into the lumen of the aneurysm sac. The delivery catheter also optionally comprises a wire or obturator of a size that fills at least a portion of the lumen of the catheter. The wire or obturator can further comprise a handle to assist removal of the wire or obturator and enable the passage of fluid through the delivery catheter and into the void of the ballstent to expand the ballstent.

[0025] The delivery catheter can also be constructed as a double-lumen catheter, wherein the first hollow cylindrical member is dimensioned to deliver fluid from the fluid source into the void of the ballstent and a second hollow cylindrical member is dimensioned to pass over the guidance member, which acts to guide the medical device to the desired location in the lumen of the aneurysm. The guidance member is typically a flexible guide wire that may have a soft, flexible tip in a straight, angled, or j-shaped tip configuration.

[0026] Various methods can be used to compress the ballstent and enable it to travel through the lumen of a separate guide catheter, or through small diameter blood vessels. In one embodiment, the ballstent is folded to form one or more pleats prior to or after attaching the ballstent to the delivery catheter, and the pleats are rolled and compressed, similar to the folding of a non-compliant angioplasty balloon. In another embodiment, the ballstent is flattened into a planar shape, and rolled into a cylindrical shape. In another embodiment, the ballstent is compressed into a compact spherical shape. In another embodiment, the ballstent is folded and compressed into a manner similar to

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227440/3 origami. In certain embodiments, the ballstent may be folded and wrapped around the shaft of the delivery catheter.

[0027] The ballstent may be attached to the delivery catheter using a variety of materials, components, systems, and methods. The ballstent can be attached to the delivery catheter in a manner wherein the size and shape of the distal end of the delivery catheter and the size and shape of the opening in the ballstent wall are matched so that a friction fit is formed between ballstent and the delivery catheter. In an embodiment of a friction fit, an elastic sleeve or wrap can be placed around the neck of the ballstent and used to further hold the ballstent and the delivery catheter together. In another embodiment of a friction fit, a vacuum can be formed in the catheter to further hold the ballstent and the delivery catheter together. The ballstent can be attached to the delivery catheter using an adhesive, or glue. The ballstent can be attached to the delivery catheter using a weld, or solder. The ballstent can be attached to the delivery catheter by a fitting of mechanical parts on the ballstent and the delivery catheter, such as with a clamp that can be released or with a wire, polymer strand, filament, thread, or string that can be loosened or removed.

[0028] After expansion of the ballstent in the lumen of a saccular aneurysm, the ballstent may be separated from the delivery catheter using a variety of materials, components, devices, systems, and methods. For example, the expanded ballstent may be separated from the delivery catheter using components of the medical device, using a separate and distinct medical device, or combinations thereof. The ballstent may be separated from the delivery catheter using a variety of methods including physical methods, mechanical methods, electrical methods, thermal methods, chemical methods, hydraulic methods, sonic methods, and combinations thereof.

[0029] By way of example and not limitation, for electrical methods, the medical device can be configured such that electrolysis can be used to dissolve a metal weld or solder between the ballstent and the delivery catheter, or used to dissolve a portion of the metal ballstent itself. In certain embodiments, an elongated, insulated electrolysis wire or insulated conductive wire can carry an electrical current from the proximal end of the delivery catheter to the distal end of the delivery catheter where it may be electrically coupled to the weld or solder, or to the ballstent itself. A portion of the weld or solder, or a portion of the ballstent itself, may lack insulation such that the electrical current traveling through the insulated electrolysis wire will dissolve the portion of the weld, solder, or the portion of the ballstent that lacks insulation, resulting in separation of the ballstent from the

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227440/3 delivery catheter. The ballstent can have a neck for example, that can be coated with insulation on the inner wall, outer wall, or both, wherein a strip of conductive material is left exposed, uncoated, or uninsulated and whereby the wire is in electrical contact with the ballstent. During the electrolysis process a portion of the weld material or a portion of the wall of the ballstent may be separated 'into oppositely charged ions. By way of example and not limitation, for mechanical methods, the medical device can be configured such that the delivery catheter is physically separated from the ballstent by cutting or tearing a portion of the ballstent using a flexible loop of wire, polymer strand, filament, string, thread, or snare, or by using one or more blades. A mechanical separation may also occur where the delivery catheter is physically separated from the ballstent by a disengagement of mechanically mated parts, such as a clamp, or by removing a wire, polymer strand, filament, string, or thread that holds the ballstent and the delivery catheter together. By way of example and not limitation, for thermal methods, the medical device can be configured such that an adhesive bond is warmed, causing the adhesive to melt and allowing for separation of the expanded ballstent and the delivery catheter by subsequently pulling them apart. Separation of an expanded ballstent and a delivery catheter may also occur by applying a hydraulic force, by dissolving a bonding medium with a salt, an acid or base, or a chemical, or by applying sound waves such as focused or pulsed ultrasound waves. Another method, involves perforating the neck prior to usage, so that after expansion, the ballstent can be separated from the delivery catheter by pulling them apart at the line of perforation.

[0030] By way of example and not limitation, for attachment by friction bonding, the expanded ballstent and the delivery catheter can simply be pulled apart. By way of example and not limitation, for attachment by an adhesive or glue, the ballstent may be separated from the delivery catheter by mechanical mechanism such as by cutting or tearing a portion of the ballstent or the distal portion of the delivery catheter, by electrolysis of a weld, solder, or a portion of the ballstent, or by warming the adhesive bond, causing it to flow. By way of example and not limitation, for attachment by a weld or solder, the ballstent may be separated from the delivery catheter by electrolysis of a weld, solder, or a portion of the ballstent, or by a mechanical mechanism such as by cutting or tearing a portion of the ballstent or the distal portion of the delivery catheter.

[0031] In a particular embodiment, the delivery catheter includes a hollow cylindrical member that defines a lumen. The hollow cylindrical member has a proximal end that is attached or can be attached to a fluid source. The hollow cylindrical member

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227440/3 comprises polyurethane, with a reinforcement of metal in the form of a coil or braid, and a wall thickness between about 0.05 mm and 0.25 mm. The defined lumen has a diameter between about 0.4 mm and 1.0 mm. A wire comprised of nitinol with a diameter between about 0.3 mm and 0.95 mm is placed in the lumen. A ballstent with a wall comprising gold, with a wall thickness of 15 pm and an expanded diameter of 6 mm, is attached to the distal end of the delivery catheter by friction in a manner that allows for the formation of a fluid connection between the lumen of the hollow cylindrical member and the void of the ballstent. The ballstent is folded and compressed into a cylindrical shape at the tip of the delivery catheter.

[0032] The shape and size of the ballstent may be modified after expansion. For example, prior to separation from the delivery catheter, withdrawing fluid from the void of the ballstent can reduce the size of the ballstent. Also prior to separation, a force can be applied to the ballstent through the delivery catheter by advancing the delivery catheter forward or pulling the delivery catheter back, thus modifying the shape of the ballstent. After separation, an external force can be applied to the ballstent by inflating the balloon portion of a balloon catheter adjacent to the ballstent to modify the shape of the ballstent or push a portion of the ballstent toward the aneurysm. In certain embodiments, this can reduce the amount of ballstent that protrudes from the aneurysm sac into the lumen of the adjacent parent, or native, vessel. Also, the opening of the expanded ballstent can be sealed through a variety of methods, or left open.

[0033] The present invention also relates to methods of treating saccular aneurysms, with a medical device comprising a ballstent and a delivery catheter. The method includes the steps of positioning the compressed ballstent in the lumen of an aneurysm sac using a delivery catheter, expanding the ballstent by passing fluid through the delivery catheter into the void of the ballstent, separating the delivery catheter from the expanded ballstent, and removing the delivery catheter while leaving the ballstent in an expanded state within the aneurysm sac.

[0034] One method for placement of an expanded ballstent within a saccular aneurysm includes the steps of accessing the vasculature with a needle, inserting a guide wire through the needle, removing the needle, and optionally, inserting a vascular sheath into the blood vessel. The method also includes the steps of advancing a guide catheter over a guide wire until the tip of the guide catheter is within or near the lumen of the aneurysm sac. The method also includes passing the medical device comprising a compressed

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227440/3 ballstent and the delivery catheter through the guide catheter and positioning it in the lumen of the aneurysm sac. For this method, the delivery catheter portion of the medical device preferably comprises a hollow cylindrical member with a single lumen configured to allow fluid to pass from the proximal end of the delivery catheter to the distal end of the delivery catheter and into the void of the ballstent, and not configured for a guidance member or guide wire. After the compressed ballstent is in position, the ballstent is expanded by passing fluid through the delivery catheter into the void of the ballstent until the ballstent fills at least a portion of the aneurysm sac. The delivery catheter is separated from the expanded ballstent and removed, while the ballstent remains in place in an expanded state. The guide catheter and sheath are also removed. Resultantly, the ballstent is expanded so that at least 50% to 90% and up to 100% of the aneurysm sac is filled by the expanded ballstent, or alternatively that at least 50% to 90% and up to 100% of the luminal surface of the aneurysm sac is in contact with the expanded ballstent. The instructions may further include the steps of shaping and/or sealing the expanded ballstent. The exterior surface of the ballstent optionally comprises pores or projections. The pores may have a diameter ranging in diameter from about 0.01 pm to about 100 pm. The projections may have a length that ranges between about 0.01 pm to about 57 pm.

[0035] Another method for placement of an expanded ballstent within a saccular aneurysm includes the steps of accessing the vasculature with a needle, inserting a guide wire through the needle, removing the needle, and optionally, inserting a vascular sheath into the blood vessel. The method also includes the steps of advancing a diagnostic catheter over a guide wire until the tip of the guide wire is within or near the lumen of the aneurysm sac and removing the diagnostic catheter. The method further includes passing the medical device comprising a compressed ballstent and a delivery catheter over the guide wire, and positioning the compressed ballstent in the lumen of the aneurysm sac. For this method, the delivery catheter portion of the medical device preferably comprises at least two hollow cylindrical members with each associated with a separate lumen, with one lumen configured to allow fluid to pass from the proximal end of the delivery catheter to the distal end of the delivery catheter and into the void of the ballstent, and another lumen configured for a guidance member or guide wire. After the compressed ballstent is in position, the ballstent is expanded by passing fluid through one of the hollow cylindrical members of the delivery catheter into the ballstent until the ballstent is expanded to fill at least a portion of the aneurysm sac. Then the delivery catheter is separated from the expanded ballstent and

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227440/3 removed, while the ballstent remains in place in an expanded state. Then the guide wire and sheath are also removed. Resultantly, the ballstent is expanded so that at least 50% to 90% and up to 100 % of the aneurysm sac is filled by the expanded ballstent, or alternatively that at least 50% to 90% and up to 100% of the luminal surface of the aneurysm sac is in contact with the expanded ballstent. The instructions may further include the steps of shaping and/or sealing the expanded ballstent. The exterior surface of the ballstent optionally comprises pores or projections. The pores may have a diameter ranging in diameter from about 0.01 pm to about 100 pm. The projections may have a length that ranges between about 0.01 pm to about 57 pm.

[0036] The invention includes a kit with a medical device comprising a ballstent and a delivery catheter, and instructions on use. The medical device optionally further comprises components for separation of the expanded ballstent and the delivery catheter. In one embodiment, the instructions include the steps of placing a guide catheter near or within the lumen of the aneurysm sac, passing the medical device through the guide catheter, and positioning the compressed ballstent in the lumen of the aneurysm sac. After the compressed ballstent is in position, the instructions further include the steps of expanding the ballstent until it fills at least a portion of the aneurysm sac, followed by separating the expanded ballstent from the delivery catheter, and removing the delivery catheter, while the ballstent remains in the aneurysm sac in an expanded state. The instructions may further include the steps of shaping and/or sealing the expanded ballstent. In another embodiment, the instructions include the steps of placing a guide wire near or within the lumen of the aneurysm sac, passing the medical device over the guide wire, positioning the compressed ballstent in the lumen of the aneurysm sac, and removing the guide wire. After the compressed ballstent is in position, the instructions further include the steps of expanding the ballstent until it fills the aneurysm sac, followed by separating the ballstent from the delivery catheter, and removing the delivery catheter, while the ballstent remains in the aneurysm sac in an expanded state. The instructions may further include the steps of shaping and/or sealing the ballstent.

[0037] In other embodiments, the invention includes a method of manufacturing the ballstent. The method may include forming the wall of the ballstent through electroforming or electroplating on a cylindrical mandrel, a tapered mandrel, or a mold. The method may further include forming exterior or interior layers through electroforming, electroplating, sputtering, vapor deposition, or combinations thereof. The method for

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227440/3 forming the external layer may further include methods to form pores or projections. The method further includes the steps of contacting the ballstent with a solution or suspension of a pharmaceutical, drug, or pharmacologically active molecules such that pharmaceutical, drug, or pharmacologically active molecules remain with the ballstent during placement of the ballstent in an aneurysm, thereby delivering the pharmaceutical, drug, or pharmacologically active molecules to a saccular aneurysm. With this method, after positioning the expanded ballstent in the lumen of the aneurysm sac and leaving it in place, at least some of the molecules leave the ballstent and diffuse into the surrounding cells, tissues spaces, or fluids.

[0038] As such, a medical device comprising a ballstent and a delivery catheter is provided that can be used to treat a saccular aneurysm of a blood vessel.

DESCRIPTION OF FIGURES [0039] FIGS. 1A-B are perspective views of embodiments of the ballstent of the medical device.

[0040] FIG. 2 is a plan view of an embodiment of the delivery catheter of the medical device.

[0041] FIGS. 3A-B are plan views of an embodiment of the medical device.

[0042] FIGS. 4A-E are plans views of an embodiment of the medical device in a sequence of positioning, expanding of the ballstent, followed by separation of the ballstent from the delivery catheter, wherein the medical device does not have a cylindrical member with a lumen configured for a guidewire.

[0043] FIGS. 5A-B are perspective views of embodiments of the ballstent of the medical device.

[0044] FIG. 6 is a plan view of an embodiment of the delivery catheter of the medical device.

[0045] FIGS. 7A-B are plan views of an embodiment of the medical device.

[0046] FIGS. 8A-E are plans views of an embodiment of the medical device in a sequence of positioning, expanding of the ballstent, followed by separation of the ballstent from the delivery catheter, wherein the medical device has a cylindrical member with a lumen configured for a guidewire.

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227440/3 [0047] FIGS. 9A-D are hemispherical cross-sectional views taken along a diameter of of embodiments of the ballstent.

[0048] FIG. 10 is a perspective view of the ballstent after placement of an internal support structure.

[0049] FIG. 11 is a perspective view of an embodiment of the ballstent wherein the shape of the ballstent is being changed by applying an external force using a balloon catheter.

[0050] FIGS. 12A-B are plan views of embodiments of the ballstent with external surface projections for anchoring the ballstent to the surrounding tissues.

[0051] FIG. 13 is a plan view of an embodiment of the ballstent having an elastomer joint.

[0052] FIGS. 14A is a perspective view of an embodiment of a ballstent as compressed against a delivery catheter.

[0053] FIGS. 14B is a perspective view of an embodiment of a compressed ballstent.

[0054] FIGS. 15A-D are photographs depicting an exemplary manner of folding and compressing a ballstent.

[0055] FIGS. 16A-B are cross-sectional views along a longitudinal axis of embodiments of the delivery catheter of the medical device.

[0056] FIGS. 17A-B are plan views of an embodiment of the medical device with a lumen configured to accept a guide catheter, rather than a guide wire.

[0057] FIG. 18 depicts a hemispherical cross-sectional view taken along a diameter of an embodiment of the ballstent.

[0058] FIG. 19 is a plan view of a component and a method for separating a ballstent from a delivery catheter.

[0059] FIG. 20 is a plan view of a component and a method for separating a ballstent from a delivery catheter.

[0060] FIGS. 21A-C are plan views of a component and a method for separating a ballstent from a delivery catheter.

[0061] FIG. 22 is a plan view of a component and a method for separating a ballstent from a delivery catheter.

[0062] FIGS. 23A-B are perspective views of partial cross-sections of an embodiment of the medical device wherein the ballstent has an internal neck that is attached

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227440/3 to the delivery catheter, wherein 23A depicts a compressed ballstent and 23B depicts and expanded ballstent.

[0063] FIGS. 24A-B are a perspective and axial and cross-sectional view, respectively, of embodiments of the delivery catheter of the medical device wherein the delivery catheter has been advanced through the lumen of a guide catheter.

[0064] FIG. 25 is a perspective view of a partial cross-section of an embodiment of the medical device wherein the neck of the ballstent is attached to the delivery catheter, with an elastomeric sleeve holding the neck of the ballstent to the delivery catheter, and wherein the ballstent is expanded.

[0065] FIGS. 26A-B are a perspective view and plan view, respectively, of an embodiment of the medical device wherein the ballstent is attached to the delivery catheter with and adhesive that can be warmed with a resistive heating element.

[0066] FIG. 27 is a perspective view an aneurysm filled by two ballstents.

[0067] FIG. 28 is a photograph of a means for inflating or deflating a ballstent.

[0068] FIG. 29 is a plan view an embodiment of the medical device wherein the ballstent is attached to the delivery catheter with an adhesive and separated from the delivery catheter by electrolysis of a portion of the neck of the ballstent.

[0069] FIG. 30 is a table providing exemplary dimensions for embodiments of the ballstent. The dimensions are provided for example and not limitation.

DETAILED DESCRIPTION [0070] The present invention relates to a medical device comprising an expandable metal structure known as a “ballstent” and a delivery catheter. The ballstent is a thin-walled stent-like device that can be expanded into a semi-rigid form that can remain in the body for an extended period. Specifically, the ballstent is configured for use in filling and sealing saccular aneurysms of blood vessels, especially saccular cerebral aneurysms. The delivery catheter is configured to deliver the ballstent to an aneurysm and to provide a pathway, through the lumen of a hollow cylindrical member or lumen, for fluid to move into the void of the ballstent, in order to expand it and fill at least a portion of the lumen of the aneurysm sac.

[0071] A round embodiment of the ballstent 100 is shown in FIG. 1A in an expanded state. This embodiment has an external proximal neck 116 that defines an

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227440/3 opening 112 for the passage of fluids, liquids, gases, or solids into the void of the ballstent. Another round embodiment of the ballstent 100 is shown in FIG. IB in an expanded state. This embodiment has an internal neck 116 that defines an opening 112, also for the passage of fluids, liquids, gases, or solids into the void of the ballstent. Embodiments of the delivery catheter 400 are shown in FIG. 2 and in FIGS. 3A-B.

[0072] An embodiment of the medical device 500 is shown in FIGS. 3A-B. In FIG. 3 A the ballstent 100 is in a compressed state, which optionally includes pleats or folds. In FIG. 3B the ballstent 100 is in an expanded state. Expanding the ballstent 100, as used herein, can refer to partial or complete expansion of the ballstent 100 using a fluid, liquid, gas, solid, or a combination thereof. The delivery catheter 400 is used to advance the ballstent 100 into the lumen of the aneurysm sac. The delivery catheter 400 is also used to deliver a fluid, liquid, a gas, a solid, or a combination thereof, to expand the ballstent 100 in the lumen of the aneurysm sac, or maintain ballstent expansion. In one embodiment, an electrolysis wire 320 or an insulated conductor wire is connected or electrically coupled to either a weld or solder joining the ballstent and the delivery catheter, or to the ballstent itself.

[0073] As shown in FIGS. 4A-E, in one embodiment of the medical device 500, the delivery catheter 400 advances the attached compressed ballstent 100 through the lumen of a larger guide catheter 800, beyond the distal end of the guide catheter, and into the lumen 701 of the aneurysm sac 700. Once the compressed ballstent 100 has been placed in the lumen 701 of the aneurysm sac 700, the removable wire or obturator 404 is removed from the delivery catheter. The removable wire or obturator 404 may include a handle 408 or other device to facilitate insertion and removal. Then, a fluid source, such as the syringe 314 can be connected to the connection port 406 and fluid can be moved from the syringe 314 into the central void or space 108 of the ballstent 100, resulting in expansion of the ballstent within the lumen 701 of the aneurysm sac 700 and filling at least a portion of the aneurysm sac. As shown in FIGS. 4D-E, after the ballstent 100 is expanded, the delivery catheter 400 and the ballstent 100 are separated and the delivery catheter and guide catheter 800 are removed while leaving the expanded ballstent in the lumen 701 of the aneurysm sac 700. A variety of methods and devices can be used to separate the delivery catheter from the ballstent 100. In one embodiment, the delivery catheter 400 comprises an electrolysis wire 320 or the insulated conductor wire. For this embodiment, after the ballstent 100 is expanded, a DC current is applied to the electrolysis wire 320 or the insulated conductor

02235920X112-01

227440/3 wire to dissolve a portion of the weld or solder 316 between the ballstent 100 and the delivery catheter 400, or alternatively to dissolve a portion of the ballstent 100 by electrolysis. Once the weld or solder 316 is dissolved, or alternatively a portion of the ballstent 100 is dissolved, the delivery catheter 400 is separated from the ballstent and the delivery catheter and the guide catheter 800 are removed.

[0074] Another round embodiment of the ballstent 100 is shown in FIG. 5 A in an expanded state. This embodiment has an external proximal neck 116 that defines an opening f 12 for the passage of fluids, liquids, gases, or solids into the void of the ballstent. This embodiment also has an external distal neck 118 that defines an opening 114 for the passage of a guide wire 302. Another round embodiment of the ballstent 100 is shown in FIG. 5B in an expanded state. This embodiment has an internal proximal neck 116 that defines an opening 112, also for the passage of fluids, liquids, gases, or solids into the void of the ballstent. Further, this embodiment has an internal distal neck 118 that defines an opening 114 for the passage of a guide wire 302.

[0075] Another embodiment of the medical device 500 is shown in FIGS. 7A-B. In FIG. 7A the ballstent 100 is in compressed state, which optionally includes pleats or folds. In FIG. 7B the ballstent 100 is in an expanded state. The delivery catheter 300 is used to advance the ballstent 100 over a guide wire 302 and into the lumen of the aneurysm sac. The delivery catheter 300 is also used to deliver a fluid, liquid, gas, solid, or a combination thereof, to expand the ballstent 100 in the lumen 701 of the aneurysm sac 700. In one embodiment, an electrolysis wire 320 or an insulated conductor wire is connected or electrically coupled to either a weld or solder joining the ballstent and the delivery catheter, or to the ballstent itself.

[0076] As shown in FIGS. 8A-E, in one embodiment of the medical device 500, the delivery catheter 300 advances the attached compressed ballstent 100 over a guide wire 302 and into the lumen 701 of the aneurysm sac 700. Once the compressed ballstent 100 has been placed in the lumen 701 of the aneurysm sac 700, the guide wire 302 is removed. Then the wire or obturator 404 is removed from the delivery catheter 300. The wire or obturator 404 may include a handle 408 or other device to facilitate insertion and removal. Then, a fluid source, such as the syringe 314 is connected to the connection port 308 and fluid is moved from the syringe 314 into the central void or space 108 of the ballstent 100 resulting in expansion of the ballstent until it fills at least a portion of the lumen of the aneurysm sac 701. As shown in FIG. 8D-E, after the ballstent 100 is expanded, the delivery

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227440/3 catheter 300 and the ballstent 100 are separated and the delivery catheter is removed while leaving the expanded ballstent 100 within the lumen 701 of the aneurysm sac 700. In one embodiment, an electrolysis wire 320 or an insulated conductor wire is connected or electrically coupled to either a weld or solder joining the ballstent and the delivery catheter, or to the ballstent itself. For this embodiment, after the ballstent 100 is expanded, a DC current is applied to the electrolysis wire 320 or the insulated conductor wire to dissolve a portion of the weld or solder 316 between the ballstent 100 and the delivery catheter 300, or alternatively to dissolve a portion of the ballstent 100 by electrolysis. Once the weld or solder 316 is dissolved, or alternatively a portion of the ballstent 100 is dissolved, the delivery catheter 300 is separated from the ballstent 100 and the delivery catheter 100 and the guide catheter 800 are removed.

[0077] The medical device 500 can be used as part of various systems, methods, and medical kits. These systems, methods, and medical kits can be used to treat saccular arterial aneurysms, such as a saccular cerebral aneurysm. Alternatively, these systems, methods and medical kits can be used to treat a variety of medical conditions. In one embodiment, the systems, methods, and medical kits can be used to occlude biological conduits in patients in need thereof, the biological conduits including arteries, veins, vascular structures, ducts, airways, bile ducts, pancreatic ducts, enterocutaneous fistulas, ureters, fallopian tubes, and urethras, among others. The medical kit includes the medical device and instructions for use. The medical kit may also contain additional components for carrying out a variety of treatments using the medical device 500.

[0078] A typical method for using the medical device 500 to treat a saccular aneurysm includes accessing the vascular system of a human with a needle, passing a guidance member, or guide wire, 302 into the vessel, optionally placing a vascular sheath, advancing the medical device comprising a compressed ballstent 100 and a delivery catheter 300 or 400 and advancing it until the compressed ballstent is located in the lumen 701 of an aneurysm sac 700. Then the ballstent 100 is expanded by passing a fluid, liquid, gas, or solid material, or combinations thereof, through the delivery catheter and into the central void or space 108 of the ballstent. The delivery catheter and the expanded ballstent are then separated and the delivery catheter is removed from the body, while the expanded ballstent remains in place within the lumen 701 of the aneurysm sac 700. The position of the ballstent 100 during and after the procedure may be monitored by any suitable methods,

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227440/3 including fluoroscopy, computed tomography, MRI and ultrasound, including intravascular ultrasound.

The Ballstent [0079] The ballstent 100 may be composed of a single continuous layer or wall 122, as shown in FIG. 9A. The ballstent wall 122 comprises a material, preferably a metal that is biocompatible and ductile, that can form a thin-wall construction, and can assume a variety of shapes after expansion. By way of example and not limitation, the metal can 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. Ballstents can be made from alternative materials that can be formed into thin-walled structures that are sufficiently rigid or semi-rigid to tolerate compression and expansion, and can maintain an expanded state in vivo. Alternative materials include polymers or plastics that are reinforced with metal coils or braids, and other materials with similar properties. The materials comprising the wall of the ballstent and the thickness of the wall of the ballstent are selected such that the ballstent 100 has sufficient rigidity to remain in an expanded state in vivo under typical physiologic conditions after expansion and separation from the delivery catheter, even where the pressure inside and outside the central void or space 108 of the ballstent is the same or similar. The central layer 122 of the ballstent wall 102 has an interior surface 106 and exterior surface 124 that define a wall thickness 120. In particular for FIGS. 9A and 9B, the distance between the interior surface 106 and the exterior surface 124 is the overall wall thickness 120 of the wall 102. Preferably, the central layer 122 of the ballstent wall 100 has a thickness 120 from about 3 pm to about 60 pm. The wall thickness 120 can be uniform. For example, the ballstent wall 102 may have a uniform thickness of 3 pm, 5 pm, 10 pm, 15 pm, 20 pm, 30 pm, 40 pm, 50 pm, or 60 pm. Alternatively, the thickness of the ballstent wall at different locations may vary in thickness. Alternatively, the ballstent 100 may be composed of a single porous layer or wall 122, as shown in FIG. 9B, with pores 1300 wherein at least some pores extend all the way from the internal surface 106 to the external surface 124. For this embodiment, the wall 102 may be of a uniform thickness or a varied thickness.

02235920X112-01

227440/3 [0080] Alternatively, the ballstent 100 may have an additional coating or layer 104 on the exterior surface 124 of the central layer 122, as shown in FIG. 9C. The ballstent wall 102 and any additional exterior layers define an exterior surface 110 that, when expanded, contacts the internal wall of the aneurysm. The exterior layer 104 can be of a uniform or varied thickness, preferably between about 1 pm and about 59 pm. The exterior coating or layer 104 may be porous and contain a plurality of pores 200, as shown in FIGS. 9C and 9D. Alternatively, the exterior layer 104 can be smooth, with limited porosity or projections. For example, the exterior layer 104 may be a polished metal surface. In one embodiment, portions of the exterior layer 104 can be smooth, while other portions can be porous or contain projections. In one embodiment, the surface variations can include a pattern. In particular for FIGS. 9C, the distance between the interior surface 106 and the exterior surface 110 is the overall wall thickness 120 of the wall 102.

[0081] The porous or spongy nature of the exterior layer 104 can contain (or be configured to contain) solutions that include drugs, pharmacologically active molecules, or pharmaceutical compositions within the pores 200. As such, solutions such as drugs, pharmacologically active molecules, or pharmaceutical compositions can be delivered to the treatment site. Drugs, pharmacologically active molecules, or pharmaceutical compositions that promote thrombosis, stimulate cell proliferation or extracellular matrix production, or tissue growth are examples that can be placed in the pores 200 of the exterior layer 104. The drugs, pharmacologically active molecules, or pharmaceutical compositions are incorporated into the pores 200 of the wall or the exterior layer 104 prior to positioning the ballstent 100 at the desired location. The drug compositions may be delivered into the pores 200 via capillary or wicking action. The pores 200 range from about 0.01 pm to about 100 pm in diameter. Pore diameters for each ballstent may vary according to the specific drugs, pharmacologically active molecules, or pharmaceutical compositions to be incorporated and the desired rate of release from the ballstent in vivo. By way of example and not limitation, the ballstent 100 may have a porous exterior layer 104 where the pore diameter averages from about 0.01 pm to about 0.05 pm, about 0.05 pm to about 0.5 pm, 0.5 pm to about 5 pm, about 5 pm to about 25 pm, about 25 pm to about 100 pm, about 0.05 pm to about 100 pm, or about 0.01 pm to about 100 pm.

[0082] The drugs, pharmacologically active molecules, or pharmaceutical compositions may include thrombin, platelet-derived growth factor, Ethiodol®, Sotradecol®, or combinations thereof. Other pharmaceutical compounds and compositions

022359201112-01

227440/3 that promote thrombosis, stimulate cell proliferation, stimulate the synthesis of extracellular matrix, or the growth of tissue into the porous external wall of the ballstent 100 may also be used. Such drugs or pharmaceutical compositions may include molecules to promote cell proliferation, extracellular matrix production, or tissue growth, such that the expanded ballstent 100 will become more firmly attached to the tissue at the treatment location. The dosages and manner in which the drugs, pharmacologically active molecules, or pharmaceutical compositions are incorporated into the ballstent wall or exterior layer 104 are a matter of choice depending on the treatment performed. Other compounds may be used to promote blood clotting or thrombosis around the ballstent. For embodiments of the ballstent 100 with a porous layer 104, over time, the ballstent 100 remains expanded with the ballstent eventually becoming affixed to the surrounding tissue. The exterior surface of the ballstent may also comprise one or more projections, as described, that can increase the strength of the attachment of the expanded ballstent to the adjacent tissue, and thereby reduce the risk of ballstent movement or migration. The projections may have a length that ranges between about 0.01 pm to about 67 pm, and can have a branched construction. In some embodiments, the projections are rigid, or semi-rigid. In other embodiments, the projections are flexible and hair-like, and may further comprise globular ends, similar to the projections on the surface of the footpad of the gecko.

[0083] Alternatively, the ballstent 100 may comprise an additional layer or liner

1400 on the interior surface 106 of the central layer 122, as shown in FIG. 9D. The interior layer may be made from the same materials as the central layer, or can be made of different materials. The interior layer may be comprised gold, platinum, silver, alloys thereof, or combinations thereof. The additional layer 1400 on the interior surface 106 of the central layer 122 of the ballstent 100 may also be composed of a polymer, plastic, latex, rubber, woven or knitted fiber material, metal, or another material, or combinations thereof. Preferably, the interior layer 1400 is an elastomeric coating that is bonded to the interior surface 106 of the central layer 122. The interior layer 1400 can be a variety of thicknesses, preferably ranging between about 0.1 pm and about 59 pm. The total thickness of the wall 102, including the central layer 122, the exterior layer 104, and the interior layer 1400 is preferably between 2 pm and 60 pm, regardless if the wall contains one, two, three, or more layers. The interior layer 1400 can be comprised of polymers, latex, or elastomers. In a preferred embodiment, the interior layer 1400 is comprised of Parylene™. The interior layer 1400 adds mechanical properties (such as strength) to the wall 102. Further, the

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227440/3 interior layer 1400, optionally, can form a seal that prevents the escape of fluids from the ballstent 100, should the central layer 122 contain a defect or hole. The ballstent central layer 122 and any additional layers define an interior surface 106 or 1410, such that when the ballstent is expanded, with a fluid, liquid, gas, or solid, a central void or space 108 is defined. In particular for FIGS. 9D, the distance between the interior surface 1410 and the exterior surface 110 is the overall wall thickness 120 of the wall 102.

[0084] Advantageously, the ballstent 100 can be delivered into the lumen 701 of a saccular aneurysm 700, expanded, and then separated from the delivery catheter 300, such that the delivery catheter can be removed while the ballstent remains in place filling a portion, substantially all, or all of the lumen of the aneurysm in an expanded state. The expanded ballstent 100 will typically conform to the shape of the saccular aneurysm cavity in which it is placed. The expanded ballstent 100 can also be shaped with external force, such as a physical force applied by the inflated balloon portion 1102 of an adjacent balloon catheter 1100, as shown in FIG. 11. With precise placement and shaping, the ballstent 100 can be positioned such that the aneurysm lumen 701 or cavity is completely or substantially filled and sealed, and further with none of the ballstent, or a minimal amount of the ballstent, extending into the lumen of the parent vessel 1202, from which the aneurysm has formed.

[0085] As illustrated in FIGS. 1A-B and FIGS. 3A-B, the ballstent 100 has one or more openings 112 and 114 defined by the wall 102 or by one or more necks 116 and 118. Fluid can enter the opening 112 and move into the central void or space 108 defined by the interior surface 106 or 1410, thereby expanding the ballstent. In various embodiments, one or both of the necks 116 and 118 can project away from the wall 102 of the ballstent 100 or they can project into the void 108 of the ballstent 100. The necks 116 and 118 can be used for attaching the ballstent to the delivery catheter and may function in separating the ballstent 100 from the delivery catheter. Additionally, the necks 116 and 118 can be designed and dimensioned such that the opening 112 or 118 can be closed or partially closed before, during, or after separation of the expanded ballstent from the delivery catheter. One or more openings 112 or 114 may remain open. Optionally, before, during, or after separation, the necks 116 and 118 may be folded, pinched, or closed to form a seal. The necks 116 and 118 have a length ranging between about 0.5 mm and 20 mm, preferably a length between about 0.5 mm and about 5 mm. The necks 116 and 118 may define the openings 112 and 114, respectively, having diameters between about 0.25 mm and about 2

02235920M12-01

227440/3 mm. The necks 116 and 118 may protrude into the central void or space 108 for a length ranging between about 0.5 mm and about 20 mm, and preferably for a length between about 0.5 mm and about 5 mm, while defining the openings 112 and 114, respectively, having diameters between about 0.25 mm and about 5 mm. The thickness of the wall of either or both of the necks 116 and 118 may be the same as the main body of the ballstent or may be thinner or thicker than the wall of main body of the ballstent.. Preferably, either or both of the necks 116 and 118 have a thickness between about 3 pm and about 60 pm. With an embodiment of the ballstent wherein the neck(s) extends into the central void or space 108 of the ballstent 100 the external surface of the ballstent retains a more rounded surface contour, and therefore there may be a reduced risk of damage to the aneurysm wall or the adjacent tissue with placement of the ballstent. One or both of the necks 116 or 118 can be coated or insulated on the inner wall, outer wall, or both, wherein a strip of conductive material, including an uncoated or uninsulated section of a weld or solder, or portion of the ballstent itself, is left exposed, uncoated, or uninsulated, and whereby a conductive wire is in electrical contact with the uncoated or uninsulated portion of the weld or solder, or ballstent 100.

[0086] Various expanded ballstent shapes are acceptable, as required to treat saccular aneurysm of various shapes, including circular, oblong, and irregular, so long as the shape is generally rounded and the expanded ballstent comprises a single lobe. Regardless of the formed shape, when a ballstent is expanded in the lumen or cavity 701 of an aneurysm sac 700, the ballstent is designed to conform, at least partially, to the shape of the cavity.

[0087] In various embodiments, the dimensions of the ballstents 100 are selected based upon the size and shape of the saccular aneurysm being treated. Preferred shapes of the ballstent 100 include round, oblong, and irregular. The diameter of the round expanded ballstent 100 ranges from about 2 mm to about 30 mm, and preferably has an expanded diameter ranging from about 2 mm to about 20 mm. The expanded length of oblong ballstents preferably ranges between about 2 mm to about 30 mm. The ballstent 100 may have an expanded volume that ranges between about 0.001 cc to about 63 cc. In preferred embodiments, the expanded diameter of the round ballstent 100 ranges from about 2 mm to about 10 mm, while the preferred expanded volume ranges from about 0.004 cc to about 40 cc. In preferred embodiments, the expanded length of the oblong ballstent 100 ranges between about 2 mm to about 30 mm.

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227440/3 [0088] In other embodiments, one or more portions of the ballstent wall 102 may be thicker than the remaining portions of the wall. By way of example and not limitation, the wall in the middle of the body of the ballstent may be thicker or thinner than the wall in the proximal and distal portions of the ballstent, or the wall of a neck may be thicker or thinner than the main body of the ballstent. Optionally, the entire ballstent wall can be porous, as shown in FIG. 9B, with pores extending from the internal surface 106 to the external surface 124. During expansion of the ballstent of this embodiment, fluid may travel under pressure from the void or space 108 of the ballstent, through the wall 102 and leave the ballstent at the exterior surface 124. Preferably, for this embodiment, the pores range from 1 pm - 100 pm in diameter.

[0089] The ballstent comprises a central wall or layer 122, optionally with an exterior wall or layer 104, and also optionally with an interior wall or layer 1400, as shown in FIG. 9C. As mentioned, the construct of the central layer or wall 122 and the layers 104 and 1400 can be uniform, porous, or combinations thereof.

[0090] In one construction, the central layer or wall 122 of the ballstent 100 is continuous and comprised of gold. To this preferred construction, an exterior layer 104 comprised of porous gold can be added. Additionally, an interior layer 1400 comprised of Parylene™ may be present. In certain embodiments wherein electrolysis is used to separate the expanded ballstent 100 from the delivery catheter, certain portions of the ballstent (such as the neck or body) are coated with an insulator or polymer, such as Parylene™ (including the external surface, the internal surface, or both the internal and external surfaces) while a portion of the neck or body remains uncoated or uninsulated. In this instance, the uncoated or uninsulated portion is solubilized by the passage of an electrical current into the uncoated or uninsulated during electrolysis. In certain embodiments, the uncoated or uninsulated portions are created by masking during the coating process. In other embodiments, the coating or insulation is removed from the uncoated or uninsulated portions, as through etching or ablation, such as with laser etching or laser ablation.

[0091] The central void or space 108 of the ballstent 100 can be filled with fluids, solids, or combinations thereof. A fluid is a substance having particles that easily move and change their relative position without a separation of the mass. Fluids that can be used to expand the ballstent 100 include liquids, gases, and combinations thereof. By way of example and not limitation, the fluid may be water, a saline solution, a radiographic contrast solution, or a mixture thereof. In one embodiment, the fluid may further include a

02235920X112-01

227440/3 solution or suspension of a drug, pharmacologically active molecules, or a pharmaceutical preparation. By way of example and not limitation, the drug, pharmacologically active molecules, or a pharmaceutical preparation may increase local thrombosis, cell proliferation, extracellular matrix production, or tissue growth into or around the wall 102 of the expanded ballstent 100 when it is positioned in the lumen of a saccular aneurysm.

[0092] In one embodiment, the shape of an expanded ballstent is maintained by placing solid material or support structures into the central void or space 108 of the expanded ballstent 100. Examples of this solid material include metal or polymeric coils or wires, metal or polymeric solid support structures, radially expansile materials, beads, particles, spheres, or microspheres. In certain embodiments, these solid materials can also be used to help expand the ballstent. In other embodiments, these solid materials are added after the ballstent expansion. In one embodiment, as shown in FIG. 10, the aneurysm 700 within the blood vessel 1202 is filled with a ballstent containing at least one coil or expansile wire 1204. In one aspect, the ballstent 100 may be expanded by the coil or expansile wire 1204 only, while in other aspects, the ballstent 100 may be expanded by a fluid, and the solid materials may be added later to provide support to maintain the expanded shape of the ballstent. Other suitable biocompatible solid materials may also be used. The solid fill members can function as a lattice to insure the structural integrity of the ballstent 100. For example, the coil 1204 can promote the structural integrity of the ballstent 100 and reduce compression of the ballstent 100. In one embodiment, solid material may be designed and manufactured to match a ballstent of a particular size or shape, and may be packaged as part of the medical device for use with the packaged ballstent.

[0093] Embodiments of the ballstent can include features designed to secure the ballstent in place once it has been expanded in the lumen of an aneurysm sac. These features can be biological or physical, or a combination thereof. In one embodiment, the exterior surface 110 of the ballstent 100 may be coated with molecules that can bind to adjacent thrombus or tissue. These molecules can be affixed to the ballstent through a variety of methods, including chemical bonds such as with hydrogen bonding or covalent bonding. Alternatively, these molecules can be affixed to the ballstent through encapsulation of a porous layer or encapsulation of projections. Representative molecules that can be affixed to the wall of ballstents include fibrin, and molecules that can link to fibrin through covalent and non-covalent bonding. With such a coating, the ballstent can be

02235920X112-01

227440/3 anchored to the fibrin-rich clot that forms between the aneurysm and the ballstent. In another embodiment, the ballstent 100 may comprise a porous external layer or wall 104 or a wall with external projections to promote thrombus formation on the external surface 110 or in the pores 200 of the ballstent and promote cell proliferation, extracellular matrix production, or tissue growth into or around the wall 102 of the ballstent 100 such that the ballstent 100 will, over time, become more strongly attached to the tissue in the adjacent aneurysm wall. As shown in another embodiment, the exterior surface 124 or 110 of the ballstent 100 further comprises one or more projections therefrom, which can be used to anchor the ballstent 100 to the surrounding tissue, specifically the wall a saccular aneurysm, and hold the ballstent in the desired location. In a macroscopic form, the projections may be composed of nitinol or any other suitable biocompatible material. The projections may be straight, curved, hook-shaped, or configured as pigtail hooks 1800 as shown in FIG. 12A. FIG. 12B depicts an expanded ballstent 100 that is anchored to the wall 704 of an aneurysm 700. The size and shape of the projections may be selected based upon the condition being treated, and may be designed and dimensioned to provide sufficient anchoring support without causing excessive damage to the wall of the aneurysm or the surrounding tissue. Alternatively, microscopic projections or filaments may be used to anchor the ballstent. For some embodiments, these microscopic projections range in length from 0.01 pm to about 57 pm, and can be straight or branching.

[0094] In order to facilitate advancement of the ballstent through the vascular system, some embodiments of the ballstent 100 comprise two or more metallic portions 1900A-B that are joined by a flexible joint 1902, as shown in FIG. 13. In certain embodiments, this flexible joint can comprise a variety of materials that are flexible and biocompatible, including various polymers or elastomers. The joint 1902 allows for better maneuverability and increased trackability as the compressed ballstent is advanced to the desired location. In other embodiments, the ballstent 100 may include three or more metallic or rigid portions that are joined through two or more flexible joints.

[0095] In order to facilitate advancement of the ballstent through the vascular system, the ballstent 100 can be compressed into various shapes and dimensions. Optionally, this compression can include various forms and patterns of folding or pleating. For example, one or more pleats can be made in the ballstent 100 and then the pleats can be wrapped into a cylindrical shape. Alternatively, the ballstent 100 may be flattened into a planar shape and then rolled into a cylindrical shape. Alternatively, the ballstent 100 may

02235920X112-01

227440/3 be compressed into a compact spherical shape. Additionally, the portions of the ballstent 100 may be twisted or braided during compression. In certain instances, the ballstent may be compressed around the delivery catheter 300, as in FIG. 7A. In other instances, the ballstent may be compressed around the obturator 404, as in FIG. 3A. In other embodiments, the ballstent 100 may be compressed on itself, without a central catheter or obturator.

[0096] In FIG. 14A, the ballstent 100 has been pleated, folded, and wrapped around the hollow cylindrical member 304 of the delivery catheter 300, as shown in FIG. 14A. In FIG. 14B, the ballstent 100 has been similarly pleated and wrapped without the delivery catheter. In another embodiment, the ballstent 100 is folded into pleats, then the pleats of the folded ballstent are wrapped around the hollow cylindrical member 304 of the delivery catheter 300, and the ballstent is compressed against the delivery catheter. In another embodiment, the ballstent 100 is folded into pleats, then the pleated folds of the folded ballstent are wrapped around the removable wire or obturator 404, and then the ballstent is compressed against the removable wire or obturator 404. In another embodiment, the ballstent 100 is folded into pleats, and then the pleated folds are rolled into a generally cylindrical shape without a removable wire or obturator, or catheter, acting as central fixation point.

[0097] In various embodiments, the ballstent 100 is attached to the delivery catheter 300, 400, then the pleats are formed, and then the pleated folds are wrapped and compressed onto the delivery catheter 300, or the obturator 404. In another embodiment, the ballstent 100 is first folded to form pleats, then attached to the delivery catheter 300, 400, and then the pleated folds are wrapped and compressed onto the outer surface of the delivery catheter 300, or obturator 404. In another embodiment, the ballstent 100 may be folded and compressed into a variety of shapes in a manner similar to Japanese origami, as shown in FIGS. 15 A-D.

[0098] In certain embodiments, the ballstent 100 is fully expanded to treat a saccular aneurysm. In other embodiments, the ballstent 100 need not be fully expanded to treat a saccular aneurysm, but may successfully seal the aneurysm while partially expanded. In all embodiments, the ballstent remains in an expanded state (partially or completely) after detachment from the delivery catheter. An expanded state refers to the at least partial distention of the ballstent 100, such as at least 20%, 50%, 75%, or 90% and up to 100% of the maximum ballstent volume.

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227440/3 [0099] By way of example and not limitation, FIG. 30 provides exemplary dimensions for an embodiment of the ballstent 100.

Ballstent Formation [00100] The central layer 122 of the wall of the ballstent 102, the interior layer 1400, and the exterior layer 104,, may be formed by any suitable method. For example, in a preferred embodiment, the central layer 122 of the wall 102 is formed by electro forming or electroplating. A conductive mandrel is placed in a solution of metal ions, which coat the mandrel to form a layer of the ballstent 100. The shape of the ballstent 100 can be modified by modifying the shape of the mandrel. The thickness of the central layer 122 of the wall 102 can be modified by varying the process time. Regions of different wall thicknesses and the pattern of thickness differences may be produced by masking. In other exemplary methods of forming the ballstent 100, the central layer 122 of the wall 102 of the ballstent 100 may be formed by vapor deposition, wherein vapors from one or more polymers, pure metals, or metal alloys are condensed upon a substrate or mold (not shown). The mold may be removed to provide a hollow shell composed of the pure metal or metal alloy.

[00101] An exterior layer 104 may be formed on the outside of the central layer 122 of the ballstent 100 by additional electroplating or electro forming, by vapor deposition, or by sputter deposition, wherein material is eroded from a target (e.g., a metal or metal alloy) and is then deposited onto a substrate (e.g., a mandrel or mold) forming a thin layer on the substrate.

[00102] An interior layer 1400 may be formed on the inside of the central layer 122 of the ballstent 100 by additional electroplating or electro forming, or by vapor deposition, or by sputter deposition.

[00103] An exterior layer 104 may be formed on the outside of the central layer 122 of the ballstent 100 by additional vapor deposition. In some instances, the central layer 122 may be formed by electro forming or electroplating and the interior or exterior layers are formed by vapor deposition.

[00104] In some instances, it may be desirable to incorporate an elastomer layer into the ballstent 100, either as an interior or an exterior layer. In these instances, the elastomer can be added by incorporating a pre-formed material into the desired orientation, or by vapor deposition, or other methods.

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227440/3 [00105] The wall 102 of the main body of the ballstent 100 may be formed by different methods than the neck 116. The central layer 122 of the ballstent 100 may be formed by different methods than the exterior layer or coating 104 or the interior layer or coating 1400.

[00106] Two-dimensional sheets of metal may be manipulated and secured in the desired configuration to form the wall 102 and/or the exterior layer 104. These two dimensional sheets may further comprise rubber, plastic, polymer, woven or knitted fiber materials, or other materials, or combinations thereof. By way of example and not limitation, one or more two-dimensional sheets of a metal may be folded into a ballstent shape and welded, soldered, glued, or bonded together. Similarly, two-dimensional sheets of material may be manipulated and secured to form the exterior layer 104 or the interior layer 1400.

[00107] In various embodiments wherein the wall 102 of the ballstent 100 comprises metal, an annealing process is used to improve ductility and facilitate folding, compressing, and/or expanding the ballstent 100. By way of example and not limitation, a typical annealing process includes heating the ballstent 100 at approximately 300°C for a period of about one hour, followed by an immediate quench in distilled water at room temperature.

The Delivery Catheter [00108] The ballstent 100 is advanced and positioned within human body by an elongated portion of the medical device known as the “delivery device”. A delivery device is an elongated surgical instrument that defines at least one lumen, or potential lumen, having a proximal and a distal end that is dimensioned to deliver fluid from a fluid source at the proximal end into the central void or space 108 of the ballstent 100, which is attached to the distal end. Further, any medical device or component of a medical device that can position the ballstent 100 at a desired location in the vascular system, such as the lumen of a saccular aneurysm, facilitate the expansion of the ballstent, and then facilitate the separation of the ballstent from the delivery device is generally acceptable as a delivery device. Typically, the delivery device is a catheter (a “delivery catheter”). Preferably, the delivery catheter may be any flexible catheter, hollow wire, removable core wire, or combinations thereof, suitable for accessing locations with the vascular system, including the delivery

02235920X112-01

227440/3 catheters 300 and 400. The delivery catheter may also be any other type of catheter, hollow wire, or removable core wire, or alternatively a needle or trochar, or combinations thereof, suitable for accessing locations with the vascular system.

[00109] A catheter is a flexible, tubular, elongate medical device configured for insertion into bodily compartments, including blood vessels, to permit the injection or the withdrawal of fluids, amongst other functions. Catheters are often comprised of polymers or plastics and optionally further comprise metal, such as in a coil or braid configuration. Catheters can be configured to enable attachment to ballstents, facilitate the delivery of compressed ballstents to the lumen of an aneurysm sac, facilitate the expansion of compressed ballstents, and separate from expanded ballstents. The delivery catheter 300 or 400 can be configured to pass through the vascular system with the attached ballstent 100 in a compressed form, as shown in FIGS. 3A and 7A. After expansion, the ballstent 100 is separated from the delivery catheter 300, thereby allowing the expanded ballstent to remain in place while the delivery catheter is removed from the body. In this way, delivery catheters are similar to angioplasty balloons, which are configured to enable attachment to traditional tubular stents, to facilitate the delivery of attached compressed traditional tubular stents to the lumen of a specific segment of a blood vessel, enable expansion of compressed traditional tubular stents, and separate from expanded traditional tubular stents.

[00110] Preferably, the delivery device is a catheter 300 and 400, as shown in FIG. 2 and FIG. 6, which can carry an attached compressed ballstent 100 to the lumen of a saccular aneurysm. The delivery catheter 300 and 400 is composed of a biocompatible material. By way of example and not limitation, the delivery catheter 300 and 400 and various components thereof may be composed of silicone rubber, natural rubber, polyvinyl chlorides, polyurethane, copolyester polymers, thermoplastic rubbers, siliconepolycarbonate copolymers, polyethylene ethyl-vinyl-acetate copolymers, woven polyester fibers, or combinations thereof. In one embodiment, the wall of the delivery catheter 300 and 400, may be reinforced with a metal, such as coiled or braided stainless steel or nitinol, to enhance control and reduce kinking of the delivery catheter 300 and 400 during use. Metals suitable for delivery catheter reinforcement include stainless steel and nitinol.

[00111] As shown in FIG. 2, 3A-B, 6, 7A-B and 16A-B, the delivery catheter 300 and 400 will have a hollow, or potentially hollow, cylindrical member that defines a lumen to allow for passage of fluid from the proximal end of the delivery catheter to the distal end of the delivery catheter and into the central void 108 of the ballstent. The delivery catheter

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227440/3

300 or 400 is designed and dimensioned such that it can be inserted in the body to deliver the compressed ballstent 100 to a desired location, facilitate the expansion of the ballstent, and facilitate the separation of the expanded ballstent from the delivery catheter. When a single lumen delivery catheter 400 is used, the compressed ballstent may be positioned in the lumen of a saccular aneurysm after being advanced through a separate larger guide catheter that is positioned with its distal end within or near the aneurysm. Once in the lumen of the aneurysm sac and out of the guide catheter, the compressed ballstent 100 can be expanded, and then the expanded ballstent and the delivery catheter can be separated, and the delivery catheter and the guide catheter can be removed from the body, while the expanded ballstent remains in place. The hollow, or potentially hollow, cylindrical member 306 of delivery catheter 400 has a wall thickness ranging from about 0.05 mm to about 0.25 mm. Preferably, wall thickness of the hollow cylindrical member 306 ranges from about 0.1 mm to about 0.2 mm. The lumen 312 defined by the hollow cylindrical member 306 for the purpose of enabling the passage of fluid into the central void or space of the ballstent 108 has a diameter ranging from about 0.4 mm to about 1.0 mm. The proximal end of the hollow cylindrical member 306 includes a port or hub 308 or 406 to communicate with a pressurized fluid source, such as a syringe 314 or a pump (not shown) containing, for example, water, saline or a radiographic contrast solution. Fluids for expanding the ballstent are received into the delivery catheter 300 or 400 through the hub or port 308 or 406.

[00112] For some embodiments, the medical device is advanced in the body over a guidance member 302, as shown in FIG. 8B. Examples of a guidance member include a flexible guide wire. The guide wire 302 can comprise metal in the form of a flexible thread, coil, or slender rod. For example, the basic angiography guide wire consists of a fixed solid metal core covered by a metal spring coil. In other situations, a delivery catheter is advanced over a needle or trochar. The guide wire 302 occupies a lumen in the delivery catheter, with such lumen defined by the tubular portion of the delivery catheter. Once located in place, the guide wire 302 can be removed in order to allow the injection or withdrawal of fluids.

[00113] As shown in FIG. 6 and FIG. 16B, the delivery catheter 300 may include an additional hollow cylindrical member that defines a second lumen 324 to receive a guidance member, such as a guide wire 302, to assist in the guidance of the ballstent 100 component of the medical device to the desired location. This second lumen 324 is generally adjacent and parallel to the first lumen 312. As shown in FIG. 6 and FIG. 16B the

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227440/3 delivery catheter may be a double lumen catheter, with one lumen 312 configured to enable the passage of fluid from a fluid source 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 accept a guidance member, such as a guide wire 302, to facilitate advancement and positioning of the medical device in the vascular system. As shown in FIG. 16B, the delivery catheter 300 includes two hollow cylindrical members, each with a lumen, wherein the hollow cylindrical members 304 or 306 have a wall thickness ranging from about 0.05 mm to about 0.25 mm. Preferably, the hollow cylindrical member 304 or 306 wall thickness ranges from about 0.1 mm to about 0.2 mm. The lumen defined by the hollow cylindrical member 304 for the accepting a guide wire 302 has a diameter ranging from about 0.25 mm to about 0.5 mm. The diameter of the lumen for the passage of fluid into the ballstent 312 and the diameter of the lumen for accepting a guidance member 324 may be similarly dimensioned. Alternatively, the diameter of the lumen for the passage of fluid into the ballstent may be larger or smaller than the diameter of the lumen for accepting a guidance member. For a delivery catheter with two lumens, the first and second hollow cylindrical members may be similarly dimensioned. Alternatively, the second hollow cylindrical member may have a larger diameter to accept the guidance member, or a smaller diameter. The proximal end of the second hollow cylindrical member 304 includes a guide wire port 310. The guide wire port 310 facilitates the insertion of the guide wire 302 into the second hollow cylindrical member 304. The guide wire 302 is fed through the second hollow cylindrical member 304 and extended out of the distal end of the delivery catheter 300. In this embodiment, the delivery catheter 300 is advanced over the guide wire 302 until the compressed ballstent 100 is positioned in the lumen of a saccular aneurysm. Once the compressed ballstent 100 is in the desired position, the ballstent 100 is expanded by fluid provided to the first hollow cylindrical member 306 by the syringe 314 connected to the ballstent expansion port 308 or 406. Fluids such as saline, solutions of radiographic contrast agents, or solutions of drugs, such as thrombin, can be used to expand the compressed ballstent. The guide wire 302 is preferably an angiographic wire of sufficient length for the distal tip of the guide wire to reach the aneurysm, and a proximal end extending out and away from the point of entry into the vascular system. In some embodiments, the guide wire 302 has a straight or angled distal tip, while in other embodiments, the guide wire 302 has a curved J-shaped distal tip, typically constructed from a shape-memory alloy or a braided metal that causes the tip to return to the J-shape

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227440/3 after any applied stress is removed. The materials and dimensions of the guide wire 302 may be selected based upon the diameter, length, and tortuosity of the blood vessels being traversed. Typically, the guide wire 302 may be composed of any suitable biocompatible materials and have an outer diameter ranging between 0.3 mm to 0.95 mm.

[00114] FIGS. 3A-B depict longitudinal views of a single lumen embodiment of the delivery catheter portion of the medical device 500. FIG. 3A depicts a longitudinal views of a single lumen embodiment of the medical device 500 with the ballstent in a compressed form. FIG. 3B depicts a longitudinal view of a single lumen embodiment of the medical device 500 with the ballstent in an expanded form. FIGS. 7A-B depict longitudinal views of a double lumen embodiment of the delivery catheter portion 300 of the medical device 500. FIG. 7A depicts a longitudinal view of a double lumen embodiment of the medical device 500 with the ballstent in a compressed form. FIG. 7B depicts a longitudinal view of a double lumen embodiment of the medical device 500 with the ballstent in an expanded form. As shown in FIGS. 8A-E, the delivery catheter 300 moves over the guide wire 302 to deliver the ballstent 100 to the lumen of a saccular aneurysm 701, to deliver fluid to expand the ballstent in the aneurysm, and then separate therefrom. In certain embodiments, a modified infusion wire having a removable core can be used as a single lumen delivery catheter. An infusion wire is a modified guide wire wherein the solid metal core can be removed to leave a lumen that can be used to inject fluids. An infusion wire with a removable core can be modified such that a ballstent can be attached to the distal end and expanded through the wire lumen, after the removal of the core wire.

[00115] FIG. 2 depicts a longitudinal view of a single lumen embodiment of the delivery catheter portion 400 of the medical device 500. As shown in FIGS. 4A-E, for the single lumen embodiment, the delivery catheter 300 moves through the lumen of a guide catheter 800 to deliver the compressed ballstent 100 to the lumen 701 of a saccular aneurysm 700. For this single lumen embodiment, the delivery catheter 400 does not include a hollow cylindrical member that defines a lumen that is dimensioned to allow for the passage of a guidance member, or guide wire.

[00116] FIG. 6 depicts a longitudinal view of a double lumen embodiment of the delivery catheter portion 300 of the medical device 500. As shown in FIGS. 8A-E, for the double lumen embodiment, the delivery catheter 300 moves over a guidance member or guide wire 302 to deliver the compressed ballstent 100 to the lumen 701 of a saccular aneurysm 700.

02235920X112-01

227440/3 [00117] As shown in FIGS. 17A-B, in another embodiment, the delivery catheter of the medical device can be configured with a lumen that can accept a guide catheter 800 as a guidance member. With this configuration, the medical device can be advanced in a triaxial configuration, with the medical device 500 advanced over a guide catheter 800, which is advanced over a guide wire. In certain embodiments, the proximal hub on the guide catheter can be removed to allow the lumen of the hollow cylindrical member 304 of delivery catheter 300 of the medical device 500 to accept the guide catheter 800. In certain instances, this embodiment of the medical device can result in better control over the delivery of the compressed ballstent to the aneurysm and better trackability of the compressed ballstent 100 as it is advanced to the desired location. As shown, in one aspect, the hollow cylindrical member 304 of delivery catheter 300 may be annular shaped and fully encircle the guidance catheter 800, while in other aspects, the delivery catheter may engage 60%, 70%, 80%, 90% or more of the circumference of the guidance catheter.

[00118] The dimensions of the delivery catheter 300 or 400 are a matter of design choice depending upon the size of aneurysm to be treated and the location of the aneurysm in the vascular system. The distance between the aneurysm to be treated and the site of insertion of the delivery medical device into the vascular system, will determine, in part, the length of the delivery catheter 300 or 400. Delivery catheter lengths range between 5 cm and 300 cm, with preferable ranges between 75 cm and 225 cm. The smallest diameter blood vessel segment in the path between the site of insertion of the medical device into the vascular system and the aneurysm to be treated, will determine, in part, the diameter of the delivery catheter. Delivery catheter diameters range between 2 Fr and 7 Fr, with preferable ranges between 3 Fr and 5 Fr.

[00119] In some embodiments, the proximal end of the delivery catheter 400 is configured with a Luer hub or taper 406 or 308 that may facilitate a Luer-Lok™ or LuerSlip™ type connection for connecting a fluid source, such as a syringe 314, to the lumen 312 of a hollow cylindrical member configured to transmit fluid from the proximal end of the delivery catheter to the central void or space of the ballstent 100. As shown, in FIG. 28, the lumen 312 of a delivery catheter 400 is connected to a fluid source, such as the syringe 314, through a female Luer fitting 2802. A stopcock 2804 may be positioned between the fluid source and the delivery catheter 400 to enable greater control over the movement of fluid into and out of the delivery catheter.

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227440/3

Attaching the Ballstent to the Delivery Catheter and Separating the Expanded Ballstent from the Delivery Catheter [00120] The ballstent 100 may be attached to, or engaged with, the delivery catheter in a variety of ways. For example, the ballstent 100 may be affixed to the delivery catheter by a friction fit, using an adhesive or glue, by a weld or solder, by a junction or uniting of components, or by the application of a compressive force from a clamp, ring, elastomer sleeve or wrap, or compressive balloon. Various methods and devices may be used to separate the expanded ballstent from the delivery catheter. By way of example and not limitation, these methods and devices may be broadly categorized as physical or mechanical, electrical, thermal, chemical, hydraulic, and sonic.

[00121] In one embodiment, a physical or mechanical attachment is made between a ballstent and a delivery catheter, wherein the coupled parts are configured to fit tightly together and remain together by friction. After expansion of the ballstent, the physician slips the distal end of delivery catheter out of the neck of the ballstent to effect separation, a process that may be facilitated by moving a guide catheter 800 forward to abut the expanded ballstent 100 prior to withdrawing the delivery catheter, as shown in FIG. 23B. In one embodiment shown in FIG. 18, the neck 1600 of the ballstent 100 is inverted and located within the central void or space 108 of the ballstent. The exterior surface 1602 of the neck 1600 engages the distal end of the hollow cylindrical member 306 of the delivery catheter 400 by friction. When the ballstent 100 is compressed, it engages the distal end 1706 of the core wire or obturator 404 by friction. As shown in FIGS. 18, 23A-B, and 24A-B, the distal portion 1706 of the core wire or obturator 404 of the delivery catheter 400 has a smaller diameter than the more proximal portion 1707. In other embodiments, the distal portion 1706 of the core wire or obturator 404 of the delivery catheter 400 has the same diameter as the more proximal portion 1707. After the compressed ballstent 100 is positioned in the lumen of a saccular aneurysm, the core wire or obturator 404 is removed. This creates a fluid pathway through the lumen 312 of the delivery catheter 400 and into the central void or space 108 of the ballstent 100. Once the obturator 404 is removed, a fluid source 314 can be connected to hub 406 and fluid can be injected into the void 108 of the the ballstent 100 until it is expanded. After the ballstent 100 is expanded, the distal end of the guide catheter 800 is advanced forward against the wall of the expanded ballstent 100 and the distal end of the delivery catheter 400 is withdrawn from the neck of the ballstent

022359201112-01

227440/3

1600 to separate the delivery catheter from the expanded ballstent, allowing the delivery catheter to be removed while leaving the expanded ballstent in the lumen of the saccular aneurysm. In this way, the guide catheter 800 functions as a buttress against the exterior surface of the ballstent 112, while the expanded ballstent is separated from the delivery catheter. Alternatively, the ballstent and delivery catheter can be separated by other physical methods.

[00122] In another embodiment, as shown in FIG. 25, a mechanical attachment is made between a ballstent and a delivery catheter wherein an external neck 1714 on the ballstent 100 is configured to fit tightly around the distal end of the hollow cylindrical member 306 of the delivery catheter 400. An elastic sleeve or wrap 1724 is attached to distal end of the hollow cylindrical member 306 of the delivery catheter 400 and extended around at least a portion of the external neck 1714 of the ballstent 100 to hold the neck of the ballstent against the distal end of the hollow cylindrical member 306 of the delivery catheter 400. Once the ballstent is expanded in the lumen of the saccular aneurysm, the expanded ballstent 100 is separated from distal end of the hollow cylindrical member 306 of the delivery catheter 400 by using the guide catheter 800, similar to above, to buttress the ballstent while the distal end of the hollow cylindrical member 306 of the delivery catheter 400 is pulled away from the expanded ballstent.

[00123] In another embodiment, the ballstent 100 is attached to the distal end of the hollow cylindrical member 306 of the delivery catheter 400 with an adhesive, glue, weld, or solder. In this embodiment, the expanded ballstent 100 is separated from delivery catheter 400 by mechanical methods. The expanded ballstent 100 may be separated from the delivery device by a number of mechanical methods that cut, tear, or otherwise physically degrade a portion of the ballstent to separate the remainder of ballstent from the delivery catheter 400.

[00124] As shown in FIG. 19, in one embodiment, a flexible, thin loop of material 2200 may be positioned to encircle the outside of the external neck of the ballstent 2202. The loop of material can be comprised of various thin, strong, and flexible materials such as a wire, polymer strand, filament, string, thread, or snare. After expansion of the ballstent, the loop can be pulled toward the proximal end of the delivery catheter 2204 to sever the neck 2202 of the ballstent 100, and separate the expanded ballstent from the delivery catheter. Preferably, the loop is pulled through a lumen in the delivery catheter dimensioned to accept the loop as it is pulled back. In another embodiment (not shown), a flexible thin

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227440/3 loop of material (in certain embodiments representing a loop snare or modified loop snare) can be advanced by a second catheter until the loop is placed around the outside of the proximal portion of the external neck of an expanded ballstent. The loop can then be snugged against the neck and withdrawn into the second catheter in order to sever the neck

116 of the ballstent 100 and separate the ballstent from the delivery catheter.

[00125] In another embodiment shown in FIG. 20, a distal end 2500 of a thin loop of material (such as a wire, polymer strand, filament, string, or thread) is affixed in a loop to the ballstent neck 2202, while the proximal end 2506 of the loop material extends to the proximal end of the delivery catheter 2508. After expansion of the ballstent 100, the loop of material is pulled toward the proximal end of the delivery catheter 2204, which tears a portion of the neck 2202 away from the expanded ballstent 100 to separate the ballstent from the delivery catheter.

[00126] In another embodiment shown in FIGS. 21A-C, the neck 2202 of the ballstent 100 may be cut by one or more blades 2302A-D. In this embodiment, a cutting device 2304 is advanced over the delivery catheter 2204. The cutting device 2304 has a cutting region 2308 that includes the blades 2302A-D. When the expanded ballstent 100 is to be separated from the delivery catheter, the cutting device 2304 is positioned such that the neck 2202 is within the cutting region 2308. The blades 2302A-D may then be actuated to sever the neck 2202. By way of example and not limitation, the blades 2302A-D may be actuated by rotation of the cutting device, insertion of a wire, retraction of a wire, or other suitable methods. FIGS. 21B-C are cross-sectional views along line B-B of the cutting region prior to (FIG. 21B) and during actuation of the blades (FIG. 21C).

[00127] In another embodiment, shown in FIG. 22, the neck 2202 of the ballstent 100 may define a plurality of circumferential perforations 2406 that may be tom to separate the ballstent from the delivery catheter 2204.

[00128] In another embodiment, a ring structure is fixed to the distal end of the delivery catheter, while a second ring structure is fixed to the proximal end of the ballstent, with a mating of the two rings attaching the ballstent to the delivery catheter. After expansion of the ballstent, the rings can be disengaged, resulting in separation of the expanded ballstent 100 and the delivery catheter. The unlocking of the rings could be accomplished by actuating a spring-loaded clamp or other similar methods in order to release the ballstent.

02235920X112-01

227440/3 [00129] In other embodiments, hydraulic methods may be used to separate the expanded ballstent 100 from the delivery catheter device. In one embodiment, the expanded ballstent 100 separates from the delivery catheter after fluid is injected through a lumen to actuate a mechanical joint between the ballstent 100 and the delivery catheter, resulting in separation of the expanded ballstent 100 and the delivery catheter.

[00130] In one embodiment, a mechanical attachment is made between a ballstent and a delivery catheter wherein a portion of the ballstent is attached to the distal portion of the delivery catheter using one or more welds or solder 316 that are not insulated, and sensitive to electrolysis. For this embodiment, an electrolysis wire 320 or an insulated conductor wire extends along the length of the delivery catheter from the proximal end of the delivery catheter 300 or 400. The electrolysis wire 320 or an insulated conductor wire can electrically couple a source of electrical current outside the patient’s body to the weld or solder that attaches the ballstent to the delivery catheter. In this way, the electrolysis wire 320 or the insulated conductor wire is in electrical communication with the weld or solder that attaches the ballstent to the delivery catheter. In various embodiments, the insulated conductor wire or the electrolysis wire 320 can lie within the wall of the delivery catheter 300 or 400, along the exterior surface of the delivery catheter, or within a lumen of the delivery catheter. The electrolysis wire 320 or insulated conductor wire is in electrical communication with the weld or solder between the ballstent and the delivery catheter. In some embodiments, the electrolysis wire 320 is insulated, wherein the weld or solder is not insulated. In some embodiments, the electrolysis wire 320 and the ballstent 100 are insulated, while the weld or solder 316 is not insulated. In other embodiments, the electrolysis wire 320 and the weld or solder 316 is insulated, but a portion of the ballstent 100 is not insulated. An electrical current is applied to the electrolysis wire 320 or the insulated conductor wire after the ballstent 100 is expanded. The current is applied in an amount and for a time sufficient to dissolve at least a portion of the weld or solder and separate the delivery catheter from the ballstent 100, leaving the ballstent expanded at the desired position while the delivery catheter is removed. In another embodiment, the current is applied in an amount and for a time sufficient to dissolve at least a portion of the ballstent and separate the delivery catheter from the ballstent 100, leaving the ballstent expanded at the desired position while the delivery catheter is removed. In one embodiment the current is a direct current (DC) while in another embodiment, the current is an alternating current (AC). The electrolysis wire 320 or the insulated conductor wire is in electrical

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227440/3 communication with the weld or solder 316. In this embodiment, a DC current is applied to the insulated conductor wire or the electrolysis wire 320 after the ballstent 100 is expanded.

The DC current dissolves at least a portion of the weld or solder 316, resulting in separation of the ballstent 100 and the delivery catheter, and leaving the ballstent 100 expanded at the desired position while the delivery catheter is removed.

[00131] FIG. 29 depicts another embodiment for separating an expanded ballstent and the delivery catheter by electrolysis. For this embodiment, a portion of the ballstent 100 is affixed to the delivery catheter 400 by an adhesive 318. An electrolysis wire 320 or an insulated conducting wire extends along the length of the delivery catheter from the proximal end of the delivery catheter 400, where it can be coupled to a power source or source of electrical current 3100 outside the patient’s body, to the distal portion of the delivery catheter where it is coupled to the proximal portion of the ballstent 100. In this way, the electrolysis wire 320 or insulated conducting wire is in electrical communication with the portion 3102 of the ballstent that is not insulted and that is not bonded to the delivery catheter. In various embodiments, the electrolysis wire 320 or the insulated conductor wire can lie within the wall of the delivery catheter 400, along the exterior surface of the delivery catheter, or within a lumen of the delivery catheter. In another embodiment, the insulated conductor wire or the electrolysis wire 320 is in electrical communication with the proximal portion of the ballstent 3103. In some embodiments, the electrolysis wire 320 is insulated, wherein a proximal portion 3102 of the ballstent 100 is not insulated. In some embodiments, the electrolysis wire 320 and the remainder of the ballstent 100 and 116 are insulated, while a proximal portion 3102 of the ballstent 100 is not insulated. An electrical current or charge is applied to the electrolysis wire 320 after the ballstent 100 is expanded. The current is applied in an amount and for a time sufficient to dissolve at least a portion of the non-insulated portion 3102 of the ballstent 100, resulting separation the delivery catheter from the ballstent 100, leaving the ballstent expanded at the desired position while the delivery catheter 400 is removed. In one embodiment the current is a direct current (DC) while in another embodiment, the current is an alternating current (AC). In this embodiment, a DC current is applied to the electrolysis wire 320 or the insulated conductor wire after the ballstent 100 is expanded. The ballstent 100 functions as a cathode, while a grounding pad 3106 functions as an anode. The DC current dissolves at least a portion of the non-insulated portion 3102 of the ballstent 100, resulting in separation of the ballstent 100 and the delivery catheter, and leaving the ballstent 100 expanded at the desired position

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227440/3 while the delivery catheter is removed. In one embodiment, the exterior, the interior, or both of the ballstent neck 116 may be coated with an insulating substance, such as a polymer including but not limited to Parylene™. In another embodiment, the exterior, the interior, or both of the ballstent neck 116 and the ballstent (except for portion 3102) may be coated with an insulating substance, such as a polymer including but not limited to Parylene™. The electrolysis wire 320 or the insulated conductor wire is then brought into physical contact, or otherwise electrically coupled, with a portion 3102 of the neck 116 that is uncoated and not otherwise insulated. The uncoated portion 3102 of the neck 116 may be intentionally left uncoated during the coating process or may be exposed after coating by etching or ablation, as with a laser, or other suitable processes. The remainder of the ballstent may be coated and insulated (inside surface, outside surface, or both surfaces) to reduce the time required to dissolve the portion 3102 of the ballstent that is not coated or insulated.

[00132] In another embodiment, as shown in FIGS. 26A-B, a mechanical attachment is made between a ballstent and a delivery catheter wherein a portion of the ballstent is attached to the distal portion of the delivery catheter using an adhesive or binding agent 2700 that melts with heating (such as with a low melting temperature binding agent) when applied between the hollow cylindrical member 306 of the delivery catheter 400, and the ballstent. After expansion of the ballstent, an electrical current is passed through the resistance heating element 2702 in electrical communication with a conduction wire 2704, resulting in warming of the adhesive or binding agent. As the binding agent 2700 is melted, the ballstent 100 is separated from the delivery catheter 306. The binding agent 2700 may be metal (e.g. gold foil) or a polymer binding agent that is positioned at the neck of the ballstent.

[00133] In another embodiment, a mechanical attachment is made between a ballstent and a delivery catheter wherein a portion of the ballstent is attached to the distal portion of the delivery catheter using one or more bonds that are sensitive to chemical dissolution. The bonding medium may be composed such that the bonding medium dissolves when contacted by a solution with a high salt concentration, an acid, a base, or a specific chemical. By way of example and not limitation, a cover or other shielding device may be removed from the region where the ballstent 100 is joined to the delivery catheter to expose the bonding medium. Also by way of example and not limitation, injection or infusion of a solution with a high salt concentration, an acid, a base, or a specific chemical

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227440/3 to the region of the bonding, after expansion of the ballstent at the desire location can result in dissolution of the bonding medium and separation of the expanded ballstent and the delivery catheter.

[00134] In another embodiment, a mechanical attachment is made between a ballstent and a delivery catheter wherein a portion of the ballstent is attached to the distal portion of the delivery catheter using one or more bonds that are sensitive to chemical dissolution. The bonding medium may be composed such that the bonding medium dissolves when contacted by a solution with a high salt concentration, an acid, a base, or a specific chemical. By way of example and not limitation, a cover or other shielding device may be removed from the region where the ballstent 100 is joined to the delivery catheter to expose the bonding medium. Also by way of example and not limitation, injection or infusion of a solution with a high salt concentration, an acid, a base, or a specific chemical to the region of the bonding, after expansion of the ballstent at the desire location can result in dissolution of the bonding medium and separation of the expanded ballstent and the delivery catheter.

[00135] In another embodiment, a mechanical attachment is made between a ballstent and a delivery catheter wherein a portion of the ballstent is attached to the distal portion of the delivery catheter using one or more adhesives, glues, bonds, welds, or solder that are sensitive to sonic waves. In this embodiment, the bond between the ballstent 100 and the delivery catheter is broken using sound waves, such as focusing pulsed ultrasound waves, resulting in separation of the delivery catheter and the expanded ballstent.

[00136] In one embodiment, the wall opening of the expanded ballstent 100 is left open at the end of the procedure. In other embodiments, the wall opening of the expanded ballstent 100 is closed prior to the end of the procedure. By way of example and not limitation, an opening may be sealed by applying an external force, such as with the inflation of the balloon portion of a balloon catheter adjacent to the expanded ballstent. Alternatively, an opening may be sealed by snugging a loop of flexible material around the external surface of the neck of the ballstent 100 prior to separation of the expanded ballstent and the delivery catheter. In this method, the loop of material may comprise a wire, polymer strand, filament, string, thread, or snare.

[00137] According to any of the methods where the ballstent 100 is separated from delivery catheter, one or more radiopaque markers may be incorporated into the appropriate portions of the ballstent or delivery catheter to assist in the positioning of the

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227440/3 ballstent, expansion of the ballstent, separation of the expanded ballstent from the delivery catheter, and removal of the delivery catheter after separation. For example, a radiopaque marker band or spot may be incorporated into the medical device to identify the location where separation is intended to occur. In addition, radiopaque material may be incorporated into the ballstent. Also, a radiopaque spot or marker band or spot may be incorporated into distal end of the delivery catheter so that the tip of the delivery catheter can be seen under fluoroscopy while pulling the delivery catheter away from the expanded ballstent. A radiopaque spot or marker band may also be placed onto the detachment components, as need be. The radiopaque marker may be comprised of various radiodense materials, including but not limited to a metal band, a metal spot or line, or a line of barium.

[00138] According to any of the methods where the ballstent 100 is separated from delivery catheter, one or more radiopaque markers may be incorporated into the appropriate portions of the ballstent or delivery catheter to assist in position of the ballstent, expansion, separation of the expanded ballstent from the delivery catheter, and removal of the delivery catheter after separation. For example, a radiopaque marker band or spot may be incorporated into the medical device to identify the location where separation is designed to occur. In addition, radiopaque material may be incorporated into the ballstent. Also, a radiopaque marker band or spot may be incorporated into distal end of the delivery catheter so that the tip of the delivery catheter can be seen under fluoroscopy while pulling the delivery catheter away from the expanded ballstent. A radiopaque marker may also be placed onto the detachment components, as need be. The radiopaque marker may be comprised of various radiodense materials, including but not limited to a metal band, a metal spot or line, or a line of barium.

Methods of Use [00139] The shape of a ballstent 100 that has been expanded in the lumen of a saccular aneurysm is determined, in part, by the formed shape of the ballstent. For example, in some embodiments, the ballstent 100 is manufactured into a round, oblong, irregular, or non-spherical orientation to match the contours of the cavity for a particular saccular aneurysm 700. The expanded shape is also determined by the size and shape of the lumen of the saccular aneurysm. The expanded shape can also be determined by the application of an external force, such by inflating the balloon portion of a balloon catheter adjacent to the

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227440/3 expanded ballstent. In certain embodiments of the methods, the balloon portion 1102 of a balloon catheter 1100 is inflated in the lumen of the parent blood vessel 1202 adjacent to the expanded ballstent 100 in the lumen of the aneurysm sac, thereby pushing the wall 1104 of the ballstent 100 toward the aneurysm. In other embodiments, the ballstent 100 is manufactured into a non-spherical orientation to match the contours of the cavity for a particular saccular aneurysm 700.

[00140] In all embodiments, the expanded shape of the ballstent 100 is determined by the following factors: 1) the manufactured shape of the ballstent 100; 2) the degree of ballstent expansion; 3) the size and shape of the aneurysm 700; and 4) the effect of any applied external force on the ballstent after expansion. By way of example and not limitation, the manufactured size and shape of the ballstent 100 may be determined by making measurements of the aneurysm 700. The measurements can be made by using medical images, including two dimensional and three dimensional reconstructions, and standard distance reference markers. Other methods of measuring the aneurysm may also be used.

[00141] In another embodiment, the position, size, and shape of the expanded ballstent can be manipulated while positioned within the aneurysm 700. In this embodiment, it is not necessary to determine the precise contours of the aneurysm 700 prior to inserting the ballstent 100. The ballstent 100 is shaped by the degree of expansion of the ballstent and the application of external forces. For example, an external force may be applied by inflating the balloon portion of a balloon catheter adjacent to the expanded ballstent, or by tools inserted through or around the delivery catheter 400 or guide catheter 800. In other embodiments, the ballstent 100 may be shaped in a step prior to or after the step of separating the expanded ballstent from the delivery catheter 400.

[00142] In embodiments, the ballstent is designed so that the exterior surface 110 or 124 of the expanded ballstent 100 makes contact with a substantial portion of the inner surface 704 of the aneurysm 700. In some embodiment, the exterior surface 110 or 124 of the ballstent 100 makes contact with at least 50%, 75%, 90% or more of the inner surface 704 of the aneurysm 700, including up to 100%. In embodiments, the expanded ballstent is designed to fill the lumen of the aneurysm sac 701. In one embodiment, the expanded ballstent 110 fills at least 50%, 75%, 90% or more of the volume of the lumen 701 of the aneurysm 700, including up to 100%.

02235920\l 12-01

227440/3 [00143] In all embodiments, the ballstents are configured to maintain their expanded shapes and expanded ballstents are not designed for, or intended to be, compressed or flattened into disc-like structures before or after separation from the delivery catheter.

[00144] By way of example and not limitation, a method of using the device 500 to treat a patient may include the steps of examining a patient and collecting diagnostic medical images to identify a saccular aneurysm. The vascular system may be accessed using any suitable method including accessing an artery using the Seidinger technique. A guide wire 302 is then inserted into the vascular system. Then a guide catheter 800 is inserted into the vascular system and advanced into or near the lumen of the saccular aneurysm. The position and luminal dimensions of the saccular aneurysm are then visualized by an intra-arterial injection of radiographic contrast solution under fluoroscopy. The guide wire 302 is removed and the medical device 500 is then inserted through the guide catheter 800 until the compressed ballstent is advanced into the lumen 701 of the aneurysm 700. The ballstent 100 is then expanded in the lumen 701 of the aneurysm 700. A radiographic contrast solution may be injected into the parent vessel 1202 of the aneurysm 700 to confirm that the size of the expanded ballstent 100 is appropriate and that it is properly positioned in aneurysm. Once proper placement and sizing of the expanded ballstent 100 has been confirmed, the expanded ballstent is separated from the delivery catheter 300 or 400 by any of the methods disclosed herein, and the delivery catheter is removed. The expanded ballstent 100 is left in the patient, where subsequent examination may be conducted to determine if additional treatment is necessary. The expanded ballstent 100 left in the patient functions to prevent bleeding or expansion of the aneurysm, and as such it alleviates future medical problems the patient might experience had the aneurysm 700 not been treated.

[00145] By way of example and not limitation, a method of using the device 500 to treat a patient may include the steps of examining a patient and collecting diagnostic medical images to identify a saccular aneurysm. The vascular system may be accessed using any suitable method including accessing an artery using the Seidinger technique. A guide wire 302 is then inserted into the vascular system. Then a guide catheter 800 is inserted into the vascular system and advanced with the guide wire 302 until the guide wire 302 is positioned in or near the lumen of the saccular aneurysm. The position and luminal dimensions of the saccular aneurysm are then visualized by an intra-arterial injection of

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227440/3 radiographic contrast solution under fluoroscopy. The guide catheter 800 is removed and the medical device 500 is then inserted over the guide wire until the compressed ballstent 100 is advanced into the lumen 701 of the aneurysm 700. The guide wire 302 is removed. The ballstent is expanded 100 in the lumen 701 of the aneurysm 700. A radiographic contrast solution may be injected into the parent vessel 1202 of the aneurysm 700 to confirm that the size of the ballstent 100 is appropriate and that it is properly positioned in aneurysm. Once proper placement and sizing of the expanded ballstent 100 has been confirmed, the expanded ballstent is separated from the delivery catheter 300 or 400 by any of the methods disclosed herein and the delivery catheter is removed. The expanded ballstent 100 is left in the patient, where subsequent examination may be conducted to determine if additional treatment is necessary. The expanded ballstent 100 left in the patient functions to prevent bleeding or expansion of the aneurysm, and as such it alleviates future medical problems the patient might experience had the aneurysm 700 not been treated.

[00146] In various embodiments, a medical kit may be provided for treating a patient with the medical device. The medical kit may include the medical device 500, a guide wire 302, one or more guide catheters 800, one or more ballstent support structures, and methods for separating the expanded ballstent 100 from the delivery catheter 300 or 400 including separate medical devices for separation, components of the medical device 500 for separation, and methods of use. The medical kit may further include instructions for use.

[00147] Two or more ballstents 100A-B may be used in combination to fill the lumen or void 701 of the aneurysm sac 700, as illustrated in FIG. 27. Additionally, a second, third, or more ballstents may be required to fill the remaining portion of the aneurysm sac not filled by the first ballstent.

A Hypothetical Method of Treating a Patient Having a Cerebral Aneurysm [00148] A hypothetical method for using the medical device 500 to treat a patient having a saccular cerebral aneurysm may begin with one or more pre-surgical consultations, where a number of tests may be performed. The tests may include blood tests, urine tests, an electrocardiogram, and imaging tests including a head CT, a head MRI, and a cerebral angiogram, among others. From the diagnostic imaging tests, images and measurements of the aneurysm may be obtained demonstrating the position, size, and shape of the aneurysm.

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227440/3

The consultations may occur several days before, or on the same day, that the procedure is performed.

[00149] On the day of the procedure, the patient is prepared for the procedure and typically given local anesthesia. The patient’s groin is then prepped and draped in an aseptic manner. Then a physician accesses a femoral artery in the patient with a micropuncture set. A 0.035” soft tip guide wire 302 is inserted in a retrograde fashion into the femoral artery. A 6Fr vascular sheath is placed. A 5Fr diagnostic catheter is advanced over the guide wire until the tip of the 5Fr diagnostic catheter is in the lumen of the saccular cerebral aneurysm, where it can act as a guide catheter 800. While the physician is positioning the guide catheter 800, a surgical assistant prepares the ballstent portion 100 of the medical device by wetting the porous exterior layer 104 of the ballstent with a solution containing thrombin. The medical device 500 is advanced through the guide catheter 800 and positioned in the lumen 701 of the aneurysm sac 700. The tip of the guide catheter 800 is pulled back, exposing the compressed ballstent 100. After the compressed ballstent 100 is in the desired position, the compressed ballstent is expanded by injecting a saline solution through the lumen 312 of the delivery catheter 300 or 400 and into the central void 108 of the ballstent until the ballstent expands to fill at least a portion of the aneurysm. The physician obtains an angiogram of the aneurysm 700 and the parent artery 1202 by injection of radiographic contrast material in order to confirm that the expanded ballstent 100 is positioned properly within the lumen 701 of the saccular aneurysm 700 and fills the aneurysm adequately. The physician then connects the proximal end of the electrolysis wire 320 or the insulated conductor wire to a DC power source and applies a current to the electrolysis wire or insulated conductor wire which is electrically coupled to the neck 116 of the ballstent 100 in an amount, and for a time sufficient, to result in the dissolution of a circumferential strip of the neck of the ballstent that is uncoated and without insulation, resulting in separation of the expanded ballstent and the delivery catheter. The physician obtains another angiogram of the aneurysm 700 and the parent artery 1202 in order to confirm that the expanded, released ballstent 100 is positioned properly within the lumen of the saccular aneurysm and fills the aneurysm adequately. The physician removes the delivery catheter 400, and the guide catheter 800. The physician advances a balloon catheter 1100 over the guide wire 302 until the balloon 1102 is adjacent to the expanded ballstent 100. The balloon portion 1102 of the balloon catheter 1100 is then inflated with a saline solution until it fills the lumen of the parent artery 1202 and flattens and pushes the

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227440/3 wall 1104 of the expanded ballstent 100 toward the aneurysm 700. The physician obtains another angiogram of the aneurysm 700 and the parent artery 1202 in order to confirm that the expanded, released ballstent is positioned properly within the lumen of saccular aneurysm, fills the aneurysm adequately, and that the lumen of the parent artery 1202 is free of obstruction. The physician withdraws the balloon catheter 1100, the guide wire 302, and the sheath and achieves hemostasis of the femoral artery puncture with compression. The patient is then transported to a recovery room. During and after recovery, the physician periodically monitors the patient as well as the position of the metal ballstent 100 and the completeness of the sealing of the aneurysm 700.

[00150] It will be appreciated that the devices and methods of the present invention are capable of being incorporated in the form of a variety of embodiments, only a few of which have been illustrated and described above. The disclosures herein may be embodied in other specific forms without departing from its spirit or essential characteristics. The described embodiments are to be considered in all respects only as illustrative and not restrictive and the scope of the present invention is, therefore indicated by the appended claims rather than by the foregoing description. All changes that come within the meaning and range of equivalency of the claims are to be embraced within their scope.

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227440/4

CLAIMS