JP7485486B2 - Medical device including a detachable balloon - Patents.com - Google Patents

Description

CROSS-REFERENCE TO RELATED APPLICATIONS
This disclosure relates to U.S. Provisional Patent Application No. 62/476,533, filed March 24, 2017, entitled “Expandable Body Devices and Methods of Making and Using”; U.S. Provisional Patent Application No. 62/553,705, filed September 1, 2017, entitled “Metalized, Metal Plated, Partially Metalized, Partially Metal Plated, Encased, Expandable Body Devices and Methods of Making and Using”; and U.S. Provisional Patent Application No. 62/553,705, filed September 1, 2017, entitled “Metalized, Metal Plated, Partially Metalized, Partially Metal Plated, Encased, Expandable Body Devices and Methods of Making and Using.” This application claims priority to U.S. Provisional Patent Application No. 62/623,287, filed January 29, 2018, entitled "Expandable Body Medical Devices and Methods of Making and Using"; and U.S. Provisional Patent Application No. 62/629,532, filed February 12, 2018, entitled "Metal, Polymer, Metallized, Metal Plated, Partially Metallized, Partially Metal Plated, and Metal Wrapped Expandable Body Medical Devices and Methods of Making and Using," the entire contents of each of which are incorporated herein by reference in their entirety.

The present disclosure relates to a first medical device comprising a balloon and a catheter or catheter assembly, where the balloon "detachable balloon catheter" can be delivered to a desired location in a patient in such a manner that the expanded balloon can be retained within the patient's body in a pleated, folded, expanded, and separate form from the catheter or catheter assembly while the catheter or catheter assembly is removed from the human patient. The present disclosure also describes a second medical device comprising an elongated or expandable body configured for use with a detachable balloon catheter, using all or a portion of the elongated or expandable body to help retain the size, shape, or position of the separate balloon of the detachable balloon catheter. Systems and kits comprising a detachable balloon catheter medical device and one or more elongated or expandable body medical devices are described. Use of a detachable balloon catheter medical device or system comprising a detachable balloon catheter medical device and one or more elongated or expandable body medical devices to reduce the flow of blood or other biological fluids in saccular aneurysms, arteries, veins, left atrial appendages, paravalvular leaks, other blood-containing structures, biological conduits, and biological spaces are described. Also disclosed are kits that include a detachable balloon catheter medical device and one or more elongated or expandable body medical devices, optionally together with other medical devices.

The ability of a percutaneous medical device to reach a specific location in the body depends on several factors. First, the device must be long enough to reach from the location where it was inserted (i.e., the insertion site) to the location where treatment is desired (i.e., the treatment site). Second, the device should be flexible enough to navigate a tortuous path from the insertion site to the treatment site, a property known as "traceability." For embolic devices, traceability includes the flexibility of the catheter or catheter assembly used to place the implant, as well as the implant itself. However, increasing the flexibility of the implant to improve the medical device's ability to reach a specific location in the body may increase the risk of it later deflated or compacting, potentially resulting in the reopening of the treated blood-containing structure, biological conduit segment, or biological space. Third, the device should have a low enough outer diameter or "profile" to easily pass through arteries, veins, or other biological conduits or spaces with small or irregular lumen diameters. Fourth, the device may generally be more easily and precisely placed when delivered over a guidewire. However, adding a guidewire lumen to a medical device typically increases its outer diameter, which can offset some of the advantages of the "over-the-wire" approach.

An aneurysm is a localized excessive enlargement of an artery caused by a weakening of the arterial wall. Aneurysms can rupture without warning, causing internal bleeding. Bleeding from a ruptured aneurysm in the brain can cause stroke and sometimes death. Outside the brain, bleeding from a ruptured aneurysm in the body can cause low blood pressure and sometimes death. There are two main types of aneurysms, fusiform and saccular aneurysms. Saccular aneurysms are round or saccular aneurysms joined or attached to an artery or artery branch by a neck. Saccular aneurysms can occur throughout the body, but are most commonly found in the arteries of the brain. Fusiform aneurysms are an outer sac of an aneurysm that expands in all directions without a distinct neck or stem. Fusiform aneurysms are less common than saccular aneurysms and are often left untreated because they rarely rupture. The rate of spontaneous rupture of saccular aneurysms increases with the size of the aneurysm, so large aneurysms seen during a medical or surgical evaluation are usually treated. Ruptured saccular aneurysms are almost always treated when possible. Saccular aneurysms can be treated surgically with placement of surgical clips to remove the saccular aneurysm from the bloodstream, or preferentially with minimally invasive catheter-based procedures.

Minimally invasive catheter-based endovascular devices and treatment methods have been developed to occlude, embolize, seal, or reduce blood flow within saccular aneurysms. During some treatments, small metal wire segments ("coils") are placed into the aneurysm sac to occlude the aneurysm or prevent further enlargement and rupture, a procedure known as "coiling." To treat an aneurysm with coils, a physician inserts a catheter into the lumen of the vascular system and places the catheter tip into the aneurysm sac. With the catheter tip in place, the physician pushes individual coils through the catheter and into the aneurysm lumen. During and after treatment, a thrombus forms within and around the coil, resulting in embolic occlusion of the aneurysm. Over time, the thrombus matures into fibrous tissue, covering the neck of the aneurysm and sealing the aneurysm from the neoartery. Although effective, coiling of saccular cerebral aneurysms has drawbacks. Coil placement is difficult to control, often resulting in protrusion of the coil into the parent vessel or migration of the coil to non-target locations, sometimes resulting in embolization of the flight defect. In the case of coil migration, physicians may be forced to attempt coil retrieval from non-target locations. Many coils are typically required during treatment, resulting in high costs and long treatment times. Furthermore, coils only partially fill the aneurysm sac. Thrombus and scar tissue accumulate and the aneurysm must be completely sealed, a process that can take months to years and is often incomplete. Slow sealing of the aneurysm may reduce the effectiveness of coils in treating acute aneurysm rupture with subarachnoid hemorrhage. Sealing of the aneurysm after coiling is often incomplete, placing patients at persistent risk of aneurysm rupture and resulting in unacceptably high retreatment rates. Even if the use of coils is initially effective, recanalization of the aneurysm occurs, resulting in blood flow returning to the aneurysm and increased risk of rupture. Incomplete filling of saccular aneurysms and inadequate sealing of the aneurysm with coils is especially common in the neck region of saccular aneurysms, where coil density is low and blood flow velocity is high. Coils are prone to compression, further exposing the aneurysm neck and increasing the recurrence rate of the aneurysm.

In some embodiments of the second medical device or first elongate body, a metal is selected and then the coil is made by a series of turns from a primary (1°) structure to a secondary (2°) structure to a tertiary (3°) structure. The primary structure is "stock" wire and is fabricated in a straight form with any range of diameters. Most stock wire used in coil manufacturing ranges from 0.00175 to 0.003 inches. The diameter of the stock wire is the primary factor that determines the "stiffness" of the coil. The stock wire is wound around mandrels of various diameters to create the secondary structure of the coil. The diameter of the secondary structure, along with the number of turns per unit length around the mandrel, represent two additional factors that affect the stiffness of the product. The secondary diameter determines the historical coil grouping, where coils considered to be "10" coils are typically wound to about 0.010 inches and coils considered to be "18" coils are typically wound to about 0.015 inches. However, many manufacturers currently make coils with secondary diameters between 0.010 and 0.015 inches, including 0.012 and 0.014 inch coil wire. The secondary diameter has important implications for both stiffness and packing damping. Finally, secondary structures can be molded into any number of tertiary configurations (helical, convoluted, spherical, etc.) and are developed with specific tertiary diameters and lengths, parameters that serve as central factors in package labeling and coil selection during interventional procedures. For example, coils are typically packaged as "3mm x 4cm," with the millimeter measurement being the tertiary diameter measurement and the centimeter measurement being the length measurement. As the metal for coils is readily available, so are the manufacturers that can mold it into a myriad of designs.

Biocompatibility of the first elongated body and the expandable body is very important. Biocompatible first elongated bodies and expandable bodies are composed primarily of inert materials, allowing for effective treatment without concern for systemic host responses. Metal alloys with proven records of patient safety have become the primary source for first elongated body, expandable body, and coil manufacturing. Nitinol, platinum, nickel, iridium, and tungsten are the primary metals used in construction and are usually developed as alloys to reach optimal strength. The strength of metals is determined experimentally and is called the modulus of rigidity or shear modulus. The modulus of rigidity is the shear modulus of elasticity defined as the ratio of shear stress to shear strain. The modulus of rigidity can be experimentally determined from the slope of the stress-strain curve created during torsion testing performed on metal specimens. Platinum (92%)/tungsten (8%) alloy has become the workhorse material for many current first elongated body and coil designs. Many metals in pure alloy form are readily available in hundreds of permutations from distributors worldwide.

Recently, traditional tubular stents have been indicated for the treatment of cerebral aneurysms. These stents are placed on a delivery device and placed in the parent vessel adjacent to the aneurysm. The stent is then expanded in the parent vessel with the delivery device, after which the delivery device is removed. The expanded metal stent diverts flow from the aneurysm sac and promotes thrombosis of the aneurysm. Although often effective, these "diverting" stents have drawbacks. First, the stent can cover and divert blood flow from important arterial branches adjacent to the aneurysm, causing ischemia and stroke. Second, the stent can cause thrombus and intimal hyperplasia in the parent vessel, causing thromboembolism and narrowing of the lumen that can lead to ischemia and stroke. Third, long-term anticoagulation is required after the stent is placed to divert flow, increasing the risk of hemorrhagic complications and stroke, and is contraindicated in patients who have already experienced aneurysm rupture and subarachnoid hemorrhage.

Recently, vascular plugs made of braided or woven nitinol wires have been indicated for the treatment of cerebral aneurysms. These devices pass through the lumen of a catheter and expand into the aneurysm sac when the catheter that guided their placement is retracted. The expanding device diverts flow from the aneurysm sac and promotes thrombosis of the aneurysm. Although often effective, these "intrasaccular" devices have drawbacks. First, in their compressed form, the devices are stiff and difficult to advance through the tortuous arteries of the cerebral circulation. Second, a large number of device sizes are required to treat many sizes and shapes of aneurysms. Despite the wide selection of sizes offered, the fit between the device and the aneurysm can be suboptimal increasing the risk of aneurysm persistence or recurrence. Third, intrasaccular devices are susceptible to compression and compaction that can reopen the aneurysm neck, increasing the risk of aneurysm persistence or recurrence.

Previous attempts have been made to develop and use detachable balloons for the treatment of saccular aneurysms. A detachable polymer balloon connected to a catheter is advanced into the aneurysm, inflated, and removed in an attempt to completely fill and occlude the aneurysm neck and sac. These devices and their associated methods of use suffer from several drawbacks that ultimately led to their abandonment in favor of other devices and methods. First, the balloons often did not completely occlude the aneurysm neck or completely fill the aneurysm sac, thus increasing the risk of aneurysm persistence or recurrence. Second, the balloons were typically made of flexible polymers such as latex and silicone, which generally resist tissue incorporation. This reduced fixation of the device to the aneurysm wall and increased the risk of balloon migration and embolization of the downstream arterial segment. Third, the balloons were elastic and used valves to maintain the high internal pressures after detachment necessary to maintain their expanded size and shape. Unfortunately, there was a significant rate of valve failure resulting in balloon deflation leading to aneurysm recanalization and balloon migration.

There remains an unmet clinical need for medical devices, catheter-based medical devices, systems, and methods for effectively and reliably occluding, embolizing, sealing, or reducing blood flow within saccular aneurysms, including cerebral aneurysms. The devices should be low profile, flexible, easy to use, and capable of rapid, highly precise placement. Additionally, the devices should provide immediate and complete occlusion of the aneurysm neck and sac with one or a few devices requiring limited size and number to treat the majority of aneurysms at a reasonable cost, reducing the need for chronic anticoagulation. Finally, the devices should provide durable and permanent occlusion and sealing of saccular aneurysms with low device collapse, compression, or compaction, and low rates of aneurysm persistence or recanalization.

In certain clinical situations, patients may benefit from occlusion, embolization, or sealing and reducing blood flow in an artery or arterial segment. Clinical situations in which endovascular arterial occlusion is beneficial include bleeding from damaged blood vessels, reducing blood flow to tumors, and isolating abnormalities and malformations by rerouting blood within the vascular system. Therefore, minimally invasive, catheter-based endovascular procedures have been developed to occlude arteries and arterial segments.

Medical devices for endovascular arterial occlusion include coils that can be pushed through a catheter (i.e., "pushable coils") that are deposited into the lumen of the target arterial segment. There are advantages to using coils for arterial occlusion. The devices are flexible and very long and thin, allowing easy advancement into small, distal and tortuous vessels. They are also relatively inexpensive. However, as with their use in saccular aneurysms, they have drawbacks. Accurate placement of coils within the artery is difficult, and misplacement, migration, and non-target embolization are common. Because they present a porous barrier to blood flow, many coils are often required for complete arterial occlusion, leading to increased treatment time and cost. Slow recanalization or reopening of the treated arterial segment is common with coiling.

Endovascular medical devices for arterial occlusion also include self-expanding vascular plugs that can be pushed through a catheter and deposited in the lumen of the target arterial segment. There are advantages to using vascular plugs for arterial occlusion. The devices can be placed with greater precision than coils. Also, a single device is often all that is needed for arterial occlusion, reducing the complexity of treatment. However, like coils, there are disadvantages. The devices are often difficult to place in stiff, small, distal, and tortuous arteries, and the time required for the device to completely occlude the artery can be increased. They also frequently exhibit slow recanalization of the treated arterial segment.

Previous attempts have been made to develop and use detachable balloons for arterial occlusion, in which a polymer balloon is inflated to fill the lumen of the target arterial segment and detached from the catheter. A compliant detachable polymer balloon connected to the catheter is advanced into the target arterial segment, inflated, and detached in an attempt to completely fill and occlude the arterial segment. There are two major advantages to using detachable balloon catheters for arterial occlusion. First, these devices have a low profile and are very flexible, allowing for the treatment of small, distal, and tortuous arteries. Second, after inflation, the expanded, compliant balloons generally conform well to the irregularities of the surrounding vessel wall, often providing a good seal against the arterial wall and good acute occlusion performance. However, these devices and associated methods of use have several drawbacks and have been largely abandoned in favor of other devices and methods. First, the devices are typically made from compliant polymers such as latex and silicone, which generally resist tissue uptake. Reduced fixation of the device to the arterial wall increases the risk of balloon migration. Second, the balloon is elastic and uses a valve to maintain the high internal pressure after detachment, which is necessary to maintain the expanded size and shape. Unfortunately, there is a substantial rate of valve failure that results in balloon deflation, often resulting in recanalization of the treated arterial segment and increasing the risk of balloon migration. Third, the polymers used to manufacture the balloon are biodegradable in vivo. Breakdown of the balloon wall increases the risk of balloon deflation and recanalization of the treated arterial segment.

There is an unmet clinical need for medical devices, catheter-based medical devices, systems, and methods that efficiently and reliably embolize, seal, or reduce blood flow in arteries and arterial segments. The devices are needed to be low profile, highly flexible, easy to use, and capable of rapid, highly accurate placement. Additionally, the devices should have a reasonable cost and provide immediate and complete arterial occlusion with one or a few devices requiring a limited number of sizes and shapes to occlude most arteries. Finally, the devices should provide durable and permanent occlusion and sealing of saccular aneurysms with low rates of device withering, compression, compaction, and migration, and low rates of aneurysm recanalization.

The left atrial appendage (LAA) is a small, sac-like projection of the muscular wall of the left atrium. The LAA is generally considered a vestigial structure and has no defined function. In a normal heart, the heart contracts with each heartbeat. During left atrial contraction, blood in the left atrium and LAA is ejected into the left ventricle. Electrical impulses control the timing of the beating of the various ventricles of the heart. When these impulses are not conducted in an orderly fashion, rapid and chaotic impulses can occur, reducing the coordination of atrial contractions and limiting the ejection of blood from the left atrium and LAA, a condition known as atrial fibrillation, which affects an estimated 2.7 million Americans. Blood flow in the left atrium and LAA of patients with atrial fibrillation is slow, increasing the risk of blood clot formation. When blood clots form in the LAA, they break free from the walls of the LAA and are pumped out of the heart. As a result, people with atrial fibrillation are five to seven times more likely to suffer a stroke than the general population. Patients with atrial fibrillation who are at risk of developing blood clots in the left atrium and LAA may take blood thinners to reduce their stroke risk. Patients who are contraindicated to taking blood thinners or who do not want to take blood thinners chronically may be eligible for a procedure to seal the LAA, which would reduce their risk of stroke and eliminate the need to take blood-thinning medications. Boston Scientific developed the Watchman, a catheter-delivered device, to occlude and seal the LAA. Although effective in reducing strokes in patients with atrial fibrillation, patients who received the Watchman in clinical trials showed a higher rate of embolic strokes than expected. Also, doctors were unable to implant the Watchman in some patients who had been assigned to get the device.

Some patients with atrial fibrillation may benefit from embolizing, occluding, sealing, or reducing the flow of blood in their LAA. Clinical settings in which occlusion of the LAA is beneficial include reducing the risk of embolic stroke in patients with atrial fibrillation in whom chronic anticoagulation is contraindicated. Medical devices and methods for minimally invasive, catheter-based occlusion of the LAA have been developed. Currently available devices generally comprise a porous cover over an expandable metal cage with a retaining hook. Although effective, these devices have drawbacks. The porous cover can seep into and out of the LAA, increasing the risk of thrombus formation on the device. The cage support structures are rigid when compressed, making it more difficult to advance the device into the LAA. When expanded, they are rigid and may not optimally fit the highly variable shape of the LAA. Gaps between the device and the wall of the LAA allow thrombus to escape from around the expanded device, which can also cause stroke. The outer diameter of the delivery system or the compressed, cloth-covered metal cage is large, and a large hole through the interatrial septum is necessary to gain access to the left atrium from venous access. Holes left in the interatrial septum after treatment may be slow to heal, resulting in persistent left-to-right shunting of blood, increasing the work the heart must do. Holes also increase the risk of paradoxical emboli of thrombi from the right atrium entering the left atrium and then reaching the arterial circulation.

There remains an unmet clinical need for medical devices, catheter-based medical devices, systems, and methods to effectively and reliably occlude, embolize, seal, or reduce blood flow within the LAA. The devices should be low profile, highly flexible, easy to use, and capable of rapid, highly precise placement. Additionally, the devices should provide immediate and complete occlusion of the LAA, present a firm, well-cleaned surface to the left atrium, and rapidly endothelialize, resulting in a durable, highly permanent occlusion rate of the LAA.

In certain clinical situations, patients may benefit from occluding, embolizing, sealing, and reducing blood flow in veins or venous segments. Clinical situations in which endovascular venous occlusion is beneficial include damaged blood vessels such as bleeding esophageal varices, painful veins such as pelvic varices, and rerouting blood within the vascular system to isolate vascular abnormalities and malformations. Therefore, minimally invasive, catheter-based endovascular procedures have been developed to occlude veins and venous segments.

Intravascular venous occlusion medical devices include pushable coils delivered via a catheter and deposited in the lumen of the target vein segment. There are advantages to using venous occlusion coils. The devices are flexible and highly elongated, making them easy to advance into small, distal, and tortuous vessels. They are also relatively inexpensive. However, as with their use in arteries, accurate placement of coils in veins is difficult, and misplacement, migration, and non-target embolization are common. Device migration is especially common in veins, as the diameter of the vein increases from distal to proximal. When placed in a vein, the coils become free and are prone to travel long distances. Often, coils traveling in veins end up in critical structures such as the right atrium, right ventricle, or pulmonary artery.
Because they present a porous barrier to blood flow, multiple coils are often required for complete venous embolization, resulting in increased treatment time and costs. Finally, slow recanalization of treated venous segments is also common.

Intravascular medical devices for venous occlusion also include self-expanding vascular plugs that can be pushed through a catheter and deposited in the lumen of the target vein segment. There are advantages to using vascular plugs for venous occlusion. The devices can be placed with greater precision than coils. Also, a single device is often all that is needed for venous occlusion, reducing the complexity of treatment. However, like coils, there are drawbacks. The devices are often stiff, making them difficult to place in small, distal, and tortuous veins. Like coils, vascular plugs present a porous barrier to blood flow, which can increase the time required for the device to completely occlude the vein. They also often exhibit slow recanalization of the treated vein segment. Like coils, migration is also common, and coils placed intravenously often remain in vital structures such as the right atrium, right ventricle, or pulmonary artery.

Previous attempts have been made to develop and use detachable balloons for venous occlusion, where a polymer balloon is inflated to fill the lumen of the target vein and removed from the catheter. A compliant detachable polymer balloon coupled to a catheter is advanced into the target vein segment, inflated, and removed in an attempt to completely fill and occlude the vein segment. There are two major advantages to using detachable balloon catheters for venous occlusion. First, these devices have a low profile and are very flexible, allowing for the treatment of small, distal, and tortuous veins. Second, after expansion, the expanded, compliant balloons generally conform well to irregularities around the vessel wall, often providing good acute occlusion performance and excellent sealing against the vein wall. However, these devices and associated methods of use have several drawbacks and have been largely abandoned in favor of other devices and methods. First, the devices are typically made from compliant polymers such as latex and silicone, which generally resist tissue incorporation. Reduced fixation of the device to the vein wall increases the risk of balloon migration. Second, the balloon is elastic and uses a valve to maintain the high internal pressure after separation that is necessary to maintain the expanded size and shape. Unfortunately, there is a substantial rate of valve failure resulting in balloon deflation, often resulting in recanalization or reopening of the treated vein segment, increasing the risk of balloon migration. As with coils and vascular plugs, migration is common, and detachable balloons placed in veins often remain in vital structures such as the right atrium, right ventricle, or pulmonary artery. Third, the polymers used to manufacture the balloon are biodegradable in vivo. Disruption of the balloon wall increases the risk of balloon deflation and reopening or reopening of the treated vein segment.

There is an unmet clinical need for medical devices, catheter-based medical devices, systems, and methods to efficiently and reliably occlude, embolize, seal, and reduce blood flow in veins and vein segments. The devices should be low profile, highly flexible, easy to use, and capable of rapid, highly accurate deployment. Additionally, the devices should provide immediate and complete venous occlusion with one or a few devices having a reasonable cost, requiring a limited size and shape for most occlusion of most veins. Finally, the devices should provide durable, permanent occlusion of veins with low rates of device withering, compression, compaction, or migration, and low rates of recanalization of treated vein segments.

Valves in the heart can become blocked and leak, resulting in reduced cardiac output, increased cardiac workload, or both. These faulty valves can be repaired or replaced, either during surgery or minimally invasive procedures. After valve repair and replacement, new leaks may develop in areas adjacent to the valve, reducing cardiac output and increasing the workload of the heart. These leaks can also cause kidney damage and lead to blood damage, including hemolysis of red blood cells, which can result in anemia. Patients who develop these "paravalvular leaks" can benefit from occlusion of the leaking pathways, improving cardiac output, reducing the strain on the heart, and reducing blood damage. Currently, there are no medical devices specifically approved for the treatment of paravalvular leaks. Physicians sometimes use self-expanding vascular plugs that can be pushed through a catheter and deposited in the lumen of the paravalvular leaking pathway to occlude it. However, this approach has drawbacks. The devices are stiff and difficult to place. They also present a porous surface to the bloodstream that prevents some devices from completely occluding the leaking pathway, which can be large and have high blood flow rates. The irregular porous surface of the device is susceptible to thrombus formation. Subsequent subsequent release and embolization of these thrombi can lead to stroke. As with many porous devices, complete endothelialization of the vascular plug is slow and often incomplete, resulting in a persistently increased risk of thrombus formation and thromboembolism.

There remains an unmet clinical need for medical devices, catheter-based medical devices, systems, and methods for effectively and reliably occluding paravalvular leaks. The devices must be low profile, highly flexible, easy to use, and capable of rapid, precise deployment. Additionally, the devices must provide rapid and complete occlusion of the leak pathway, be resistant to thrombus formation, and have a surface that rapidly endothelializes. Finally, the devices must provide durable and permanent occlusion of the leak pathway with low rates of device collapse, compression, or compaction, and recanalization.

In certain clinical situations, patients may benefit from the occlusion, embolization, or sealing and reduction of the flow of fluids or materials within a biological conduit. Clinical situations in which occlusion of an intravascular conduit is beneficial include the intentional occlusion of fallopian tubes to prevent pregnancy. Minimally invasive, catheter-based endovascular procedures have been developed to occlude biological conduits.

There remains an unmet clinical need for medical devices, catheter-based medical devices, systems, and methods for effectively and reliably occluding biological conduits. The devices are required to be low profile, highly flexible, easy to use, and capable of being rapidly positioned with high precision. Additionally, the devices should provide immediate and complete duct occlusion with one or a few devices with reasonable cost, and require limited sizes and shapes to occlude most conduits. Finally, the devices should provide durable, permanent occlusion of the conduit with low rates of device withering, compression, compaction, or migration, and low rates of recanalization of the treated conduit segment. Examples of biological conduits include arteries, veins, thoracic ducts, lymphatic ducts, pancreatic ducts, bile ducts, fallopian tubes, bronchi, ureters, urethras, esophagus, duodenum, jejunum, ileum, colon, ducts deferens, salivary ducts, parotid ducts, mammary ducts, Schlemm's canal, lacrimal and nasolacrimal ducts, cerebral aqueducts, peripheral nerve sheaths, and other tubular structures or channels in humans that carry biological fluids and suspensions, solid or semi-solid biological materials, gases, or air. Examples of biological fluids, solid or semi-solid biological materials, gases, or air include blood, lymphatic fluid, cerebrospinal fluid, urine, bile, pancreatic juices, saliva, milk, tears, aqueous humor, eggs, semen, pulmonary secretions, food, water, feces, expired or exhaled air.

There is an unmet clinical need for medical devices, catheter-based medical devices, systems, and methods for effective and reliable placement of balloons, elongate bodies, and expandable bodies in biological spaces. The devices need to be low profile, flexible, easy to use, rapidly deployable with precision, and resistant to collapse, compression, compaction, or migration. As used herein, biological space can mean a contiguous area or expanse in a human patient, including a contiguous area or expanse that is free, available, or unoccupied.

Additionally, there remains a need for methods of manufacturing medical devices for treating, occluding, or sealing saccular aneurysms (including cerebral aneurysms), arteries, veins, other hollow vessels or blood-containing structures, or biological conduits or spaces, which incorporate detachable polymer balloons, detachable metallic balloons, detachable polymer-coated metallic balloons (including fully polymer-coated metallic balloons, and partially polymer-coated metallic balloons), and detachable metallized polymer balloons (including fully metallized polymer balloons and partially metallized polymer balloons). The balloon is then expandable to fill the void at the target location, and there remains a need to manufacture detachable balloon medical devices that can be delivered through the lumen of an artery, vein, blood-containing structure, or biological conduit or space, where the balloon can be inflated, fill the void at the target location, and then removed from the delivery device, catheter, catheter assembly, and the balloon remains in an expanded or partially expanded configuration without the need for a valve or other device to maintain inflation pressure within the balloon. There remains a further need to produce a detachable balloon medical device, which has acceptable biocompatibility, optionally uses a textured or microtextured surface to reduce the risk of balloon migration and promote tissue incorporation into the balloon wall. There remains a need to produce a metallized polymer balloon of such a medical device by applying metal to the surface of the polymer balloon by a mechanical process such as wire wrapping, an electrochemical process such as electroplating, electroforming, sputtering, or a combination thereof. There also remains a need to produce a medical device comprising an elongated or expandable body that can be delivered through the lumen of a second catheter of a (first) medical device that includes a detachable balloon, and used to fill a void at a target location, either in an aneurysm, an artery, a vein, the LAA, a perivalvular leak pathway, a blood-containing structure, a biological conduit, or the central void or interior volume of a detachable balloon.

The present invention relates to medical devices comprising detachable balloon catheters or catheter assemblies and the use of these medical devices for occlusion, sealing or reduction of blood or other biological fluids in saccular aneurysms, arteries, veins, left atrial appendages (LAA), paravalvular leaks, other blood-containing structures, biological conduits or biological spaces. The detachable balloon of the detachable balloon catheter may comprise a polymer balloon, a metal balloon, a polymer-coated metal balloon, or a metallized polymer balloon. The present disclosure also relates to medical devices comprising elongated or expandable bodies and their use with detachable balloons, and catheters, or catheter assemblies, where one or more elongated or expandable bodies, or solid fluids can pass through the catheter of a medical device comprising a detachable balloon or catheter assembly, and a portion of the elongated or expandable body can be disposed adjacent to the expanded balloon, within the central void of the expanded balloon, or both within the expanded balloon and the central void of the expanded balloon to maintain the size, shape and position of the expanded balloon.

The present disclosure relates to device components, device methods and systems for delivering and positioning various embodiments of a detachable balloon of a detachable balloon catheter, the detachable balloon being sized and configured to fill and/or seal at least a portion of a saccular aneurysm, an artery, a vein, the LAA, a perivalvular leak pathway, other blood-containing structure, a biological conduit, or a biological space that is in place in the expanded state of the detachable balloon. The present disclosure also relates to device components, devices, methods and systems for delivering and positioning various embodiments of an elongated body or an expanded body after positioning and expanding the detachable balloon of a detachable balloon catheter. The elongated body or an expandable body is sized and configured to fill or seal at least a portion of a saccular aneurysm, an artery, a vein, the LAA, a perivalvular leak pathway, other blood-containing structure, a biological conduit, or a biological space that is in place in the expanded state of the detachable balloon, the elongated body or an expandable body that remains in place in the elongated or expanded state. The present disclosure describes medical devices or device components of specific lengths to enable the various described treatments. The present disclosure also describes devices or device components, including catheters, catheter assemblies, and detachable balloons, including retention structures, that enable the various described treatments.

The present disclosure solves some of the long-standing limitations of other devices designed for these purposes. Elongated books such as vascular embolization coils are highly flexible and trackable and can be advanced through tortuous arteries and veins and into small, distal vessels, allowing embolization of a wide range of blood-containing structures. However, when used alone, these vascular coil elongated bodies often result in slow or incomplete embolization. Expandable bodies such as vascular plugs are generally much stiffer than vascular coils, but similarly present a porous surface to the bloodstream when catheter passage is constrained. The present disclosure describes highly flexible medical devices that place a balloon at a target location that presents a solid surface to the blood or biological fluid flow, and then place one or more flexible elongated or expandable bodies that provide support for the balloon, help maintain size and shape by resisting balloon deflation, compression, and compaction, and, in certain instances, help maintain the position of the balloon to reduce the risk of balloon migration.

The present disclosure describes the use of a highly flexible catheter or catheter assembly (also referred to as a "delivery catheter" or "first catheter") to deliver a highly flexible detachable balloon, such that the assembly of the expanded balloon and one or more elongated or expandable bodies is generated in vivo to be highly resistant to collapse, compression, compaction, or movement, and the use of the same highly flexible catheter or catheter assembly to deliver a highly flexible elongated or expandable body. The present disclosure also describes a medical device.
A component of a detachable balloon catheter incorporating a guidewire lumen (also referred to as a "guidewire catheter" or "second catheter") can be moved and used to direct the passageway of the elongate body or expandable body to various locations, while the expanded balloon of the detachable balloon catheter remains fixed in position, allowing a second medical device to seal the detachable balloon and either fix the position of the detachable balloon to reduce the risk of balloon migration, or maintain the expanded size and shape of the expandable balloon to reduce the risk of balloon deflation, compression, or compaction.

A detachable balloon catheter having a structure for guidewire insertion that can move independently of the detachable balloon and can be used to deliver an elongated or expandable body reduces the overall device diameter or profile while improving device performance. A detachable balloon catheter with at least two catheter assemblies, one configured for guidewire insertion and capable of moving independently of the detachable balloon, is also used to deliver the elongated or expandable body, and another catheter holds the detachable balloon to the catheter assembly, also allows for the use of a mechanical latch that can hold the detachable balloon to the catheter assembly. When the guidewire catheter is in the mechanical latch, the detachable balloon remains attached to the delivery catheter. When the guidewire catheter is retracted from the mechanical latch, the detachable balloon can be separated from the delivery catheter.

The combination of these different elements creates a detachable balloon catheter. When used with one or more elongated or expandable bodies to produce a low profile, highly flexible system, immediate and complete occlusion of arteries, veins, and other blood-containing structures and other biological conduits provides simple and immediate mechanical removal of the expanded and supported balloon from the catheter assembly, resulting in a detachable balloon and coil assembly that is highly resistant to folding, compression, compaction, or migration.

The polymeric balloon may comprise a single continuous layer of polymer, except for the openings at the proximal and distal ends. The polymeric balloon may further comprise one or more non-metallic coatings, including a coating on the exterior surface. The surface of the polymeric balloon may be modified to improve biocompatibility, to promote endothelialization of the blood-contacting surface, to roughen the surface texture to reduce the risk of balloon migration after placement in vivo, to smoothen the surface texture to reduce biomolecule or cell attachment and reduce tissue damage after placement in vivo, or to increase the strength of the bond formed between the balloon and the surrounding tissue after placement in vivo. Surface modification may include plasma etching, surface roughening or smoothing, alteration of the surface chemistry, attachment of molecules or biomolecules, or various combinations of these methods.

The polymeric balloon may comprise a proximal neck, a distal neck, or both a proximal neck and a distal neck. Metal structures, including tubular structures or segments, may be coupled to the proximal neck to form a proximal neck assembly. These metal structures may comprise radiopaque metals that are clearly visible under fluoroscopy, may be part of an assembly for attaching the polymeric balloon to a catheter or catheter assembly, may be part of an assembly for removing the polymeric balloon from a catheter or catheter, may help guide a catheter, including a second catheter of the first medical device, through the central void and interior volume, or may help reduce leakage from the first lumen of the first medical device during inflation of the balloon.

The metal, polymer, or metal and polymer structures, including tubular structures or segments, may be joined to the distal neck of the polymer balloon to form a proximal neck assembly. These metal, polymer, or metal and polymer structures may comprise a radiopaque metal that is clearly visible under fluoroscopy, may be part of an assembly for attaching the polymer balloon to a catheter or catheter assembly, may be part of an assembly for detaching the polymer balloon from a catheter or catheter assembly, may help guide a catheter, including a second catheter of the first medical device, through the central void or interior volume of the balloon, or may help reduce leakage from the first lumen of the first medical device during inflation of the balloon. The metal, polymer, or metal and polymer structures, including tubular structures or segments, may be joined to the distal neck of the polymer balloon to form a distal neck assembly. These metallic, polymeric, or metallic and polymeric structures may comprise a radiopaque metal that is clearly visible under fluoroscopy, may be part of an assembly for attaching a polymeric balloon to a catheter or catheter assembly, may be part of an assembly for detaching a polymeric balloon from a catheter or catheter assembly, may help guide a catheter, including a second catheter of the first medical device, through a central void or interior volume of the balloon, or may help reduce leakage from the first lumen of the first medical device during balloon inflation.

The metal balloon may comprise a single continuous layer of metal, except for the openings at the proximal and distal ends. The surface of the metal balloon may be modified to improve biocompatibility, to promote endothelialization of the blood-contacting surface, to roughen the surface texture to reduce the risk of balloon migration after placement in vivo, to smoothen the surface texture to reduce adhesion of biomolecules or molecules and to reduce tissue damage after placement in vivo, or to increase the strength of the bond that forms between the balloon and the surrounding tissue after placement in vivo. Surface modification may include roughening or smoothing the surface, changing the surface chemistry, attaching molecules or biomolecules, or various combinations of these methods.

The metallic balloon may comprise a proximal neck, a distal neck, or both a proximal neck and a distal neck. A metallic, polymeric, or metallic and polymeric structure, including a tubular structure or segment, may be joined with the proximal neck to form a proximal neck assembly. These metallic, polymeric, or metallic and polymeric structures may comprise radiopaque metals that are clearly visible under fluoroscopy, may be part of an assembly for attaching the polymeric balloon to a catheter or catheter assembly, may be part of an assembly for detaching the polymeric balloon from a catheter or catheter assembly, may help guide a catheter, including a second catheter of the first medical device, through the central void or interior volume of the balloon, or may help reduce leakage from the first lumen during inflation of the balloon.

Metallic, polymeric, or metallic and polymeric structures, including tubular structures or segments, may be coupled to the distal neck of a metallic balloon to form a distal neck assembly. These metallic, polymeric, or metallic and polymeric structures may comprise a radiopaque metal that is clearly visible under fluoroscopy, may be part of an assembly for attaching a polymeric balloon to a catheter or catheter assembly, may be part of an assembly for detaching a polymeric balloon from a catheter or catheter assembly, may help guide a catheter, including a second catheter, of the first medical device through a central void or interior volume of the balloon, or may help reduce leakage from the first lumen of the first medical device during inflation of the balloon.

The polymer-coated metal balloon comprises a single continuous layer of metal, except for the openings at the proximal and distal ends, and one or more non-metallic coatings may further comprise one or more polymer coatings or layers on the inner surface, outer surface, or inner and outer surfaces. The surface of the polymer-coated metal balloon may be modified to improve biocompatibility, to promote endothelialization of blood-contacting surfaces, to roughen the surface texture to reduce the risk of balloon migration after placement in vivo, to increase the strength of the bond between the balloon and the surrounding tissue after placement in vivo, surface modification may include plasma etching, surface roughening or smoothing, alteration of the surface chemistry, molecules or biomolecules, or various combinations of these methods.

The polymer coated metal balloon may comprise a proximal neck, a distal neck, or both a proximal neck and a distal neck. A metal structure, a polymer structure, or a metal and polymer structure, including a tubular structure or segment, may be connected and joined to the proximal neck to form a proximal neck assembly. These metal structures, polymer structures, or metal and polymer structures may comprise radiopaque metals that are clearly visible under fluoroscopy, may be part of an assembly for attaching the polymer balloon to a catheter or catheter assembly, may be part of an assembly for removing the polymer balloon from a catheter or catheter assembly, may help guide a catheter, including a second catheter of the first medical device, through the central void or interior volume of the balloon, and may help reduce leakage from the first lumen of the first medical device during inflation of the balloon.

Metallic, polymeric, or metallic and polymeric structures, including tubular structures or segments, may be coupled to the distal neck of a polymer-coated metallic balloon to form a distal neck assembly. These metallic, polymeric, or metallic and polymeric structures may comprise radiopaque metals that are clearly visible under fluoroscopy, may be part of an assembly for attaching or detaching a polymeric balloon to a catheter or catheter assembly, may help guide a catheter, including a second catheter of the first medical device, through a central void or interior volume of the balloon, or may help reduce leakage from the first lumen of the first medical device during balloon inflation.

The metallized polymer balloon may comprise a continuous layer of a single polymer, except for the openings at the proximal and distal ends. The metallized polymer balloon may further comprise one or more metal structures, layers, or coatings, including discontinuous metal structures, as well as continuous metal structures, layers, or coatings. The metal may be applied to the polymer balloon by sputter coating, vapor deposition, electroplating, or electroforming, by applying a metal wire or mesh to the surface of the metal balloon, or by various combinations of these methods. The metal wire or mesh may be applied in a ring, coil, braid, woven, or linear form, or combinations thereof. The metal structure, layer, or coating may be present on the exterior surface, the interior surface, or both the exterior and interior surfaces. In particular, the surface of the metallized polymer balloon may be modified to improve biocompatibility, to roughen the surface texture to promote endothelialization of blood-contacting surfaces, to reduce the risk of balloon migration after placement in vivo, or to increase the strength of the bond that forms between the balloon and the surrounding tissue after placement in vivo. Surface modification may include plasma etching, roughening or smoothing the surface, changing the surface chemistry, attaching molecules or biomolecules, or various combinations of these methods.

The metallized polymer balloon may comprise a proximal neck, a distal neck, or both a proximal and a distal neck. A metal structure, a polymer structure, or a metal and polymer structure, including a tubular structure or segment, may be coupled to the proximal neck to form a proximal neck assembly. These metal structures, polymer structures, or metal and polymer structures may comprise radiopaque metals that are clearly visible under fluoroscopy, may be part of an assembly for attaching the polymer balloon to a catheter or catheter assembly, may be part of an assembly for detaching the polymer balloon from a catheter or catheter assembly, may help guide a catheter, including a second catheter of the first medical device, through a central void or interior volume of the balloon, or may help reduce leakage from the first lumen of the first medical device during inflation of the balloon.

Metallic, polymeric, or metallic and polymeric structures, including tubular structures or segments, may be coupled to the distal neck of a metallized polymeric balloon to form a distal neck assembly. These metallic, polymeric, or metallic and polymeric structures may comprise a radiopaque metal that is clearly visible under fluoroscopy, may be part of an assembly for attaching a polymeric balloon to a catheter or catheter assembly, may be part of an assembly for detaching a polymeric balloon from a catheter or catheter assembly, may help guide a catheter, including a second catheter of the first medical device, through a central void or interior volume of the balloon, or may help reduce leakage from the first lumen of the first medical device during inflation of the balloon.

The present invention provides devices, systems and methods for reducing blood flow within an occluded or saccular aneurysm, wherein the elongated or expandable body is disposed adjacent to the expanded balloon, within the central cavity of the expanded balloon, or both adjacent to the expanded balloon and within the central cavity of the expanded balloon.

Detachable polymer balloons, metal balloons, polymer-coated metal balloons, and metallized balloons are described, where the balloons are made of low conformable polymer materials such as polyethylene terephthalate (PET) and materials such as gold that can achieve a pleated, foldable low profile, are highly flexible, expand at low pressure, and promote rapid endothelialization at the blood contacting surface and rapid tissue incorporation and anchoring to the surrounding aneurysm at the non-blood contacting surface. The polymer balloons, metal balloons, polymer-coated metal balloons, and metallized polymer balloons can be modified to promote attachment to adjacent aneurysm walls and reduce the rate of balloon migration in vivo. Elongated bodies such as coils can be modified for use with polymer balloons, metal balloons, polymer-coated metal balloons, and metallized polymer balloons. These elongated bodies can be configured in a straight or nearly straight, soft, pliable form, allowing the adjunctive use of one or several long, straight, or nearly straight coils to treat a wide range of aneurysm sizes and shapes with a relatively small number of balloon and coil sizes and shapes.

A flexible, low profile catheter or catheter assembly is disclosed herein that can be used to deliver both a detachable balloon and a coil to an aneurysm. Such a catheter assembly comprises a second catheter configured to receive both a guidewire and a coil, which can be moved forward or backward while the expandable balloon remains fixed in place. This feature provides the advantages of over-the-wire delivery along with the ability to precisely position the coil both adjacent to the expanded detachable balloon and inside the expanded detachable balloon. The result is a detachable, implantable balloon and coil assembly that can immediately and completely embolize the neck and sac of an aneurysm in vivo, and that can maintain its occlusion for extended periods by resisting degradation, migration, deflation, compression or compaction without the need for high pressure in the balloon or valve to maintain that pressure.

In one example, a pleated and folded gold metal balloon is advanced over the aneurysm guidewire into the aneurysm sac using a two-catheter assembly of a first catheter and a guidewire coupled or operably joined to the balloon, and a second catheter configured to deliver an elongated or expandable body. Fluid is injected under pressure from the hub of the first catheter through the first lumen into the central cavity of the balloon, causing the balloon to expand. The first catheter is then used to pull back the expanded balloon until it presses against the neck of the aneurysm. The second catheter is then advanced into the aneurysm lumen or sac over the guidewire, the guidewire is removed, and an elongated body (also called a "vascular coil") approximately 100 cm long is advanced through the lumen of the second catheter into the aneurysm sac behind the expanded balloon. Several segments of the vascular coil contact the inner surface of the aneurysm wall and the outer surface of the aneurysm wall. The loops of the vascular coil exert a force on the wall of the expanded balloon in a direction toward the aneurysm neck, helping to seal the aneurysm neck and reducing the risk of migration or movement of the expanded balloon. After confirming the correct position of the balloon and proper occlusion of the aneurysm neck and sac, the vascular coil is detached from its delivery system, the expanded balloon is detached from the catheter, and the catheter along with the vascular coil delivery system is removed. Removal of the vascular coil may occur by mechanical, electrolytic, or electrothermal means. In this example, the gold metal balloon is able to withstand deflation, compression, or compaction without placing additional support material within the central void of the balloon. Using the above approach, multiple elongated bodies, expandable bodies, or vascular coils can be placed into the aneurysm sac behind the expanded balloon at any time prior to removal of the balloon from the first catheter.

In another example, the pleated and folded polymer balloon is advanced over the guidewire into the aneurysm sac using a two-catheter assembly, a first catheter coupled or operably joined to the balloon and a guidewire, and a second catheter configured to deliver the elongated or expandable body. Fluid is injected under pressure through the first lumen from the hub of the first catheter into the central cavity of the balloon, causing the balloon to expand. The first catheter is then used to pull back the expanded balloon until it presses against the neck of the aneurysm. The second catheter is then advanced over the guidewire into the aneurysm lumen or sac, the guidewire is removed, and a distal portion of the vascular coil elongated body, approximately 100 cm long, is advanced through the lumen of the second catheter and the aneurysm sac behind the expanded balloon. Some segments of the distal portion of the vascular coil contact the inner surface of the aneurysm wall and other segments of the distal portion of the vascular coil contact the outer surface of the expanded balloon wall. A force is applied to the outer surface of the expanded balloon wall in the direction towards the aneurysm neck to help seal the aneurysm neck and reduce the risk of the expanded balloon migration or movement. The second catheter is then pulled back until its tip is in the central cavity of the expanded balloon and the remaining proximal portion of the vascular coil is placed within the expandable central cavity. Some segments of the proximal portion of the vascular coil contact the inner surface of the wall of the expanded balloon. The loops of the vascular coil apply an outward force to the inner surface of the wall of the expanded balloon to help the expanded balloon resist collapse, compression or compaction, maintaining closure of the aneurysm neck and reducing the risk of the balloon migration or movement. After confirming occlusion of the aneurysm neck and sac, the vascular coil is detached from its delivery system, the expanded balloon is detached from the first catheter, and the catheter and vascular coil delivery system are removed. Detachment of the vascular coil may occur by mechanical, electrolytic, or electrothermal means. In some examples, one or more elongate bodies or vascular coils are placed in the aneurysm sac and one or more separate elongate bodies, expandable bodies, or vascular coils are placed in the expanded balloon. In some examples, the balloon is a metallized polymer balloon with an outer layer of gold or titanium present on the outer surface of the polymer balloon at a thickness of 1 μm. In these examples, the polymer balloon or metallized polymer balloon cannot resist collapse, compression, or compaction without additional support material placed in the central cavity of the balloon.

In another example, after placing an expanded balloon at the aneurysm neck and positioning a single vascular coil, with the distal portion of the vascular coil in the aneurysm sac behind the expanded balloon and the remaining proximal portion of the vascular coil in the central cavity of the expanded balloon, the physician concludes that the balloon diameter is too small and the length of the vascular coil is too short before removing either. The physician then removes the catheter coil from the patient, deflates the balloon by applying a vacuum to the inflation portion of the hub of the first catheter, and removes the balloon from the patient. The physician then selects a larger diameter balloon and a longer length vascular coil according to the method described above, places them in the aneurysm, verifies that the balloon diameter and coil length are appropriate, separates the vascular coil and expanded balloon, and removes the catheter and any elongated body delivery system.

The present disclosure presents devices, systems, and methods for occluding, embolizing, or reducing blood flow in an artery, in which a detachable balloon is placed in the lumen of the artery and maintained in an expanded configuration. Optionally, one or more elongated or expanded bodies are placed adjacent to the expanded balloon, in the central void of the expanded balloon, or both adjacent to the expanded balloon and in the central void of the expanded balloon. Detachable polymer balloons, metal balloons, polymer-coated metal balloons, and metallized polymer balloons are described, where the balloons are made of low conformable polymer materials such as PET and metals such as gold that can achieve pleated folded low profiles, are highly flexible, expand at low pressures, and promote rapid tissue uptake and fixation to the surrounding arterial wall. The outer surfaces of the polymer balloons, metal balloons, polymer-coated metal balloons, and metallized polymer balloons can be modified to promote attachment to adjacent arterial walls and reduce the rate of balloon migration in vivo. Elongated bodies such as coils can be modified for use with detachable polymer balloons, metal balloons, polymer-coated metal balloons, and metallized polymer balloons. These elongated bodies can be configured in a straight or nearly straight, soft, and flexible configuration, with one or a few supplemental long, straight, or nearly straight coils to treat a wide range of artery sizes with a relatively small number of balloon and coil sizes.

Described herein are flexible, low profile catheters or catheter assemblies that can be used to deliver both a detachable balloon and a coil to a target arterial segment. Such catheter assemblies include a second catheter configured to receive both a guidewire and a coil, allowing the second catheter to move forward or backward while the expanded detachable balloon remains fixed in place. This feature provides the advantages of over-the-wire delivery along with the ability to precisely position the coil both adjacent to the expanded detachable balloon and inside the expanded detachable balloon. The result is a detachable, implantable balloon and coil assembly that can immediately and completely embolize an artery in vivo and maintain that occlusion by resisting degradation, migration, deflation, compression or compaction without the need for high pressure in the balloon or valve to maintain that pressure.

In one example, the pleated and folded gold metal balloon is advanced over a guidewire into a selected arterial segment using a two catheter assembly, a first catheter coupled or operably joined to the balloon and a second catheter configured for insertion over the guidewire. Fluid is injected under pressure from the hub of the first catheter through the first lumen into the central cavity of the balloon, causing expansion of the balloon. After confirming correct placement of the balloon and adequate occlusion of the selected arterial segment, the expanded balloon is detached from the first catheter and the guidewire and catheter are removed from the patient. Removal may occur by mechanical, electrolytic, or electrothermal means. In this example, the gold metal balloon is able to resist collapse, compression, or compaction without additional support material disposed within the central cavity of the balloon.

In another example, the pleated and folded polymer balloon is advanced over a guidewire into a selected arterial segment using a two-catheter assembly, a first catheter coupled or operably joined to the balloon and a second catheter configured for insertion of the guidewire and delivery of the elongated or expandable body. Fluid is injected from the hub of the first catheter through the first lumen into the central cavity of the balloon, causing expansion of the balloon. After confirming correct placement of the balloon and proper occlusion of the selected arterial segment, the physician removes the guidewire and pulls back the second catheter until its tip is within the central cavity of the expanded balloon. The physician then places the elongated body of the vascular coil through the lumen of the second catheter into the central cavity of the expandable balloon. Some segments of the vascular coil contact the inner surface of the wall of the expanded balloon. The loops of the vascular coil exert an outward force on the inner surface of the expanded balloon to help the expanded balloon resist deflation, compression, or compaction, to maintain occlusion of the arterial segment, and to reduce the risk of balloon movement or migration. After confirming occlusion of the selected arterial segment, the vascular coil is detached from its delivery system and the expanded balloon is removed. Detachment may occur by mechanical, electrolytic, or electrothermal means. In some examples, more than one elongate body, expandable body, or vascular coil is disposed on the expanded balloon. In some examples, the balloon comprises a distal neck assembly having an elastomeric or male valve that closes the distal opening of the balloon after retraction of the guidewire and second catheter. In addition to providing hemostasis within the expandable balloon, the valve may provide the primary means of attachment of the balloon to the second catheter or the assembly of the first and second catheters.

In some examples, the distal portion of the elongate body, expandable body, or vascular coil is disposed in the distal arterial lumen of the expanded polymer balloon, and the proximal portion of the elongate body, expandable body, or vascular coil is disposed in the central cavity of the expanded balloon to close at least a portion of the distal opening of the balloon. In some examples, the balloon is a metallized polymer balloon, and an outer layer of gold or titanium is present on the outer surface of the polymer balloon with a thickness of less than 1 μm. In these examples, the polymer balloon or metallized polymer balloon cannot resist collapse, compression, or compaction without additional support material disposed within the central cavity of the balloon.

The present disclosure presents devices, systems, and methods for occluding, embolizing, or reducing blood flow in a vein, where a detachable balloon is placed in the lumen of the vein and maintained in an expanded configuration. Optionally, one or more elongated or expandable bodies are placed in the expanded balloon, in the central cavity of each balloon, or in both adjacent expanded balloons and the central cavity of the expanded balloon. Detachable polymer balloons, metal balloons, polymer-coated metal balloons, and metallized polymer balloons are described, where the balloons are made of a less compliant polymer material, such as PET, and a metal, such as gold, that forms pleats and folds to achieve a low profile, making them more flexible, expanding at low pressures, and promoting rapid tissue incorporation and fixation to the surrounding vein wall. The outer surface of the polymer balloon, metal balloon, polymer-coated metal balloon, and metallized polymer balloon is modified to promote attachment to adjacent vein walls and reduce the rate of balloon migration in vivo. Self-expanding structures can be added to the proximal or distal neck of the balloon, which contacts the wall of the adjacent vein segment and reduces the risk of balloon migration. Elongated bodies such as coils can be used with detachable polymer balloons, metal balloons, polymer-coated metal balloons, and metallized polymer balloons. These elongated bodies can be configured in a straight, soft, flexible form, allowing the use of one or a few long, straight, nearly straight coils as an adjunct to treat a wide range of vein sizes with a relatively small number of balloon and coil sizes.

A flexible, low profile catheter or catheter assembly is described herein that is used to deliver both a detachable balloon and a coil to a target vein segment. Such a catheter assembly is a second catheter configured to accept both a guidewire and a coil, the shaft of which can be moved forward or backward while the expanded detachable balloon remains fixed in place. This feature provides the advantages of over-the-wire delivery along with the ability to precisely position the coil both adjacent to the expanded detachable balloon and inside the expanded detachable balloon. The result is a removable, implantable balloon and coil assembly that can completely occlude a vein immediately in vivo, and maintain that occlusion for extended periods of time by resisting degradation, migration, deflation, compression or compaction without the need for high pressure in the balloon or valve to maintain that pressure.

In one example, the pleated and folded gold metal balloon is advanced into the selected vein segment using a three catheter assembly including a first catheter coupled or operably joined to the balloon, a second catheter configured for insertion of a guidewire, and a third catheter configured to restrain a self-expanding retention structure coupled to the proximal or distal neck of the balloon. The third catheter is retracted while the balloon is maintained in place, resulting in the self-expanding retention structure expanding and a portion of the retention structure engaging the wall of the vein. Fluid is injected under pressure from the hub of the first catheter through the first lumen into the central cavity of the balloon, causing expansion of the balloon. After confirming correct placement of the balloon and adequate occlusion of the selected vein segment, the expanded balloon is removed from the first catheter and the guidewire and catheter are removed. Removal may occur by mechanical, electrolytic, or electrothermal means. In this example, the gold metal balloon is able to resist deflation, compression, or compaction without placing additional support material within the central cavity of the balloon.

In another example, the pleated and folded polymer balloon is advanced over the guidewire into the selected vein segment using an assembly of three catheters: a first catheter bonded or operably connected to the balloon, a second catheter configured for insertion of the guidewire, and a third catheter configured to restrain a self-expanding retention structure bonded to the distal or proximal neck of the balloon. The third catheter is retracted leaving the balloon in place, resulting in expansion of the self-expanding retention structure and engagement of a portion of said retention structure with the wall of the vessel. Fluid is injected under pressure from the hub of the first catheter through the first lumen into the central void of the balloon to expand the balloon. After verifying correct placement of the balloon and adequate occlusion of the selected vein segment, the physician removes the guidewire and pulls back the second catheter until its tip is in the central void of the expanded balloon. The physician then positions the vascular coil elongate body through the lumen of the second catheter and into the central void of the expandable balloon. Some segments of the vascular coil contact the inner surface of the wall of the expanded balloon. The loops of the vascular coil exert an outward force on the inner surface of the wall of the expanded balloon to help the expanded balloon resist deflation, compression, or compaction, maintain occlusion of the vein segment, and reduce the risk of balloon movement or migration. After confirming occlusion of the selected vein segment, the vascular coil is detached from its delivery system, the expanded balloon is detached from the first catheter, and the catheter and vascular coil delivery system are removed. The detachment may be by mechanical, electrolytic, or electrical means. In some examples, a plurality of elongate bodies, expandable bodies, or vascular coils are disposed within the expanded balloon. In some examples, the balloon includes a distal neck assembly having an elastomeric or resilient valve that closes a distal opening in the balloon after retraction of the guidewire and second catheter. In addition to providing hemostasis within the expandable balloon, the valve may provide a primary means for attaching the balloon to the second catheter, the first catheter, or an assembly of the first and second catheters.

In some examples, a distal portion of the elongate body, expandable body, or vascular coil is placed in the lumen of the vein distal to the expanded balloon, and a proximal portion of the elongate body, expandable body, or vascular coil is placed in the central void of the expanded balloon to close at least a portion of the distal opening of the balloon. In some examples, a retention structure is bonded to the proximal neck of the balloon, and in other examples, a retention structure is bonded to the distal neck of the balloon. In some examples, the balloon is a metallized polymer balloon with an outer layer of gold or titanium present on the outer surface of the polymer balloon with a thickness of 1 μm or less. In these examples, the polymer balloon or metallized polymer balloon cannot withstand collapse, compression, or compaction without additional support material placed inside the central void of the balloon.

The present disclosure provides devices, systems and methods for occluding, embolizing or reducing blood flow in the left atrial appendage, in which a detachable balloon is positioned in the lumen of the left atrial appendage and maintained therein in an expanded configuration. Optionally, one or more elongate or expandable bodies are positioned adjacent to the expanded balloon, within the central void of the expanded balloon, or both adjacent to the expanded balloon and within the central void of the expanded balloon. Detachable polymer balloons, metal balloons, polymer-coated metal balloons, and metallized polymer balloons are described that are formed from low-compliance polymeric materials such as PET or metals such as gold, which can be pleated and folded to achieve a low profile, have high flexibility, expand at low pressures, and promote rapid tissue uptake and fixation to the surrounding left atrial appendage wall. The exterior surfaces of the polymer balloons, metal balloons, polymer-coated metal balloons, and metallized polymer balloons can be modified to promote attachment to the adjacent left atrial appendage wall and reduce the rate of balloon migration in vivo. Elongated bodies such as coils can be modified for use with detachable polymer balloons, metal balloons, polymer-coated metal balloons, and metallized polymer balloons. These elongated bodies can be configured in straight or nearly straight, pliable, flexible configurations, allowing the adjunctive use of one or a few long, straight or nearly straight coils to treat a range of left atrial appendage sizes with fewer balloons and smaller coil sizes.

A flexible, low profile catheter or catheter assembly is disclosed herein that can be used to deliver both a detachable balloon and a coil to the left atrial appendage. Such a catheter assembly includes a second catheter configured to receive both a guidewire and a coil, which can be moved forward or backward while the expanded detachable balloon remains fixed in place, thereby providing the advantages of over-the-wire delivery in addition to the ability to precisely position the coil both adjacent to and within the expanded detachable balloon. The result is a detachable, implantable balloon and coil assembly that can immediately and completely occlude the left atrial appendage in vivo, without the need for high pressures inside the balloon or valves to maintain those pressures, and that can maintain said occlusion over time by resisting degradation, migration, deflation, and compression.

In one example, the pleated and folded gold metal balloon is advanced over the guidewire into the left atrial appendage using an assembly of three catheters: a first catheter bonded or operably coupled to the balloon, a second catheter configured for insertion of the guidewire, and a third catheter configured to restrain a self-expanding retention structure bonded to the distal or proximal neck of the balloon. Leaving the balloon in place, the third catheter is retracted, resulting in expansion of the self-expanding retention structure and engagement of a portion of said retention structure with the wall of the left atrial appendage. Fluid is injected under pressure from the hub of the first catheter through the first lumen and into the central cavity of the balloon to expand the balloon. After confirming correct placement of the balloon and adequate occlusion of the left atrial appendage, the expanded balloon is detached from the first catheter and guidewire, and the catheter is removed. Separation may be accomplished by mechanical, electrolytic, or electrical means. In this example, the gold metal balloon is capable of withstanding deflation, compression, or compaction without additional support material disposed within the central cavity of the balloon.

In another example, the pleated and folded polymer balloon is advanced over the guidewire into the left atrial appendage using an assembly of three catheters: a first catheter bonded or operably coupled to the balloon, a second catheter configured for insertion of the guidewire, and a third catheter configured to restrain a self-expanding retention structure bonded to the distal neck of the balloon. Leaving the balloon in place, the third catheter is retracted, resulting in expansion of the self-expanding retention structure bonded to the balloon and engagement of a portion of said retention structure with the wall of the left atrial appendage. Fluid is injected under pressure from the hub of the first catheter through the first lumen and into the central cavity of the balloon to expand the balloon. After verifying correct placement of the balloon and adequate occlusion of the left atrial appendage, the physician removes the guidewire and pulls back the second catheter until its tip is in the central cavity of the expanded balloon. The physician then positions the vascular coil elongate body through the lumen of the second catheter and into the central cavity of the expandable balloon. Some segments of the vascular coil contact the inner surface of the wall of the expanded balloon. The loops of the vascular coil exert an outward force on the inner surface of the wall of the expanded balloon to help the expanded balloon resist deflation, compression, or compaction, maintain occlusion of the left atrial appendage, and reduce the risk of balloon movement or migration. After confirming occlusion of the left atrial appendage, the vascular coil is detached from its delivery system, the expanded balloon is detached from the first catheter, and the catheter and vascular coil delivery system are removed. The separation may be by mechanical, electrolytic, or electrical means. In some examples, a plurality of elongated bodies, expandable bodies, or vascular coils are disposed within the expanded balloon. In some examples, the balloon is a metallized polymer balloon with an outer layer of gold or titanium present on the outer surface of the polymer balloon with a thickness of 1 μm or less. In these examples, the polymer balloon or metallized polymer balloon cannot resist deflation, compression, or compaction without additional support material disposed within the central cavity of the balloon.

The present disclosure provides devices, systems and methods for occluding, embolizing or reducing blood flow in a paravalvular leak pathway, in which a detachable balloon is positioned in the lumen of the paravalvular leak pathway and maintained therein in an expanded configuration. Optionally, one or more elongate or expandable bodies are positioned adjacent to the expanded balloon, within the central void of the expanded balloon, or both adjacent to the expanded balloon and within the central void of the expanded balloon. Detachable polymer balloons, metal balloons, polymer-coated metal balloons, and metallized polymer balloons are described that are formed from low-compliance polymeric materials such as PET or metals such as gold, which can be pleated and folded to achieve a low profile, have high flexibility, expand at low pressures, and promote rapid tissue uptake and fixation to the wall of the surrounding artery. The exterior surface of the polymer balloons, metal balloons, polymer-coated metal balloons, and metallized polymer balloons can be modified to promote attachment to adjacent tissue and reduce the rate of balloon migration in vivo. Elongated bodies such as coils can be modified for use with detachable polymer balloons, metal balloons, polymer-coated metal balloons, and metallized polymer balloons. These elongated bodies can be configured in straight or nearly straight, pliable, flexible configurations, allowing the adjunctive use of one or a few long, straight or nearly straight coils to treat a wide range of artery sizes with a relatively small number of balloons and relatively small coil sizes.

A flexible, low profile catheter or catheter assembly is disclosed herein that can be used to deliver both a detachable balloon and a coil to a targeted paravalvular leak pathway. Such a catheter assembly includes a second catheter configured to receive both a guidewire and a coil, which can be moved forward or backward while the expanded detachable balloon remains fixed in place. This technical feature provides the advantages of over-the-wire delivery in addition to the ability to precisely position the coil both adjacent to and within the expanded detachable balloon. The result is a detachable, implantable balloon and coil assembly that can immediately and completely occlude a paravalvular leak pathway in vivo without the need for high pressures inside the balloon or valves to maintain those pressures, and that can maintain said occlusion over time by resisting degradation, migration, deflation, and compression.

In one example, a detachable balloon catheter including a gold metal balloon, a first catheter operably coupled to the balloon, and a second catheter configured for insertion over the guidewire is advanced over the guidewire until an appropriate length of the pleated and folded gold metal balloon is positioned such that the distal portion of the balloon is distal to the perivalvular leak pathway and the proximal portion of the balloon is proximal to the perivalvular leak pathway. Fluid is injected under pressure from the hub of the first catheter through the first lumen and into the central cavity of the balloon to expand the balloon. After confirming correct placement of the balloon and adequate occlusion of the leak pathway, the expanded balloon is detached from the first catheter and guidewire, and the catheter is removed from the patient. Separation may be accomplished by mechanical, electrolytic, or electrical means. In this example, the gold metal balloon is capable of withstanding deflation, compression, or compaction without additional support material positioned within the central cavity of the balloon.

In another example, a detachable balloon catheter including a polymer balloon, a first catheter bonded or operably coupled to the balloon, and a second catheter configured for guidewire insertion and delivery of an elongated or expandable body is advanced over the guidewire until an appropriate length of the pleated and folded polymer balloon is positioned such that the distal portion of the balloon is distal to the paravalvular leak pathway and the proximal portion of the balloon is proximal to the paravalvular leak pathway. Fluid is injected under pressure from the hub of the first catheter through the first lumen and into the central void of the balloon to expand the balloon. After confirming correct placement of the balloon and adequate occlusion of the paravalvular leak pathway, the physician removes the guidewire and pulls back the second catheter until its tip is in the central void of the expanded balloon. The physician then positions the vascular coil elongated body through the lumen of the second catheter and into the central void of the expandable balloon, with some portion of the vascular coil contacting the inner surface of the wall of the expanded balloon. The loops of the vascular coil exert an outward force on the inner surface of the wall of the expanded balloon to help the expanded balloon resist deflation, compression, or compaction, maintain occlusion of the paravalvular leak pathway, and reduce the risk of balloon movement or migration. After confirming occlusion of the paravalvular leak pathway, the vascular coil is detached from its delivery system, the expanded balloon is detached from the first catheter, and the catheter and vascular coil delivery system are removed. Separation may be accomplished by mechanical, electrolytic, or electrical means.

In some examples, a plurality of elongate bodies, expandable bodies, or vascular coils are disposed within the expanded balloon. In some examples, a distal portion of the elongate body, expandable body, or vascular coil is disposed in the perivalvular leak pathway distal to the expanded polymer balloon, and a proximal portion of the elongate body, expandable body, or vascular coil is disposed in the central cavity of the expanded balloon to close at least a portion of the distal opening of the balloon. In some examples, the balloon includes a distal neck assembly having an elastomeric or resilient valve that closes the distal opening in the balloon after the second catheter is pulled back. In some examples, the balloon is a metallized polymer balloon with an outer layer of gold or titanium present on the outer surface of the polymer balloon with a thickness of 1 μm or less. In these examples, the polymer balloon or metallized polymer balloon cannot withstand collapse, compression, or compaction without additional support material disposed within the central cavity of the balloon.

The present disclosure provides devices, systems and methods for occluding, embolizing or reducing the flow of biological fluids or materials in a biological conduit, in which a detachable balloon is positioned in the lumen of the biological conduit and maintained therein in an expanded configuration. Optionally, one or more elongate or expandable bodies are positioned adjacent to the expanded balloon, within the central void of the expanded balloon, or both adjacent to the expanded balloon and within the central void of the expanded balloon. Detachable polymer balloons, metal balloons, polymer-coated metal balloons, and metallized polymer balloons are described as being formed from low-compliance polymeric materials such as PET or metals such as gold, which can be pleated and folded to achieve a low profile, have high flexibility, expand at low pressures, and promote rapid tissue uptake and fixation to the wall of the surrounding biological conduit. The exterior surface of the polymer balloons, metal balloons, polymer-coated metal balloons, and metallized polymer balloons can be modified to promote attachment to the wall of the adjacent biological conduit and reduce the rate of balloon migration in vivo. Elongated bodies such as coils can be modified for use with the detachable polymer balloons, metal balloons, polymer-coated metal balloons, and metallized polymer balloons described herein. These elongated bodies can be configured in straight, pliable, flexible configurations, allowing the adjunctive use of one or a few long, straight or nearly straight coils to treat a wide range of conduit sizes with a relatively small number of balloons and relatively small coil sizes.

A flexible, low profile catheter or catheter assembly is disclosed herein that can be used to deliver both a detachable balloon and a coil to a targeted biological conduit segment. Such an assembly includes a shaft configured to receive both a guidewire and a coil, which can be moved forward or backward while the expanded detachable balloon remains fixed in place. This technical feature provides the advantages of over-the-wire delivery, as well as the ability to precisely position the coil both adjacent to and within the expanded detachable balloon. The result is a detachable, implantable balloon and coil assembly that can immediately and completely occlude a biological conduit in vivo, without the need for high pressures inside the balloon or valves to maintain those pressures, and that can maintain said occlusion over time by resisting degradation, migration, deflation, and compression.

In one example, the pleated and folded gold metal balloon is advanced over the guidewire into the selected biological conduit segment using an assembly of three catheters: a first catheter bonded or operably coupled to the balloon, a second catheter configured for insertion of the guidewire, and a third catheter configured to constrain a self-expanding retention structure bonded to the distal or proximal neck of the balloon. Leaving the balloon in place, the third catheter is retracted, resulting in expansion of the self-expanding retention structure and engagement of a portion of said retention structure with the wall of the biological conduit. Fluid is injected under pressure from the hub of the first catheter, through the first lumen, and into the central cavity of the balloon to expand the balloon. After confirming occlusion of the selected biological conduit segment, the expanded balloon is detached from the first catheter and the guidewire, and the catheter is removed. Separation may be accomplished by mechanical, electrolytic, or electrical means. In this example, the gold metal balloon is capable of withstanding deflation, compression, or compaction without additional support material disposed within the central cavity of the balloon.

In another example, a pleated and folded polymer balloon is advanced over a guidewire into a selected biological conduit segment using an assembly of three catheters: a first catheter bonded or operably coupled to the balloon, a second catheter configured for insertion of the guidewire, and a third catheter configured to constrain a self-expanding retention structure bonded to the distal neck of the balloon. Leaving the balloon in place, the third catheter is retracted, resulting in expansion of the self-expanding retention structure bonded to the balloon and engagement of a portion of said retention structure with the wall of the biological conduit. Fluid is injected under pressure from the hub of the first catheter, through the first lumen, and into the central cavity of the balloon to expand the balloon. After confirming correct placement of the balloon and adequate occlusion of the selected biological conduit segment, the physician removes the guidewire and pulls back the second catheter until its tip is in the central cavity of the expanded balloon. The physician then places the vascular coil elongate body in the central cavity of the expandable balloon through the lumen of the second catheter, with some segments of the proximal portion of the vascular coil contacting the inner surface of the wall of the expanded balloon. The loops of the vascular coil exert an outward force on the inner surface of the wall of the expanded balloon to help the expanded balloon resist deflation, compression, or compaction, to maintain occlusion of the biological conduit segment, and to reduce the risk of balloon movement or migration. After confirming occlusion of the selected biological conduit segment, the vascular coil is detached from its delivery system, the expanded balloon is removed from the first catheter, and the catheter and vascular coil delivery system are removed. The detachment may be accomplished by mechanical, electrolytic, or electrical means. In some examples, multiple elongate bodies, expandable bodies, or vascular coils are placed within the expanded balloon.

In some examples, a plurality of elongate bodies, expandable bodies, or vascular coils are disposed within the expanded balloon. In some examples, a distal portion of the elongate bodies, expandable bodies, or vascular coils is disposed in the biological conduit distal to the expanded balloon, and a proximal portion of the elongate bodies, expandable bodies, or vascular coils is disposed in the central void of the expanded balloon to close at least a portion of the distal opening of the balloon. In some examples, the balloon includes a distal neck assembly having an elastomeric or resilient valve that closes the distal opening in the balloon after the second catheter is pulled back.
In some instances, the retention structure is bonded to the proximal neck of the balloon, and in other instances, the retention structure is bonded to the distal neck of the balloon. In some instances, the balloon is a metallized polymer balloon with an exterior layer of gold or titanium present on the exterior surface of the polymer balloon with a thickness of 1 μm or less. In these instances, the polymer balloon or metallized polymer balloon would not be able to withstand collapse, compression, or compaction without additional support material disposed within the central cavity of the balloon.

The present disclosure also relates to the manufacture of detachable polymer balloons, detachable metal balloons, detachable polymer-coated metal balloons (including fully polymer-coated metal balloons and partially polymer-coated metal balloons), and detachable metallized polymer balloons (including fully metallized polymer balloons and partially metallized polymer balloons). Methods for applying one or more metals to a surface of a balloon that comprises or substantially comprises a polymer, such as PET, polyamide (nylon), or polyether block amide (Pebax), may include mechanical methods, such as wrapping the metal in the form of a wire coil or other pattern; electrochemical methods, such as electroplating, electroforming, or sputtering; or various combinations of mechanical or electrochemical methods.

FIG. 1 is a plan view of one embodiment of a balloon having both proximal and distal necks with defined overall geometric dimensions. FIG. 1 is a plan view of one embodiment of a balloon having both proximal and distal necks with defined overall geometric dimensions. 2A-2D are tables illustrating ranges of values for the overall geometric dimensions of the balloon embodiment shown in FIG. FIG. 13 is a plan view of another embodiment of a balloon having both proximal and distal necks with defined overall geometric dimensions. FIG. 13 is a plan view of another embodiment of a balloon having both proximal and distal necks with defined overall geometric dimensions. 4 is a table illustrating ranges of values for the overall geometric dimensions of the balloon embodiment shown in FIG. 3. 4 is a table illustrating ranges of values for the overall geometric dimensions of the balloon embodiment shown in FIG. 3. 4 is a table illustrating ranges of values for the overall geometric dimensions of the balloon embodiment shown in FIG. 3. 4 is a table illustrating ranges of values for the overall geometric dimensions of the balloon embodiment shown in FIG. 3. 2 is a cross-sectional view of a proximal portion of the balloon embodiment shown in FIG. 1 with its geometric dimensions defined. FIG. 4 is a cross-sectional view of a proximal portion of the balloon embodiment shown in FIG. 3 with its geometric dimensions defined. 5B is a table illustrating ranges of values for the proximal geometric dimensions of the balloon embodiment shown in FIG. 5A. 5B is a table illustrating ranges of values for the proximal geometric dimensions of the balloon embodiment shown in FIG. 5A. 5C is a table illustrating ranges of values for the proximal geometric dimensions of the balloon embodiment shown in FIG. 5B. 5C is a table illustrating ranges of values for the proximal geometric dimensions of the balloon embodiment shown in FIG. 5B. 1 provides a cross-sectional view of a portion of the outer wall of a metal, metallized, polymeric, or hybrid balloon showing seven embodiments of layering. 8A-8J are plan views of an embodiment of a balloon having the shape of the embodiment shown in FIG. 1, incorporating the various layer types defined in FIG. 7 in various regions of the balloon. 9A-9L are plan views of an embodiment of a balloon having the shape of the embodiment shown in FIG. 3, incorporating the various layer types defined in FIG. 3 in various regions of the balloon. 10A-10D are cross-sectional views of a portion of the outer wall of various embodiments of a balloon incorporating single or multiple layers and smooth or textured outer surfaces. 11A-11H are partial cross-sectional views of eight embodiments of balloons having the shape of the embodiment shown in FIG. 3 incorporating stretchable structures in their necks. 4 provides a cross-sectional view of a balloon having the shape of the embodiment shown in FIG. 3 incorporating an expandable structure in both its proximal and distal necks, illustrating its ability to trap air bubbles in four different orientations. 13A-13D are plan views of one embodiment of a detachable balloon delivery system comprising a guidewire and three catheters, including details of the proximal configuration and purpose of each catheter. 14A-14C are plan and cross-sectional views illustrating the configuration of the proximal hub of one embodiment of a detachable balloon delivery system before and after unlocking and retracting the second catheter from the first catheter. 15A-15C are plan and cross-sectional views showing the configuration of the proximal hub of one embodiment of a detachable balloon delivery system before and after unlocking and retracting the second catheter from the first catheter and the second catheter from the third catheter. 16A-16D are plan and cross-sectional views of one embodiment of a detachable balloon delivery system with an inserted guidewire, comprising a guidewire, three catheters, and three lumens. 17A-17C are partial cross-sectional views illustrating operation of a mechanical latch attachment system with a previously retracted guidewire according to one embodiment. 18A-18D are partial cross-sectional views illustrating the operation of a mechanical latch attachment system with a guidewire remaining inserted according to one embodiment. 19A-19G are plan views illustrating a first sequence of operation of a mechanical latch attachment system according to one embodiment. 20A-20E are cross-sectional detail views illustrating a first sequence of operation of a mechanical latch attachment system according to one embodiment. 21A-21E are cross-sectional detail views illustrating a second sequence of operation of a mechanical latch attachment system according to one embodiment. 22A-22I are plan views illustrating a third sequence of operation of a mechanical latch attachment system according to one embodiment. 23A-23H are cross-sectional detail views illustrating a third sequence of operation of a mechanical latch attachment system according to one embodiment. 24A-24I are plan views illustrating a fourth sequence of operation of a mechanical latch attachment system according to one embodiment. 25A-25I are cross-sectional detail views illustrating a fourth sequence of operation of a mechanical latch attachment system according to one embodiment. 26A-26F show plan, perspective, cross-sectional and detailed views of a male tubular structure of a mechanical latch attachment system according to one embodiment with defined overall geometric dimensions. 27 is a table listing ranges of values for geometric dimensions of an embodiment of the male tubular structure of the mechanical latch attachment system shown in FIG. 26. 28A-28G show plan, perspective, and cross-sectional views of a female tubular structure of a mechanical latch attachment system according to one embodiment with defined overall geometric dimensions. 29 is a table listing ranges of values for geometric dimensions of an embodiment of the female tubular structure of the mechanical latch attachment system shown in FIG. 28. 30A-30D are partial cross-sectional plan views showing the operation of an attachment system for an elastomeric tubular structure according to a first embodiment, in which the elastomeric tubular structure is joined within the proximal neck of a balloon and in frictional contact with the exterior of a first catheter. 31A-31D are partial cross-sectional plan views showing the operation of an attachment system for an elastomeric tubular structure according to a second embodiment, in which the elastomeric tubular structure is joined in frictional contact to the outside of the proximal neck of a balloon and to the outside of a first catheter. 32A-32D are partial cross-sectional plan views illustrating the operation of an attachment system for an elastomeric tubular structure according to a third embodiment, in which the elastomeric tubular structure is frictionally bonded to the outside of a first catheter and to the outside of a proximal neck of a balloon. 33A-33B are cross-sectional views of the proximal portion of the balloon embodiment shown in FIG. 5A illustrating operation of the attachment system of the elastomeric tubular structure according to the embodiment shown in FIG. 34A-34B are cross-sectional views of the proximal portion of the balloon embodiment shown in FIG. 5A illustrating operation of the attachment system of the elastomeric tubular structure according to the embodiment shown in FIG. 35A-35B are cross-sectional views of the proximal portion of the balloon embodiment shown in FIG. 5A illustrating operation of the attachment system of the elastomeric tubular structure according to the embodiment shown in FIG. 36A-36F are plan views illustrating a first sequence of operation of the attachment system for the elastomeric tubular structure according to the embodiment shown in FIG. 37A-37E are cross-sectional detail views illustrating a first sequence of operation of an attachment system for an elastomeric tubular structure according to the embodiment shown in FIG. 38A-38J are partial cross-sectional plan views illustrating a second sequence of operation of the attachment system for the elastomeric tubular structure according to the embodiment shown in FIG. 39A-39H are cross-sectional detail views illustrating a second sequence of operation of the attachment system for an elastomeric tubular structure according to the embodiment shown in FIG. 40A-40K are plan views of an embodiment of a balloon having the shape of the embodiment shown in FIG. 3, incorporating the various layer types defined in FIG. 3 in various regions of the balloon. 41A-H are cross-sectional detail views illustrating a third sequence of operation of the attachment system for an elastomeric tubular structure according to the embodiment shown in FIG. 42A-C are plan and cross-sectional views of an elastomeric or resilient tubular structure of a friction fit attachment system according to one embodiment with its geometric dimensions defined. FIG. 43 is a table setting forth ranges of values for geometric dimensions of an embodiment of the elastomeric or resilient tubular structure of the friction fit attachment system shown in FIG. 44A-B are cross-sectional views illustrating the operation of a valve assembly in a distal nosecone according to one embodiment, whereby retraction of the second catheter closes the valve and prevents fluid flow through the distal neck of the balloon. 45A-F are plan views illustrating a first sequence of operation of a friction fit attachment system including an elastomeric or resilient valve and an elastomeric or resilient tubular structure according to the embodiment shown in FIGS. 30 and 44. 46A-E are cross-sectional detail views showing a first sequence of operation of a friction fit attachment system including an elastomeric or resilient valve and an elastomeric or resilient tubular structure according to the embodiment shown in FIGS. 30 and 44. 47A-J are plan views illustrating a second sequence of operation of a friction fit attachment system including an elastomeric or resilient valve and an elastomeric or resilient tubular structure according to the embodiment shown in FIGS. 30 and 44. 48A-I are cross-sectional detail views showing a second sequence of operation of a friction fit attachment system including an elastomeric or elastic valve and an elastomeric or elastic tubular structure according to the embodiment shown in FIGS. 30 and 44. 49A-D show plan, cross-sectional and perspective views of a distal nosecone incorporating a valve assembly according to one embodiment. FIG. 50 is a cross-sectional view of the distal valve assembly shown in FIGS. 49A-D, defining its overall geometric dimensions. FIG. 51 is a table setting forth ranges of values for the geometric dimensions of the distal valve assembly shown in FIG. 52A-C are cross-sectional views of an embodiment of a balloon having various components attached to its proximal and distal necks. 53A-C are plan partial cross-sectional views illustrating the operation of an electrolytic detachment system according to a first embodiment in which an electrolytically sensitive tubular structure functioning as an anode is bonded into both the proximal neck of the balloon and the first catheter. 54A-C are partial cross-sectional plan views illustrating the operation of an electrolytic detachment system according to a second embodiment in which an electrolytically sensitive tubular structure acting as an anode is bonded to the exterior of both the proximal neck of the balloon and the first catheter. 55A-E are cross-sectional and detailed cross-sectional views of a tubular structure susceptible to electrolysis that serves as the anode of an electrolytic separation system according to one embodiment, defining its overall geometric dimensions. FIG. 56 is a table setting forth ranges of values for the geometric dimensions of the anode embodiment shown in FIG. 57A-D are plan, cross-sectional, detailed cross-sectional and perspective views of the anode shown in FIG. 58A-E are plan views illustrating a first sequence of operation of the electrolytic separation system according to the embodiment shown in FIGS. 55 and 57. 59A-E are cross-sectional detail views illustrating a first sequence of operation of the electrolytic separation system according to the embodiment shown in FIGS. 55 and 57. 60A-I are plan views illustrating a second sequence of operation of the electrolytic separation system according to the embodiment shown in FIGS. 55 and 57. 61A-H are cross-sectional detail views illustrating a second sequence of operation of the electrolytic separation system according to the embodiment shown in FIGS. 55 and 57. 62A-I are plan views illustrating a third sequence of operation of the electrolytic separation system according to the embodiment shown in FIGS. 55 and 57. 63A-I are cross-sectional detail views illustrating a third sequence of operation of the electrolytic separation system according to the embodiment shown in FIGS. 55 and 57. 64A-D are plan partial cross-sectional views illustrating the operation of an electrical and thermal isolation system according to a first embodiment in which a heat sensitive tubular structure is bonded into both the proximal neck of the balloon and the first catheter. 65A-D are cross-sectional and detailed cross-sectional views of a heat sensitive tubular structure used in an electrical thermal isolation system according to the embodiment shown in FIG. 64, defining its overall geometric dimensions. FIG. 66 is a table setting forth ranges of values for the geometric dimensions of the embodiment of the heat sensitive tubular structure shown in FIG. 67A-D are plan partial cross-sectional views illustrating the operation of an electrical-thermal isolation system according to a second embodiment in which the distal end of the first catheter is heat sensitive. 68A-D are cross-sectional and detailed cross-sectional views of the heat-sensitive distal end of a first catheter used in the electrical-thermal isolation system according to the embodiment shown in FIG. 67 defined by its overall geometric dimensions. FIG. 69 is a table setting forth ranges of values for the geometric dimensions of an embodiment of the heat sensitive distal end of the first catheter shown in FIG. 70A-D are plan partial cross-sectional views illustrating the operation of an electrical and thermal isolation system according to a third embodiment in which a heat sensitive material bonds a first catheter to an expandable structure in the proximal balloon neck. 71A-C are cross-sectional and detailed cross-sectional views of a thermal junction used in the electrical and thermal isolation system according to the embodiment shown in FIG. 70, defining its general geometric dimensions. FIG. 72 is a table setting forth ranges of values for the geometric dimensions of the thermal joints shown in FIG. 73A-F are plan views illustrating a first sequence of operation of the electrical and thermal isolation system according to the embodiment shown in FIGS. 64 and 65. FIG. 74A-E are cross-sectional detail views illustrating a first sequence of operation of the electrical and thermal isolation system according to the embodiment shown in FIGS. 64 and 65. FIG. 75A-I are plan views illustrating a second sequence of operation of the electrical and thermal isolation system according to the embodiment shown in FIGS. 64 and 65. FIG. 76A-K are cross-sectional detail views illustrating a second sequence of operation of the electrical and thermal isolation system according to the embodiment shown in FIGS. 64 and 65. FIG. 77A-I are plan views illustrating a third sequence of operation of the electrical and thermal isolation system according to the embodiment shown in FIGS. 64 and 65. FIG. 78A-K are cross-sectional detail views illustrating a third sequence of operation of the electrical and thermal isolation system according to the embodiment shown in FIGS. 64 and 65. FIG. 79A-B are partial cross-sectional views of a balloon with two embodiments of an expandable retention structure. 80A-F are plan views showing a first sequence of operation of a detachable balloon catheter incorporating an expandable retention structure secured to the distal neck of the balloon and a mechanical latch attachment system in accordance with one embodiment. 81A-I are plan views showing a second sequence of operation of a detachable balloon catheter incorporating an expandable retention structure secured to the distal neck of the balloon and a mechanical latch attachment system in accordance with one embodiment. 82A-I are plan views showing a third sequence of operation of a detachable balloon catheter incorporating an expandable retention structure secured to the distal neck of the balloon and a mechanical latch attachment system in accordance with one embodiment. 83A-D are plan, cross-sectional, and perspective views illustrating a pleating and folding sequence for a balloon according to one embodiment. 84A-B are cross-sectional views of pleated balloons according to embodiments using three or five pleats with specific defined geometric dimensions. FIG. 85 is a table listing ranges of dimensional values for balloons, including the embodiment shown in FIG. 84, and their associated pleat designs. FIG. 86 is a schematic illustration of a second catheter and a second medical device functioning as a coil delivery system according to one embodiment having defined overall geometric dimensions. FIG. 87 is a table listing ranges of values for dimensions of a second catheter and second medical device that function as the coil delivery system shown in FIG. 86 when based on a 0.014" guidewire platform. FIG. 88 is a table listing ranges of values for dimensions of a second catheter and second medical device that function as the coil delivery system shown in FIG. 86 when based on a 0.018" guidewire platform. FIG. 89 is a table setting forth a range of dimensional values for a second catheter and second medical device that function as the coil delivery system shown in FIG. 86 when based on a 0.035/0.038" guidewire platform. FIG. 90 is a table setting forth ranges of values for the length dimensions of a second catheter and a second medical device that function as the coil delivery system shown in FIG. 86 for three common guidewire platforms. FIG. 91 is a table setting forth a range of diameter dimension values for a second catheter and a second medical device that function as the coil delivery system shown in FIG. 86 for three common guidewire platforms. 92A-C are cross-sectional views of a terminal branch aneurysm according to one embodiment having its overall geometric dimensions defined. 93A-M are cross-sectional views of a terminal bifurcation aneurysm illustrating a sequence of treatment with a detachable balloon catheter according to one embodiment. 94A-M are cross-sectional views of a terminal bifurcation aneurysm with a smaller SAC daughter aneurysm illustrating a sequence of treatment with a detachable balloon catheter according to one embodiment. 95A-B are cross-sectional views of a sidewall aneurysm with its overall geometric dimensions defined before and after treatment with a detachable balloon catheter according to one embodiment. 96A-B are cross-sectional views of a terminal bifurcation aneurysm with its overall geometric dimensions defined before and after treatment with a detachable balloon catheter according to one embodiment. 97A-B are schematic diagrams showing the direction of tapered blood flow and lumen diameter in arteries and veins. 98A-B are schematic diagrams showing arterial and venous occlusion using a detachable balloon catheter having an expandable retention structure that is deployed during venous treatment to additionally place a vascular coil within the expanded balloon and secure the balloon. Figures 99A-B are cross-sectional views of a left atrial appendage with its overall geometric dimensions defined, before and after treatment with a detachable balloon catheter, using an expandable retention structure to ensure assisted placement of the balloon and vascular coil within the expanded balloon in one embodiment. 100A-B are partial cross-sectional views of an aortic valve with paravalvular leakage before and after treatment using a detachable balloon catheter with assisted placement of a vascular coil within an expanded balloon according to one embodiment. 101A-F are plan views showing a first sequence of operation of a detachable balloon catheter incorporating an expandable retention structure secured to the proximal neck of the balloon and a mechanical latch attachment system in accordance with one embodiment. 102A-J are plan views showing a second sequence of operation of a detachable balloon catheter incorporating an expandable retention structure secured to the proximal neck of the balloon and a mechanical latch attachment system according to one embodiment. 103A-I are plan views showing a third sequence of operation of a detachable balloon catheter incorporating an expandable retention structure secured to the proximal neck of the balloon and a mechanical latch attachment system according to one embodiment of the expandable retention structure. FIG. 104 includes images of treatment of a canine terminal bifurcation aneurysm with a metal balloon and coils according to one embodiment. FIG. 105 includes images of treatment of a canine sidewall aneurysm with a metal balloon and coils according to one embodiment. FIG. 106 includes images of treatment of a canine complex bifurcation aneurysm with a metal balloon and coils according to one embodiment. 107A-E include images of various steps in the treatment of a canine complex bifurcation aneurysm according to one embodiment. FIG. 108 includes images of various steps in the treatment of a canine sidewall aneurysm according to one embodiment. FIG. 109 illustrates the difference in radiation between a metal balloon and a platinum coil according to one embodiment. 110A-D include images of various steps in the treatment of a canine sidewall aneurysm with a polymeric balloon and coils according to one embodiment. FIG. 111 includes images of treatment of an open aneurysm neck segment in a dog with additional coils according to one embodiment. FIG. 112 includes images of treatment of a canine terminal bifurcation aneurysm with only a metal balloon according to one embodiment. FIG. 113 includes images of treatment of a canine terminal bifurcation aneurysm with coils only according to one embodiment. FIG. 114 includes images comparing treatment of a canine terminal bifurcation aneurysm with a metal balloon and a vascular coil versus a coil alone according to one embodiment. 115A-B include images of endothelialization of a canine terminal bifurcation aneurysm neck following balloon and coil placement according to one embodiment. FIG. 116 includes images relating to the immediate effects of treatment of a dog internal mammary artery according to one embodiment. FIG. 117 includes images depicting a canine internal thoracic artery one month after treatment according to one embodiment. FIG. 118 includes images relating to the effectiveness of a metal balloon in treating a canine carotid artery hemorrhage according to one embodiment. FIG. 119 includes images relating to an Amplatzer Vascular Plug II according to one embodiment and its effect on treating canine carotid artery bleeding. FIG. 120 includes images associated with advancing a metal balloon over a guidewire into a canine superior mesenteric artery, according to one embodiment. 121A-B include images related to the treatment of a canine axillary artery with a metallic balloon according to one embodiment. FIG. 122 includes images relating to the placement of a coil inside an expanded metal balloon in a dog carotid artery according to one embodiment. 123A-C include images associated with detachment of a metal balloon in a canine internal thoracic artery according to one embodiment. FIG. 124 includes comparative images of histopathology one month after implantation of various embodiments of the disclosed medical devices in a canine internal mammary artery, according to one embodiment. FIG. 125 includes images relating to the advancement of a polymer and metal wire balloon over a guidewire into a canine axillary artery, according to one embodiment. FIG. 126 includes images relating to the expansion of a polymer and metal wire balloon in a dog axillary artery, according to one embodiment. 127A-C include images relating to the placement of a coil in an expandable polymer and metal wire balloon according to one embodiment. 128A-D include images relating to treatment of a dog brachial artery with a polymer only balloon and one coil according to one embodiment. FIG. 129 includes images relating to a mechanical latch release mechanism according to one embodiment.

The present disclosure generally relates to medical devices 1 that can be used alone or in combination to treat a human patient. In describing these medical devices, the proximal end generally refers to the end that is outside the patient and within reach of the physician. The distal end generally refers to the end that is pushed or advanced into the patient. For the individual components of the medical devices described herein, the same proximal and distal directions are generally maintained as shown in Figures 1A and 3A. For the detachable balloon 10 portion of the medical devices described herein, a first axis 706 extends along the centerline of the device between the proximal region 110 and the distal region 120 of the detachable balloon 10, and a second axis 708 extends perpendicular to the first axis 706.

The present disclosure relates to a medical device 1 comprising a detachable balloon 10 and a catheter or catheter assembly 5, the detachable balloon 10 configured for expansion and separation with a fluid from the catheter or catheter assembly 5 in vivo. After separation of the expanded detachable balloon 10 from the catheter or catheter assembly 5, the detachable balloon 10 is configured to maintain the expanded configuration. These devices are also referred to herein as a "detachable balloon catheter" or "first medical device" 1. The term balloon as used herein refers to a hollow structure having a non-porous wall 30 comprising a lightweight or thin material that can be inflated or expanded comprising injection of a fluid into a central void 115, as shown in Figures 1A and 3A. As used herein, a balloon can also be referred to as a "hollow expandable structure" or an "expandable hollow structure". Various shapes and sizes of the detachable balloon 10 are described. A detachable balloon 10 having one or more layers including a polymer layer 99 and a metal layer 90 is described as shown in Figures 7, 8A-J, and 9A-L, and is described with various surface treatments and textures as shown in Figures 10A-D. As shown in Figures 79A-B and 98B, balloons having various retention structures 731 and surface textures and their reduced risk of migration of the detachable balloon 10 in vivo are described, including catheters 5 configured for expansion of the detachable balloon 10, catheters 5 configured to receive a guidewire 40, catheters 5 configured for delivery of an expandable or elongated body 720, catheters 5 configured for injection of X-ray contrast, and catheters 5 configured to constrain the retention structures 731 prior to deployment as shown in Figures 13A-D, 14A-C, 15A-C, and 16A-D.

As shown in Figures 17A-C, 18A-D, 26A-H, and 28A-G, various means of attaching the detachable balloon 10 to the catheter and catheter assembly 5 are described, including joining or bonding the parts; a friction fit (or friction fit) 202 created using an elastomeric or male annular structure 204, as shown in Figures 33A-B, 34A-B, 35A-B, and 42A-C; a friction fit 202 created using an elastomeric or elastic bulb 192, as shown in Figures 44A-B, 46A-E, 49A-D, and 50; glues and adhesives; and other joining methods. Various means of removing the balloon 10 from the catheter and catheter assembly 5 are described, including separation of the connected parts, as shown in Figures 19A-G, 20A-E, and 21A-E; pulling the catheter or catheter assembly 5 away from the expanded detachable balloon 10 by overcoming the friction fit 202, as shown in Figures 30A-D, 31A-D, 32A-D, 36A-F, and 37A-E; dissolving a portion of the structure joining the detachable balloon 10 to the catheter or catheter assembly 5 by electrolysis, as shown in Figures 53A-C, 54A-C, 57A-D, 58A-E, and 59A-E; and melting a portion of the structure joining the detachable balloon 10 to the catheter or catheter assembly 5 by heating, as shown in Figures 64A-D, 67A-D, 70A-D, 73A-F, and 74A-E.

Various configurations of the detachable balloon 10 and the detachable balloon catheter 1 are described along with associated methods of manufacturing them. In one example, the detachable balloon 10 portion of the detachable balloon catheter 1 is configured in a compressed, deflated, or pleated folded configuration and configured for permanent implantation into a human patient. As shown in Figures 1A, 3A, and 5A-B, the detachable balloon 10 generally comprises a distal region 120, a proximal region 110 generally opposite the distal region 110, and an intermediate region 100 transitioning between the proximal and distal regions 110 and 120. A first axis 706 extends along the centerline of the device between the proximal region 110 and the distal region 120. A second axis 708 extends perpendicular to the first axis 706. The wall 30 generally extends continuously from the proximal region 110 through the intermediate region 100 to the distal region 120. The wall 30 has an outer surface and an inner surface that defines a central void 115 or interior volume. As shown in Figures 30A-D, the removable balloon 10 has an opening in the wall 30 in the proximal region 110 that allows the passage of fluid from the first catheter 173 into the central void 115 or interior volume of the balloon 10 and allows the passage of a portion of the second catheter 174 into the central void 115 or interior volume of the balloon 10. As shown in Figures 37A-E and 44A, the removable balloon 10 has an opening in the wall 30 in the distal region 120 that allows a portion of the second catheter 174 to exit the central void 115 or interior volume of the balloon 10.

Various configurations of catheter assemblies are described. As shown in Figures 13B-C and 14A-C, the first catheter 173, together with the second catheter 174, define a first lumen 162 of circular cross section to allow passage of fluid from the proximal end of the first catheter 173 to the distal end of the first catheter and into the central void 115 or interior volume of the detachable balloon 10. The first catheter 173 further comprises a proximal end coupled to a first proximal hub 179 and a distal portion operably coupled or joined to an opening in the wall 30 of the proximal region 110 of the balloon 10. The second catheter 174 defines a second lumen 163 of circular cross section configured to receive at least one of a guidewire 40, an elongated or expandable body 720, or a coagulation fluid. The second catheter 174 comprises a proximal end connected to a second proximal hub 178; a proximal portion passing through the proximal hub 179 of the first catheter 173; and a distal portion passing through the proximal opening, central void 115, and distal opening of the balloon 10. The passage of fluid through the first catheter 173 to the central void 115 or the interior volume of the balloon 10 can cause the balloon 10 to expand.

The present disclosure also relates to a medical device comprising an elongated or expandable body 720. Here, these devices are also referred to as "second medical devices" 700. As used herein, the elongated body 720 is a long, thin, flexible structure that can be pushed or carried through the lumen of a catheter and implanted in a patient. The elongated body 720 can occupy space and form complex shapes, but does not expand during or after placement. As used herein, the expandable body 720 is an elongated, thin, flexible structure that can be constrained, folded, compressed, or pleated, pushed or carried through the lumen of a catheter in a folded form, and implanted in a patient, and at least a portion of the expandable body 720 can expand in size during or after placement. An elongated expandable body 720 that can be used with a first medical device comprising a detachable balloon catheter 1 is described.

In some embodiments, the solidification fluid comprises an adhesive that can be injected as a fluid into the central cavity 115 of the balloon 10 through the first lumen 162 or the second lumen 163 or into the biological space 904 adjacent to the expanded balloon 10, and the solidification fluid becomes solid or semi-solid after passing through the first lumen 162 or the second lumen 163. Some examples of solidification fluids include adhesives such as cyanoacrylate or UV-curable adhesives, ethylene vinyl alcohol, Onyx® copolymers, or particles that increase in viscosity with physiological salts. In some embodiments, the solid solidification agent acts to help the expanded and separated balloon 10 of the detachable balloon catheter 1 resist collapse, compression, or compaction. In some embodiments, the solid solidification agent acts to help maintain the position of the expanded and separated balloon 10 of the detachable balloon catheter 1. In some embodiments, the solid solidifying agent acts to reduce the flow of blood or other biological fluids or suspensions through the treated artery 317, vein 318 or other biological conduit 900. In some embodiments, the solid solidifying agent acts to occupy the biological space 904.

Continuing with the deployment sequence after expansion of the detachable balloon 10, the second catheter 174 can be moved forward or backward while the balloon 10 remains fixed in place, as shown in Figures 14A-B and 19D-E. After removing the guidewire 40, all or part of the elongated or expandable body 720 or one or more second medical devices 700 comprising a coagulation fluid can be placed through the lumen 163 of the second catheter 174 into the biological space 904 adjacent to the balloon 10, as shown in Figures 16A-D and 41A-D. The second catheter 174 is then pulled back until the distal tip of the second catheter 174 is located in the central cavity 115 of the balloon, and the first catheter 173 and balloon remain fixed in place. All or part of one or more second medical devices 700, including the elongated or expandable body 720, the solidification fluid, or other balloon support material, can be passed through the second lumen 163 of the second catheter 174 and placed into the central cavity 115 of the balloon 10, as shown in FIG. 41E.

As shown in Figures 41F-H, the balloon and all or a portion of one or more elongated or expandable bodies 720, clotting fluid, or other balloon support material remain in the patient, but following placement of all or a portion of one or more second medical devices comprising elongated or expandable bodies 720, clotting fluid, or other balloon support material, are separated from the expanded balloon, and the first and second catheters 173 and 174 may be removed from the patient.

In some embodiments, as shown in Figures 83A-D and 84A-B, the compressed or folded balloon-expandable body 10 comprises a balloon 10, and portions of the wall 30 of the balloon 10 are squeezed or compressed together or in a much smaller space than the expanded balloon 10. In some embodiments, the constrained balloon 10 is forced and held to a smaller diameter than the expanded balloon 10. In some embodiments, the balloon portion 10 of the detachable balloon catheter 1 is pleated, folded, or compressed into a shape that occupies a smaller space or a smaller diameter than the expanded balloon 10, which is referred to as a "deliverable configuration." In some embodiments, the expandable body portion 720 of the second medical device 700 is also constrained or compressed into a shape that occupies a smaller space or a smaller diameter than the expanded expandable body 720, which is referred to as a deliverable configuration.

Also described are saccular aneurysms 320, arteries 317, veins 318, left atrial appendages 800, perivalvular leaks 808, other blood-containing structures, biological conduits 900, or other biological spaces 904 using a detachable balloon catheter with or without the aid of one or more elongate bodies 720.

A general approach to treating a saccular aneurysm 320 using a detachable balloon catheter 1 and an elongated or expandable body 720 according to one embodiment is shown sequentially in Figures 93A-M. A detachable balloon catheter 1 is selected with an appropriately sized balloon 10 based on standard imaging methods. A guidewire 40 is placed within the aneurysm 320 using standard percutaneous delivery methods. The detachable balloon catheter 1 is advanced over the guidewire 40 and the balloon 10 is positioned and deployed within the aneurysm lumen 322 and expanded. The detachable balloon catheter 1 is then pulled back to ensure intimate contact between the balloon 10 and the aneurysm neck 324. The guidewire 40 is retracted. The first and second elongated bodies 720 and 721 are advanced through the second catheter 174 and one or more coils or first elongated bodies are positioned within the aneurysm lumen 322 distal to the expanded balloon 10. The first catheter 173 is then detached from the proximal neck 130 of the balloon 10 using a detachment system, which may have various embodiments. Finally, the first catheter 173 is pulled back. The expanded and detached balloon 10 and the first elongated body 720 are retained in the patient to provide a complete and durable embolization of the aneurysm 320. The above general approach can be applied to the treatment of saccular aneurysms 320 of different and more complex shapes, for example, terminal bifurcation aneurysms 320 with small daughter aneurysms in the sac, as shown in Figs. 94A-M. By including the additional step of pulling back the distal tip of the second catheter 174 into the cavity 115 of the balloon 10 and placing one or more coils or the first elongated body 720 into the cavity 115 of the balloon 10, the balloon 10 can be strengthened against external compression, as shown in Figs. 94K-L. The final configuration of the treated aneurysm 320, including the expanded balloon 10, the first elongate body 720 within the aneurysm lumen 322, and the first elongate body 720 within the cavity 115 of the balloon 10, is shown in Figures 94M, 95B, and 96B.
balloon

As shown in Figures 1-6, various removable balloon shapes and sizes are described. In some embodiments, the removable balloon 10 can be characterized as including a proximal region 110, an intermediate region 100, and a distal region 110, where the proximal and distal regions 110 and 120 are generally opposed to one another. For each body, the proximal region 110, the intermediate region 100, and the distal region 120 form the integral structure of the removable balloon 10. For this feature, the proximal region 110, the intermediate region 100, and the distal region 120 together form the "main body" of the removable balloon 10, excluding the proximal and distal necks 130 and 140. In some embodiments, without the intermediate region 100, the removable balloon can be characterized as including a proximal region 110 and a distal region 120, where the proximal and distal regions 110 and 120 are generally opposed to one another. For each of these bodies, the proximal region 110 and the distal region 120 form the integral structure of the removable balloon 10. For this characterization, the proximal and distal regions 110 and 120 together form the "main body" of the detachable balloon 10, excluding the proximal and distal necks 130 and 140. The detachable balloon 10 may be further defined by a first axis 706 and a second axis transverse to the first axis. In one aspect, the first axis 706 extends between the proximal neck 130 and the distal neck 140.

In some embodiments, the removable balloon 10 is configured to assume a general shape comprising one lobe, excluding the proximal and distal necks 130 and 140 or the neck assemblies 135 and 142, if present. Some removable balloons may be configured to assume an approximately spherical, spheroidal, oblate spheroidal, prolate spheroidal, ellipsoidal, oblate spheroidal, or prolate spheroidal shape, excluding the proximal and distal necks 130 and 140 or the neck assemblies 135 and 142, if present, when expanded. Some removable balloons comprise a proximal region 110, a distal region 120, and an intermediate region 100, when expanded. Other removable balloons comprise a proximal region 110, a distal region 120, and a distal region 120, without an intermediate region 100, when expanded. In some embodiments, the intermediate region 100 of the removable balloon 10 is approximately cylindrical, when expanded. In some embodiments, the detachable balloon 10 is configured to assume a generally rectangular or cylindrical shape when expanded, excluding the proximal and distal necks 130 and 140 and neck assemblies 135 and 142, if present.

In some embodiments, the detachable balloon 10 can be defined and described by the proximal region 110 and the distal region 120, each of which is approximately hemispherical. The hemispherical shape is defined by a semimajor axis and a semiminor axis formed by each region, which may be parallel to the first axis 706 or the second axis 708, depending on the length of each axis. In various embodiments, other embodiments of the hemisphere of the proximal region 110 have semimajor and semiminor axes that are different from the axes of the distal region 120. In other embodiments, the hemisphere of the proximal region 110 has semimajor and semiminor axes that are the same as the axes of the distal region 120. Similarly, for each distal and proximal region 110, the semimajor and semiminor axes may be different or the same from one another, so that the corresponding regions can have the shape of an approximately flattened hemisphere, an oblate hemisphere, or a hemisphere. The detachable balloon 10 may also be fabricated in many other configurations having an approximately spheroidal or ellipsoidal shape.

The proximal region 110 of some removable balloons 10, when expanded, is generally round in shape, except for the proximal and distal necks 130 and 140, if any, or the neck assemblies 135 and 142, if any, as shown in FIGS. 3A and 3B. The proximal region 110 of some removable balloons 10, when expanded, forms the shape of a hemisphere, a flattened hemisphere, an oblate hemisphere, a semi-ellipsoid, a flattened semi-ellipsoid, an oblate semi-ellipsoid, or a paraboloid, except for the proximal and distal necks 130 and 140, if any, or the neck assemblies 135 and 142, if any, as shown in FIGS. 1A and 5A. The proximal region 110 of some removable balloons 10, when expanded, is generally conical, except for the proximal and distal regions 130 and 140, if any, or the neck assemblies 135 and 142, if any, as shown in FIGS.

The distal region 120 of some expandable detachable balloons 10 is generally round in shape, except for the proximal and distal necks 130 and 140 or neck assemblies 135 and 142, if present, as shown in FIG. 3A. The distal region 120 of some detachable balloons 10, when expanded, forms a hemispherical, flattened hemispherical, oblate hemispherical, semi-ellipsoidal, flattened semi-ellipsoidal, oblate semi-ellipsoidal, or paraboloidal shape, except for the proximal and distal necks 130 and 140 or neck assemblies 135 and 142, if present. The distal region 120 of the detachable balloon 10, when expanded, is generally conical in shape, except for the proximal and distal necks 130 and 140 or neck assemblies 135 and 142, if present. The distal region 120 of the detachable balloon 10 is generally conical in shape, except for the proximal and distal necks 130 and 140 or neck assemblies 135 and 142, if present, as shown in FIG. 1A.

For some embodiments, the detachable balloon 10 is configured such that when expanded, the intermediate region 100 assumes a shape that is approximately cylindrical, and the proximal and distal regions 110 and 120 form approximately a hemisphere, flattened hemisphere, prolate hemisphere, or paraboloid, excluding the proximal and distal necks 110 and 120 and neck assemblies 135 and 142. In other embodiments, the detachable balloon 10 is configured such that when expanded, the intermediate region assumes a shape that is approximately cylindrical, and the proximal and distal regions 110 and 120 assume a shape that is approximately conical, excluding the proximal and distal necks 110 and 120 and neck assemblies 135 and 142.

For some detachable balloons, as shown in Figures 1A-B, 2A-D, 5A, and 6A-B, the intermediate region 100 is approximately cylindrical and the proximal or distal regions 110 and 120 are conical, with the proximal or distal regions 110 and 120 having a cone angle (defined as the angle between the wall 30 of the balloon and the first axis 706 of the balloon) of 20 to 75 degrees. In one embodiment, the shape of the intermediate region of the detachable balloon can be defined by the rotation about the first axis 706 of a variable radius arc formed along the first axis 706, with the maximum radius for the variable arc being equal to either the maximum radius 720 of the distal region 120 or the maximum radius 710 of the proximal region 110. For some embodiments, the expanded detachable balloon has a total length 709 along the first axis 706 that is less than or equal to the maximum diameter 712 of the detachable balloon expanded along the second axis 708.

As shown in Figures 1A-B, 2A-D, 3A-B, and 4A-C, some removable balloons 10 are configured to have a maximum diameter when expanded, measured parallel to the second axis 708, of 2-40 mm, measured partially parallel to the second axis 708. Some removable balloons 10 are configured to have a maximum length when expanded, excluding the proximal and distal necks 130 and 140 and neck assemblies 135 and 142, of 2-80 mm, measured parallel to the first axis 706. Some removable balloons, including the proximal region 110, the intermediate region 100, and the distal region 120, have a maximum length when expanded, excluding the length of the proximal and distal necks 130 and 140 and neck assemblies 135 and 142, of 2-40 mm, measured parallel to the first axis 706. Some removable balloons 10, when expanded, have a maximum diameter measured parallel to the second axis 708 that is greater than a maximum length measured parallel to the first axis 706, excluding the length of the proximal and distal neck regions 130 and 140 and neck assemblies 135 and 142, if any. Some removable balloons 10, when expanded, have a maximum diameter measured parallel to the second axis 708 that is equal to a maximum length measured parallel to the first axis 706, excluding the length of the proximal and distal neck regions 130 and 140 and neck assemblies 135 and 142, if any. Some removable balloons 10, when expanded, have a maximum length measured parallel to the first axis 706 that is greater than a maximum diameter measured parallel to the second axis 708, excluding the proximal and distal neck regions 130 and 140 and neck assemblies 135 and 142, if any. In some embodiments, the expanded detachable balloon 10 has a length from the proximal neck 130 to the distal neck of about 4-30 mm or more, and a maximum diameter 712 of about 4-30 mm or more.

In some embodiments, as shown in Figures 3A-B, 4A-C, 5B, and 6C-D, the maximum radial lengths for the proximal and distal regions 110 and 120 are equal such that the detachable balloon has a substantially circular cross-section when viewed in cross section along the first axis 706. For some other embodiments, the radial lengths at any similar location for the proximal and distal regions 110 and 120 are not equal such that the expanded detachable balloon 10 does not have a substantially circular cross-section when viewed in cross section along the second axis 708.

In one aspect, various configurations of the detachable balloon 10 can be obtained by independently varying the maximum length (also referred to as "height") along the first axis 706 of the proximal and distal regions 110 and 120, as shown in Figures 1A-B, 2A-D, 3A-B, and 4A-C. For example, the height 713 of the proximal region 110 may be less than the height 714 of the distal region 120 in other examples. In other examples, the height 713 of the proximal region 110 may be equal to the height 714 of the distal region 120. In other examples, the height 713 for the proximal region 110 may be greater than the height for the distal region 120. Although both detachable balloons 10 have the same maximum diameter, the difference in the height of the proximal and distal regions 110 and 120 of each detachable balloon results in a difference in the overall shape of the detachable balloon 10.

In other embodiments, the height 713 and the height 714 of the proximal and distal regions 110 and 120, respectively, can produce a wide variety of configurations of the detachable balloon 10 in the first embodiment. In the first embodiment, the height 713 of the proximal region 110 can be about 2 mm and the height 714 of the distal region 120 can be about 4 mm. In the second embodiment, the height 713 of the proximal region 110 can be about 3 mm and the height 714 of the distal region 120 can be about 3 mm. In the third embodiment, the height 713 of the proximal region 110 can be about 2 mm and the height 714 of the distal region 120 can be about 3.5 mm. In the fourth embodiment, the height 713 of the proximal region 110 can be about 3 mm and the height 714 of the distal region 120 can be about 4 mm. As shown in Figures 3A-B, the detachable balloon 10 can have several configurations that can be approximately spheroidal or approximately spherical.

The wall 30 of the detachable balloon may include one or more layers, as shown in FIG. 7. The thickness of the wall 30 may range from 5 to 400 μm or from 0.0002 to 0.016 μm, as shown in FIGS. 5A-B and 6A-D.

Some sizes and shapes of the detachable balloon 10 may be suitable for treating some conditions, while others may be appropriate for treating other conditions. For example, a round or spherical detachable balloon 10 may be suitable for treating a saccular aneurysm 320 as shown in FIG. 93A-M and an LAA 800 as shown in FIG. 99A-B. In contrast, a cylindrical detachable balloon may be suitable for treating an artery 317 as shown in FIG. 98A, a vein 318 as shown in FIG. 98B, a paravalvular leak 808 as shown in FIG. 100A-B, and a biological conduit 900. In other clinical applications, the detachable balloon may be configured to assume an expanded shape comprising two or more lobes, excluding the proximal and distal necks 130 and 140 and the neck assemblies 135 and 142, if any.

In some embodiments, all or a portion of the detachable balloon 10 of the detachable balloon catheter 1 is non-compliant. In some embodiments, all or a portion of the detachable balloon 10 of the detachable balloon catheter 1 is semi-compliant. In some embodiments, all or a portion of the detachable balloon 10 of the detachable balloon catheter 1 is compliant. In some embodiments, all or a portion of the detachable balloon 10 of the detachable balloon catheter 1 expands <2%, <4%, <6%, <8%, <10%, or >10% when inflated to a pressure between 1 and 20 atmospheres.

In some embodiments, the detachable balloon 10 comprises an opening in the proximal region 110 to allow fluid to pass from the catheter or catheter assembly 5 into the detachable balloon 10. In some embodiments, the proximal opening in the detachable balloon 10 comprises a proximal neck 130 that extends away from the detachable balloon 10 or into the central cavity 115 of the detachable balloon 10, as shown in Figures 1A-B, 3A-B, and 5A-B.

11A-D, one or more annular structures, tubular structures, telescopic structures, catheter segments, or telescopic catheter segments may be joined to the proximal neck 130 of the detachable balloon 10. Such a structure is referred to as a "proximal telescope" 190 and, together with the proximal neck 130, forms a proximal neck assembly 135.

Various configurations of the proximal telescope 190 may be employed to achieve various embodiments of the proximal neck assembly 135. The proximal telescope 190 may be shorter than, longer than, or the same length as the proximal neck 130 of the detachable balloon 10. The proximal telescope 190 may protrude distally, proximally, both distally and proximally, or may not protrude distally or proximally of the proximal neck. The outer surface of the proximal telescope 190 may be bonded to the inner surface of the proximal neck 130. The inner surface of the proximal telescope 190 may be bonded to the outer surface of the proximal neck 130. The proximal telescope 190 may be bonded to the proximal neck 130 with an adhesive or glue. The proximal telescope 190 may be rigid, may comprise a metal, or may comprise a radiopaque metal that is visible under fluoroscopy. The metallic proximal telescope 190 may comprise platinum, iridium, gold, silver, stainless steel, nitinol, titanium, or alloys or combinations thereof. The proximal telescope 190 may be flexible and comprise a polymer. The polymeric proximal telescope 190 may comprise Pebax, nylon, polyimide, PTFE, or combinations thereof. The polymeric proximal telescope 190 may comprise a polymer or a polymer having a Shore durometer hardness of 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49, 50, 51, 52, 53, 54, 55, 56, 57, 58, 59, 60, 61, 62, 63, 64, 65, 66, 67, 68, 69, 70, 71, 72, 73, 74, 75, 76, 77, 78, 79, or 80D. The inner layer of the wall of the polymeric proximal telescope 190 may comprise a lubricious polymer, including, but not limited to, PTFE, polyimide, composites, or a mixture of polyimide and PTFE. The wall of the polymeric proximal telescope 190 may comprise an intermediate layer located between the outer layer and the inner layer, including metal wires comprising Nitinol or stainless steel, and including spiral, coil, braided, woven, or linear patterns. The wall of the polymeric proximal telescope 190 may comprise an intermediate layer located between the outer layer and the inner layer. The proximal telescope 190 may comprise a lubricious coating on its inner, outer, or inner/outer surface. The proximal telescope 190 may comprise a hydrophilic coating, such as the Serene coating from SurModics.

The proximal telescope 190 may include a marker band 612 that is clearly visible under fluoroscopy. The marker band 612 may comprise platinum, iridium, gold, silver, or alloys or combinations thereof. The marker band 612 may be bonded to the distal end, the proximal end, or both the proximal and distal ends of the proximal telescope 190.

Various dimensions of the proximal telescope 190 may be specified to achieve various embodiments of the proximal neck assembly 135. The inner diameter or lumen diameter of the proximal telescope 190 may be 0.024 to 0.108 inches. The outer diameter or overall diameter of the proximal telescope 190 may be 0.026 to 0.110 inches. The proximal telescope 190 may have a length of 0.3 to 30 mm either before or after separation of the detachable balloon 10 from the first catheter 173, as measured parallel to the first axis 706. The outer diameter of the proximal neck 130 or proximal neck assembly 135 of the detachable balloon 10 may be 0.042 to 0.108 inches, as measured parallel to the second axis 708.

The proximal neck assembly 135 of the detachable balloon 10 may further comprise a proximal nose cone to reduce the risk of damaging the walls of the saccular aneurysm 320, the artery 317, the vein 318, the LAA 800, other blood-containing structures, the biological conduit 900, or the biological space 904 when the detachable balloon catheter 1 is advanced or retracted. Although not shown, the proximal nose cone 198 is structurally and functionally similar to the distal nose cone shown in FIGS. 44A-B and 52A-B. The proximal nose cone 198 may have a tapered proximal end, a tapered distal end, or tapered proximal and distal ends. In other embodiments, the proximal nose cone 198 comprises one piece, while in other embodiments, the proximal nose cone 198 may comprise two or more pieces joined together, including those joined together with a glue or adhesive. In some embodiments, the proximal nosecone 198 comprises one or more polymers including polyetheretherketone (PEEK), polycarbonate, nylon, polyimide, Pebax, PTFE, silicone, polyurethane, copolyester polymer, thermoplastic rubber, silicone-polycarbonate copolymer, polyethylene ethyl-vinyl-acetate (PEVA) copolymer, biocompatible elastomer, biocompatible elastic material, or biocompatible adhesive. In some embodiments, the length of the proximal nosecone 198 is between 1 and 10 mm. In some embodiments, the proximal nosecone 198 has an outer diameter between 0.058 and 0.18 inches. In some embodiments, the proximal nosecone 198 is bonded to the proximal neck 130. In some embodiments, the proximal nosecone is bonded to a portion of the proximal neck assembly 190 that includes the proximal telescope 190. In some embodiments, the proximal nosecone 198 is bonded to both the proximal neck 130 and a portion of the proximal neck assembly 135. In some embodiments, the proximal nosecone 198 is joined to a portion of the exterior surface of the proximal balloon neck 130 or to a portion of the proximal neck assembly 135. In some embodiments, at least a portion of the proximal neck 130 comprises a layer of radiopaque metal that is visible under fluoroscopy.

In some embodiments, the detachable balloon comprises an opening in the distal region 120 to allow a portion of the catheter or catheter assembly 5 to pass into and through the central cavity 115 of the detachable balloon 10, and optionally extend distally of the detachable balloon, thereby allowing the guidewire 40 and/or the second catheter 174 to pass completely through the detachable balloon 10. In some embodiments, the distal opening in the detachable balloon 10 comprises a distal neck 140 that extends away from the detachable balloon 10 or into the central cavity 115 of the detachable balloon 10, as shown in Figures 1A-B and 3A-B.

As shown in Figures 11E-H and 52C, one or more annular structures, tubular structures, telescopic structures, catheter segments, or telescopic catheter segments may be joined to the distal neck 140 of the detachable balloon 10. Such a structure is called a "distal telescope" 185 and, together with the distal neck 140, forms the distal neck assembly 142.

Various configurations of the distal telescope 185 may be employed to achieve various embodiments of the distal neck assembly 142. The distal telescope 185 may be longer than, shorter than, or the same as the distal neck 140 of the detachable balloon 10. The distal telescope 185 may project proximally, distally, both distally and proximally, or may not project either distally or proximally of the distal neck 140. The outer surface of the distal telescope 185 of the distal neck 140 may be bonded to the inner surface of the distal neck 140. The inner surface of the distal telescope 185 may be connected to the outer surface of the distal neck 140. The distal telescope 185 may be bonded to the distal neck 140 with an adhesive or glue. The distal telescope 185 may be rigid, may comprise a metal, or may comprise a radiopaque metal that is visible during fluoroscopic transmission. The metal distal telescope 185 may comprise platinum, iridium, gold, silver, stainless steel, nitinol, titanium, or alloys thereof or combinations thereof. The distal telescope 185 may be flexible and may comprise a polymer. The polymer distal telescope 185 may comprise Pebax, nylon, polyimide, PTFE, or combinations thereof. The polymeric distal telescope 185 may comprise a polymer or a polymer having a Shore Durometer hardness of 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49, 50, 51, 52, 53, 54, 55, 56, 57, 58, 59, 60, 61, 62, 63, 64, 65, 66, 67, 68, 69, 70, 71, 72, 73, 74, 75, 76, 77, 78, 79, or 80D. The inner layer of the wall of the polymeric distal telescope 185 may comprise a lubricious polymer, including PTFE, polyimide, composites, or a mixture of polyimide and PTFE. The wall of the polymeric distal telescope 185 may comprise an intermediate layer located between the outer layer and the inner layer, such intermediate layer comprising metal wire, including metal wire including nitinol or stainless steel, and metal wire configured in a spiral, coil, braid, woven, or linear pattern. The distal telescope 185 may comprise a lubricious coating on its inner surface, outer surface, or both. The distal telescope 185 may comprise a hydrophilic coating, such as Selene coating from SurModics.

The distal telescope 185 may include a marker band 612 that is clearly visible under fluoroscopy. The marker band 612 may not include platinum, iridium, gold, silver, or alloys or combinations thereof. The marker band 612 may be bonded to the distal end, the proximal end, or both the proximal and distal ends of the distal telescope 185.

Various dimensions of the distal telescope 185 may be specified to achieve various embodiments of the distal neck assembly 142. The inner diameter or lumen diameter of the distal telescope 185 may be 0.024 to 0.108 inches. The outer diameter or overall diameter of the distal telescope 185 may be 0.026 to 0.110 inches. The distal telescope 185 may have a length of 0.3 to 30 mm measured parallel to the first axis 706 either before or after separation of the detachable balloon 10 from the first catheter 173. The inner diameter of the distal neck 140 or distal neck assembly 142 may be 0.024 to 0.068 inches measured parallel to the second axis 708. The outer diameter of the distal neck 140 or distal neck assembly 142 may be 0.030 to 0.096 inches measured parallel to the second axis 708.

In some embodiments of the detachable balloon catheter 1, the outer diameter of the distal telescope 185 is larger than the inner diameter of the proximal telescope 190, so that the proximal portion of the distal telescope 185 cannot enter the first lumen 162. In some embodiments, the outer diameter of the distal telescope 185 of the detachable balloon catheter 1 is larger than the inner diameter of the proximal neck 130, so that the proximal portion of the distal telescope 185 cannot enter the first lumen 162. In some embodiments of the detachable balloon catheter 1, the outer diameter of the distal telescope 185 is larger than the inner diameter of the first catheter 173, so that the proximal portion of the distal telescope 185 cannot enter the first lumen 162.

44A-B and 52A-B, the distal neck assembly 142 of the detachable balloon 10 further comprises a distal nose cone 191 to reduce the risk of damage to the walls of the saccular aneurysm 320, the artery 317, the vein 318, the LAA 800, other blood-containing structures, the biological conduit 900 or the biological space 904 when the detachable balloon catheter 1 is advanced or retracted. The distal nose cone 191 may have a tapered proximal end, a tapered distal end, or tapered proximal and distal ends. In some embodiments, the distal nose cone 191 may comprise one piece, while in other embodiments, the distal nose cone 191 comprises two or more pieces joined together, including those joined together with a glue or adhesive, as shown in FIGS. 49A-D. In some embodiments, the distal nosecone 191 comprises one or more polymers including polyetheretherketone (PEEK), polycarbonate, nylon, polyimide, Pebax, PTFE, silicone, polyurethane, copolyester polymer, thermoplastic rubber, silicone-polycarbonate copolymer, polyethylene ethyl-vinyl-acetate (PEVA) copolymer, biocompatible elastomer, biocompatible elastic material, or biocompatible adhesive. In some embodiments, the length of the distal nosecone 191 is between 1 and 10 mm. In some embodiments, the distal nosecone 191 has an outer diameter between 0.058 and 0.18 inches. In some embodiments, the distal nosecone 191 is bonded to the distal neck 140. In some embodiments, the distal nosecone 191 is bonded to a portion of the distal neck assembly 142 that includes the distal telescope 185. In some embodiments, the distal nosecone 191 is bonded to both the distal neck 140 and a portion of the distal neck assembly 142. In some embodiments, a portion of the inner surface of the distal nosecone 191 is joined to a portion of the outer surface of the distal balloon neck 140 or to a portion of the distal neck assembly 142. In some embodiments, at least a portion of the distal neck 140 comprises a layer of radiopaque metal that is visible under fluoroscopy.

The removable balloon 10 may be a polymer balloon 12, as shown in Figs. 7.7, 8B, and 9B, and comprises a continuous layer of polymer 99, except for any proximal and distal openings in the removable balloon 10. The continuous polymer layer 99 of the removable polymer balloon 12 may comprise PET, nylon, or Pebax. The thickness of the polymer layer 99 of the removable polymer balloon 12 may range between 5-300 μm or between 0.0002-0.012 inches. The removable polymer balloon 12 may comprise an additional layer of a non-metallic coating or polymer 97, which may be continuous or discontinuous, inside the continuous polymer layer 99, which may be continuous or discontinuous, or outside the continuous polymer layer 99, as shown in Figs. 7.5, 8B, and 9B. The additional layer of non-metallic coating or polymer 97 may comprise polyurethane, silicone, or poly(p-xylylene) (Parylene). The non-metallic coating or additional layer of polymer 97 of the detachable polymer balloon 12 may have a thickness of 0.1 to 100 μm. The overall thickness of the wall 30 of the detachable polymer balloon 12 may range between 5 to 300 μm, or between 0.0002 to 0.012 inches. The detachable polymer balloon 12 may not have sufficient strength to maintain an expanded or partially expanded configuration in vivo after separation from the catheter or catheter assembly 5. If no solid or semi-solid material not from the patient is present in the central void 115 of the expanded detachable balloon after separation from the first and second catheters 173 and 174, the detachable polymer balloon 12 may not have sufficient strength to maintain an expanded or partially expanded configuration in vivo after separation from the catheter or catheter assembly 5. If the detachable polymer balloon 12 is implanted in an unsealed configuration, the detachable polymer balloon 12 may not have sufficient strength to maintain an expanded or partially expanded configuration in vivo after separation from the catheter or catheter assembly 5. If the pressure in the central void 115 or the internal volume of the expanded detachable polymer balloon is not greater than the pressure outside the expanded detachable polymer balloon 12, the detachable polymer balloon 12 may not have sufficient strength to maintain an expanded or partially expanded configuration in vivo after separation from the catheter or catheter assembly 5. By using mold and balloon blowing techniques, the detachable polymer balloon 12 can be made to closely conform to the size and shape of various vascular structures, biological conduits 900, or biological spaces, including but not limited to saccular aneurysms 320, segments of arteries 317, segments of veins 318, the LAA 800, segments of paravalvular leak pathways 808, segments of biological conduits 900, or specific biological spaces.

In some embodiments, all or a portion of the detachable polymer balloon 12 of the detachable balloon catheter 1 is non-compliant. In some embodiments, all or a portion of the detachable polymer balloon 12 of the detachable balloon catheter 1 is semi-compliant. In some embodiments, all or a portion of the detachable polymer balloon 12 of the detachable balloon catheter 1 is compliant. In some embodiments, all or a portion of the detachable polymer balloon 12 of the detachable balloon catheter 1 expands <2%, <4%, <6%, <8%, <10%, or >10% when inflated at a pressure in the range of 1-20 atmospheres.

In some embodiments, the outer surface of the polymeric detachable balloon 12 of the detachable balloon catheter 1 comprises a surface structure, as shown in Figures 10B-D. In some embodiments, the outer surface of the polymeric detachable balloon 12 of the detachable balloon catheter 1 comprises a surface structure having a height of 0.01-1 μm. In some embodiments, the outer surface of the proximal region 110 of the polymeric detachable balloon 12 of the detachable balloon catheter 1 comprises a surface structure or a surface structure having a height of 0.01-1 μm, while the intermediate region 100 and the distal region 120 are smooth or smoother than the proximal region 110, as shown in Figure 10A. In some embodiments, the outer surface of the proximal region 110 of the polymeric detachable balloon 12 of the detachable balloon catheter 1 configured for implantation in a saccular aneurysm 320 or LAA 800 comprises a surface structure or a surface structure having a height of 0.01-1 μm, while the intermediate region 100 and the distal region 120 are smooth or smoother than the proximal region 110.

The detachable balloon 10 may be a metallized polymer balloon 14, as shown in Figs. 7.2, 8C, 8E, 9C, and 9E, and comprises a continuous layer of polymer 99, except for any proximal and distal openings in the detachable balloon, and a metal layer 90, which may be continuous or discontinuous. The continuous polymer layer 99 of the detachable metallized polymer balloon 14 may comprise PET, nylon, or Pebax and may range between 5-300 μm, or between 0.0002-0.012 inches. The continuous polymer layer 99 may be an outer layer. The metal layer 90 may comprise gold, titanium, platinum, or combinations or alloys thereof. The metal layer 90 may also comprise silver, vanadium, aluminum, nickel, tantalum, zirconium, chromium, silicone, magnesium, niobium, scandium, cobalt, palladium, manganese, molybdenum, alloys thereof, and combinations thereof. Other biocompatible rigid materials or combinations of materials may be used.

The metal layer 90 may have a thickness ranging between 0.1 and 100 μm. The metal layer 90 may be an outer layer. The detachable metallized polymer balloon 14 may include additional layers of non-metallic coatings, polymers, or adhesives 97, which may be continuous or discontinuous, may be internal to the continuous polymer layer 99, or external to the continuous polymer layer 99, and may be internal to the metal layer 90 or external to the metal layer 90, as shown in Figures 7.3, 7.4, 7.6, 8C-J, and 9C-J. The additional layers of non-metallic coatings, polymers, or adhesives may include polyurethane, silicone, or Parylene. The additional layers of non-metallic coatings, polymers, or adhesives 97 may have a thickness ranging between 0.1 and 100 μm. The additional layers of non-metallic coatings, polymers, or adhesives 97 may be an outer layer, an inner layer, or both an outer layer and an inner layer. The overall thickness of the wall 30 of the removable metallized polymer balloon 14 may range between 5-300 μm, or between 0.0002-0.012 inches. At least a portion of the exterior surface of the removable metallized polymer balloon 14 may comprise a rounded, pebbled, or granular surface structure, as shown in Figures 10B-D, where the pebbles or granules have a surface height of 0.01-10 μm. At least a portion of the exterior surface of the removable metallized polymer balloon 14 may comprise a metal having a rounded, pebbled, or granular surface structure, where the pebbles or granules have a surface height of 0.01-10 μm. At least a portion of the wall 30 of the removable metallized polymer balloon 14 may be formed by electroplating or electroforming. The electroplated or electroformed metal may be present on at least a portion of the intermediate region 100 of the removable metallized polymer balloon 14, on at least a portion of the proximal region 110 of the removable metallized polymer balloon 14, on at least a portion of the proximal region 110 and intermediate region 100, on at least a portion of the distal region 120 and intermediate region 100 of the removable metallized polymer balloon 14, on at least a portion of the proximal region 110, intermediate region 100, and distal region 120 of the removable metallized polymer balloon 14. In some embodiments, a fully metallized or fully plated removable metallized polymer balloon 14 can be provided by plating the entire outer layer of the continuous polymer removable balloon 12 inner or base layer 99, creating a variety of sizes and shapes of fully metallized or fully plated removable metallized polymer balloons 14. In some embodiments, the partially metallized or partially plated removable polymer balloon 20 can be plated on a portion of the inner layer or outer layer of the base layer 99 of the continuous polymer removable balloon 12 to create a variety of sizes and shapes of partially metallized or partially plated removable metallized polymer balloons 20.

The metal portion 90 of the removable metallized polymer balloon 14 may be formed as a wire and configured as a spiral, coil, braid, woven, or straight, as shown in Figures 9I-L. The metal wire may be bonded to the adjacent polymer layer 99 by glue or adhesive 95. The metal wire may be present on at least a portion of the intermediate region 100 of the removable metallized polymer balloon 14, on at least a portion of the proximal region 110 of the removable metallized polymer balloon 14, on at least a portion of the distal region 120 of the removable metallized polymer balloon 14, on at least a portion of the proximal region 110 and intermediate region 100 of the removable metallized polymer balloon 14, on at least a portion of the distal region 120 and intermediate region 100 of the removable metallized polymer balloon 14, on at least a portion of the proximal region portion 110, intermediate region 110, and distal region 120 of the removable metallized polymer balloon 14. The cross-sectional shape of the metal wire may be circular, elliptical, square, or rectangular. The metal wire 10 can have a diameter or width of 10-1000 μm. The detachable metallized polymer balloon 14 may range between 5-1500 μm or between 0.0002-0.060 inches.

In one example, the metal portion 90 of the removable metallized polymer balloon 14 is formed as a wire and bonded to the outer surface of the continuous polymer layer 99 with a glue or adhesive 95, as shown in FIG. 7.3. In another example, the metal portion 90 of the removable metallized polymer balloon 14 is formed as a wire and bonded to the outer surface of the continuous polymer layer 99 with a glue or adhesive 95, and one or more non-metallic layers comprising a coating and adhesive 97 are applied to the outer surface of the removable polymer balloon 12 having the metal wire, as shown in FIG. 7.6, and the coating and adhesive 97 comprises polyurethane, silicone, or Parylene.

The detachable metallized polymer balloon 14 may have sufficient strength to maintain an expanded or partially expanded configuration in vivo after separation from the catheter or catheter assembly 14. If no solid or semi-solid material not from the patient is present in the central void 115 of the detachable expanded metal balloon 16 after separation from the first and second catheters 173 and 174, the detachable metallized polymer balloon 14 may have sufficient strength to maintain an expanded or partially expanded configuration in vivo after separation from the catheter or catheter assembly 14 when the detachable metallized polymer balloon 14 is implanted in an unsealed configuration. If the pressure in the central cavity 115 or interior volume of the expanded detachable metallized polymer balloon 14 is greater than the pressure outside the expanded detachable metallized polymer balloon 14, the detachable metallized polymer balloon 14 may have sufficient strength to maintain an expanded or partially expanded configuration in vivo after separation from the catheter or catheter assembly 14.

The detachable metallized polymer balloon 14 may not have sufficient strength to maintain an expanded or partially expanded configuration after separation from the catheter or catheter assembly 5. If no solid or semi-solid material not originating from the patient is present within the central void 115 of the expanded detachable metallized polymer balloon 14 after separation from the first and second catheters 173 and 174, the detachable metallized polymer balloon 14 may not have sufficient strength to maintain an expanded or partially expanded configuration after separation from the catheter or catheter assembly 5. If the detachable metallized polymer balloon 14 is implanted in an unsealed configuration, the detachable metallized polymer balloon 14 may not have sufficient strength to maintain an expanded or partially expanded configuration after separation from the catheter or catheter assembly 5. If the pressure in the central void 115 or interior volume of the expanded detachable metallized polymer balloon 14 is greater than the pressure outside the expanded detachable metallized polymer balloon 14, the detachable metallized polymer balloon 14 may not have sufficient strength to maintain the expanded or partially expanded configuration after separation from the catheter or catheter assembly 5.

By using mold and balloon blowing techniques and then applying a layer of metal 90 by electroplating, electroforming, or bonding metal wires, a removable metalized polymer balloon 14 can be made to closely conform to the size and shape of various vascular structures, biological conduits 900, or biological spaces, including, but not limited to, saccular aneurysms 320, segments of arteries 317, segments of veins 318, the LAA 800, perivalvular leak pathways 808, biological conduits 900, or specific biological spaces.

According to various embodiments of a partially or completely metallized detachable balloon 14, the metal layer 90 may be present in only a proportion of the wall 30 of the detachable balloon 10 up to a majority of the detachable metallized polymer balloon 14, as desired, as shown in Figures 7.1, 7.2, 7.3, 7.4, 7.6, 8A, 8C-J, 9A, and 9C-L. By way of example and not limitation, the metal layer 90 may cover 100% of the main body or intermediate region 100 of the detachable metallized polymer balloon 14, or less than 100% of the main body or intermediate region 100. Similarly, the metal layer 90 may cover 100% of the proximal region 110 of the detachable metallized polymer balloon 14, or less than 100% of the proximal region 110. Similarly, the metal layer 90 may cover 100% of the distal region 120 of the removable metallized polymer balloon 14, or less than 120% of the distal region. The metal layer 90 may cover 1-99% of the removable metallized polymer balloon 14.

In some embodiments, all or a portion of the detachable metallized polymer balloon 14 of the detachable balloon catheter 1 is non-compliant. In some embodiments, all or a portion of the detachable metallized polymer balloon 14 of the detachable balloon catheter 1 is semi-compliant. In some embodiments, all or a portion of the detachable metallized polymer balloon 14 of the detachable balloon catheter 1 is compliant. In some embodiments, all or a portion of the detachable metallized polymer balloon 14 of the detachable balloon catheter 1 expands <2%, <4%, <6%, <8%, <10%, or >10% when inflated at a pressure of <20 atmospheres.

In some embodiments, as shown in Figures 10B-D, the outer surface of the metallized polymer detachable balloon 14 of the detachable balloon catheter 1 comprises a surface structure. In some embodiments, the outer surface of the metallized polymer detachable balloon 14 of the detachable balloon catheter 1 comprises a surface structure having a height of 0.01-1 μm. In some embodiments, the outer surface of the proximal region 110 of the metallized polymer detachable balloon 14 of the detachable balloon catheter 1 comprises a surface structure or a surface structure having a height of 0.01-1 μm, while the intermediate region 100 and the distal region 120 are smooth or are smoother than the proximal region 110. In some embodiments, the outer surface of the proximal region 110 of the metallized polymer detachable balloon 14 of the detachable balloon catheter 1 configured for implantation into the saccular aneurysm 320 or LAA 800 comprises a surface structure or a surface structure having a height of 0.01 to 1 μm, while the intermediate region 100 and the distal region 120 are smooth or smoother than the proximal region 110, as shown in FIG. 10A.

In some embodiments, the outer surface of the metallized polymer detachable balloon 14 of the detachable balloon catheter 1 comprises a titanium layer that is 5-500 angstroms thick. In some embodiments, the outer surface of the metallized polymer detachable balloon 14 of the detachable balloon catheter 1 comprises a gold layer that is 100-10,000 ounces thick. In some embodiments, the outer layer of the metallized polymer detachable balloon 14 of the detachable balloon catheter 1 comprises a gold layer that is 0.1-3 μm thick, or 0.1, 0.2, 0.3, 0.4, 0.5, 0.6, 0.7, 0.8, 0.9, 1.0, 1.1, 1.2, 1.3, 1.4, 1.5, 1.6, 1.7, 1.8, 1.9, 2.0, 2.1, 2.2, 2.3, 2.4, 2.5, 2.6, 2.7, 2.8, 2.9, or 3.0 μm thick. In some embodiments, the exterior of the metallized polymer removable balloon 14 of the removable balloon catheter 1 comprises a gold layer having a thickness of 0.1 to 3 μm, the inner layer being made by sputtering or vacuum deposition, and the outer layer being made by electroplating or electroforming. In some embodiments, the exterior of the metallized polymer removable balloon 14 of the removable balloon catheter 1 comprises a gold layer having a thickness of 0.1 to 3 μm, the inner layer being made by sputtering or vacuum deposition, and the gold layer being made by electroplating or electroforming.

In some embodiments, the outer surface of the metallized polymer detachable balloon 14 of the detachable balloon catheter 1 configured for implantation into a saccular aneurysm 320 or LAA 800 comprises a titanium layer that is 5-500 angstroms thick. In some embodiments, the outer surface of the metallized polymer detachable balloon 14 of the detachable balloon catheter 1 configured for implantation into a saccular aneurysm 320 or LAA 800 comprises a gold layer that is 100-10,000 angstroms thick.

As shown in Figs. 7.1, 8A, and 9A, the detachable balloon 10 may be a detachable metal balloon 16 comprising a continuous layer of metal 90, except for any proximal and distal openings. The continuous metal layer 90 of the detachable metal balloon 16 may comprise gold, platinum, or combinations or alloys thereof. The overall thickness of the wall 30 of the detachable metal balloon 16 may range between 5 and 300 μm, or between 0.0002 and 0.012 inches. A portion of the outer surface of the detachable metal balloon 16 may comprise a rounded, pebbled, or granular surface structure, as shown in Figs. 10B-D, with the pebbles or granules having a surface height of 0.01 to 10 μm. At least a portion of the wall 30 of the detachable metal balloon 16 may be formed by electroplating or electroforming. At least a portion of the wall 30 of the detachable metal balloon 16 may be annealed. In some embodiments, the metal balloon 16 can be referred to as an expandable metal structure, a hollow metal structure, or a hollow, expandable metal structure.

The detachable metal balloon 16 may have sufficient strength to maintain an expanded or partially expanded shape in vivo after separation from the catheter or catheter assembly 16. The detachable metal balloon 16 may have sufficient strength to maintain an expanded or partially expanded shape in vivo after separation from the catheter or catheter assembly 16 if no solid or semi-solid material not originating from the patient is present in the central void 115 of the expanded detachable metal balloon 16 after separation from the first and second catheters 173 and 174. The detachable metal balloon 16 may have sufficient strength to maintain an expanded or partially expanded shape in vivo after separation from the catheter or catheter assembly 16 if the detachable metal balloon 16 is implanted in an unsealed configuration. The detachable metal balloon 16 may have sufficient strength to maintain an expanded or partially expanded shape in vivo after separation from the catheter or catheter assembly 16, provided that the pressure in the central cavity 115 or interior volume of the expanded detachable metal balloon 16 is not greater than the pressure outside the expanded detachable metal balloon 16.

The detachable metal balloon 16 may not have sufficient strength to maintain an expanded or partially expanded shape in vivo after separation from the catheter or catheter assembly 16. If no solid or semi-solid material not originating from the patient is present in the central void 115 of the expanded detachable metal balloon 16 after separation from the first and second catheters 173 and 174, the detachable metal balloon 16 may not have sufficient strength to maintain an expanded or partially expanded shape in vivo after separation from the catheter or catheter assembly 16. If the detachable metal balloon 16 is implanted in an unsealed configuration, the detachable metal balloon 16 may not have sufficient strength to maintain an expanded or partially expanded shape in vivo after separation from the catheter or catheter assembly 16. If the pressure in the central cavity 115 or interior volume of the expanded detachable metal balloon 16 is not greater than the pressure outside the expanded detachable metal balloon 16, the detachable metal balloon 16 may not have sufficient strength to maintain an expanded or partially expanded shape in vivo after separation from the catheter or catheter assembly 16.

By fabricating conductive mandrels 740 of various sizes and shapes and then applying a metal layer 90 by electroplating or electroforming, detachable metal balloons 16 can be made to closely conform to the size and shape of various defect structures, biological conduits 900, or biological spaces, including, but not limited to, saccular aneurysms 320, segments of arteries 317, segments of veins 318, the LAA 800, perivalvular leak pathways 808, segments of biological conduits 900, or specific biological spaces.

In some embodiments, a portion of the detachable metal balloon 16 of the detachable balloon catheter 1 is non-compliant. In some embodiments, all or a portion of the detachable metal balloon 16 of the detachable balloon catheter 1 expands <2% during expansion.

In some embodiments, the outer surface of the detachable metal balloon 16 of the detachable balloon catheter 1 comprises a surface structure. In some embodiments, the outer surface of the metal detachable balloon 16 of the detachable balloon catheter 1 comprises a surface structure having a height of 0.01 to 1 μm. In some embodiments, the outer surface of the proximal region 110 of the metal balloon 16 of the detachable balloon catheter 1 comprises a surface structure or a surface structure having a height of 0.01 to 1 μm, while the intermediate and distal regions 120 are smooth or are smoother than the proximal region 110. In some embodiments, the outer surface of the proximal region 110 of the metal balloon 16 of the detachable balloon catheter 1 configured for implantation into a saccular aneurysm 320 or LAA 800 comprises a surface structure or a surface structure having a height of 0.01 to 1 μm, while the intermediate region 100 and distal region 120 are smooth or are smoother than the proximal region 110.

The detachable balloon 10, except for any proximal and distal openings in the detachable polymer-coated metal balloon 18, may be a polymer-coated metal balloon 18, and may comprise a continuous layer of metal 90. The detachable polymer-coated metal balloon 18 may comprise gold, platinum, or a combination or alloy thereof. The detachable polymer-coated metal balloon 18 may comprise an additional layer of a non-metallic coating or polymer 97, which may be continuous or discontinuous, and may be external to the continuous metal layer 90, internal to the continuous metal layer 90, or both internal and external to the continuous metal layer 90. The additional layer of non-metallic coating or polymer 97 may comprise polyurethane, silicone, or Parylene. The additional layer of non-metallic coating, polymer, or adhesive 97 may be continuous or discontinuous, and may be external to the continuous metal layer 90, internal to the continuous metal layer, or both internal and external to the continuous metal layer. The additional layer of non-metallic coating or polymer 97 may comprise polyurethane, silicone, or Parylene. The additional layer of non-metallic coating, polymer or adhesive 97 may comprise a material that insulates the metal layer 90 from passing electrical current to the interior or exterior surface of the detachable polymer coated metal balloon 18. The additional layer of non-metallic coating or polymer 97 of the detachable polymer coated metal balloon 18 may have a thickness of 0.1 to 100 μm. The total thickness of the wall 30 of the polymer coated metal balloon 18 may range between 5 to 300 μm, or between 0.0002 to 0.012 inches. At least a portion of the wall 30 of the polymer coated metal balloon 18 may be formed by electroplating or electroforming. The detachable polymer coated metal balloon 18 may be annealed.

The detachable polymer-coated metal balloon 18 may have sufficient strength to maintain an expanded or partially expanded configuration in vivo after separation from the catheter or catheter assembly 5. If no solid or semi-solid material not from the patient is present in the central void 115 of the expanded detachable polymer-coated metal balloon 18 after separation from the first and second catheters 173 and 174, the detachable polymer-coated metal balloon 18 may have sufficient strength to maintain an expanded or partially expanded configuration in vivo after separation from the catheter or catheter assembly 5 when the detachable polymer-coated metal balloon 18 is implanted in an unsealed configuration. The detachable polymer-coated metal balloon 18 may have sufficient strength to maintain an expanded or partially expanded configuration in vivo after separation from the catheter or catheter assembly 5, provided that the pressure in the central void 115 or interior volume of the expanded detachable polymer-coated metal balloon 10 is no greater than the pressure outside the expanded detachable polymer-coated metal balloon 18.

The detachable polymer-coated metal balloon 18 may not have sufficient strength to maintain an expanded or partially expanded configuration in vivo after separation from the catheter or catheter assembly 5. The detachable polymer-coated metal balloon 18 may not have sufficient strength to maintain an expanded or partially expanded configuration in vivo after separation from the catheter or catheter assembly 5 if no solid or semi-solid material not originating from the patient is present in the central void 115 of the expanded detachable polymer-coated metal balloon 18 after separation from the first and second catheters 173 and 174. The detachable polymer-coated metal balloon 18 may not have sufficient strength to maintain an expanded or partially expanded configuration in vivo after separation from the catheter or catheter assembly 5 if the detachable polymer-coated metal balloon 18 is implanted in an unsealed configuration. If the pressure in the central void 115 or interior volume of the expanded detachable polymer-coated metal balloon 18 is not greater than the pressure outside the expanded detachable polymer-coated metal balloon 18, the detachable polymer-coated metal balloon 18 may not have sufficient strength to maintain an expanded or partially expanded configuration in vivo after separation from the catheter or catheter assembly 5.

By fabricating conductive mandrels 740 of various sizes and shapes, applying a metal layer 90 by electroplating or electroforming, and then applying one or more layers 97 of a non-metallic coating or polymer, a removable polymer-coated metal balloon 18 can be made to closely conform to the size and shape of various vascular structures, biological conduits 900, or biological spaces, including, but not limited to, saccular aneurysms 320, segments of arteries 317, segments of veins 318, the LAA 800, perivalvular leak pathways 808, segments of biological conduits 900, or specific biological spaces 904.

In some embodiments, all or a portion of the detachable polymer-coated metal balloon 18 of the detachable balloon catheter 1 is non-compliant. In some embodiments, all or a portion of the detachable polymer-coated metal balloon 18 of the detachable balloon catheter 1 expands <2% upon expansion.

In some embodiments, the outer surface of the polymer-coated metal detachable balloon 18 of the detachable balloon catheter 1 comprises a surface structure. In some embodiments, the outer surface of the polymer-coated metal detachable balloon 18 of the detachable balloon catheter 1 comprises a surface structure having a height of 0.01 to 1 μm. In some embodiments, the proximal region 110 of the polymer-coated metal balloon 18 of the detachable balloon catheter 1 comprises a surface structure or a surface structure having a height of 0.01 to 1 μm, while the intermediate region 100 and the distal region 120 are smooth or are smoother than the proximal region 110. In some embodiments, the outer surface of the proximal region 110 of the polymer-coated metal balloon 18 of the detachable balloon catheter 1 configured for implantation in a saccular aneurysm 320 or LAA 800 comprises a surface structure or a surface structure having a height of 0.01 to 1 μm, while the intermediate region 110 and the distal region 120 are smooth or are smoother than the proximal region 110.

The detachable balloon 10 further comprises an expandable metal retention structure 731, as shown in FIG. 98B, to reduce the risk of migration after placement of the lumen of a segment of a vein 318, the LAA 800, or other blood-containing structure, biological conduit 900, or biological space. Such a feature can provide an additional factor of safety when filling or occluding a vein segment 318, for example, because the lumen diameter of the vein increases in the direction of flow, as shown in FIG. 97B. Thus, migration of the device within the vein 318 is not self-limiting, and the device may reach the left atrium, right ventricle, or a branch of the pulmonary artery branch, causing symptoms of pulmonary embolism. In contrast, the lumen diameter of the artery 317 generally decreases in the direction of flow, as shown in FIG. 97A. Thus, migration of the device within the artery 317 is self-limiting, as shown in FIG. 98A, and the use of the expandable metal retention structure 731 may be less critical when filling or occluding an artery segment 317 with the detachable balloon 10.

The expandable metal retention structure 731 may be attached to either the proximal neck 130 of the detachable balloon 10 as shown in Figures 79A and 100-103, or the distal neck 140 of the detachable balloon 10 as shown in Figures 79B and 80-82. The proximal attached expandable metal retention structure 731 is advantageous when the detachable balloon catheter 1 is inserted in the direction of blood flow, and the distal attached expandable metal retention structure 731 is advantageous when the detachable balloon catheter 1 is inserted in the direction against blood flow. After expansion, the diameter of the portion of the metal retention structure 731 is equal to or greater than the diameter of the expanded detachable balloon 10. As shown in Figure 98B, the portion of the expandable metal retention structure 731 is configured to contact the vein 318, LAA 800, aneurysm 320, biological conduit 900, or other blood-containing or biological space. The expandable metal retention structure 731 comprises a plurality of elongated ribs 604 or elongated 730. In the case of a proximal attached expandable metal retention structure 731, as shown in FIG. 79A, the expandable metal retention structure 731 may comprise a plurality of elongated ribs 604 extending from both the proximal and distal retention rings 602 and 606 of the expandable metal retention structure 731. At least one of the elongated ribs 604 may comprise a barb 608 configured to engage a portion of the wall of the artery 317, vein 318, LAA 800, aneurysm 320, biological conduit 900, or other blood containing structure or biological space. In some embodiments, the elongated ribs 604 are outwardly biased. In the case of a distal attached expandable metal retention structure 731, as shown in FIG.
The proximal retaining ring 602 comprises a plurality of elongate arms 730 extending therefrom. A free end of at least one elongate arm 730 may comprise a hook 733 configured to engage a portion of the artery 317, vein 318, LAA 800, aneurysm 320, biological conduit 900, or blood-containing structure or biological space.

In some embodiments, the expandable metal retention structure 731 is self-expanding. The retention structure 731 may comprise Nitinol or stainless steel. When expanded, the outer diameter of the ring structure ranges from 3-40 mm, which is the diameter of the expandable detachable balloon 10, 3-40 mm.

The detachable balloon catheter 1 comprising the expandable metal retention structure 731 may further comprise an outer catheter (referred to as a "third catheter") as shown in Figures 15A-C and 16A-D, with the distal portion of the third catheter 175 passing over at least a portion of the expandable retention structure 731 and retaining the expandable retention structure 731 in a constrained, compressed or folded configuration as shown in Figures 80A, 81A, 82A, 101A, 102A and 103A. The third catheter 175 may further comprise a proximal hub. The proximal hub may be configured with a radiocontrast injection port 177. The distal portion of the third catheter 175 may further comprise a side hole so that at least some of the radiocontrast injected into the port on the hub of the third catheter 175 can exit through the side hole. In some embodiments, as shown in Figures 80B, 81B, 82B, 101B, 102B, and 103B, the distal end of the third catheter 175 may be pulled back while the restrained, compressed, or folded retention structure 731 remains held in place, resulting in expansion of the retention structure 731. In some embodiments, the third catheter 175 may be pulled back before expansion of the detachable balloon 10. In some embodiments, the third catheter 175 may be pulled back after expansion of the detachable balloon 10.

In one embodiment, the retention structure 731 is made of a highly elastic material such as Nitinol and comprises a plurality of elongated arms 730 extending distally from the proximal retention ring 602 engaged with the distal neck 140 of the detachable balloon, as shown in FIG. 79B. Such an embodiment of the retention structure 731 is optimized to resist movement of the detachable balloon 10 with blood or other bodily fluids flowing from the distal neck 140 of the detachable balloon 10 toward the proximal neck 140. The distal end of each elongated arm 730 further comprises a hook configured to engage a wall of the artery 317, vein 318, LAA 800, or other blood-containing structure, biological conduit 900, or a portion of a biological space when the retention structure 731 is engaged. FIGS. 80A-F, 81A-I, and 82A-I show various sequences of operation of the detachable balloon catheter 1 having such an embodiment of the retention structure 731. As shown in Figures 80A, 81A, and 82A, during delivery of the detachable balloon 10 having the retention structure 731 by the detachable balloon catheter 1, the retention structure 731 is compressed by the third catheter 175 having the distal marker band 612. After confirming proper positioning, as shown in Figures 80B, 81B, and 82B, the third catheter 175 is pulled back and the retention structure 731 expands. The detachable balloon 10 is then expanded, as shown in Figures 80C, 81C, and 82C. Optionally, as shown in Figures 81D-F and 82F, placement of one or more coils or elongated bodies 720 in the central cavity 115 of the expanded detachable balloon 10 provides reinforcement against compression. Optionally, as shown in FIGS. 82D-E, one or more coils or other elongate bodies 720 (either different coils or other elongate bodies 720 or the same coils or other elongate bodies 720, disposed in the central cavity 115 of the expanded detachable balloon 10) facilitate embolic occlusion of the biological space distal to the expanded detachable balloon 10. As shown in FIGS. 80D-F, 81G-I, and 82G-I, the expanded detachable balloon 10 is then removed from the first catheter 173.

In another embodiment, as shown in FIG. 19A, the retention structure 731 is made of a highly elastic material, such as Nitinol, and includes a plurality of elongated ribs 604 extending from a proximal retention ring 602 engaged to the first catheter 173 to a distal retention ring 606 engaged to the proximal neck 130 of the removable balloon 10. Such an embodiment of the retention structure 731 is optimized to resist movement of the removable balloon 10, which would cause blood or other bodily fluids to flow from the proximal neck 130 to the distal neck 130 of the removable balloon 10. Each elongated rib 604 further includes a barb 608 configured to engage a wall of an artery 317, a vein 318, an LAA 800, or other blood-containing structure, a biological conduit 900, or a portion of a biological space when the retention structure 731 is expanded. Figures 101A-F, 102A-J, and 103A-I show various sequences of operation of the detachable balloon catheter 1 having such an embodiment of the retention structure 731. As shown in Figures 101A, 102A, and 103A, during delivery of the detachable balloon 10 having the retention structure 731 by the detachable balloon catheter 1, the retention structure 731 is compressed by the third catheter 175 having the distal marker band 612. After confirming proper positioning, as shown in Figures 101B, 102B, and 103B, the third catheter 175 is pulled back to expand the retention structure 731. The detachable balloon is then expanded as shown in Figures 101C, 102C, and 103C. Optionally, as shown in Figures 102D-G and 103F, placement of one or more coils or other elongated bodies 720 in the central cavity 115 of the expanded detachable balloon 10 provides reinforcement against compression. Optionally, one or more coils or other elongated bodies 720 (either different coils or other elongated bodies 720 or the same coils or other elongated bodies 720, disposed within the central cavity 115 of the expanded detachable balloon 10) facilitate embolic occlusion of the biological space distal to the expanded detachable balloon 10, as shown in Figures 103D-E. The expanded detachable balloon 10 is then removed from the first catheter 173, as shown in Figures 101D-F, 102H-J, and 103G-I.

In some embodiments, the outer surface of the detachable balloon 10 comprises a surface structure. In certain instances, these surface structures increase the surface roughness and increase the frictional forces between the outer surface of the detached balloon and the saccular aneurysm 320, artery 317, vein 318, LAA 800, perivalvular leak pathway 808, other blood-containing structures, or biological conduits 900, or spaces, thereby reducing the risk of movement and migration of the detachable balloon 10 after deployment. In some embodiments, the surface structures have a height of 0.01 to 1 μm. In some embodiments, the outer surface of the detachable balloon 10 comprises a rounded, pebbled, or granular structure.

In some embodiments, the outer surface of the detachable balloon 10 includes a lubricious coating. In certain instances, this lubricious or hydrophilic coating reduces frictional forces between the outer surface of the detachable balloon 10 and the saccular aneurysm 320, artery 317, vein 318, LAA 800, paravalvular leak path 808, other blood-containing structures, or biological conduits or spaces, thereby reducing the risk of tissue damage during deployment and expansion of the detachable balloon 10. In some embodiments, the lubricious or hydrophilic coating is a hydrophilic coating, such as SurModics, Inc.'s Serene ^™ coating, or BioInteractions Ltd.'s Assist ^™ coating.
Catheter Assembly

The present disclosure relates to an embodiment of a first medical device 1 including a detachable balloon 10 and a catheter or catheter assembly 5, as shown in Figures 13A-D, 14A-C, 15A-C, and 16A-D, where the detachable balloon 10 is configured to expand with a fluid and separate from the catheter or catheter assembly 5 in vivo.

The first catheter 173 of the detachable balloon catheter 1 has a proximal end, a lumen configured to receive the second catheter 174, and a distal end joined or operably connected to the proximal region 110 of the detachable balloon 10, as shown in Figures 13C, 14A-C, and 16A-D. In various embodiments, the first catheter 173 is joined to a portion of the proximal neck 130 of the detachable balloon 10, or to a portion of the proximal neck assembly 135 of the detachable balloon 10, or to a tubular segment inserted between the first catheter 173 and the proximal neck 130 or the proximal neck assembly 135 of the detachable balloon 10.

In some embodiments, the outer layer of the wall of the first catheter 173 comprises a polymer or includes Pebax, nylon, polyimide, and PTFE. In some embodiments, the inner layer of the wall of the first catheter 173 comprises a lubricious polymer or includes PTFE, polyimide, a blend, or a blend of polyimide and PTFE. In some embodiments, the first catheter 173 includes an intermediate layer including a metal, the intermediate layer being located between the outer layer and the inner layer. The metal of the intermediate layer of the first catheter 173 may be configured as a wire, including metals or wires configured in a spiral, coil, braid, woven, or linear pattern, or combinations thereof. In some embodiments, the metal or metal wire comprises Nitinol or stainless steel. In some embodiments, the wire is round and has a diameter of 0.0005 to 0.0030 inches. In some embodiments, the wire is configured in a coil having a pitch of 0.0010 to 0.0060 inches. In some embodiments, the wire is flat and has a thickness of 0.0005-0.0060 inches and a width of 0.001-0.030 inches. In some embodiments, the wire is configured in a braid, the braid has lengths per inch (PPI) of 50-300, and in some embodiments, the wire is wrapped in an "under one, over two" pattern of braid. In some embodiments, the proximal portion of the wire in the first catheter 173 is flat and has a thickness of 0.0005-0.0060 inches and a width of 0.001-0.030 inches and is configured in a braided configuration with picks per inch of length. The wire in the distal portion of the first catheter 173 is round and has a diameter of 0.0005-0.0030 inches and is configured in a coil pattern with a pitch of 0.0010-0.0060 inches.

In some embodiments, no metal or metal wire is present in the distal segment of the first catheter 173 joined to the male tubular structure, and the tubular structure includes a metal (also called an "anode") 390 that is sensitive to electrolysis or corrosion, as shown in Figures 53A-C and 54A-C, or a heat sensitive tubular structure 410, as shown in Figures 64A-D.

In some embodiments, the first catheter 173 includes a lubricious or hydrophilic coating, including a lubricious or hydrophilic coating present on the inner surface, the outer surface, or both the inner and outer surfaces of the first catheter 173. In some embodiments, the lubricious or hydrophilic coating is present on a distal portion of the first catheter 173 but is not present on a proximal portion of the first catheter 173.

In some embodiments, the outer layer at the proximal end of the first catheter 173 comprises a material having a Shore durometer hardness of 40-90D. In some embodiments, the outer layer at the proximal end of the first catheter 173 comprises nylon. In some embodiments, the outer layer at the distal end of the first catheter 173 comprises a material having a Shore durometer hardness of 20-60D. In some embodiments, the outer layer at the proximal end of the first catheter 173 comprises nylon.

In some embodiments, as shown in Figures 53B, 54B and 64A, the distal end of the first catheter 173 includes a marker band 612 that is visible during fluoroscopy and is configured to identify the location where separation of the dilatation balloon and the first catheter 173 is designed to occur.

In some embodiments, the first catheter 173 includes a hub and a shaft. In some embodiments, the proximal hub of the first catheter 173 includes a valve including a Tuohy-Borst adapter 186 incorporating a valve. In some embodiments, the first catheter 173 includes a male tubular structure joined to the distal end of the first catheter 173, thereby forming a first catheter assembly, as shown in Figures 30A-D, 31A-D, 32A-D, 33A-B, 34A-B, 35A-B, 37A-E, 42A-C, 43, 53A-C, 54A-C, 59A-E, 64A-D, 67A-D, 70A-D, and 74A-E. In some embodiments, as shown in Figures 30A-D, 33A-B, 37A-E, 53A-C, 54A-C, 59A-E, 64A-D, 67A-D, 70A-D, and 74A-E, the outer surface of the first catheter 173 or part of the first catheter assembly is bonded to a portion of the inner surface of the proximal neck 130 or proximal neck assembly 135 of the detachable balloon 10. In some embodiments, the first catheter 173 or part of the first catheter assembly is bonded to a portion of the distal neck 140 or distal neck assembly 142 of the detachable balloon. Although not shown, this distal bond configuration is structurally and functionally similar to the proximal bond configuration described above. In some embodiments, the outer surface of the first catheter 173 or part of the first catheter assembly is bonded to a portion of the inner surface of the distal neck 140 or distal neck assembly 142 of the detachable balloon.

In some embodiments, the inner or lumen diameter of the first catheter 173 is between 0.025 and 0.068 inches. In some embodiments, the outer diameter of the first catheter 173 is between 0.031 and 0.096 inches. In some embodiments, the length of the first catheter 173 is between 45 and 245 cm.

In some embodiments, the wall of the first catheter 173 is continuous from the proximal end to the distal end. In one example, the outer layer of the proximal portion of the first catheter 173 comprises nylon with a Shore durometer hardness of 40-90D, the middle portion of the first catheter 173 comprises Pebax with a Shore durometer hardness of 20-60D, and the distal portion of the first catheter 173 comprises nylon with a Shore durometer hardness of 40-90D. As shown in Figures 30A-D, 31A-D, 33A-B and 34A-B, the distal portion of the first catheter 173 is joined to the proximal neck assembly 135 of the balloon 10 by a friction fit formed between a portion of the proximal neck 130 or the outer surface of the first catheter 173 and an elastomeric tubular segment 204 joined or bonded to the proximal neck 130 or proximal neck assembly 135 of the detachable balloon. In some embodiments, the distal portion of the first catheter 173 or the first catheter assembly of the detachable balloon catheter 1 is coupled with the distal neck 140 or distal neck assembly 142 of the detachable balloon, and the wall of the segment of the first catheter 173 passing through the central void 115 or the interior volume of the detachable balloon 10 includes an opening for fluid to exit the lumen 163 of the second catheter 174. Although not shown, this distal joint configuration is structurally and functionally similar to the proximal joint configuration described above. In some embodiments, as shown in Figures 13C and 14A-C, the proximal hub of the first catheter 173 or the first catheter assembly of the detachable balloon catheter 1 includes a port (also called an "inflation port") 162 for injecting fluid into the first lumen (also called an "inflation lumen") 162.

As shown in FIG. 13B and FIG. 14A-C, the second catheter 174 of the detachable balloon catheter 1 has a proximal end, an open distal end, and a lumen 163 configured to receive the guidewire 40. In some embodiments, the outer layer of the wall of the second catheter 174 comprises a polymer or comprises Pebax, nylon, polyimide, or PTFE. In some embodiments, the inner layer of the wall of the second catheter 174 comprises a lubricious polymer or comprises PTFE, polyimide, composite, or a blend of polyimide and PTFE. In some embodiments, the second catheter 174 comprises an intermediate layer comprising a metal, the intermediate layer being located between the outer layer and the inner layer. In some embodiments, the intermediate layer comprising a metal is configured as a wire. In some embodiments, the intermediate layer comprising a metal is configured in one or more of a spiral, coil, braid, woven, or linear pattern. In some embodiments, the intermediate layer comprises Nitinol or stainless steel. In some embodiments, the intermediate layer wire is round and has a diameter of 0.0005-0.0030 inches. In some embodiments, the intermediate layer wire is configured in coils with a pitch of 0.0010-0.0060 inches. In some embodiments, the intermediate layer wire is flat and has a thickness of 0.0005-0.0060 inches and a width of 0.001-0.030 inches. In some embodiments, the intermediate layer wire is configured in braids with 50-300 picks per linear inch (PPI) or braids wound in an "under one, over two" pattern. In one example, the intermediate layer wire in the proximal portion of the second catheter 174 is flat and configured in braids with a thickness of 0.0005-0.0060 inches and a width of 0.001-0.030 inches and 50-300 picks per linear inch. The wire of the middle layer of the distal portion of the second catheter 174 is round and has a diameter of 0.0005-0.003 inches and is configured in a coil pattern with a pitch of 0.0010-0.0060 inches. In some embodiments, the second catheter 174 includes a lubricious or hydrophilic coating or includes a lubricious or hydrophilic coating on the inner surface, the outer surface, or both the inner and outer surfaces of the second catheter 174. The lubricious or hydrophilic coating includes a Serene coating manufactured by SurModics Inc. In some embodiments, a lubricious or hydrophilic coating is present on the distal portion of the second catheter 174 but not on the proximal portion of the second catheter 174. In some embodiments, the proximal end of the second catheter 174 includes a material with a Shore durometer hardness of 40-90D. In some embodiments, the outer layer of the proximal end of the second catheter 174 includes nylon. In some embodiments, the outer layer of the proximal end of the second catheter 174 comprises a nylon having a Shore durometer hardness of 40-90 D. In some embodiments, the distal end of the second catheter 174 comprises a material with a Shore durometer hardness of 20-60 D, or Pebax with a Shore durometer hardness of 20-60 D. In some embodiments, the distal end of the second catheter 174 comprises a material with a Shore durometer hardness of 40-90 D, or Nylon with a Shore durometer hardness of 40-90 D. In some embodiments, the second catheter 174 comprises at least two marker bands 612 that are visible during fluoroscopy and are configured to aid in the passage of a coil through the lumen of the second catheter 174 and to aid in the detachment of a coil passed through the lumen of the second catheter 174. In some embodiments, the first marker band 612 is 0.3-1.5 mm from the distal end of the second catheter 174 and the second marker band 612 is 2.0-4.0 mm proximally from the distal end of the second catheter 174. In some embodiments, the inner diameter or lumen diameter of the second catheter 174 is 0.025-0.068 inches. In some embodiments, the inner diameter or lumen diameter of the second catheter 174 is 0.012-0.048 inches. In some embodiments, the outer diameter of the second catheter 174 is 0.018-0.068 inches. In some embodiments, the second catheter 174 includes a hub and a shaft. In some embodiments, the length of the second catheter 174 is 50-250 cm. In some embodiments, the wall of the second catheter 174 is continuous from the proximal end to the distal end. In some embodiments of the detachable balloon catheter 1, the wall of the segment of the second catheter 174 that passes through the central cavity 115 or interior volume of the balloon includes openings for fluid to exit the lumen of the second catheter 174. In one example, the outer layer of the proximal portion of the second catheter 174 includes a material with a Shore durometer hardness of 40-90D, the outer layer of the distal end of the second catheter 174 includes a material with a Shore durometer hardness of 40-90D, and the distal end of the second catheter 174 includes a material with a Shore durometer hardness of 20-60D sandwiched between segments of material with a Shore durometer hardness of 40-90D. In another example, the outer layer of the proximal portion of the second catheter 174 comprises nylon having a Shore durometer hardness of 40-90 D, and the outer layer of the distal end of the second catheter 174 comprises Pebax having a Shore durometer hardness of 20-60 D, with the Pebax at the distal end of the second catheter 174 sandwiched between segments of nylon having a Shore durometer hardness of 40-90 D. In some embodiments, the distal portion of the second catheter 174 of the detachable balloon catheter 1 is coupled or operably coupled to a portion of the one or more elastomeric valves 192 by a friction fit 202. In some embodiments, the distal portion of the second catheter 174 of the detachable balloon catheter 1 is joined or operably coupled to a portion of the one or more elastomeric valves 192 by a friction fit 202, and the elastomeric valve 192 is contained within a distal nosecone 191 that is coupled to the distal neck 140 or distal neck assembly 142 of the detachable balloon. In some embodiments, the distal portion of the second catheter 174 of the detachable balloon catheter 1 is joined or operably coupled to a portion of the one or more elastomeric valves 192 and spacers 196 and 197 by a friction fit 202. In some embodiments, the distal portion of the second catheter 174 of the detachable balloon catheter 1 is joined or operably coupled to a portion of the one or more elastomeric valves 192 or spacers 196 and 197 by a friction fit 202, the elastomeric valves 192 and spacers 196 and 197 being contained within a distal nosecone 191 coupled to the distal neck 140 or distal neck assembly 142 of the detachable balloon. In some embodiments, the distal portion of the second catheter 174 of the detachable balloon catheter 1 is joined or operably coupled to a portion of the one or more elastomeric valves 192 by a friction fit 202, the one or more elastomeric valves 192 and the one or more spacers 196 and 197 overlapping a segment of the material of the second catheter 174 having a Shore durometer hardness of 40-90D that is inserted into the material of the second catheter 174 having a Shore durometer hardness of 20-60D. In some embodiments, the distal portion of the second catheter 174 of the detachable balloon catheter 1 is angled. In some embodiments, the angle between the distal portion of the second catheter 174 of the detachable balloon catheter 1 and the proximal portion of the second catheter 174 is between 1 and 70 degrees. In some embodiments, the proximal hub of the second catheter 174 of the detachable balloon catheter 1 is configured for injection of fluid into the second lumen. In some embodiments, the color of the outer surface of the first catheter 173, the second catheter 174, or the third catheter 175 is configured to help the physician safely use the device. In some embodiments, the color of the most proximal portion of the second catheter 174 is one color (a first color) and the color of the more distal portion of the second catheter 174 is another color (a second color). The length of the most proximal portion is configured to correspond to the length from the distal end of the (packaged) second catheter 174 to the distal end of the male tubular structure 510, or from the distal end of the (packaged) second catheter 174 to a position 1-10 mm distal to the distal end of the male tubular structure 510, so that if the physician sees the second color while retracting the second catheter 174, retraction will be stopped to avoid inadvertent dislodgement of the balloon 510. In some embodiments, a flexible elongate structure is joined to the hub 179 of the first catheter 173 and the hub 178 of the second catheter 174, and the extended length of the flexible elongate structure may correspond to the length from the distal end of the (packaged) second catheter 174 to the distal end of the male tubular structure, or from the distal end of the (packaged) second catheter 174 to a position 1-10 mm distal to the distal end of the male tubular structure 510, such that while retracting the second catheter 174, the flexible elongate structure prevents the physician from over-retracting the second catheter 174 and avoids inadvertent dislodgement of the balloon 510. To proceed with the removal, the physician may first remove, disconnect, or cut the flexible elongate structure and then further retract the second catheter 174.

The third catheter 175 of the detachable balloon catheter 1 has a proximal end, an open distal end, and a lumen 164 configured to receive the first catheter 173. The inner surface of the third catheter 175 and the outer surface 173 of the first catheter define a third lumen 164 that allows the passage of fluid from the proximal hub 180 of the third catheter 175 to the distal end of the third catheter 175 and to a space adjacent to the distal end of the third catheter 175. In some embodiments, the third lumen 164 is configured for the infusion of fluids including water, saline, radiocontrast agents, solutions including therapeutic agents or drugs, and mixtures thereof. In some embodiments, the outer layer of the wall of the third catheter 175 includes a polymer, Pebax, nylon, polyimide, or PTFE. In some embodiments, the inner layer of the wall of the third catheter 175 includes a lubricious polymer, PTFE, polyimide, or a composite, or a mixture of polyimide and PTFE. In some embodiments, the third catheter 175 comprises an intermediate layer comprising a metal, the intermediate layer being located between the outer layer and the inner layer. In some embodiments, the metal of the intermediate layer is configured as a wire. In some embodiments, the metal wire of the intermediate layer is configured in a spiral, coil, braid, woven, or straight pattern. In some embodiments, the metal or metal wire of the intermediate layer comprises Nitinol or Stainless Steel. In some embodiments, the metal wire of the intermediate layer is round and has a diameter of 0.0005-0.0030 inches. In some embodiments, the metal wire of the intermediate layer is configured in a coil with a pitch of 0.0010-0.0060 inches. In some embodiments, the metal wire of the intermediate layer is flat and has a thickness of 0.0005-0.0060 inches and a width of 0.001-0.030 inches. In some embodiments, the metal wire of the intermediate layer is configured in a braid with a length of 50-300 "picks per inch" (PPI), including a braid wound in a "one through two over" pattern. For example, the wire in the proximal section of the third catheter 175 is flat and has a thickness of 0.0005-0.0060 inches, a width of 0.001-0.030 inches, and is configured in a braided configuration with 50-300 picks per inch of length. The wire in the distal section of the third catheter 175 is round, has a diameter of 0.0005-0.003 inches, and is configured in a coil pattern with a pitch of 0.0010-0.0060 inches. In some embodiments, the third catheter 175 includes a lubricious or hydrophilic coating present on the inner surface, the outer surface, or both the inner and outer surfaces of the third catheter 175. In some embodiments, the third catheter 175 includes a Serene coating from SurModics. In some embodiments, a lubricious or hydrophilic coating is present on the distal section of the third catheter 175, but not on the proximal section of the third catheter 175. In some embodiments, the proximal end catheter 175 of the third catheter comprises a material having a Shore durometer hardness of 40-90D. In some embodiments, the outer layer of the proximal end of the third catheter 175 comprises nylon. In some embodiments, the outer layer of the proximal end of the third catheter 175 comprises nylon having a Shore durometer hardness of 40-90D. In some embodiments, the distal end of the third catheter 175 comprises a material having a Shore durometer hardness of 20-60D. In some embodiments, the outer layer of the distal end of the third catheter 175 comprises Pebax. In some embodiments, the outer layer of the distal end of the third catheter comprises Pebax having a Shore durometer hardness of 40-90D. In some embodiments, the distal end of the third catheter 175 comprises a marker band 612 that is visible under fluoroscopy and is configured to identify the location of the tip of the third catheter 175. In some embodiments, the inner or lumen diameter of the third catheter 175 is between 0.033 and 0.098 inches. In some embodiments, the outer diameter of the third catheter 175 is between 0.039 and 0.114 inches. In some embodiments, the third catheter 175 includes a proximal hub 180 and a shaft. In some embodiments, the length of the third catheter 175 is between 40 and 235 cm. In some embodiments, the wall of the third catheter 175 is continuous from the proximal end to the distal end. In some embodiments, the wall of the distal portion of the third catheter 175 includes an opening for fluid to exit the lumen 164 of the third catheter 175.

In some embodiments, the detachable balloon catheter 1 includes a detachable balloon 10 and a catheter assembly 5. In some embodiments of the detachable balloon catheter 1 including the catheter assembly 5, the first lumen is defined by an annular gap between the inner surface of the first catheter 173 and the outer surface of the second catheter 174. In some embodiments of the detachable balloon catheter 1 including the catheter assembly 5, fluid communication can be established between the proximal hub 179 of the first catheter 173, the first lumen 162, and the central void 115 or the interior volume of the balloon. In some embodiments of the detachable balloon catheter 1 including the catheter assembly 5, the inner diameter of the first catheter 173 is 0.003 to 0.012 inches larger than the outer diameter of the second catheter 174. In some embodiments of the detachable balloon catheter 1 including the catheter assembly 5, the second lumen 163 is defined by the inner surface of the second catheter 174. In some embodiments of the detachable balloon catheter 1 with the catheter assembly 5, fluid communication can be provided between the proximal hub 178 of the second catheter 174 and a space adjacent to the distal end of the second catheter 174. In some embodiments of the detachable balloon catheter 1 with the catheter assembly 5, a portion of the second catheter 174 is inserted through one or more elastomeric or elastic valves 192. In some embodiments of the detachable balloon catheter 1 with the catheter assembly 5, an outer surface of a portion of the second catheter 174 is in contact with an inner surface of the one or more elastomeric valves 192. In some embodiments of the detachable balloon catheter 1 with the catheter assembly 5, the one or more elastomeric valves 192 seal against the second catheter 174. In some embodiments of the detachable balloon catheter 1 with the catheter assembly 5, the second catheter 174 is longer than the first catheter 173. In some embodiments of the detachable balloon catheter 1 including the catheter assembly 5, the second catheter 174 is longer than the first catheter 173, which is longer than the third catheter 175. In some embodiments of the detachable balloon catheter 1 including the catheter assembly 5, the wall of the first catheter 173 is continuous from the proximal end to the distal end, and the wall of the second catheter 174 is continuous from the proximal end to the distal end. In some embodiments of the detachable balloon catheter 1 including the catheter assembly 5, the wall of the first catheter 173 is continuous, and the wall of the segment of the second catheter 174 that passes through the central void 115 or internal volume of the balloon 10 includes an opening for fluid to exit the lumen 162 of the second catheter 174. In some embodiments of the detachable balloon catheter 1 including the catheter assembly 5, the proximal hub 178 of the second catheter 174 is proximal to the proximal hub 179 of the first catheter 173, a portion of the second catheter 174 passes through the lumen 162 of the first catheter 173, and the distal end of the second catheter 174 is distal to the distal end of the first catheter 173. In some embodiments of the detachable balloon catheter 1 including the catheter assembly 5, a portion of the second catheter 174 passes through a valve or a valved Tuohy-Borst adapter 186 joined to the hub 179 of the first catheter 173. In some embodiments of the detachable balloon catheter 1 including the catheter assembly 5, an outer surface of a portion of the second catheter 174 contacts an inner surface of the valve. In some embodiments of the detachable balloon catheter 1 including the catheter assembly 5, a portion of the second catheter 174 is received within the distal neck 140 of the balloon 10. In some embodiments of the detachable balloon catheter 1 including the catheter assembly 5, a portion of the second catheter 174 passes through the distal neck 140 of the balloon 10. In some embodiments of the detachable balloon catheter 1 including the catheter assembly 5, the inner diameter of the distal neck 140 of the balloon 10 is 0.001, 0.002, 0.003 or 0.004 inches larger than the outer diameter of the second catheter 174. In some embodiments of the detachable balloon catheter 1 including the catheter assembly 5, a portion of the second catheter 174 is received within a ring structure, tubular structure, telescoping structure, catheter segment, or telescoping catheter segment 185 joined to the distal balloon neck 140. In some embodiments of the detachable balloon catheter 1 including the catheter assembly 5, a portion of the second catheter 174 is inserted through a ring structure, tubular structure, telescoping structure, catheter segment, or telescoping catheter 185 joined to the distal balloon neck 140. In some embodiments of the detachable balloon catheter 1 including the catheter assembly 5, the inner diameter of the ring structure, tubular structure, nested structure, catheter segment, or nested catheter segment 185 joined to the distal neck 140 of the balloon 10 is 0.001 to 0.004 inches larger than the outer diameter of the second catheter 174. In some embodiments of the detachable balloon catheter 1 including the catheter assembly 5, the length of the ring structure, tubular structure, nested structure, catheter segment, or nested catheter segment joined to the distal neck 140 of the balloon 10 is 0.3 to 6.0 mm.

In some embodiments of the detachable balloon catheter 1 including the catheter assembly 5, the proximal hub of the third catheter 175 may be joined to the proximal hub 179 of the first catheter 173. In some embodiments of the detachable balloon catheter 1 including the catheter assembly, the engagement or joining of the proximal hubs 179 and 180 of the first and third catheters 173 and 175 prevents or reduces leakage during injection of fluid into the third lumen 164. In some embodiments of the detachable balloon catheter 1 including the catheter assembly 5, once joined, the proximal hub 180 of the third catheter 175 and the proximal hub 179 of the first catheter 173 may be separated or separated after rotating the lock. In some embodiments of the detachable balloon catheter 1 including the catheter assembly 5, the third catheter 175 may be advanced or retracted while the first catheter 173 remains fixed in place. In some embodiments of the detachable balloon catheter 1 including the catheter assembly 5, when the proximal hub 180 of the third catheter 175 and the proximal hub 179 of the first catheter 173 are separated, the third catheter 175 can be advanced or retracted while the first catheter 173 remains fixed in place. In some embodiments of the detachable balloon catheter 1 including the catheter assembly 5, when the proximal hub 180 of the third catheter 175 and the proximal hub 179 of the first catheter 173 are separated, the proximal hub 180 of the third catheter 175 includes a valve to prevent leakage during injection of fluid into the third lumen. In some embodiments of the detachable balloon catheter 1 including the catheter assembly 5, the proximal hub 180 of the third catheter 175 includes a Tuohy-Borst adapter 186 with a valve. In some embodiments of the detachable balloon catheter 1 including the catheter assembly 5, a first portion of the first and second catheters 173 and 174 pass through a valve or Tuohy-Borst adapter 186 of the third catheter 175. In some embodiments of the detachable balloon catheter 1 including the catheter assembly 5, an outer surface of a portion of the first catheter 173 contacts an inner surface of the valve. In some embodiments of the detachable balloon catheter 1 including the catheter assembly 5, a proximal hub 179 of the first catheter 173 and a proximal hub 178 of the second catheter 174 are proximal to a proximal hub 180 of the third catheter 175. In some embodiments of the detachable balloon catheter 1 including the catheter assembly 5, a portion of the first and second catheters 173 and 174 pass through a proximal hub 180 of the third catheter 175. In some embodiments of the detachable balloon catheter 1 including the catheter assembly 5, portions of the first and second catheters 173 and 174 pass through the lumen 164 of the third catheter 175. In some embodiments of the detachable balloon catheter 1 including the catheter assembly 5, portions of the first and second catheters 173 and 174 are distal to a distal end of the third catheter 175. In some embodiments, the proximal hub 180 of the third catheter 175 of the detachable balloon catheter 1 includes a port 177 for injection of fluid into the third lumen 164.
Attachment/Detachment System

The present disclosure relates to a medical device 1 comprising a detachable balloon 10 and a catheter or catheter assembly 5, where the detachable balloon 10 is configured to separate from the catheter or catheter assembly 5 in vivo. In some embodiments, as shown in Figures 17A-C, 18A-D, 19A-G, 20A-E, 21A-E, 26A-H, 27, 28A-G, and 29, a distal end of the first catheter assembly and a portion of the balloon proximal neck assembly 135 join to form a mechanical attachment 500 between the first catheter 173 and the balloon 10. As shown in Figures 17A, 18A, and 20A-C, the mechanical attachment is configured to engage when the second catheter 174 passes through the attachment site, and to disengage when the second catheter 174 is removed from the attachment site, as shown in Figures 17B-C, 18B-D, and 20D-E.

In some embodiments, as shown in FIGS. 17A-C, 18A-D, and 20A-E, the detachable balloon 10 is operably coupled and decoupled from the first catheter 173 by opening and closing a mechanical latch 500. The mechanical latch 500 includes a tubular male structure 510 coupled to the distal end of the first catheter 173. As shown in FIGS. 26A-H and 27, the male tubular structure 510 defines a detachable assembly lumen extending from a male proximal end 506 to a female distal end 508. The male distal end 508 includes at least one movable arm 512 having a distal tab 513 projecting radially outward from an outer surface. Between the arms 512 are longitudinal recesses 514 that allow fluid to flow radially through the male tubular structure 510. By way of example and not limitation, the nominal dimensions and acceptable preferred dimensional ranges of various potential embodiments of the male tubular structure 510 described in Figures 26A-H are presented in tabular form in Figure 27. The mechanical latch 500 further comprises a female tubular structure 520 coupled to the balloon proximal neck 130 or proximal neck assembly 135. The female tubular structure 520 defines a second removable assembly lumen extending from a female proximal end 524 to a female distal end 528 as shown in Figures 28A-G and 29. The nominal dimensions and acceptable preferred dimensional ranges of various potential embodiments of the female tubular structure 510 described in Figures 28A-G are presented in tabular form in Figure 29.

The male tubular structure may also have two arms and tabs, four arms and tabs, five arms and tabs, or six arms and tabs 528. The second catheter 174 of the detachable balloon catheter 1 is configured to secure the male tubular structure 510 to the female tubular structure 520 in one configuration, and in a second configuration, the male tubular structure 510 is free to move relative to the female tubular structure 520. When the male tubular structure 510 is received in the second removable assembly lumen of the female tubular structure 520 and a portion of the shaft of the second catheter 174 is received in the first removable assembly lumen of the male structure, the second catheter 174 exerts a radially outward force on at least one arm of the male tubular structure 510, resulting in an engaged configuration in which the male tubular structure 510 is joined to the female tubular structure 520. When the male tubular structure 510 is received within the second removable assembly lumen of the female tubular structure 520 and the shaft of the second catheter 174 is withdrawn from within the first removable assembly lumen of the male structure, the removable assembly changes from an engaged configuration to a disengaged configuration, the assembly of the first catheter 173 and the male tubular structure 510 can be separated from the assembly of the female tubular structure 520 and the balloon proximal neck 130, and the first catheter 173 and the balloon 10 can be pulled apart. In some embodiments, the inner diameter of the female tubular structure 520 is 0.0005, 0.001, 0.002 or 0.003 inches larger than the outer diameter of the male tubular structure 510, and the male and female tubular structures 510 and 520 can be in a slip-fit engagement. In some embodiments, the male tubular structure 510 and the female tubular structure 520 are manufactured by machining, casting, or other suitable methods. In some embodiments, the proximal end of the female tubular structure 520 includes an annular flange 526. In some embodiments, the male tubular structure 510 includes one or more depth stop projections extending from an outer surface, and the annular flange 526 of the male tubular structure 520 defines one or more corresponding depth stop recesses 514, which are received in the depth stop recesses 514 of the female tubular structure 520 to limit insertion of the male structure 510 into the female structure 520. The depth stop projections of the male tubular structure 510 and the corresponding depth stop recesses 514 of the female tubular structure 520 operably engage with each other, such that rotation of the male structure 510 rotates the female structure 520. In some embodiments, the male tubular structure 510 comprises a metal, a radiopaque metal, nitinol, stainless steel, platinum, iridium, gold, silver, titanium, or a combination or alloy thereof. In some embodiments, the female tubular structure 520 comprises a metal, a radiopaque metal, platinum, iridium, gold, silver, stainless steel, nitinol, titanium, or an alloy or combination thereof. In some embodiments, the male tubular structure 510 comprises two movable arms 512. In some embodiments, the two movable arms 512 are disposed at antipodal points on the distal end of the male tubular structure 510. In some embodiments, the male tubular structure 510 comprises three movable arms 512. In some embodiments, the three movable arms 512 are disposed at equidistant points on the distal end 508 of the male tubular structure 510. In some embodiments, at least one movable arm 512 of the male tubular structure 510 is biased inwardly when the removable assembly is in the disengaged configuration. In some embodiments, the at least one movable arm 512 of the male tubular structure 510 is biased inwardly when the removable assembly is in the disengaged configuration and displaces radially outwardly when the removable assembly is in the engaged configuration. When the removable assembly is in the engaged configuration, at least a portion of the distal tab 513 of the at least one movable arm 512 of the male tubular structure 510 extends distally beyond at least a portion of the distal end 528 of the female tubular structure 520 and at least a portion of the distal tab 513 of the at least one movable arm 512 of the male tubular structure 510 extends radially beyond at least a portion of the outer surface of the female tubular structure 520, thereby retaining the male tubular structure 510 within the female tubular structure 520. When the second catheter 174 is withdrawn from within the first removable assembly lumen of the male structure and the removable assembly changes from an engaged configuration to a disengaged configuration, the assembly of the first catheter and the male tubular structure 510 can be separated from the assembly of the proximal neck 130 of the balloon 10 and the female tubular structure 520 by pulling the first catheter 173 and the balloon 10 apart.

In some embodiments, the inner or lumen diameter of the male tubular structure 510 is between 0.025 and 0.068 inches. In some embodiments, the outer diameter of the male tubular structure 510 is between 0.028 and 0.093 inches. In some embodiments, the inner and outer diameters of the female tubular structure 520 are between 0.031 and 0.096 inches.

In one embodiment, the attachment and detachment assembly of the detachable balloon catheter 1 includes mated parts. A male tubular structure is received within the female tubular structure. The male tubular structure is a generally tubular structure having walls that define a lumen or conduit. The lumen extends from the proximal end to the distal end of the male tubular structure 510. The lumen is dimensioned to receive the movable second catheter 174 while also providing a conduit for fluid through the detachment assembly for inflation of the detachable balloon. The male and female tubular structures are machined to close tolerances to engage one another in a slip-fit engagement.

The proximal end of the male tubular structure is received and coupled to the distal end of the delivery device. The distal end of the male tubular structure is defined by two or more fingers 513, which may have different lengths in various embodiments. Each finger 513 has an outward projection that extends beyond the outer diameter of the wall. Notably, the fingers 513 are biased inwardly toward the central axis of the male tubular structure. As such, the projections generally do not extend beyond the outer diameter of the wall without the application of a radially outward force. To hold the male tubular structure to the female tubular structure, a radially outward force is provided by the movable second catheter 174 when positioned in the assembly. In one aspect, the movable second catheter 174 applies a radially outward force directly to at least one of the fingers 513. Other embodiments of the male tubular structure also include a support bar 516 disposed between the fingers 513. When the second catheter 174 is withdrawn, the support bar 516 assists in aligning the male tubular structure 510 with the female tubular structure 520 and also prevents the guidewire 40 from becoming entangled in the separation assembly.

The wall also includes one or more depth stop projections that engage complementary recesses 514 in the proximal face of the female tubular structure. In addition to limiting the insertion of the male tubular structure into the female tubular structure, the depth stop projections also allow rotation of the female tubular structure and the detachable balloon as the delivery device is rotated. In various embodiments, the male tubular structure is constructed of Nitinol or stainless steel. When the mechanical latch is engaged, an annular shoulder of the male component contacts, among other things, an annular shoulder of the female component, allowing the transmission of axial compressive forces from the first catheter 173 to the proximal neck 130 of the detachable balloon 10.

The female tubular structure 520 includes a tubular wall defining a lumen dimensioned to receive the male tubular structure. The proximal end of the female tubular structure includes an annular flange defining one or more recesses 514. The distal end of the female tubular structure is coupled to the proximal neck 130 of the detachable balloon. In various embodiments, the female tubular structure is constructed of a radiopaque metal, including but not limited to platinum, rhodium, or alloys thereof.

To allow removal of the detachable balloon 10 from the first catheter 173, the second catheter 174 is retracted from the first catheter 173. This action removes interference between the fingers 513 of the male component 510 and the distal edge 530 of the female component 520. The first catheter 173 is then retracted to release the mechanical latch 500. It should be noted that the separation process may be performed with the guidewire 40 in place as shown in Figures 17A-17C, or without the guidewire 40 in place as shown in Figures 18A-18D. It should also be noted that the separation process may be performed with a coil or other elongated or expandable body 720 instead of the guidewire 40. The mechanical latch 500 may be used to attach the detachable balloon 10 and other expandable bodies of various sizes and shapes to the catheter system.

The mechanical latch 500 may be compatible with deployment of a detachable balloon 10 when used alone as shown in FIGS. 19A-19G and 20A-20E, when used in combination with one or more elongate bodies 720 disposed within the balloon 10 as shown in FIGS. 22A-22I and 23A-23H, or when used in combination with one or more elongate bodies 720 disposed both within and distal to the balloon 10 as shown in FIGS. 24A-24I and 25A-25I.

Figures 19A-19G and 20A-20E show a first sequence of operation of a detachable balloon catheter 1 with a mechanical latch 500 attachment system according to one embodiment. The balloon 10 is positioned and expanded. The guidewire 40 is retracted. The second catheter 174 is retracted from the male and female tubular structures 510 and 520 of the latch, separating the first catheter 173 from the proximal neck 130 of the balloon 10. Finally, the first catheter 173 is retracted.

21A-21E and 22A-22I show a second sequence of operation of a detachable balloon catheter 1 with a mechanical latch 500 attachment system according to one embodiment. The balloon 10 is positioned and expanded. The second catheter 174 is retracted from the latch male and female tubular structures 510 and 520, separating the first catheter 173 from the proximal neck 130 of the balloon 10. The first catheter 173 is retracted. Finally, the guidewire 40 is retracted.

22A-22I and 23A-23H show a third operation sequence of a detachable balloon catheter 1 with a mechanical latch 500 attachment system according to one embodiment. The balloon 10 is positioned and expanded. The guidewire 40 is retracted. The second catheter 174 is partially retracted. One or more coils or first elongate body 720 are positioned within the central cavity 115 of the expanded balloon 10. The second catheter 174 is retracted from the male and female tubular structures 510 and 520 of the latch, separating the first catheter 173 from the proximal neck 130 of the balloon 10. Finally, the first catheter 173 is retracted.

24A-24I and 25A-25I show a fourth sequence of operation of a detachable balloon catheter 1 with a mechanical latch 500 attachment system according to one embodiment. The balloon 10 is positioned and expanded. The guidewire 40 is retracted. A coil or portion of the first elongate body 720 is positioned distal to the expanded balloon 10. The second catheter 174 is partially retracted. The remaining portion of the first elongate body 720 is positioned within the central void 115 of the expanded balloon 10. The second catheter 174 is retracted from the male and female tubular structures 510 and 520 of the latch, separating the first catheter 173 from the proximal neck 130 of the balloon 10. Finally, the first catheter 173 is retracted.

The present disclosure relates to a medical device comprising a detachable balloon 10 and a catheter or catheter assembly 5, where the detachable balloon 10 is configured to separate from the catheter or catheter assembly 5 in vivo. In some embodiments, the balloon 10 is joined or operably coupled to a first catheter 173 by an elastomeric tubular structure 204.

In some embodiments, the elastic tubular segment 204 is coupled to the proximal neck 130 of the balloon 10 and configured to frictionally fit with the distal end of the first catheter 173. In some examples, the detachable balloon of the detachable balloon catheter 1 is expanded in the artery 317, vein 318, LAA 800, aneurysm 320, biological conduit 900, or other blood-containing or biological space 904, and at least a portion of the outer surface of the detachable balloon 10, or a portion of the outer surface of the expandable retention structure 731 attached to the balloon 10, is in contact with at least a portion of the wall of the artery 317, vein 318, LAA 800, aneurysm 320, biological conduit 900, or other blood-containing or biological space 904, and the first catheter 173 is separated from the assembly of the proximal neck 130 of the balloon 10 and the elastomeric tubular structure 204 by pulling the first catheter 173 away from the assembly of the proximal neck 130 of the balloon 10 and the elastomeric tubular segment 204. In some embodiments, the elastomeric tubular structure 204 is configured to create a friction fit 202 with the distal end of the first catheter 173, and when the detachable balloon is expanded in an artery, vein, LAA 800, aneurysm 320, biological conduit 900, or other blood-containing or biological space, and at least a portion of the outer surface of the balloon, or a portion of the outer surface of the expandable retention structure 731 attached to the balloon, contacts at least a portion of the wall of the arterial wall 317, vein 318, LAA 800, aneurysm 320, biological conduit 900, or other blood-containing or biological space 904, the first catheter 173 may be separated from the assembly of the proximal neck 130 of the detachable balloon 10 and the elastomeric tubular segment 204 by pulling the first catheter 173 away from the assembly of the proximal neck 130 of the detachable balloon 10 and the elastomeric tubular segment 204. In some embodiments, the distal end of the elastomeric tubular segment 204 is inserted into the proximal neck 130 or proximal neck assembly 135 of the removable balloon 10, and the elastomeric tubular segment 204 is bonded to the inner surface of the proximal neck 130 or proximal neck assembly 135 of the removable balloon 10. In some embodiments, the distal end of the elastomeric tubular structure 204 is inserted onto the proximal neck 130 or proximal neck assembly 135 of the balloon, and the first tubular structure is bonded to the outer surface of the proximal neck 130 or proximal neck assembly 135 of the balloon. In some embodiments, the distal portion of the elastomeric tubular segment 204 is adhered to the proximal neck 130 or proximal neck assembly 135 of the removable balloon with a glue or adhesive. In some embodiments, when assembling the detachable balloon catheter 1, the proximal end of the elastomeric tubular structure 204 is stretched open and the distal end of the first catheter 173 is inserted into the proximal end of the stretched first friction fit 202 structure to form a friction fit 202 between the proximal portion of the elastomeric tubular structure 204 and the distal portion of the first catheter 173. In some embodiments, the outer surface of the ring structure, tubular structure, nested structure, catheter segment, or nested catheter segment is bonded to the inner surface of the proximal neck 130 to form the proximal neck assembly 135, and the friction fit structure is glued or bonded to the ring structure, tubular structure, nested structure, catheter segment, or nested catheter segment. In some embodiments, the inner surface of the ring structure, tubular structure, nested structure, catheter segment, or nested catheter segment is bonded to the outer surface of the proximal neck 130 to form the proximal neck assembly 135. In some embodiments, the ring structure, tubular structure, nested structure, catheter segment, or nested catheter segment comprises a metal, platinum, iridium, gold, silver, stainless steel, nitinol, titanium, or alloy, or a combination thereof. In some embodiments, at least a portion of the ring structure, tubular structure, nested structure, catheter segment, or nested catheter segment is radiopaque and visible under fluoroscopy, which can assist the physician in determining when the first catheter 173 has separated from the detachable balloon 10. In some embodiments, the friction fit 202 between the elastomeric tubular structure 204 and the first catheter 173 is made without glue, adhesive, or welding.

In some embodiments, the elastomeric tubular structure 204 is adhered to the distal end of the first catheter 173 and configured to form a friction fit 202 with the proximal neck 130 of the removable balloon 10 when the removable balloon is expanded within the artery, vein, LAA 800, aneurysm 320, biological conduit 900, or other blood-containing or biological space, such that at least a portion of the outer surface of the balloon, or a portion of the outer surface of the expandable retention structure 731 attached to the balloon, contacts at least a portion of the wall of the artery 317, vein 318, LAA 800, aneurysm 320, biological conduit 900, or other blood-containing or biological space 904, and the elastomeric tubular structure 204 can be separated from the proximal neck 130 of the removable balloon 10 by pulling apart the assembly of the first catheter 173, the elastomeric tubular structure 204, and the removable balloon 10. In some embodiments, the proximal end of the elastomeric tubular structure 204 is inserted into the distal end of the first catheter 173 and the elastomeric tubular structure 204 is bonded to the inner surface of the distal end of the first catheter 173. In some embodiments, the proximal end of the elastomeric tubular structure 204 is inserted over the distal end of the first catheter 173 and the elastomeric tubular structure 204 is bonded to the outer surface of the distal end of the first catheter 173. In some embodiments, the elastomeric tubular structure 204 is adhered to the distal end of the first catheter 173 with a glue or adhesive. In some embodiments, when assembling the detachable balloon catheter 1, the distal end of the elastomeric tubular structure 204 is stretched open and the proximal neck 130 or proximal neck assembly 135 of the detachable balloon 10 is inserted into the stretched open elastomeric tubular structure 204, forming a friction fit 202 between the distal portion of the elastomeric tubular structure 204 and the proximal neck 130 or proximal neck assembly 135 of the detachable balloon 10. In some embodiments, the inner surface of the ring structure, tubular structure, nested structure, catheter segment, or nested catheter segment 190 is bonded to the outer surface of the proximal neck 130 of the detachable balloon 10 to form the proximal neck assembly 135. In some embodiments, the ring structure, tubular structure, nested structure, catheter segment, or nested catheter segment 190 comprises a metal, platinum, iridium, gold, silver, stainless steel, nitinol, titanium, or alloys, or combinations thereof. In some embodiments, at least a portion of the ring structure, tubular structure, nested structure, catheter segment, or nested catheter segment 190 may be radiopaque and visible under fluoroscopy to assist the physician in determining when the first catheter 173 has separated from the detachable balloon 10. In some embodiments, the friction fit 202 between the elastomeric tubular structure 204 and the proximal neck 130 or proximal neck assembly 135 of the detachable balloon 10 is made without glue, adhesive, or welding.

In some embodiments, the elastomeric tubular segment 204 is a sleeve or a wrap. In some embodiments, the elastomeric tubular segment 204 is elastic or resilient. In some embodiments, the elastomeric tubular segment 204 comprises an elastomeric or elastic material. In some embodiments, the elastomeric tubular structure 204 comprises a biocompatible thermoplastic elastomeric material. In some embodiments, the elastomeric tubular segment 204 comprises nylon, Pebax, polyurethane, thermoplastic polyurethane, silicone, clonoprene, or other biocompatible elastomeric or elastic material. In some embodiments, the elastomeric tubular segment 204 comprises a material having a Shore durometer of 25D to 80D.

By way of example and not limitation, nominal dimensions and acceptable preferred dimensional ranges for various potential embodiments of the elastomeric tubular segment 204 depicted in FIGS. 42A-42C are presented in tabular form in FIG. 43. In some embodiments, the outer diameter of the elastomeric tubular segment 204 is between 0.031 and 0.096 inches after insertion of the first catheter 173. In some other embodiments, the outer diameter of the elastomeric tubular segment 204 is between 0.035 and 0.100 inches after insertion of the first catheter 173.

Note that in the elastomeric tubular segment 204, the detachment process may occur with the guidewire 40 extending through the central cavity 115 of the expanded detachable balloon and terminating distally of the expanded detachable balloon, or in the absence of the guidewire 40. Note also that the detachment process may occur with a coil or other elongated or expandable body 10 within the lumen of the first catheter 173 or the second catheter 174. The elastomeric tubular structure 204 may be used to mount detachable balloons 10 of various sizes and shapes.

The elastomeric tubular segment 204 is adapted for deployment of a detachable balloon 10 when used alone as shown in FIGS. 36A-36F and 37A-37E, when used in combination with one or more first elongate bodies 720 disposed within the balloon 10 as shown in FIGS. 38A-38J and 39A-39H, or when used in combination with one or more first elongate bodies 720 disposed both within and distal to the balloon 10 as shown in FIGS. 40A-40K and 41A-41H.

36A-36F and 37A-37E show a first operation sequence of the detachable balloon catheter 1 with the elastomeric tubular segment attachment system according to the embodiment shown in FIG. 30. The elastomeric tubular segment 204 is joined in frictional contact 202 to the outside of the first catheter 173 within the proximal neck 130 of the balloon 10. The balloon 10 is positioned and expanded. With the elastomeric tubular segment 204 held in place by the third catheter 175, the first catheter 173 can be separated from the proximal neck 130 of the balloon 10 by retracting the first catheter 173. Finally, the guidewire 40 is retracted.

38A-38J and 39A-39H show a second operation sequence of the detachable balloon catheter 1 having the elastomeric tubular segment 204 attachment system according to the embodiment shown in FIG. 30. The elastomeric tubular segment 204 is joined in frictional contact 202 with the outside of the first catheter 173 within the proximal neck 130 of the balloon 10. The balloon 10 is positioned and expanded. The guidewire 40 is retracted. One or more coils or first elongate bodies 720 are placed within the expanded balloon 10. With the elastomeric tubular segment 204 held in place by the third catheter 175, retraction of the first catheter 173 can separate the first catheter 173 from the proximal neck 130 of the balloon 10.

40A-40K and 41A-41H show a third operation sequence of the detachable balloon catheter 1 with the elastic tubular segment 204 attachment system according to the embodiment shown in FIG. 30. The elastomeric tubular segment 204 is joined in frictional contact 202 with the outside of the first catheter 173 within the balloon proximal neck 130. The balloon 10 is positioned and expanded. The guidewire 40 is retracted. A coil or part of the first elongated body 720 is placed distal to the expanded balloon 10. The second catheter 174 is partially retracted. The remaining part of the first elongated body 720 is placed within the expanded balloon 10. With the elastomeric tubular segment 204 held in place by the third catheter 175, retraction of the first catheter 173 (with the second catheter 174) can separate the first catheter 173 from the proximal neck 130 of the balloon 10.

The present disclosure relates to a medical device comprising a detachable balloon 10 and a catheter or catheter assembly 5, the detachable balloon 10 configured to separate from the catheter or catheter assembly 5 in vivo. In some embodiments, the balloon 10 is joined or operably coupled to a second catheter 174 by a friction fit 202 provided by an elastomeric or resilient valve 192, as shown in Figures 44A-44B and 52A-52B. In some embodiments, the detachable balloon catheter 1 comprises a removable assembly for joining the detachable balloon 10 to the second catheter 174, the removable assembly comprising one or more elastomeric valves 192 joined to the distal neck 140 or distal neck assembly 142 of the detachable balloon 10, the one or more elastomeric valves 192 configured to create a friction fit 202 with the distal portion of the second catheter 174.

In some embodiments, as shown in FIGS. 49A-49D, one or more elastomeric or elastic valves 192 are in the shape of a disk with a central orifice, such as a central orifice or aperture that includes a round puncture, a slit along an axis, or orthogonal slits across two axes. The central orifice or aperture through the entire thickness of the valve 192 may be a slit resembling a plus or minus sign, or a round puncture. In some embodiments, one or more elastomeric valves 192 include a polymer, silicone, polyurethane, or rubber. In one embodiment, a single valve 192 is used that includes a silicone rubber disk of a thickness of 0.010 inches and a durometer ranging from about 40 Shore A to about 90 Shore A with a round puncture central aperture. In some embodiments, one or more washers or spacers are positioned proximal to 197, distal to 196, or both proximal and distal to 197 and 196 of one or more elastomeric valves 192, as shown in FIGS. 44A-44B, 50, and 52A-52B. In some embodiments, the proximal and distal spacers 197 and 196 are disk-shaped with a central orifice, such as a circular puncture, a slit along a diameter, or a central orifice including orthogonal slits spanning two diameters. In some embodiments, the proximal and distal spacers 197 and 196 may comprise an elastomer or other elastic material, such as a polymer including silicone, polyurethane, or rubber. By way of example and not limitation, nominal dimensions and acceptable and preferred dimensional ranges for various potential embodiments of the elastomeric or elastic valve 192 and proximal and distal spacers 197 and 196 described in FIG. 50 are shown in tabular form in FIG. 51.

In some embodiments, as shown in FIGS. 44A-44B and 52A-52B, one or more elastomeric or resilient valves 192 and proximal and distal spacers 197 and 196 are included in a distal nosecone 191. In some embodiments, the lumen or inner surface 193 of the distal nosecone 191, including one or more elastomeric valves 192, proximal spacer 197 and distal spacer 196, is bonded to the distal neck 140, distal neck assembly 142 or distal telescoping structure 185 of the detachable balloon 10. The nosecone 191 may include multiple valves 192 arranged in series with various combinations of central aperture geometries.

The attachment system, including the elastomeric or resilient valve 192 in the distal nosecone 191 and the elastomeric tubular segment 204 integral with the proximal neck assembly 135, is adapted for deployment of a detachable balloon 10 when used alone as shown in FIGS. 45A-45F and 46A-46F, when used in combination with one or more first elongated bodies 720 disposed within the balloon 10 as shown in FIGS. 47A-47J and 48A-48I, or when used in combination with one or more first elongated bodies 720 disposed both internally and distally of the balloon 10, which are structurally and functionally similar to those shown in FIGS. 40A-40K, 41A-41H, 47A-47J, and 48A-48I.

45A-45F and 46A-46E show a first operation sequence of the attachment system with the elastomeric or elastic valve 192 and the elastomeric or elastic tubular segment 204 according to the embodiment shown in FIGS. 30 and 44. The balloon 10 is positioned and expanded. With the elastomeric tubular segment 204 held in place by the third catheter 175, the first catheter 173 can be retracted (along with the second catheter 174) to separate the first catheter 173 from the proximal neck 130 of the balloon 10. Finally, the guidewire 40 is retracted, closing the valve 192.

47A-47J and 48A-48 show a second operation sequence of the attachment system including the elastomeric or elastic valve 192 and the elastomeric or elastic tubular segment 204 according to the embodiment shown in FIGS. 30 and 44. The balloon 10 is positioned and expanded. The guidewire 40 is retracted. The second catheter 174 is partially retracted, closing the valve 192. One or more coils or first elongate bodies 720 are placed within the expanded balloon 10. With the elastomeric tubular segment 204 held in place by the third catheter 175, the first catheter 173 can be retracted (along with the second catheter 174) to separate the first catheter 173 from the proximal neck 130 of the balloon 10.

In some embodiments, when an expanded detachable balloon 10 of a detachable balloon catheter 1 including one or more elastomeric or elastic valves 192 joined to the distal neck 140 or distal neck assembly 142 of the detachable balloon 10 is expanded in an artery 317, a vein 318, an LAA 800, an aneurysm 320, a biological conduit 900 or other blood-containing or biological space 904, and at least a portion of the outer surface of the balloon 10, or a portion of the outer surface of an expandable retention structure 731 attached to the balloon 10, contacts at least a portion of the wall of the artery 317, a vein 318, an LAA 800, an aneurysm 320, a biological conduit 900 or other blood-containing or biological space 904, the second catheter 174 can be separated from the expanded detachable balloon 10 by pulling the second catheter 174 and the expanded detachable balloon 10 apart.

In some embodiments, when the detachable balloon 10 of the detachable balloon catheter 1 is expanded in the artery 317, vein 318, LAA 800, aneurysm 320, biological conduit 900 or other blood-containing or biological space 904, and at least a portion of the outer surface of the expanded detachable balloon 10, or a portion of the outer surface of the expandable retention structure 731 attached to the balloon 10, is in contact with at least a portion of the wall of the artery 317, vein 318, LAA 800, aneurysm 320, biological conduit 900 or other blood-containing or biological space 904, the second catheter 174 can be separated from the expanded detachable balloon 10 by pulling the second catheter 174 and the expanded balloon 10 apart.

In some embodiments, when the detachable balloon 10 of the detachable balloon catheter 1 is expanded in the artery 317, vein 318, LAA 800, aneurysm 320, biological conduit 900, or other blood-containing or biological space 904, and at least a portion of the outer surface of the expanded detachable balloon 10, or a portion of the outer surface of the expandable retention structure 731 attached to the balloon 10, is in contact with at least a portion of the wall of the artery 317, vein 318, LAA 800, aneurysm 320, biological conduit 900, or other blood-containing or biological space 904, the assembly of the second catheter 174 and the first catheter 173 can be separated from the expanded detachable balloon 10 by pulling the assembly of the second catheter 174, the first catheter 173, and the expanded balloon 10 apart.

In some embodiments, one or more elastomeric or elastic valves 192 are configured to close the distal opening, distal neck 140, distal telescoping segment 185 or distal neck assembly 142 of the expanded detachable balloon 10 when the second catheter 174 is separated from the expanded detachable balloon 10. In some examples, the one or more elastomeric or elastic valves 192 are configured to reduce blood flow through the central void 115 or the interior volume of the expanded detachable balloon 10 following removal of the second catheter 174 from the expanded detachable balloon 10.

In some embodiments, the outer diameter of one or more elastomeric or resilient valves 192 is between 0.018 and 0.068 inches. It should be noted that with a valve 192 configured for friction fit 202, the detachment process can occur with a guidewire 40 extending through the valve 192 and terminating distal to the expanded detachable balloon 10, or in the absence of a guidewire 40. It should also be noted that the detachment process can occur with a coil or other elongated or expandable body 720 in the lumen 162 of the first catheter 173 or the lumen 163 of the second catheter 174. Detachable balloons 10 of various sizes and shapes. The valve 192 may be used to attach detachable balloons 10 of various sizes and shapes.

The present disclosure relates to a medical device comprising a detachable balloon 10 and a catheter or catheter assembly 5, where the detachable balloon 10 is configured to separate from the catheter or catheter assembly 5 in vivo. In some embodiments, the balloon is joined or operably coupled to a first catheter 173 by a tubular structure susceptible to electrolysis, also referred to as an "anode" 390. In some embodiments, the detachable balloon catheter 1 may comprise an electrolytic separation system including an anode 390 disposed between the first catheter 173 and the detachable balloon 10.

An example of a detachable balloon catheter 1 includes an anode 390, a conductor extending from the hub or proximal end of the first catheter 173 in electrical communication with the anode 390, the proximal end of the anode 390 being joined to the distal end of the first catheter 173, and the distal end of the anode 390 being joined to the proximal neck 130 or proximal neck assembly 135 of the balloon 10. When an electric current is flowing through the conductor while the anode 390 is immersed in a liquid containing an electrolyte for a time sufficient to cause at least a portion of the anode 390 to dissolve and separate the proximal and distal ends of the anode 390, the first catheter 173 can be separated from the detachable balloon by pulling apart the assembly of the first catheter 173, the proximal portion of the anode 390, the assembly of the proximal neck 130 or distal neck assembly 135 of the detachable balloon 10, and the distal portion of the anode 390.

In some embodiments, the adhesion between the first catheter 173 and the anode 390 is performed using an adhesive or glue, and the adhesion between the anode 390 and the proximal neck 130 or the proximal neck assembly 135 of the detachable balloon 10, or both, is performed using an adhesive or glue, or a non-conductive or insulating adhesive or glue. In some embodiments, the adhesive or glue between the anode 390 and the proximal neck 130 or the proximal neck assembly 135 of the detachable balloon 10 electrically insulates the balloon from the anode 390. In some embodiments, the adhesive or glue between the first catheter 173 and the anode 390 electrically insulates the first catheter 173 from the anode 390. In some embodiments, the wall of the anode 390 includes an inner layer that is more sensitive to electrolysis and an outer layer that defines an exterior surface that is less sensitive to electrolysis or corrosion. In some embodiments, the inner layer of the anode 390 includes stainless steel. In some embodiments, the outer layer of the anode 390 that is not susceptible to electrolysis or corrosion comprises gold, silver, platinum, iridium, titanium, a non-conductive polymer, a non-conductive coating, or an alloy, or a combination thereof. In some embodiments, the wall of the anode 390 comprises an inner layer that defines an inner surface that is not susceptible to electrolysis or corrosion, a middle layer that is more susceptible to electrolysis or corrosion, and an outer layer that defines an outer surface that is not susceptible to electrolysis or corrosion. In some embodiments, the inner layer of the anode 390 comprises gold, silver, platinum, iridium, titanium, a non-conductive polymer, a non-conductive coating, or an alloy, or a combination thereof. In some embodiments, the outer layer of the anode 390 comprises gold, silver, platinum, iridium, titanium, a non-conductive polymer, a non-conductive coating, or an alloy, or a combination thereof. In some embodiments, the non-conductive polymer is parylene, polyurethane, or silicone. In some embodiments, the middle layer of the anode 390 comprises stainless steel, 300 series stainless steel, 400 series stainless steel, 302 stainless steel, 304 stainless steel, 316 stainless steel, 316L stainless steel, or 316LVM stainless steel. In some embodiments, at least a portion of the stainless steel portion of the anode 390 is heat treated. In some embodiments, the outer layer of the anode 390 is absent, and the middle layer or stainless steel layer is exposed on the outer surface of the ring-shaped region of the anode 390. In some embodiments, the inner and outer layers of the anode 390 are absent, and the middle layer or stainless steel layer is exposed on the inner and outer surfaces of the ring-shaped region of the anode 390. In some embodiments, a stress concentration line or strip is formed in the ring-shaped region to allow a physician to break the anode 390 in vivo. In some embodiments, the outer surface of the distal portion of the first catheter 173 covers a portion of the inner surface of the anode 390, thereby protecting at least a portion of the inner surface of the anode 390 from electrolysis or corrosion. In some embodiments, the inner surface of the distal portion of the first catheter 173 covers a portion of the outer surface of the anode 390, thereby protecting at least a portion of the outer surface of the anode 390 from electrolysis or corrosion. In some embodiments, the outer surface of the proximal neck 130 or the proximal neck assembly 135 covers a portion of the inner surface of the anode 390, thereby protecting at least a portion of the inner surface of the anode 390 from electrolysis or corrosion. In some embodiments, the inner surface of the proximal neck 130 or the proximal neck assembly 135 covers a portion of the outer surface of the anode 390, thereby protecting at least a portion of the outer surface of the anode 390 from electrolysis or corrosion.

In some embodiments, the detachable balloon catheter 1 includes an electrolytic detachment subsystem including an electrical circuit, a portion of which is supported on the first catheter 173 and configured to cause detachment of the anode 390, thereby causing detachment of the expanded detachable balloon 10 from the first catheter 173. In some embodiments, at least a portion of the electrical circuit is supported on the first catheter 173 and configured to cause electrolysis or corrosion at the ring-shaped region of the anode 390, causing detachment of a portion of the anode 390 distal to the ring-shaped region from a portion of the anode 390 proximal to the ring-shaped region, thereby causing detachment of the inflated balloon 10 from the first catheter 173. In some embodiments, the electrolytic detachment subsystem is configured to apply a current in a manner that forms the anode 390 in the region of the ring-shaped region of the anode 390 to cause the anode 390 to detach so that the distal end of the first catheter 173 can detach from the balloon 10. In some examples, the portion of the anode 390 distal to the ring-shaped region is separated from the portion of the anode 390 proximal to the ring-shaped region. In some embodiments, the electrolytic separation subsystem is configured to deliver a constant current of 1-10 mA, which includes delivering the current to the anode 390. In some embodiments, the anode 390 is a ring-shaped region of the anode 390 that includes stainless steel on the outer surface of the ring-shaped region.

In some embodiments, the outer surface of the ring structure, tubular structure, nested structure, catheter segment, or nested catheter segment is bonded to the inner surface of the proximal neck 130 to form the proximal neck assembly 135, and the anode 390 is bonded or bonded to the ring structure, tubular structure, nested structure, catheter segment, or nested catheter segment. In some embodiments, the inner surface of the ring structure, tubular structure, nested structure, catheter segment, or nested catheter segment is bonded to the outer surface of the proximal neck 130 of the detachable balloon 10 to form the proximal neck assembly 135. In some embodiments, the ring structure, tubular structure, nested structure, catheter segment, or nested catheter segment comprises a metal, platinum, iridium, gold, silver, stainless steel, nitinol, titanium, or an alloy or combinations thereof. In some embodiments, at least a portion of the ring structure, tubular structure, nested structure, catheter segment, or nested catheter segment is radiopaque and visible under fluoroscopy to assist the physician in determining that the first catheter 173 has separated from the detachable balloon 10. In some embodiments, the inner surface of the ring structure, tubular structure, nested structure, catheter segment, or nested catheter segment 190 is bonded to the outer surface of the proximal neck 130 of the detachable balloon 10 to form the proximal neck assembly 135. In some embodiments, the ring structure, tubular structure, nested structure, catheter segment, or nested catheter segment comprises a metal, platinum, iridium, gold, silver, stainless steel, nitinol, titanium, or an alloy or combinations thereof. In some embodiments, the ring structure, tubular structure, nested structure, catheter segment, or at least a portion of the nested catheter segment is radiopaque and visible under fluoroscopy, which can assist the physician in determining that the first catheter 173 has been separated from the detachable balloon. In some embodiments, the tubular structure or ring-like structure 185 is present in the wall of the distal portion of the first catheter 173. In some embodiments, the tubular structure or ring-like structure 190 present in the wall of the distal portion of the first catheter comprises a metal, platinum, iridium, gold, silver, stainless steel, nitinol, titanium, or an alloy or combinations thereof. In some embodiments, the tubular structure or ring-like structure 190 present in the wall of the distal portion of the first catheter 173 is radiopaque and visible under fluoroscopy, which can assist the physician in determining that the first catheter 173 has been separated from the detachable balloon. In some embodiments, the tubular or ring-like structure 190 is present in the wall of the distal portion of the first catheter 173, and in other embodiments, the tubular or ring-like structure 190 is glued or bonded to the outer surface of the distal portion of the first catheter 173.

In some embodiments, the detachable balloon catheter 1 further includes a conductor extending from the hub or proximal end of the first catheter 173 and making an electrical connection with the cathode tubular structure 405. In some embodiments, at least a portion of the one or more conductors are embedded in the wall of the first catheter 173 and serve as electrical conductors for the electrolytic separation subsystem and provide structural reinforcement to the wall of the first catheter 173. In some embodiments, at least a portion of the conductors are routed through the wall of the first catheter 173 in a spiral, coiled, braided, or straight configuration. In some embodiments, the one or more conductors are wires or are copper wires with an electrically insulating polymer coating. In some embodiments, the electrolytic separation subsystem is configured to deliver a constant current to the anode 390. In some embodiments, the proximal hub 179 of the first catheter 173 includes an electrical jack, and the proximal end of the electrical lead connected to the anode 390 is connected to the electrical jack. In some embodiments, the proximal hub 179 of the first catheter 173 includes an electrical jack, and the proximal end of a conductor wire connected to the cathode tubular structure 405 on the first catheter is connected to the electrical jack.

In some examples, after electrolysis or corrosion of a portion of the anode 390, the assembly of the distal portion of the anode 390, the proximal neck 130 or proximal neck assembly 135 of the detachable balloon, and the expanded detachable balloon can be separated from the assembly of the proximal portion of the anode 390 and the first catheter 173 by pulling the first catheter 173 while the expanded detachable balloon 10 remains fixed in place. In some examples, after electrolysis or corrosion of a portion of the anode 390, the assembly of the distal portion of the anode 390, the proximal neck 130 or proximal neck assembly 135 of the detachable balloon 10, and the expanded detachable balloon can be separated from the assembly of the proximal portion of the anode 390, the first catheter 173, and the second catheter 174 by pulling the first and second catheters 173 and 174 while the expanded detachable balloon 10 remains fixed in place. In some instances, when the inflated detachable balloon 10 engages the wall of a saccular aneurysm 320, an artery 317, a vein 318, an LAA 800, other blood-containing structure, a duct 900, or a biological space 904, the first catheter 173 assembly and the detachable balloon 10 assembly are pulled apart.

By way of example and not limitation, the nominal dimensions and acceptable preferred dimensional ranges of various potential embodiments of the anodes depicted in Figures 55A-55E and 57A-57D are presented in tabular form in Figure 56. In some embodiments, the inner or lumen diameter of the anode is between 0.025 and 0.068 inches. In some embodiments, the outer diameter of the anode is between 0.029 and 0.072 inches.

Note that with the anode 390, the detachment process can occur with or without the guidewire 40 extending through the central cavity 115 of the expanded detachable balloon and terminating distally of the expanded detachable balloon. Note also that the detachment process can occur with a coil or other elongated or expandable body 10 within the lumen 162 of the first catheter 173 or the lumen 163 of the second catheter 174. The anode 390 can be used to attach detachable balloons 10 of various sizes and shapes.

The electrolytic separation system including the anode 390 is adapted for deployment of a detachable balloon 10 when used alone as shown in Figures 58A-58E and 59A-59E, when used in combination with one or more elongate bodies 720 disposed within the balloon 10 as shown in Figures 60A-60I and 61A-61H, or when used in combination with one or more elongate bodies 720 disposed both within and distal to the balloon 10 as shown in Figures 62A-62I and 63A-63I.

58A-58E and 59A-59E show a first operation sequence of the electrolytic separation system according to the embodiment shown in FIGS. 55 and 57. The balloon 10 is positioned and expanded. The electrolytic separation controller 406 is connected to the hub 179 of the first catheter 173 by a cable 407, and the balloon 10 is separated by electrolysis. Finally, the guidewire 40, the first catheter 173, and the second catheter 174 are simultaneously retracted.

60A-60I and 61A-61H show a second operation sequence of the electrolytic separation system according to the embodiment shown in FIG. 55 and FIG. 57. The balloon 10 is positioned and expanded. The guidewire 40 is retracted. The second catheter 174 is partially retracted and one or more coils or the first expandable body 720 are positioned within the expanded balloon 10. The electrolytic separation controller 406 is connected to the hub 179 of the first catheter 173 by the cable 407, and the balloon 10 is electrolytically separated. Finally, the guidewire 40, the first catheter 173 and the second catheter 174 are simultaneously retracted.

62A-62I and 63A-63I show a third operation sequence of the electrolytic separation system according to the embodiment shown in FIG. 55 and FIG. 57. The balloon 10 is positioned and expanded. The guidewire 40 is retracted. A coil or part of the first expandable body 720 is positioned distal to the expanded balloon 10. The second catheter 174 is partially retracted and the remaining part of the first expandable body 720 is positioned within the expanded balloon 10. The electrolytic separation controller 406 is connected to the hub 179 of the first catheter 173 by the cable 407, and the balloon 10 is separated by electrolysis. Finally, the guidewire 40, the first catheter 173 and the second catheter 174 are simultaneously retracted.

In one embodiment, as shown in Figures 55A-55E and 57A-57D, a stainless steel (SST) ring is attached to the proximal neck 130 of the removable balloon 10 and the first catheter 173. The SST ring 224 may be constructed from any biocompatible stainless steel alloy, including but not limited to 300 series stainless steel or 400 series stainless steel, preferably 304, 316, 316L or 316LVM stainless steel. In another embodiment, the stainless steel (SST) ring 224 is attached to the proximal neck 130 by welding or gluing after the formation of the removable balloon 10. In other embodiments, the neck 215 may be constructed from stainless steel and may be incorporated during the formation of the removable balloon 10 or may be subsequently welded or glued to the body. The SST ring 224 or SST neck 215 may be constructed from any biocompatible stainless steel alloy, including but not limited to 300 series stainless steel or 400 series stainless steel, preferably 304, 316, 316L or 316LVM stainless steel. In various embodiments, the SST ring 224 includes an insulating coating. The insulating coating 226 may be any biocompatible polymer coating. In one aspect, the insulating coating 226 is a dielectric material. A portion of the polymer coating is removed from the outer surface of the ring 224 to expose a metal surface that may have a strip or ring 228 configuration. In other embodiments, the exposed metal surface can be formed by masking this area of the ring 228 before applying the coating and then removing the masking material. When a desired current is applied, electrolysis occurs and the uncoated metal strip is severed, thereby separating the expanded detachable balloon 10 from the first catheter 173. The metal strip may be exposed by any suitable method, including but not limited to laser etching or laser ablation. In other embodiments, the metal strip at the separation site may be exposed before or after folding or compressing the detachable balloon 10. By way of example and not limitation, in one embodiment, the exposed metal in the area may be gold plated, and in other embodiments, the exposed metal is stainless steel. In one embodiment, the neck 215 or ring 224 has an average wall thickness of 23 μm±5 μm, and the laser etched separation site has an average wall thickness of about 15 μm, a width of about 125 μm, and is located about 1 mm from the end of the neck 215. In this embodiment, the laser etched portion is subsequently masked during the electroforming process. The width W of the separation site (i.e., the exposed metal surface of the strip or ring configuration) may range from about 0.1 mm to about 0.4 mm. The separation site may be located anywhere along the length N1 of the neck. In some embodiments, W may be located in the area of the neck 215 formed by the metal ring 224. In one particular embodiment, the exposed strip of the separation site has a width W of 0.25 mm±0.03 mm and is located about 0.51 mm±0.03 mm from the end of the neck.

The present disclosure relates to a medical device comprising a detachable balloon 10 and a catheter or catheter assembly 5, where the detachable balloon 10 is configured to separate from the catheter or catheter assembly 5 in vivo. In some embodiments, the balloon 10 is coupled or operably coupled to a first catheter 173 by a heat sensitive tubular structure 204 or a tubular structure that is solid at body temperature but melts upon application of heat above body temperature.

In some embodiments, the detachable balloon catheter 1 comprises a removable assembly for coupling the detachable balloon to the first catheter 173, the removable assembly comprising a heat sensitive tubular structure comprising a material that melts at a temperature between 50° C. and 100° C. In some examples, when the heat sensitive tubular structure is warmed above its melting point for a time sufficient to cause at least a portion of the heat sensitive tubular structure to melt and separate from the heat sensitive tubular structure, the assembly of the distal portion of the heat sensitive tubular structure, the proximal neck 130 or proximal neck assembly 135 of the detachable balloon 10, and the expanded detachable balloon can be separated from the assembly of the proximal portion of the heat sensitive tubular structure and the first catheter 173 by pulling on the first catheter 173 while the expanded detachable balloon 10 remains fixed in place. In some examples, when the heat-sensitive tubular structure is warmed above its melting point for a time sufficient to cause at least a portion of the heat-sensitive tubular structure to melt and separate from the heat-sensitive tubular structure, the distal portion of the heat-sensitive tubular structure, the proximal neck 130 or proximal neck assembly 135 of the detachable balloon 10, and the expanded detachable balloon assembly can be separated from the proximal portion of the heat-sensitive tubular structure 410, the first catheter 173 and second catheter 174 assembly by pulling on the first and second catheters 173 and 174 while the expanded detachable balloon 10 remains fixed in place. In some examples, the first catheter 173 assembly and the detachable balloon 10 assembly are pulled apart when the expanded detachable balloon 10 engages the walls of the saccular aneurysm 320, artery 317, vein 318, LAA 800, other blood-containing structure, biological conduit 900, or biological space 904.

In some embodiments, the heat-sensitive tubular structure includes a polymer segment. In some embodiments, the proximal end of the heat-sensitive tubular structure is bonded to the distal end of the first catheter 173, and the distal end of the heat-sensitive tubular structure 410 is bonded to the proximal neck 130 or proximal neck assembly 135 of the removable balloon 10. In some embodiments, the distal end of the first catheter 173 is bonded or bonded to the heat-sensitive tubular structure using a glue or adhesive. In some embodiments, the distal end of the heat-sensitive tubular structure and the proximal neck 130 or proximal neck assembly 135 of the removable balloon 10 are bonded or bonded to the heat-sensitive tubular structure using a glue or adhesive. In some embodiments, the distal end of the first catheter 173 is bonded or glued to the heat-sensitive tubular structure 410, and the distal end of the heat-sensitive tubular structure 410 and the proximal neck 130 or proximal neck assembly 135 of the detachable balloon 10 are bonded or glued using a glue or adhesive.

In some embodiments, the heat sensitive tubular structure comprises a material that forms at least a portion of the distal end of the first catheter 173. In some embodiments, the distal end of the heat sensitive tubular structure portion 411 of the first catheter 173 and the neck 130 or proximal neck assembly 135 of the detachable balloon 10 are bonded or adhered using a glue or adhesive.

In some embodiments, the heat-sensitive tubular structure includes a material that forms a bond 409 between the distal end of the first catheter 173 and the proximal neck 130 or proximal neck assembly 135 of the removable balloon 10, and the first catheter 173 can be separated from the removable balloon 10 upon melting of at least a portion of the heat-sensitive bond 409.

In some embodiments, the detachable balloon catheter 1 includes an electrothermal isolation subsystem with an electrical circuit, a portion of which is supported on the first catheter 173 and configured to deliver energy to the heat-sensitive tubular structure in a manner that raises at least a portion of the heat-sensitive tubular structure to a temperature between 50°C and 100°C. In some embodiments, the electrothermal isolation subsystem includes an electrical circuit, at least a portion of which is supported on the first catheter 173, the electrical circuit includes a resistive heating element, and the electrothermal isolation subsystem is configured to deliver an electrical current to the resistive heating element. In some embodiments, when an electrical current passes through the resistive heating element, the resistive heating element heats up to a temperature between 50°C and 100°C. In some examples, when the resistive heating element heats up to a temperature between 50°C and 100°C, at least a portion of the heat-sensitive tubular structure heats up to a temperature between 50°C and 100°C. In some embodiments, the resistive heating element includes wire, wires including nickel, chromium, iron, aluminum, copper, or combinations thereof, Nichrome wire, Kanthal wire, Constantan wire, Evanohm wire, Balco wire, Cupron wire, or Manganin wire. In some embodiments, at least a portion of the resistive heating element or wire is disposed adjacent to the heat-sensitive tubular structure. In some embodiments, the electrothermal isolation subsystem includes one or more conductors, including a conductor that is a wire or an insulated wire. In some embodiments, at least a portion of the one or more conductors are embedded in the wall of the first catheter 173 and function as both a conductor of the first electrothermal isolation subsystem and a structural reinforcement for the wall of the first catheter 173. In some embodiments, the conductors pass through at least a portion of the wall of the first catheter 173 in a spiral, coiled, braided, or straight configuration. In some embodiments, the electrothermal isolation subsystem is configured to deliver a constant current or voltage to the resistive heating element or wire.

In some embodiments, the third medical device 1 includes an electrothermal isolation subsystem for use with a detachable balloon catheter 1 including a heat-sensitive tubular structure. In some embodiments, the third medical device 1 includes an electrical circuit, a portion of which is supported on the third medical instrument 412 and is configured to supply energy to a distal portion of the third medical device 412 in a manner that raises the distal portion of the third medical device 412 to a temperature between 50° C. and 100° C. In some embodiments, the third medical device 412 includes an electrical circuit, at least a portion of which is supported on the third medical device 412, the electrical circuit comprising a resistive heating element, and the third medical device 412 is configured to deliver an electrical current to the resistive heating element. In some embodiments, the electrothermal isolation subsystem of the third medical device 412 is configured to deliver an electrical current to the resistive heating element in a manner that raises the temperature of the resistive heating element to a temperature between 50° C. and 100° C. In some examples, the first medical device 1 is configured such that when the third medical device 412 is inserted into the lumen 162 of the first catheter 173 of the first medical device 1 and advanced to the resistive heating element portion of the third medical device 412 and positioned within or adjacent to the heat-sensitive tubular structure 410 of the first medical device 1, which melts at a temperature between 50°C and 100°C, and an electric current flows through the resistive heating element of the third medical device 412 in such a manner that the temperature of the resistive heating element rises to a temperature between 50°C and 100°C, at least a portion of the heat-sensitive tubular structure 410 of the first medical device 1 melts and the first catheter 173 of the first medical device 1 can be separated from the proximal neck 130 or proximal neck assembly 135 of the detachable balloon 10 of the first medical device 1. In some embodiments, the outer diameter of the portion of the third medical device 1 that heats to a temperature between 50° C. and 100° C. is 0.001, 0.002, 0.003, 0.004, 0.005, 0.006, 0.007, 0.008, 0.009, or 0.010 inches less than the inner diameter of the first catheter 173 of the first medical device 1 in or near the heat sensitive tubular structure 410. In some embodiments, the resistive heating element of the third medical device 1 is a wire, a wire comprising nickel, chromium, iron, aluminum, copper or combinations thereof, Nichrome wire, Kanthal wire, Constantan wire, Evanohm wire, Balco wire, Cupron wire, or Manganin wire. In some embodiments, the resistive heating element or wire is disposed on the outer surface of the third medical device 1 or the outer surface of the catheter of the third medical device 412. In some embodiments, the third medical device 412 includes one or more second conductors, at least a portion of which is embedded in the wall of the third medical device 412 or the catheter of the third medical device 412 and serves as both an electrical conductor for the second electrothermal isolation subsystem and a structural reinforcement for the wall of the third medical device 412 or the catheter of the third medical device 412. In some embodiments, at least a portion of the conductors of the third medical device 412 are threaded through the wall of the third medical device 412 or the catheter of the third medical device 412 in a spiral, coiled, braided or straight manner. In some embodiments, the conductors of the third medical device 412 are wires. In some embodiments, the electrothermal isolation subsystem of the third medical device 412 is configured to deliver a constant current or voltage to the resistive heating element or wire of the third medical device 412.

In some examples, after melting of a portion of the heat-sensitive tubular structure, the assembly of the distal portion of the heat-sensitive tubular structure, the proximal neck 130 or proximal neck assembly 135 of the detachable balloon 10, and the expanded detachable balloon may be separated from the assembly of the proximal portion of the heat-sensitive tubular structure and the first catheter 173 by pulling the first catheter 173 with the expanded detachable balloon 10 fixed in place. In some examples, after melting of a portion of the heat-sensitive tubular structure 410, the assembly of the distal portion of the heat-sensitive tubular structure 410, the proximal neck 130 or proximal neck assembly 135 of the detachable balloon 10, and the expanded detachable balloon 10 may be separated from the assembly of the proximal portion of the heat-sensitive tubular structure 410, the first catheter 173, and the second catheter 174 by pulling the first and second catheters 173 and 174 with the expanded detachable balloon 10 fixed in place. In some instances, when the inflated detachable balloon 10 engages the walls of the saccular aneurysm 320, artery 317, vein 318, LAA 800, other blood-containing structure, biological conduit 900, or biological space 904, the first catheter 173 assembly and the detachable balloon 10 assembly are pulled apart.

It should be noted that with the heat-sensitive tubular structure, the detachment process may occur with the guidewire 40 extending through the central cavity 115 of the expanded detachable balloon and terminating distally of the expanded detachable balloon, or in the absence of the guidewire 40. It should also be noted that the detachment process may occur with the coil or other elongated or expandable body 10 within the lumen of the first catheter 173 or the second catheter 174. The heat-sensitive tubular structure may be used to mount detachable balloons of various sizes and shapes.

The electrothermal isolation system, including the heat sensitive tubular structure 410, the heat sensitive distal portion 411 of the first catheter 173, or the heat sensitive bond 409 between the distal end of the first catheter 173 and the proximal neck 130 of the detachable balloon 10, is adapted for deployment of the balloon 10 when used alone as shown in FIGS. 73A-73F and 74A-74E, when used in combination with one or more elongated bodies 720 disposed within the balloon 10 as shown in FIGS. 75A-75I and 76A-76K, or when used in combination with one or more elongated bodies 720 disposed both within and distal to the balloon 10 as shown in FIGS. 77A-77I and 78A-78K.

73A-73F and 74A-74E show a first operation sequence of the electrothermal isolation system according to the embodiment shown in FIGS. 64 and 65. The balloon 10 is positioned and expanded. The guidewire 40 and the second catheter 174 are retracted and replaced with a heating catheter 412. The electrothermal isolation controller 406 is connected to the heating catheter 412 by a cable 407, and the balloon 10 is peeled off by melting the heat-sensitive first tubular structure 410. Finally, the first catheter 173 and the heating catheter 412 are simultaneously retracted.

75A-75I and 76A-76K show a second operation sequence of the electrothermal detachment system according to the embodiment shown in FIG. 64 and FIG. 65. The balloon 10 is positioned and expanded. The guidewire 40 is retracted. The second catheter 174 is partially retracted and one or more coils or expandable bodies 720 are positioned within the expanded balloon 10. The guidewire 40 and second catheter 174 are retracted and replaced with a heating catheter 412. The electrothermal detachment controller 406 is connected to the heating catheter 412 by a cable 407, and the balloon 10 is detached by melting the heat-sensitive first tubular structure 410. Finally, the first catheter 173 and the heating catheter 412 are simultaneously retracted.

77A-77I and 78A-78K show a third operation sequence of the electrothermal detachment system according to the embodiment shown in FIGS. 64 and 65. The balloon 10 is positioned and expanded. The guidewire 40 is retracted. A portion of the coil or elongated body 720 is positioned distal to the expanded balloon 10. The second catheter 174 is partially retracted and the remaining portion of the elongated body 720 is positioned within the expanded balloon 10. The guidewire 40 and the second catheter 174 are retracted and replaced with a heating catheter 412. The electrothermal detachment controller 406 is connected to the heating catheter 412 by a cable 407, and the balloon 10 is detached by melting the heat-sensitive first tubular structure 410. The first catheter 173 and the heating catheter 412 are simultaneously retracted.

In one embodiment, a resistance wire 400 is incorporated into the third medical device 1 coaxially and internally to the first catheter 173. A heat sensitive coupling 410 couples the proximal neck 130 of the detachable balloon 10 to the first catheter 173. In one aspect, the heat sensitive coupling 410 is a tubular structure with one end affixed or glued to the detachable balloon and the other end affixed or glued to the first catheter 173. In another aspect, the heat sensitive coupling is the heat sensitive distal end 411 of the first catheter 173, which is affixed or glued to the proximal neck 130 or proximal neck assembly 135 of the detachable balloon 10. In another aspect, the heat sensitive coupling is a heat sensitive bond 409 between the first catheter 173 and the proximal neck 130 or proximal neck assembly 135 of the detachable balloon 10. During deployment of the detachable balloon and one or more elongate bodies or coils 720, the second catheter 174 remains within the first catheter 173. After expansion of the detachable balloon 10 and deployment of the one or more elongate bodies or coils 720 at one or more desired locations, the second catheter 174 is exchanged for a third medical device 412. At its distal tip, the third medical device 412 features both a marker band 612 and a resistive wire 400 segment that electrically engages a pair of conductive wires 402 embedded within the catheter and extending to its proximal end for connection to a separate controller 406. Using the separate controller 406, an electrical current is applied through the conductive wires 402 and the resistive wire 400. The applied current is sufficient to heat the segments of the resistive wire 400 and the nearby heat-sensitive tubular structure 410 to a temperature ranging from about 40° C. to about 95° C., melting the heat-sensitive couplings 409, 410, or 411 and separating the expanded detachable balloon 10 from the first catheter 173. Optionally, the distal neck 140 of the detachable balloon 10 may be held to the distal end 194 of the second catheter 174 by a valve 192 mounted in a distal nose cone 191. This valve 191 closes the distal neck 140 of the detachable balloon 10 when the second catheter 174 is removed, blocking blood flow through the central cavity 115 or the interior volume of the expanded detached balloon 10.

In another embodiment, a segment of the resistive wire 400 is adjacent to or incorporated into the heat-sensitive coupling between the first catheter 173 and the proximal neck 130 or proximal neck assembly 135 of the detachable balloon 10, and the resistive wire segment 400 is embedded in the wall of the first catheter 173 or disposed within the first lumen 162 of the detachable balloon catheter 1 and is electrically engaged to a pair of conductive wires 402 that extend to the proximal end of the detachable balloon catheter 1 for connection to a separate controller 406 using a cable 407.

In one aspect shown in Figures 64A-64D and 65A-65D, the heat sensitive coupling is a heat sensitive tubular structure 410 that is affixed or glued to the removable balloon at one end and affixed or glued to the first catheter 173 at the other end. By way of example and not limitation, the nominal dimensions and acceptable preferred dimensional ranges of various potential embodiments of the heat sensitive tubular structure 410 described in Figures 65A-65D are shown in tabular form in Figure 66. In some embodiments, the inner or lumen diameter of the heat sensitive tubular structure 410 is between 0.025 and 0.078 inches. In some embodiments, the outer diameter of the heat sensitive tubular structure 410 is between 0.027 and 0.080 inches.

In another aspect shown in Figures 67A-67D and 68A-68D, the heat sensitive coupling is incorporated into the distal end of the first catheter 173, which is affixed or glued to the proximal neck 130 or proximal neck assembly 135 of the detachable balloon 10. By way of example and not limitation, the nominal dimensions and acceptable preferred dimensional ranges of various potential embodiments of the heat sensitive distal end of the first catheter 173 described in Figures 68A-68D are shown in tabular form in Figure 69.

In another aspect shown in Figures 70A-70D and 71A-71C, the heat sensitive coupling 410 is a connection between the first catheter 173 and the proximal neck 130 or proximal neck assembly 135 of the detachable balloon 10. Dimensions of various potential embodiments of the heat sensitive connection to the first catheter 173 described in Figures 71A-71C and acceptable preferred ranges of dimensions are shown in tabular form in Figure 72.

After the detachable balloon 10 and optionally one or more elongate bodies or coils are in place, the second catheter 174 can be removed or left in the first catheter 173. An electric current is passed through the conductive wire 402 and the resistive wire 400. The applied electric current is sufficient to heat a segment of the resistive wire 400 and the nearby heat sensitive coupling 410 to a temperature in the range of about 40° C. to about 95° C., melting the heat sensitive coupling 410 and separating the expanded detachable balloon 10 from the first catheter 173. Optionally, the distal neck 140 of the detachable balloon 10 may be held to the distal end 194 of the second catheter 174 by a valve 192 mounted in the distal nose cone 191. This valve 192 closes the distal neck 140 of the detachable balloon 10 when the second catheter 174 is removed, blocking blood flow through the central void 115 or the interior volume of the expanded detached balloon 10.
Complete detachable balloon catheter or first medical device

The medical device 1 including the detachable balloon may further include a first catheter 173 coupled to the proximal end of the detachable balloon 10. In some embodiments, the first catheter is coupled to the proximal neck 130 of the detachable balloon 10. In some embodiments, the first catheter 173 is coupled to the detachable balloon 10 by a friction fit 202. In some embodiments, the first catheter 173 is coupled to the detachable balloon 10 by glue, adhesive, solder or welding.

The medical device 1 with a detachable balloon may further include a second catheter 174 that passes through the central cavity 115 of the detachable balloon and couples to the distal end or neck 140 of the detachable balloon. In some embodiments, the second catheter 174 is coupled to the detachable balloon by a friction fit through an elastomeric or elastic valve 192, including an elastomeric or elastic valve 192 that is part of the distal nosecone 191 assembly. In some embodiments, the tip of the second catheter 174 further includes one or two marker bands 612 that are configured to be visible during fluoroscopy and to aid in the delivery and separation of the expandable body from the first elongate body 720 or the second elongate body 721.

In some embodiments of the medical device with the detachable balloon 10, the tip of the second catheter 174 is movable and can be advanced into the biological space 904 adjacent or distal to the expanded detachable balloon 10. As used herein, making the second catheter 174 movable refers to manipulating the control mechanism of its proximal hub 178 or turning the hemostatic valve of the Tuohy Borst adapter 186 on the first catheter 173 to reduce friction between the hemostatic valve and the outer surface of the adjacent second catheter 174, so that the second catheter 174 can be advanced into the biological space 904 distal to the remaining fixed assembly of the detachable balloon 10 and the first catheter 173 and steered or guided to a desired location. The second catheter 174 can also be made movable and guideable by other suitable means, including but not limited to mechanical placement, magnetic interaction, or the use of electric current, among others, or a combination thereof.

In some embodiments of the medical device 1 including the detachable balloon 10, the tip of the second catheter 174, when expanded, can be advanced into the biological space distal to the detachable balloon 10. One or more first elongate bodies 720 or expandable bodies can be placed through the lumen 163 of the second catheter 174 in the biological space 904 adjacent to the expanded balloon 10 before separating the first catheter 173 from the detachable balloon 10. In this manner, the second catheter 174 can also be referred to as a "coiling catheter". In some embodiments of the medical device 1 including the detachable balloon 10, the tip of the second catheter 174, when expanded, can be pulled back into the central space 115 of the detachable balloon 10. One or more first elongate bodies 720 or expandable bodies can be placed through the lumen 163 of the second catheter 174 in the central space 115 of the detachable balloon 10 before separating the first catheter 173 from the detachable balloon 10. One or more first elongate or expandable bodies 720 may be placed through the lumen 163 of the second catheter 174 into the remaining portion of the lumen 322 of the aneurysm 320 that is not filled with the expanded balloon 10. The tip of the second catheter 174 may be repositioned into the remaining portion of the lumen 322 of the aneurysm 320 that is not filled with the expanded balloon 10, after which one or more additional first elongate or expandable bodies 720 or medical devices may be placed. The tip of the second catheter 174 may again be repositioned into the remaining portion of the lumen 322 of the aneurysm 320 that is not filled with the expanded balloon 10, after which one or more additional first elongate or expandable bodies 720 or medical devices may be placed. The assembly of the first and second catheters 173 and 174 may be separated or detached from the expanded balloon 10, and the first and second catheters 173 and 174 may be removed. Manipulation of the components at the hub can cause the second catheter 174 to advance or retract relative to the expanded balloon 10, the first catheter 173, or the third catheter 175. The second catheter 174 can be movably and forwardly advanced relative to the expanded balloon 10, the first catheter 173, or the third catheter 175 to facilitate placement of one or more first elongate or expandable bodies 720 or medical devices into the unfilled lumen 322 of the aneurysm 320 behind the expanded balloon 10. The second catheter 174 can further include one or more radiopaque marker bands 612 to aid in identifying the catheter tip location using fluoroscopy and to aid in the placement and detachment of the first elongate or expandable body 720 or medical device placed through the lumen 163 of the second catheter 174.

In some embodiments, the ring structure, tubular structure, telescoping structure, catheter segment or telescoping catheter segment 185 is attached to the distal neck 140 of the detachable balloon and helps to form a tight seal between the outer surface of the second catheter 174 and the distal neck 140 or neck assembly of the detachable balloon 10, facilitating expansion of the detachable balloon 10 or facilitating sliding of the distal neck 140 of the detachable balloon 10 over the second catheter 174 during expansion of the detachable balloon 10. During expansion of the detachable balloon 10, the ring structure, tubular structure, telescoping structure, catheter segment or telescoping catheter structure 185 allows the body of the detachable balloon 10 to be shortened in the axial direction 706. In the case of a medical device 1 comprising a detachable balloon 10 intended for use in treating a saccular aneurysm 320, this maximizes the distance between the distal end of the expanded detachable balloon 10 and the dome of the aneurysm 320, and the first elongate body 720 or expandable body 10 may be positioned in the sac or lumen of the aneurysm 322 distal to the expanded detachable balloon 10 with minimal risk of injuring, rupturing or puncturing the often fragile dome of the aneurysm 320. The ring structure, tubular structure, nested structure, catheter segment or nested catheter segment 185 may also reduce leakage of injected fluid media from the detachable balloon during inflation, reduce the pressure required for inflation, and reduce the collapse rate of the detachable polymer balloon and the detachable flexible metallized polymer balloon 14 after expansion in vivo. In some embodiments, the ring, tubular or nested structure 185 may be a section of metal tubing including gold, platinum, iridium, tantalum, or combinations or alloys thereof, which may also function as a radiopaque marker visible under fluoroscopy. In one aspect, the radiopaque ring, tubular or nested structure may enhance the visibility of the detachable balloon 10 under fluoroscopic imaging. In another aspect, the radiopaque ring, tubular or nested structure 185 may aid the physician in positioning the tip of the second catheter 174 prior to placing all or a portion of the first elongate body 720 or the expandable body 10 in vivo, including placement within or adjacent to the central cavity 115 of the expanded detachable balloon 10. Alternatively, the ring structure, tubular structure, nested structure, catheter segment or nested catheter segment 185 may be constructed of a polymer and include radiopaque marker spots or bands 612 to enhance visibility of the detachable balloon 10 under fluoroscopic imaging. In another aspect, the radiopaque marker spots or bands 612 or the ring structure, tubular structure or nested structure 185 may aid the physician in positioning the tip of the second catheter 174 prior to placing all or a portion of the first elongate body 720 or expandable body 10 in vivo, including placement within or adjacent to the central void 115 of the expanded detachable balloon 10.
Detachable Balloon Catheter Manufacturing - Fabrication of Detachable Polymer Balloons and Detachable Metallized Polymer Balloons

The methods of manufacturing the first medical device 1 disclosed herein include methods of manufacturing a detachable polymer balloon 12, a detachable metallized polymer balloon 14, a detachable flexible metallized polymer balloon, a detachable rigid metallized polymer balloon, a detachable metal balloon 16, and a detachable polymer-coated metal balloon 18.

In one embodiment, the first medical device 1 is made by manufacturing a first catheter 173, manufacturing a second catheter 174, and manufacturing a detachable polymer balloon 12 having proximal and distal openings, thereby making a first polymer layer 99 of the detachable polymer balloon 12 that is continuous except for the proximal and distal openings, forming the wall 30 of the detachable polymer balloon 12 into a pleated and folded configuration, and bonding or operably coupling the pleated folded detachable polymer balloon to the first catheter 173 in a manner that allows separation of the detachable polymer balloon 12 from the first catheter 173 after expansion into a patient. In another example, the expanded detachable metallized polymer balloon 14 is bonded or operably coupled to the first catheter 173 in a manner that allows separation of the detachable metallized polymer balloon 14 from the first catheter 173 after expansion into a patient, and the wall 30 of the detachable metallized polymer balloon 14 is formed into a pleated folded configuration. The polymer layer 99 is continuous except at the proximal and distal openings, and the detachable balloon 10 without the metal layer 90 is referred to as a "detachable polymer balloon," "polymer balloon," "detachable polymer-only balloon," or "polymer-only balloon" 12.

In some embodiments, the polymer layer 99 of the removable polymer balloon 12 comprises PET, nylon or Pebax. In some embodiments, the removable polymer balloon 12 is manufactured by blow molding. In some embodiments, the removable polymer balloon 12 is formed with a distal region 120, a proximal region 110 generally opposite the distal region 120, and an intermediate region 100 transitioning from the distal region 120 to the proximal region 110, while in other embodiments, the removable polymer balloon 12 is formed with a distal region 120 and a proximal region 110 without an intermediate region 100. In some embodiments, the removable polymer balloon 12 has a rated burst pressure of 1-30 atmospheres. In some embodiments, the removable polymer balloon 12 has a wall 30 of 5-75 μm in thickness. In some embodiments, at least a portion of the outer surface of the removable polymer balloon 12 comprises a textured surface. In some embodiments, at least a portion of the outer surface of the removable polymer balloon 12 comprises a textured surface, and the distance between the highest portion of the outer surface of the removable balloon 10 and the lowest portion of the outer surface of the removable polymer 10 is 0.0001 to 1 μm.

In one embodiment, the first medical device 1 is made by manufacturing a first catheter 173, manufacturing a second catheter 174, and manufacturing a detachable polymer balloon 12 having a proximal opening and a distal opening, thereby creating a first polymer layer 99 of the detachable polymer balloon 12 that is continuous except for the proximal and distal openings, expanding the detachable polymer balloon 12, adding a first metal layer 90 having a thickness in the range of 0.0005 to 1 μm to at least a portion of the outer surface of the detachable polymer balloon 12 through a sputter coating or deposition process, forming the wall 30 of the detachable metallized polymer balloon 14 into a pleated, folded configuration, and bonding or operably coupling the pleated, folded detachable polymer balloon 14 to the first catheter 173 in a manner that allows for separation of the detachable metallized polymer balloon 14 from the first catheter 173 after expansion into the patient. In another example, the expanded detachable metallized polymer balloon 14 is bonded or operably coupled to the first catheter 173 in a manner that allows for separation of the detachable metallized polymer balloon 14 from the first catheter 173 after expansion in the patient, after which the wall 30 of the detachable metallized balloon 14 forms pleats and is formed into a folded configuration. A detachable metallized polymer balloon 14 without a structural metal layer 90 is also referred to as a "flexible metallized polymer balloon" or a "detachable flexible metallized polymer balloon". In some embodiments, the structural metal layer 90 is a metal layer 90 where the primary purpose of the metal is load bearing, rather than other purposes such as improved visualization by fluoroscopy, improved biocompatibility, inducing a biological response in adjacent tissues (such as stimulating the growth of an endothelial layer on the surface of the balloon 10) or conducting electricity, among other purposes. In some embodiments, the structural metal layer 90 is a metal layer 90 with a thickness of more than 1 μm.

In some embodiments, the first metal layer 90 is gold, titanium, or a combination thereof. In some embodiments, the first metal layer 90 is continuous, and in other embodiments, the first metal layer 90 is discontinuous. In some embodiments, the first metal layer 90 is formed in the proximal region 110, the intermediate region, the distal region 120, the proximal and intermediate regions, the intermediate region and the distal region 120, or the proximal, intermediate and distal regions. In some embodiments, prior to creating the first metal layer 90, one or more masks are applied to the outer surface of the removable polymer balloon such that only a portion of the outer surface of the removable polymer balloon is covered with the first metal layer 90. In some embodiments, the rated burst pressure of the removable flexible metallized polymer balloon is 1-30 atmospheres. In some embodiments, the thickness of the wall 30 of the removable flexible metallized polymer balloon is 5-75 μm. In some embodiments, at least a portion of the outer surface of the removable flexible metallized polymer balloon includes a textured surface. In some embodiments, at least a portion of the outer surface of the removable flexible metallized polymer balloon comprises a textured surface, and the distance between the highest point on the outer surface of the balloon and the lowest point on the outer surface of the balloon is 0.0001 to 1 μm.

In another embodiment, the first medical device 1 is made by manufacturing a first catheter 173, manufacturing a second catheter 174, manufacturing a detachable polymer balloon 12 having proximal and distal openings, thereby creating a first polymer layer 99 of the detachable polymer balloon 12 that is continuous except for the proximal and distal openings, expanding the polymer balloon 12, and coating at least a portion of the outer surface of the detachable balloon 10 with a first metal layer 99 in a thickness range of 0.0005 to 1 μm through a sputter coating or deposition process. layer 90, and a second metal layer 90 having a thickness of 1 to 50 μm is added to at least a portion of the outer surface of the first metal layer 90 through an electroforming or electroplating process to form the wall 30 of the removable metallized polymer balloon 14 into a pleated, folded configuration, and bond or operably connect the pleated, folded, removable metallized polymer balloon 14 to the first catheter 173 in a manner that allows for separation of the removable metallized polymer balloon 14 from the first catheter 173 after expansion in a patient. In another example, the expanded removable metallized polymer balloon 14 is bonded or operably connected to the first catheter 173 in a manner that allows for separation of the removable metallized polymer balloon 14 from the first catheter 173 after expansion in a patient, after which the wall 30 of the removable metallized balloon 14 is formed into a pleated, folded configuration. A detachable metallized polymer balloon 14 having a structural metal layer 90 is also referred to as a "rigid metallized polymer balloon" or a "detachable rigid metallized polymer balloon." In this context, the structural metal layer 90 is a metal layer 90 in which the primary purpose of the metal is load-bearing, rather than other purposes such as improved visualization by fluoroscopy, improved biocompatibility, inducing a biological response in adjacent tissue (such as stimulating the growth of an endothelial layer on the surface of the balloon 10) or conducting electricity, among other purposes. In some embodiments, the structural metal layer 90 is a metal layer 90 that is greater than 1 μm thick.

In some embodiments, the removable rigid metallized polymer balloon is manufactured by an electroforming or electroplating process, and the second metal layer 90 comprises gold, platinum, or a combination thereof. In some embodiments, the removable rigid metallized polymer balloon is manufactured by an electroforming or electroplating process, and the second metal layer 90 is continuous, and in other embodiments, the removable rigid metallized polymer balloon is manufactured by an electroforming or electroplating process, and the second metal layer 90 is discontinuous. In some embodiments, the removable rigid metallized polymer balloon is manufactured by an electroforming or electroplating process, and the second metal layer 90 is formed on the proximal region 110, the intermediate region 100, the distal region 120, the proximal region 110 and the intermediate region 100, the intermediate region 100 and the distal region 120, or the proximal region 110, the intermediate region 100, and the distal region 120. In some embodiments, the removable rigid metallized polymer balloon is manufactured by an electroforming or electroplating process, and one or more masks are applied to the outer surface of the removable metallized balloon prior to creating the second metal layer 90, such that only a portion of the outer surface of the removable metallized balloon is covered with the second metal layer 90. In some embodiments, the removable rigid metallized polymer balloon manufactured by an electroforming or electroplating process has a rated burst pressure of 5-50 atmospheres. In some embodiments, the removable flexible metallized polymer balloon manufactured by an electroforming or electroplating process has a wall 30 thickness of 6-100 μm. In some embodiments, at least a portion of the outer surface of the removable rigid metallized polymer balloon manufactured by an electroforming or electroplating process comprises a textured surface. In some embodiments, at least a portion of the outer surface of the removable rigid metallized polymer balloon manufactured by an electroforming or electroplating process comprises a textured surface, and the distance between the highest portion of the outer surface of the balloon and the lowest portion of the outer surface of the balloon is 0.0001-1 μm.

In another embodiment, the first medical device 1 is made by manufacturing a first catheter 173, manufacturing a second catheter 174, and manufacturing a removable polymer balloon 12 having proximal and distal openings, thereby creating a first polymer layer 99 of the removable polymer balloon 12 that is continuous except for the proximal and distal openings, expanding the removable polymer balloon 12, adding a first adhesive layer 95 to at least a portion of the outer surface of the balloon 10, and applying a 25-100% adhesive coating to the outer adhesive coated surface of the expanded balloon 10 in a spiral, coil, braid, woven or linear pattern. um thick metal wire, thereby creating a first metal layer 90, adding a second adhesive layer 95 to at least a portion of the exterior adhesive coated surface and to at least a portion of the exterior metal wire covered surface of the expanded balloon, and drying, hardening or curing the adhesive layer 95 to form the wall 30 of the detachable metallized balloon 14 into a pleated, folded configuration and bond or operably connect the detachable metallized polymer balloon 14 to the first catheter 173 in a manner that allows separation of the detachable metallized polymer balloon 14 from the first catheter 173 after expansion in a patient. In another example, the expanded detachable metallized polymer balloon 14 is bonded or operably connected to the first catheter 173 in a manner that allows separation of the detachable metallized polymer balloon 14 from the first catheter 173 after expansion in a patient, and the wall 30 of the detachable metallized balloon 14 is formed into a pleated, folded configuration. A detachable metallized polymer balloon 14 having a structural metal layer 90 is also referred to as a "rigid metallized polymer balloon" or a "detachable rigid metallized polymer balloon." In this context, the structural metal layer 90 is a metal layer 90, and the primary purpose of the metal is load-bearing, rather than other purposes such as improved visualization by fluoroscopy, improved biocompatibility, inducing a biological response in adjacent tissue (such as stimulating the growth of an endothelial layer on the surface of the detachable balloon 10), or conducting electricity, among other purposes. In some embodiments, the structural metal layer 90 is a metal layer 90, and the thickness of the metal wire applied to the polymer base layer 99 is greater than 1 μm.

In some embodiments, the detachable rigid metallized polymer balloon is manufactured by applying a metal wire to the surface of the detachable polymer balloon, and the first adhesive layer comprises urethane. In some embodiments, the detachable rigid metallized polymer balloon is manufactured by applying a metal wire to the surface of the detachable polymer balloon, and the first adhesive layer is continuous, while in other embodiments, the first adhesive layer is discontinuous. In some embodiments, the detachable rigid metallized polymer balloon is manufactured by applying a metal wire to the surface of the detachable polymer balloon, and the first adhesive layer is formed on the proximal region 110, the intermediate region 100, the distal region 120, the proximal region 10 and the intermediate region 100, the intermediate region 100 and the distal region 110120, or the proximal region 110, the intermediate region 100, and the distal region 120. In some embodiments, the detachable rigid metallized polymer balloon is fabricated by applying a metal wire to the surface of the detachable polymer balloon, and one or more masks are applied to the outer surface of the detachable polymer balloon prior to applying the first adhesive layer, and at least a portion of the outer surface of the detachable polymer balloon is coated with the first adhesive layer. In some embodiments, the detachable rigid metallized polymer balloon is fabricated by applying a metal wire to the surface of the detachable polymer balloon, and the first adhesive layer is formed by immersing the balloon in a solution comprising urethane in a solvent with a urethane concentration ranging from 1 to 20% or spraying the balloon in a solution comprising urethane in a solvent with a urethane concentration ranging from 1 to 20%. The detachable rigid metallized polymer balloon is fabricated by applying a metal wire to the surface of the detachable polymer balloon, and the metal wire is wrapped around the expanded detachable balloon. When the detachable rigid metallized polymer balloon is fabricated by applying a metal wire to the surface of the detachable polymer balloon, the first metal layer 90 comprises gold, platinum, or a combination thereof. In some embodiments, the removable rigid metallized polymer balloon is fabricated by applying a metal wire to the surface of the removable polymer balloon, and the pitch and angle of the wire turns are uniform, and in other embodiments, the pitch and angle of the wire turns are non-uniform. In some embodiments, the removable rigid metallized polymer balloon is fabricated by applying a metal wire to the surface of the removable polymer balloon, and the second adhesive layer comprises urethane. In some embodiments, the removable rigid metallized polymer balloon is fabricated by applying a metal wire to the surface of the polymer balloon 12, and the second adhesive layer is continuous, and in other embodiments, the second adhesive layer is discontinuous. In some embodiments, the removable rigid metallized polymer balloon is fabricated by applying a metal wire to the surface of the removable polymer balloon, and the second adhesive layer is formed on the proximal region 110, the intermediate region 100, the distal region 120, the proximal region 110 and the intermediate region 100, the intermediate region 100 and the distal region 120, or the proximal region 110, the intermediate region 100, and the distal region 120. In some embodiments, the detachable rigid metallized polymer balloon is fabricated by applying metal wire to the surface of the detachable polymer balloon, and one or more masks are applied to the exterior surface of the detachable metallized balloon prior to applying the second adhesive layer, and at least a portion of the exterior surface of the detachable metallized balloon is coated with the second adhesive layer. In some embodiments, the detachable rigid metallized polymer balloon is fabricated by applying metal wire to the surface of the detachable polymer balloon, and the second adhesive layer is formed by immersing the balloon in a solution comprising urethane in a solvent with a urethane concentration ranging from 1-20%, and in other embodiments, the second adhesive layer is formed by spraying the balloon in a solution comprising urethane in a solvent with a urethane concentration ranging from 1-20%. In some embodiments, the detachable rigid metallized polymer balloon is fabricated by applying a metal wire to the surface of the detachable polymer balloon, and the second adhesive layer is formed on the proximal region 110, the intermediate region 100, the distal region 120, the proximal region 110 and the intermediate region 100, the intermediate region 100 and the distal region 120, or the proximal region 110, the intermediate region 100, and the distal region 120. In some embodiments, the detachable rigid metallized polymer balloon is fabricated by applying a metal wire to the surface of the detachable polymer balloon, and one or more masks are applied to the outer surface of the detachable metallized balloon prior to applying the second adhesive layer, and at least a portion of the outer surface of the detachable metallized balloon is coated with the second adhesive layer. In some embodiments, the detachable rigid metallized polymer balloon fabricated by applying a metal wire to the surface of the detachable polymer balloon has a rated burst pressure of 5 to 50 atmospheres. In some embodiments, the thickness of the wall 30 of the removable flexible metallized polymer balloon produced by applying metal wire to the surface of the removable polymer balloon is 6 to 400 μm. In some embodiments, at least a portion of the outer surface of the removable rigid metallized polymer balloon produced by applying metal wire to the surface of the removable polymer balloon comprises a textured surface. In some embodiments, at least a portion of the outer surface of the removable rigid metallized polymer balloon produced by applying metal wire to the surface of the polymer balloon 12 comprises a textured surface, and the distance between the highest part of the outer surface of the balloon 10 and the lowest part of the outer surface of the balloon 10 is 0.0001 to 1 μm.

Disclosed herein are methods for making detachable polymer balloons, detachable metallized polymer balloons, detachable metallized balloons 16, and detachable polymer coated metal balloons 18. The detachable balloons may be comprised of only polymers, only metals, or a combination of polymers and metals. The detachable balloons may be comprised of only a single polymer, only a single metal, or a combination of a single polymer and a single metal. The detachable balloons may be comprised of only multiple polymers, only multiple metals, or a combination of multiple polymers and multiple metals. The detachable balloons may be comprised of a single polymer and multiple metals or multiple polymers and a single metal. As used herein, a detachable metallized polymer balloon includes a detachable metallic polymer balloon, a detachable metal plated polymer balloon, a detachable partially metallized polymer balloon, a detachable partially metallized plated polymer balloon, a detachable partially metal plated polymer balloon, and a detachable wire wound or wrapped polymer balloon, and refers to a detachable polymer balloon having at least one metal region incorporated into the wall 30 of the detachable polymer balloon 12, or a detachable balloon 10 with a continuous layer of polymer 99 except for the proximal or distal opening, if any.

In some embodiments, the metal portion of the detachable metallized polymer balloon 14 or polymer coated metal balloon 18 may or may not be the outermost surface of the detachable balloon 10. In various embodiments, the detachable balloon 10 may also include a thin polymer coating over the polymer 99 or metal 90 layer, including the detachable polymer coated polymer balloon 12, the detachable metallized polymer balloon 14, the detachable metal balloon 16, and the detachable polymer coated metal balloon 18.

One method involves the manufacture of a metal or metal-containing detachable balloon having a distal region 120, a proximal region 110 generally opposite the distal region 120, and an optional intermediate region 100 transitioning from the distal region 120 to the proximal region 110. A central or first axis 706 extends between the proximal neck 130 and the distal neck 140 of the detachable balloon 10. The wall 30 of the detachable balloon 10 extends continuously from the proximal region 110 through the intermediate region 100 to the distal region 120, defining the outer surface of the detachable balloon 10 and the inner surface of the detachable balloon 10. The inner surface defines a central void 115 or interior volume of the detachable balloon 10. The method involves making a detachable polymer balloon and applying a metal layer 90 to the detachable polymer balloon, including by sputtering, electroplating, electroforming, using adhesives, mechanical means, or a combination thereof. In one embodiment, the metal portion of the wall 30 of the removable balloon 10 may be continuous throughout the entire balloon. In another embodiment, the metal portion of the wall 30 of the removable balloon 10 may be discontinuous and may include only one or more portions of the wall 30 of the removable balloon 10. In one embodiment, all or a portion of the exterior surface of the removable balloon 10 may include metal. In another embodiment, all or a portion of the interior surface of the removable balloon 10 may include metal. In another embodiment, all or a portion of the exterior and interior surfaces of the removable balloon 10 may include metal. In one embodiment, none of the exterior surfaces of the removable balloon 10 may include metal. In another embodiment, none of the interior surfaces of the removable balloon 10 may include metal. In another embodiment, none of the exterior and interior surfaces of the removable balloon 10 may include metal.

In some embodiments, the detachable metallized polymer balloon 14 may be fabricated from one or more base polymer materials. In various embodiments, the substrate may include PET, nylon, Pebax, or other melt processable aliphatic or semi-aromatic polyamides, polyurethanes (including perethane or carbotan), polyvinyl chloride, polyethylene, silicone elastomers, PTFE, and combinations thereof. One skilled in the art will appreciate that the polymer or polymer layers of the detachable metallized balloon may be made from any synthetic or natural polymer known in the art. The detachable metallized balloon may be made using a single metal, a single metal alloy or amalgam, two different metals, two different metal alloys or amalgams, or two or more different metals, metal alloys or amalgams. Metals that may be used include, but are not limited to, gold, platinum, iridium, silver, nickel, stainless steel, titanium, and combinations or alloys thereof.

In one embodiment, the detachable metallized balloon may include a continuous base layer of PET (except for the openings in the proximal and distal regions 110 and 120, if any) and a continuous outer layer of gold, the gold layer being <1 μm thick. In one embodiment, the detachable metallized balloon may include a continuous base layer of PET (except for the openings in the proximal and distal regions 110 and 120, if any) and a continuous outer layer of gold, the gold layer being >1 μm thick. In one embodiment, the detachable metallized balloon may include a continuous base layer of nylon (except for the openings in the proximal and distal regions 110 and 120, if any) and a continuous outer layer of gold, the gold layer being <1 μm thick. In one embodiment, the detachable metallized balloon may include a continuous base layer of nylon (except for the openings in the proximal and distal regions 110 and 120, if any) and a continuous outer layer of gold, the gold layer being >1 μm thick. In one embodiment, the detachable metallized balloon may include a continuous base layer of Pebax (except for the openings in the proximal and distal regions 110 and 120, if any) and a continuous outer layer of gold, where the gold layer is <1 μm thick. In one embodiment, the detachable metallized balloon includes a continuous base layer of Pebax (except for the openings in the proximal and distal regions 110 and 120, if any) and a continuous outer layer of gold, where the gold layer is >1 μm thick.

In one embodiment, the detachable metallized balloon may include a continuous base layer of PET (except for the openings in the proximal and distal regions 110 and 120, if any) and an outer layer of gold, where the gold layer is <1 μm thick and covers only a portion of the PET base layer. In one embodiment, the detachable metallized balloon may include a continuous base layer of PET (except for the openings in the proximal and distal regions 110 and 120, if any) and an outer layer of gold, where the gold layer is >1 μm thick and covers only a portion of the PET base layer. In one embodiment, the detachable metallized balloon may include a continuous base layer of nylon (except for the openings in the proximal and distal regions 110 and 120, if any) and an outer layer of gold, where the gold layer is <1 μm thick and covers only a portion of the nylon base layer. In one embodiment, the detachable metallized balloon may include a continuous base layer of nylon (except for the openings in the proximal and distal regions 110 and 120, if any) and an outer layer of gold, where the gold layer is >1 μm thick and covers only a portion of the nylon base layer. In one embodiment, the detachable metallized balloon may include a continuous base layer of Pebax (except for the openings in the proximal and distal regions 110 and 120, if any) and an outer layer of gold, where the gold layer is <1 μm thick and covers only a portion of the Pebax base layer. In one embodiment, the detachable metallized balloon may include a continuous base layer of Pebax (except for the openings in the proximal and distal regions 110 and 120, if any) and an outer layer of gold, where the gold layer is >1 μm thick and covers only a portion of the Pebax base layer.

In one embodiment, the removable metallized balloon may include a continuous base layer of PET (except for the openings in the proximal and distal regions 110 and 120, if any) and an intermediate layer of gold, where the gold layer is >1 μm thick and covers only a portion of the PET base layer and the outer layer of polymer, polyurethane, or silicone. In one embodiment, the removable metallized balloon may include a continuous base layer of nylon (except for the openings in the proximal and distal regions 110 and 120, if any) and an intermediate layer of gold, where the gold layer is >1 μm thick and covers only a portion of the nylon base layer and the outer layer of polymer, polyurethane, or silicone. In one embodiment, the removable metallized balloon may include a continuous base layer of Pebax (except for the openings in the proximal and distal regions 110 and 120, if any) and an intermediate layer of gold, where the gold layer is >1 μm thick and covers only a portion of the Pebax base layer and the outer layer of polymer, polyurethane, or silicone.

In one embodiment, the removable metallized balloon may include a continuous base layer of PET (except for the openings in the proximal and distal regions 110 and 120, if any) and an intermediate layer of gold, where the gold layer is >1 μm thick and covers all of the PET base layer and the outer layer of polymer, polyurethane or silicone. In one embodiment, the removable metallized balloon may include a continuous base layer of nylon (except for the openings in the proximal and distal regions 110 and 120, if any) and an intermediate layer of gold, where the gold layer is >1 μm thick and covers all of the nylon base layer and the outer layer of polymer, polyurethane or silicone. In one embodiment, the removable metallized balloon may include a continuous base layer of Pebax (except for the openings in the proximal and distal regions 110 and 120, if any) and the gold layer is >1 μm thick and covers all of the Pebax base layer and the outer layer of polymer, polyurethane or silicone.

In one embodiment, the detachable metallized balloon may include a continuous base layer of PET (except for the openings in the proximal and distal regions 110 and 120, if any) and a continuous outer layer of titanium, the titanium layer being <1 μm thick. In one embodiment, the detachable metallized balloon may include a continuous base layer of nylon (except for the openings in the proximal and distal regions 110 and 120, if any) and a continuous outer layer of titanium, the titanium layer being <1 μm thick. In one embodiment, the detachable metallized balloon may include a continuous base layer of Pebax (except for the openings in the proximal and distal regions 110 and 120, if any) and a continuous outer layer of titanium, the titanium layer being <1 μm thick.

In one embodiment, the detachable metallized balloon may include a continuous base layer of PET (except for the openings in the proximal and distal regions 110 and 120, if any) and an outer layer of titanium, where the titanium layer is <1 μm thick and covers only a portion of the PET base layer. In one embodiment, the detachable metallized balloon may include a continuous base layer of nylon (except for the openings in the proximal and distal regions 110 and 120, if any) and a continuous outer layer of titanium, where the titanium layer is <1 μm thick and covers only a portion of the nylon base layer. In one embodiment, the detachable metallized balloon may include a continuous base layer of Pebax (except for the openings in the proximal and distal regions 110 and 120, if any) and an outer layer of titanium, where the titanium layer is <1 μm thick and covers only a portion of the Pebax base layer.

In various embodiments, the removable metallized balloon may include a continuous inner layer of PET, nylon, or Pebax, a continuous middle layer comprising gold, platinum, iridium, or silver, and a continuous outer layer of polyurethane or silicone. In various embodiments, the removable metallized balloon may include a continuous inner layer of PET, nylon, or Pebax, a discontinuous middle layer comprising gold, platinum, iridium, or silver, and a continuous outer layer of polyurethane or silicone. In various embodiments, the removable metallized balloon may include a continuous inner layer of PET, nylon, or Pebax, a continuous middle layer comprising gold, platinum, iridium, or silver, and a discontinuous outer layer of polyurethane or silicone.

The polymeric material of the detachable polymeric balloon 12 or the detachable metallized polymeric balloon 14 may be manufactured by extruding one or more polymeric materials to form the detachable balloon 10. Extrusion may be accomplished by forcing one or more polymeric materials through a die to form a tube. In some embodiments, the polymeric material may be warmed or heated to soften the polymeric material prior to extrusion. In some embodiments, the polymeric material may have a melting point of about 238°C. In other embodiments, the polymeric material may have a melting point of 178°C. One skilled in the art will appreciate that the polymeric material may have a melting point higher than the temperature used to deposit or attach the metal on the detachable balloon 10.

The manufacture of the polymeric material of the detachable polymer balloon or detachable metallized polymer balloon 14 may include the preparation of a mold. The mold may be dimensioned so that the polymeric material of the detachable polymer balloon or detachable metallized polymer balloon 14 (e.g., balloon inner layer or base layer material) produced from the mold has a desired shape and size for a desired use (e.g., balloon inner layer or base layer structure). Uses may include, but are not limited to, treating, occluding, or sealing saccular aneurysms, arteries, veins, LAA, 800, paravalvular leak paths, other blood-containing structures, or other biological conduits 900 or spaces. In one example, a detachable balloon intended for use in occluding cerebral aneurysms may have a generally spherical shape and a diameter of 2-12 mm or greater. In another example, a detachable balloon intended for use in occluding arteries and veins may have a generally cylindrical shape and a diameter of 2-24 mm or greater. In another example, a detachable balloon intended for use in occluding the LAA may have a generally spherical or cylindrical shape and may have a diameter of 16-36 mm or greater than 36 mm.

The mold may be used to manufacture a removable polymer balloon with only a proximal opening, or with a proximal opening and a distal opening. The mold may be used to manufacture a removable polymer balloon with only a proximal opening and a proximal neck 130, or with a proximal opening, a proximal neck 130, a distal opening, and a distal neck 140. Fluid from outside the removable polymer balloon can pass through the proximal opening of the removable balloon 10 and enter the central void 115 or space defined by the inner surface of the removable balloon. When fluid enters the central void 115 or space of the removable balloon 10 under pressure and the removable balloon 10 is not restrained by an external force, the removable balloon 10 can expand.

The detachable balloon 10 can expand by the expansion of the balloon wall 30, or by the stretching of the material of the balloon wall 30, or by the expansion of the balloon wall 30 and the stretching of the material of the balloon wall 30. Detachable rigid balloons, such as the detachable metal balloon 16 or the detachable polymer-coated metal balloon 18, expand primarily by expansion alone. Detachable compliant balloons, such as the detachable silicone balloon, expand primarily by stretching the material of the balloon wall 30 only. Detachable semi-elastic balloons, such as the PET, nylon or Pebax detachable balloons, expand by expansion and by the stretching of the material of the balloon wall 30 that predominates. In various embodiments, one or both necks can protrude away from the wall 30 of the detachable balloon 10, or they can protrude into the central void 115 or into the space of the detachable balloon 30.

The detachable balloon necks 130 and 140 and neck assemblies 135 and 142 can be used to attach the detachable balloon 10 to the first catheter 173 and to attach the detachable balloon 10 to the second catheter 174. The detachable balloon necks 130 and 140 and neck assemblies 135 and 142 can be involved in separating the expanded detachable balloon 10 from the first catheter 173. In one example, an elastomeric tubular structure 204 can be coupled to the proximal neck 130 of the detachable balloon 10 and used to form a friction fit 202 with the distal end of the first catheter 173. After expansion of the detachable balloon 10, the third catheter 175 can be advanced forward until it abuts the proximal end of the elastomeric tubular structure 204, and the first catheter 173 can be retracted to separate the detachable expansion balloon 10 and the first catheter 173. In another example, an elastomeric or resilient valve 192 can be coupled to the distal neck 140 or distal neck assembly 142 of the detachable balloon 10 and used to form a friction fit 202 with a distal portion of the second catheter 174. After expansion of the detachable balloon 10, the third catheter 175 is advanced forward until it abuts the proximal neck 130 of the detachable balloon 10 or the proximal region 110 of the detachable balloon 10, and the second catheter 174 is pulled back, resulting in separation of the expanded detachable balloon 10 and the second catheter 174. In another example, the female tubular structure 520 is coupled to the proximal neck 130 of the detachable balloon 10, and the male tubular structure 510 is coupled to the distal end of the first catheter 173 and the detachable balloon 10, and the first catheter 173 and the detachable balloon 10 can be coupled by mating the male and female tubular structures 510 and 520 and inserting the second catheter 174 through the lumen of the mated portions. After the detachable balloon 10 is expanded in vivo, the second catheter 174 can be retracted and the first catheter 173 can be separated from the expanded detachable balloon 10.

The detachable balloon neck and neck assembly can be designed and dimensioned to provide points for attaching the retention structure 731 to the detachable balloon. In one embodiment, a self-expanding Nitinol retention structure 731 with a proximal ring and distal arms and hooks 733 can be bonded to the distal neck 140 of the detachable balloon. In another embodiment, a self-expanding Nitinol retention structure 731 with a proximal and distal ring with an elongated structure including barbs 608 or hooks 733 inserted between the proximal and distal rings can be glued to the proximal neck 130 of the detachable balloon 10.

The detachable balloon neck and neck assembly can be designed and dimensioned to reduce fluid leakage from the central void 115 of the detachable balloon 10 portion of the detachable balloon catheter 1 during balloon expansion. In some embodiments, a tubular structure 185 having an inner or lumen diameter that closely matches the outer diameter of the second catheter 174 can be bonded to the distal neck 140 of the detachable balloon. When the second catheter 174 extends through this tubular structure 185, the length of the tubular structure and the width of the gap between the tubular structure 185 and the second catheter 174 can affect the leakage rate of fluid injected into the central void 115 of the balloon, and the time required for the detachable balloon 10 to fully expand can be reduced. In some embodiments, a tubular structure 190 having an inner or lumen diameter that closely matches the outer diameter of the first catheter 173 can be bonded to the proximal neck 130 of the detachable balloon 10. When the distal end of the first catheter 173 is inserted into this proximal neck tubular structure 190, the length of the tubular structure 190 and the width of the gap between the tubular structure 190 and the first catheter 173 affect the leakage rate of the fluid injected into the central cavity 115 of the balloon 10, and the time required for the detachable balloon 10 to fully expand can be reduced.

The detachable balloon neck and neck assembly can be designed and dimensioned to enhance the fluoroscopy of the balloon neck and neck assembly. In some embodiments, a ring-like or tubular structure containing a radiopaque metal visible during fluoroscopy can be bonded to the inner or outer surface of the proximal or distal necks 130 and 140 to improve visualization of the detachable balloon portion of the detachable balloon catheter 1 in vivo. In some embodiments, a layer of a radiopaque metal visible during fluoroscopy can be applied to the proximal or distal necks 130 and 140 of the detachable balloon 10 during electroforming or electroplating of the polymer detachable balloon to improve visualization of the detachable balloon portion of the detachable balloon catheter 1 in vivo.

The detachable balloon neck and neck assembly can be designed and dimensioned to reduce the risk of air embolism in vivo. In most interventional procedures using balloon catheters, a small amount of air remains in the balloon during use. With standard angioplasty balloon catheters, except in the event of inadvertent balloon rupture, this air remains trapped in the balloon during use and is removed upon removal of the angioplasty balloon catheter. With the use of a detachable balloon catheter 1, residual air trapped in the balloon remains with the balloon in the patient, with the attendant risk of embolism of that air in the distal circulation, which can cause serious effects, particularly in the cerebral circulation. As shown in FIG. 12, the coupling of tubular structures to the proximal and distal necks 130 and 140 of the detachable balloon can reduce leakage of air trapped in the separated balloon, with the tubular structures extending into the central cavity 115 of the detachable balloon.

In some embodiments, one or more necks or neck assemblies can be designed and dimensioned to include an opening that can be closed or partially closed before, during, or after separation of the expanded detachable balloon from the first catheter 173. For example, an elastomeric or resilient valve 192 can be included in a distal nosecone 191 with one or more spacers 196 proximal, distal, or both proximal and distal to the valve, as needed. The distal nosecone 191 including the valve can be coupled to the distal neck 140 or distal neck assembly 142 of the detachable balloon. During assembly of the detachable balloon catheter 1, a second catheter 174 can be inserted through the valve 192 to create an over-the-wire device to increase the strength of attachment between the catheter assembly 5 of the detachable balloon catheter 1 and the detachable balloon 10 of the detachable balloon catheter 1. After expansion of the detachable balloon in the artery 317 or vein 318 and separation of the expanded balloon from the catheter assembly 5, the elastomeric or elastic valve 192 closes, thereby stopping or reducing the flow of blood through the central cavity 115 of the inflated balloon 10.

The detachable balloon neck may have a length ranging from about 0.5 mm to 60 mm, preferably from about 0.5 mm to about 5 mm. The neck may define an opening having a diameter between about 0.25 mm to about 5 mm. The neck may have a diameter of about 0.25 mm to about 5 mm, and may protrude into the central void 115 or space over a length ranging from about 1 mm to 60 mm, preferably from about 0.5 mm to 5 mm, while defining an opening having a diameter of about 0.25 mm to about 5 mm. The wall thickness of one or both necks may be the same as the detachable balloon body 100, thinner than the wall 30 of the detachable balloon body 100, or thicker than the wall 30 of the detachable balloon body 100. Preferably, either or both necks have a wall 30 thickness between about 3 μm to about 300 μm, with a typical thickness being 60 μm or less. In embodiments of the detachable balloon in which the proximal and distal necks 130 and 140 extend into the central void 115 or space of the detachable balloon 10, the outer surface of the detachable balloon 10 may retain a more rounded surface contour, thereby reducing the risk of injury to the vessel wall or adjacent tissue due to placement of the detachable balloon 10.

A variety of expanded detachable balloon shapes are permitted as needed to treat saccular aneurysms, vessel segments, LAA, other blood-containing structures, biological conduits 900, or biological spaces of various shapes. In various embodiments, a mold can be used to manufacture the detachable polymer balloon or a portion of the detachable polymer balloon, with the dimensions of the detachable polymer balloon or the detachable polymer balloon portion being selected based on the size and shape of the saccular aneurysm, arterial or venous segment, LAA, other blood-containing structure, or biological conduit 900 segment or space being treated.

Preferred shapes of detachable balloons for treatment of arteries, veins, and other biological conduits 900 include cylindrical shapes with conical ends, as there is no need to provide a round surface for the flow of blood or other biological fluids, and the conical end shapes usually provide the lowest profile and outer diameter after pleating and folding. The length of the detachable balloon's mid-region can affect occlusion performance. A longer mid-region is generally preferred, if possible, because there is less blood leakage around the expanded balloon with a longer contact surface with the adjacent tissue. A longer mid-region is preferred for occlusion of arteries and veins, especially with detachable polymer balloons and detachable soft metallized polymer balloons, which are soft. Therefore, detachable balloons for occlusion of arteries, veins, and other biological conduits 900 are often longer than they are wide. Increasing the length of the detachable balloon's mid-region 100 with the detachable rigid metallized polymer balloon 14, the detachable metal balloon 14, and the detachable polymer-coated metal balloon 18 increases the stiffness of the distal portion of the detachable balloon catheter 1, which reduces its deliverability.

The dimensions of a typical saccular aneurysm 320, including terminal branch aneurysms and sidewall aneurysms, are defined in Figures 92A-92C, 95A and 96A. The preferred shape of the detachable balloon for the treatment of a saccular aneurysm 320 is spherical or cylindrical with a short intermediate region. The length or diameter of the detachable balloon 10 along the second axis 708 is important because it determines the diameter of the aneurysm neck 324 that can be covered and occluded. The length or diameter of the balloon 10 along the first axis 706 is also important because a longer length and diameter along this axis will bring the tip of the second catheter 174 closer to the dome of the aneurysm 320, which is usually the weakest part of the aneurysm 320 and the part most susceptible to rupture or puncture. Therefore, when selecting a balloon 10 for treating a saccular aneurysm 320, it is important that the balloon 10 has a length or diameter along the second axis 708 sufficient to cover the aneurysm neck 324 but not longer than the aneurysm width, and also that the balloon 10 has a minimum length or diameter along the first axis 706 that is still effective. When using this shape of the balloon 10 to treat a saccular aneurysm 320, the unfilled body and dome of the aneurysm 320 can be filled with one or more coils or elongated bodies 720, which are generally softer and less traumatic to the aneurysm wall than the distal neck 140 of the detachable balloon catheter 1 or the second catheter 174. Therefore, detachable balloons 10 for treating a saccular aneurysm 320 are often wider than they are long. Because the proximal region 110 of the detachable balloon 10 disposed within the saccular aneurysm 320 faces the blood, a rounded proximal region 110 is preferred. Given that the dome of the aneurysm 320 is often fragile, a rounded distal region 120 is also preferred over a conical or square distal end.

Preferred shapes of the detachable balloon 10 for treatment of the LAA 800 include a cylindrical shape with a mid-region that is a mid-length and rounded ends. A detachable balloon 10 with a longer mid-region is acceptable because the LAA 800 is generally long and the "dome" of the LAA 800 is not particularly fragile and susceptible to rupture or puncture. A rounded proximal region 110 is preferred because the proximal end 110 of the detachable balloon 10 positioned in the LAA 800 faces the blood. Preferred shapes of the detachable balloon 10 for treatment of paravalvular leaks include a cylindrical shape with a long mid-region and rounded or conical ends. Both the proximal and distal ends of the detachable balloon positioned in a paravalvular leak face the blood, so rounded proximal and distal regions 110 and 120 are preferred.

For example, the detachable balloon 10 or a portion of the detachable balloon 10 may be configured as a cylinder with round, hemispherical, conical, or flat ends. The diameter of a cylindrical expanded detachable balloon 10 or a portion of the detachable balloon 10 may range from about 2 mm to about 30 mm. The expanded length of a rectangular detachable balloon may range from about 5 mm to about 60 mm. The detachable balloon may have an expanded volume ranging from about 0.005 mL to about 65 mL. The expanded diameter of a cylindrical detachable balloon may range from about 2 mm to about 40 mm, the expanded volume may range from about 0.004 mL to about 40 mL, and the expanded length of a spherical detachable balloon may range from about 2 mm to about 20 mm.

The detachable balloon has one or more openings defined by the wall 30 or one or more necks 130 and 140. In various embodiments, one or both of the necks 130 and 140 can protrude away from the wall of the detachable balloon 10 or into the central void 115 or space of the detachable balloon. Additionally, the necks 130 or 140 can be designed and dimensioned to close or partially close the opening before, during, or after separation of the expanded detachable balloon 10 from the first catheter 173. The necks have a length ranging from about 0.5 mm to 60 mm, preferably about 0.5 mm to about 5 mm. The necks 130 and 140 may define an opening having a diameter between about 0.25 mm and about 5 mm. The necks 130 and 140 may protrude into the central void 115 or space with a length ranging from about 1 mm to 60 mm, preferably about 0.5 mm to 5 mm, while defining an opening having a diameter between about 0.25 mm and about 5 mm, preferably about 0.25 mm and about 5 mm. The thickness of the wall 30 of either or both of the necks 130 and 140 may be the same as, thinner than, or thicker than the wall 30 of the body 100 of the removable balloon 10. Either or both of the necks 130 and 140 have a wall thickness 30 between about 3 μm and about 500 μm. In an embodiment of the removable balloon 10 in which the necks 130 and 140 extend into the central void 115 or space of the removable balloon 10, the outer surface of the removable balloon 10 retains a more rounded surface contour, so that the risk of injury to the vessel wall or adjacent tissue may be reduced by the placement of the removable balloon 10.

In other embodiments, one or more portions of the detachable balloon wall 30 may be thicker than the remaining portions of the wall 30. By way of example and not limitation, the wall 30 of the body or intermediate region 100 of the detachable balloon 10 may be thicker than the walls of the proximal region 110 and the distal region 120, or the necks 130 and 140, of the detachable balloon 10. By way of example and not limitation, the wall 30 of the proximal region 120 of the detachable balloon 10 may be thicker. By way of example and not limitation, the wall 30 of the proximal region 120 of the detachable balloon 10 may be thicker than the wall of the distal region 140, or the necks 130 and 140, of the detachable balloon 10. By way of example and not limitation, the wall 30 of the distal region 120 of the detachable balloon 10 may be thicker than the wall 30 of the proximal region 110, or the wall 30 of the necks 130 and 140, of the detachable balloon 10. By way of example and not limitation, the walls 30 of the intermediate region 100 and the walls of the proximal and distal necks 130 and 140 of the detachable balloon 10 may be thicker than the walls of the proximal and distal regions 110 and 120 of the detachable balloon 10. By way of example and not limitation, the walls 30 of the proximal and distal necks 130 and 140 may be thicker than the walls 30 of the intermediate region 100 of the detachable balloon 10.

The detachable metallized polymer balloon 14 may be manufactured using various extrusion and molding techniques using an "inner layer" or "base layer" material that is formed into the detachable balloon or a portion of the detachable balloon, and the material used to manufacture the detachable balloon inner layer or base layer structure is a polymer. Those skilled in the art will appreciate that any process known in the art for manufacturing balloons may be used to manufacture the detachable balloon inner layer or base layer structure.

The removable balloon inner layer or base layer structure may be manufactured by using various types of molding processes. In some embodiments, the removable balloon may be manufactured using blow molding, compression molding, extrusion molding, injection molding, matrix molding, rotational molding, thermoforming, transfer molding, vacuum assisted resin transfer molding, vacuum forming, or any molding means known in the art. The removable balloon inner layer or base layer structure may be created using various extrusion techniques. One skilled in the art will understand that any manufacturing method known in the art may be used.

The material used to form the removable balloon inner layer or base layer structure may begin in the form of a billet that may be placed in a container and forced through a die opening. The creation of the removable balloon inner layer or base layer structure mold may be accomplished using direct or forward extrusion techniques known in the art, where the billet is forced through a stationary container. The production of the removable balloon inner layer or base layer structure may be accomplished by using indirect or backward extrusion, where the billet and container move together to force the billet through a die. The creation of the removable balloon inner layer or base layer structure mold may be accomplished by hydrostatic extrusion, where the billet is surrounded by a pressurized liquid. The extrusion methods used include the use of one or more dies configured to provide an extruded material with both an inner and outer surface. Those skilled in the art will understand that the mold for the removable balloon inner layer or base layer structure may be manufactured by any extrusion means known in the art.

The removable polymer balloon or the removable balloon including the removable balloon inner layer or base layer structure may be manufactured from a variety of materials including polymers using blow molding techniques. The blow molding technique may include heating the removable balloon inner layer or base layer material to a temperature that softens or pliables the removable balloon inner layer or base layer material. This temperature may be the melting point of the removable balloon inner layer or base layer material. The appropriate temperature for softening or melting the removable balloon inner layer or base layer material may vary based on the removable balloon inner layer or base layer material. If PET is the removable balloon inner layer or base layer material, the removable balloon inner layer or base layer material may be heated to about 238°C. The removable balloon inner layer or base layer material may be a material without a defined melting point. If the removable balloon inner layer or base layer material does not have a melting point, the base material may be heated to its Vicat softening temperature.

The blow molded removable balloon inner layer or base layer structure may be made from a cut section of extruded removable balloon inner layer or base layer material. The cut section may be about 18 inches long. The cut section may be 10 inches long. The cut section may be 24 inches long. One skilled in the art will understand that the cut section may be of any length known in the art. The cut section may have any diameter known in the art. In some embodiments, the blow molded removable balloon inner layer or base layer structure may be manufactured using a preform.

The cut portion of the extruded removable balloon inner layer or base layer material may be heated to a suitable temperature to soften the material. The heated removable balloon inner layer or base layer material may be extruded into a hollow tube or parison. The softened parison may be placed into a removable balloon inner layer or base layer structure mold that is closed around the softened parison. Upon entering the removable balloon inner layer or base layer structure mold, fluid or air may be forced or blown into the parison to allow the parison to take the shape of the removable balloon inner layer or base layer structure mold. The air forced into the parison should provide sufficient pressure to the inner diameter of the parison to expand the parison into the mold surface. One skilled in the art will appreciate that the fluid or air may be blown into either end of the parison. The removable balloon mold may have a temperature lower than the temperature of the softened parison. The removable balloon inner layer or base layer structure mold may have a temperature sufficient to keep the softened parison soft until it is filled with enough air to fit into the removable balloon inner layer or base layer structure mold. In some embodiments, the removable balloon inner layer or base layer structure mold may have a temperature lower than the temperature of the warm flexible parison before the softened parison is placed into the removable balloon inner layer or base layer structure mold. The heated base material must be properly oriented. Proper placement of the parison requires that the softened portion be contained in a cavity so that the parison can be reshaped relative to the internal structure of the removable balloon inner layer or base layer structure mold.

The removable balloon may be made using injection blow molding, in which softened removable balloon inner layer or base layer material is injection molded into a core pin. The core pin may be configured to provide pressure to the inner surface of the removable balloon inner layer or base layer material. After the removable balloon inner layer or base layer material is deposited on the core pin, the core pin may be placed into a removable balloon inner layer or base layer structure mold that is closed around the core pin and the base material. Fluid may be forced or blown into the inner surface of the removable balloon inner layer or base layer material to expand the removable balloon inner layer or base layer material and conform to the internal shape of the removable balloon inner layer or base layer structure mold. The removable balloon inner layer or base layer structure mold may have an initial temperature that keeps the removable balloon inner layer or base layer material soft. The removable balloon inner layer or base layer structure mold may have a temperature that is low enough to set the molded shape. One skilled in the art will appreciate that the removable balloon inner layer or base layer structure mold can be altered to keep the removable balloon inner layer or base layer material soft until the removable balloon inner layer or base layer structure mold temperature is reduced and molded into the desired shape that locks the removable balloon inner layer or base layer material into the shape of the removable balloon inner layer or base layer structure. In some embodiments, the removable balloon inner layer or base layer structure may be reheated using a suitable device, such as a core rod, to stretch the removable balloon inner layer or base layer structure.

The formed removable balloon inner layer or base layer structure may be further processed and shaped using processes such as cutting off excess material by rolling a knife or blade around the removable balloon inner layer or base layer structure. At this point, the removable balloon inner layer or base layer structure may be manufactured into a removable balloon of a removable balloon catheter 1 without applying additional layers or surface coatings to the removable balloon inner layer or base layer structure. In these embodiments, the removable balloon inner layer or base layer structure is a polymer balloon and can be used to make a removable balloon catheter 1 with a removable polymer balloon 10. Alternatively, additional layers or coatings can be applied to the structure of the inner layer or base layer 99 of the polymer balloon 12 to create a polymer coated polymer balloon or a metallized polymer balloon 14.

The creation of the inner layer or detachable balloon base layer 99 structure may include bonding a needle to the detachable balloon inner layer or base layer structure. Bonding the needle to the detachable balloon inner layer or base layer structure is important for part processing. The bonded needle may be useful to facilitate simplified processing and testing of the detachable balloon inner layer or base layer structure assembly. In this regard, the proximal end of the detachable balloon inner layer or base layer structure may be flared and bonded to the needle. The needle may be bonded to the distal end of the detachable balloon inner layer or base layer structure. In some embodiments, the needle may be bonded to both the proximal and distal ends of the detachable balloon inner layer or base layer structure. Bonding may be accomplished by any means known in the art. One bonding method may include providing a UV-cured adhesive and applying the adhesive to the end of the detachable balloon inner layer or base layer structure. In embodiments where only one end of the detachable balloon inner layer or base layer structure is bonded to the needle, the opposite end may be plugged. The plugging may be achieved using a UV-cured adhesive. Occlusion may be accomplished by heating the end of the removable balloon inner layer or base layer structure until it becomes pliable, at which point the end of the removable balloon inner layer or base layer structure is reshaped until it is closed. Those skilled in the art will understand that occlusion and bonding can be accomplished by any means known in the art. Those skilled in the art will also understand that the needle can be replaced with any tool known in the art to aid in simplified processing and testing of removable balloon inner layer or base layer structures, or polymer balloons.

The removable balloon inner layer or base layer structure may be coated using a variety of techniques. In some embodiments, the removable balloon inner layer or base layer structure may be coated using one or more of these processes: sputter coating or deposition, vapor deposition, electroforming or electroplating. The method of forming the outer layer may further include a method of forming pores or protrusions.

Coating of the removable balloon inner layer or base layer structure may be accomplished by physical vapor deposition. In some embodiments, physical vapor deposition is accomplished using sputter deposition, where material is released from a source material and deposited on the removable balloon. Sputter deposition is a process carried out in a vacuum chamber environment. Special process considerations must be taken into account to handle the removable balloon inner layer or base layer structure in a vacuum environment. It is important to maintain the shape of the removable balloon inner layer or base layer structure in the vacuum so that the removable balloon inner layer or base layer structure is adequately coated. To maintain the shape of the removable balloon inner layer or base layer structure in a vacuum environment, the pressure within the removable balloon inner layer or base layer structure must be equal to or greater than the pressure outside the removable balloon inner layer or base layer structure. In some embodiments, the removable balloon inner layer or base layer structure is vented to a vacuum chamber, thus providing equal pressure on the inside and outside of the removable balloon inner layer or base layer structure. In other embodiments, the removable balloon inner layer or base layer structure is attached to a manifold that allows the removable balloon inner layer or base layer structure to maintain a positive pressure relative to the vacuum chamber pressure without exceeding a pressure that would cause deformation or rupture of the removable balloon inner layer or base layer structure. To maintain pressure equilibrium or positive pressure between the inside and outside of the removable balloon, the removable balloon may be fluidly connected to a device that assists in maintaining the pressure equilibrium. The device for maintaining the pressure equilibrium may be a sputter rack. The sputtering rack may be flat to allow for sputtering one side at a time. The sputtering rack may be configured to allow for simultaneous double-sided sputtering. The sputter rack may include a manifold. The manifold may be fluidly connected to one or more removable balloons in parallel. The removable balloons may be fluidly connected to the manifold in series. The removable balloon inner layer or base layer structure may be fluidly connected to the manifold via a needle connected to the removable balloon. In some embodiments, a Luer connection may be used to connect the needle to the manifold. Those skilled in the art will appreciate that the needles can be connected to the manifold using any means known in the art for fluidly connecting the needles. A balancing balloon may be fluidly connected to the manifold to maintain equilibrium between the inner and outer portions of the removable balloon inner layer or base layer structure. The balancing balloon may be inflated when pressure in the chamber is reduced. The balancing balloon may provide pressure to the inner surface or central void 115 of one or more removable balloon inner layer or base layer structures fluidly connected to the manifold. In some embodiments, the sputter rack is fluidly connected to one, two to six, seven to twelve, twelve to forty, or more than forty removable balloon inner layer or base layer structures. Those skilled in the art will appreciate that the sputter rack may be fluidly connected to any number of removable balloon inner layer or base layer structures.

Sputter deposition may be accomplished using several steps. Components such as the removable balloon inner or base layer structure, needle, and manifold may be marked to identify various aspects of the removable balloon inner or base layer structure. The markings may be used to identify the composition of the removable balloon inner or base layer structure. The markings may identify the composition of the removable balloon inner or base layer structure. After marking the various components, a sputtering rack may be loaded onto the removable balloon inner or base layer structure. The removable balloon inner or base layer structure may be fluidly connected to the rack via a Luer connection on the needle. One skilled in the art will appreciate that the connection between the rack and the needle may be any connection known in the art. Once the removable balloon inner or base layer structure is in place, pressure may increase within the manifold. Increasing the pressure on the manifold may result in higher pressure within the removable balloon inner or base layer structure. This increase in pressure may remove wrinkles and creases in the inner or base layer structure of the removable balloon. One skilled in the art will appreciate that the pressure increase should be increased enough to remove wrinkles, but not to a pressure sufficient to damage the removable balloon inner or base layer structure. In some embodiments, the pressure is increased by fluidly connecting a syringe to the manifold. The pressure may be increased by pumping air into the manifold. One skilled in the art will appreciate that any means known in the art may be used to increase the pressure.

After any wrinkles or creases are removed from the detachable balloon inner layer or base layer structure, the syringe or other pumping device may be detached and removed from the sputter rack. The balancing balloon may be deflated and placed on the manifold and pushed into the tunnel. The balancing balloon may be fluidly connected to the rack via tubes or hoses by suitable means. The balancing balloon may be placed in a tube or other containment method that allows the balancing balloon to expand under vacuum while controlling the position of the balancing balloon during the vacuum phase. The balancing balloon may be placed in a containment chamber to prevent the balancing balloon from becoming too large during the sputtering process. The balancing balloon may be placed in the containment chamber by lowering via gravity or by pushing or pulling it into place by known means. The sputter rack may then be placed in a vacuum chamber and air may be evacuated from the vacuum chamber to or near vacuum pressure. The sputter deposition process may include a target that is a source of coating material. The sputter deposition process may include a substrate positioned such that material from the target is expelled toward the substrate. The substrate in the vacuum chamber is an individual detachable balloon inner layer or base layer structure. The target may be bombarded by a high-speed plasma stream of gas. The etching species may be any etching species known in the art. In some embodiments, the etching species may be charged or neutral. Those skilled in the art will appreciate that the etching species may be any gas suitable for plasma etching the source or target. The duration of the etching process may vary from no etching to the maximum amount of etching allowed without deforming the detachable balloon inner layer or base layer structure.

The target or source may be made of a metal selected from the group consisting of gold, platinum, silver, titanium, vanadium, aluminum, nickel, tantalum, zirconium, chromium, silicon, magnesium, niobium, scandium, cobalt, palladium, manganese, molybdenum, alloys thereof, and combinations thereof. Other biocompatible rigid materials or combinations of materials may be used. The target or source may be bombarded for a time sufficient to deposit titanium on the surface of the removable balloon inner layer or base layer structure at a thickness of 1 angstrom to 10,000 angstroms, preferably 50 to 500 angstroms. The source may be bombarded for a time sufficient to deposit gold on the surface of the removable balloon inner layer or base layer structure at a thickness of 1 angstrom to 10,000 angstroms, preferably 250 to 5000 angstroms, or 1000 angstroms. In some embodiments, titanium may be deposited on the removable balloon inner layer or base layer structure prior to the deposition of gold. In some embodiments, gold may be deposited on the surface of the removable balloon inner layer or base layer structure prior to titanium deposition. In some embodiments, once a sufficient coating of metal has been deposited on one side of the removable balloon inner layer or base layer structure, the removable balloon inner layer or base layer structure may be moved to an anti-chamber where the vacuum may be released. The pallet may be flipped, rotated, or moved to coat the other side of the removable balloon inner layer or base layer structure using the method used to coat the first side of the removable balloon inner layer or base layer structure. In some embodiments, the removable balloon inner layer or base layer structure may be placed in a sputtering environment where both sides of the removable balloon inner layer or base layer structure may be coated without the need to change the position of the sputtering rack. The coated removable balloon inner layer or base layer structure may be placed in custom packaging tubes. One skilled in the art will appreciate that the coated removable balloon inner layer or base layer structure may be placed in any packaging known in the art.

The removable balloon inner layer or base layer structure may also be coated using electroplating techniques. This includes electroplating a removable balloon inner layer or base layer structure having an outer surface layer of metal, including an outer surface layer of metal produced by vapor deposition or sputtering. Electroplating generally involves dissolving a metal in a circulating solution and immersing the metal surface layer or coating in the solution until at least a portion of the metal surface layer or coating of the removable balloon inner layer or base layer structure is covered or coated with the metal circulating in the solution. Those skilled in the art will appreciate that additional surface layers of metal can be added to the metal surface layer or coating of the removable balloon inner layer or base layer structure using any electroplating method known in the art. As with conventional electroplating, the anode 390 and cathode 405 are submerged in the circulating metal solution. In the present disclosure, the anode 390 may be any conventional anode known in the art of electroplating. The surface of the metal-coated removable balloon inner layer or base layer structure acts as a cathode 405 and is coated externally by the metal circulating in the solution. To achieve the electrical conductivity required for electroplating the metal-coated removable balloon inner layer or base layer structure surface, a support fixture or other support structure is used to create an electrical contact to the negative side of the electroplating power supply. In some embodiments, a hypodermic tube splint may be inserted into the needle. The hypodermic tube splint may include one or more openings that allow fluid to pass from an external source to the internal void of the metal-coated removable balloon inner layer or base layer structure. The hypodermic tube splint may include a connection for connection to a female Luer hub. The assembly may further include a one-way injection port. Those skilled in the art will understand that the hypodermic tube splint may have any means of connecting to a needle known in the art. The metal coated removable balloon inner layer or base layer structure may be rotated during electroforming or electroplating to promote uniform deposition of metal on the outer surface of the metal coated removable balloon inner layer or base layer structure during electroforming or electroplating. The hypodermic tube splint may be mounted on a rack or similar device that includes a means for rotating the metal coated removable balloon inner layer or base layer structure assembly. The hypodermic tube splint may be connected to a needle injection port and a rack assembly to suspend the metal coated removable balloon inner layer or base layer structure in a bath. A support structure that allows electrical connection of the needle while maintaining the needle position within the electroforming or electroplating solution is preferred. The support structure may rotate one or more of the individual metal coated removable balloon inner layer or base layer structures using gears, belts, pulleys or other suitable means. The support structure also provides a common electrical connection so that the metal coated removable balloon inner layer or base layer structure is referenced at an electrical potential that promotes electroforming or electroplating. The metal coated removable balloon inner or base layer structure may be immersed in an electroforming or electroplating bath at a temperature between 100° F. and 250° F., or about 160° F. One skilled in the art will recognize that the bath may be at any temperature necessary to successfully electroform or electroplate the metal coated removable balloon inner or base layer structure with the metal circulating in the solution. The metal circulating in the solution may be a metal selected from the group consisting of gold, platinum, silver, titanium, vanadium, aluminum, nickel, tantalum, zirconium, chromium, silicon, magnesium, niobium, scandium, cobalt, palladium, manganese, molybdenum, alloys thereof and combinations thereof, or other conductive, biocompatible, rigid, or semi-rigid materials or combinations of materials.

The central layer of the wall 30 of the removable balloon 10, the inner layer of the wall 30 of the removable balloon 10, and the outer layer of the wall 30 of the removable balloon 10 may be formed by any suitable method. In some preferred embodiments, the wall 30 of the removable balloon 10 has two layers. The inner layer of the wall 30 of the removable balloon 10 includes PET, nylon, or Pebax and is formed by blow molding fabrication. The outer layer of the wall 30 of the removable balloon 10 includes a metal layer 90 including gold or titanium formed by sputter deposition or vapor deposition. In some preferred embodiments, the removable balloon 10 has three layers. The inner layer of the wall 30 of the removable balloon 10 includes PET, nylon, or Pebax and is formed by blow molding fabrication. The central layer of the wall 30 of the removable balloon 10 includes gold or titanium formed by sputter deposition or vapor deposition. The outer layer of the wall 30 of the removable balloon 10 includes gold or platinum formed by electroforming or electroplating.

In some embodiments, the conductive mandrel 740 is placed in a solution of metal ions to coat the outer surface of the mandrel 740 and form a layer of the removable balloon. For example, in some preferred embodiments, the conductive mandrel 740 is a removable balloon inner or base layer structure comprising a polymer formed by a blow molding process. The removable balloon inner or base layer structure is coated on its outer surface with gold or titanium by sputter deposition or vapor deposition. The shape of the mandrel 740 (and therefore the shape of the removable balloon) can be changed by changing the shape of the polymer inner or base layer formed by the blow molding process. The thickness of any layer of the removable balloon, including but not limited to the metal or metal layer, can be changed by changing the process time or conditions. Additional surface layers may be formed by additional electroplating or electroforming. Additional surface layers may be formed by vapor deposition or sputter deposition, where material is eroded from a target (e.g., a metal or metal alloy) and deposited on a substrate, such as the mandrel 740 or a mold, to form a thin layer on the substrate. Similarly, the inner layer may be formed by additional electroplating or electroforming, or by vapor deposition or sputter deposition. In another exemplary method of forming a removable balloon, the central layer of the wall 30 of the removable balloon 10 may be formed by vapor deposition, whereby vapor from one or more polymers, pure metals, or alloys is condensed onto a substrate or mold. The mold may be removed to provide a hollow shell comprised of a polymer, pure metal, or metal alloy. In various embodiments, after deposition or formation of one or more metal layers 90, the outer surface of the removable balloon may be further coated with a polymer, such as by use of a polymer-containing solution. This additional coating may include an outer coating of a urethane-containing solution, which may further act to secure the metal or metal layer to the removable balloon, including the inner or base layer.

In various embodiments, only desired portions or regions of the removable balloon include the metal layer 90 deposited by electroforming or electroplating. In various embodiments, only portions or regions of the metal-coated removable balloon inner layer or base layer structure are further coated with additional metal by electroforming or electroplating. In various embodiments, various portions or regions of the removable balloon may have different wall configurations or thicknesses. In some embodiments, the different wall structures or thicknesses are produced by masking portions or regions of the removable balloon inner layer or base layer structure prior to vapor deposition or sputter deposition. In some of these embodiments, additional metal may be applied to portions or regions of the removable balloon inner layer or base layer structure that are covered with metal by vapor deposition or sputter deposition. In some embodiments, the different wall structures or thicknesses are produced by masking or coating portions of the removable balloon inner layer or base layer structure that are coated with metal prior to electroforming or electroplating. In some of these embodiments, additional metal may be applied to portions or regions of the metal-coated removable balloon inner layer or base layer structure that are not masked or coated prior to electroforming or electroplating.

According to various embodiments, the metal layer 90 of the removable balloon may comprise various patterns. For example, one or more masks may be applied to the outer surface of the removable balloon inner layer or base layer structure prior to further coating with a polymer or metal. In some embodiments, a first metal or metal layer may be applied by sputter deposition, and then a second metal layer 90 may be formed by electroforming or electroplating, with one or more masks applied before or after the formation of the first metal layer. For these embodiments, various portions of the removable balloon inner layer or base layer structure may have a layer 90 without metal, one metal layer, or two or more metal layers 90. The one or more outer metal layers may be deposited as one or more narrow bands, an arcuate configuration, multiple bands of uniform different widths, multiple bands of different widths, or combinations thereof. Those skilled in the art will appreciate that other configurations may be provided.

In some embodiments, the detachable balloon may include a metallized polymer balloon, where the metal layer 90 is incomplete, discontinuous, or present on only a portion of the wall 30 of the detachable balloon 10. Such an incomplete or discontinuous layer may be produced by electroplating, electroplating, vapor deposition, or sputter deposition. In some detachable balloon embodiments, the metal layer 90 is formed on a polymer inner layer or base layer structure, where some areas or portions of the wall 30 of the detachable balloon 10 have a metal layer 90 produced by electroforming or electroplating, and other areas or portions of the detachable balloon without a metal layer 90 produced by electroforming or electroplating. In some embodiments, the detachable partially metallized polymer balloon 20 has a central or intermediate region 100 that includes a gold layer produced by electroforming or electroplating that is rigid or semi-rigid, while the proximal and distal regions 110 and 120 of the detachable balloon include a polymer layer but do not include a gold layer produced by electroforming or electroplating, and are more flexible, where the polymer layer includes PET, nylon, Pebax, or other polymers. The proximal region 110 may have a generally tapered shape terminating at a proximal neck 130 having a metal layer 90 produced by electroforming or electroplating, or at a proximal neck 130 not having a metal layer 90 produced by electroforming or electroplating. The distal region 120 may have a generally tapered shape terminating at a distal neck 140 having a metal layer 90 produced by electroforming or electroplating, or at a distal neck 140 not having a metal layer 90 produced by electroforming or electroplating. The partially metallized detachable balloon may include a proximal or distal "fluted" portion of the detachable balloon between the proximal neck 130 and the proximal region 110 or the distal neck 140 and the distal region 120. In some embodiments, the grooved portion 150 may contain no metal or a metal layer less than 1 μm thick, acting as a flexible "hinge" region when the partially metallized polymer detachable balloon is pleated, folded, and mounted on the delivery system and advanced within the patient's body. In some embodiments, all or part of the grooved region may or may not contain metal manufactured by electroforming or electroplating, or metal greater than 1 μm thick.

In some embodiments, the pleated folded partially metallized polymer balloon bonded or operably connected to the first or second catheter 174 may include alternating regions of stiffer material (including metal or metal greater than 1 μm thick produced by electroforming or electroplating) and more flexible material (including soft polymer only or soft polymer with metal greater than 1 μm thick) that forms the pleats and produces a folded partially metallized polymer balloon with rigid or semi-rigid regions 170 inserted through flexible regions 165 to facilitate advancement into the patient's body, including advancement over a guidewire 40, advancement through a guide catheter, and advancement through tortuous paths. The detachable balloon with alternating flexible and rigid or semi-rigid regions 170 is sufficiently flexible when pleated and folded to move through tortuous paths and traverse the twists and turns of the vasculature when bonded or operably connected to a catheter or catheter assembly 5 while being strong enough to withstand compression, compaction, or collapse after expansion in vivo.

The wall thickness of the metallized portion of the polymer-only and partially metallized detachable balloon may be uniform or each portion may have a different thickness. For example, the wall 30 of the metallized portion of the detachable partially metallized polymer balloon 20 may have a uniform thickness of 3, 5, 10, 15, 20, 30, 40, 50, 60, 70, 80, 90, 100 or up to 200 μm, including any value between 3 μm and 200 μm, regardless of material. Alternatively, the thickness of the wall 30 of the metallized portion of the detachable partially metallized polymer balloon 20 at different locations along the detachable balloon 10 may vary. The thickness may vary between each individual metallized region and each polymer-only or non-metallized region. The wall thickness may vary within the individual metallized regions and each polymer or non-metallized region according to some embodiments. In some embodiments, the metallized portion of the detachable partially metallized polymer balloon may be 3-100 μm thick, including metallized regions where the metal is deposited by electroplating or electroforming. In some embodiments, the polymer wall 30 or the non-metallized portion of the removable partially metallized polymer balloon 20 may have a thickness in the range of about 3 to 60 μm. In some embodiments, a cross-section of the pleated and folded wall 30 of the removable partially metallized polymer balloon 20 may show a more flexible region 165 that includes one or more metal layers less than 1 μm thick, or a metal layer 90 greater than 1 μm thick, sandwiched between stiffer regions 170 that include only polymer, or that include one or more polymer layers and a metal layer 90 fabricated by electroplating or electroforming. In some embodiments of the removable partially metallized polymer balloon 20, the proximal neck 130 and proximal region 110 of the partially metallized polymer balloon 20 include a polymer layer 99 and a metal layer 90 fabricated by electroplating or electroforming, or a metal layer 90 greater than 1 μm thick, while the distal region 120 includes only polymer, or a polymer layer 99 and a metal layer 90 less than 1 μm thick.

In various embodiments, all or a portion of the exterior or interior surfaces of the detachable balloon 10, including the polymer balloon 12, the metallized polymer balloon 14, the metal balloon 16, and the polymer coated metal balloon 18, may be coated by known means with a variety of materials having properties ranging from hydrophobic to hydrophilic properties, urethanes, other metals, or combinations thereof. The coatings can achieve a variety of purposes including improved biocompatibility, enhanced blood contact, surface texturing, or conformal coatings to improve part durability, including coatings that reduce the risk of delamination of the metal layer 90 from the polymer layer 99.

In some embodiments of the detachable metallized polymer balloon 14, the metal wire or ribbon may be applied to all or a portion of the outer surface of the polymer balloon 12 or the polymer inner or base layer structure. The metal wire may be provided in a variety of thicknesses and shapes. By way of example and not limitation, the metal wire may have a circular cross section and a diameter ranging between 25 μm and 600 μm. In a preferred embodiment, the round metal wire has a diameter of about 50-200 μm. Alternatively, the metal wire may be provided as a flat ribbon or semi-flat "half round" wire. The width of the flat wire typically ranges from about 25 μm to about 600 μm in width and about 20 μm to about 300 μm in thickness. In particular, the width of the flat ribbon wire may be 25, 50, 75, 100, 125, 150, 175, 200, 225, 250, 275, 300, 325, 350, 375, 400, 425, 450, 475, 500, 525, 550, 575, or up to 600 μm, including any value between 25 μm and 600 μm. Similarly, the thickness of the flat ribbon protruding from the surface of the detachable balloon may be 20, 30, 40, 50, 60, 70, 80, 90, 100, 110, 120, 130, 140, 150, 160, 170, 180, 190, 200, 210, 220, 230, 240, 250, 260, 270, 280, and 300 μm, including any value between 20 μm and 300 μm. Other wire shapes may be used, such as wires with non-linear or irregular cross-sectional profiles. The pitch and number of wire loops (loop density), and the wrap angle may vary both between and within embodiments. As such, the metal wire may be uniformly wrapped and arranged in some embodiments of the detachable metallized balloon, while other embodiments may vary the pitch, number of loops, wrap angle, or combinations thereof.

In some embodiments, after placing the metal wire or ribbon on the outer surface of the polymer balloon 12 or the polymer inner or base layer 99 structure, the resulting metallized polymer balloon 14 is coated with a polymer or adhesive. In some embodiments, a coating including a urethane composition is used to further bond the metal wire to the removable polymer balloon 12 or the inner or base layer 99 structure. The urethane composition may be provided in a concentration range of 2% to 10% urethane in a solvent. By way of example and not limitation, the solvent may include tetrahydrofuran ("THF") or oxolane; however, other solvents may be used. In one aspect, the solvent, such as THF, may chemically modify, react, or bond with the surface of the removable polymer balloon 12 or the inner or base layer 99 structure. In this manner, a strong bond is formed between the urethane layer and the removable polymer balloon 12 or the polymer inner or base layer 99 structure, further securing the wire to the outer surface of the removable balloon 10. The urethane coating may be applied by any suitable method, including, but not limited to, dip coating or spray coating. The preferred method results in a more even or uniform distribution of the urethane composition over and between the metal wires applied to the surface of the removable polymer balloon 12 or polymer inner or base layer 99 structure. The preferred method increases the force required to cause delamination of the metal wires from the removable balloon 10. The preferred method reduces the risk of fracturing or breaking of the metal wires. The preferred method allows for the simultaneous coating of multiple metallized polymer balloons 14. Using the preferred method, coated metallized polymer balloons 14 may be manufactured at a reasonable cost.

In one embodiment, the detachable polymer balloon 12 or polymer inner or base layer 99 structure is prepared in a manner similar to that of a typical angioplasty balloon. For example, a tubular polymer material is cut to a desired length and includes material that forms a distal neck 140 and a proximal neck 130 at opposite ends of the balloon. One end of the balloon is bonded to a tubular structure (e.g., a blunt needle) that forms a leak-tight conduit to the balloon interior. The tubular structure also allows for an additional tube to be threaded inside the balloon. This additional tube provides a means to inflate the balloon and also acts as a splint to secure the balloon during the manufacturing process. The additional tube may be engaged to a valve, such as a Luer valve, so that the balloon can be inflated and remain inflated during the process of adding metal. To complete the manufacturing of the detachable polymer balloon 12 or polymer inner or base layer 99 structure, the remaining necks or openings are filled and sealed. In one embodiment, the remaining openings are filled with an ultraviolet (UV) curable adhesive that is cured to seal the balloon. The removable polymer balloon 12 or polymer inner or base layer 99 structure is then pressurized or expanded and placed in an apparatus capable of applying wire to the surface of the removable polymer balloon 12 or polymer inner or base layer 99 structure. Optionally, the pressurized removable polymer balloon 12 or polymer inner or base layer 99 structure may be coated with a urethane solution prior to applying the metal wire. In one embodiment, the apparatus capable of applying wire to the surface of the removable polymer balloon 12 or polymer inner or base layer 99 structure is a wrapping system similar to a lathe, such that the attached balloon 10 rotates about its longitudinal axis. Once the balloon is attached, one end of the wire is attached to the polymer balloon 12, which is rotated. While the polymer balloon 12 is rotating, the wire is wrapped around the desired portion of the polymer balloon 12 with the desired pitch, loop density and angle. After wrapping, the end of the wire is attached to the polymer balloon 12. The wire wrapped polymer balloon is removed from the wire wrapping assembly and coated at least once with a urethane-based composition. In one embodiment, the entire wire-wrapped polymeric balloon may be coated with a urethane composition as described herein. In another embodiment, a mask may be placed over the portion of the polymeric balloon that is covered with wire so that only the wrapped portion is coated. After the urethane coating has cured, the wire-wrapped polymeric balloon may be depressurized (deflated) and pleated and folded. The pleated and folded detachable wire-wrapped polymeric balloon may be in a collapsed or delivery configuration.

(Manufacture of Detachable Balloon Catheters - Manufacture of Detachable Metal Balloons and Detachable Polymer Coated Balloons)
The hollow metallized expandable body 10 can be fabricated by a method of depositing a metal, such as gold, by electroforming onto a sacrificial mandrel 740 made of a conductive material, such as aluminum. The sacrificial mandrel 740 can then be removed from the interior of the expandable body 10 by a process such as drilling and acid etching. The electroforming process can produce a rounded, pebbled or granular structure on the exterior surface of the expandable body. The metallized expandable body 10 may further undergo an annealing process to improve the flexibility of the expandable body. In one embodiment, the gold expandable body 10 is heated at about 300° C. for about 1 hour and then immediately quenched in a distilled water bath at room temperature. Finally, a polymer coating can be applied to the expandable body 10 to modify its mechanical, electrical or biocompatible properties. The polymer coating may include parylene, polyurethane, PTFE, silicone or other biocompatible polymers. The coating may be applied by dipping, spinning, spraying or other deposition processes specialized for the particular polymer. The coating may be applied to the entire exterior of the expandable body 10 or only to selected areas by masking out the areas that will not be coated.

(Manufacture of Detachable Balloon Catheters - Pleated and Folded Detachable Balloon)
To facilitate advancement of a partially or fully metallized or partially or fully plated detachable balloon through the vasculature, the detachable balloon can be compressed into various shapes and sizes, as shown in Figures 83A-D and 84A-B. For example, a partially or fully metallized or partially or fully plated detachable balloon can be pleated, folded, and optionally compressed to a diameter small enough to pass through a 3-9 Fr or larger guide catheter, or to be maneuvered through an artery, vein, atrium (including atrium and ventricle), other blood-containing structure, biological conduit, or other biological space. The pleats, folds, and optional compression can include a variety of formats and patterns. As shown in Figures 84A-B and 85, the number and length of the pleats can be optimized for the expanded diameter and wall thickness of the detachable balloon. For example, a partially or fully metallized or partially or fully plated detachable balloon may be pleated, folded, and compressed to a diameter small enough to pass through a 3-8 Fr guide catheter or to be maneuvered through a cerebral artery. Optionally, this compression may include various types and patterns of pleating, folding, or compression.

In some embodiments, the detachable balloon of the detachable balloon catheter 1 is configured to expand from a compressed or deflated configuration to an expanded configuration, and when the detachable balloon is in the compressed or deflated configuration, the wall 30 of the detachable balloon 10 is in a pleated configuration including a plurality of pleats folded in a clockwise direction about the first axis 706 or a counterclockwise direction about the first axis 706 to form a folded-over region of the detachable balloon. In some embodiments, when the detachable balloon of the detachable balloon catheter 1 is in the compressed or deflated configuration, the wall 30 of the detachable balloon 10 is in a pleated configuration including a plurality of pleats folded in a clockwise direction about the first axis 706 or a counterclockwise direction about the first axis 706 to form a folded-over region of the detachable balloon, and when the detachable balloon is in the expanded configuration, the plurality of pleats are not folded. In some embodiments, each pleat 742 of the plurality of pleats of the detachable balloon of the detachable balloon catheter 1 includes ridges extending in a proximal-distal direction and in a radial direction from the first axis 706. In some embodiments, each pleat 742 includes ridges extending in a proximal-distal direction, and each pleat 742 of the plurality of pleats of the detachable balloon of the detachable balloon catheter 1 is separated from any immediately adjacent pleat 742 by an insertion trough extending in a proximal-distal direction. In some embodiments, the pleated configuration of the pleated balloon of the detachable balloon catheter 1 includes an alternating ridge-trough arrangement. In some embodiments, each pleat 742 of the plurality of pleats of the pleated balloon of the detachable balloon catheter 1 is folded over the immediately adjacent pleat 742 in a clockwise direction relative to the first axis 706 or in a counterclockwise direction relative to the first axis 706. In some embodiments, the detachable balloon of the detachable balloon catheter 1 is configured to assume an expanded configuration by substantially eliminating the pleated configuration or the pleats present in the collapsed or compressed configuration.

In some embodiments, the compressed or deflated detachable balloon of the detachable balloon catheter 1 may be expanded by injecting water, saline, radiocontrast or a combination thereof into the central void 115 or internal volume of the detachable balloon. In some embodiments, the detachable balloon of the detachable balloon catheter 1 is configured to be expanded from a compressed or deflated configuration to an expanded configuration by applying a pressure of less than 10 atmospheres, less than 5 atmospheres, less than 4 atmospheres, less than 3 atmospheres, less than 2 atmospheres or less than 1 atmosphere to the central void 115 or internal volume of the detachable balloon. In some embodiments, the central void 115 or internal volume of the detachable balloon of the detachable balloon catheter 1 may be pressurized during passage of fluid from the proximal hub of the first catheter 173 through the first lumen 162 to the central void 115 or internal volume of the detachable balloon 10. In some embodiments, the detachable balloon catheter 1 is configured to allow fluid to be injected from the hub 179 of the first catheter 173 through the lumen 162 of the first catheter 173 into the central void 115 or interior volume of the detachable balloon 10 at a rate faster than the fluid leaks from the central void 115 or interior volume of the detachable balloon 10 into the space adjacent to the detachable balloon 10. In some embodiments, the expansion of the detachable balloon 10 of the detachable balloon catheter 1 causes a shortening of the detachable balloon 10 along a plane parallel to the first axis 706.

Various methods can be used to pleat, fold and compress the partially or fully metallized or partially or fully plated detachable balloon to allow it to pass through various lumens and conduits. These include, but are not limited to, the lumens of guide catheters, arteries 317, veins 318, the atria (including the atria and ventricles), other blood-containing structures, biological conduits 900 or other biological spaces 904.

In one embodiment, the partially or fully metallized or partially or fully plated detachable balloon is folded to form one or more pleats before or after attaching the partially or fully metallized or partially or fully plated detachable balloon to the first catheter 173, and the pleats are rolled and compressed, similar to the folding of a non-compliant angioplasty balloon. In another embodiment, the partially or fully metallized or partially or fully plated detachable balloon is flattened into a planar shape and rolled into a cylindrical shape. In certain embodiments, the partially or fully metallized or partially or fully plated detachable balloon may be folded and wrapped around the first catheter 173.

For example, one or more pleats may be made in the partially or fully metallized or partially or fully plated detachable balloon and then the pleats may be wrapped into a cylindrical shape. The partially or fully metallized or partially or fully plated detachable balloon may be flattened into a planar shape and then rolled into a cylindrical shape. Alternatively, the partially or fully metallized or partially or fully plated detachable balloon may be compressed into a compact spherical shape. Additionally, a portion of the partially or fully metallized or partially or fully plated detachable balloon may be twisted or braided during compression. In certain examples, the partially or fully metallized or partially or fully plated detachable balloon may be compressed around the first catheter 173. In other embodiments, the partially or fully metallized or partially or fully plated detachable balloon may be compressed by itself without a central mandrel, including a catheter mandrel.

In another embodiment, pleats are formed in the partially or fully metallized or partially or fully plated removable balloon, and then the pleats are wrapped around the hollow cylindrical member of the first catheter 173, and the partially or fully metallized or partially or fully plated removable balloon 14 or 20 is compressed against the first catheter 173. In another embodiment, pleats are formed in the partially or fully metallized or partially or fully plated removable balloon 14 or 20, and then the pleats are wrapped around a removable wire mandrel, and then the partially or fully metallized or partially or fully plated removable balloon 14 or 20 is compressed against the removable wire mandrel. In another embodiment, pleats are formed in the partially or fully metallized or partially or fully plated removable balloon 14 or 20, and then the pleats are rolled into a generally cylindrical shape without a removable wire or catheter serving as a central fixation point or mandrel.

In various embodiments, a partially or fully metallized or partially or fully plated detachable balloon is attached to the first catheter 173, then pleats are formed, and then the pleats are folded, wrapped or compressed onto the first catheter 173. In another embodiment, a partially or fully metallized or partially or fully plated detachable balloon is first pleated and attached to the first catheter 173, and then the pleats are wrapped or compressed onto the outer surface of the first catheter 173.

In some embodiments, excess material may be removed from one or both ends of the removable balloon inner layer or base layer structure, or the partially or fully metallized or partially or fully plated pleats prior to pleating, the proximal end of the proximal neck 130, or the distal end of the distal neck 140 of the removable balloon. The excess material may be removed by cutting the neck. Cutting may be accomplished by rotating the inner layer or base layer structure of the removable balloon, or the partially or fully metallized or partially or fully plated removable balloon under a fixed blade, or by rotating a blade over the inner layer or base layer structure of the removable balloon, or the proximal neck 130 or the distal neck 140 of the partially or fully metallized or partially or fully plated removable balloon 14 or 20. In some examples, heat may be used to soften the neck or the end of the neck prior to cutting. Those skilled in the art will recognize the removable balloon inner layer or base layer structure, or the excess material at the end of the removable balloon neck that is partially or fully metallized or partially or fully plated, using methods well known in the art.

The partially or fully metallized or partially or fully plated detachable balloon may be mounted on the pleated and folded mandrel before or after removing excess material from the proximal neck 130 or the distal neck 140. In this regard, as part of the custom packaging system, the needle hub pre-mounted with the partially or fully metallized or partially or fully plated detachable balloon is replaced with the mandrel. To keep the mandrel 740 stationary during shipping, a stopper or other stabilizing means can be placed at the tip of the mandrel 740 when the mandrel 740 and the partially or fully metallized or partially or fully plated detachable balloon are placed in the shipping tube. The stopper may be a piece of foam or other material known in the art. The pleated and folded mandrel 740 reduces the risk of compression of the partially or fully metallized or partially or fully plated removable balloon during shipping and set up and prevents the partially or fully metallized or partially or fully plated removable balloon from being overly compressed during pleating, folding and compression. This is accomplished by sizing the outer diameter of the mandrel 740 to the desired final inner diameter corresponding to the outer diameter of the second catheter 174 or the outer diameter of the telescoping segment 185 that will be used during assembly of the complete medical device 1, including but not limited to those disclosed in co-filed PCT applications PCT/US2014/030869 and PCT/US2015/050783, commonly referred to as the Blockstent Microcatheter device and Ballstent Microcatheter device.

Once the partially or fully metallized or partially or fully plated detachable balloon 741 and mandrel 740 are placed in the transport tube with the stabilizing means, the transport tube is sent to a third party where the partially or fully metallized or partially or fully plated detachable balloon is removed and pleated. As shown in Figures 77-79, the pleated partially or fully metallized or partially or fully plated detachable balloon may have multiple pleats. In a preferred embodiment, the pleated partially or fully metallized or partially or fully plated detachable balloon may have three pleats. In some examples, the pleated partially or fully metallized or partially or fully plated detachable balloon may have only one pleat 742 or as many as ten pleats. Those skilled in the art will recognize that a partially or fully metallized or partially or fully plated detachable balloon may have as many pleats as are necessary to compress the partially or fully metallized or partially or fully plated detachable balloon to a size such that the partially or fully metallized or partially or fully plated detachable balloon can be advanced through the vascular system using a delivery system.

In some embodiments, the partially or fully metallized or partially or fully plated detachable balloon may form pleats without heating the head. In some embodiments, it may be advantageous to form pleats in the partially or fully metallized or partially or fully plated detachable balloon without extending the residence time of the pleat head. By forming pleats in the partially or fully metallized or partially or fully plated detachable balloon without heating the head and without extending the residence time of the pleat head, the partially or fully metallized or partially or fully plated detachable balloon may be expanded without permanent folding. The partially or fully metallized or partially or fully plated detachable balloon 741 may be folded on the mandrel 740 while in the fold-head. In some embodiments, the partially or fully metallized or partially or fully plated detachable balloon may form pleats and be removed from the mandrel 740. After the partially or fully metallized or partially or fully plated detachable balloons are pleated and folded, they are packaged for shipment and the pleat and fold information is recorded on the packaging tube.

The formation of the pleats is accomplished by compressing the partially or fully metallized or partially or fully plated removable balloon between two or more pleats. This compression results in a lobular shape or shapes of the partially or fully metallized or partially or fully plated removable balloon. These lobes are then folded in one direction around the central axis of the partially or fully metallized or partially or fully plated removable balloon, thereby forming the partially or fully metallized or partially or fully plated removable balloon into a tubular shape concentric with and approximating the dimensions of one or both ends.

(Detachable Balloon Catheter - Manufacturing of Detachable Balloon Catheter Assembly The partially or fully metallized or partially or fully plated detachable balloon may be attached to the delivery system, first catheter 173 or second catheter 174 using a variety of materials, components, systems and methods. The partially or fully metallized or partially or fully plated detachable balloon may be attached to the first catheter 173 such that the size and shape of the distal end of the first catheter 173 and the size and shape of the opening in the wall 30 of the partially or fully metallized or partially or fully plated detachable balloon 14 or 20 match to form a friction fit 202 between the first catheter 173 and the partially or fully metallized or partially or fully plated detachable balloon 14 or 20. In one embodiment of the friction fit 202, an elastic sleeve or wrap 204 is attached within the proximal neck 130 of the detachable balloon 10, generally shown as 206, such that the sleeve can engage the first catheter 173. Alternatively, the elastic sleeve or wrap 204 may be It may be placed around the proximal neck 130 of the partially or fully metallized or partially or fully plated detachable balloon 14 or 20 and may be used to hold the partially or fully metallized or partially or fully plated detachable balloon 14 or 20 and the first catheter 173 together. In another embodiment of the friction fit 173, the partially or fully metallized or partially or fully plated detachable balloon 14 or 20 may be attached to the first catheter 173 using an adhesive or glue, or welding or solder. The partially or fully metallized or partially or fully plated detachable balloon 14 or 20 may be attached to the first catheter 173 by fitting a releasable clamp or a mechanical part, such as a wire, polymer strand, filament, thread or string that can be loosened or removed, to the partially or fully metallized or partially or fully plated detachable balloon 14 or 20 and the first catheter 173.

The method may also include welding or joining all or a portion of the proximal neck 130 or distal neck 140 segments to the partially or fully metallized or partially or fully plated detachable balloon 14 or 20, or both the proximal neck 130 and distal neck 140 segments. In other embodiments, the proximal neck segment 130, the distal neck segment 140, or both the proximal neck segment 130 and the distal neck segment 140 may be joined during an electroforming process to form a partially or fully metallized or partially or fully plated detachable balloon 14 or 20.

(Elongated expandable body)
The present disclosure relates to a medical device 1 that includes an elongated or expandable body 720. These devices are also referred to herein as "second medical devices." As used herein, the elongated body 720 is a long, thin, flexible structure that can be pushed or carried through a lumen of a catheter and implanted in a patient. The elongated body 720 occupies space and can form complex shapes, but does not expand during or after deployment. As used herein, the expandable body 720 is a long, thin, flexible structure that can be pushed or carried through a lumen of a catheter in a constrained, collapsed, compressed, or pleated, folded form, and implanted in a patient, and a portion of the expandable body 720 can expand in size during or after deployment. An elongated expandable body 720 that can be used with a detachable balloon catheter 1 is described.

As shown in FIG. 86, the first elongated or expandable body 10 of the second medical device 1 is joined to the second elongated body of the second medical device 1 by a detachable bond or joint after the first elongated or expandable body 10 is positioned within a saccular aneurysm, artery, vein, LAA, perivalvular leak, blood-containing space, biological conduit 900 or space, or the central void 115 or interior volume of an expanded detachable balloon of the first medical device. The first elongated or expandable body 10 of the second medical device 1 is joined to the second elongated body of the second medical device 1, and after ejection of the first elongated or expandable body 10 of the second medical device 1 from the distal end of the second catheter 174 of the first medical device 1, the second elongated body of the second medical device 721 can be separated from the first elongated body 720 of the second medical device 700, and the second elongated body 721 can be removed from the patient while leaving the first elongated or expandable body 720 in the patient. In some embodiments, the first elongated or expandable body 720 acts to stimulate thrombus formation and fibrosis in the aneurysm lumen or sac 722.

The first elongated body or coil may include a primary wire having a diameter of 0.00175 to 0.003 inches. This primary wire may be wound on itself to provide an overall or secondary diameter of the coil having a diameter of 0.010 to 0.040 inches. This secondary shape of the first elongated body or coil may further be formed into a tertiary shape having a diameter of about 2 to 100 mm or 0.1 to 4 inches.

Standard nominal values for the diameters (and their associated coil sizes) of the guidewire 40 are 0.014 inches, 0.018 inches, and 0.035 inches/0.038 inches. FIG. 91 summarizes the minimum and maximum diameters of the various second catheters 173 (or guidewire shafts), first elongate bodies 720 (or coils), and second elongate bodies 721 (or pusher wires) for the first and second medical device 1 and 700 embodiments corresponding to these three guidewire platforms. FIG. 90 summarizes the minimum and maximum lengths of these elements. FIGS. 87-89 detail the nominal dimensions of these elements and the range of acceptable and recommended dimensions.

In various embodiments, the first elongate body or coil comprises an elongate, straight, yet flexible first elongate body or coil that is not provided with a tertiary shape, but may have a length between about 10 cm and about 400 cm. The straight first elongate body or coil may be deployed within the aneurysm, within a detachable balloon, or the first elongate body or coil may extend into both the aneurysm and the detachable balloon. The straight, flexible first elongate body or coil may be used with a variety of balloons of any size and shape. In one aspect, the first elongate body or coil is formed into a secondary shape by an expanded detachable balloon. The balloon imparts an ideal secondary shape to the first elongate body or coil by constraining them within the balloon.

Straight coils are desirable to reduce friction during passage through various catheters and/or delivery devices. A long straight first elongate body or coil also allows for the use of only a single first elongate body or coil for each balloon. When treating an aneurysm with a single detachable balloon and one first elongate body or coil, the user has more flexibility to reposition the balloon and first elongate body or coil during treatment. The combination of a single detachable balloon and first elongate body or coil also reduces overall treatment time.

In various aspects, the first elongate body or coil can be manufactured to include one or more distal loops. The loops can be deformed under tension for delivery through one or more catheters and return to their natural loop shape as they exit the catheter. The loops on the elongate straight first elongate body or coil also protect the posterior wall of the aneurysm 320 from spearing or puncturing that may occur when using a first elongate body or coil without loops. In various other embodiments, the first elongate body or coil may include one, two, three, four or more end loops, or no end loops. The first elongate body or coil can be advanced and deployed by a second elongate body, pusher wire, or pusher catheter that joins or contacts the proximal end of the first elongate body or coil so that the first elongate body or coil remains in a desired position. Similarly, for embolization of peripheral arteries or veins, a low friction straight first elongate body or coil with 0, 1, 2, 3 or 4 loops on the distal end can be used to allow the use of a single first elongate body or coil, which facilitates blocking the opening in the distal neck of the balloon with the first elongate body or coil and reduces blood flow through the balloon. The first elongate body or coil can be positioned such that one loop is located outside the detachable balloon while another loop is located within the neck or central void of the detachable balloon.

In some methods, the operator may gently push the first loop out of the second catheter 174 to block the opening in the distal neck of the balloon, pull the tip of the second catheter 174 back into the central cavity of the balloon, and then deploy the remainder of the first elongate body or coil within the balloon. At this point, the operator may release any remaining tension in the delivery system and obtain an angiogram to confirm complete occlusion. If the size or position of the detachable balloon or first elongate body or coil is not appropriate, the first elongate body or coil may then be removed or repositioned, the detachable balloon may be deflated and repositioned, removed, or replaced, and the first elongate body or coil may be reinserted or a new first elongate body or coil may be inserted. When the operator is satisfied with the placement of the detachable balloon and first elongate body or coil, the operator may remove the first elongate body or coil and the expanded balloon, and remove the first catheter 173 and the second elongate body 721.

In some methods, the operator may gradually push the distal loop of the first elongate body or coil out of the second catheter 174 to configure the aneurysm sac 722, then push several straight portions of the first elongate body or coil into the aneurysm sac behind or adjacent to the dilatation balloon, and then pull the tip of the second catheter 174 back into the central cavity 115 of the balloon 10 and deploy the remainder of the first elongate body or coil within the balloon. At this point, the operator may release any remaining tension in the delivery system and obtain an angiogram to confirm complete occlusion. If the size or position of the detachable balloon or first elongate body or coil is not appropriate, the first elongate body or coil may then be removed or repositioned, the detachable balloon may be deflated and repositioned, removed or replaced, the first elongate body or coil may be reinserted, or a new first elongate body or coil may be inserted. When the operator is satisfied with the placement of the detachable balloon and the first elongate body or coil, the operator can detach the first elongate body or coil and the expanded balloon and remove the first catheter 173 and the second elongate body 721.

In various embodiments, as shown in FIG. 93F, the first elongate body or coil 720 can be manufactured to include one or more distal loops 702 and one or more proximal loops. The loops can deform under tension for delivery through one or more catheters and return to their natural loop shape as they exit the catheter. The distal loop 702 can be configured such that the first elongate body or coil 720 has a flat surface against the adjacent tissue or balloon wall 30, reducing the risk of wall puncture as it is pushed forward. The proximal loop can be configured such that the shape is more easily grasped by a snare catheter. For example, when a first elongate body or coil having both distal and proximal loops is placed in the central void of an expanded detachable balloon in a blood vessel, the distal loop 702 can be placed in the blood vessel lumen distal to the expanded balloon 10 to fill at least a portion of the opening of the distal neck 140 of the balloon, and the central portion of the first elongate body or coil 720 can be placed in the central void 115 of the expanded detachable balloon. The first catheter 173 may then be removed from the proximal neck 130 of the expanded detachable balloon 10. The proximal loop may then be placed in the vascular lumen proximal to the expanded balloon 10. In embodiments where the first elongate body or coil 720 is joined to the second elongate body 721, the first elongate body or coil 720 may then be removed from the second elongate body 721. In situations where placement of the detachable balloon 10 is determined to be undesirable after removal of the expanded detachable balloon 10 and the first elongate body or coil 720, a snare catheter may be used to grasp the proximal loop or loops of the detached first elongate body or coil 720, and the first elongate body or coil 720 may be removed from the patient. A snare catheter may then be used to grasp the proximal neck 130 of the expanded detached balloon 10, and the balloon 10 may be deflated by retracting it into a guide catheter or sheath and removed from the patient.

In some embodiments, the combination of a detachable balloon 10 and a single first elongate body or coil 720 can be used to completely occlude a wide-necked bifurcation aneurysm having a width of 12 mm and a height of less than 10 mm. In one aspect, one or more first elongate bodies or coils 720 can be provided in a kit. The kit may include a first elongate body or coil 720 ranging from about 10 cm to 400 cm. For example, and without limitation, a single kit may include about 1 to 30 first elongate bodies or coils that are 10, 20, 30, 40, 50, 60, 70, 80, 90, 100, 110, 120, 130, 140, 150, 160, 170, 180, 190, 200, 210, 220, 230, 240, 250, 260, 270, 280, 290, 300, 310, 320, 330, 340, 350, 360, 370, 380, 390, or 400 cm in length.

When treating a patient using a detachable balloon and a single first elongate body or coil, the length of the first elongate body or coil used may be determined by the desired coil packing density of the aneurysm, the detachable balloon, or both. As used herein, packing density refers to the percentage of the cavity defined by the aneurysm, the detachable balloon, or both that is filled by the first elongate body or coil. In various embodiments, the packing density may be in the range of about 5% to 75% (e.g., 5%, 10%, 15%, 20%, 25%, 30%, 35%, 40%, 45%, 50%, 55%, 60%, 65%, 70%, or 75%) packing density).

In some embodiments, the second medical device 700 includes a first elongated or expandable body 720 configured for permanent implantation into a human patient joined to a second elongated body 721 configured to push or carry the first elongated or expandable body 720 into the lumen 163 of the second catheter 174 of the first medical device, including the detachable balloon catheter 1, and to pull or carry the first elongated or expandable body 720 out of the lumen 163 of the second catheter 174. The first elongated body 720 and the second elongated body 721 are configured to pass through the lumen 163 of the second catheter 174 and enter the human patient in an elongated form. In some embodiments, the second medical device 700 includes an expandable body 720 configured for permanent implantation into a human patient joined to a second elongated body 721 configured to push or carry the expandable body 720 into and pull or carry the expandable body 720 out of the lumen 163 of the second catheter 174. The expandable body 720 is configured to pass through the lumen 163 of the second catheter 174 and into the human patient in an elongated, constrained, compressed, or collapsed configuration.

In some embodiments, at least a portion of the first elongated or expandable body 720 is configured for implantation into the central void 115 or interior volume of the detachable balloon 10 of the first medical device 1. In all embodiments, the first elongated or expandable body 720 can be separated from the second elongated body 721, and the second elongated body 721 can be removed from the lumen 163 of the second catheter 174 while leaving the first or expandable elongated body 720 in place in the patient. In some embodiments, the second elongated body 720 can be a wire, a coiled wire, a catheter, or a laser cut tube comprising Nitinol. In some embodiments of the second medical device 700 in which the second elongated body is a catheter or laser cut tube comprising Nitinol, at least a portion of the first elongated body 720 is within the lumen of the catheter or laser cut tube comprising Nitinol of the second elongated body 721.

The elongate body may be made from wire, polymers, and other flexible materials, and combinations thereof. The elongate body is generally not formed from a self-expanding material, and generally the elongate body is not formed to be self-expanding. Examples of elongate bodies include coils, metal coils, coils comprising metal, polymer coils, coils comprising metal and polymer, coiled wire, coiled metal wire, coiled wire comprising metal, coiled wire comprising metal and polymer, strands, polymer strands, metal strands, strands comprising metal, strands comprising polymer and metal, vascular coils, assemblies of wires, assemblies of metal wires, assemblies of wires comprising metal, assemblies of polymer strands, assemblies of wires or strands comprising metal and polymer, assemblies of coiled wires, assemblies of coiled metal wires, assemblies of coiled wires comprising metal, assemblies of coiled polymer strands, assemblies of coiled structures comprising metal and wire, strands. assemblies of wires, assemblies of polymer strands, assemblies of metal strands, assemblies of strands containing metal, and assemblies of strands containing polymer and metal, assemblies of braided wires, assemblies of braided metal wires, assemblies of braided metal containing wires, assemblies of braided wires containing metal and polymer, assemblies of braided strands, assemblies of braided polymer strands, assemblies of braided strands containing polymer and metal, assemblies of woven wires, assemblies of woven metal wires, assemblies of woven metal containing wires, assemblies of woven wires containing metal and polymer, assemblies of woven strands, assemblies of woven polymer strands, and assemblies of woven polymer strands containing polymer and metal, and combinations thereof.

The expandable body may be made from wires, polymers, and other flexible materials, as well as combinations thereof. The expandable body is typically formed from a self-expanding material, or is typically formed such that the expandable body 10 is self-expanding. Examples of expandable bodies include self-expanding wires, nitinol wires, assemblies of wires, assemblies of metal wires, assemblies of wires including metal, assemblies of polymer strands, assemblies of wires or strands including metal and polymer, assemblies of coiled wires, assemblies of coiled metal wires, assemblies of coiled metal-containing wires, assemblies of coiled polymer strands, assemblies of coiled structures including metal and wires, assemblies of strands, assemblies of polymer strands, assemblies of metal strands, assemblies of strands including metal, and assemblies of strands including polymer and metal, assemblies of braided wires, assemblies of braided metal wires, assemblies of braided metal-containing wires, assemblies of braided wires including metal and polymer, assemblies of braided strands, assemblies of braided polymer strands, assemblies of braided strands including polymer and metal, assemblies of woven wires, assemblies of woven metal wires, assemblies of woven metal-containing wires, assemblies of woven wires including metal and polymer, assemblies of woven strands, assemblies of woven polymer strands, assemblies of woven polymer and metal strands, balloons, and combinations thereof.

In some embodiments, the expandable body's wires, strands, coils, coiled wires, wire assemblies, strand assemblies, coil assemblies, coiled wire assemblies, woven wire assemblies, woven strand assemblies, woven coil assemblies, coiled wire assemblies, wire braid assemblies, strand braid assemblies, coil braid assemblies, coiled wire braid assemblies, and combinations thereof are self-expanding. In some embodiments, the expandable body's wires, strands, coils, coiled wires, wire assemblies, coil assemblies, coiled wire assemblies, woven wire assemblies, woven coil assemblies, coiled wire woven assemblies, wire braid assemblies, coil braid assemblies, coiled wire braid assemblies, and combinations thereof comprise Nitinol.

In some embodiments, the first elongate or expandable body 10 of the second medical device 1 comprises a coiled wire, the primary diameter of the coiled wire is 0.00175-0.003 inches in diameter, and the secondary diameter of the coiled wire is 0.010-0.050 inches in diameter. In some embodiments, the first elongate or expandable body 10 has a tertiary structure that does not have a preformed loop or shape and is configured to form a straight or unformed tertiary shape when relaxed, or is configured as a straight vascular coil. In some embodiments, at least a portion of the first elongate or expandable body 10 has a spiral, spherical, or complex tertiary structure. In some embodiments, at least a portion of the first elongate or expandable body 10 is configured to form a coil, spiral, or complex tertiary shape when relaxed. In some embodiments, the coiled wire is a vascular coil. In some embodiments, the distal portion of the first elongate body or expandable body 10 comprises one loop of a tertiary structure and the remainder of the first elongate body or expandable body 10 comprises a tertiary structure that has no pre-formed loop or shape when relaxed; or the distal portion of the first elongate body or expandable body 10 comprises one loop of a tertiary structure and the remainder of the first elongate body or expandable body 10 comprises a tertiary structure that is configured to form a straight or unformed tertiary shape when relaxed. In some embodiments, the distal portion of the first elongate or expandable body 10 includes two loops of tertiary structure and the remainder of the first elongate or expandable body 10 includes a tertiary structure that has no preformed loops or shapes when relaxed, or the distal portion of the first elongate or expandable body 10 includes two loops of tertiary structure and the remainder of the first elongate or expandable body 10 includes a tertiary structure configured to form a linear or unformed tertiary shape when relaxed. In some embodiments, the distal portion of the first elongate or expandable body 10 includes three loops of tertiary structure and the remainder of the first elongate or expandable body 10 includes a tertiary structure that has no preformed loops or shapes when relaxed, or the distal portion of the first elongate or expandable body 10 includes three loops of tertiary structure and the remainder of the first elongate or expandable body 10 includes a tertiary structure configured to form a linear or unformed tertiary shape when relaxed. In some embodiments, the distal portion of the first elongate or expandable body 10 includes four or more tertiary loops when relaxed and the remainder of the first elongate or expandable body 10 includes a tertiary structure that has no preformed loops or shapes when relaxed, or the first elongate or expandable body 10 includes four tertiary loops and the remainder of the first elongate or expandable body 10 includes a tertiary structure configured to form a straight or unformed tertiary shape when relaxed. The tertiary diameter of the looped, coiled, shaped, or tertiary portion of the first elongate or expandable body 10 can be 2-100 mm. In some embodiments, the first elongate or expandable body 10 includes platinum, iridium, nickel, tungsten, or a combination thereof.

In some embodiments, the first elongate or expandable body 10 of the second medical device 1 is a wire having a primary diameter of 0.005-0.050 inches. In some embodiments, the first elongate or expandable body 10 is a wire with no secondary or tertiary diameter or shape. In some embodiments, the first elongate or expandable body 10 is a wire and has no preformed loops or shapes. In some embodiments, the first elongate or expandable body 10 is a wire and is configured to form a straight or unformed tertiary shape upon relaxation. In some embodiments, the first elongate or expandable body 10 is a straight vascular coil. In some embodiments, the first elongate or expandable body 10 is a wire and at least a portion of the first elongate or expandable body 10 has a spiral, spherical, or complex tertiary structure. In some embodiments, the first elongate or expandable body 10 is a wire, a portion of the first elongate or expandable body 10 has a spiral, spherical, or complex tertiary structure, and the remainder of the first elongate or expandable body 10 comprises a tertiary structure with no preformed loops or shapes when relaxed. In some embodiments, the first elongate or expandable body 10 is a wire, a distal portion of the first elongate or expandable body 10 comprises one loop of the tertiary structure, and the remainder of the first elongate or expandable body is configured to form a straight or unformed tertiary shape when relaxed, or a distal portion of the first elongate or expandable body comprises one loop of the tertiary structure, and the remainder of the first elongate or expandable body comprises a tertiary structure with no preformed loops or shapes when relaxed. In some embodiments, the first elongate or expandable body is a wire, a distal portion of the first elongate or expandable body includes two loops of a tertiary structure and the remainder of the first elongate or expandable body includes a tertiary structure with no preformed loops or shapes when relaxed, or the distal portion of the first elongate or expandable body includes two loops of a tertiary structure and the remainder of the first elongate or expandable body includes a tertiary structure configured to form a linear or unformed tertiary shape when relaxed. In some embodiments, the first elongate or expandable body is a wire, a distal portion of the first elongate or expandable body includes three loops of a tertiary structure and the remainder of the first elongate or expandable body includes a tertiary structure with no preformed loops when relaxed, or the distal portion of the first elongate or expandable body includes three loops of a tertiary structure and the remainder of the first elongate or expandable body includes a tertiary structure configured to form a linear or unformed tertiary shape when relaxed. In some embodiments, the first elongated or expandable body 10 is a wire and the distal portion of the first elongated or expandable body 10 comprises a tertiary structure configured to form a linear or unformed tertiary shape when relaxed, or the distal portion of the first elongated or expandable body 10 comprises one loop of the tertiary structure and the remainder of the first elongated or expandable body 10 comprises a preformed loop or shapeless tertiary structure when relaxed. In some embodiments, the first elongated or expandable body 10 is a wire and the distal portion of the first elongated or expandable body 10 comprises two loops of the tertiary structure and the remainder of the first elongated or expandable body 10 comprises a preformed loop or shapeless tertiary structure when relaxed, or the distal portion of the first elongated or expandable body 10 comprises two loops of the tertiary structure and the remainder of the first elongated or expandable body 10 comprises a tertiary structure configured to form a linear or unformed tertiary shape when relaxed. In some embodiments, the first elongate or expandable body 10 is a wire and a distal portion of the first elongate or expandable body 10 comprises three loops of a tertiary structure and the remainder of the first elongate or expandable body 10 comprises a tertiary structure that has preformed loops or no shape when relaxed, or the distal portion of the first elongate or expandable body 10 comprises three loops of a tertiary structure and the remainder of the first elongate or expandable body 10 comprises a tertiary structure that is configured to form a straight or unformed tertiary shape when relaxed. In some embodiments, the first elongate or expandable body 10 is a wire and a distal portion of the first elongate or expandable body 10 comprises four or more loops of a tertiary structure and the remainder of the first elongate or expandable body 10 comprises a tertiary structure that is configured to form a straight or unformed tertiary shape when relaxed, or the distal portion of the first elongate or expandable body 10 comprises four loops of a tertiary structure and the remainder of the first elongate or expandable body 10 comprises a tertiary structure that is configured to form a straight or unformed tertiary shape when relaxed. In some embodiments, the first elongate or expandable body 10 is a wire and the tertiary diameter of the looped, coiled, or formed portion of the first elongate or expandable body 10 is between 2-100 mm. In some embodiments, the first elongated or expandable body 10 is a wire comprising Nitinol, where the Nitinol wire is plated or coated with platinum or gold, or further comprises one or more radiopaque markers visible under fluoroscopy, where the radiopaque markers comprise platinum, iridium, gold, tungsten, or combinations thereof, or are a ring or band of radiopaque markers around a portion of the wire.

In some embodiments, the second medical device 1 includes a first elongate or expandable body 10 configured to be delivered by a catheter of the second medical device 700 through a lumen 163 of the second catheter 174 of the detachable balloon catheter 1. In some embodiments, the catheter of the second medical device 700 includes a radiopaque marker band 612 that is visible under fluoroscopy, including where the radiopaque marker includes platinum, iridium, gold, tungsten, or a combination thereof.

In some embodiments, the first elongated body 720 of the second medical device 700 comprises a wire assembly, a coiled wire assembly, a braided wire assembly, a woven wire assembly, or other expandable body 720. In some embodiments, the expandable body 720 of the second medical device 700 comprises a wire assembly, a coiled wire assembly, a braided wire assembly, a woven wire assembly, or other expandable body 720. In some embodiments, the first expandable body 720 of the second medical device 700 comprises a self-expanding wire assembly, a coiled wire assembly, a braided wire assembly, a woven wire assembly, or other expandable body 720. In some embodiments, the wire assembly, coiled wire assembly, braided wire assembly, or woven wire assembly expandable body 720 is configured to be formed into a generally cylindrical shape when not in a compressed, collapsed, constrained, or elongated configuration. In some embodiments, the expandable body 720 of the wire assembly, coiled wire assembly, braided wire assembly, or woven wire assembly is configured to form a generally cylindrical shape when not in a compressed, collapsed, constrained, or elongated configuration. In some embodiments, the expandable body 720 of the wire assembly, coiled wire assembly, braided wire assembly, or woven wire assembly is configured to form a general shape and size having a maximum diameter of 2-100 mm when not in a compressed, collapsed, constrained, or elongated configuration. In some embodiments, the expandable body 720 of the second medical device 700 comprises nitinol, nitinol wire, or nitinol wire plated or coated with platinum or gold. In some embodiments, the nitinol wire expandable body 720 further comprises one or more radiopaque markers that are visible under fluoroscopy, including when the radiopaque marker comprises platinum, iridium, gold, tungsten, or a combination thereof.

In some embodiments, the first elongated or expandable body 10 of the second medical device 1 comprises a polymer strand or a polymer strand plated or coated with platinum or platinum or gold. In some embodiments, the polymer strand portion of the first elongated or expandable body 10 of the second medical device 1 further comprises one or more radiopaque markers visible under fluoroscopy, including a radiopaque marker of platinum, iridium, gold, tungsten or combinations thereof, including a ring or band of radiopaque markers around a portion of the polymer strand.

In some embodiments, the first elongated or expandable body 10 is 10-400 cm long, 70-400 cm long, or 10-70 cm long. In some embodiments, the first elongated or expandable body 10 includes a lubricious or hydrophilic layer or coating, a Serene® coating sold by SurModics, or an Assist® coating sold by BioInteractions. In some embodiments, the first elongated or expandable body 10 includes an outer layer including a lubricious outer layer, a PTFE outer layer, a polyimide outer layer, or a composite of PTFE and polyimide. In some embodiments, the second elongated body of the second medical device 1 includes a lubricious or hydrophilic layer or coating, a Serene® coating sold by SurModics, or an Assist® coating sold by BioInteractions. In some embodiments, the second elongate body of the second medical device 1 includes an outer layer that includes a PTFE outer layer, a polyimide outer layer, or an outer layer that includes a composite of PTFE and polyimide. In some embodiments, the second elongate body of the second medical device 1 includes visual or tactile markings that allow a user to determine the length of the first elongate or expandable body 10 that has been pushed distally relative to the distal tip of the second catheter 174.

In some embodiments, the first elongated or expandable body 10 of the second medical device 1 and the second elongated body of the second medical device 1 are configured to separate by mechanical means. In some embodiments, the first elongated body 10 of the second medical device 1 and the second elongated body of the second medical device 1 are configured to separate by electrolysis or corrosion. In some embodiments, the first elongated or expandable body 10 of the second medical device 1 and the second elongated body of the second medical device 1 are configured to separate at a region between the first elongated or expandable body 10 and the second elongated body that is sensitive to electrolysis or corrosion, or at a region between the first elongated or expandable body 10 and the second elongated body that comprises stainless steel. In some embodiments, the second elongated body of the second medical device 1 is configured to allow the passage of an electric current from a proximal portion of the second elongated body to the region that is sensitive to electrolysis or corrosion. In some embodiments, at least a portion of the second elongate body of the second medical device 1 is configured to allow passage of direct current. In some embodiments, at least a portion of the second elongate body of the second medical device 1 is covered with a material that insulates it from electrical conduction. In some embodiments, at least a portion of the segment that is sensitive to electrolysis or corrosion or configured for dissolution by electrolysis is not covered with a material that insulates it from electrical conduction. In some embodiments, the first elongate or expandable body 10 of the second medical device 1 and the second elongate body of the second medical device 1 are configured to separate by electrothermal methods. In some embodiments, the separation occurs in a region between the first elongate or expandable body 10 and the second elongate body that can be melted by heating. In some embodiments, the second medical device 1 is configured to allow passage of electrical current from a proximal portion of the second elongate body to a resistive heating element on or near a region between the first elongate or expandable body 10 and the second elongate body that can be melted by heating. In some embodiments, at least a portion of the second elongate body of the second medical device 1 is covered with a material that insulates it from electrical conduction.
In some embodiments, the first elongated or expandable body 10 of the second medical device 1 and the second elongated body of the second medical device 1 are not joined, and the second elongated body of the second medical device 1 is configured to push the first elongated or expandable body 10 through the lumen of the second catheter 174 of the first medical device 1. In some embodiments, the second elongated body 721 of the second medical device 700 is configured to eject the first elongated or expandable body 720 of the second medical device 700 from the distal end of the lumen 163 of the second catheter 174 of the first medical device 1. In some embodiments, the second elongated body 721 of the second medical device 700 can be removed from the lumen 163 of the second catheter 174 of the first medical device 1 after ejecting the first elongated or expandable body 720 of the second medical device 700 from the distal end of the lumen 163 of the second catheter 174 of the first medical device 1.

In some examples, beads, balls, microspheres, bioabsorbable material, adhesive, glue, solidified polymer, solidified foam, or combinations thereof are threaded from the proximal end of the second catheter 174, through the lumen 163 of the second catheter 174, and into the central void 115 or interior volume of the detachable balloon 10 of the detachable balloon catheter 1 to help maintain the expanded size and shape of the detached balloon 10.

(Guidewire)
The lumen 163 of the second catheter 174 can be configured to accept a guidewire 40 having a diameter between 0.010 and 0.038 inches, including guidewires having a diameter of 0.010, 0.011, 0.012, 0.013, 0.014, 0.015, 0.016, 0.017, 0.018, 0.033, 0.034, 0.035, 0.036, 0.037 or 0.038 inches. The lumen 163 of the second catheter 174 can be configured to accept a guidewire 40 having a length between 50 and 500 cm, or between 200 and 400 cm.

Systems Including a First Medical Device and One or More Second Medical Devices
In some embodiments, the first elongated or expandable body 10 of the second medical device 1 comprises a wire assembly, a coiled wire assembly, a braided wire assembly, a woven wire assembly, or other expandable body 10. In some embodiments, the first elongated or expandable body 10 of the second medical device 1 comprises a self-expanding wire assembly, a coiled wire assembly, a braided wire assembly, a woven wire assembly, or other expandable body 10. In some embodiments, the wire assembly, coiled wire assembly, braided wire assembly, or woven wire assembly expandable body 10 is configured to form the general shape and size of the expanded detachable balloon of the first medical device 1 when not in a compressed, deflated, constrained, or elongated configuration.

In some embodiments, the second elongated body 721 of the second medical device 700 includes visual or tactile markings that allow a user to determine the length of the first elongated or expandable body 720 that has been pushed distally relative to the distal tip of the second catheter 174. In some embodiments, the hub 178 of the second catheter 174 of the detachable balloon catheter 1 is configured to allow the distal end of the first elongated or expandable body 720 to be inserted into the lumen 163 of the second catheter 174 of the detachable balloon catheter 1, and is also configured to be joined with the distal end of a carrier structure or carrier that receives, restrains or otherwise engages at least a portion of the first elongated or expandable body 720 and the second elongated body 721. This helps physicians use long or very long coils, up to 400 cm in length or more, by providing a longer, more rigid path to guide the coil or first elongated body 720 to the patient. In one example, the second catheter 174 of the detachable balloon catheter 1 is 130 cm long and the carrier structure is 300 cm long. If the hub 178 of the second catheter 174 of the detachable balloon catheter 1 is joined to the carrier, then a 400 cm first elongated or expandable body 720 can be used with a 430 cm long second elongated body 721. If the distal end of the second elongated body 721 is pushed into the proximal end of the second catheter 174 of the detachable balloon catheter 1, then the carrier and the second catheter 174 of the detachable balloon catheter 1 can be separated and the second catheter 721 can be removed from the carrier and used to push the remainder of the first elongated or expandable body 720 out of the second catheter 174 of the detachable balloon catheter 1. In some embodiments, the carrier is configured in a coil shape. In some embodiments, a portion of the first or expandable elongated body 720 of the second medical device 1 is configured to contact the inner surface of the expanded detachable balloon 10 of the first medical device 1. In some embodiments, the maximum overall or tertiary diameter of the first elongated or expandable body 720 of the second medical device 700 ranges from 5% smaller than the maximum diameter of the expanded detachable balloon 10 of the first medical device 1 to 20% larger than the maximum diameter of the expanded detachable balloon 10 of the first medical device 1. In some embodiments, the maximum overall or tertiary diameter of the first elongated or expandable body 720 of the second medical device 700 is 1, 2, 3, 4, 5, 6, 7, 8, 9, or 10 mm larger than the maximum diameter of the expanded detachable balloon 10 of the first medical device 1. In some embodiments, the volume of the one or more first elongated or expandable bodies of the second medical device 1 fills 5-75% of the volume of the central cavity 115 of the expanded detachable balloon 10.

Kits Including a First Medical Device and One or More Second Medical Devices
As disclosed herein, aspects and embodiments relate to kits incorporating first and second medical devices 1 & 700. Such kits include at least one first medical device 1 and one or more second medical devices 700 configured for use with the first medical device 1.

In one example, the kit may include one first medical device 1 configured for use with a 0.014 inch guidewire 40 having a detachable polymer balloon 12 with a diameter of 6 mm and a length of 10 mm, and a second medical device 700 in which the first elongated body 720 is a coiled wire or coil having a secondary diameter of 0.014 inch configured without a tertiary shape or structure and a length that provides a packing density of 25% when entirely disposed within the central void 115 of the expanded detachable balloon 10 of the first medical device 1.

Such a kit may further include additional medical devices. In one embodiment, the kit may include a first medical device 1, a second medical device 700, and a guidewire 40 configured for use with the first medical device 1, configured to pass through the lumen 163 of the second catheter 174 of the first medical device 1, and may have a length greater than the length of the second catheter 174 of the first medical device 1.

In some embodiments, the kit may include a first medical device 1, a second medical device 700, and a detachment controller 406 configured to i) cause separation of the first catheter 173 and the detachable balloon 10 of the first medical device 1, ii) separate the first elongate or expandable body 720 from the second elongate body 721, or iii) separate the first catheter 173 and the detachable balloon 10 of the first medical device 1 and also separate the first elongate or detachable body 720 from the second elongate body. In some embodiments, the kit may further include one or more cables 407 or connectors that make electrical connections between i) the first medical device 1 and the controller 406, ii) between the second medical device 700 and the controller 406, or iii) between the first medical device 1 and the controller 406 and between the second medical device 700 and the controller 406.

(Device usage example)
A series of steps are associated with the deployment of a detachable balloon within a saccular aneurysm. First, a guidewire may be positioned so that its distal tip is located within the lumen of the aneurysmal sac. A first medical device including a pleated and folded detachable balloon may then be advanced over the guidewire through the neck or mouth of the aneurysm. After the pleated and folded detachable balloon is placed within the lumen of the aneurysmal sac, radioactive or radiopaque contrast may be injected into the parent artery under fluoroscopy to assess the position of the pleated and folded detachable balloon. Once proper positioning of the detachable balloon within the lumen of the aneurysmal sac is achieved and confirmed, the detachable balloon is then inflated or expanded. A source of fluid medium, such as a syringe, an inflation device (e.g., Endoflator® by Karl Storz, not shown), or a pump is connected to the inflation port of the hub of the first catheter, and a fluid medium is injected into the central cavity of the detachable balloon, which results in the expansion of the detachable balloon until it fills at least a portion of the lumen of the aneurysm sac. After expansion, the first catheter is pulled back into the aneurysm lumen, drawing the expanded detachable balloon to the neck of the aneurysm. After the expanded balloon is positioned at the neck of the aneurysm, radioactive or radiopaque contrast may be injected into the parent artery under fluoroscopy to evaluate the position of the expanded balloon and confirm the neck occlusion of the aneurysm. A second catheter may then be advanced into the lumen of the aneurysm sac, the guidewire removed, and one or more first elongated bodies or coils may be delivered through the lumen of the second catheter (second lumen) into the lumen of the aneurysm sac. The first elongated body or coil exerts a continuous force on the detachable balloon that provides a tight seal between the expandable balloon and the aneurysm neck. After placement of the elongated body or coil in the lumen of the aneurysm sac, radioactive or radiopaque contrast may be injected into the parent artery under fluoroscopy to assess the location of the first elongated body or coil and to confirm aneurysm neck occlusion. The second catheter may then be pulled back into the central cavity of the detachable balloon, and one or more first elongated bodies or coils may be delivered through the lumen (second lumen) of the second catheter into the central cavity of the expanded detachable balloon. The first elongated body or coil exerts an outward force on the inner wall of the expanded detachable balloon to keep the expanded detachable balloon in an expanded state; maintains contact between the outer wall of the detachable balloon and the inner wall of the aneurysm; and prevents collapse, compression, or compaction of the detachable balloon due to external compressive forces, including external compressive forces from portions of the first elongated body or coil present in the lumen of the aneurysm sac. The first elongate body or coil disposed in the lumen of the aneurysm sac and the central void or interior volume of the detachable balloon may be separate or the same. In some embodiments, the same first elongate body or coil is disposed in both locations, with the distal portion of the first elongate body or coil first disposed in the lumen of the aneurysm sac, and then the second catheter is retracted to allow the proximal portion of the first elongate body or coil to be disposed in the central void of the detachable balloon. Finally, the first catheter is detached from the detachable balloon (together with the second catheter), leaving the detachable balloon and the elongate body or coil in the lumen of the aneurysm sac and in the central void of the detachable balloon to occlude the neck and the aneurysm sac.

A series of steps are associated with the deployment of a detachable balloon within an artery, vein, or biological conduit. First, a guidewire may be positioned such that its distal tip is located within the lumen of the artery, vein, or biological conduit. Next, a first medical device including a pleated and folded detachable balloon may be advanced over the guidewire into the segment of the artery, vein, or biological conduit selected for occlusion. After positioning the pleated and folded detachable balloon in the lumen of the selected segment of the artery, vein, or biological conduit, radioactive or radiopaque contrast may be injected into the artery, vein, or biological conduit under fluoroscopy to assess the position of the pleated and folded detachable balloon. Once proper positioning of the detachable balloon within the lumen of the artery, vein, or biological conduit is achieved and confirmed, the detachable balloon is inflated or expanded. A source of fluid media, such as a syringe, an inflation device (e.g., Endoflator® by Karl Storz, not shown), or a pump is connected to the inflation port of the hub of the first catheter and a fluid media is injected into the central cavity of the detachable balloon, resulting in expansion of the detachable balloon until it fills at least a portion of the lumen of the artery, vein, or biological conduit. After the expanded balloon is positioned in the lumen of the artery, vein, or biological conduit, a radiological or x-ray contrast agent is injected into the lumen of the artery, vein, or biological conduit under fluoroscopy to evaluate the location of the expanded balloon and confirm occlusion of the artery, vein, or biological conduit. The guidewire may be removed. Optionally, a solution containing a drug or therapeutic agent, a solution or suspension containing embolic particles, or a combination thereof is injected into the lumen of the target segment of the artery, vein, or biological conduit. The distal end of the first elongate body or coil may be delivered through the lumen of the second catheter (second lumen) into the lumen of the artery, vein or biological conduit adjacent and distal to the expanded detachable balloon. The second catheter may then be retracted into the central cavity of the expanded detachable balloon, and the remainder of the first elongate body or coil may be delivered through the lumen of the second catheter (second lumen) into the central cavity of the expanded detachable balloon. Optionally, an additional first elongate body or coil may be delivered through the lumen of the second catheter (second lumen) into the central cavity of the expanded detachable balloon. The first elongate body or coil exerts an outward force on the inner wall of the expanded detachable balloon to keep the expanded detachable balloon in an expanded state; maintains contact between the outer wall of the detachable balloon and the inner wall of the artery, vein or biological conduit; and prevents the detachable balloon from collapsing, compressing or consolidating due to external compressive forces, including external compressive forces from the portion of the first elongate body or coil present in the lumen of the artery, vein or biological conduit. The first elongate body or coil disposed within the lumen of the artery, vein or biological conduit and the central cavity or interior volume of the detachable balloon may be separate or the same. Finally, the first catheter (along with the second catheter) is removed from the detachable balloon, leaving a central void of the detachable balloon, elongate body or coil and detachable balloon within the lumen of the artery, vein or biological conduit to occlude the artery, vein or biological conduit.

After accessing the left atrium, a series of steps are associated with the deployment of a detachable balloon in the left atrial appendage (LAA). First, a guidewire may be positioned so that its distal end is located within the lumen of the LAA. Next, a first medical device including a pleated and folded detachable balloon may be advanced over the guidewire and through the neck or ostium of the LAA. After the pleated and folded detachable balloon is positioned in the lumen of the LAA sac, radiological or x-ray contrast may be injected into the parent artery under fluoroscopy to assess the position of the pleated and folded detachable balloon. Once proper positioning of the detachable balloon within the lumen of the LAA sac is achieved and confirmed, the third catheter is pulled back, resulting in expansion of the retention structure and engagement of the arms and hooks of the retention structure with the wall of the LAA. Gently pulling on the first catheter confirms sufficient wall engagement. The detachable balloon is inflated or expanded. A source of fluid medium, such as a syringe, an inflation device (e.g., Endoflator® by Karl Storz, not shown), or a pump is connected to an inflation port on the hub of the first catheter and fluid medium is injected into the central space, resulting in expansion of the detachable balloon until it fills at least a portion of the lumen of the LAA sac. After expansion of the detachable balloon, a radiographic or x-ray contrast agent is injected into the left atrium under fluoroscopy to evaluate the position of the expanded balloon and confirm LAA occlusion. The second catheter is pulled back into the central space of the expanded detachable balloon, and one or more first elongate bodies or coils can be delivered through the lumen (second lumen) of the second catheter into the central space of the expanded detachable balloon. The first elongate body or coil exerts an outward force on the inner wall of the expanded detachable balloon to keep the expanded detachable balloon in an expanded state; maintains contact between the outer wall of the detachable balloon and the inner wall of the LAA; and prevents the detachable balloon from collapsing, compressing or consolidating due to external compressive forces, including external compressive forces. Finally, the first catheter is detached from the detachable balloon and removed (along with the second and third catheters), leaving the detachable balloon, retention structure and elongate body or coil within the central void of the detachable balloon to occlude the neck and sac of the LAA.

After accessing the left atrium, a series of steps are associated with the deployment of a detachable balloon within the LAA. First, a guidewire may be positioned so that its distal end is located within the lumen of the LAA sac. Next, a first medical device including a pleated, folded detachable balloon may be advanced over the guidewire into the lumen of the LAA and positioned so that the proximal end of the pleated, folded detachable balloon is at the neck of the LAA. After positioning of the pleated, folded detachable balloon, radiological or x-ray contrast may be injected into the parent artery under fluoroscopy to assess the position of the pleated, folded detachable balloon. Once proper positioning of the detachable balloon within the lumen of the LAA is achieved and confirmed, the detachable balloon is inflated or expanded. A source of fluid media, such as a syringe, an inflation device (e.g., Endoflator® by Karl Storz, not shown), or a pump, is connected to an inflation port on the hub of the first catheter, and fluid media is injected into the central cavity of the detachable balloon, resulting in expansion of the detachable balloon until it occludes the neck of the LAA and fills at least a portion of the lumen of the LAA sac. After the expanded balloon is positioned at the neck of the LAA, radiological or x-ray contrast may be injected into the parent artery under fluoroscopy to evaluate the position of the expanded balloon and confirm occlusion of the neck of the LAA. A second catheter may then be advanced into the lumen of the LAA sac, the guidewire removed, and one or more first elongated bodies or coils may be fed through the lumen of the second catheter (second lumen) into the lumen of the LAA sac. The first elongated bodies or coils exert a continuous force on the detachable balloon that provides a tight seal between the expanded balloon and the neck of the LAA. After the elongate body or coil is positioned within the lumen of the LAA sac, radioactive or x-ray contrast may be injected into the parent artery under fluoroscopy to assess the location of the first elongate body or coil and to confirm occlusion of the neck of the LAA. The second catheter may then be pulled back into the central cavity of the detachable balloon, and one or more first elongate bodies or coils may be delivered through the lumen (second lumen) of the second catheter into the central cavity of the expanded detachable balloon. The first elongate body or coil exerts an outward force on the inner wall of the expanded detachable balloon to keep the expanded detachable balloon in an expanded state; maintains contact between the outer wall of the detachable balloon and the inner wall of the LAA; and prevents deflation, compression, or consolidation of the detachable balloon due to external compressive forces, including external compressive forces from portions of the first elongate body or coil present within the lumen of the LAA sac. The first elongate body or coil disposed in the lumen of the LAA sac and the central void or interior volume of the detachable balloon may be separate or the same. In some embodiments, the same first elongate body or coil is disposed in both locations, with the distal portion of the first elongate body or coil first disposed in the lumen of the LAA sac, and then the second catheter is pulled back so that the proximal portion of the first elongate body or coil can be disposed in the central void of the detachable balloon. Finally, the first catheter (along with the second catheter) is detached and removed from the detachable balloon, leaving the detachable balloon and the elongate body or coil in the lumen of the LAA sac and in the central void of the detachable balloon to occlude the neck and LAA sac.

Various drawings and images relating to various aspects of the use, deployment, assembly, and experimental testing of various embodiments of the devices, systems, and methods disclosed herein are shown in Figures 104-129. The figures relate to Examples 1-26, which are described in more detail below.

(Bench and in vivo examples)
Examples 1, 6 and 11 demonstrate the treatment of canine venous sac distal bifurcation aneurysms with metallic balloons and coils. Animal 15C035 was treated with study GNA1504W. The efficacy of treatment was evaluated by angiography and histology.

A surgical procedure was performed to create a carotid artery bifurcation in the right neck, and a single venous pouch terminal bifurcation aneurysm was created using a segment of the external jugular vein. After aneurysm creation, angiography was used to evaluate the size, shape, patency and blood flow of the parent vessel and aneurysm. The parent vessel diameter and aneurysm size (including neck diameter, aneurysm width, height and depth) were determined using QVA on the day of aneurysm creation.

A distal carotid bifurcation aneurysm in animal 15C035 was treated with an 8 mm x 6 mm metal balloon Ballstent Microcatheter (gold body, stainless steel and gold proximal neck, gold distal neck). After balloon expansion, four Barricade coils (Blockade Medical) were placed into the dome of the aneurysm behind the expanded balloon through the lumen of the second catheter of the Ballstent Microcatheter. The Barricade coils were removed by electrolysis using a standard Barricade removal box and handheld removal cable (Blockade Medical). After placement of the Barricade coil, the expanded balloon was removed from the first catheter by electrolysis using a modified Barricade removal box with a 3 minute duty cycle and a modified Barricade handheld removal cable adapted to connect to the proximal hub of the Ballstent Microcatheter. Immediately after treatment, the interventionalist estimated the aneurysm to be 95% occluded. A final angiogram of animal 15C035 was performed 28 days after treatment. Angiograms were used to visually assess aneurysm occlusion percentage, aneurysm size (including neck diameter and aneurysm width, height, and depth), parent vessel patency and diameter, and protrusion of the balloon or Barricade coil into the parent vessel. A QVA was performed to assess parent vessel diameter and aneurysm size. On the final day, animal 15C035 underwent a limited necropsy. Right neck aneurysm tissue and adjacent vessel segments were collected, including test articles. At the final follow-up, the interventional physician estimated that the aneurysm was 95-100% occluded.

The aneurysm site and reference vessel were excised and processed in paraffin. The remaining explants were processed and embedded in Spurr resin. The resulting blocks were then sectioned to include three consecutive aneurysm levels. Two slides were made at each level of each aneurysm and reference arterial segment and stained with hematoxylin and eosin (H&E) and elastin trichrome (ET). All slides obtained were evaluated for aneurysm occlusion, patency of the parent vessel, endothelialization of the implanted balloon and coils, tissue and inflammatory reactions around the implanted balloon and coils, and healing of the aneurysm sac. Histological analysis showed that the endothelialized neointima had progressed to complete coverage of the balloon. The neointima was generally fully mature and fibromuscular, with no residual fibrin. There was complete aneurysm neck occlusion (100% occlusion).

Examples 2, 5 and 12B demonstrate the treatment of canine venous sac sidewall aneurysms with metallic balloons and coils. Animal 15C036 was treated with study GNA1504W. The efficacy of treatment was evaluated by angiography and histology.

A surgical procedure was performed to create a carotid wide-necked sidewall aneurysm in the left carotid artery using a segment of the external jugular vein. After aneurysm creation, angiography was used to assess the size, shape, patency, and blood flow of the parent vessel and aneurysm. The parent vessel diameter and aneurysm size (including neck diameter and aneurysm width, height, and depth) were determined using QVA on the day of aneurysm creation.

A left carotid sidewall aneurysm in animal 15C036 was treated with a 6 mm × 4.5 mm metal balloon Ballstent Microcatheter (gold body, stainless steel and gold proximal neck, gold distal neck). After balloon expansion, the second catheter of the Ballstent Microcatheter was advanced into the aneurysm sac while the expanded balloon and first catheter remained fixed in place. Four Barricade coils (Blockade Medical) were placed into the dome of the aneurysm behind the expanded balloon through the lumen of the second catheter of the Ballstent Microcatheter. The Barricade coils were removed by electrolysis using a standard Barricade removal box and handheld removal cable (Blockade Medical). After placement of the Barricade coil, the expanded balloon was removed from the first catheter by electrolysis using a modified Barricade removal box with a 3 minute duty cycle and a modified Barricade handheld removal cable adapted to connect to the proximal hub of the Ballstent Microcatheter. Immediately after treatment, the interventionalist estimated that the aneurysm was 95% occluded.

Interim and final angiograms of animal 15C036 were performed on days 36 and 63, respectively. Angiograms were used to visually assess aneurysm occlusion rate (%), aneurysm size (including width, height, depth, and neck), parent vessel patency and diameter, and balloon or barricade coil protrusion into the parent vessel prior to termination. A QVA was performed to assess parent vessel diameter and aneurysm size. On the day of termination, animal 15C036 underwent limited necropsy. Left carotid aneurysm tissue and adjacent vessel segments were collected, including specimens. At final follow-up, the interventional physician estimated the aneurysm to be 100% occluded.

The aneurysm site and reference vessel were excised and processed in paraffin. The remaining explants were processed and embedded in Spurr resin. The resulting blocks were sectioned to include three consecutive aneurysm levels. Two slides were made at each level of each aneurysm and reference arterial segment and stained with H&E and ET. All resulting slides were evaluated for aneurysm occlusion, patency of the parent vessel, endothelialization of the implanted balloon and coils, tissue and inflammatory reactions around the implanted balloon and coils, and healing of the aneurysm sac. Histological analysis showed complete coverage of the balloon with endothelialized neointima. The neointima was fully mature and fibromuscular, with no residual fibrin. There was complete aneurysm neck occlusion (100% occlusion).

Example 3 demonstrates the treatment of a canine venous sac complex bifurcation aneurysm with a metallic balloon and coils. Animal 15C026 was treated with study GNA1502W. The efficacy of treatment was evaluated by angiography.

A surgical procedure was performed to create a carotid artery bifurcation in the right neck followed by the creation of a complex bifurcation aneurysm using a segment of the external jugular vein. After aneurysm creation, angiography was used to assess the size, shape, patency, and blood flow of the parent vessel and aneurysm. The parent vessel diameter and aneurysm size (including neck diameter and aneurysm width, height, and depth) were determined using quantitative vascular analysis (QVA) on the day of aneurysm creation.

A complex bifurcated carotid bifurcation aneurysm in animal 15C026 was treated with an 8 mm x 6 mm metal balloon Ballstent Microcatheter (gold body, stainless steel and gold proximal neck, gold distal neck). After balloon expansion, the second catheter of the Ballstent Microcatheter was advanced into the aneurysm sac while the expanded balloon and first catheter remained fixed in place. The 0.014 inch guidewire was removed from the second catheter and 17 Barricade coils (Blockade Medical) were placed through the lumen of the second catheter into the dome of the aneurysm behind the expanded balloon. The Barricade coils were removed by electrolysis using a standard Barricade removal box and handheld removal cable (Blockade Medical). After placement of the Barricade coil, the expanded balloon was removed from the first catheter by electrolysis using a modified Barricade removal box with a 3 minute duty cycle and a modified Barricade handheld removal cable adapted to connect to the proximal hub of the Ballstent Microcatheter. Immediately after treatment, the interventional physician estimated that the aneurysm was 75% occluded.

A final angiogram of animal 15C026 was performed on day 35. Angiograms were used to visually assess aneurysm occlusion rate (%), aneurysm size (including width, height, depth, and neck), parent vessel patency and diameter, and protrusion of the balloon or barricade into the parent vessel prior to termination. A QVA was performed to assess parent vessel diameter and aneurysm size. On the day of termination, animal 15C026 underwent a limited necropsy. Right neck aneurysm tissue and adjacent vessel segments were collected, including test articles. At final follow-up, the interventional physician estimated the aneurysm to be 100% occluded.

Example 4 demonstrates the treatment of canine venous sac complex bifurcation aneurysms with metallic balloons and coils. Animal 15C027 was treated with study GNA1502W. The efficacy of treatment was evaluated by angiography.

Surgical procedures were performed to create a carotid artery bifurcation in the right neck followed by the creation of a complex bifurcation aneurysm using a segment of the external jugular vein. After aneurysm creation, angiography was used to assess parent vessel and aneurysm size, shape, patency, and blood flow. Parent vessel diameter and aneurysm size (including neck diameter and aneurysm width, height, and depth) were determined using QVA on the day of aneurysm creation.

A complex bifurcated carotid bifurcation aneurysm in animal 15C027 was treated with an 8 mm × 6 mm metal balloon Ballstent Microcatheter (gold body, stainless steel and gold proximal neck, gold distal neck). After balloon expansion, the tip of a second catheter was advanced into the aneurysm sac while the expanded balloon and first catheter positions were held fixed, and 10 Barricade coils (Blockade Medical) were placed into the dome of the aneurysm behind the expanded balloon through the lumen of the second catheter of the Ballstent Microcatheter. The Barricade coils were removed by electrolysis using a standard Barricade removal box and handheld removal cable (Blockade Medical). After placement of the Barricade coil, the expanded balloon was removed from the first catheter by electrolysis using a modified Barricade removal box with a 3 minute duty cycle and a modified Barricade handheld removal cable adapted to connect to the proximal hub of the Ballstent Microcatheter.

Interim and final angiograms of animal 15C027 were performed on day 35. Angiograms were used to assess % aneurysm occlusion, aneurysm size (including width, height, depth, and neck), parent vessel patency and diameter, and protrusion of the balloon, Metaactive Accessory coil, or Barricade coil into the parent vessel prior to termination. A QVA was performed to assess parent vessel diameter and aneurysm size. On the day of termination, animal 15C027 underwent a limited necropsy. Right neck aneurysm tissue and adjacent vessel segments were collected, including test articles. At final follow-up, the interventional physician estimated the aneurysm to be 100% occluded.

Example 7 demonstrates the treatment of a canine venous sac sidewall aneurysm with a polymer balloon and coils. Animal 17C013 was treated with study GNA1802N. The efficacy of treatment was evaluated by angiography.

A surgical procedure was performed to create a carotid wide-necked sidewall aneurysm in the left carotid artery using a segment of the external jugular vein. After aneurysm creation, angiography was used to assess the size, shape, patency, and blood flow of the parent vessel and aneurysm. The parent vessel diameter and aneurysm size (including neck diameter and aneurysm width, height, and depth) were determined using QVA on the day of aneurysm creation.

The left carotid sidewall aneurysm in 17C013 was treated with a 6 mm x 4.5 mm polymer balloon Ballstent Microcatheter. After balloon expansion, the tip of the second catheter was advanced into the aneurysm sac. The distal portion of one blockade barricade coil (a 50 cm long straight coil with one 4 mm preformed loop at its distal end) was placed through the lumen of the second catheter of the Ballstent Microcatheter into the aneurysm sac behind the expanded balloon. The tip of the second catheter was then pulled back into the central cavity of the expanded balloon and the remainder of the coil was placed into the central cavity of the expanded balloon.

Example 8 demonstrates the treatment of a canine venous sac distal bifurcation aneurysm with a metal balloon and coils. The patent aneurysm neck remaining after the initial treatment was treated with additional coils. Animal 15C033 was treated with study GNA1504W. The efficacy of treatment was evaluated by angiography.

A surgical procedure was performed to create a carotid artery bifurcation in the right neck followed by the creation of a single venous sac terminal bifurcation aneurysm using a segment of the external jugular vein. After aneurysm creation, angiography was used to assess the size, shape, patency and blood flow of the parent vessel and aneurysm. The parent vessel diameter and aneurysm size (including neck diameter and aneurysm width, height and depth) were determined using QVA on the day of aneurysm creation.

A distal carotid bifurcation aneurysm in animal 15C033 was treated with an 8 mm x 6 mm metal balloon Ballstent Microcatheter (gold body, stainless steel and gold proximal neck, gold distal neck). After balloon expansion, one Metaactive Medical Nitinol coil and three Barricade Coils (Blockade Medical) were placed into the dome of the aneurysm behind the expanded balloon through the lumen of the second catheter of the Ballstent Microcatheter. The Metaactive Nitinol coil was pushed out of an Accessory Coil Delivery Catheter that was advanced into the aneurysm sac using a pusher wire. The Barricade coils were removed by electrolysis using a standard Barricade removal box and handheld removal cable (Blockade Medical). After placement of the Metaactive and Barricade coils, the expanded balloon was removed from the first catheter by electrolysis using a modified Barricade removal box with a 3 minute duty cycle and a modified Barricade handheld removal cable adapted to connect to the proximal hub of the Ballstent Microcatheter. After removal of the expanded balloon, the first and second catheter assembly was removed from the animal, and the second catheter was removed from the first catheter, reinserted into the animal and advanced over a 0.014 inch guidewire into the neck segment of the aneurysm adjacent to the expanded balloon. A fourth Barricade coil was placed in the residual aneurysm neck and removed as described above. Immediately after treatment, the interventionalist estimated the aneurysm to be 95% occluded.

A terminal angiogram of animal 15C033 was performed on day 29. Angiograms were used to visually assess aneurysm occlusion rate (%), aneurysm size (including neck diameter and aneurysm width, height, and depth), parent vessel patency and diameter, and balloon or barricade coil protrusion into the parent vessel. A QVA was performed to assess parent vessel diameter and aneurysm size. On the final day, animal 15C033 underwent a limited necropsy. Right neck aneurysm tissue and adjacent vessel segments were collected, including test articles. At final follow-up, the interventional physician estimated the aneurysm to be 95-100% occluded.

Example 9 demonstrates the treatment of a canine venous sac distal bifurcation aneurysm using a metal balloon alone. Animal 15C005 was treated with study GNA1502W. The efficacy of treatment was evaluated by angiography.

A surgical procedure was performed to create a carotid artery bifurcation in the right neck, followed by the creation of a single venous sac terminal bifurcation aneurysm using a segment of the external jugular vein. After aneurysm creation, angiography was used to assess the size, shape, patency, and blood flow of the parent vessel and aneurysm. The parent vessel diameter and aneurysm size (including neck diameter and aneurysm width, height, and depth) were determined using QVA on the day of aneurysm creation.

A terminal carotid bifurcation aneurysm in animal 15C005 was treated with an 8 mm x 6 mm metal balloon Ballstent Microcatheter (gold body, stainless steel and gold proximal neck, gold distal neck). The expanded balloon was removed from the first catheter by electrolysis using a modified Barricade removal box (Blockade Medical) with a 3 minute duty cycle and a modified Barricade handheld detachment cable adapted to connect to the proximal hub of the Ballstent Microcatheter. No coils were placed into the aneurysm sac or the expanded balloon. Immediately after treatment, the interventionalist estimated the aneurysm to be 90% occluded.

A terminal angiogram of animal 15C005 was performed on day 27. Angiograms were used to visually assess aneurysm occlusion rate (%), aneurysm size (including neck diameter and aneurysm width, height, and depth), parent vessel patency and diameter, and balloon protrusion into the parent vessel. A QVA was performed to assess parent vessel diameter and aneurysm size. On the final day, animal 15C005 underwent a limited necropsy. Right neck aneurysm tissue and adjacent vessel segments were collected, including test articles. At final follow-up, the interventional physician estimated the aneurysm to be 95% occluded.

Examples 10 and 11 demonstrate the treatment of a canine venous sac distal bifurcation aneurysm with coils alone. Animal 13C009 was treated with study GNA1307W. The efficacy of treatment was evaluated by angiography and histology.

For animal 13C009, a surgical procedure was performed to create a carotid artery bifurcation in the right neck, followed by the creation of a single venous sac terminal bifurcation aneurysm using a segment of the external jugular vein. After aneurysm creation, angiography was used to assess parent vessel and aneurysm size, shape, patency, and blood flow. Parent vessel diameter and aneurysm size (including neck diameter and aneurysm width, height, and depth) were determined using QVA on the day of aneurysm creation.

The distal carotid bifurcation aneurysm of animal 13C009 was treated with 17 Axium coils (Medtronic) and delivered to the aneurysm sac using a 2.4F Rebar-18 microcatheter (ev3) and Instant Detacher (ev3). The calculated volume of delivered coils was 225 ^mm3 compared to an estimated aneurysm volume of 351 ^mm3 , resulting in coil packing of 64% of the estimated aneurysm volume. The interventionalist noted minimal blood flow into the coil complex at the aneurysm neck after treatment, but was unable to deliver additional coils. Immediately after treatment, the interventionalist estimated the aneurysm to be 85-99% occluded.

A final angiogram was performed on animal 13C009 on day 25. Angiograms were used to visually assess aneurysm occlusion rate, aneurysm size (including neck diameter and aneurysm width, height, and depth), parent vessel patency and diameter, and balloon protrusion into the parent vessel. A QVA was performed to assess parent vessel diameter and aneurysm size. On the final day, animal 15C005 underwent limited necropsy. Right neck aneurysm tissue including the Axium coil and adjacent vessel segment were collected. At final follow-up, the interventionalist estimated the aneurysm to be 85-99% occluded.

The aneurysm site and reference vessel were excised and processed in paraffin. The remaining explants were processed and embedded in Spurr resin. The resulting blocks were sectioned to include three consecutive aneurysm levels. Two slides were made at each level of each aneurysm and reference arterial segment and stained with H&E and ET. All obtained slides were evaluated for aneurysm occlusion, patency of the parent vessel, endothelialization of the implanted balloon and coil, tissue and inflammatory reactions around the implanted balloon and coil, and healing of the aneurysm sac. Histological analysis showed incomplete coverage of the coils by endothelialized neointima due to significant recanalization of the neck. The neck occlusion rate was low (50% at two of the three section levels) due to the presence of a dense network of wide recanalization channels to the aneurysm body and extending to its center in the sac. There was significant vascularization in the sac between the coils. The upper half of the aneurysm showed a dense network of wide vascular channels.

For treatment of animals 15C035, see Example 1.

Example 12A demonstrates the treatment of a canine venous sac distal bifurcation aneurysm with a metallic balloon and coils. Animal 15C008 was treated with study GNA1502W. The efficacy of treatment was evaluated by histological examination.

A surgical procedure was performed to create a carotid artery bifurcation in the right neck, followed by the creation of a single venous pouch terminal bifurcation aneurysm using a segment of the external jugular vein. After aneurysm creation, angiography was used to assess the size, shape, patency, and blood flow of the parent vessel and aneurysm. The parent vessel diameter and aneurysm size (including neck diameter and aneurysm width, height, and depth) were determined using QVA on the day of aneurysm creation.

Animal 15C008 had a distal carotid bifurcation aneurysm treated with an 8 mm x 6 mm metal balloon Ballstent Microcatheter (gold body, stainless steel and gold proximal neck and gold distal neck). After balloon expansion, 12 Barricade coils (Blockade Medical) were placed through the lumen of the second catheter of the Ballstent Microcatheter into the dome of the aneurysm behind the expanded balloon.
The Barricade coil was removed by electrolysis using a standard Barricade removal box and handheld detachment cable (Blockade Medical, Inc.) After placement of the Barricade coil, the expanded balloon was removed from the first catheter by electrolysis using a modified Barricade removal box with a 3 minute duty cycle and a modified Barricade handheld detachment cable adapted to connect to the proximal hub of the Ballstent Microcatheter.

A terminal angiogram of animal 15C035 was performed on day 85. On the final day, animal 15C008 underwent a limited necropsy. Right neck aneurysm tissue and adjacent vessel segments were collected, including the test article. The aneurysm site and reference vessel were excised and processed in paraffin. The remaining explants were processed and embedded in Spurr resin. The resulting blocks were sectioned to include three consecutive aneurysm levels. Two slides were made at each level of each aneurysm and reference arterial segment and stained with H&E and ET. All resulting slides were evaluated for aneurysm occlusion, patency of the parent vessel, endothelialization of the implanted balloon and coils, tissue and inflammatory reactions around the implanted balloon and coils, and healing of the aneurysm sac. Histological analysis showed complete coverage of the balloon with endothelialized neointima. The neointima was completely mature and fibromuscular, with no residual fibrin. There was complete aneurysm neck occlusion (100% occlusion).

Examples 13 and 14 demonstrate the treatment of a segment of the canine internal mammary artery with a metal balloon, an Amplatzer Vascular Plug IV, or a Cook Nester coil. Animals 15C001, 15C004, 17C006, and 17C008 were treated with studies GNA1501W and GNA1701W. The efficacy of treatment was evaluated by angiography.

On the day of treatment (day 0), all animals underwent an interventional procedure in which bilateral occlusion of the internal mammary arteries was attempted with test and control articles. Animals were prepared for surgery per protocol. Contrast angiograms were performed on day 0 pre-treatment, during treatment (when possible), and after treatment. QVA was performed prior to placement of test and control articles to ensure that the target vessel segment was selected such that the diameter of the test and control articles was 25-50% larger than the diameter of the target vessel.

A single 4 mm metal balloon Blockstent Microcatheter (gold body and neck), a single 4 mm Amplatzer Vascular Plug IV, or two 3 mm Cook Nester coils were implanted in the internal mammary artery of dogs. Treated vessel segments were monitored with serial angiography, as appropriate, until complete occlusion of the target vessel segment was observed or 60 minutes had elapsed. In study GNA1501W, 100% immediate occlusion was observed in 2 of 4 Blockstent (4 mm) treatments and 0 of 4 Cook Nester coil treatments. In study GNA1701W, 100% immediate occlusion was observed in 4 of 4 Blockstent (4 mm) treatments and 4 of 4 Amplatzer Vascular Plug IV treatments. Mean balloon inflation pressure was 3 atm. The average time to complete occlusion was more than 30 minutes with Amplatzer Vascular Plug IV therapy.

At the final follow-up of 27 days, all animals were evaluated using contrast angiography to determine the degree of occlusion of vessels treated with test and/or control. On the final day, animals underwent limited necropsy. Treated tissue and adjacent vessel segments were collected, including the test article. In Study GNA1501W, 100% chronic occlusion was observed in 4 of 4 Blockstent (4mm) treatments and 0 of 4 Cook-Nester coil treatments. In Study GNA1701W, 100% chronic occlusion was observed in 3 of 4 Blockstent (4mm) treatments and 0 of 4 Amplatzer Vascular Plug IV treatments.

Example 15 demonstrates the treatment of a bleeding canine carotid artery with a metallic balloon. Animal 17C002 was treated with study GNA1701W. The effect of treatment was evaluated by angiography.

The right carotid artery was exposed and an arteriotomy was performed with a 4Fr introducer sheath to induce controlled bleeding, followed by treatment with a 6mm metal balloon Blockstent Microcatheter (gold body and neck). The time to complete hemostasis was assessed using serial angiograms to detect extravasation and direct visualization to detect vascular bleeding. Bleeding completely stopped immediately after balloon placement.

Example 16 demonstrates the treatment of a bleeding canine carotid artery with the Amplatzer Vascular Plug II. Animal 17C001 was treated with study GNA1701W. The efficacy of treatment was evaluated by angiography.

The right carotid artery was exposed and an arteriotomy was created with a 4Fr introducer sheath to induce controlled bleeding, which was then treated with a 6mm Amplatzer Vascular Plug II. The time to complete hemostasis was assessed using serial angiograms to detect extravasation and direct visualization to detect vascular bleeding. After treatment with the Amplatzer Vascular Plug II, there was persistent bleeding.

Example 17 demonstrates advancement of a metal balloon over a guidewire into the superior mesenteric artery of a dog. Animal 17C005 was treated with study GNA1701W. The entire body was evaluated by angiography.

A 0.014 inch guidewire was placed into the superior mesenteric artery and a pleated, folded 4 mm metal balloon Blockstent Microcatheter (gold body and neck) was easily advanced over the guidewire into the superior mesenteric artery.

Example 18 demonstrates the treatment of the canine axillary artery with a metallic balloon. Animal 17C003 was treated with study GNA1701W. The effect of treatment was evaluated by angiography.

On the day of treatment (day 0), animal 17C003 underwent an interventional procedure in which bilateral occlusion of the axillary artery was attempted with the test and control articles. Contrast angiograms were performed on day 0 pre-treatment, during treatment (when possible), and after treatment. QVA was performed prior to placement of the test and control articles to ensure that the target vessel segment was selected such that the diameter of the test and control articles was 25-50% larger than the diameter of the target vessel.

A single 6 mm metal balloon Blockstent Microcatheter (gold body and neck) or a single Amplatzer Vascular Plug II was implanted into the axillary artery of dogs. Treated vessel segments were monitored with serial angiograms, as needed, until complete occlusion of the target vessel segment was observed or 60 minutes had elapsed. In Study GNA1701W, 100% immediate occlusion was observed with 4 of 4 Blockstent (6 mm) treatments and 4 of Amplatzer Vascular Plug II treatments. Mean balloon inflation pressure was less than 4 atmospheres. Mean time to complete occlusion was greater than 30 minutes with Amplatzer Vascular Plug II treatments.

At the final follow-up time point of 28 days, animals were evaluated using contrast angiography to determine the degree of occlusion of the treated vessels. On the final day, animals underwent limited necropsy. Treated tissues and adjacent vessel segments were collected, including test and control articles. In Study GNA1701W, 100% chronic occlusion was observed in 4 of 4 Blockstent (6 mm) treatments and 0 of 4 Amplatzer Vascular Plug II treatments.

Example 19 demonstrates the placement of a coil within an expanded metal balloon in the canine carotid artery. Animal 17C008 was treated with study GNA1701W. The effect of treatment was evaluated by angiography.

A single 6 mm metal balloon Blockstent Microcatheter (gold body and neck) was implanted in the right carotid artery of a dog. The treated vessel segment was monitored by serial angiography. After complete occlusion of the carotid artery was confirmed, the guidewire was removed and the second catheter of the Blockstent Microcatheter was pulled back until its tip was inside the expanded balloon, and the second catheter was detached from the elastomeric valve present in the distal nose cone that was joined to the distal neck of the balloon. A 6 mm coil was placed into the expanded balloon through the lumen of the second catheter. The coil was removed by electrolysis using a standard Barricade removal box and handheld removal cable (Blockade Medical).

Example 20 demonstrates the treatment of the canine internal mammary artery with a metallic balloon. Animal 17C006 was treated with study GNA1701W. The effect of treatment was evaluated by angiography.

On the day of treatment (day 0), animals underwent an interventional procedure to occlude the internal mammary arteries bilaterally. Animals were prepared for surgery per protocol. Contrast angiograms were performed on day 0 pre-treatment, during treatment (when possible), and after treatment. QVA was performed before placement of test and control articles to ensure that target vessel segments were selected such that the diameters of the test and control articles were 25-50% larger than the diameter of the target vessel.

A single 4 mm metal balloon Blockstent Microcatheter (gold body and neck) or a single 4 mm Amplatzer vascular plug IV was implanted into the internal mammary artery of dogs. Treated vessel segments were monitored with serial angiograms as needed. See Examples 13 and 14 for acute results of this study.

At the final follow-up time point of 28 days, animals were evaluated using contrast angiography to determine the degree of occlusion of the treated vessels. On the final day, animals underwent limited necropsy. Treated tissues and adjacent vessel segments were collected, including test and control articles. See Examples 13 and 14 for chronic outcomes of this study.

Example 21 demonstrates the treatment of a segment of the canine internal mammary artery with a metal balloon, an Amplatzer Vascular Plug IV, or a Cook Nester coil. Animals 15C004, 17C005, and 17C006 were treated with studies GNA1501W and GNA1701W. The efficacy of treatment was evaluated by histopathology.

On the day of treatment (day 0), all animals underwent interventional procedures and attempted bilateral occlusion of the internal mammary artery with test and control articles. Animals were prepared for surgery per protocol. Contrast angiograms were performed on day 0 pre-treatment, during treatment (when possible), and after treatment. QVA was performed prior to placement of test and control articles to ensure that the target vessel segment was selected such that the diameter of the test and control articles was 25-50% larger than the diameter of the target vessel.

A single 4 mm Blockstent Microcatheter (gold body and neck), a single 4 mm Amplatzer Vascular Plug IV, or two 3 mm Cook Nester coils were implanted in the internal mammary artery of dogs. See Examples 13 and 14 for acute angiographic results of this study.

At final follow-up on days 27-28, all animals were evaluated using contrast angiography to determine the degree of occlusion of test and control treated vessels. On the final day, animals underwent limited necropsy. Treated tissues and adjacent vessel segments were collected, including test and control articles. See Examples 13 and 14 for chronic angiographic results of this study.

All vessels were dissected, processed and embedded. Device areas were embedded in epoxy resin (Spurr) and reference levels were embedded in paraffin. Resulting blocks were sectioned and stained with H&E and ET for recognition of local tissue reactions, evidence of infection, and/or immunological responses caused by the experimental procedure or device. Three implantation levels (proximal, mid and distal) and two reference levels (proximal reference and distal reference) were collected from each vessel. Histology demonstrated vessel occlusion with the metal Blockstent balloon in 98% (n=4), with the Amplatzer Vascular Plug IV in 55% (n=4) and with the Cook Nester coil in 81% (n=4).

Examples 22, 23 and 24 demonstrate the treatment of the canine axillary artery with a metalized polymer balloon. Animal 17C014 was treated with study GNA1703N. The effect of treatment was evaluated by angiography.

On the day of treatment (day 0), all animals underwent an interventional procedure, attempting bilateral occlusion of the internal mammary arteries with the test article. Animals were prepared for surgery per protocol. Contrast angiograms were performed on day 0 pre-treatment, during treatment (when possible), and after treatment. QVA was performed prior to test article placement to ensure that the target vessel segment was selected such that the test article diameter was 25-50% larger than the target vessel diameter.

For animal 17C014, a single 4 mm polymer and metal Blockstent Microcatheter (gold wire applied to the outer surface of the mid-region of the PET balloon) was implanted in the internal mammary artery. After balloon expansion, the third catheter of the Blockstent Microcatheter was advanced forward until its distal tip abutted the proximal end of the elastomeric tubular segment attached to the proximal neck of the balloon, while the first and second catheters remained fixed, and the expanded balloon and the first and third catheters of the Blockstent Microcatheter remained fixed in place, and the second catheter was separated from the elastomeric valve in the distal nosecone attached to the distal neck of the balloon. The 0.014 inch guidewire was removed from the second catheter and two 6 mm Barricade coils (Blockade Medical) were advanced through the lumen of the second catheter and placed in the central cavity of the balloon. The Barricade coils were removed by electrolysis using a standard Barricade removal box and handheld removal cable (Blockade Medical). The first and second catheter assembly was pulled back while the third catheter remained fixed in place, resulting in the removal of the expanded coiled balloon from the first catheter. Immediately after removal for animal 17C014, the treated vessel segment was 100% occluded.

At the final follow-up time point of 30 days, animals were evaluated using contrast angiography to determine the degree of occlusion of the treated vessels. On the final day, animal 17C014 underwent a limited necropsy. Treated tissue and adjacent vessel segments were harvested, including test article. There was 100% chronic occlusion of the treated vessel segments in animal 17C014.

Example 25 demonstrates treatment of the canine brachial artery with a polymer balloon. Animal 17C013 was treated with study GNA1802N. The effect of treatment was evaluated by angiography.

On the day of treatment (day 0), animal 17C013 underwent an interventional procedure to occlude the brachial arteries bilaterally. The animal was prepared for surgery per protocol. Contrast angiograms were performed pre-treatment on day 0, during treatment (when possible), and after treatment. QVA was performed prior to test article placement to ensure that the target vessel segment was selected such that the test article diameter was 25-50% larger than the target vessel diameter.

For animal 17C013, a single 6 mm polymeric Blockstent Microcatheter (metal-free PET balloon) was implanted in the left brachial artery. The pleated and folded balloon was placed over a 0.014 inch guidewire in the axillary artery and inflated to less than 2 atmospheres of pressure. The Blockstent did not have a tip nose cone or elastomeric valve. A Barricade coil (Blockade Medical) with two 4 mm loops at its distal end was advanced through the lumen of the second catheter. The distal 4 mm loop was placed in the artery distal to the inflated balloon. The tip of the second catheter was pulled back into the central cavity of the inflated balloon while the inflated balloon and first catheter were held in place. The proximal 4 mm loop of the coil and the remainder of the coil (straight portion) were placed inside the central cavity of the balloon. Immediately after insertion of the coil, there was 100% occlusion of the treated vessel segment.

Example 26 demonstrates the use of a mechanical latch to attach a polymer balloon to a first catheter and the use of a mechanical latch to detach a polymer balloon from a first catheter.

A benchtop test was performed using a detachable balloon catheter incorporating a mechanical latching attachment system. Starting with both the guidewire and second catheter extended beyond the distal nosecone, saline was injected into the proximal hub and the balloon extended through the annular lumen between the first and second catheters, as shown in Frame A. In this configuration, the balloon resisted removal from the first catheter under tensile load, as shown in Frame B. The second catheter was then pulled back past the proximal neck of the balloon, unlatching the male tubular structure of the first catheter from the female tubular structure mounted within the proximal neck of the balloon, as shown in Frame C. The first catheter was then pulled back, removing the first catheter from the balloon, as shown in Frame D. Finally, the guidewire was retracted from the detached balloon, as shown in Frame E.

It will be understood that the devices and methods of the present disclosure can be incorporated into many embodiments, only a few of which have been illustrated and described above. The disclosure herein may be embodied in other specific forms without departing from its spirit or essential characteristics. The described embodiments are to be considered only as illustrative and not limiting, and the scope of the disclosure is thus indicated by the appended claims rather than the foregoing description. All changes that come within the meaning and range of equivalency of the claims are intended to be embraced within their scope.

Examples of Treatment of Human Patients
Example 27: Treatment of Basilar Artery Aneurysm Using a Detachable Flexible Metal-Coated Polymer Balloon Catheter and Single Elongated Body
A detachable balloon catheter (or first medical device) is provided that includes a pleated, folded, detachable, flexible, metal-coated polymer balloon and a catheter assembly that includes a first catheter and a second catheter.

The detachable balloon has a proximal neck and a distal neck. A female tubular structure is bonded to the proximal neck of the detachable, flexible, metal-coated polymer balloon. The distal portion of the female tubular structure protrudes into the central cavity of the balloon. A telescoping catheter segment having proximal and distal marker bands is bonded to the distal neck of the detachable balloon. The proximal portion of the telescoping catheter segment protrudes into the central cavity of the detachable balloon. Excluding the length of the proximal and distal necks, the detachable balloon has a diameter of 8 mm (measured in a plane parallel to the second axis) and a length of 5.3 mm (measured in a plane parallel to the first axis). The proximal and distal regions 110 and 120 of the detachable balloon are rounded. The wall of the detachable balloon includes a single-wall 10 μm thick inner layer of PET made by blow molding and a single-wall 1000 Å thick outer layer of gold made by sputter deposition on the outer surface of the PET base layer.

The first catheter includes a proximal end having a hub including a port for injection of fluid and a distal end generally opposite the proximal end, the distal end of the first catheter being joined to the proximal end of a male tubular structure having three arms and a tab. The distal end of the male tubular structure is operably coupled to a female tubular structure that is joined to the proximal neck of the detachable balloon. The distal end of the first catheter further includes a fluoroscopic marker band. The hub of the first catheter also includes a rotating, valved lock configured to secure the hub of the first catheter to the shaft of the second catheter. The second catheter includes a proximal end having a hub including a port for receiving a 0.014 inch guidewire and an open distal end. The second catheter further includes two fluoroscopic marker bands that facilitate placement and removal of the first elongated body. The second catheter is longer than the first catheter. The proximal portion of the second catheter passes through the hub of the first catheter and is secured to the hub of the first catheter by a rotating valve lock. The central portion of the second catheter passes through the lumen of the first catheter. The distal portion of the second catheter passes through the proximal neck opening, central void, distal neck opening, and telescopic catheter segment of the pleated and folded detachable balloon and extends distally to the distal end of the telescopic catheter segment of the detachable balloon. The inner surface of the first catheter and the outer surface of the second catheter define a first lumen that allows passage of a fluid medium from the proximal end of the first catheter to the distal end of the first catheter and into the central void of the detachable balloon. The lumen of the second catheter defines a second lumen.

The physician advances a needle into the right femoral artery of a patient with a saccular terminal aneurysm of the basilar artery and advances a 0.035 inch guidewire retrograde into the artery. The needle is removed and a 6 Fr introducer sheath is placed into the right femoral artery. A 6 Fr guide catheter with a Tuohy-Borst adaptor is inserted into the introducer sheath and advanced over the guidewire to the origin of the right vertebral artery. A standard digital subtraction angiogram is performed to confirm the dimensions of the aneurysm. The diameter of the aneurysm neck is measured to be 6 mm, the aneurysm width and depth to be 9 mm, and the aneurysm height to be 12 mm. The 0.035 inch guidewire is removed and a 300 cm 0.014 inch guidewire is inserted and advanced until its tip enters the aneurysm sac. The physician removes residual air from the detachable balloon catheter and advances it over the guidewire until the pleated and folded detachable balloon is centered in the aneurysm sac. An inflation device filled with a mixture of 50% saline and 50% radiopaque contrast (by volume) is attached to the inflation port of the first catheter and the inflation device is used to inject the saline and contrast mixture through the first catheter lumen and into the central cavity of the balloon at a pressure of 2 atmospheres, resulting in full expansion of the balloon. The physician then pulls back on the expanded detachable balloon by pulling on the assembly of the first and second catheters until the proximal surface of the expanded detachable balloon contacts the neck of the aneurysm. Occlusion of the neck of the aneurysm by the expanded detachable balloon is confirmed by injection of radiopaque contrast through the 6Fr guide catheter using the Tuohy-Borst side arm. The physician opens the valved rotation lock on the hub of the first catheter to allow movement of the second catheter and advances the tip of the second catheter over the guidewire to the distal end of the aneurysm sac not filled with the expanded detachable balloon while maintaining the position of the expanded detachable balloon and the first catheter. The 0.014 inch guidewire is removed. Injection of radiographic contrast through the lumen of the second catheter, into the hub of the second catheter, and into the lumen of the venous lumen distal to the expanded detachable balloon confirms occlusion of the aneurysm by the expanded detachable balloon. The physician then selects a second medical device including a 100 cm long first elongate body including a coiled platinum wire joined to a second elongate body including a pusher wire. The first elongate body has a secondary diameter of 0.014 inch and includes a single 4 mm tertiary loop at the distal end, and when associated, the remainder of the first elongate body has no tertiary shape. The first elongate body is joined to the second elongate body (the pusher wire) by mechanical attachment. The guidewire is removed from the lumen of the second catheter, and the first elongate body is inserted into the lumen of the second catheter and advanced into the aneurysm sac under fluoroscopic guidance. The physician advances the distal 70 cm of the first expandable body into the aneurysm sac using the visual markings on the second elongate body of the second medical device for guidance. While advancing the first expandable body into the aneurysm sac, the physician increases the pressure in the inflation device and the detachable balloon to maintain full balloon expansion. Injection of radiocontrast through the 6Fr guide catheter using the side arm of the Tuohy-Borst adaptor confirms occlusion of the aneurysm neck by the expanded detachable balloon and proper positioning of the expanded detachable balloon and the first elongate body. Under fluoroscopy, the second catheter, with its tip within the central void of the expanded detachable balloon, is withdrawn proximal to the proximal portion of the telescoping catheter segment coupled to the distal neck of the expanded detachable balloon, while the detachable balloon and first catheter remain fixed and unchanged. The physician then advances the remaining 30 cm of the first expandable body into the central cavity of the expanded detachable balloon. Injection of radiocontrast through the 6Fr guide catheter using the side arm of the Tuohy-Borst adaptor confirms occlusion of the aneurysm neck by the expanded detachable balloon and proper alignment of the expanded detachable balloon and the first elongated body. The physician removes the first elongated body from the second elongated body by placing the proximal end of the second elongated body of the second medical device into a handle provided on the second medical device, and removes the second elongated body from the patient. The physician then withdraws the tip of the second catheter until it is proximate the union of the male and female tubular structures, releasing the union between the male and female structures. The physician then uses the marker bands on each catheter and a radiopaque female tubular structure bonded to the proximal neck of the detachable balloon to confirm separation and withdraws the first and second catheters from the patient, leaving the expanded detached balloon and the first elongated body within the aneurysm sac. Injection of radiocontrast through the 6Fr guide catheter using the side arm of the Tuohy-Borst adaptor confirms complete occlusion of the aneurysm neck and sac with the expanded detachable balloon and proper placement of the expanded detachable balloon and the first elongated body. The physician then removes the right femoral artery introducer sheath and seals the right femoral artery hole with an occlusion device, successfully occluding the saccular aneurysm. Over the next several months, the elongated body within the central cavity of the balloon helps the balloon resist deflation and compression or compaction. A thin outer layer of gold on the surface of the balloon induces a complete layer of new endothelium on the blood-contacting surface of the balloon that completely seals the neck of the aneurysm, and also induces the formation of a capsule of tissue that holds the balloon in place.

Example 28: Treatment of Basilar Artery Aneurysm Using a Detachable Rigid Metal-Coated Polymer Balloon Catheter and a Single Elongated Body
A detachable balloon catheter (or first medical device) is provided that includes a pleated and folded detachable rigid metal coated polymer balloon and a catheter assembly including a first catheter and a second catheter.

The detachable balloon has a proximal neck and a distal neck. A female tubular structure is bonded to the proximal neck of the detachable, flexible, metal-coated polymer balloon. The distal portion of the female tubular structure protrudes into the central void of the balloon. A telescoping catheter segment having proximal and distal marker bands is bonded to the distal neck of the detachable balloon. The proximal portion of the telescoping catheter segment protrudes into the central void of the detachable balloon. Excluding the length of the proximal and distal necks, the detachable balloon has a diameter of 8 mm (measured in a plane parallel to the second axis) and a length of 5.3 mm (measured in a plane parallel to the first axis). The proximal and distal regions 110 and 120 of the detachable balloon are curvilinear. The wall of the detachable balloon includes an inner layer of 10 μm single-wall thickness PET fabricated by blow molding, a middle layer of 1000 Å single-wall thickness gold fabricated by sputter deposition on the outer surface of the PET base layer, and an outer layer of 12.5 μm single-wall thickness gold fabricated by electrolysis.

The first catheter includes a proximal end having a hub including a port for injecting fluid and a distal end generally opposite the proximal end, the distal end of the first catheter being joined to the proximal end of a male tubular structure having three arms and a tab. The distal end of the male tubular structure is operably coupled to a female tubular structure that is joined to the proximal neck of the detachable balloon. The distal end of the first catheter further includes a fluoroscopic marker band. The hub of the first catheter also includes a rotating valve lock configured to secure the hub of the first catheter to the shaft of the second catheter. The second catheter includes a proximal end having a hub including a port for receiving a 0.014 inch guidewire and an open distal end. The second catheter further includes two fluoroscopic marker bands to facilitate placement and removal of the first elongated body. The second catheter is longer than the first catheter. The proximal portion of the second catheter passes through the hub of the first catheter and is secured to the hub of the first catheter by a rotating valve lock. The central portion of the second catheter passes through the lumen of the first catheter. The distal portion of the second catheter forms pleats and passes through the opening of the proximal neck of the folded detachable balloon, the central void, the opening of the distal neck, and the telescopic catheter segment, and extends distally to the distal end of the telescopic catheter segment of the distal neck of the detachable balloon. The inner surface of the first catheter and the outer surface of the second catheter define a first lumen that allows passage of a fluid medium from the proximal end of the first catheter to the distal end of the first catheter and into the central void. The lumen of the second catheter defines a second lumen.

The physician advances the needle into the right femoral artery of a patient with a saccular terminal aneurysm of the basilar artery and advances a 0.035 inch guidewire retrograde into the artery. The needle is removed and a 6 Fr introducer sheath is placed into the right femoral artery. A 6 Fr guide catheter with a Tuohy-Borst adaptor is inserted into the introducer sheath and advanced over the guidewire to the origin of the right vertebral artery. A standard digital subtraction angiogram is performed and the dimensions of the aneurysm are confirmed. The diameter of the aneurysm neck is measured to be 6 mm, the aneurysm width and depth to be 9 mm, and the aneurysm height to be 12 mm. The 0.035 inch guidewire is removed and a 300 cm 0.014 inch guidewire is inserted and advanced until its tip is within the aneurysm sac. The physician removes residual air from the detachable balloon catheter and advances it over the guidewire until the pleated and folded detachable balloon is centered in the aneurysm sac. An inflation device filled with a mixture of 50% saline and 50% radiopaque contrast (by volume) is attached to the inflation port of the first catheter and the inflation device is used to inject the saline and contrast mixture through the lumen of the first catheter into the central cavity of the balloon at 5 atmospheres of pressure, resulting in full expansion of the balloon. The physician then pulls back on the expanded detachable balloon by pulling on the assembly of the first and second catheters until the proximal surface of the expanded detachable balloon contacts the neck of the aneurysm. Injection of radiopaque contrast through the 6Fr guide catheter using the Tuohy-Borst side arm confirms occlusion of the neck of the aneurysm by the expanded detachable balloon. The physician opens the valved rotation lock on the hub of the first catheter to allow movement of the second catheter and advances the tip of the second catheter over the guidewire to the distal end of the aneurysmal sac not filled with the expanded detachable balloon while maintaining the position of the expanded detachable balloon and the first catheter. The 0.014 inch guidewire is removed. Injection of radiocontrast through the lumen of the second catheter into the hub of the second catheter and into the venous lumen distal to the expanded detachable balloon confirms occlusion of the aneurysm by the expanded detachable balloon. The physician then selects a second medical device including a 70 cm long first elongate body including a coiled platinum wire joined to a second elongate body including a pusher wire. The first elongate body has a secondary diameter of 0.014 inch and includes a single 4 mm tertiary loop at the distal end, and when associated, the remainder of the first elongate body has no tertiary shape. The first elongate body is joined to the second elongate body (the pusher wire) by a mechanical attachment. The guidewire is removed from the lumen of the second catheter and the first elongate body is inserted into the lumen of the second catheter and advanced into the aneurysm sac under fluoroscopic guidance. The physician advances the entire 70 cm of the first expandable body into the aneurysm sac, using the visual markings on the second elongate body of the second medical device for guidance. Injection of radiological contrast through a 6 Fr guide catheter using the side arm of a Tuohy-Borst adaptor confirms occlusion of the aneurysm neck with the expanded detachable balloon and proper placement of the expanded detachable balloon and first elongate body. The physician places the proximal end of the second elongate body of the second medical device into a handle provided on the second medical device, detaches the first elongate body from the second elongate body, and removes the second elongate body from the patient. The physician then withdraws the tip of the second catheter until it is proximate the union of the male and female tubular structures, releasing the union between the male and female structures. The physician then withdraws the first and second catheters from the patient, leaving the detached expanded balloon and first elongated body in the aneurysm sac, using the marker bands of each catheter and a radiopaque female tubular structure bonded to the proximal neck of the detachable balloon to confirm separation. Injection of radiocontrast through the 6Fr guide catheter using the side arm of the Tuohy-Borst adaptor confirms complete occlusion of the aneurysm neck and sac by the expanded detachable balloon and by proper placement of the expanded detachable balloon and first elongated body. The physician then removes the right femoral artery introducer sheath and seals the right femoral artery hole with an occlusion device, successfully occluding the saccular aneurysm. Over the next several months, the elongated body within the central cavity of the balloon helps the balloon resist deflation, compression, or compaction. A thin outer layer of gold on the surface of the balloon induces a complete layer of new endothelium on the blood-contacting surface of the balloon that completely seals the neck of the aneurysm, and also induces the formation of a capsule of tissue that holds the balloon in place.

Example 29: Treatment of the Gastroduodenal Artery Using a Detachable Flexible Metal-Coated Polymer Balloon Catheter and a Single Elongated Body
A detachable balloon catheter (or first medical device) is provided that includes a detachable, flexible, pleated, folded metal-coated polymer balloon and a catheter assembly that includes a first catheter and a second catheter.

The detachable balloon has a proximal neck and a distal neck. A female tubular structure is bonded to the proximal neck of the detachable, flexible, metal-coated polymer balloon. The distal portion of the female tubular structure protrudes into the central void of the balloon. A telescoping catheter segment having proximal and distal marker bands is bonded to the distal neck of the detachable balloon. The proximal portion of the telescoping catheter segment protrudes into the central void of the detachable balloon. Excluding the length of the proximal and distal necks, the detachable balloon has a diameter of 4 mm (measured in a plane parallel to the second axis) and a length of 6.8 mm (measured in a plane parallel to the first axis). The proximal and distal regions 110 and 120 of the detachable balloon are conical with a cone angle of 45°. The wall of the detachable balloon includes a single-wall 10 μm thick inner layer of PET made by blow molding and a single-wall 1000 Å thick outer layer of gold made by sputter deposition on the outer surface of the PET base layer.

The first catheter includes a hub and a proximal end including a port for injecting fluid, and a distal end generally opposite the proximal end, and is coupled to the proximal end of a male tubular structure having three arms and a tab. The distal end of the male tubular structure is coupled to a female tubular structure that is operably joined to the proximal neck of the detachable balloon. Additionally, the distal end of the first catheter includes an X-ray fluoroscopy marker band. The hub of the first catheter also includes a rotating valve lock configured to secure the hub of the first catheter to the shaft of the second catheter. The second catheter includes a proximal end having a hub including a port for receiving a 0.014 inch guidewire, and an open distal end. The second catheter further includes two X-ray fluoroscopy marker bands to facilitate placement and removal of the first elongated body. The second catheter is longer than the first catheter. The proximal portion of the second catheter passes through the hub of the first catheter and is secured to the hub of the first catheter by a rotating valve lock. The intermediate portion of the second catheter passes through the lumen of the first catheter. The distal portion of the second catheter passes through the proximal neck opening, central void, distal neck opening, and telescopic catheter segment of the pleated and folded detachable balloon and extends distally to the distal end of the distal neck telescopic catheter segment of the detachable balloon. The inner surface of the first catheter and the outer surface of the second catheter define a first lumen to allow fluid medium to pass from the proximal end of the first catheter to the distal end of the first catheter and enter the central void of the detachable balloon. The lumen of the second catheter defines a second lumen.

The physician advances the needle into the right femoral artery of a patient with liver metastases from liver cancer scheduled for radioembolization and advances a 0.035 inch guidewire in a retrograde fashion. The needle is removed and a 6 French introducer sheath is placed into the right femoral artery. A 6 French guide catheter with a Tuohy-Borst adaptor is inserted into the introducer sheath, advanced over the guidewire, and used to engage the proximal origin of the celiac artery. A standard digital subtraction angiogram is performed and the diameter of the gastroduodenal artery is measured at 3 mm. The 0.035 inch guidewire is removed and a 300 cm 0.014 inch guidewire is inserted and advanced through the gastroduodenal artery into the distal superior mesenteric artery. The physician removes residual air from the detachable balloon catheter and advances it over the guidewire until the proximal end of the pleated, folded detachable balloon is positioned at the origin of the gastroduodenal artery. An inflation device filled with a mixture of 50% saline and 50% radiopaque contrast (by volume) is attached to the inflation port of the first catheter, and the inflation device is used to inject the saline and contrast mixture through the lumen of the first catheter into the central space of the balloon at a pressure of 2 atmospheres, resulting in full expansion of the balloon. Occlusion of the gastroduodenal artery by the expanded detachable balloon is confirmed by injecting radiopaque contrast through the 6Fr guide catheter using the side arm of the Tuohy-Borst. The physician then removes the second medical device provided with a detachable balloon catheter as a kit, the second medical device comprising a 20 cm long first elongate body comprising a coiled platinum wire joined to a second elongate body comprising a pusher wire. The first elongate body has a secondary diameter of 0.014 inches and includes a single 4 mm tertiary loop at the distal end, and when relevant, the remainder of the first elongate body has no tertiary shape. The first elongate body is joined to the second elongate body (pusher wire) by a mechanical attachment. The guidewire is removed from the lumen of the second catheter and the first elongate body is inserted into the lumen of the second catheter and advanced until the distal 4 mm loop is advanced distally to the tip of the second catheter. Using fluoroscopy, the physician confirms that the distal portion of the first elongate body of the second medical device is located in the lumen of the gastroduodenal artery adjacent and distal to the expanded detachable balloon. The physician opens the valved rotation lock on the hub of the first catheter, allowing movement of the second catheter, and withdraws the second catheter under fluoroscopy until its tip is within the central cavity of the expanded detachable balloon and proximal to the proximal portion of the telescoping catheter segment coupled to the distal neck of the expanded detachable balloon, while the positions of the expanded detachable balloon and first catheter remain fixed and unchanged. The physician advances the remaining portion of the first expandable body into the central cavity of the expanded detachable balloon, using the fluoroscopic marker band on the second catheter for guidance. Occlusion of the gastroduodenal artery by the expanded detachable balloon and proper placement of the expanded detachable balloon and first elongated body is confirmed by injecting radiocontrast through the 6Fr guide catheter using the side arm of the Tuohy-Borst adaptor. The physician places the proximal end of the second elongated body of the second medical device into a handle provided in a kit including the detachable balloon catheter and the second medical device, detaches the first elongated body from the second elongated body, and removes the second elongated body from the patient. The physician then withdraws the tip of the second catheter until it is adjacent the union of the male and female tubular structures, releasing the union between the male and female structures. The physician then withdraws the first and second catheters from the patient, leaving the expanded detached balloon and the first elongated body in the gastroduodenal artery, using the marker bands of each catheter and a radiopaque female tubular structure bonded to the proximal neck of the detachable balloon to confirm separation. Complete occlusion of the gastroduodenal artery by the expanded detachable balloon and proper placement of the expanded detachable balloon and the first elongated body is confirmed by injecting radiocontrast through the 6Fr guide catheter using the side arm of the Tuohy-Borst adapter. The physician then removes the right femoral artery introducer sheath and seals the hole in the right femoral artery with a closure device, successfully occluding the gastroduodenal artery. Over the next several months, the elongated body within the central cavity of the balloon helps the balloon resist deflation, compression, or compaction. A thin gold outer layer on the surface of the balloon induces the formation of a capsule of tissue that seals off a portion of the artery and holds the balloon in place.

Example 30: Treatment of the gastroduodenal artery using a detachable metal balloon catheter
A detachable balloon catheter (or first medical device) is provided that includes a pleated and folded detachable metal balloon and a catheter assembly that includes a first catheter, a second catheter and a third catheter.

The detachable balloon has a proximal neck and a distal neck. The outer surface of the distal end of the elastomeric tubular segment is bonded to the inner surface of the proximal neck of the detachable balloon. The distal end of the first catheter is inserted into the proximal end of the elastomeric tubular segment to form a friction fit. The inner surface of the proximal portion of the distal nose cone is bonded to the outer surface of the distal end of the distal neck of the detachable balloon. The distal nose cone includes an elastic bulb and two spacers, one proximally and one distally, to form a friction fit. Excluding the length of the proximal and distal necks, the detachable balloon has a diameter of 4 mm (measured in a plane parallel to the second axis) and a length of 6.8 mm (measured in a plane parallel to the first axis). The proximal and distal regions 110 and 120 of the detachable balloon are conical with a cone angle of 45°. The wall of the detachable balloon includes a single-wall 10 μm thick inner layer of PET made by blow molding and a single-wall 1000 Å thick outer layer of gold made by sputter deposition on the outer surface of the PET base layer.

The first catheter includes a proximal end having a hub including a port for injecting fluid and a distal end operably coupled to the proximal end of the elastomeric tubular segment portion of the proximal neck assembly. The distal end of the first catheter further includes a fluoroscopic marker band. The hub of the first catheter also includes a rotating valve lock configured to secure the hub of the first catheter to the shaft of the second catheter. The second catheter includes a proximal end having a hub including a port for receiving a 0.014 inch guidewire and an open distal end. The second catheter further includes a fluoroscopic marker at the distal end. The hub of the third catheter also includes a rotating valve lock configured to secure the hub of the third catheter to the shaft of the first catheter. The distal end of the third catheter further includes a fluoroscopic marker band.

The first catheter is longer than the third catheter. The proximal portion of the first catheter passes through the hub of the third catheter and is secured to the hub of the third catheter by a rotating valve lock. The intermediate portion of the first catheter passes through the lumen of the third catheter. The distal portion of the first catheter extends distally to the distal end of the third catheter. The inner surface of the third catheter and the outer surface of the first catheter define a third lumen to allow passage of a fluid medium, including a radiocontrast solution, from the proximal end of the third catheter to the distal end of the third catheter and out of the third catheter and into the lumen of an artery or vein when used in vivo.

The second catheter is longer than the first catheter. The proximal portion of the second catheter passes through the hub of the first catheter and is secured to the hub of the first catheter by a rotating valve lock. The central portion of the second catheter passes through the lumen of the first catheter. The distal portion of the second catheter passes through the proximal neck opening, central void, distal neck opening, distal neck radiopaque tubular structure and friction fit valve and spacer of the distal nose cone of the pleated and folded detachable balloon and extends distally to the distal end of the distal nose cone of the detachable balloon. A portion of the shaft of the second catheter is operably coupled to the elastomeric valve of the distal nose cone of the detachable balloon by a friction fit. The inner surface of the first catheter and the outer surface of the second catheter define a first lumen that allows a fluid medium to pass from the proximal end of the first catheter to the distal end of the first catheter and into the central void of the detachable balloon. The lumen of the second catheter defines a second lumen.

The physician advances a needle into the right femoral artery of a patient with liver metastases from hepatocellular carcinoma scheduled for radioembolization and advances a 0.035 inch guidewire retrograde into the artery. The needle is removed and a 6 Fr introducer sheath is placed into the right femoral artery. A 6 Fr guide catheter with a Tuohy-Borst adaptor is inserted into the introducer sheath and advanced over the guidewire and used to engage the proximal origin of the celiac artery. A standard digital subtraction angiogram is performed and the diameter of the gastroduodenal artery is measured at 3 mm. The 0.035 inch guidewire is removed and a 300 cm 0.014 inch guidewire is inserted and advanced through the gastroduodenal artery into the distal superior mesenteric artery. The physician removes residual air from the detachable balloon catheter and advances it over the guidewire until the proximal end of the pleated, folded detachable balloon is located at the origin of the gastroduodenal artery. An inflation device filled with a mixture of 50% saline and 50% radiopaque contrast (by volume) is attached to the inflation port of the first catheter and the inflation device is used to inject the mixture of saline and contrast through the lumen of the first catheter and into the central cavity of the balloon at a pressure of 4 atmospheres, resulting in full inflation of the balloon. The physician opens the rotating valve lock on the hub of the third catheter and advances the tip of the third catheter forward until it enters the celiac artery while the first catheter, the second catheter, and the detachable balloon remain fixed in place. The physician closes the rotating valve lock on the hub of the third catheter. Occlusion of the gastroduodenal artery by the expanded detachable balloon is confirmed by injecting radiopaque contrast into the hub of the third catheter. The physician opens the rotating valve lock on the hub of the third catheter and advances the tip of the third catheter forward until it abuts the proximal end of the elastomeric tubular segment. While the third catheter is fixed in place, the physician withdraws the assembly of the first and second catheters, leaving the detachable balloon, the third catheter, and the guidewire in place. Injection of radiocontrast into the hub of the third catheter confirms closure of the elastomeric valve of the distal nose cone and complete occlusion of the gastroduodenal artery by the expanded detachable balloon. The physician removes the third catheter and the guidewire from the patient. The physician then removes the introducer sheath in the right femoral artery and closes the hole in the right femoral artery with a closure device, successfully occluding the gastroduodenal artery. Over the next several months, the elongated body within the central cavity of the balloon helps the balloon resist deflation, compression, or compaction, and the thin outer layer of gold on the surface of the balloon induces the formation of a capsule of tissue that seals the segment of the artery and holds the balloon in place.

Example 31: Treatment of the Left Ovarian Vein with a Detachable Flexible Metallized Polymer Balloon Catheter with Distal Neck Retention Structure and Single Elongated Body
A detachable balloon catheter (or first medical device) is provided that includes a pleated, folded, detachable, flexible, metal-coated polymer balloon and a catheter assembly that includes a first catheter, a second catheter, and a third catheter.

The detachable balloon has a proximal neck and a distal neck. A female tubular structure is bonded to the proximal neck of the detachable, flexible, metal-coated polymer balloon. The distal portion of the female tubular structure protrudes into the central void of the balloon. A telescoping catheter segment having proximal and distal marker bands is bonded to the distal neck of the detachable balloon. The proximal portion of the telescoping catheter segment protrudes into the central void of the detachable balloon. The inner surface of the proximal ring of the Nitinol retention structure is bonded to the outer surface of the distal neck of the detachable balloon. The arms and hooks of the Nitinol retention structure extend distally from the proximal ring. Excluding the length of the proximal and distal necks, the detachable balloon has a diameter of 10 mm (measured in a plane parallel to the second axis) and a length of 16.8 mm (measured in a plane parallel to the first axis). The proximal and distal regions of the detachable balloon are conical with a cone angle of 45°. The wall of the detachable balloon includes a single-wall 20 μm thick inner layer of blown PET and a single-wall 1000 Å thick outer layer of gold sputter-deposited on the outer surface of the PET base layer.

The first catheter includes a proximal end having a hub including a port for injecting fluid and a distal end operably coupled to the proximal end of the elastomeric tubular segment portion of the proximal neck assembly. The distal end of the first catheter further includes a fluoroscopic marker band. The hub of the first catheter also includes a rotating valve lock configured to secure the hub of the first catheter to the shaft of the second catheter. The second catheter includes a proximal end having a hub including a port for receiving a 0.014 inch guidewire and an open distal end. The second catheter further includes a fluoroscopic marker at the distal end. The distal end of the third catheter has a side hole configured to allow fluid injected into the third catheter to exit the lumen of the catheter. The hub of the third catheter also includes a rotating valve lock configured to secure the hub of the third catheter to the shaft of the first catheter. The distal end of the third catheter further includes a fluoroscopic marker band.

The proximal portion of the first catheter passes through the hub of the third catheter and is fixed to the hub of the third catheter by a rotating valve lock. The intermediate and distal portions of the first catheter are within the lumen of the third catheter. For the proximal and intermediate portions of the third catheter, the inner surface of the third catheter and the outer surface of the first catheter define a third lumen that allows a fluid medium containing a radiocontrast solution to pass from the proximal end of the third catheter to the distal end of the third catheter, and when used in vivo, it can exit the third catheter and enter the lumen of an artery or vein. For the distal portion of the third catheter, the outer surface of the folded detachable balloon, which forms pleats with the inner surface of the third catheter, the retention structure, and the second catheter define a third lumen that allows a fluid medium containing a radiocontrast solution to pass from the proximal end of the third catheter to the distal end of the third catheter, and when used in vivo, it can exit the third catheter and enter the lumen of an artery or vein. The arms and hooks of the Nitinol retention structure extend distally from the proximal ring and are completely covered and restrained by the third catheter.

The second catheter is longer than the first catheter and the third catheter. A proximal portion of the second catheter passes through the hub of the first catheter and is secured to the hub of the first catheter by a rotating valve lock. A central portion of the second catheter passes through the lumen of the first catheter. A distal portion of the second catheter passes through the proximal neck opening, the central void, and the distal neck opening and extends distally to the distal end of the third catheter. The inner surface of the first catheter and the outer surface of the second catheter define a first lumen that allows a fluid medium to pass from the proximal end of the first catheter to the distal end of the first catheter and enter the central void of the detachable balloon. The lumen of the second catheter defines a second lumen.

The physician advances the needle into the right femoral vein of a patient with pelvic pain and left ovarian varicose veins and advances a 0.035 inch guidewire into the vein in an antegrade manner. The needle is removed and a 7 Fr introducer sheath is placed into the right femoral vein. A 7 Fr guide catheter with a Tuohy-Borst adapter is inserted into the introducer sheath and advanced over the guidewire into the distal portion of the dilated left ovarian vein. A standard digital subtraction angiogram is performed and the diameter of the left ovary is measured to be 7 mm. The 0.035 inch guidewire is removed and a 300 cm long 0.014 inch guidewire is inserted and advanced into the distal left ovarian vein. The physician removes residual air from the detachable balloon catheter and advances it over the guidewire until the proximal end of the pleated and folded detachable balloon is positioned in the distal left ovarian vein. The physician opens the rotating valve lock on the hub of the third catheter and pulls back the tip of the third catheter until both the retention structure and the pleated, folded balloon are exposed, while the first catheter, the second catheter, and the detachable balloon remain fixed in place. The physician closes the rotating valve lock on the hub of the third catheter. The position of the pleated, folded, detachable balloon and proper engagement of the retention structure hooks to the vein wall are confirmed by injecting radiocontrast into the hub of the third catheter and the gentle tabs of the first catheter. An inflation device filled with a mixture of 50% saline and 50% radiocontrast (by volume) is attached to the inflation port of the first catheter and the inflation device is used to inject the saline and contrast mixture through the lumen of the first catheter and into the central cavity of the balloon at a pressure of 2 atmospheres, resulting in full expansion of the balloon. Occlusion of the left ovarian vein by the expanded detachable balloon is confirmed by injection of radiocontrast through the lumen of the third catheter, into the hub of the third catheter, and into the lumen of the vein adjacent to the expanded detachable balloon. The 0.014 inch guidewire is removed. Occlusion of the left ovarian vein is confirmed by injection of radiocontrast through the lumen of the second catheter, into the hub of the second catheter, and into the lumen of the vein distal to the expanded detachable balloon. The physician then removes the second medical device provided with the detachable balloon catheter as a kit, the second medical device including a 100 cm long first elongated body including a coiled platinum wire coupled to a second elongated body including a pusher wire. The first elongated body has a secondary diameter of 0.014 inches and includes a single 4 mm tertiary loop at the distal end, and when associated, the remainder of the first elongated body has no tertiary shape. The first elongated body is joined to the second elongated body (the pusher wire) by a mechanical attachment. The guidewire is removed from the lumen of the second catheter and the first elongate body is inserted into the lumen of the second catheter and advanced until the distal 4 mm loop advances distally to the tip of the second catheter. Using fluoroscopy, the physician confirms that the distal portion of the first elongate body of the second medical device is located in the lumen of the left ovarian vein adjacent and distal to the expanded detachable balloon. The physician opens the valved rotation lock on the hub of the first catheter to allow movement of the second catheter and, under fluoroscopy, withdraws the second catheter until its tip is within the central cavity of the expanded detachable balloon and proximal to the proximal portion of the telescoping catheter segment coupled to the distal neck of the expanded detachable balloon, while leaving the positions of the expanded detachable balloon, the first catheter, and the third catheter fixed and unchanged. The physician advances the remaining portion of the first expandable body into the central cavity of the expanded detachable balloon, using the fluoroscopic marker band on the second catheter for guidance. Injection of radiocontrast through the lumen of the third catheter, into the hub of the third catheter, and into the lumen of the vein adjacent to the expanded detachable balloon, confirms occlusion of the left ovarian vein by the expanded detachable balloon, and proper placement of the expanded detachable balloon and the first elongate body. The physician places the proximal end of the second elongate body of the second medical device into a handle provided in a kit including a detachable balloon catheter and the second medical device, detaches the first elongate body from the second elongate body, and removes the second elongate body from the patient. The physician then withdraws the tip of the second catheter until it is adjacent the coupling of the male and female tubular structures, releasing the coupling between the male and female structures. The physician then withdraws the first and second catheters from the patient, leaving the expanded detached balloon and the first elongated body in the left ovarian vein, using the marker bands of each catheter and a radiopaque female tubular structure bonded to the proximal neck of the detachable balloon to confirm separation. Occlusion of the left ovarian vein by the expanded detachable balloon and proper placement of the expanded detachable balloon and the first elongated body is confirmed by injecting radiocontrast through the lumen of the third catheter, into the hub of the third catheter, and into the lumen of the vein adjacent to the expanded detachable balloon. The physician removes the third catheter, then removes the introducer sheath in the right femoral vein, and manually applies pressure to close the hole in the right femoral vein, successfully occluding the left ovarian vein. Over the next several months, the elongated body in the central cavity of the balloon helps the balloon resist deflation, compression, or compaction, and the thin outer layer of gold on the balloon surface induces the formation of a capsule of tissue that occludes a segment of the vein and holds the balloon in place.

Example 32: Treatment of Gastroesophageal Venous Varices Using a Detachable Flexible Metal Coated Polymer Balloon Catheter with Proximal Neck Retention Structure and a Single Elongated Body
A detachable balloon catheter (or first medical device) is provided that includes a pleated, folded, detachable, flexible, metal-coated polymer balloon and a catheter assembly that includes a first catheter, a second catheter and a third catheter.

The detachable balloon has a proximal neck and a distal neck. A female tubular structure is bonded to the proximal neck of the detachable, flexible, metallized polymer balloon. The distal portion of the female tubular structure projects into the central cavity of the balloon. A telescoping catheter segment having proximal and distal marker bands is bonded to the distal neck of the detachable balloon. The proximal portion of the telescoping catheter segment projects into the central cavity of the detachable balloon. The inner surface of the distal ring of the Nitinol retention structure is bonded to the outer surface of the proximal neck of the detachable balloon. The elongated arms and barbs of the Nitinol retention structure extend distally from the distal ring and then meet at the proximal ring. Excluding the length of the proximal and distal necks, the detachable balloon has a diameter of 10 mm (measured in a plane parallel to the second axis) and a length of 16.8 mm (measured in a plane parallel to the first axis). The proximal and distal regions of the detachable balloon are conical with a cone angle of 45°. The wall of the detachable balloon includes a single-wall 20 μm thick inner layer of blown PET and a single-wall 1000 Å thick outer layer of gold sputter-deposited on the outer surface of the PET base layer.

The first catheter includes a proximal end having a hub including a port for injecting a fluid and a distal end operably coupled to the proximal end of the elastomeric tubular segment portion of the proximal neck assembly. The distal end of the first catheter further includes a fluoroscopic marker band. The hub of the first catheter also includes a rotating valve lock configured to secure the hub of the first catheter to the shaft of the second catheter. The second catheter includes a proximal end having a hub including a port for receiving a 0.014 inch guidewire and an open distal end. The second catheter further includes a fluoroscopic marker at the distal end. The third catheter includes a proximal end having a hub including a port for injecting a radiocontrast agent and an open distal end. The distal end of the third catheter has a side hole configured to allow fluid injected into the third catheter to exit the catheter lumen. The hub of the third catheter also includes a rotating valve lock configured to secure the hub of the third catheter to the shaft of the first catheter. The distal end of the third catheter further includes an X-ray fluoroscopy marker band.

The proximal portion of the first catheter passes through the hub of the third catheter and is fixed to the hub of the third catheter by a rotating valve lock. The intermediate and distal portions of the first catheter are within the lumen of the third catheter. For the proximal and intermediate portions of the third catheter, the inner surface of the third catheter and the outer surface of the first catheter define a third lumen that allows the passage of a fluid medium containing a radiocontrast solution from the proximal end of the third catheter to the distal end of the third catheter, so that when used in vivo, it can exit the third catheter and enter the lumen of an artery or vein. For the distal portion of the third catheter, the inner surface of the third catheter and the outer surface of the retention structure, the pleated and folded detachable balloon, and the second catheter define a third lumen that allows the passage of a fluid medium containing a radiocontrast solution from the proximal end of the third catheter to the distal end of the third catheter, so that when used in vivo, it can exit the third catheter and enter the lumen of an artery or vein. A Nitinol retention structure bonded to the proximal neck of the detachable balloon is completely covered and restrained by a third catheter.

The second catheter is longer than the first catheter and the third catheter. A proximal portion of the second catheter passes through the hub of the first catheter and is secured to the hub of the first catheter by a rotating valve lock. A central portion of the second catheter passes through the lumen of the first catheter. A distal portion of the second catheter passes through the proximal neck opening, the central void, and the distal neck opening and extends distally to the distal end of the third catheter. The inner surface of the first catheter and the outer surface of the second catheter define a first lumen that allows a fluid medium to pass from the proximal end of the first catheter to the distal end of the first catheter and into the central void of the detachable balloon. The lumen of the second catheter defines a second lumen.

Under fluoroscopy, the physician advances a needle into the liver of a patient with cirrhosis and bleeding gastroesophageal varices to locate the branch of the right hepatic vein. The physician advances a 0.035 inch guidewire retrograde into the hepatic vein and inserts a 7 Fr introducer sheath into the hepatic vein. A flexible, curved needle is then inserted into the 7 Fr introducer sheath and advanced from the hepatic vein branch through the liver parenchyma into the portal vein branch. The physician advances a 0.035 inch guidewire retrograde into the portal vein, removes the needle, and places a stent intravenously from the portal vein through the liver parenchyma to reduce portal vein pressure. A 5 Fr diagnostic catheter is then advanced into the largest gastroesophageal vein collateral arising from the portal vein over the 0.035 inch guidewire. The 0.035 inch guidewire is removed and a 300 cm 0.014 inch guidewire is inserted and advanced into the gastroesophageal adrenal gland and the 5 Fr diagnostic catheter is removed. The physician removes residual air from the detachable balloon catheter and advances it over the guidewire until the proximal end of the pleated, folded detachable balloon is positioned in the gastroesophageal adrenal vein. The physician opens the rotating valve lock on the hub of the third catheter and pulls back the tip of the third catheter until both the pleated, folded balloon and the retention structure are exposed, while the first catheter, second catheter and detachable balloon remain fixed in place. The physician closes the rotating valve lock on the hub of the third catheter. The position of the pleated, folded detachable balloon and proper engagement of the barbs of the retention structure with the vein wall are confirmed by injecting radiocontrast into the hub of the third catheter and the smooth tabs of the first catheter. An inflation device filled with a mixture of 50% saline and 50% radiopaque contrast (by volume) is attached to the inflation port of the first catheter and the inflation device is used to inject the saline and contrast mixture through the lumen of the first catheter into the central space of the balloon at a pressure of 2 atmospheres, resulting in full inflation of the balloon. Occlusion of the gastroesophageal collateral vein by the expanded detachable balloon is confirmed by injecting radiopaque contrast through the lumen of the third catheter, into the hub of the third catheter, and into the lumen of the vein adjacent to the expanded detachable balloon. The 0.014 inch guidewire is removed. Occlusion of the left ovarian vein by the expanded detachable balloon is confirmed by injecting radiopaque contrast through the lumen of the second catheter, into the hub of the second catheter, and into the lumen of the vein distal to the expanded detachable balloon. The physician then removes the second medical device provided with a detachable balloon catheter as a kit, the second medical device including a 100 cm long first elongate body including a coiled platinum wire coupled to a second elongate body including a pusher wire. The first elongate body has a secondary diameter of 0.014 inches and includes a single 4 mm tertiary loop at the distal end, and when related, the remainder of the first elongate body has no tertiary shape. The first elongate body is joined to the second elongate body (pusher wire) by a mechanical attachment. The guidewire is removed from the lumen of the second catheter and the first elongate body is inserted into the lumen of the second catheter and advanced until the distal 4 mm loop has advanced distally to the tip of the second catheter. The physician uses fluoroscopy to verify that the distal portion of the first elongate body of the second medical device is located in the lumen of the accessory gastroesophageal vein adjacent and distal to the expanded detachable balloon. The physician opens the valved rotation lock of the hub of the first catheter, allowing movement of the second catheter, and withdraws the second catheter under fluoroscopic guidance until its tip is within the central cavity of the expanded detachable balloon and proximal to the proximal portion of the telescoping catheter segment coupled to the distal neck of the expanded detachable balloon, while the positions of the expanded detachable balloon, first catheter, and third catheter remain fixed and unchanged. The physician advances the remaining portion of the first expandable body into the central cavity of the expanded detachable balloon, using the fluoroscopic marker bands on the second catheter for guidance. Occlusion of the gastroesophageal collateral vein by the expanded detachable balloon and proper placement of the expanded detachable balloon and first elongated body are confirmed by injecting radiocontrast through the lumen of the third catheter, into the hub of the third catheter, and into the lumen of the vein adjacent to the expanded detachable balloon. The physician places the proximal end of the second elongate body of the second medical device into a handle provided in a kit including the detachable balloon catheter and the second medical instrument, detaches the first elongate body from the second elongate body, and removes the second elongate body from the patient. The physician then withdraws the tip of the second catheter until it is adjacent to the bond of the male and female tubular structures, releasing the bond between the male and female structures. The physician then withdraws the first and second catheters from the patient, leaving the expanded, detached balloon and first elongate body in the gastroesophageal collateral vein, using the marker bands on each catheter and the radiopaque female tubular structure bonded to the proximal neck of the detachable balloon to confirm separation. Injection of radiocontrast through the lumen of the third catheter, into the hub of the third catheter, and into the lumen of the vein adjacent to the expanded detachable balloon, confirms occlusion of the gastroesophageal collateral vein by the expanded detachable balloon and proper placement of the expanded detachable balloon and first elongated body. The physician removes the third catheter, then removes the introducer sheath from the liver and seals the hole in the liver with pledgets, successfully reducing portal vein pressure and occluding the major gastroesophageal collateral vein. Over the next several months, the elongated body within the central cavity of the balloon helps the balloon resist deflation, compression, or compaction. A thin gold outer layer on the balloon surface induces the formation of a capsule of tissue that seals off a portion of the vein and holds the balloon in place.

Example 33: Treatment of the Left Atrial Appendage Using a Detachable Flexible Metallized Polymer Balloon Catheter with Distal Neck Retention Structure and a Single Elongated Body
A detachable balloon catheter (or first medical device) is provided that includes a pleated, folded, detachable, flexible, metal-coated polymer balloon and a catheter assembly that includes a first catheter, a second catheter, and a third catheter.

The detachable balloon has a proximal neck and a distal neck. A female tubular structure is bonded to the proximal neck of the detachable, flexible, metallized polymer balloon. The distal portion of the female tubular structure protrudes into the central cavity of the balloon. A telescoping catheter segment having proximal and distal marker bands is bonded to the distal neck of the detachable balloon. The proximal portion of the telescoping catheter segment protrudes into the central cavity of the detachable balloon. The inner surface of the proximal ring of the Nitinol retention structure is bonded to the outer surface of the distal neck of the detachable balloon. The arms and hooks of the Nitinol retention structure extend distally from the proximal ring. Excluding the length of the proximal and distal necks, the detachable balloon has a diameter of 26 mm (measured in a plane parallel to the second axis) and a length of 32 mm (measured in a plane parallel to the first axis). The proximal and distal regions 110 and 120 of the detachable balloon 10 are curvilinear. The wall of the detachable balloon includes a single-wall 30 μm thick inner layer of PET made by blow molding and a single-wall 1000 Å thick outer layer of gold made by sputter deposition on the outer surface of the PET base layer.

The first catheter includes a proximal end having a hub including a port for injecting fluid and a distal end operably coupled to the proximal end of the elastomeric tubular segment portion of the proximal neck assembly. The distal end of the first catheter further includes a fluoroscopic marker band. The hub of the first catheter also includes a rotating valve lock configured to secure the hub of the first catheter to the shaft of the second catheter. The second catheter includes a proximal end having a hub including a port for receiving a 0.038 inch guidewire and an open distal end. The second catheter further includes a fluoroscopic marker at the distal end. The distal end of the third catheter has a side hole configured to allow fluid injected into the third catheter to exit the lumen of the catheter. The catheter also includes a rotating valve lock configured to secure the hub of the third catheter to the shaft of the first catheter. The distal end of the third catheter further includes a fluoroscopic marker band.

The proximal portion of the first catheter passes through the hub of the third catheter and is fixed to the hub of the third catheter by a rotating valve lock. The middle and distal portions of the first catheter are within the lumen of the third catheter. For the proximal and middle portions of the third catheter, the inner surface of the third catheter and the outer surface of the first catheter define a third lumen to allow passage of a fluid medium including a radiocontrast solution from the proximal end of the third catheter to the distal end of the third catheter and to allow it to exit the third catheter. For the distal portion of the third catheter, the outer surface of the detachable balloon, which is pleated and folded with the inner surface of the third catheter, the retention structure, and the second catheter define a third lumen to allow passage of a fluid medium including a radiocontrast solution from the proximal end of the third catheter to the distal end of the third catheter and to allow it to exit the third catheter. The arms and hooks of the Nitinol retention structure extend distally from the proximal ring and are completely covered and restrained by the third catheter.

The second catheter is longer than the first catheter and the third catheter. The proximal portion of the second catheter passes through the hub of the first catheter and is secured to the hub of the first catheter by a rotating valve lock. The central portion of the second catheter passes through the lumen of the first catheter. The distal portion of the second catheter passes through the proximal neck opening, the central void, and the distal neck opening and extends distally to the distal end of the third catheter. The inner surface of the first catheter and the outer surface of the second catheter define a first lumen that allows a fluid medium to pass from the proximal end of the first catheter to the distal end of the first catheter and into the central void of the detachable balloon. The lumen of the second catheter defines a second lumen.

The physician advances the needle into the right femoral vein of a patient with atrial fibrillation with contraindications to chronic anticoagulation and advances a 300 cm long 0.038 inch guidewire into the vein in an antegrade direction. The needle is removed and an 8 Fr introducer sheath is inserted into the right femoral vein. An 8 Fr guide catheter with a Tuohy-Borst adapter is inserted into the introducer sheath and advanced over the guidewire into the right atrium. Under transesophageal ultrasound guidance, a puncture is made in the atrial septum, the puncture tract is dilated using a serial myofascial dilator, and the 8 Fr guide catheter is advanced into the left atrium. A 5 Fr diagnostic catheter is used to advance the guidewire deep into the left atrial appendage (LAA). The diameter of the LAA is measured using transesophageal ultrasound, demonstrating a diameter of 20 mm near the neck. The physician removes residual air from the detachable balloon catheter and advances it over the guidewire until the proximal end of the pleated, folded detachable balloon is positioned in the LAA just distal to the neck of the LAA. The physician opens the rotating valve lock on the hub of the third catheter and pulls back the tip of the third catheter until both the retention structure and the pleated, folded balloon are exposed, while the first catheter, second catheter, and detachable balloon remain fixed in place. The physician closes the rotating valve lock on the hub of the third catheter. Injection of radiocontrast into the hub of the third catheter and the smooth tabs of the first catheter confirms the position of the pleated, folded detachable balloon and proper engagement of the hooks of the retention structure to the wall of the LAA. Transesophageal cardiac ultrasound is used for confirmation. An inflation device filled with a mixture of 50% saline and 50% radiopaque contrast (by volume) is attached to the inflation port of the first catheter, and the inflation device is used to inject the mixture of saline and contrast through the lumen of the first catheter at a pressure of 2 atmospheres into the central cavity of the balloon, resulting in full expansion of the balloon. Occlusion of the LAA by the expanded detachable balloon is confirmed by injecting radiopaque contrast through the lumen of the third catheter into the hub of the third catheter and into the lumen of the LAA adjacent to the expanded detachable balloon. Transesophageal cardiac ultrasound is used for confirmation. The physician then removes the second medical device provided with the detachable balloon catheter as a kit, the second medical device including a 300 cm long first elongate body including a coiled platinum wire joined to a second elongate body including a pusher wire. The first elongate body has a secondary diameter of 0.035 inches and includes a single 6 mm tertiary loop at the distal end, and when relevant, the remainder of the first elongate body has no tertiary shape. The first elongate body is joined to the second elongate body (pusher wire) by a mechanical attachment. The physician opens the valved rotation lock on the hub of the first catheter, allowing movement of the second catheter, and under fluoroscopic guidance withdraws the second catheter until its tip is within the central cavity of the expanded detachable balloon and proximal to the proximal portion of the telescopic catheter segment attached to the distal neck of the expanded detachable balloon, while the positions of the expanded detachable balloon, the first catheter, and the third catheter remain fixed and unchanged. The guidewire is removed from the lumen of the second catheter, and the first elongate body is inserted into the lumen of the second catheter and advanced until the distal 6 mm loop is within the central cavity of the expanded detachable balloon. The physician advances the remaining portion of the first expandable body into the central cavity of the expanded detachable balloon, using the fluoroscopic marker band on the second catheter for guidance. Occlusion of the LAA by the expanded detachable balloon and proper placement of the expanded detachable balloon and the first elongate body are confirmed by injecting radiocontrast through the lumen of the third catheter into the hub of the third catheter and the lumen of the LAA adjacent to the expanded detachable balloon using transesophageal cardiac ultrasound. The physician places the proximal end of the second elongate body of the second medical device into a handle provided in a kit including the detachable balloon catheter and the second medical device, detaches the first elongate body from the second elongate body, and removes the second elongate body from the patient. The physician then withdraws the tip of the second catheter until it is adjacent to the coupling of the male and female tubular structures, releasing the coupling between the male and female structures. The physician then withdraws the first and second catheters from the patient, leaving the separated dilated balloon and first elongated body in the LAA, using the marker bands of each catheter and a radiopaque female tubular structure bonded to the proximal neck of the detachable balloon to confirm separation. Occlusion of the LAA by the dilated detachable balloon and proper placement of the dilated detachable balloon and first elongated body are confirmed by injecting radiocontrast through the lumen of the third catheter, into the hub of the third catheter, and into the lumen of the LAA adjacent to the dilated detachable balloon. Transesophageal cardiac ultrasound is used for confirmation. The physician removes the third catheter and the 8Fr guide catheter, then removes the right femoral vein introducer sheath, and manually applies pressure to seal the hole in the right femoral vein, successfully occluding the LAA. Over the next several months, the elongated body in the central cavity of the balloon helps the balloon resist deflation, compression, or compaction. A thin outer layer of gold on the surface of the balloon induces a complete layer of new endothelium on the blood-contacting surface of the balloon, which completely seals the neck of the LAA and holds the balloon in place.

Example 34: Treatment of Aortic Valve Paravalvular Leak Using a Detachable Flexible Metal-Coated Polymer Balloon Catheter and Single Elongated Body
A detachable balloon catheter (or first medical device) is provided that includes a pleated, folded, detachable, flexible, metal-coated polymer balloon and a catheter assembly that includes a first catheter and a second catheter.

The detachable balloon includes a proximal neck and a distal neck. A female tubular structure is bonded to the proximal neck of the detachable, flexible, metal-coated polymer balloon. The distal portion of the female tubular structure protrudes into the central cavity of the balloon. A telescoping catheter segment having proximal and distal marker bands is bonded to the distal neck of the detachable balloon. The proximal portion of the telescoping catheter segment protrudes into the central cavity of the detachable balloon. Excluding the length of the proximal and distal necks, the detachable balloon has a diameter of 6 mm (measured in a plane parallel to the second axis) and a length of 16 mm (measured in a plane parallel to the first axis). The proximal and distal regions 110 and 120 of the detachable balloon 10 are curvilinear. The walls of the detachable balloon include a single-wall 14 μm thick inner layer of PET made by blow molding and a single-wall 1000 Å thick outer layer of gold made by sputter deposition on the outer surface of the PET base layer.

The first catheter includes a proximal end having a hub including a port for injection of fluid and a distal end generally opposite the proximal end, the distal end of the first catheter being joined to the proximal end of a male tubular structure having three arms and a tab. The distal end of the male tubular structure is operably coupled to a female tubular structure joined to the proximal neck of the detachable balloon. The distal end of the first catheter further includes an X-ray fluoroscopy marker band. The hub of the first catheter also includes a rotating valve lock configured to secure the hub of the first catheter to the shaft of the second catheter. The second catheter includes a proximal end having a hub including a port for receiving a 0.014 inch guidewire and an open distal end. The second catheter further includes two X-ray fluoroscopy marker bands to facilitate placement and removal of the first elongated body. The second catheter is longer than the first catheter. The proximal portion of the second catheter passes through the hub of the first catheter and is secured to the hub of the first catheter by a rotating valve lock. The central portion of the second catheter passes through the lumen of the first catheter. The distal portion of the second catheter passes through the proximal neck opening, central void, distal neck opening, and telescopic catheter segment of the pleated and folded detachable balloon and extends distally to the distal end of the distal neck telescopic catheter segment of the detachable balloon. The inner surface of the first catheter and the outer surface of the second catheter define a first lumen to allow a fluid medium to pass from the proximal end of the first catheter to the distal end of the first catheter and into the central void of the detachable balloon. The lumen of the second catheter defines a second lumen.

The physician advances the needle into the right femoral artery of a patient undergoing transcatheter aortic valve replacement and now has a paravalvular leak. A 0.035 inch guidewire is advanced retrograde into the artery. The needle is removed and a 6 French introducer sheath is placed into the right femoral artery. A 6 French guide catheter with a Tuohy-Borst adaptor is inserted into the introducer sheath and advanced over the guidewire and into the left ventricle. A standard digital subtraction angiogram is performed to identify the paravalvular leak pathway. The diameter of the paravalvular leak pathway is identified as 4 mm. The length of the paravalvular leak pathway is identified as 12 mm. The tip of the 6 French guide catheter is withdrawn back into the aorta just distal to the paravalvular leak and catheterized into the paravalvular leak pathway using a 5 French diagnostic catheter and a 300 cm 0.014 inch guidewire and the guidewire is placed into the left ventricle. The 5 French diagnostic catheter is removed. The physician removes residual air from the detachable balloon catheter and advances it over the guidewire until the distal end of the pleated and folded detachable balloon is located just inside the left ventricle and the proximal end of the pleated and folded detachable balloon is located just inside the aorta. An inflation device is filled at the inflation port of the first catheter and used to inject a mixture of saline and contrast at 2 atmospheres of pressure through the lumen of the first catheter into the central space of the balloon, resulting in full expansion of the balloon. A transesophageal ultrasound is used to confirm full occlusion of the paravalvular leak. The physician then removes the second medical device provided with the detachable balloon catheter as a kit, the second medical device comprising an 80 cm long first elongated body comprising a coiled platinum wire joined to a second elongated body comprising a pusher wire. The first elongated body has a secondary diameter of 0.014 inches and includes a single 4 mm tertiary loop at the distal end, and when related, the remainder of the first elongated body has no tertiary shape. The first elongate body is joined to the second elongate body (pusher wire) by a mechanical attachment. The physician opens the valved rotation lock on the hub of the first catheter, allowing movement of the second catheter, and under fluoroscopic guidance, pulls back the second catheter until its tip is within the central cavity of the expanded detachable balloon and proximal to the proximal portion of the telescoping catheter segment coupled to the distal neck of the expanded detachable balloon, the positions of the expanded detachable balloon and the first catheter remain fixed and unchanged. The guidewire is removed from the lumen of the second catheter, and the first elongate body is inserted into the lumen of the second catheter and advanced until the distal 4 mm loop advances into the central cavity of the balloon. The physician then advances the remaining portion of the first expandable body into the central cavity of the expanded detachable balloon, using the fluoroscopic marker band on the second catheter for guidance. Transesophageal cardiac ultrasound is used to confirm complete occlusion of the paravalvular leak. Fluoroscopy is used to confirm proper placement of the expanded detachable balloon and first elongate body. The physician places the proximal end of the second elongate body of the second medical device into a handle provided in a kit including the detachable balloon catheter and the second medical device, detaches the first elongate body from the second elongate body, and removes the second elongate body from the patient. The physician then withdraws the tip of the second catheter until it is adjacent to the bond of the male and female tubular structures, releasing the bond between the male and female structures. The physician then withdraws the first and second catheters from the patient, leaving the expanded detached balloon and first elongate body in the perivalvular leak pathway, using the marker bands of each catheter and the radiopaque female tubular structure bonded to the proximal neck of the detachable balloon to confirm separation. The 6Fr guide catheter is advanced into the left ventricle and radiocontrast is injected through the 6Fr guide catheter using the side arm of the Tuohy-Borst adapter to confirm complete occlusion of the paravalvular leak and proper placement of the expanded detachable balloon and the first elongated body. The physician then removes the 6Fr guide catheter and introducer sheath in the right femoral artery and seals the hole in the right femoral artery with the closure device, successfully occluding the aortic paravalvular leak. Over the next several months, the elongated body in the central cavity of the balloon helps the balloon resist deflation, compression, or consolidation. The thin outer layer of gold on the balloon surface induces a complete layer of new endothelium on the blood-contacting surface of the balloon, inducing the formation of a capsule of tissue that seals the paravalvular leak pathway and holds the balloon in place.

Example 35: Treatment of Basilar Artery Aneurysm Using a Detachable Flexible Metal-Coated Polymer Balloon Catheter and Single Elongated Body
In this treatment example, a detachable balloon catheter including a flexible metal-coated polymer balloon with a diameter of 8 mm and a length of 5.3 mm excluding the proximal and distal necks is placed in the basilar aneurysm as described in Example 1. A 100 cm first elongate body is then placed such that its distal portion is in the aneurysm sac distal to the expanded detachable balloon and its proximal portion is in the central space of the expanded detachable balloon as described in Example 1. In this example, prior to removal of either the first elongate body or the expanded detachable balloon, the physician determines whether the diameter of the expanded detachable balloon is too small and the length of the first elongate body is too short to provide adequate treatment. The physician removes the first elongate body from the expanded detachable balloon by pulling on the second elongate body, which is then removed from the patient. The physician then uses an inflation device to apply negative pressure to the inflation port of the hub of the first catheter of the detachable balloon catheter, resulting in deflation of the expanded detachable balloon. The physician removes the detachable balloon from the aneurysm by pulling on the first catheter of the detachable balloon catheter and removes the detachable balloon catheter from the patient. The physician then successfully treats the aneurysm with a detachable balloon catheter having a larger balloon and a second medical device having a longer first elongate body using the method described in Example 1.

Example 36: Treatment of the Left Atrial Appendage Using a Detachable Flexible Metal-Coated Polymer Balloon Catheter and a Single Elongated Body
In this example treatment, the left atrial appendage (LAA) is treated with a detachable balloon catheter as described in Example 7. After exposing the retention mechanism and expanding the detachable balloon of the detachable balloon catheter, the physician determines that the expanded detachable balloon extends into the right atrium. The physician uses an inflation device to apply negative pressure to the inflation port of the hub of the first catheter of the detachable balloon catheter to deflate the expanded detachable balloon. The physician opens the rotating valve lock on the hub of the third catheter and advances the tip of the third catheter forward while holding the detachable balloon, first catheter, and second catheter fixed in place until the balloon is covered by the third catheter and the retention structure is deflated and covered by the third detachable balloon. The physician advances the detachable balloon catheter further into the LAA and successfully completes treatment of the LAA using the method described in Example 7.

Example 37: Treatment of basilar artery aneurysms using a detachable, flexible, metal-coated polymer balloon catheter and a single elongated body.
A detachable balloon catheter (or first medical device) is provided including a pleated, folded, detachable, flexible, metal coated polymer balloon and a catheter assembly including a first catheter and a second catheter, as described in Example 1, except that: i) the male tubular structure is replaced by an electrolysis or anode sensitive tubular structure, the proximal end of the anode 390 is bonded to the distal end of the first catheter, and the distal end of the anode 390 is bonded to the female tubular structure of the detachable balloon proximal neck assembly; ii) the inner surface of the platinum cathode ring structure is bonded to the outer surface of the central section of the first catheter; iii) the hub of the first catheter further includes an electrical jack; iv) a conductive wire electrically connects the anode 390 to the electrical jack on the hub of the first catheter; and v) a conductive wire electrically connects the platinum cathode ring structure on the first catheter to the electrical jack on the hub of the first catheter.

The physician places the expanded detachable balloon and first elongate body into the aneurysm until the detachment step as described in Example 1. An electrically conductive cable is used to electrically connect between the electrolysis detachment controller and the electrical jack on the hub of the first catheter. A current of 2 mA is applied to the anode 390, corroding and dissolving the exposed stainless steel ring. The current is applied until the anode 390 disconnects. The remainder of the procedure is then continued as described in Example 1 until successful completion.

Example 38: Treatment of Basilar Artery Aneurysm Using a Detachable Flexible Metal-Coated Polymer Balloon Catheter and Single Elongated Body
i) There is provided a detachable balloon catheter (or first medical device) comprising a pleated, folded, detachable, flexible, metallized polymer balloon and a catheter assembly comprising a first catheter and a second catheter, as described in Example 1, except that the male tubular structure is replaced by a heat sensitive tubular structure, a proximal end of the heat sensitive tubular structure is joined to a distal end of a first catheter, and a distal end of the heat sensitive tubular structure is joined to a female tubular structure of a proximal neck assembly of the detachable balloon.

The physician positions the expanded detachable balloon and the first elongated body within the aneurysm until the detachment step, as described in Example 1. The first elongated body is detached from the second elongated body, as described in Example 1. The second elongated body is removed from the second catheter of the detachable balloon catheter, and the second catheter is removed from the patient. A third device including a catheter having a conductive wire and a resistive wire segment at its distal end is advanced into the lumen of the second catheter of the detachable balloon catheter until the resistive wire segment is disposed within the heat-sensitive tubular structure. An electrically conductive cable is used to electrically connect the electric thermal detachment controller to the electrical jack of the hub of the third medical device. When an electric current is applied to the resistive wire, the resistive wire heats up, melting the heat-sensitive tubular structure and severing the heat-sensitive tubular structure. The first catheter of the detachable balloon catheter and the third medical device are removed from the patient, as described in Example 1, and the remainder of the procedure is then continued until successfully completed.

Example 39: Treatment of Basilar Artery Aneurysms Using a Detachable, Flexible, Metal-Coated, Polymeric Balloon Catheter and Two or More Elongated Bodies
A detachable balloon catheter (or first medical device) is provided that includes a pleated, folded, detachable, flexible, metal-coated polymer balloon and a catheter assembly that includes a first catheter and a second catheter.

The detachable balloon includes a proximal neck and a distal neck. A female tubular structure is bonded to the proximal neck of the detachable, flexible, metal-coated polymer balloon. The distal portion of the female tubular structure protrudes into the central void of the balloon. A telescoping catheter segment having proximal and distal marker bands is bonded to the distal neck of the detachable balloon. The proximal portion of the telescoping catheter segment protrudes into the central void of the detachable balloon. The detachable balloon has a diameter of 8 mm (measured in a plane parallel to the second axis) and a length of 5.3 mm (measured in a plane parallel to the first axis), excluding the length of the proximal and distal necks. The proximal and distal regions 110 and 120 of the detachable balloon 10 are curvilinear. The wall of the detachable balloon includes a single-wall 10 μm thick inner layer of PET made by blow molding and a single-wall 1000 Å thick outer layer of gold made by sputter deposition on the outer surface of the PET base layer.

The first catheter includes a proximal end having a hub including a port for injecting fluid and a distal end generally opposite the proximal end, the distal end of the first catheter being joined to the proximal end of a male tubular structure having three arms and a tab. The distal end of the male tubular structure is operably coupled to a female tubular structure that is joined to the proximal neck of the detachable balloon. The distal end of the first catheter further includes an X-ray fluoroscopy marker band. The hub of the first catheter also includes a rotating valve lock configured to secure the hub of the first catheter to the shaft of the second catheter. The second catheter includes a proximal end having a hub including a port for receiving a 0.014 inch guidewire and an open distal end. The second catheter further includes two X-ray fluoroscopy marker bands to facilitate placement and removal of the first elongated body. The second catheter is longer than the first catheter. The proximal portion of the second catheter passes through the hub of the first catheter and is secured to the hub of the first catheter by a rotating valve lock. The central portion of the second catheter passes through the lumen of the first catheter. The distal portion of the second catheter passes through the proximal neck opening, central void, distal neck opening, and telescopic catheter segment of the pleated and folded detachable balloon and extends distally to the distal end of the distal neck telescopic catheter segment of the detachable balloon. The inner surface of the first catheter and the outer surface of the second catheter define a first lumen to allow a fluid medium to pass from the proximal end of the first catheter to the distal end of the first catheter and into the central void of the detachable balloon. The lumen of the second catheter defines a second lumen.

The physician advances a needle into the right femoral artery of a patient with a saccular terminal aneurysm of the basilar artery and advances a 0.035 inch guidewire retrograde into the artery. The needle is removed and a 6 Fr introducer sheath is placed into the right femoral artery. A 6 Fr guide catheter with a Tuohy-Borst adaptor is inserted into the introducer sheath and advanced over the guidewire to the origin of the right vertebral artery. A standard digital subtraction angiogram is performed and the dimensions of the aneurysm are confirmed. The diameter of the aneurysm neck is measured as 6 mm, the aneurysm width and depth are measured as 9 mm, and the aneurysm height is measured as 12 mm. The 0.035 inch guidewire is removed and a 2 Fr catheter is advanced over the 0.014 inch guidewire until its tip is within the aneurysm sac. A 12 mm x 40 cm framing coil is placed into the aneurysm sac. The 2 Fr catheter is removed. The physician removes residual air from the detachable balloon catheter and advances it over the 0.014 inch guidewire until the pleated and folded detachable balloon is centered in the aneurysm sac and centered in the loops of the pre-placed framing coil. An inflation device filled with a mixture of 50% saline and 50% radiopaque contrast (by volume) is attached to the inflation port of the first catheter and the inflation device is used to inject the saline and contrast mixture through the lumen of the first catheter at 2 atmospheres of pressure into the central cavity of the balloon, resulting in full expansion of the balloon. The physician then pulls back the expanded detachable balloon by pulling on the assembly of the first and second catheters until the proximal surface of the expanded detachable balloon contacts the loops of the pre-placed framing coil at the aneurysm neck. The physician opens the valved rotation lock on the hub of the first catheter to allow movement of the second catheter and advances the tip of the second catheter over the guidewire to the distal end of the aneurysm sac not filled with the expanded detachable balloon while maintaining the position of the expanded detachable balloon and the first catheter. The physician then selects a second medical device including a 100 cm long first elongate body including a coiled platinum wire joined to a second elongate body including a pusher wire. The first elongate body has a secondary diameter of 0.014 inches and includes a single 4 mm tertiary loop at the distal end, and when associated, the remainder of the first elongate body has no tertiary shape. The first elongate body is joined to the second elongate body (the pusher wire) by a mechanical attachment. The guidewire is removed from the lumen of the second catheter and the first elongate body is inserted into the lumen of the second catheter and advanced into the aneurysm sac under fluoroscopic guidance. The physician advances the distal 70 cm of the first expandable body into the aneurysm sac, using the visual markings on the second elongated body of the second medical device for guidance. Injection of radiological contrast through the 6Fr guide catheter using the side arm of the Tuohy-Borst adaptor confirms continued occlusion of the aneurysm neck by the framing coil and the expanded detachable balloon, as well as proper placement of the expanded detachable balloon and first elongated body. Under fluoroscopy, the second catheter is withdrawn until its tip is within the central void of the expanded detachable balloon and adjacent to the proximal portion of the telescoping catheter segment coupled to the distal neck of the expanded detachable balloon, while the detachable balloon and first catheter remain fixed and unchanged. The physician then advances the remaining 30 cm of the first expandable body into the central void of the expanded detachable balloon. Injection of radiocontrast through the 6Fr guide catheter using the side arm of the Tuohy-Borst adaptor confirms occlusion of the aneurysm neck by the framing coil and expanded detachable balloon, as well as proper placement of the expanded detachable balloon and first elongate body. The physician places the proximal end of the second elongate body of the second medical device into a handle on the second medical device, detaches the first elongate body from the second elongate body, and removes the second elongate body from the patient. The physician then withdraws the tip of the second catheter until it is adjacent to the bond of the male and female tubular structures, releasing the bond between the male and female structures. The physician then withdraws the first and second catheters from the patient, leaving the expanded detached balloon and first elongate body in the aneurysm sac, using the marker bands on each catheter and the radiopaque female tubular structure bonded to the proximal neck of the detachable balloon to confirm separation. Injection of radiocontrast through the 6Fr guide catheter using the side arm of the Tuohy-Borst adaptor confirms complete occlusion of the aneurysm neck and sac with the framing coil and expanded detachable balloon, as well as proper placement of the expanded detachable balloon and first elongated body. The physician then removes the right femoral artery introducer sheath and seals the right femoral artery hole with a closure device, successfully occluding the saccular aneurysm. Over the next several months, the elongated body within the central cavity of the balloon helps the balloon resist deflation, compression, or consolidation. The thin outer layer of gold on the balloon surface induces a complete layer of new endothelium on the blood-contacting surface of the balloon that completely seals the aneurysm neck, and also induces the formation of a capsule of tissue that holds the balloon in place. In this example, the expanded detached balloon is used to fill the center of the aneurysm after placement of one or more framing coils, and is used in place of one, several, or many finishing coils.

(Other treatment examples)
Those skilled in the art will appreciate that the above Examples 27, 28, 35, 37, and 38 can be used to treat other types of saccular aneurysms, including sidewall aneurysms and other types of bifurcation aneurysms. Those skilled in the art will appreciate that the methods described in Examples 31-38 can be used to treat other blood-containing structures, biological conduits, and biological spaces.
Aspects and embodiments of the present disclosure are presented in the following sections:

Aspects and embodiments related to methods of manufacturing the systems and devices disclosed herein:

[Aspect 1]
(1)(a)(i) a distal region, a proximal region generally opposite the distal region, and an intermediate region transitioning from the distal region to the proximal region;
(ii) a wall having an outer surface and an inner surface, the inner surface defining a central void or interior volume, the wall extending generally continuously from a proximal region through an intermediate region to a distal region;
(iii) an opening in the wall at the proximal region that allows for the passage of fluid from the first catheter into the central cavity or interior volume of the balloon and also allows for the passage of a portion of the second catheter into the central cavity or interior volume of the balloon;
(iv) an opening in the wall of the distal region that allows passage of a portion of the second catheter into the central cavity or interior volume of the balloon;
a compressed, deflated, or pleated, folded balloon configured for permanent implantation within a human patient, further comprising, upon expansion;
(b) defining a first lumen for permitting the passage of fluid from a proximal end of the first catheter to a distal end of the first catheter and into a central void or interior volume of the balloon;
(i) a proximal end coupled to a first proximal hub; and
(ii) a first catheter including a distal portion operably coupled or joined to an opening in the wall of the proximal region of the balloon;
(c) defining an elongate body, an expandable body, or a second lumen configured to receive a coagulation fluid;
(i) a proximal end coupled to a proximal hub;
(ii) a proximal portion that passes through the proximal hub of the first catheter;
(iii) an opening in the wall of the balloon at a proximal region and a distal portion that passes through a central void or interior volume of the balloon and extends beyond the opening in the wall of the balloon at a distal region; and
(iv) a second catheter including a distal upper end having an open end;
A first medical device comprising:
(2) a second medical device including a first elongate or expandable body configured for permanent implantation within a human patient joined to a second elongate body configured to push the first elongate or expandable body into a lumen of the second catheter and pull the first elongate or expandable body out of the lumen of the second catheter;
Including,
the balloon can be expanded by passage of fluid through the first catheter into a central void or interior volume of the balloon;
After expansion of the balloon, the second catheter can be moved forward or backward while keeping the expanded balloon fixed in place;
After expansion of the balloon, all or a portion of one or more second medical devices including an elongate body, an expandable body, or a coagulation fluid can be positioned through the lumen of the second catheter into the biological space adjacent to the balloon;
After expansion of the balloon, the second catheter can be pulled back while keeping the first catheter and balloon fixed in place until a distal tip of the second catheter is disposed within the central void or interior volume of the balloon, and all or a portion of one or more second medical devices including the elongate body, the expandable body, the solidification fluid or other balloon support material can be passed through a second lumen of the second catheter and disposed within the central void or interior volume of the balloon;
after expansion of the balloon and deployment of all or a portion of the one or more second medical devices, including the elongate body, the expandable body, the clotting fluid or other balloon support material, the first catheter can be separated from the expanded balloon, and the first and second catheters can be removed from the patient, leaving the balloon and all or a portion of the one or more elongate bodies, the expandable body, the clotting fluid or other balloon support material remaining within the patient;
the first elongate or expandable body is configured to pass in an elongate, constrained, compressed, or collapsed configuration through a lumen of the second catheter of the first medical device and into a human patient;
at least a portion of the first elongate or expandable body is configured for implantation within the interior volume of the balloon of the first medical device;
the first elongate body or the expandable body is separable from the second elongate body;
1. A system including one or more medical devices for the treatment of a human patient, characterized in that the second elongate body can be removed from the lumen of the second catheter while leaving the first elongate body in place within the patient.
[Aspect 2]
2. The system of aspect 1, wherein the balloon of the first medical device comprises a polymer.
[Aspect 3]
3. The system of claim 2, wherein the polymer comprises polyethylene terephthalate (PET), polyamide (nylon), or polyether block amide (Pebax).
[Aspect 4]
The system of any one of aspects 1 to 3, wherein the proximal portion of the balloon includes a proximal neck protruding from the balloon, and a radiopaque tubular segment that is clearly visible under fluoroscopy is joined to the proximal neck of the balloon.
[Aspect 5]
The system of any one of aspects 1 to 3, wherein the distal portion of the balloon includes a distal neck protruding from the balloon, and a radiopaque tubular segment that is clearly visible under fluoroscopy is joined to the distal neck of the balloon.
[Aspect 6]
The system of any one of aspects 1 to 3, wherein the proximal portion of the balloon includes a proximal neck protruding from the balloon, a radiopaque tubular segment being joined to the proximal neck of the balloon, and the distal portion of the balloon includes a distal neck protruding from the balloon, a radiopaque tubular segment being joined to the distal neck of the balloon.
[Aspect 7]
The system of any one of aspects 1 to 6, wherein the first catheter or first medical device includes a radiopaque marker that is clearly visible under fluoroscopy at or near the distal end of the first catheter.
[Aspect 8]
The system of aspect 1, wherein after expansion of the balloon of the first medical device, the second catheter of the first medical device can be moved forward or backward while the first catheter of the first medical device remains fixed in place.
[Aspect 9]
The system of aspect 1, wherein the second catheter of the first medical device comprises two radiopaque markers at or near the distal end of the catheter that are clearly visible under fluoroscopy, the radiopaque markers being configured to aid in the passage of the first elongated body or the expandable body through the lumen of the second catheter and to aid in the removal of the first elongated body or the expandable body passing through the lumen of the second catheter.

[Aspect 10]
10. The medical device of embodiment 9, wherein the first marker band is 0.3-1.5 mm from the distal end of the second catheter of the first medical device.
[Aspect 11]
10. The medical device of aspect 9, wherein the first marker band is 0.3, 0.4, 0.5, 0.6, 0.7, 0.8, 0.9, 1.0, 1.1, 1.2, 1.3, 1.4, or 1.5 mm proximal to the distal end of the second catheter.
[Aspect 12]
Aspect 12. The medical device of any one of aspects 9-11, wherein the second marker band is 2.0-4.0 mm proximal to the distal end of the second catheter of the first medical device.
[Aspect 13]
13. The system of any one of aspects 4-7 and 9-12, wherein the radiopaque marker comprises platinum, iridium, gold, tungsten, or a combination thereof.
[Aspect 14]
2. The system of aspect 1, wherein the first elongate or expandable body of the second medical device comprises a coiled wire.
[Aspect 15]
15. The system of claim 14, wherein the coiled wire has a primary diameter of 0.00175 to 0.003 inches.
[Aspect 16]
16. The system of aspect 14 or 15, wherein the first elongate or expandable body of the second medical device is a coiled wire, and the coiled wire has a secondary diameter of 0.010 to 0.050 inches.
[Aspect 17]
The secondary diameter of the coiled wire of the first elongate body or the expandable body is 0.010, 0.011, 0.012, 0.013, 0.014, 0.015, 0.016, 0.017, 0.018, 0.019, 0.020, 0.021, 0.023, 0.024, 0.025, 0.026, 0.027, 0.028, 0.029, 0.030 , 0.031, 0.032, 0.033, 0.034, 0.035, 0.036, or 0.037, 0.038, 0.039, 0.040, 0.041, 0.042, 0.043, 0.044, 0.045, 0.046, 0.047, 0.048, 0.049 or 0.050 inches.
[Aspect 18]
18. The system of any one of aspects 14-17, wherein the first elongate body or the expandable body has a tertiary structure that does not have a preformed loop or shape.
[Aspect 19]
Aspects 18. The system of any one of aspects 14-17, wherein the first elongate body or the expandable body is configured to form a straight or unformed tertiary shape upon relaxation.
[Aspect 20]
18. The medical device of any one of aspects 14-17, wherein the coiled wire is a straight vascular coil.
[Aspect 21]
6. The system of aspect 5, wherein at least a portion of the first elongate body or the expandable body has a helical, spherical, or complex tertiary structure.
[Aspect 22]
18. The system of any one of aspects 14-17, wherein the first elongate body or the expandable body is a coiled wire, and at least a portion of the first elongate body or the expandable body is configured to form a coil, a helix, or a complex tertiary shape when relaxed.
[Aspect 23]
18. The medical device of any one of aspects 14 to 17, wherein the coiled wire is a vascular coil.
[Aspect 24]
24. The system of any one of aspects 20-23, wherein the first elongate body or a distal portion of the expandable body comprises one loop of a tertiary structure, and when relaxed, the remainder of the first elongate body or the expandable body comprises a tertiary structure that does not have a preformed loop or shape.
[Aspect 25]
24. The system of any one of aspects 20-23, wherein a distal portion of the first elongate body or the expandable body comprises one loop of a tertiary structure, and a remaining portion of the first elongate body or the expandable body comprises a tertiary structure configured to form a straight or unformed tertiary shape when the ... comprises a tertiary structure configured to form a straight or unformed tertiary shape when the remaining portion of the first elongate body comprises a tertiary structure configured to form a straight or unformed terti
[Aspect 26]
24. The system of any one of aspects 20-23, wherein a distal portion of the first elongate body or the expandable body comprises a tertiary structure that does not have a preformed loop or shape when relaxed, comprising two tertiary structure loops and a remaining portion of the first elongate body or the expandable body.
[Aspect 27]
24. The system of any one of aspects 20-23, wherein a distal portion of the first elongate body or the expandable body comprises a tertiary structure configured to form a straight or unformed tertiary shape comprising the two tertiary structure loops and the remaining portion of the first elongate body or the expandable body.
[Aspect 28]
24. The system of any one of aspects 20-23, wherein the distal portion of the first elongate body or the expandable body comprises three loops of a tertiary structure while the remainder of the first elongate body or the expandable body comprises a tertiary structure that has no preformed loops or shapes.
[Aspect 29]
24. The system of any one of aspects 20-23, wherein the distal portion of the first elongate body or the expandable body comprises three loops of a tertiary structure, and the remaining portion of the first elongate body or the expandable body comprises a tertiary structure configured to form a straight or unformed tertiary shape when ...
[Aspect 30]
24. The system of any one of aspects 20-23, wherein the distal portion of the relaxed first elongate body or the expandable body comprises four or more loops of preformed loops or shapeless tertiary structures.
[Aspect 31]
24. The system of any one of aspects 20-23, wherein a distal portion of the first elongate body or the expandable body comprises a tertiary structure configured to form a straight or unformed tertiary shape, including four tertiary structure loops and a remaining portion of the first elongate body or the expandable body.
[Aspect 32]
31. The system of any one of aspects 21-30, wherein the tertiary diameter of the looped, coiled or shaped portion of the first elongate body or the expandable body is between 2 and 100 mm.
[Aspect 33]
The tertiary diameter of the looped, coiled or formed portion of the first elongate body or expandable body is 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49, 50, 51, 52, 53, 54, 55, 56, 57, 58, 59, 60, 61, 62, 63, 64, 65, 66, 67, 68, 69, 70, 71, 72, 73, 74, 75, 76, 77, 78, 79, 80, 81, 82, 83, 84, 85, 86, 87, 88, 89, 90, 91, 92, 93, 94, 95, 96, 97, 98, 99, 100, 101, 102, 103, 104, 105, 106, 107, 108, 109, 110, 111, 112, 113, 114, 115, 116, 117, 118, 119 31. The system of any one of aspects 21-30, wherein the distance between the first and second electrodes is 0, 51, 52, 53, 54, 55, 56, 57, 58, 59, 60, 61, 62, 63, 64, 65, 66, 67, 68, 69, 70, 71, 72, 73, 74, 75, 76, 77, 78, 79, 80, 81, 82, 83, 84, 85, 86, 87, 88, 89, 90, 91, 92, 93, 94, 95, 96, 97, 98, 99, or 100 mm.
[Aspect 34]
Aspects 33. The system of any one of aspects 14-32, wherein the first elongate body or the expandable body comprises platinum, iridium, nickel, tungsten, or a combination thereof.
[Aspect 35]
2. The system of aspect 1, wherein the first elongate or expandable body of the second medical device is a wire.
[Aspect 36]
35. The system of claim 34, wherein the wire has a diameter of 0.005 to 0.050 inches.
[Aspect 37]
The wire diameters are 0.005, 0.006, 0.007, 0.009, 0.010, 0.011, 0.012, 0.013, 0.014, 0.015, 0.016, 0.017, 0.018, 0.019, 0.020, 0.021, 0.023, 0.024, 0.025, 0.026, 0.027, 0.028, 0.029, 0. 35. The system of claim 34, wherein the diameter of the gap is 0.030, 0.031, 0.032, 0.033, 0.034, 0.035, 0.036, or 0.037, 0.038, 0.039, 0.040, 0.041, 0.042, 0.043, 0.044, 0.045, 0.046, 0.047, 0.048, 0.049, or 0.050 inches.
[Aspect 38]
37. The system of claim 35 or 36, wherein the diameter of the wire is a primary diameter.
[Aspect 39]
38. The system of any one of aspects 34-37, wherein the wire has no secondary diameter.
[Aspect 40]
38. The system of any one of aspects 34-37, wherein the first elongate body or the expandable body has a tertiary structure that does not have a preformed loop or shape.
[Aspect 41]
Aspects 37. The system of any one of aspects 34-36, wherein the first elongate body or the expandable body is configured to form a straight or unformed tertiary shape when relaxed.
[Aspect 42]
37. The medical device of any one of aspects 34-36, wherein the coiled wire is a straight vascular coil.
[Aspect 43]
The system of any one of aspects 34-36, wherein at least a portion of the first elongate body or the expandable body has a helical, spherical, or complex tertiary structure.
[Aspect 44]
37. The system of any one of aspects 34-36, wherein when relaxed, the first elongate body or a distal portion of the expandable body comprises one loop of a tertiary structure, and a remaining portion of the first elongate body or the expandable body comprises a preformed loop or a tertiary structure that does not have a shape.
[Aspect 45]
The system of any one of aspects 34-36, wherein when relaxed, the first elongate body or a distal portion of the expandable body comprises one loop of a tertiary structure, and a remaining portion of the first elongate body or the expandable body comprises a tertiary structure configured to form a straight or unformed tertiary shape.
[Aspect 46]
37. The system of any one of aspects 34-36, wherein when relaxed, the first elongate body or a distal portion of the expandable body comprises two loops of a tertiary structure, and a remaining portion of the first elongate body or the expandable body comprises a preformed loop or a tertiary structure that has no shape.
[Aspect 47]
Aspects 34-36, the system of any one of aspects 34-36, wherein when relaxed, the first elongate body or a distal portion of the expandable body comprises two loops of a tertiary structure, and a remaining portion of the first elongate body or the expandable body comprises a tertiary structure configured to form a straight or unformed tertiary shape.
[Aspect 48]
37. The system of any one of aspects 34-36, wherein when relaxed, the distal portion of the first elongate body or the expandable body comprises three loops of a tertiary structure, and a remaining portion of the first elongate body or the expandable body comprises preformed loops or a tertiary structure that has no shape.
[Aspect 49]
37. The system of any one of aspects 34-36, wherein when relaxed, the distal portion of the first elongate body or the expandable body comprises three loops of a tertiary structure, and a remaining portion of the first elongate body or the expandable body comprises a tertiary structure configured to form a straight or unformed tertiary shape.
[Aspect 50]
The system of any one of aspects 34-36, wherein when relaxed, the first elongate body or the distal portion of the expandable body comprises four or more loops of a tertiary structure.
[Aspect 51]
50. The system of any one of aspects 34-49, wherein the tertiary diameter of the looped, coiled or shaped portion of the first elongate body or the expandable body is between 2 and 100 mm.
[Aspect 52]
The tertiary diameter of the looped, coiled or formed portion of the first elongate body or expandable body is 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49, 50, 51, 52, 53, 54, 55, 56, 57, 58, 59, 60, 61, 62 , 63, 64, 65, 66, 67, 68, 69, 70, 71, 72, 73, 74, 75, 76, 77, 78, 79, 80, 81, 82, 83, 84, 85, 86, 87, 88, 89, 90, 91, 92, 93, 94, 95, 96, 97, 98, 99, or 100 mm.
[Aspect 53]
The system of any one of aspects 34 to 51, wherein the wire comprises Nitinol.
[Aspect 54]
53. The system of embodiment 52, wherein the Nitinol wire is plated or coated with platinum or gold.
[Aspect 55]
54. The system of claim 52 or 53, wherein the Nitinol wire further comprises one or more radiopaque markers that are clearly visible under fluoroscopy.
[Aspect 56]
55. The system of aspect 54, wherein the radiopaque marker comprises platinum, iridium, gold, tungsten, or a combination thereof.
[Aspect 57]
56. The system of aspect 54 or 55, wherein the radiopaque marker is in the form of a ring or band around the portion of the wire.
[Aspect 58]
The system of any one of aspects 34-56, wherein the second medical device further includes a catheter, and the first elongate or expandable body of the second medical device is configured to be carried by the catheter of the second medical device and through the lumen of the second catheter of the first medical device.
[Aspect 59]
58. The system of aspect 57, wherein the distal portion of the catheter comprises a radiopaque marker that is clearly visible under fluoroscopy.
[Aspect 60]
60. The system of aspect 58, wherein the radiopaque marker comprises platinum, iridium, gold, tungsten, or a combination thereof.
[Aspect 61]
The system of aspect 1, wherein the first elongate or expandable body of the second medical device comprises a wire assembly, a coiled wire assembly, a braided wire assembly, a woven wire assembly, or other expandable body.
[Aspect 62]
61. The system of aspect 60, wherein the first elongate body or the expandable body of the second medical device is self-expanding.
[Aspect 63]
The system of aspects 60 or 61, wherein the wire assembly, coiled wire assembly, braided wire assembly, or woven assembly is configured to form into the general shape and size of the expanded balloon of the first medical device when not in a compressed, collapsed, constrained, or elongated configuration.
[Aspect 64]
63. The system of any one of aspects 60-62, wherein the wire assembly, coiled wire assembly, braided wire assembly, or woven assembly is configured to form a generally cylindrical shape when not in the compressed, collapsed, constrained, or elongated configuration.
[Aspect 65]
63. The system of any one of aspects 60-62, wherein the wire assembly, coiled wire assembly, braided wire assembly, or woven assembly is configured to form a generally spherical shape when not in the compressed, collapsed, constrained, or elongated configuration.
[Aspect 66]
65. The system of any one of aspects 60-64, wherein the first elongate body or expandable body of the second medical device comprises Nitinol.
[Aspect 67]
66. The system of embodiment 65, wherein the Nitinol wire is plated or coated with platinum or gold.
[Aspect 68]
The system of any one of aspects 65 or 66, wherein the Nitinol wire further comprises one or more radiopaque markers that are clearly visible under fluoroscopy.
[Aspect 69]
68. The system of aspect 67, wherein the radiopaque marker comprises platinum, iridium, gold, tungsten, or a combination thereof.
[Aspect 70]
2. The system of aspect 1, wherein the first elongate or expandable body of the second medical device comprises polymeric strands.
[Aspect 71]
70. The system of embodiment 69, wherein the polymer strands are plated or coated with platinum or gold.
[Aspect 72]
The system of any one of aspects 69 or 70, wherein the polymer strand further comprises one or more radiopaque markers that are visible under fluoroscopy.
[Aspect 73]
72. The system of aspect 71, wherein the radiopaque marker comprises platinum, iridium, gold, tungsten, or a combination thereof.
[Aspect 74]
73. The system of claim 71 or 72, wherein the radiopaque marker is in the form of a ring or band around the portion of the polymer strand.
[Aspect 75]
Aspect 74. The system of any one of aspects 1-73, wherein the first elongate body or the expandable body is 10-400 cm in length.
[Aspect 76]
74. The system of any one of the preceding aspects, wherein the first elongate body or the expandable body is 10-70 cm in length.
[Aspect 77]
74. The system of any one of the preceding aspects, wherein the first elongate body or the expandable body is 70-400 cm in length.
[Aspect 78]
74. The system of any one of the preceding aspects, wherein the first elongate body or the expandable body is 10, 20, 30, 40, 50, 60, 70, 80, 90, 100, 110, 120, 130, 140, 150, 160, 170, 180, 190, 200, 210, 220, 230, 240, 250, 260, 270, 280, 290, 300, 310, 320, 330, 340, 350, 360, 370, 380, 390, or 400 cm in length.
[Aspect 79]
Aspect 78. The system of any one of aspects 1-77, wherein the first elongate body or the expandable body comprises a lubricious layer or coating.
[Aspect 80]
79. The system of embodiment 78, wherein the lubricious layer or coating is hydrophilic.
[Aspect 81]
80. The system of embodiment 78 or 79, wherein the coating is a Serene® coating available from SurModics, Inc. or an Assist® coating available from Biolnteractions, Inc.
[Aspect 82]
80. The system of claim 78 or 79, wherein the lubricious layer is PTFE, polyimide, or a PTFE and polyimide composite.
[Aspect 83]
Aspect 1, the system of any one of aspects 1-81, wherein the second elongate body comprises a lubricious layer or coating.
[Aspect 84]
83. The system of embodiment 82, wherein the lubricious layer or coating is hydrophilic.
[Aspect 85]
84. The system of embodiment 82 or 83, wherein the coating is a Serene® coating available from SurModics, Inc. or an Assist® coating available from Biolnteractions, Inc.
[Aspect 86]
84. The system of claim 82 or 83, wherein the lubricating layer is PTFE, polyimide, or a PTFE and polyimide composite.
[Aspect 87]
The system of any one of aspects 1-85, wherein the second elongate body of the second medical device includes visual or tactile markings that enable a user to determine the length of the first elongate body or the expandable body that has been pushed distally relative to the distal tip of the second catheter.
[Aspect 88]
Aspects 1-87. The system of any one of aspects 1-86, wherein the first elongate body or expandable body of the second medical device is coupled to the second elongate body of the second medical device by a bond or joint that can be separated after the first elongate body is positioned within an artery, vein, left atrial appendage, aneurysm, blood-containing space, biological conduit, or central void or interior volume of an expanded balloon of the first medical device.
[Aspect 89]
a first elongate body or expandable body of a second medical device is joined to a second elongate body of a second medical device, and after expelling the first elongate body or expandable body of the second medical device from a distal end of a second catheter of the first medical device,

Aspects 1-87. The system of any one of aspects 1-86, wherein the second elongate body of the second medical device can be separated from the first elongate body or the expandable body of the second medical device, and the second elongate body can be removed from the patient while leaving the first elongate body or the expandable body within the patient.
[Aspect 90]
89. The system of aspect 87 or 88, wherein the first elongate body or expandable body of the second medical device and the second elongate body of the second medical device are configured to be separated by mechanical means.
[Aspect 91]
90. The system of aspect 87 or 88, wherein the first elongate body or expandable body of the second medical device and the second elongate body of the second medical device are configured to separate by electrolysis or erosion.
[Aspect 92]
91. The system of any one of aspects 87, 88, and 90, wherein the separation region between the first elongate body or the expandable body and the second elongate body is susceptible to electrolysis or corrosion.
[Aspect 93]
92. The system of embodiment 90 or 91, wherein the segment that is susceptible to electrolysis or corrosion comprises stainless steel.
[Aspect 94]
The system of any one of aspects 90-92, wherein the second elongate body of the second medical device is configured to allow passage of an electric current from a proximal portion of the second elongate body to an area that is sensitive to electrolysis or corrosion.
[Aspect 95]
94. The system of aspect 93, wherein at least a portion of the second elongate body of the second medical device is configured to allow the passage of direct current.
[Aspect 96]
Aspects 95. The system of any one of aspects 90-94, wherein at least a portion of the second elongate body of the second medical device is covered with a material that insulates it from electrical conduction.
[Aspect 97]
96. The system of any one of aspects 90-95, wherein at least a portion of the segment that is susceptible to electrolysis or corrosion or configured to be dissolved by electrolysis is not covered with a material that insulates it from electrical conduction.
[Aspect 98]
90. The system of aspect 87 or 88, wherein the first elongate body or expandable body of the second medical device and the second elongate body of the second medical device are configured to separate by electrothermal means.
[Aspect 99]
98. The system of aspect 97, wherein the separation occurs in a region between the first elongate body or expandable body and the second elongate body that can be melted by heating.
[Aspect 100]
The system of aspect 97 or 98, wherein the second medical device is configured to allow passage of an electric current from a proximal portion of the second elongate body to a heat-resistant element at or near the area between the first elongate body or expandable body and the second elongate body that can be melted by heating.
[Aspect 101]
100. The system of any one of aspects 97-99, wherein at least a portion of the second elongate body of the second medical device is covered with a material that insulates it from electrical conduction.
[Aspect 102]
87. The system of any one of aspects 1-86, wherein the first elongate body or expandable body of the second medical device and the second elongate body of the second medical device are not joined, and the second elongate body of the second medical device is configured to push the first elongate body or expandable body of the second medical device through the lumen of the second catheter of the first medical device.
[Aspect 103]
The system of aspect 101, wherein the second elongate body of the second medical device is configured to eject the first elongate body or the expandable body of the second medical device from the distal end of the lumen of the second catheter of the first medical device.
[Aspect 104]
The system of aspect 101 or 102, wherein the second elongate body of the second medical device can be removed from the lumen of the second catheter of the first medical device after expulsion of the first elongate body or the expandable body of the second medical device from the distal end of the lumen of the second catheter of the first medical device.
[Aspect 105]
A system according to any one of aspects 1 to 103, comprising a carrier for a first elongate body or expandable body and at least a portion of a second elongate body, wherein an end of the carrier holding a distal end of the first elongate body or expandable body is configured to join a proximal hub of a second catheter.
[Aspect 106]
105. The system of aspect 104, wherein the carrier is configured in a coil shape.
[Aspect 107]
Aspects 1-105, the system of any one of aspects 1-105, wherein a portion of the first elongate or expandable body of the second medical device is configured to contact an inner surface of an expanded balloon of the first medical device.
[Aspect 108]
The system of any one of aspects 1-106, wherein the maximum overall or tertiary diameter of the first elongate body or expandable body of the second medical device is in the range of 5% smaller to 20% larger than the maximum diameter of the expanded balloon of the first medical device.
[Aspect 109]
The system of any one of aspects 1-107, wherein the maximum overall or tertiary diameter of the first elongate or expandable body of the second medical device is 1, 2, 3, 4, 5, 6, 7, 8, 9, or 10 mm greater than the maximum diameter of the expanded balloon of the first medical device.
[Aspect 110]
Aspects 1-109. The system of any one of aspects 1-108, wherein the volume of the one or more first elongate bodies or expandable bodies of the second medical device fills 5-75% of the volume of the central void of the expanded balloon.
[Aspect 111]
20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49, 50, 51, 52, 53, 54, 55, 56, 57, 58, 59, 60, 61, 62, 63, 64, 65, 66, 67, 68, 69, 70, 71, 72, 73, 74, 75, 76, 77, 78, 79, 80, 81, 82, 83, 84, 85, 86, 87, 88, 89, 90, 91, 92, 93, 94, 95, 96, 97, 98, 99, 100, 101, 102, 103, 104, 105, 106, 107, 108, 109, 110, 111, 112, 113, 114, 115, 116, 117, 118, 120, 114, 125, 126, 127, 128, 130, 132, 133, 134, 135, 136, 137, 138, 140, 142, 143, 144, 145, 109. The system of any one of the preceding aspects, wherein the system satisfies 37, 38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49, 50, 51, 52, 53, 54, 55, 56, 57, 58, 59, 60, 61, 62, 63, 64, 65, 66, 67, 68, 69, 70, 71, 72, 73, 74, or 75%.
[Aspect 112]
The system of any one of aspects 1-110, wherein the first elongate body or the expandable body is flexible, the second elongate body is flexible, or the first elongate body and the second elongate body are flexible.
[Aspect 113]
advancing a first medical device over the guidewire into the artery, vein, left atrial appendage, other blood-containing structure, biological conduit, or biological space;
Expanding a balloon of the first medical device;
removing the guidewire from the lumen of the second catheter of the first medical device;
pulling back the second catheter of the first medical device while holding the expanded balloon of the first medical device fixed in place until a distal end of the second catheter of the first medical device is disposed within the central void or inner lumen of the expanded balloon of the first medical device;
Passing a first elongate or expandable body of a second medical device through the lumen of the second catheter of the first medical device and disposing within the central void or inner lumen of the expanded balloon of the first medical device;
Separating the first elongate body or the expandable body of the second medical device from the second elongate body of the second medical device;
Separating the balloon of the first medical device from the first catheter of the first medical device;
A method of using the system of any one of aspects 1-111 in a human patient, removing the first catheter of the first medical device, the second catheter of the first medical device, and the second elongate body of the second medical device from the patient.
[Aspect 114]
advancing a first medical device over the guidewire into the artery, vein, left atrial appendage, other blood-containing structure, biological conduit, or biological space;
Expanding a balloon of the first medical device;
removing the guidewire from the lumen of the second catheter of the first medical device;
passing a distal portion of the first elongate body or expandable body of the second medical device through the lumen of the second catheter of the first medical device and placing the distal portion of the first elongate body or expandable body of the second medical device within the lumen of the artery, vein, other blood-containing structure, biological conduit, or biological space distal to the expanded balloon;
pulling back the second catheter of the first medical device while holding the expanded balloon of the first medical device fixed in place until a distal end of the second catheter of the first medical device is disposed within the central void or inner lumen of the expanded balloon of the first medical device;
a remaining portion of the first elongate body or expandable body of the second medical device is passed through the lumen of the second catheter of the first medical device and disposed in a central void or inner lumen of the expanded balloon of the first medical device;
Separating the first elongate body or the expandable body of the second medical device from the second elongate body of the second medical device;
Separating the balloon of the first medical device from the first catheter of the first medical device;
A method of using the system of any one of aspects 1-111 to treat an artery, vein, other blood-containing structure, biological conduit, or biological space of a human patient, comprising removing the first catheter and the second catheter of the first medical device, and the second elongate body of the second medical device from the patient.
[Aspect 115]
advance a first medical device over the guidewire into the aneurysm sac;
Expanding a balloon of the first medical device within the aneurysm sac;
pulling back the expanded balloon of the first medical device until a portion of an outer surface of the expanded balloon contacts a portion of the neck of the aneurysm;
removing the guidewire from the lumen of the second catheter of the first medical device;
Optionally, while keeping the expanded balloon of the first medical device fixed in place, advancing a second catheter of the first medical device into the aneurysm sac distal to the expanded balloon;
passing a distal portion of the first elongate body or expandable body of the second medical device through the lumen of the second catheter of the first medical device and positioning the distal portion of the first elongate body or expandable body of the second medical device within the aneurysm sac distal to the expanded balloon;
pulling back the second catheter of the first medical device while holding the expanded balloon of the first medical device fixed in place until a distal end of the second catheter of the first medical device is disposed within the central void or inner lumen of the expanded balloon of the first medical device;
a remaining portion of the first elongate body or expandable body of the second medical device is passed through the lumen of the second catheter of the first medical device and disposed within the central void or inner lumen of the expanded balloon of the first medical device;
Separating the first elongate body or the expandable body of the second medical device from the second elongate body of the second medical device;
Separating the balloon of the first medical device from the first catheter of the first medical device;
A method of using the system of any one of aspects 1-111 in a human patient, removing the first catheter and the second catheter of the first medical device and the second elongate body of the second medical device from the patient.
[Aspect 116]
Use of the system described in aspect 114, wherein when a distal portion of the first elongate body or expandable body of the second medical device is positioned within the aneurysm or left atrial appendage and a proximal portion of the second elongate body of the second medical device is positioned within the central void of the expanded detachable balloon, the volume of the portion of the first elongate body or expandable body within the aneurysm or left atrial appendage fills 5-75% of the volume of the remaining unfilled aneurysm or portion of the left atrial appendage, and the volume of the portion of the first elongate body or expandable body within the central void of the expanded balloon fills 5-75% of the volume of the central void of the expanded balloon.
[Aspect 117]
116. The use of the system of aspect 115, wherein 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49, 50, 51, 52, 53, 54, 55, 56, 57, 58, 59, 60, 61, 62, 63, 64, 65, 66, 67, 68, 69, 70, 71, 72, 73, 74, or 75% of the volume of the aneurysm or left atrial appendage not filled by the expanded balloon is filled by the first elongate body or expandable body.
[Aspect 118]
116. The use of the system of aspect 115, wherein the central void of the expanded balloon is filled to 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49, 50, 51, 52, 53, 54, 55, 56, 57, 58, 59, 60, 61, 62, 63, 64, 65, 66, 67, 68, 69, 70, 71, 72, 73, 74, or 75% of its volume.

Aspects and embodiments relating to the elongate body, removal of the elongate body, and the separate expansion balloon as disclosed herein:
[Aspect 1]
A medical device including an elongate body, wherein the elongate body is a coiled wire, and at least a portion of the first elongate body or the expandable body is configured to form a coiled, helical, or complex tertiary shape when relaxed.
[Aspect 2]
The medical device of embodiment 1, wherein the distal portion of the elongate body comprises one loop of the tertiary structure, the central portion of the elongate body comprises a tertiary structure that has no preformed loop or shape when relaxed, and the proximal portion of the elongate body comprises one loop of the tertiary structure.
[Aspect 3]
The medical device of embodiment 1, wherein the distal portion of the elongate body comprises two loops of a tertiary structure, the central portion of the elongate body comprises a tertiary structure that has no preformed loops or shape when relaxed, and the proximal portion of the elongate body comprises two loops of a tertiary structure.
[Aspect 4]
The medical device of embodiment 1, wherein the distal portion of the elongate body comprises three loops of a tertiary structure, the central portion of the elongate body comprises a tertiary structure that has no preformed loops or shape when relaxed, and the proximal portion of the elongate body comprises three loops of a tertiary structure.
[Aspect 5]
The medical device of embodiment 1, wherein the distal portion of the elongate body comprises one loop of the tertiary structure, the central portion of the elongate body comprises a tertiary structure configured to form a straight or unformed tertiary shape when relaxed, and the proximal portion of the elongate body comprises one loop of the tertiary structure.
[Aspect 6]
The medical device of embodiment 1, wherein the distal portion of the elongate body comprises two loops of a tertiary structure, the central portion of the elongate body comprises a tertiary structure configured to form a straight or unformed tertiary shape when relaxed, and the proximal portion of the elongate body comprises two loops of a tertiary structure.
[Aspect 7]
The medical device of embodiment 1, wherein the distal portion of the elongate body comprises three loops of a tertiary structure, the central portion of the elongate body comprises a tertiary structure configured to form a straight or unformed tertiary shape when relaxed, and the proximal portion of the elongate body comprises three loops of a tertiary structure.
[Aspect 8]
2. The medical device of embodiment 1, wherein the distal portion of the elongate body comprises a tertiary structure having no preformed loops or shapes when relaxed, and the proximal portion of the elongate body comprises one loop of the tertiary structure.
[Aspect 9]
2. The medical device of embodiment 1, wherein the distal portion of the elongate body comprises a tertiary structure having no preformed loops or shapes when relaxed, and the proximal portion of the elongate body comprises two loops of the tertiary structure.
[Aspect 10]
2. The medical device of embodiment 1, wherein the distal portion of the elongate body comprises a tertiary structure having no preformed loops or shapes when relaxed, and the proximal portion of the elongate body comprises three loops of the tertiary structure.
[Aspect 11]
The medical device of embodiment 1, wherein the distal portion of the elongate body comprises a tertiary structure configured to form a straight or unformed tertiary shape when relaxed, and the proximal portion of the elongate body comprises one loop of the tertiary structure.
[Aspect 12]
The medical device of embodiment 1, wherein the distal portion of the elongate body comprises a tertiary structure configured to form a straight or unformed tertiary shape when relaxed, and the proximal portion of the elongate body comprises two loops of the tertiary structure.
[Aspect 13]
The medical device of embodiment 1, wherein the distal portion of the elongate body comprises a tertiary structure configured to form a straight or unformed tertiary shape when relaxed, and the proximal portion of the elongate body comprises three loops of the tertiary structure.

Aspects and embodiments relating to kits incorporating medical devices as disclosed herein:
[Aspect 1]
(1)(a)(i) a distal region, a proximal region generally opposite the distal region, an intermediate region transitioning from the distal region to the proximal region, a first axis extending proximally-distally between the proximal and distal regions, and a second axis perpendicular to the first axis;
(ii) a wall having an outer surface and an inner surface, the inner surface defining a central void or interior volume, the wall extending generally continuously from a proximal region through an intermediate region to a distal region;
(iii) an opening in the wall at the proximal region that allows for the passage of fluid from the first catheter into the central cavity or interior volume of the balloon and also allows for the passage of a portion of the second catheter into the central cavity or interior volume of the balloon;
(iv) an opening in the wall of the distal region that allows passage of a portion of the second catheter into the central cavity or interior volume of the balloon;
a compressed, deflated or pleated, folded balloon configured for permanent implantation within a human patient;
(b) defining a first lumen for permitting the passage of fluid from a proximal end of the first catheter to a distal end of the first catheter and into a central void or interior volume of the balloon;
(i) a proximal end coupled to a first proximal hub; and
(ii) a first catheter including a distal portion operably coupled or joined to an opening in the wall of the proximal region of the balloon;
(c) defining an elongate body, an expandable body, or a second lumen configured to receive a coagulation fluid;
(i) a proximal end coupled to a proximal hub;
(ii) a portion that passes through the proximal hub of the first catheter;
(iii) a distal portion that passes through the central void or interior volume of the balloon and exits the central void or interior volume of the balloon through an opening in the wall of the distal region of the balloon;
(iv) a second catheter including an open distal end;
and (2) one or more first medical devices comprising: (a) one or more elongate or expandable bodies configured to pass through a second catheter of the first medical device in a compressed, collapsed, compressed, or elongated form; and (b) one or more second medical devices comprising a delivery system for the one or more elongate or expandable bodies;
Including,
the balloon can be expanded by passage of fluid through the first catheter and into a central cavity of the balloon;
After expansion of the balloon, the second catheter can be moved forward or backward while keeping the expanded balloon fixed in place;
After expansion of the balloon, one or more of an elongate body, an expandable body, or a coagulation fluid can be disposed through the lumen of the second catheter into the biological space adjacent to the balloon;
After expansion of the balloon, the second catheter can be pulled back until a distal end of the second catheter is positioned within the central cavity of the expanded balloon and one or more of the elongate body, the expandable body, or the coagulation fluid can pass through the lumen of the second catheter and into the central cavity of the balloon;
1. A kit including a medical device for treating a human patient, characterized in that after expansion of the balloon and deployment of the elongate body, expandable body, or coagulation fluid, the first catheter can be separated from the expanded balloon, and the first and second catheters can be removed from the patient while leaving the balloon and one or more elongate bodies, expandable bodies, or coagulation fluids in the patient.
[Aspect 2]
2. The kit of embodiment 1, wherein the wall of the balloon comprises a single layer of polymer.
[Aspect 3]
3. The kit of claim 1 or 2, wherein the wall of the balloon comprises a single layer of polyethylene terephthalate (PET), polyamide (nylon), or polyether block amide (Pebax).
[Aspect 4]
4. The kit of claim 2 or 3, wherein the balloon comprises a continuous layer of polymer.
[Aspect 5]
4. The kit of embodiment 2 or 3, wherein the balloon comprises a discontinuous layer of polymer.
[Aspect 6]
6. The kit according to any one of embodiments 2 to 5, wherein the balloon has a wall thickness of 5 to 300 μm.
[Aspect 7]
The kit of any one of embodiments 2 to 5, wherein the balloon has a wall thickness of 0.0002 to 0.012 inches.
[Aspect 8]
The kit of any one of the preceding aspects, comprising a balloon having a proximal neck and a distal neck.
[Aspect 9]
2. The kit of embodiment 1, wherein at least a portion of the wall of the balloon comprises two or more polymeric layers.
[Aspect 10]
10. The kit of claim 9, wherein the inner layer of the balloon comprises polyethylene terephthalate, polyamide, or polyether block amide.
[Aspect 11]
11. The kit of embodiment 10, wherein the inner layer of the balloon has a wall thickness of 5 to 300 μm.
[Aspect 12]
12. The kit of embodiment 10 or 11, wherein the layer of polyethylene terephthalate, polyamide, or polyether block amide comprises a continuous layer.
[Aspect 13]
12. The kit of claim 10 or 11, wherein the layer of polyethylene terephthalate, polyamide, or polyether block amide comprises a discontinuous layer.
[Aspect 14]
The kit of any one of embodiments 9 to 13, further comprising one or more outer layers or coatings comprising polyurethane, silicone, or poly(p-xylylene) (Parylene).
[Aspect 15]
The kit of embodiment 14, wherein the outer layer or coating of the balloon has a wall thickness of 0.1 to 100 μm.
[Aspect 16]
16. The kit of embodiment 14 or 15, wherein the layer of polyurethane, silicone, or poly(p-xylylene) comprises a continuous layer.
[Aspect 17]
16. The kit of embodiment 14 or 15, wherein the layer of polyurethane, silicone, or poly(p-xylylene) comprises a discontinuous layer.
[Aspect 18]
18. The kit of any one of embodiments 2 to 17, comprising one or more layers or coatings comprising a metal having a thickness of 0.001 to 1 μm.
[Aspect 19]
20. The kit of embodiment 18, wherein the metal comprises gold or an alloy thereof.
[Aspect 20]
20. The kit of embodiment 18, wherein the metal comprises titanium or an alloy thereof.
[Aspect 21]
20. The kit of embodiment 18, wherein the metal comprises gold, titanium, or an alloy thereof, or a combination thereof.
[Aspect 22]
22. The kit of any one of aspects 18 to 21, wherein the metal layer or coating comprises an exterior layer.
[Aspect 23]
23. The kit of any one of aspects 2 to 22, wherein the balloon has a total wall thickness of 5 to 400 μm.
[Aspect 24]
The total thickness of the balloon wall is 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43 , 44, 45, 46, 47, 48, 49, 50, 51, 52, 53, 54, 55, 56, 57, 58, 59, 60, 61, 62, 63, 64, 65, 66, 67, 68, 69, 70, 71, 72, 73, 74, 75, 76, 77, 78, 79, 80, 81, 82, 83, 84, 85, 86, 87, 88, 89, 90, 91, 92, 93, 94, 95, 96, 97, 98, 99, 100, 200, 300, or 400 μm.
[Aspect 25]
23. The kit of any one of aspects 2 to 22, wherein the balloon has an overall wall thickness of 0.0002 to 0.016 inches.
[Aspect 26]
2. The kit of embodiment 1, wherein the wall of the balloon comprises a single layer of metal.
[Aspect 27]
27. The kit of embodiment 26, wherein the balloon comprises a continuous layer of metal.
[Aspect 28]
27. The kit of embodiment 26, wherein the balloon comprises a discontinuous layer of metal.
[Aspect 29]
29. The kit of any one of aspects 26 to 28, wherein the wall of the balloon comprises gold or an alloy thereof.
[Aspect 30]
29. The kit of any one of aspects 26 to 28, wherein the wall of the balloon comprises platinum, or an alloy thereof.
[Aspect 31]
31. The kit according to any one of aspects 26 to 30, wherein the balloon has a wall thickness of 5 to 300 μm.
[Aspect 32]
31. The kit of any one of aspects 26 to 30, wherein the balloon has a wall thickness of 0.0002 to 0.012 inches.
[Aspect 33]
33. The kit of any one of aspects 26-32, comprising one or more outer layers or coatings, one or more inner layers or coatings, or both one or more outer layers or coatings and one or more inner layers or coatings.
[Aspect 34]
34. The kit of embodiment 33, wherein the outer layer or coating and the inner layer or coating comprise one or more polymers.
[Aspect 35]
35. The kit of embodiment 33 or 34, wherein the inner layer or coating and the outer layer or coating comprise a material that renders the metallic layer non-conductive to the inner or outer surface of the balloon.
[Aspect 36]
36. The kit of embodiment 35, wherein the one or more polymers comprise polyurethane, silicone, or poly(p-xylylene).
[Aspect 37]
37. The kit of claim 35 or 36, wherein each outer layer or coating of the balloon has a wall thickness of 0.1 to 100 μm.
[Aspect 38]
38. The kit of any one of aspects 34-37, wherein at least one of the inner layer or coating or the outer layer or coating comprises a continuous layer.
[Aspect 39]
38. The kit of any one of aspects 34-37, wherein at least one of the inner layer or coating or the outer layer or coating comprises a discontinuous layer.
[Aspect 40]
The kit according to any one of aspects 26 to 32, comprising an intermediate layer comprising a metal, and inner and outer layers or coatings comprising a polymer.
[Aspect 41]
41. The kit of embodiment 40, wherein the inner layer or coating and the outer layer or coating are continuous layers.
[Aspect 42]
The kit of embodiment 40, wherein the inner layer or coating and the outer layer or coating are discontinuous layers.
[Aspect 43]
43. The kit of any one of aspects 40-42, wherein the inner layer or coating and the outer layer or coating comprise a material that renders the metal layer non-conductive to the inner or outer surface of the balloon.
[Aspect 44]
44. The kit of any one of embodiments 40-43, wherein the outer layer or coating and the inner layer or coating comprise polyurethane, silicone, or poly(p-xylylene).
[Aspect 45]
A kit according to any one of aspects 40 to 44, wherein the inner layer or coating of the balloon has a wall thickness of 0.1 to 100 μm and the outer layer or coating of the balloon has a wall thickness of 0.1 to 100 μm. [Aspect 46]
33. The kit of any one of aspects 26 to 32, comprising an inner layer comprising a metal, and an outer layer or coating comprising a polymer.
[Aspect 47]
46. The kit of embodiment 45, wherein the outer layer or coating comprises a continuous layer.
[Aspect 48]
46. The kit of embodiment 45, wherein the outer layer or coating comprises a discontinuous layer.
[Aspect 49]
49. The kit of any one of aspects 46-48, wherein the outer layer or coating comprises a material that renders the metallic layer non-conductive to the outer surface of the balloon.
[Aspect 50]
The kit of embodiment 49, wherein the outer layer or coating comprises polyurethane, silicone, or poly(p-xylylene).
[Aspect 51]
51. The kit according to any one of aspects 46 to 50, wherein the thickness of the outer layer or coating is from 0.1 to 100 μm.
[Aspect 52]
The total thickness of the balloon wall is 5 to 400 μm.
The total thickness of the balloon wall is 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49, 50, 51, 52, 53, 54, 55, 56, 57, 58, 59, 60, 61, 62, 63, 64, 65, 66, 67, 68, 69, 70, 71, 72, 73, 74, 75, 76, 77, 78, 79, 80, 81, 82, 83, 84, 85, 86, 87, 88, 89, 90, 91, 92, 93, 94, 95, 96, 97, 98, 99, 100, 101, 102, 103, 104, 105, 106, 107, 108, 109 ...10, 111, 11 39. The kit of any one of aspects 26 to 38, wherein the diameter of the membrane is 8, 59, 60, 61, 62, 63, 64, 65, 66, 67, 68, 69, 70, 71, 72, 73, 74, 75, 76, 77, 78, 79, 80, 81, 82, 83, 84, 85, 86, 87, 88, 89, 90, 91, 92, 93, 94, 95, 96, 97, 98, 99, 100, 200, 300, or 400 μm.
[Aspect 54]
39. The kit of any one of aspects 26 to 38, wherein the balloon has a total wall thickness of 0.0002 to 0.016 inches.
[Aspect 55]
55. The kit of any one of aspects 26-54, wherein at least a portion of the outer surface of the metal has a rounded, pebbled, or granular surface structure.
[Aspect 56]
55. The kit of any one of embodiments 26-54, wherein the outer layer comprises a metal, and an outer surface of the metal comprises a rounded, pebbled, or granular surface structure.
[Aspect 57]
57. The kit of embodiment 55 or 56, wherein the pebbles or granules have a surface height of 0.01 to 10 μm.
[Aspect 58]
58. The kit of any one of aspects 26-57, wherein at least a portion of the balloon wall is formed by electroplating or electroforming.
[Aspect 59]
59. The kit of any one of aspects 26 to 58, wherein at least a portion of the wall of the balloon is annealed.
[Aspect 60]
60. The kit of any one of aspects 26-59, wherein the balloon has sufficient strength to maintain itself in an expanded or partially expanded shape in vivo after separation from the shafts of the first and second members.
[Aspect 61]
60. The kit of any one of aspects 26-59, wherein the metal balloon has sufficient strength to maintain itself in an expanded or partially expanded shape in vivo when no solid or semi-solid material not from the patient is present within the central void of the expanded metal balloon after separation from the first and second catheters.
[Aspect 62]
60. The kit of any one of aspects 26-59, wherein the expanded metal balloon has sufficient strength to maintain itself in an expanded or partially expanded shape in vivo after separation from the first and second catheters, and wherein no solid or semi-solid material or component not derived from the patient is required within a central void or interior volume of the expanded metal balloon to help the metal balloon assume or maintain at least an expanded shape after separation of the expanded metal balloon and the first and second catheters.
[Aspect 63]
60. The kit of any one of aspects 26-59, wherein the expanded metal balloon alone has sufficient strength to maintain itself in an expanded or partially expanded shape in vivo after separation from the first and second catheters.
[Aspect 64]
60. The kit of any one of aspects 26-59, wherein after separation of the metal balloon from the first and second catheters in vivo, the pressure within the central void or interior volume of the expanded metal balloon is equal to or less than the pressure outside the expanded metal balloon.
[Aspect 65]
60. The kit according to any one of aspects 26 to 59, wherein the polymer and metal balloon are inserted in vivo in a non-sealed configuration.
[Aspect 66]
2. The kit of embodiment 1, wherein the wall of the balloon comprises a polymeric layer and a metallic layer, the metallic layer having a thickness of 1 to 300 μm.
[Aspect 67]
67. The kit of embodiment 66, wherein the balloon comprises a continuous layer of polymer.
[Aspect 68]
67. The kit of embodiment 66, wherein the balloon comprises a discontinuous layer of polymer.
[Aspect 69]
69. The kit of any one of aspects 66 to 68, wherein the polymer comprises polyethylene terephthalate, a polyamide, or a polyether block amide.
[Aspect 70]
67. The kit of embodiment 66, wherein the balloon comprises a continuous layer of metal.
[Aspect 71]
67. The kit of embodiment 66, wherein the balloon comprises a discontinuous layer of metal.
[Aspect 72]
72. The kit of any one of embodiments 66, 70, and 71, wherein the metal comprises gold or an alloy thereof.
[Aspect 73]
72. The kit of any one of embodiments 66, 70, and 71, wherein the metal comprises platinum, or an alloy thereof.
[Aspect 74]
74. The kit of any one of embodiments 66 to 73, wherein the metal layer is internal to the polymer layer.
[Aspect 75]
74. The kit of any one of embodiments 66 to 73, wherein the metallic layer is external to the polymeric layer.
[Aspect 76]
76. The kit of any one of aspects 74-75, wherein the metal is formed as a wire and configured in a spiral, coil, braid, woven, or straight shape.
[Aspect 77]
77. The kit of embodiment 75 or 76, wherein the metal is bonded to the underlying polymer by a glue or adhesive.
[Aspect 78]
77. The kit of embodiments 75 and 76, wherein the metal is attached to the underlying polymer by a glue or adhesive.
[Aspect 79]
77. The kit of aspect 75 or 76, wherein the metal is bonded or joined to the balloon by an adhesive or glue.
[Aspect 80]
80. The kit of any one of aspects 75-79, comprising a metal layer and one or more further layers or coatings of polymer external to the first polymer layer and the metal layer.
[Aspect 81]
80. The kit of embodiment 79, wherein at least one of the further polymeric layers or coatings is continuous.
[Aspect 82]
80. The kit of embodiment 79, wherein at least one of the further polymeric layers or coatings is discontinuous.
[Aspect 83]
83. The kit of any one of aspects 80 to 82, wherein the further polymer layer or coating comprises a polyurethane, a silicone, or a poly(p-xylylene).
[Aspect 84]
84. The kit of any one of aspects 76-83, wherein the metal wire is present in at least a portion of an intermediate region of the polymer and the metal balloon.
[Aspect 85]
84. The kit of any one of aspects 76-83, wherein the metal wire is present in at least a portion of the proximal region of the polymeric and metal balloon.
[Aspect 86]
84. The kit of any one of aspects 76-83, wherein the metal wire is present in at least a portion of the distal region of the polymeric and metal balloon.
[Aspect 87]
84. The kit of any one of aspects 76-83, wherein the metal wire is present in at least a portion of the proximal and intermediate regions of the polymeric and metal balloon.
[Aspect 88]
84. The kit of any one of aspects 76-83, wherein the metal wire is present in at least a portion of the distal and intermediate regions of the polymeric and metal balloon.
[Aspect 89]
84. The kit of any one of aspects 76-83, wherein the metal wire is present in at least a portion of the proximal, middle, and distal regions of the polymeric and metal balloon.
[Aspect 90]
The kit of any one of aspects 76 to 90, wherein the cross-sectional shape of the metal wire is circular, oval, square, or rectangular.
[Aspect 91]
91. The kit of any one of aspects 76 to 90, wherein the metal wire has a diameter or width of 10 to 1000 μm.
[Aspect 92]
91. The kit of any one of aspects 76-90, wherein the metal wire has a diameter or width of 10, 20, 30, 40, 50, 60, 70, 80, 90, 100, 110, 120, 130, 140, 150, 200, 250, 300, 350, 400, 450, 500, 550, 600, 650, 700, 750, 800, 850, 900, 950, or 1000 μm.
[Aspect 93]
93. The kit of any one of aspects 66-92, wherein the overall thickness of the polymer and at least a portion of the balloon wall, including the polymer, the metal wire, the adhesive, and the coating, is between 5 and 1300 μm.
[Aspect 94]
93. The kit of any one of aspects 66-92, wherein the overall thickness of the polymer and at least a portion of the balloon wall, including the polymer, metal wire, adhesive, and coating, is 5, 10, 20, 30, 40, 50, 60, 70, 80, 90, 100, 110, 120, 130, 140, 150, 200, 250, 300, 350, 400, 450, 500, 550, 600, 650, 700, 750, 800, 850, 900, 950, 1000, 1050, 1100, 1150, 1200, 1250, or 1300 μm.
[Aspect 95]
95. The kit of any one of aspects 66-94, wherein the polymer and metal balloon has sufficient strength to maintain itself in an expanded or partially expanded shape in vivo after separation from the shafts of the first and second members.
[Aspect 96]
95. The kit of any one of aspects 66-94, wherein the polymeric and metallic balloon has sufficient strength to maintain itself in an expanded or partially expanded shape in vivo when no solid or semi-solid material not from the patient is present within the central void of the expanded polymeric and metallic balloon after separation from the first and second catheters.
[Aspect 97]
95. The kit of any one of aspects 66-94, wherein the expanded polymeric and metallic balloon has sufficient strength to maintain itself in an expanded or partially expanded shape in vivo after separation from the first and second catheters, and wherein no solid or semi-solid material or component not derived from the patient is required within a central void or interior volume of the expanded polymeric and metallic balloon to help the polymeric and metallic balloon assume or maintain at least the expanded shape after separation of the expanded polymeric and metallic balloon and the first and second catheters.
[Aspect 98]
95. The kit of any one of aspects 66-94, wherein the expanded polymeric and metallic balloon alone has sufficient strength to maintain itself in an expanded or partially expanded shape in vivo after separation from the first and second catheters.
[Aspect 99]
95. The kit of any one of aspects 66-94, wherein after separation of the polymer and metal balloon from the first and second catheters in vivo, the pressure within the central void or interior volume of the expanded metal balloon is equal to or less than the pressure outside the expanded metal balloon.
[Aspect 100]
95. The kit of any one of aspects 66 to 94, wherein the polymer and metal balloon are inserted in vivo in a non-sealed configuration.
[Aspect 101]
101. The kit of any one of the preceding aspects, comprising an expandable metal retention structure, wherein after expansion, the diameter of a portion of the metal structure is equal to or greater than the diameter of the expanded balloon.
[Aspect 102]
102. The kit of aspect 101, wherein a portion of the expandable metallic retention structure is configured to contact a wall of an artery, vein, left atrial appendage, aneurysm, biological conduit, or other blood-containing or biological space.
[Aspect 103]
103. The kit of any one of aspects 101-102, wherein the expandable metal retention structure comprises a plurality of elongated ribs extending from the annular structure.
[Aspect 104]
The kit of aspect 103, wherein a free end of at least one elongated rib of the expandable metal retention structure includes a hook or barb configured to engage a portion of a wall of an artery, vein, left atrial appendage, aneurysm, biological conduit, or other blood-containing or biological space.
[Aspect 105]
13. The kit of aspects 101 or 102, wherein the expandable metal retention structure comprises a plurality of elongated ribs extending from the annular structure at both ends.
[Aspect 106]
106. The kit of aspect 105, wherein the at least one elongate rib comprises a hook or barb configured to engage a portion of a wall of an artery, vein, left atrial appendage, aneurysm, biological conduit, or other blood-containing or biological space.
[Aspect 107]
107. The kit of any one of aspects 101-106, wherein the elongated ribs are outwardly biased.
[Aspect 108]
107. The kit of any one of aspects 101-106, wherein the expandable metal retention structure is self-expanding.
[Aspect 109]
Aspects 107. The kit of any one of aspects 101-106, wherein the retention structure comprises nitinol or stainless steel.
[Aspect 110]
107. The kit of any one of aspects 101-106, wherein the outer diameter of the annular structure when expanded, measured parallel to the second axis, is between 3 and 40 mm, and the diameter of the balloon when expanded, measured parallel to the second axis, is between 3 and 40 mm.
[Aspect 111]
107. The kit of any one of aspects 101-106, wherein one end of an expandable metal retention structure is joined to a distal portion or distal neck of the balloon.
[Aspect 112]
107. The kit of any one of aspects 101-106, wherein one end of an expandable metal retention structure is joined to a proximal portion or proximal neck of the balloon.
[Aspect 113]
After expansion of the balloon, the second catheter can be pulled back while keeping the first catheter and balloon fixed in place until a distal tip of the second catheter is disposed within the central void or interior volume of the balloon, and all or a portion of one or more second medical devices including the elongate body, the expandable body, the solidification fluid or other balloon support material can be passed through a second lumen of the second catheter and disposed within the central void or interior volume of the balloon;
after expansion of the balloon and deployment of all or a portion of the one or more second medical devices, including the elongate body, the expandable body, the clotting fluid or other balloon support material, the first catheter can be separated from the expanded balloon, and the first and second catheters can be removed from the patient, leaving the balloon and all or a portion of the one or more elongate bodies, the expandable body, the clotting fluid or other balloon support material remaining within the patient;
Aspect 113. The kit of any one of aspects 1-112, further comprising one or more second medical devices comprising an elongate body, an expandable body, or a coagulation fluid, capable of being positioned through a lumen of the second catheter and into a biological space adjacent the balloon.
[Aspect 114]
114. The kit of any one of the preceding aspects, comprising a carrier for at least a portion of the first flexible elongate body and the second flexible elongate body, wherein an end of the carrier holding a distal end of the first flexible elongate body is configured for joining to a proximal hub of the second catheter.
[Aspect 115]
115. The kit of embodiment 114, wherein the carrier is configured in a coil shape.
[Aspect 116]
Aspect 114. The kit of any one of aspects 1-113, wherein a portion of the first flexible elongate body of the second medical device is configured to contact an interior surface of an expanded balloon of the first medical device.
[Aspect 117]
The kit of any one of aspects 1-113, wherein the maximum overall or tertiary diameter of the first flexible elongate body of the second medical device is in the range of 5% smaller to 20% larger than the maximum diameter of the expanded balloon of the first medical device.
[Aspect 118]
The kit of any one of aspects 1-113, wherein the maximum overall or tertiary diameter of the first flexible elongate body of the second medical device is 1, 2, 3, 4, 5, 6, 7, 8, 9, or 10 mm greater than the maximum diameter of the expanded balloon of the first medical device.
[Aspect 119]
Aspect 114. The kit of any one of aspects 1-113, wherein the volume of the first flexible elongate body of the second medical device fills 5-75% of the volume of the central void of the expanded balloon.
[Aspect 120]
The volume of the first flexible elongate body of the second medical device is 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41 , 42, 43, 44, 45, 46, 47, 48, 49, 50, 51, 52, 53, 54, 55, 56, 57, 58, 59, 60, 61, 62, 63, 64, 65, 66, 67, 68, 69, 70, 71, 72, 73, 74, or 75% of the volume of the central void of the expanded balloon.
[Aspect 121]
Aspect 114. The kit of any one of aspects 1-113, comprising a fourth medical device configured to separate the expanded balloon of the first medical device and the first catheter of the first medical device.
[Aspect 122]
122. The kit of aspect 121, wherein the fourth medical device is configured to form an electrical connection with the first catheter of the first medical device.
[Aspect 123]
122. The kit of aspect 121, wherein the fourth medical device is configured to form an electrical connection with the catheter of the third medical device.
[Aspect 124]
The kit of any one of aspects 1-113, comprising a fifth medical device configured to separate the first elongate body or the expandable body of the second medical device from the second elongate body of the second medical device.
[Aspect 125]
125. The kit of aspect 124, wherein the fifth medical device is configured to form an electrical connection with the second elongate body of the second medical device.
[Aspect 126]
Aspects 1-113, the kit of any one of aspects comprising a sixth medical device configured to separate the expanded balloon of the first medical device and the first catheter of the first medical device, and also configured to separate the first elongate body or the expandable body of the second medical device from the second elongate body of the second medical device.
[Aspect 127]
The kit of aspect 126, wherein the sixth medical device is configured to form an electrical connection with the first catheter of the first medical device and is configured to form an electrical connection with the second elongate body of the second medical device.
[Aspect 128]
128. The kit of any one of aspects 121-127, comprising a seventh medical device configured to provide an electrical connection between the fourth medical device and the first catheter of the first medical device, between the fourth medical device and the catheter of the third medical device, between the fifth medical device and the second elongate body of the second medical device, or between the sixth medical device and the first catheter of the first medical device and the second elongate body of the second medical device.
[Aspect 129]
129. The kit of aspect 128, wherein the seventh medical device comprises an electrical cable.
[Aspect 130]
130. The kit of aspect 129, wherein the seventh medical device comprises one or more electrical jacks or connectors.
[Aspect 131]
231. The kit of aspect 129 or 230, wherein the seventh medical device is configured to pass an electrical current to the first medical device, the second medical device, or the third medical device.
[Aspect 132]
132. The kit of any one of the preceding embodiments, further comprising a guidewire.
[Aspect 133]
133. The kit of embodiment 132, wherein the guidewire has a diameter of 0.010 to 0.038 inches.
[Aspect 134]
133. The kit of embodiment 132, wherein the guidewire has a diameter of 0.010, 0.011, 0.012, 0.013, 0.014, 0.015, 0.016, 0.017, 0.018, 0.033, 0.034, 0.035, 0.036, 0.037, or 0.038 inches.
[Aspect 135]
135. The kit of any one of aspects 132-134, wherein the length of the guidewire is at least twice as long as the second catheter of the first medical device.
[Aspect 136]
135. The kit according to any one of aspects 132 to 134, wherein the length of the guidewire is 50 to 500 cm.
[Aspect 137]
135. The kit according to any one of aspects 132 to 134, wherein the length of the guidewire is 200 to 400 cm.
[Aspect 138]
138. The kit of any one of aspects 132-137, wherein the formed guidewire tip is angled relative to the body of the guidewire.
[Aspect 139]
138. The kit of any one of items 132 to 137, wherein the tip of the guidewire is formed to be curved relative to the body of the guidewire.
[Aspect 140]
140. The kit of embodiment 139, wherein the curved tip generally forms a J-shape or a C-shape.

Aspects and embodiments relating to methods of manufacturing detachable balloons and detachable devices as disclosed herein:
[Aspect 1]
(1) manufacturing a first catheter;
(2) manufacturing a second catheter;
(3) manufacturing a polymeric balloon having a proximal opening, thereby forming a first polymer layer of the polymeric balloon;
(4) expanding the polymer balloon;
(5) applying a first layer of metal having a thickness in the range of 0.0005 to 1 μm to at least a portion of the exterior surface of the balloon by a sputter coating or vapor deposition process;
(6) forming the walls of the metallized balloon into pleated and folded configurations;
(7) bonding or operably coupling the metallized polymer balloon to the first catheter in a manner that permits separation of the metallized polymer balloon from the first catheter after expansion within the patient;
The balloon can form pleats and folds,
a distal end of the first catheter can be joined or operably coupled to the opening in the proximal portion of the balloon;
The second catheter passes entirely through the lumen of the first catheter;
a distal portion of the second catheter passes through the opening in the proximal portion of the balloon, through a central void or interior volume of the balloon, and through the opening in the distal portion of the balloon;
The balloon can be expanded by injection of fluid through the lumen of the first catheter, into the proximal hub of the first catheter and into the central void or interior volume of the balloon; after expansion of the balloon within the human patient, the expanded balloon can be separated from the first catheter, and the first and second catheters can be removed from the patient leaving the expanded balloon within the patient;
a balloon including an opening at a proximal portion of the balloon and an opening at a distal portion of the balloon;
1. A method of manufacturing a medical device for treatment of a human patient, comprising: a first catheter comprising a proximal hub; and a second catheter comprising a proximal hub.
[Aspect 2]
(1) manufacturing a first catheter;
(2) manufacturing a second catheter;
(3) manufacturing a polymeric balloon having a proximal opening and a distal opening, thereby forming a first polymer layer of the polymeric balloon;
(4) expanding the polymer balloon;
(5) applying a first layer of metal having a thickness in the range of 0.0005 to 1 μm to at least a portion of the exterior surface of the balloon by a sputter coating or vapor deposition process;
(6) applying a second layer of metal having a thickness of 1 to 50 μm to at least a portion of the outer surface of the first metal layer by electroforming or electroplating;
(7) forming the walls of the metallized balloon into pleated and folded configurations;
(8) bonding or operably coupling the metallized polymer balloon to the first catheter in a manner that permits separation of the metallized polymer balloon from the first catheter after expansion within the patient;
The balloon can form pleats and folds,
a distal end of the first catheter can be joined or operably coupled to an opening in the proximal portion of the balloon;
The second catheter passes entirely through the lumen of the first catheter;
a distal portion of the second catheter passes through the opening in the proximal portion of the balloon, through a central void or interior volume of the balloon, and through the opening in the distal portion of the balloon;
The balloon can be expanded by injection of fluid through the lumen of the first catheter, into the proximal hub of the first catheter and into the central void or interior volume of the balloon; after expansion of the balloon within the human patient, the expanded balloon can be separated from the first catheter, and the first and second catheters can be removed from the patient leaving the expanded balloon within the patient;
a balloon including an opening at a proximal portion of the balloon and an opening at a distal portion of the balloon;
1. A method of manufacturing a medical device for treatment of a human patient, comprising: a first catheter comprising a proximal hub; and a second catheter comprising a proximal hub.
[Aspect 3]
(1) manufacturing a first catheter;
(2) manufacturing a second catheter;
(3) manufacturing a polymeric balloon having a proximal opening and a distal opening, thereby forming a first polymer layer of the polymeric balloon;
(4) expanding the polymer balloon;
(5) applying a first adhesive layer to at least a portion of an exterior surface of the balloon;
(6) applying a metal wire having a thickness of 25-100 μm in a spiral, coil, braid, woven, or straight configuration to at least a portion of the adhesive coated outer surface of the expanded balloon, thereby forming a first metal layer;
(7) applying a second adhesive layer to at least a portion of the adhesive coated exterior surface of the expanded balloon and to at least a portion of the exterior surface coated with the metal wire;
(8) drying or curing the adhesive layer;
(9) forming the walls of the metallized balloon into pleated and folded configurations;
(10) bonding or operably coupling the metallized polymer balloon to the first catheter to permit separation of the metallized polymer balloon from the first catheter after expansion in the patient;
The balloon can form pleats and folds,
a distal end of the first catheter can be joined or operably coupled to the opening in the proximal portion of the balloon;
The second catheter passes entirely through the lumen of the first catheter;
a distal portion of the second catheter passes through the opening in the proximal portion of the balloon, through a central void or interior volume of the balloon, and through the opening in the distal portion of the balloon;
The balloon can be expanded by injection of fluid through the lumen of the first catheter, into the proximal hub of the first catheter and into the central void or interior volume of the balloon; after expansion of the balloon within the human patient, the expanded balloon can be separated from the first catheter, and the first and second catheters can be removed from the patient leaving the expanded balloon within the patient;
a balloon including an opening at a proximal portion of the balloon and an opening at a distal portion of the balloon;
1. A method of manufacturing a medical device for treatment of a human patient, comprising: a first catheter comprising a proximal hub; and a second catheter comprising a proximal hub.
[Aspect 4]
2. The method of embodiment 1, wherein the first metal layer is gold, titanium, or a combination thereof.
[Aspect 5]
2. The method of embodiment 1, wherein the balloon comprises a first metal layer that is continuous.
[Aspect 6]
2. The method of embodiment 1, wherein the balloon comprises a first metal layer that is discontinuous.
[Aspect 7]
7. The method of embodiment 6, wherein the first metal layer is formed on the proximal region, the intermediate region, the distal region, the proximal and intermediate regions, the intermediate and distal regions, or the proximal, intermediate and distal regions.
[Aspect 8]
The method of any one of claims 6 to 7, wherein one or more masks are applied to the outer surface of the polymeric balloon prior to forming the first metal layer such that only a portion of the outer surface of the polymeric balloon is covered by the first metal layer.
[Aspect 9]
3. The method of claim 2, wherein the first metal layer comprises gold, titanium, or a combination thereof.
[Aspect 10]
3. The method of embodiment 2, wherein the balloon comprises a first metal layer that is continuous.
[Aspect 11]
3. The method of embodiment 2, wherein the balloon comprises a first metal layer that is discontinuous.
[Aspect 12]
12. The method of embodiment 11, wherein the first metal layer is formed on the proximal region, the intermediate region, the distal region, the proximal and intermediate regions, the intermediate and distal regions, or the proximal, intermediate, and distal regions.
[Aspect 13]
13. The method of claim 11 or 12, wherein one or more masks are applied to the outer surface of the polymeric balloon prior to forming the first metal layer such that only a portion of the outer surface of the polymeric balloon is covered by the first metal layer.
[Aspect 14]
3. The method of embodiment 2, wherein the second metal layer comprises gold, platinum, or a combination thereof.
[Aspect 15]
3. The method of embodiment 2, wherein the balloon comprises a second metal layer that is continuous.
[Aspect 16]
3. The method of embodiment 2, wherein the balloon comprises a second metal layer that is discontinuous.
[Aspect 17]
17. The method of embodiment 16, wherein the second metal layer is formed on the proximal region, the intermediate region, the distal region, the proximal and intermediate regions, the intermediate and distal regions, or the proximal, intermediate, and distal regions.
[Aspect 18]
18. The method of claim 16 or 17, wherein one or more masks are applied to the exterior surface of the metallized balloon prior to creating the second metal layer such that only a portion of the exterior surface of the metallized balloon is covered by the first metal layer.
[Aspect 19]
The method of claim 3, wherein the first layer of adhesive comprises a urethane.
[Aspect 20]
20. The method of claim 3 or 19, wherein the balloon comprises a first adhesive layer that is continuous.
[Aspect 21]
20. The method of claim 3 or 19, wherein the balloon comprises a first adhesive layer that is discontinuous.
[Aspect 22]
22. The method of embodiment 21, wherein the first adhesive layer is formed on the proximal region, the intermediate region, the distal region, the proximal and intermediate regions, the intermediate and distal region, or the proximal, intermediate, and distal regions.
[Aspect 23]
23. The method of any one of aspects 3, 21 and 22, wherein one or more masks are applied to the outer surface of the polymeric balloon prior to applying the first layer of adhesive such that only a portion of the outer surface of the polymeric balloon is covered by the first adhesive layer.
[Aspect 24]
24. The method of any one of claims 3 and 21-23, wherein the first adhesive layer is formed by immersing the balloon in a solution comprising urethane in a solvent having a urethane concentration in the range of 1-20%.
[Aspect 25]
24. The method of any one of claims 3 and 21-23, wherein the first adhesive layer is formed by spraying the balloon in a solution comprising urethane in a solvent having a urethane concentration in the range of 1-20%.
[Aspect 26]
26. The method of any one of aspects 3 and 21-25, wherein the first metal layer comprises gold, platinum, iridium, silver, or a combination thereof.
[Aspect 27]
30. The method of embodiment 3 or 26, wherein the metal wire is wrapped around the expanded balloon.
[Aspect 28]
30. The method of claim 3 or 27, wherein the pitch and angle of the wire windings are uniform.
[Aspect 29]
30. The method of claim 3 or 27, wherein the pitch and angle of the wire windings are non-uniform.
[Aspect 30]
The method of claim 3, wherein the second layer of adhesive comprises a urethane.
[Aspect 31]
20. The method of claim 3 or 19, wherein the balloon comprises a second adhesive layer that is continuous.
[Aspect 32]
20. The method of claim 3 or 19, wherein the balloon comprises a second adhesive layer that is discontinuous.
[Aspect 33]
22. The method of embodiment 21, wherein the second adhesive layer is formed on the proximal region, the intermediate region, the distal region, the proximal and intermediate regions, the intermediate and distal region, or the proximal, intermediate, and distal regions.
[Aspect 34]
23. The method of any one of claims 3, 21 and 22, wherein one or more masks are applied to the exterior surface of the metallized balloon prior to applying the second layer of adhesive such that only a portion of the exterior surface of the metallized balloon is covered by the second adhesive layer.
[Aspect 35]
24. The method of any one of claims 3 and 21-23, wherein the second adhesive layer is formed by immersing the balloon in a solution comprising urethane in a solvent having a urethane concentration in the range of 1-20%.
[Aspect 36]
The method of any one of claims 3 and 21-23, wherein the second adhesive layer is formed by spraying the balloon in a solution comprising urethane in a solvent having a urethane concentration in the range of 1-20%.
[Aspect 37]
33. The method of embodiment 32, wherein the second adhesive layer is formed on the proximal region, the intermediate region, the distal region, the proximal and intermediate regions, the intermediate and distal region, or the proximal, intermediate, and distal regions.
[Aspect 38]
38. The method of claim 32 or 37, wherein one or more masks are applied to the exterior surface of the metallized balloon prior to applying the second layer of adhesive such that only a portion of the exterior surface of the metallized balloon is covered by the second adhesive layer.
[Aspect 39]
The method of any one of the preceding claims, wherein the polymer balloon comprises polyethylene terephthalate (PET), polyamide (nylon), or polyether block amide (Pebax).
[Aspect 40]
The method of any one of the preceding claims, wherein the polymeric balloon is produced by blow molding.
[Aspect 41]
The method of any one of aspects 1-3, forming a balloon having a distal region, a proximal region generally opposite the distal region, and an intermediate region transitioning from the distal region to the proximal region.
[Aspect 42]
The method of any one of the preceding aspects, wherein the polymer layer is continuous except for the proximal and distal openings.
[Aspect 43]
4. The method of any one of claims 1 to 3, wherein the polymeric balloon has a rated burst pressure of <30, <25, <20, <15, <10, <5, <4, <3, <2, or <1 atmosphere.
[Aspect 44]
4. The method of any one of claims 1 to 3, wherein the polymeric balloon has a single wall thickness of <75, <50, <25, <20, <15, <10, or <5 μm.
[Aspect 45]
The method of any one of the preceding aspects, wherein forming a metallized balloon forms an entire wall having a thickness in the range of 3 to 175 μm.
[Aspect 46]
The method of any one of aspects 1-3, wherein the medical device is manufactured such that at least a portion of the exterior surface of the balloon comprises a textured surface.
[Aspect 47]
47. The method of embodiment 46, wherein the distance between the highest point on the exterior surface of the balloon and the lowest point on the exterior surface of the balloon is 0.0001 to 1 μm.
[Aspect 48]
48. The method of any one of the preceding aspects, further comprising forming a wall of the metallized balloon into a pleated and folded configuration prior to bonding or operably coupling the metallized balloon to the first catheter.
[Aspect 49]
48. The method of any one of the preceding aspects, further comprising forming a wall of the metallized balloon into a pleated and folded configuration after bonding or operably coupling the metallized balloon to the first catheter.

Aspects and embodiments relating to the method of treating an artery or vein as disclosed herein:
[Aspect 1]
(a) determining the diameter and length of an arterial or vein segment to be treated and selecting a first medical device including a balloon having an expanded diameter equal to or greater than the diameter of the selected arterial or vein segment and an expanded length such that when the balloon of the first medical device is expanded, the balloon can occupy at least a portion of the lumen of the selected arterial or vein segment;
(b) placing a balloon of a first medical device within the lumen of the selected arterial or vein segment;
(c) delivering a fluid medium through the first lumen to a central void or interior volume of the balloon of the first medical device such that the expanded balloon assumes an expanded configuration filling a portion of the lumen of the selected arterial or venous segment and contacting at least a portion of a wall of said arterial or venous segment;
(d) pulling back the second catheter of the first medical device while maintaining the position of the expanded balloon of the first medical device until a distal tip of the second catheter of the first medical device is within a central void or interior volume of the expanded balloon of the first medical device;
(e) delivering a first elongate or expandable body of the second medical device from the proximal end of the second catheter of the first medical device, through the lumen of the second catheter of the first medical device, and into a central void or interior volume of the expanded balloon of the first medical device;
(f) separating the first elongate body or expandable body of the second medical device from the second elongate body of the second medical device and removing the second elongate body from the patient while leaving the first elongate body or expandable body of the second medical device in the patient; (g) repeating steps (e) and (f) until a desired percentage of the central void or interior volume of the expanded balloon of the first medical device is filled with the first elongate body or first expandable body;
(h) separating the expanded balloon of the first medical device from the first catheter of the first medical device and removing the first and second catheters of the first medical device from the patient while leaving the expanded balloon and the one or more first elongate bodies or first expandable bodies of the first medical device in the patient;
a first medical device comprising:
(i) (i-1) a distal region, a proximal region generally opposite the distal region, an intermediate region transitioning from the distal region to the proximal region, a first axis extending proximally-distally between the proximal and distal regions, and a second axis perpendicular to the first axis;
(i-2) a wall having an outer surface and an inner surface, the inner surface defining a central void or interior volume, the wall extending generally continuously from a proximal region through an intermediate region to a distal region;
(i-3) an opening in the wall in the proximal region that allows the passage of fluid from the first catheter into the central cavity or interior volume of the balloon and also allows the passage of a portion of the second catheter into the central cavity or interior volume of the balloon;
(i-4) an opening in the wall of the distal region that allows passage of a portion of the second catheter into the central cavity or interior volume of the balloon;
(i-5) a proximal neck or a proximal neck assembly; and
(i-6) a pleated and folded balloon configured for permanent implantation in a human patient, the balloon comprising a distal neck or distal neck assembly;
(ii) defining a first lumen for permitting passage of fluid from a proximal end of the first catheter to a distal end of the first catheter and into a central void or interior volume of the balloon;
(ii-1) a proximal end including a proximal hub; and
(ii-2) a first catheter including a distal portion operably coupled or joined to a proximal neck or proximal neck assembly of the balloon;
(iii) defining a second lumen configured to receive at least one of a guidewire, an elongate body, an expandable body, or a coagulation fluid;
(iii-1) a proximal end including a proximal hub;
(iii-2) a proximal portion that passes through the proximal hub of the first catheter;
(iii-3) an intermediate portion passing through the lumen of the first catheter;
(iii-4) a distal portion extending distally relative to the distal end of the first catheter;
(iii-5) a distal portion passing through the proximal neck or proximal neck assembly of the balloon;
(iii-6) a distal portion that passes through the central cavity or interior volume of the balloon;
(iii-7) a distal portion that engages or passes through a distal neck or distal neck assembly within the balloon; and
(iii-8); a second catheter including an open distal end;
(iv) the balloon can be expanded by passage of a fluid through the first catheter into a central void or interior volume of the balloon;
After expansion of the balloon, the second catheter can be moved forward or backward while keeping the expanded balloon fixed in place;
After expansion of the balloon, including before or after advancing the tip of the second catheter, one or more of the first elongate body, the expandable body, a coagulation fluid, a solution containing a drug or therapeutic agent, or a solution or suspension containing embolic particles can be disposed through the lumen of the second catheter and into the biological space adjacent to the balloon;
After expansion of the balloon, the second catheter can be pulled back until a distal tip of the second catheter is disposed within the central void or interior volume of the balloon, and one or more of the first elongate body, the expandable body, or the coagulation fluid can be passed through the lumen of the second catheter and disposed within the central void or interior volume of the balloon;
The first catheter can be separated from the expanded balloon;
the first and second catheters can be removed from the patient leaving the balloon and the one or more of the first elongate body, the expandable body, or the coagulation fluid within the patient;
a second medical device comprising:
(i) a distal portion including a first elongate body or an expandable body;
(ii) a proximal portion comprising a second elongate body or delivery system;
Including,
contacting at least a portion of the first elongate or expandable body of the second medical device with at least a portion of a wall of the expanded balloon of the first medical device after placement of the first elongate or expandable body of the second medical device within the expanded balloon of the first medical device;
after placement of the first elongate body or expandable body of the second medical device within the central void or interior volume of the expanded balloon of the first medical device, but prior to separation of the first elongate body or expandable body of the second medical device and the second elongate body of the second medical device, the second medical device can be removed from the patient;
the first elongate body or the expandable body can be separated from the second elongate body;
A method of reducing blood flow in an arterial or venous portion of a human patient using two or more medical devices, wherein after separation of a first elongate body or an expandable body from a second elongate body, the second elongate body can be removed from the patient while leaving the first elongate body or the expandable body in the patient.
[Aspect 2]
(a) determining the diameter and length of an arterial or vein segment to be treated and selecting a first medical device including a balloon having an expanded diameter equal to or greater than the diameter of the selected arterial or vein segment and an expanded length such that when the balloon of the first medical device is expanded, the balloon can occupy at least a portion of the lumen of the selected arterial or vein segment;
(b) placing a balloon of a first medical device within the lumen of the selected arterial or vein segment;
(c) delivering a fluid medium through the first lumen to a central void or interior volume of the balloon of the first medical device such that the expanded balloon assumes an expanded configuration filling a portion of the lumen of the selected arterial or venous segment and contacting at least a portion of a wall of said arterial or venous segment;
(d) delivering a first elongate or expandable body of the second medical device from the proximal end of the second catheter of the first medical device, through the lumen of the second catheter of the first medical device, and into the lumen of the artery or vein adjacent the expanded balloon of the first medical device;
(e) pulling back the second catheter of the first medical device while maintaining the position of the expanded balloon of the first medical device until a distal tip of the second catheter of the first medical device is within a central void or interior volume of the expanded balloon of the first medical device;
(f) delivering a first elongate or expandable body of the second medical device into a central void or interior volume of the expanded balloon of the first medical device, wherein at least a portion of the first elongate or expandable body of the second medical device contacts at least a portion of a wall of the expanded balloon of the first medical device;
(i) separating the first elongate body or expandable body of the second medical device from the second elongate body of the second medical device and removing the second elongate body from the patient while leaving the first elongate body or expandable body of the second medical device within the central void or interior volume of the expanded balloon of the first medical device;
(j) optionally delivering a first elongate or expandable body of the second medical device from the proximal end of the second catheter of the first medical device, through the lumen of the second catheter of the first medical device, and into a central void or interior volume of the expanded balloon of the first medical device;
(k) optionally separating the first elongate body or expandable body of the second medical device from the second elongate body of the second medical device and removing the second elongate body from the patient while leaving the first elongate body or expandable body of the second medical device within the central void or interior volume of the expanded balloon of the first medical device;
(l) optionally repeating steps (j) and (k) until a desired percentage volume of the unfilled portion of the central void or interior volume of the expanded balloon of the first medical device is filled with the first elongate body or first expandable body;
(m) separating the expanded balloon of the first medical device from the first catheter of the first medical device and removing the first and second catheters of the first medical device from the patient while leaving the expanded balloon and the one or more first elongate bodies or first expandable bodies of the first medical device in the patient;
a first medical device comprising:
(i) (i-1) a distal region, a proximal region generally opposite the distal region, an intermediate region transitioning from the distal region to the proximal region, a first axis extending proximally-distally between the proximal and distal regions, and a second axis perpendicular to the first axis;
(i-2) a wall having an outer surface and an inner surface, the inner surface defining a central void or interior volume, the wall extending generally continuously from a proximal region through an intermediate region to a distal region;
(i-3) an opening in the wall in the proximal region that allows the passage of fluid from the first catheter into the central cavity or interior volume of the balloon and also allows the passage of a portion of the second catheter into the central cavity or interior volume of the balloon;
(i-4) an opening in the wall of the distal region that allows passage of a portion of the second catheter into the central cavity or interior volume of the balloon;
(i-5) a proximal neck or a proximal neck assembly; and
(i-6) a pleated and folded balloon configured for permanent implantation in a human patient, the balloon comprising a distal neck or distal neck assembly;
(ii) defining a first lumen for permitting passage of fluid from a proximal end of the first catheter to a distal end of the first catheter and into a central void or interior volume of the balloon;
(ii-1) a proximal end including a proximal hub; and
(ii-2) a first catheter including a distal portion operably coupled or joined to a proximal neck or proximal neck assembly of the balloon;
(iii) defining a second lumen configured to receive at least one of a guidewire, an elongate body, an expandable body, or a coagulation fluid;
(iii-1) a proximal end including a proximal hub;
(iii-2) a proximal portion that passes through the proximal hub of the first catheter;
(iii-3) an intermediate portion passing through the lumen of the first catheter;
(iii-4) a distal portion extending distally relative to the distal end of the first catheter;
(iii-5) a distal portion passing through the proximal neck or proximal neck assembly of the balloon;
(iii-6) a distal portion that passes through the central cavity or interior volume of the balloon;
(iii-7) a distal portion that engages or passes through a distal neck or distal neck assembly within the balloon; and
(iii-8); a second catheter including an open distal end;
(iv) the balloon can be expanded by passage of a fluid through the first catheter into a central void or interior volume of the balloon;
After expansion of the balloon, the second catheter can be moved forward or backward while keeping the expanded balloon fixed in place;
After expansion of the balloon, including before or after advancing the tip of the second catheter, one or more of the first elongate body, the expandable body, a coagulation fluid, a solution containing a drug or therapeutic agent, or a solution or suspension containing embolic particles can be disposed through the lumen of the second catheter and into the biological space adjacent to the balloon;
After expansion of the balloon, the second catheter can be pulled back until a distal tip of the second catheter is disposed within the central void or interior volume of the balloon, and one or more of the first elongate body, the expandable body, or the coagulation fluid can be passed through the lumen of the second catheter and disposed within the central void or interior volume of the balloon;
The first catheter can be separated from the expanded balloon;
the first and second catheters can be removed from the patient leaving the balloon and the one or more of the first elongate body, the expandable body, or the coagulation fluid within the patient;
a second medical device comprising:
(i) a distal portion including a first elongate body or an expandable body;
(ii) a proximal portion comprising a second elongate body or delivery system;
Including,
after placement of the first elongate or expandable body of the second medical device within the lumen of the artery or vein adjacent to the expanded balloon of the first medical device, contacting at least a portion of the first elongate or expandable body of the second medical device with at least a portion of the wall of the artery or vein adjacent to the expanded balloon of the first medical device;
after placement of the first elongate or expandable body of the second medical device within the lumen of the artery or vein adjacent the expanded balloon of the first medical device, but prior to separation of the first elongate or expandable body of the second medical device and the second elongate body of the second medical device, the second medical device may be removed from the patient;
the first elongate body or the expandable body can be separated from the second elongate body;
A method of reducing blood flow in an arterial or venous portion of a human patient using two or more medical devices, wherein after separation of a first elongate body or an expandable body from a second elongate body, the second elongate body can be removed from the patient while leaving the first elongate body or the expandable body in the patient.
[Aspect 3] A solution containing a drug or therapeutic agent, or a solution or suspension containing embolic particles.A method as described in Aspect 1 or 2, wherein after expansion of the balloon of the first medical device and before retracting the second catheter of the first medical device into the central void or interior volume of the expanded balloon of the first medical device, a fluoroscopy contrast agent, a solution containing a drug or therapeutic agent, a coagulation fluid, a solution or suspension containing embolic particles, or a combination thereof, is injected through the lumen of the second catheter of the first medical device into the lumen of the artery or vein adjacent to the expanded balloon of the first medical device.
[Aspect 4]
The method of aspect 3, wherein a syringe or other suitable delivery system is used to inject a drug, therapeutic agent, coagulation fluid, solution or suspension containing embolic particles, or combinations thereof, through the lumen of the shaft of the second catheter and into the lumen of the artery or vein adjacent the expanded balloon of the first medical device.
[Aspect 5]
5. The method of claim 3 or 4, further comprising advancing a second catheter of the first medical device within the artery or vein while maintaining the position of the balloon of the first medical device prior to injecting a solution or suspension comprising a drug, therapeutic agent, coagulation fluid, embolic particles through the lumen of the shaft of the second catheter of the first medical device and into the lumen of the artery or vein adjacent the expanded balloon of the first medical device.
[Aspect 6]
The method of aspect 1 or 2, wherein prior to separating the expanded balloon of the first medical device from the first catheter of the first medical device, a coagulation fluid is injected from the proximal end of the first catheter of the first medical device, through the lumen of the first catheter of the first medical device, and into the central void or the internal volume of the expanded balloon of the first medical device.
[Aspect 7]
The method of any one of aspects 1-6, wherein after being positioned within the central void or interior volume of the expanded balloon, the first elongate or expandable body of the second medical device exerts a force on the wall of the expanded balloon of the first medical device.
[Aspect 8]
The method of aspect 7, wherein the force on the wall of the expanded balloon of the first medical device is outward.
[Aspect 9]
The method of any one of aspects 1-8, wherein the maximum diameter or tertiary diameter of the second medical device is equal to the maximum diameter of the expanded balloon.
[Aspect 10]
The method of any one of aspects 1-8, wherein the maximum or tertiary diameter of the first elongate or expandable body of the second medical device ranges from a value equal to a maximum diameter of the expanded balloon of the first medical device to a value 50% greater than a maximum diameter of the expanded balloon of the first medical device.
[Aspect 11]
The method of any one of aspects 1-8, wherein the maximum or tertiary diameter of the first elongate or expandable body of the second medical device is 1, 2, 3, 4, 5, 6, 7, 8, 9, or 10 mm greater than the maximum diameter of the expanded balloon of the first medical device.
[Aspect 12]
Aspect 12. The method of any one of aspects 1-11, wherein the volume of the one or more first elongate bodies or expandable bodies of the second medical device fills 5-75% of the volume of the central void of the expanded balloon.
[Aspect 13]
12. The method of any one of the preceding claims, wherein the volume of the first elongate body or expandable body of the second medical device fills 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49, 50, 51, 52, 53, 54, 55, 56, 57, 58, 59, 60, 61, 62, 63, 64, 65, 66, 67, 68, 69, 70, 71, 72, 73, 74, or 75% of the volume of the central void of the expanded balloon.
[Aspect 14]
14. The method of any one of the preceding aspects, wherein the expanded balloon is configured to contact at least 100%, 90%, 80%, 70, 60%, 50%, 40%, 30%, 20%, 10%, or 5% of the area of the lumen surface of the selected segment of the artery or vein.
[Aspect 15]
15. The method of any one of the preceding aspects, wherein the expanded balloon is configured to fill at least 100%, 90%, 80%, 70%, 60%, 50%, 40%, 30%, 20%, 10%, or 5% of the volume of the lumen of the selected segment of the artery or vein.
[Aspect 16]
The method of any one of aspects 1-15, wherein the distal portion of the second catheter of the first medical device comprises a radiopaque portion, ring or marker that is clearly visible under fluoroscopy, and fluoroscopy is used to monitor the position of the distal portion of the second catheter of the first medical device relative to the position of the distal portion of the balloon of the first medical device as the second catheter of the first medical device moves.
[Aspect 17]
17. The method of any one of aspects 1-16, wherein the distal portion of the balloon of the first medical device comprises a radiopaque portion, ring or marker that is clearly visible under fluoroscopy, and fluoroscopy is used to monitor the position of the distal portion of the second catheter of the first medical device relative to the position of the distal portion of the balloon of the first catheter as the second catheter of the first medical device moves.
[Aspect 18]
18. The method of any one of claims 1-17, wherein at least a portion of the distal telescoping structure of the first medical device comprises a radiopaque portion, ring or marker that is clearly visible under fluoroscopy, and fluoroscopy is used to monitor the position of a distal portion of the second catheter of the first medical device relative to the position of the distal telescoping structure of the first medical device as the second catheter of the first medical device moves.
[Aspect 19]
The method of any one of aspects 1-18, wherein at least a portion of the first elongate body or expandable body of the second medical device is formed from a material that is radiopaque and clearly visible under fluoroscopy, and fluoroscopy is used to monitor the placement and position of the first elongate body or expandable body of the second medical device.
[Aspect 20]
The method of any one of aspects 1-19, wherein the second catheter of the first medical device comprises one, two, or more radiopaque portions, rings or markers, and fluoroscopy is used to monitor the position of the second catheter of the first medical device relative to the position of the first elongate body or expandable body of the second medical device.
[Aspect 21]
21. The method of any one of aspects 1-20, wherein a distal portion of the first catheter of the first medical device comprises a radiopaque marker that is clearly visible under fluoroscopy, and fluoroscopy is used to monitor separation of the expanded balloon of the first medical device from the first catheter of the first medical device.
[Aspect 22]
22. The method of any one of aspects 1-21, wherein a proximal portion of the balloon of the first medical device comprises a radiopaque marker that is clearly visible under fluoroscopy, and fluoroscopy is used to monitor separation of the expanded balloon of the first medical device from the first catheter of the first medical device.
[Aspect 23]
23. The method of any one of aspects 1-22, wherein a distal portion of the first catheter of the first medical device comprises a radiopaque marker that is clearly visible under fluoroscopy, and fluoroscopy is used to monitor separation of the expanded balloon of the first medical device from the first catheter of the first medical device.
[Aspect 24]
24. The method of any one of aspects 17-23, wherein the radiopaque portion, ring, or marker comprises platinum, iridium, gold, tungsten, or a combination thereof.
[Aspect 25]
25. The method of any one of the preceding embodiments, wherein the wall of an artery or vein is damaged or ruptured.
[Aspect 26]
25. The method of any one of the preceding embodiments, wherein the wall of the artery or vein is not damaged or ruptured.
[Aspect 27]
27. The method of any one of aspects 1-26, wherein the distal neck or distal neck assembly of the second catheter of the first medical device and the balloon of the first medical device are joined by a friction fit, and the second catheter of the first medical device and the expanded balloon of the first medical device are separated by applying axial tension to the tubular segments.
[Aspect 28]
28. The method of aspect 27, wherein the distal neck or distal neck assembly of the second catheter of the first medical device and the balloon of the first medical device are connected by an elastomeric valve.
[Aspect 29]
30. The method of aspect 28, wherein the elastomeric valve serves to reduce blood flow through a central void or interior volume of the expanded balloon of the first medical device after removal of the second catheter of the first medical device from the patient.
[Aspect 30]
30. The method of any one of aspects 1-29, wherein the proximal neck or proximal neck assembly of the first catheter of the first medical device and the balloon of the first medical device are joined by a friction fit, and the first catheter of the first medical device and the expanded balloon of the first medical device are separated by applying axial tension to the elastomeric tubular segment.
[Aspect 31]
31. The method of aspect 30, wherein the proximal neck or proximal neck assembly of the first catheter of the first medical device and the balloon of the first medical device are joined by an elastomeric tubular segment.
[Aspect 32]
30. The method of any one of aspects 1-29, wherein the first catheter of the first medical device and the balloon of the first medical device are joined by a tubular structure, a male portion of the tubular structure being joined to a distal end of the first catheter and a female portion of the tubular structure being joined to a proximal neck or proximal neck assembly of the balloon of the first medical device.
[Aspect 33]
33. The method of aspect 32, wherein the proximal neck of the balloon of the first medical device is the second portion of the mechanical latch.
[Aspect 34]
34. The method of aspect 32 or 33, wherein two portions of the mechanical latch engage or are operably coupled when the second catheter of the first medical device passes through the mechanical latch.
[Aspect 35]
35. The method of aspect 34, wherein the second catheter of the first medical device is removed from the mechanical latch to separate or operatively separate the mechanical latch and the two portions of the mechanical latch.
[Aspect 36]
36. The method of aspect 35, wherein the first catheter of the first medical device and the expanded balloon of the first medical device are separated.
[Aspect 37]
The method of any one of aspects 1-29, wherein the proximal neck or proximal neck assembly of the first catheter of the first medical device and the balloon of the first medical device are joined by adhesive, glue, or solder, and the electrolysis-sensitive tubular segment of the first medical device is electrolytically eroded.
[Aspect 38]
38. The method of aspect 37, wherein the first catheter of the first medical device and the expanded balloon of the first medical device are separated following erosion of a proximal neck or a portion of a proximal neck assembly of the balloon of the first medical device.
[Aspect 39]
30. The method of any one of aspects 1-29, wherein the first catheter of the first medical device and the proximal neck or proximal neck assembly of the balloon of the first medical device are joined by adhesive, glue, or solder, and a distal portion of the first catheter of the first medical device, a portion of the proximal neck or proximal neck assembly of the balloon of the first medical device, or a portion of the bond between the distal portion of the first catheter of the first medical device and the first heat sensitive tubular segment melts upon heating.
[Aspect 40]
The method of claim 39, wherein the first catheter of the first medical device and the expanded balloon of the first medical device are pulled apart after melting of the distal portion of the first catheter of the first medical device, a portion of the proximal neck or proximal neck assembly of the balloon of the first medical device, or a portion of the bond between the distal portion of the first catheter of the first medical device and the proximal neck or proximal neck assembly of the balloon of the first medical device.
[Aspect 41]
The method of any one of aspects 1-40, wherein the first elongate body or the expandable body of the second medical device is flexible, the second elongate body of the second medical device is flexible, or the first elongate body and the second elongate body of the second medical device are flexible.
[Aspect 42]
Aspect 42. The method of any one of aspects 1-41, wherein the first catheter of the first medical device is flexible, the second catheter of the first medical device is flexible, or the first catheter and the second catheter of the first medical device are flexible.
[Aspect 43]
Aspect 1, wherein the balloon of the first medical device is detachable.
[Aspect 44]
Aspect 44. The method of any one of aspects 1-43, wherein the balloon of the first medical device is deflated or compressed prior to expansion.
[Aspect 45]
Aspect 44. The method of any one of aspects 1-43, wherein the fluid used to expand the balloon of the first medical device is water, saline, a fluoroscopy contrast agent, or a combination thereof.
[Aspect 46]
46. The method of any one of aspects 1-45, wherein a solution comprising a fluoroscopic contrast agent is injected under fluoroscopy through the second catheter of the first medical device, into the hub of the second catheter of the first medical device, and into the lumen of the artery or vein adjacent the distal tip of the second catheter of the first medical device prior to expansion of the balloon of the first medical device.
[Aspect 47]
47. The method of any one of aspects 1-46, wherein a solution comprising a fluoroscopic contrast agent is injected under fluoroscopy through the second catheter of the first medical device, into the hub of the second catheter of the first medical device, and into the lumen of the artery or vein adjacent the distal tip of the second catheter of the first medical device after expansion of the balloon of the first medical device but prior to separation of the balloon of the first medical device and the first catheter of the first medical device.
[Aspect 48]
48. The method of any one of aspects 1-47, wherein a solution comprising a fluoroscopic contrast agent is injected under fluoroscopy through the second catheter of the first medical device, into the hub of the second catheter of the first medical device, and into the lumen of the artery or vein adjacent the distal tip of the second catheter of the first medical device after separation of the balloon of the first medical device and the first catheter of the first medical device.
[Aspect 49]
Aspects 1-48, the method further comprising providing a first medical device and one or more second medical devices.

Aspects and embodiments relating to methods of treating an artery or vein with a retention structure as disclosed herein:
[Aspect 1]
(a) determining the diameter and length of an arterial or vein segment to be treated and selecting a first medical device including a balloon having an expanded diameter equal to or greater than the diameter of the selected arterial or vein segment and an expanded length such that when the balloon of the first medical device is expanded, the balloon can occupy at least a portion of the lumen of the selected arterial or vein segment;
(b) placing a balloon of a first medical device within the lumen of the selected arterial or vein segment;
(c) pulling back the third catheter of the first medical device while keeping the first catheter and balloon of the first medical device fixed in place until the retention structure of the balloon of the first medical device expands and brings a portion of the retention structure into contact with the wall of the artery or vein; (d) optionally applying axial tension on the first catheter after expansion of the retention structure to ensure attachment of the retention structure to the wall of the artery or vein;
(e) pulling back the third catheter of the first medical device until the balloon of the first medical device is exposed;
(f) delivering a fluid medium through the first lumen to a central void or interior volume of the balloon of the first medical device such that the expanded balloon assumes an expanded configuration filling a portion of the lumen of the selected arterial or venous segment and contacting at least a portion of a wall of said arterial or venous segment;
(g) pulling back the second catheter of the first medical device while maintaining the position of the expanded balloon of the first medical device until a distal tip of the second catheter of the first medical device is within a central void or interior volume of the expanded balloon of the first medical device;
(h) delivering a first elongate or expandable body of the second medical device from the proximal end of the second catheter of the first medical device, through the lumen of the second catheter of the first medical device, and into a central void or interior volume of the expanded balloon of the first medical device;
(i) separating the first elongate body or expandable body of the second medical device from the second elongate body of the second medical device and removing the second elongate body from the patient while leaving the first elongate body or expandable body of the second medical device within a central void or interior volume of the expanded balloon of the first medical device;
(j) optionally repeating steps (h) and (i) until a desired percentage of the central void or interior volume of the expanded balloon of the first medical device is filled with the first elongate body or first expandable body;
(k) separating the expanded balloon of the first medical device from the first catheter of the first medical device and removing the first and second catheters of the first medical device from the patient while leaving the expanded balloon and the one or more first elongate bodies or first expandable bodies of the first medical device in the patient;
a first medical device comprising:
(i) (i-1) a distal region, a proximal region generally opposite the distal region, an intermediate region transitioning from the distal region to the proximal region, a first axis extending proximally-distally between the proximal and distal regions, and a second axis perpendicular to the first axis;
(i-2) a wall having an outer surface and an inner surface, the inner surface defining a central void or interior volume, the wall extending generally continuously from a proximal region through an intermediate region to a distal region;
(i-3) an opening in the wall in the proximal region that allows the passage of fluid from the first catheter into the central cavity or interior volume of the balloon and also allows the passage of a portion of the second catheter into the central cavity or interior volume of the balloon;
(i-4) an opening in the wall of the distal region that allows passage of a portion of the second catheter into the central cavity or interior volume of the balloon;
(i-5) proximal neck or proximal neck assembly;
(i-6) a distal neck or a distal neck assembly; and
(i-7) a pleated and folded balloon configured for permanent implantation within a human patient comprising a self-expanding metal retention structure, wherein after expansion, a diameter of at least a portion of the self-expanding metal retention structure is equal to or greater than a diameter of the expanded balloon;
(ii) defining a first lumen for permitting passage of fluid from a proximal end of the first catheter to a distal end of the first catheter and into a central void or interior volume of the balloon;
(ii-1) a proximal end including a proximal hub;
(ii-2) a proximal portion passing through the proximal hub of the third catheter;
(ii-3) a central portion passing through the lumen of the third catheter;
(ii-4) a distal portion extending distally relative to the distal end of the third catheter; and
(ii-5) a first catheter including a distal portion operably coupled or joined to a proximal neck or proximal neck assembly of the balloon;
(iii) defining a second lumen configured to receive at least one of a guidewire, an elongate body, an expandable body, or a coagulation fluid;
(iii-1) a proximal end including a proximal hub;
(iii-2) a proximal portion that passes through the proximal hub of the first catheter;
(iii-3) an intermediate portion passing through the lumen of the first catheter;
(iii-4) a distal portion extending distally relative to the distal end of the third catheter and the distal end of the first catheter;
(iii-5) a distal portion passing through the proximal neck or proximal neck assembly of the balloon;
(iii-6) a distal portion that passes through the central cavity or interior volume of the balloon;
(iii-7) a distal portion that engages or passes through a distal neck or distal neck assembly within the balloon; and
(iii-8); a second catheter including an open distal end;
(iv) partially defining a third lumen for permitting passage of fluid from the proximal end of the third catheter to the distal end of the third catheter, the third catheter being configured to compress a retention structure of a balloon of the first medical device;
(iv-1) a proximal end including a proximal hub;
(iv-2); a third catheter including an open distal end;
Including,
(v) the third catheter of the first medical device can be moved forward or backward while the first catheter, the third catheter, and the balloon of the first medical device are fixed in place;
the balloon can be expanded by passage of fluid through the first catheter into a central void or interior volume of the balloon;
After the balloon is expanded, the second catheter can be moved forward or backward while keeping the expanded balloon fixed in place;
After expansion of the balloon, including before or after advancing the tip of the second catheter, one or more of the first elongate body, the expandable body, a coagulation fluid, a solution containing a drug or therapeutic agent, or a solution or suspension containing embolic particles can be disposed through the lumen of the second catheter and into the biological space adjacent to the balloon;
After expansion of the balloon, the second catheter can be pulled back until a distal tip of the second catheter is disposed within the central void or interior volume of the balloon, and one or more of the first elongate body, the expandable body, or the coagulation fluid can be passed through the lumen of the second catheter and disposed within the central void or interior volume of the balloon;
The first catheter can be separated from the expanded balloon;
the first and second catheters can be removed from the patient leaving the balloon and the one or more of the first elongate body, the expandable body, or the coagulation fluid within the patient;
a second medical device comprising:
(i) a distal portion including a first elongate body or an expandable body;
(ii) a proximal portion comprising a second elongate body or delivery system;
Including,
contacting at least a portion of the first elongate or expandable body of the second medical device with at least a portion of a wall of the expanded balloon of the first medical device after placement of the first elongate or expandable body of the second medical device within the expanded balloon of the first medical device;
after placement of the first elongate body or expandable body of the second medical device within the central void or interior volume of the expanded balloon of the first medical device, but prior to separation of the first elongate body or expandable body of the second medical device and the second elongate body of the second medical device, the second medical device can be removed from the patient;
the first elongate body or the expandable body can be separated from the second elongate body;
A method of reducing blood flow in an arterial or venous portion of a human patient using two or more medical devices, wherein after separation of a first elongate body or an expandable body from a second elongate body, the second elongate body can be removed from the patient while leaving the first elongate body or the expandable body in the patient.
[Aspect 2]
(a) determining the diameter and length of an arterial or vein segment to be treated and selecting a first medical device including a balloon having an expanded diameter equal to or greater than the diameter of the selected arterial or vein segment and an expanded length such that when the balloon of the first medical device is expanded, the balloon can occupy at least a portion of the lumen of the selected arterial or vein segment;
(b) placing a balloon of a first medical device within the lumen of the selected arterial or vein segment;
(c) pulling back the third catheter of the first medical device while keeping the first catheter and balloon of the first medical device fixed in place until the retention structure of the balloon of the first medical device expands and brings a portion of the retention structure into contact with the wall of the artery or vein; (d) optionally applying axial tension on the first catheter after expansion of the retention structure to ensure attachment of the retention structure to the wall of the artery or vein;
(e) pulling back the third catheter of the first medical device until the balloon of the first medical device is exposed;
(f) delivering a fluid medium through the first lumen to a central void or interior volume of the balloon of the first medical device such that the expanded balloon assumes an expanded configuration filling a portion of the lumen of the selected arterial or venous segment and contacting at least a portion of a wall of said arterial or venous segment;
(g) delivering at least a distal portion of the first elongate or expandable body of the second medical device from the proximal end of the second catheter of the first medical device, through the lumen of the second catheter of the first medical device, and into the lumen of the artery or vein adjacent the expanded balloon of the first medical device;
(h) pulling back the second catheter of the first medical device while maintaining the position of the expanded balloon of the first medical device until a distal tip of the second catheter of the first medical device is within a central void or interior volume of the expanded balloon of the first medical device;
(i) delivering at least a portion of the first elongate or expandable body of a second medical device into a central void or interior volume of the expanded balloon of the first medical device, with the remaining portion of the first elongate or expandable body of the second medical device contacting at least a portion of a wall of the expanded balloon of the first medical device;
(j) optionally separating the first elongate body or expandable body of the second medical device from the second elongate body of the second medical device and removing the second elongate body from the patient while leaving the first elongate body or expandable body of the second medical device within the central void or interior volume of the expanded balloon of the first medical device;
(k) optionally delivering a first elongate or expandable body of the second medical device from the proximal end of the second catheter of the first medical device, through the lumen of the second catheter of the first medical device, and into a central void or interior volume of the expanded balloon of the first medical device;
(l) optionally separating the first elongate body or expandable body of the second medical device from the second elongate body of the second medical device and removing the second elongate body from the patient while leaving the first elongate body or expandable body of the second medical device within the central void or interior volume of the expanded balloon of the first medical device;
(m) optionally repeating steps (k) and (l) until a desired percentage volume of the unfilled portion of the central void or interior volume of the expanded balloon of the first medical device is filled with the first elongate body or first expandable body;
(n) separating the expanded balloon of the first medical device from the first catheter of the first medical device and removing the first and second catheters of the first medical device from the patient while leaving the expanded balloon and the one or more first elongate bodies or first expandable bodies of the first medical device in the patient;
a first medical device comprising:
(i) (i-1) a distal region, a proximal region generally opposite the distal region, an intermediate region transitioning from the distal region to the proximal region, a first axis extending proximally-distally between the proximal and distal regions, and a second axis perpendicular to the first axis;
(i-2) a wall having an outer surface and an inner surface, the inner surface defining a central void or interior volume, the wall extending generally continuously from a proximal region through an intermediate region to a distal region;
(i-3) an opening in the wall in the proximal region that allows the passage of fluid from the first catheter into the central cavity or interior volume of the balloon and also allows the passage of a portion of the second catheter into the central cavity or interior volume of the balloon;
(i-4) an opening in the wall of the distal region that allows passage of a portion of the second catheter into the central cavity or interior volume of the balloon;
(i-5) proximal neck or proximal neck assembly;
(i-6) a distal neck or a distal neck assembly; and
(i-7) a pleated and folded balloon configured for permanent implantation within a human patient comprising a self-expanding metal retention structure, wherein after expansion, a diameter of at least a portion of the self-expanding metal retention structure is equal to or greater than a diameter of the expanded balloon;
(ii) defining a first lumen for permitting passage of fluid from a proximal end of the first catheter to a distal end of the first catheter and into a central void or interior volume of the balloon;
(ii-1) a proximal end including a proximal hub;
(ii-2) a proximal portion passing through the proximal hub of the third catheter;
(ii-3) a central portion passing through the lumen of the third catheter;
(ii-4) a distal portion extending distally relative to the distal end of the third catheter; and
(ii-5) a first catheter including a distal portion operably coupled or joined to a proximal neck or proximal neck assembly of the balloon;
(iii) defining a second lumen configured to receive at least one of a guidewire, an elongate body, an expandable body, or a coagulation fluid;
(iii-1) a proximal end including a proximal hub;
(iii-2) a proximal portion that passes through the proximal hub of the first catheter;
(iii-3) an intermediate portion passing through the lumen of the first catheter;
(iii-4) a distal portion extending distally relative to the distal end of the third catheter and the distal end of the first catheter;
(iii-5) a distal portion passing through the proximal neck or proximal neck assembly of the balloon;
(iii-6) a distal portion that passes through the central cavity or interior volume of the balloon;
(iii-7) a distal portion that engages or passes through a distal neck or distal neck assembly within the balloon; and
(iii-8); a second catheter including an open distal end;
(iv) partially defining a third lumen for permitting passage of fluid from the proximal end of the third catheter to the distal end of the third catheter, the third catheter being configured to compress a retention structure of a balloon of the first medical device;
(iv-1) a proximal end including a proximal hub;
(iv-2); a third catheter including an open distal end;
Including,
(v) the third catheter of the first medical device can be moved forward or backward while the first catheter, the third catheter, and the balloon of the first medical device are fixed in place;
the balloon can be expanded by passage of fluid through the first catheter into a central void or interior volume of the balloon;
After expansion of the balloon, the second catheter can be moved forward or backward while keeping the expanded balloon fixed in place;
After expansion of the balloon, including before or after advancing the tip of the second catheter, one or more of the first elongate body, the expandable body, a coagulation fluid, a solution containing a drug or therapeutic agent, or a solution or suspension containing embolic particles can be disposed through the lumen of the second catheter and into the biological space adjacent to the balloon;
After expansion of the balloon, the second catheter can be pulled back until a distal tip of the second catheter is disposed within the central void or interior volume of the balloon, and one or more of the first elongate body, the expandable body, or the coagulation fluid can be passed through the lumen of the second catheter and disposed within the central void or interior volume of the balloon;
The first catheter can be separated from the expanded balloon;
the first and second catheters can be removed from the patient leaving the balloon and the one or more of the first elongate body, the expandable body, or the coagulation fluid within the patient;
a second medical device comprising:
(i) a distal portion including a first elongate body or an expandable body;
(ii) a proximal portion comprising a second elongate body or delivery system;
Including,
after placement of the first elongate or expandable body of the second medical device within the lumen of the artery or vein adjacent to the expanded balloon of the first medical device, contacting at least a portion of the first elongate or expandable body of the second medical device with at least a portion of the wall of the artery or vein adjacent to the expanded balloon of the first medical device;
after placement of the first elongate or expandable body of the second medical device within the lumen of the artery or vein adjacent the expanded balloon of the first medical device, but prior to separation of the first elongate or expandable body of the second medical device and the second elongate body of the second medical device, the second medical device may be removed from the patient;
the first elongate body or the expandable body can be separated from the second elongate body;
A method of reducing blood flow in an arterial or venous portion of a human patient using two or more medical devices, wherein after separation of a first elongate body or an expandable body from a second elongate body, the second elongate body can be removed from the patient while leaving the first elongate body or the expandable body in the patient.
[Aspect 3]
3. The method of claim 1 or 2, wherein after expansion of the balloon of the first medical device and prior to retraction of the second catheter of the first medical device into the central void or interior volume of the expanded balloon of the first medical device, a solution containing a fluoroscopy contrast agent, a drug or therapeutic agent, a coagulation fluid, a solution or suspension containing embolic particles, or a combination thereof, is injected through the lumen of the second catheter of the first medical device and into the lumen of the artery or vein adjacent to the expanded balloon of the first medical device.
[Aspect 4]
The method of aspect 3, wherein a syringe or other suitable delivery system is used to inject a solution or suspension containing fluoroscopic contrast agents, drugs, therapeutic agents, coagulation fluids, embolic particles, or combinations thereof, through the lumen of the shaft of the second catheter of the first medical device and into the lumen of the artery or vein adjacent the expanded balloon of the first medical device.
[Aspect 5]
5. The method of claim 3 or 4, further comprising advancing a second catheter of the first medical device within the artery or vein while maintaining the position of the balloon of the first medical device prior to injecting a solution or suspension comprising a fluoroscopic contrast agent, a drug, a therapeutic agent, a coagulation fluid, or embolic particles through the lumen of the shaft of the second catheter of the first medical device and into the lumen of the artery or vein adjacent the expanded balloon of the first medical device.
[Aspect 6]
The method of any one of aspects 1 to 2, wherein prior to causing the expanded balloon of the first medical device to detach from the first catheter of the first medical device, a coagulation fluid is injected from the proximal end of the first catheter of the first medical device, through the lumen of the first catheter of the first medical device, and into the central void or interior volume of the expanded balloon of the first medical device.
[Aspect 7]
The method of any one of aspects 1-6, wherein after being positioned within the central void or interior volume of the expanded balloon, the first elongate or expandable body of the second medical device exerts a force on the wall of the expanded balloon of the first medical device.
[Aspect 8]
The method of aspect 7, wherein the force on the wall of the expanded balloon of the first medical device is outward.
[Aspect 9]
The method of any one of aspects 1-8, wherein the maximum diameter or tertiary diameter of the second medical device is equal to the maximum diameter of the expanded balloon.
[Aspect 10]
The method of any one of aspects 1-8, wherein the maximum or tertiary diameter of the first elongate or expandable body of the second medical device ranges from a value equal to a maximum diameter of the expanded balloon of the first medical device to a value 50% greater than a maximum diameter of the expanded balloon of the first medical device.
[Aspect 11]
The method of any one of aspects 1-8, wherein the maximum or tertiary diameter of the first elongate or expandable body of the second medical device is 1, 2, 3, 4, 5, 6, 7, 8, 9, or 10 mm greater than the maximum diameter of the expanded balloon of the first medical device.
[Aspect 12]
Aspect 12. The method of any one of aspects 1-11, wherein the volume of the one or more first elongate bodies or expandable bodies of the second medical device fills 5-75% of the volume of the central void of the expanded balloon.
[Aspect 13]
12. The method of any one of the preceding claims, wherein the volume of the first elongate body or expandable body of the second medical device fills 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49, 50, 51, 52, 53, 54, 55, 56, 57, 58, 59, 60, 61, 62, 63, 64, 65, 66, 67, 68, 69, 70, 71, 72, 73, 74, or 75% of the volume of the central void of the expanded balloon.
[Aspect 14]
14. The method of any one of the preceding aspects, wherein the inflated balloon is configured to contact at least 100%, 90%, 80%, 70, 60%, 50%, 40%, 30%, 20%, 10%, or 5% of the area of the luminal surface of the selected segment of the artery or vein.
[Aspect 15]
15. The method of any one of the preceding aspects, wherein the expanded balloon is configured to fill at least 100%, 90%, 80%, 70%, 60%, 50%, 40%, 30%, 20%, 10%, or 5% of the volume of the lumen of the selected segment of the artery or vein.
[Aspect 16]
The method of any one of aspects 1-15, wherein the distal portion of the second catheter of the first medical device comprises a radiopaque portion, ring or marker that is clearly visible under fluoroscopy, and fluoroscopy is used to monitor the position of the distal portion of the second catheter of the first medical device relative to the position of the distal portion of the balloon of the first medical device as the second catheter of the first medical device moves.
[Aspect 17]
17. The method of any one of aspects 1-16, wherein the distal portion of the balloon of the first medical device comprises a radiopaque portion, ring or marker that is clearly visible under fluoroscopy, and fluoroscopy is used to monitor the position of the distal portion of the second catheter of the first medical device relative to the position of the distal portion of the balloon of the first catheter as the second catheter of the first medical device moves.
[Aspect 18]
18. The method of any one of claims 1-17, wherein at least a portion of the distal telescoping structure of the first medical device comprises a radiopaque portion, ring or marker that is clearly visible under fluoroscopy, and fluoroscopy is used to monitor the position of a distal portion of the second catheter of the first medical device relative to the position of the distal telescoping structure of the first medical device as the second catheter of the first medical device moves.
[Aspect 19]
The method of any one of aspects 1-18, wherein at least a portion of the first elongate body or expandable body of the second medical device is formed from a material that is radiopaque and clearly visible under fluoroscopy, and fluoroscopy is used to monitor the placement and position of the first elongate body or expandable body of the second medical device.
[Aspect 20]
The method of any one of aspects 1-19, wherein the second catheter of the first medical device comprises one, two, or more radiopaque portions, rings or markers, and fluoroscopy is used to monitor the position of the second catheter of the first medical device relative to the position of the first elongate body or expandable body of the second medical device.
[Aspect 21]
21. The method of any one of aspects 1-20, wherein a distal portion of the first catheter of the first medical device comprises a radiopaque marker that is clearly visible under fluoroscopy, and fluoroscopy is used to monitor separation of the expanded balloon of the first medical device from the first catheter of the first medical device.
[Aspect 22]
22. The method of any one of aspects 1-21, wherein a proximal portion of the balloon of the first medical device comprises a radiopaque marker that is clearly visible under fluoroscopy, and fluoroscopy is used to monitor separation of the expanded balloon of the first medical device from the first catheter of the first medical device.
[Aspect 23]
23. The method of any one of aspects 16-22, wherein the radiopaque portion, ring, or marker comprises platinum, iridium, gold, tungsten, or a combination thereof.
[Aspect 24]
24. The method of any one of embodiments 1 to 23, wherein the wall of an artery or vein is damaged or ruptured.
[Aspect 25]
24. The method of any one of embodiments 1 to 23, wherein the wall of the artery or vein is not damaged or ruptured.
[Aspect 26]
26. The method of any one of aspects 1-25, wherein the distal neck or distal neck assembly of the second catheter of the first medical device and the balloon of the first medical device are joined by a friction fit, and the second catheter of the first medical device and the expanded balloon of the first medical device are separated by applying axial tension to the tubular segments.
[Aspect 27]
27. The method of aspect 26, wherein the distal neck or distal neck assembly of the second catheter of the first medical device and the balloon of the first medical device are connected by an elastomeric valve.
[Aspect 28]
28. The method of aspect 27, wherein the elastomeric valve serves to reduce blood flow through a central void or interior volume of the expanded balloon of the first medical device after removal of the second catheter of the first medical device from the patient.
[Aspect 29]
29. The method of any one of aspects 1-28, wherein the proximal neck or proximal neck assembly of the first catheter of the first medical device and the balloon of the first medical device are joined by a friction fit, and the first catheter of the first medical device and the expanded balloon of the first medical device are separated by applying axial tension to the elastomeric tubular segment.
[Aspect 30]
30. The method of aspect 29, wherein the proximal neck or proximal neck assembly of the first catheter of the first medical device and the balloon of the first medical device are joined by an elastomeric tubular segment.
[Aspect 31]
29. The method of any one of aspects 1-28, wherein the first catheter of the first medical device and the balloon of the first medical device are joined by a tubular structure, a male portion of the tubular structure being joined to a distal end of the first catheter and a female portion of the tubular structure being joined to a proximal neck or proximal neck assembly of the balloon of the first medical device.
[Aspect 32]
32. The method of aspect 31, wherein the proximal neck of the balloon of the first medical device is the second portion of the mechanical latch.
[Aspect 33]
33. The method of aspect 31 or 32, wherein two portions of the mechanical latch engage or are operably coupled when the second catheter of the first medical device passes through the mechanical latch.
[Aspect 34]
34. The method of aspect 33, wherein the second catheter of the first medical device is removed from the mechanical latch to separate or operatively separate the mechanical latch and the two portions of the mechanical latch.
[Aspect 35]
34. The method of aspect 33, wherein the first catheter of the first medical device and the expanded balloon of the first medical device are separated.
[Aspect 36]
29. The method of any one of aspects 1-28, wherein the proximal neck or proximal neck assembly of the first catheter of the first medical device and the balloon of the first medical device are joined by adhesive, glue, or solder, and the electrolysis-sensitive tubular segment of the first medical device is electrolytically eroded.
[Aspect 37]
37. The method of aspect 36, wherein the first catheter of the first medical device and the expanded balloon of the first medical device are separated following erosion of a proximal neck or portion of a proximal neck assembly of the balloon of the first medical device.
[Aspect 38]
29. The method of any one of aspects 1-28, wherein the first catheter of the first medical device and the proximal neck or proximal neck assembly of the balloon of the first medical device are joined by adhesive, glue, or solder, and a distal portion of the first catheter of the first medical device, a portion of the proximal neck or proximal neck assembly of the balloon of the first medical device, or a portion of the bond between the distal portion of the first catheter of the first medical device and the first heat sensitive tubular segment melts upon heating.
[Aspect 39]
The method of claim 38, wherein the first catheter of the first medical device and the expanded balloon of the first medical device are pulled apart after melting of the distal portion of the first catheter of the first medical device, a portion of the proximal neck or proximal neck assembly of the balloon of the first medical device, or a portion of the bond between the distal portion of the first catheter of the first medical device and the proximal neck or proximal neck assembly of the balloon of the first medical device.
[Aspect 40]
Aspect 40. The method of any one of aspects 1-39, wherein the self-expanding retention structure is bonded to the distal neck of the balloon of the first medical device.
[Aspect 41]
Aspect 40. The method of any one of aspects 1-39, wherein the self-expanding retention structure is bonded to the proximal neck of the balloon of the first medical device.
[Aspect 42]
Aspect 42. The method of any one of aspects 1-41, wherein the first elongate body or the expandable body of the second medical device is flexible, the second elongate body of the second medical device is flexible, or the first elongate body and the second elongate body of the second medical device are flexible.
[Aspect 43]
Aspect 43. The method of any one of aspects 1-42, wherein the first catheter of the first medical device is flexible, the second catheter of the first medical device is flexible, or the first catheter and the second catheter of the first medical device are flexible.
[Aspect 44]
Aspect 1, wherein the balloon of the first medical device is detachable.
[Aspect 45]
Aspect 45. The method of any one of aspects 1-44, wherein the balloon of the first medical device is deflated or compressed prior to expansion.
[Aspect 46]
Aspect 46. The method of any one of aspects 1-45, wherein the fluid used to expand the balloon of the first medical device is water, saline, a fluoroscopy contrast agent, or a combination thereof.
[Aspect 47]
47. The method of any one of the preceding aspects, wherein a solution comprising a fluoroscopic contrast agent is injected under fluoroscopy through the second catheter of the first medical device, into the hub of the second catheter of the first medical device, and into the lumen of the artery or vein adjacent the distal tip of the second catheter of the first medical device prior to expansion of the retention structure.
[Aspect 48]
48. The method of any one of aspects 1-47, wherein a solution comprising a fluoroscopic contrast agent is injected under fluoroscopy through the second catheter of the first medical device, into the hub of the second catheter of the first medical device, and into the lumen of the artery or vein adjacent the distal tip of the second catheter of the first medical device after expansion of the retention structure of the balloon of the first medical device but prior to expansion of the balloon of the first medical device.
[Aspect 49]
49. The method of any one of aspects 1-48, wherein a solution comprising a fluoroscopic contrast agent is injected under fluoroscopy through the second catheter of the first medical device, into the hub of the second catheter of the first medical device, and into the lumen of the artery or vein adjacent the distal tip of the second catheter of the first medical device after expansion of the balloon of the first medical device but prior to separation of the balloon of the first medical device and the first catheter of the first medical device.
[Aspect 50]
50. The method of any one of aspects 1-49, wherein a solution comprising a fluoroscopic contrast agent is injected under fluoroscopy through the second catheter of the first medical device, into the hub of the second catheter of the first medical device, and into the lumen of the artery or vein adjacent the distal tip of the second catheter of the first medical device after separation of the expanded balloon of the first medical device and the first catheter of the first medical device.
[Aspect 51]
51. The method of any one of the preceding aspects, wherein a solution comprising a fluoroscopic contrast agent is injected under fluoroscopy through the third catheter of the first medical device, into the hub of the third catheter of the first medical device, and into the lumen of the artery or vein adjacent the distal tip of the third catheter of the first medical device prior to expansion of the retention structure.
[Aspect 52]
52. The method of any one of the preceding aspects, wherein a solution comprising a fluoroscopic contrast agent is injected under fluoroscopy through the third catheter of the first medical device, into the hub of the third catheter of the first medical device, and into the lumen of the artery or vein adjacent the distal tip of the third catheter of the first medical device after expansion of the retention structure of the balloon of the first medical device but prior to expansion of the balloon of the first medical device.
[Aspect 53]
53. The method of any one of aspects 1-52, wherein a solution comprising a fluoroscopic contrast agent is injected under fluoroscopy through the third catheter of the first medical device, into a hub of the third catheter of the first medical device, and into the lumen of the artery or vein adjacent to the distal tip of the third catheter of the first medical device after expansion of the balloon of the first medical device but prior to separation of the expanded balloon of the first medical device and the first catheter of the first medical device.
[Aspect 54]
54. The method of any one of aspects 1-53, wherein a solution comprising a fluoroscopic contrast agent is injected under fluoroscopy through the third catheter of the first medical device, into the hub of the third catheter of the first medical device, and into the lumen of the artery or vein adjacent the distal tip of the third catheter of the first medical device after separation of the expanded balloon of the first medical device and the first catheter of the first medical device.
[Aspect 55]
Aspect 55. The method of any one of aspects 1-54, further comprising providing a first medical device and one or more second medical devices.

Aspects and embodiments relating to methods of treating aneurysms as disclosed herein:
[Aspect 1]
(a) determining a maximum aneurysm neck diameter, a minimum aneurysm width, a minimum aneurysm depth, and a minimum aneurysm height; and wherein the diameter of the inflated balloon is greater than the maximum aneurysm neck diameter;
The diameter of the inflated balloon is smaller than the minimum aneurysm width,
selecting a first medical device comprising a balloon having an expanded balloon diameter less than the minimum aneurysm depth, and an expanded balloon diameter less than the minimum aneurysm height;
(b) placing a balloon of a first medical device within the lumen of the aneurysm;
(c) delivering a fluid medium through the first lumen into an interior volume of the balloon of the first medical device such that the expanded balloon assumes an expanded configuration filling a portion of the aneurysm lumen but leaving a portion of the aneurysm lumen unfilled;
(d) optionally, pulling back the expanded balloon of the first medical device until at least a portion of the expanded balloon contacts at least a portion of the aneurysm neck or at least a portion of the aneurysm adjacent to the aneurysm neck;
(e) optionally, advancing a second catheter of the first medical device into the aneurysm while maintaining the position of the expanded balloon of the first medical device;
(f) delivering a first elongate or expandable body of the second medical device from the proximal end of the second catheter of the first medical device, through the lumen of the second catheter of the first medical device, and into the unfilled portion of the aneurysm lumen adjacent the expanded balloon of the first medical device;
(g) separating the first elongate body or expandable body of the second medical device from the second elongate body of the second medical device and removing the second elongate body from the patient while leaving the first elongate body or expandable body of the second medical device within the aneurysm lumen;
(h) optionally repeating steps (e) and (f) until a desired percentage volume of the unfilled portion of the aneurysm lumen adjacent the expanded balloon of the first medical device is filled with the first elongate body or the first expandable body;
(i) separating the expanded balloon of the first medical device from the first catheter of the first medical device and removing the first and second catheters of the first medical device from the patient while leaving the expanded balloon and the one or more first elongate bodies or first expandable bodies of the first medical device in the patient;
a first medical device comprising:
(i) (i-1) a distal region, a proximal region generally opposite the distal region, an intermediate region transitioning from the distal region to the proximal region, a first axis extending proximally-distally between the proximal and distal regions, and a second axis perpendicular to the first axis;
(i-2) a wall having an outer surface and an inner surface, the inner surface defining a central void or interior volume, the wall extending generally continuously from a proximal region through an intermediate region to a distal region;
(i-3) an opening in the wall in the proximal region that allows the passage of fluid from the first catheter into the central cavity or interior volume of the balloon and also allows the passage of a portion of the second catheter into the central cavity or interior volume of the balloon;
(i-4) an opening in the wall of the distal region that allows passage of a portion of the second catheter into the central cavity or interior volume of the balloon;
(i-5) a proximal neck or a proximal neck assembly; and
(i-6) a pleated and folded balloon configured for permanent implantation in a human patient, the balloon comprising a distal neck or distal neck assembly;
(ii) defining a first lumen for permitting passage of fluid from a proximal end of the first catheter to a distal end of the first catheter and into a central void or interior volume of the balloon;
(ii-1) a proximal end including a proximal hub; and
(ii-2) a first catheter including a distal portion operably coupled or joined to a proximal neck or proximal neck assembly of the balloon;
(iii) defining a second lumen configured to receive at least one of a guidewire, an elongate body, an expandable body, or a coagulation fluid;
(iii-1) a proximal end including a proximal hub;
(iii-2) a proximal portion that passes through the proximal hub of the first catheter;
(iii-3) an intermediate portion passing through the lumen of the first catheter;
(iii-4) a distal portion extending distally relative to the distal end of the first catheter;
(iii-5) a distal portion passing through the proximal neck or proximal neck assembly of the balloon;
(iii-6) a distal portion that passes through the central cavity or interior volume of the balloon;
(iii-7) a distal portion that engages or passes through a distal neck or distal neck assembly within the balloon; and
(iii-8); a second catheter including an open distal end;
(iv) the balloon can be expanded by passage of a fluid through the first catheter into a central void or interior volume of the balloon;
After expansion of the balloon, the second catheter can be moved forward or backward while keeping the expanded balloon fixed in place;
After expansion of the balloon, including before or after advancing the tip of the second catheter, one or more of the first elongate body, the expandable body, a coagulation fluid, a solution containing a drug or therapeutic agent, or a solution or suspension containing embolic particles can be disposed through the lumen of the second catheter and into the biological space adjacent to the balloon;
After expansion of the balloon, the second catheter can be pulled back until a distal tip of the second catheter is disposed within the central void or interior volume of the balloon, and one or more of the first elongate body, the expandable body, or the coagulation fluid can be passed through the lumen of the second catheter and disposed within the central void or interior volume of the balloon;
The first catheter can be separated from the expanded balloon;
the first and second catheters can be removed from the patient leaving the balloon and the one or more of the first elongate body, the expandable body, or the coagulation fluid within the patient;
a second medical device comprising:
(i) a distal portion including a first elongate body or an expandable body;
(ii) a proximal portion comprising a second elongate body or delivery system;
Including,
after placement of the first elongate or expandable body of the second medical device within the unfilled portion of the aneurysm lumen adjacent the expanded balloon of the first medical device, contacting at least a portion of the first elongate or expandable body of the second medical device with at least a portion of the wall of the aneurysm adjacent the expanded balloon of the first medical device;
after placement of the first elongate body or expandable body of the second medical device into the unfilled portion of the aneurysm lumen adjacent the expanded balloon of the first medical device, but prior to separation of the first elongate body or expandable body of the second medical device and the second elongate body of the second medical device, the second medical device may be removed from the patient;
the first elongate body or the expandable body can be separated from the second elongate body;
A method of reducing blood flow within a saccular aneurysm in a human patient using two or more medical devices, wherein after separation of a first elongate body or an expandable body from a second elongate body, the second elongate body can be removed from the patient while leaving the first elongate body or the expandable body within the patient.
[Aspect 2]
(a) determining a maximum aneurysm neck diameter, a minimum aneurysm width, a minimum aneurysm depth, and a minimum aneurysm height; and wherein the diameter of the inflated balloon is greater than the maximum aneurysm neck diameter;
The diameter of the inflated balloon is smaller than the minimum aneurysm width,
selecting a first medical device comprising a balloon having an expanded balloon diameter less than the minimum aneurysm depth, and an expanded balloon diameter less than the minimum aneurysm height;
(b) placing a balloon of a first medical device within the lumen of the aneurysm;
(c) delivering a fluid medium through the first lumen into an interior volume of the balloon of the first medical device such that the expanded balloon assumes an expanded configuration filling a portion of the aneurysm lumen but leaving a portion of the aneurysm lumen unfilled;
(d) optionally, pulling back the expanded balloon of the first medical device until at least a portion of the expanded balloon contacts at least a portion of the aneurysm neck or at least a portion of the aneurysm adjacent to the aneurysm neck;
(e) optionally, advancing a second catheter of the first medical device into the aneurysm while maintaining the position of the expanded balloon of the first medical device;
(f) delivering at least a distal portion of the first elongate or expandable body of the second medical device from the proximal end of the second catheter of the first medical device, through the lumen of the second catheter of the first medical device, and into the unfilled portion of the aneurysm lumen adjacent the expanded balloon of the first medical device;
(g) withdrawing the second catheter of the first medical device while maintaining the position of the expanded balloon of the first medical device until a distal tip of the second catheter of the first medical device is within a central void or interior volume of the expanded balloon of the first medical device;
(h) delivering a remaining portion of the first elongate or expandable body of the second medical device into a central void or interior volume of the expanded balloon of the first medical device, contacting at least a portion of the wall of the expanded balloon of the first medical device;
(i) separating the first elongate body or expandable body of the second medical device from the second elongate body of the second medical device and removing the second elongate body from the patient while leaving the first elongate body or expandable body of the second medical device within the aneurysm lumen;
(j) optionally delivering a first elongate or expandable body of the second medical device from the proximal end of the second catheter of the first medical device, through the lumen of the second catheter of the first medical device, and into a central void or interior volume of the expanded balloon of the first medical device;
(k) optionally separating the first elongate body or expandable body of the second medical device from the second elongate body of the second medical device and removing the second elongate body from the patient while leaving the first elongate body or expandable body of the second medical device within the central void or interior volume of the expanded balloon of the first medical device;
(l) optionally repeating steps (j) and (k) until a desired percentage volume of the unfilled portion of the central void or interior volume of the expanded balloon of the first medical device is filled with the first elongate body or first expandable body;
(m) separating the expanded balloon of the first medical device from the first catheter of the first medical device and removing the first and second catheters of the first medical device from the patient while leaving the expanded balloon and the one or more first elongate bodies or first expandable bodies of the first medical device in the patient;
a first medical device comprising:
(i) (i-1) a distal region, a proximal region generally opposite the distal region, an intermediate region transitioning from the distal region to the proximal region, a first axis extending proximally-distally between the proximal and distal regions, and a second axis perpendicular to the first axis;
(i-2) a wall having an outer surface and an inner surface, the inner surface defining a central void or interior volume, the wall extending generally continuously from a proximal region through an intermediate region to a distal region;
(i-3) an opening in the wall in the proximal region that allows the passage of fluid from the first catheter into the central cavity or interior volume of the balloon and also allows the passage of a portion of the second catheter into the central cavity or interior volume of the balloon;
(i-4) an opening in the wall of the distal region that allows passage of a portion of the second catheter into the central cavity or interior volume of the balloon;
(i-5) a proximal neck or a proximal neck assembly; and
(i-6) a pleated and folded balloon configured for permanent implantation in a human patient, the balloon comprising a distal neck or distal neck assembly;
(ii) defining a first lumen for permitting passage of fluid from a proximal end of the first catheter to a distal end of the first catheter and into a central void or interior volume of the balloon;
(ii-1) a proximal end including a proximal hub; and
(ii-2) a first catheter including a distal portion operably coupled or joined to a proximal neck or proximal neck assembly of the balloon;
(iii) defining a second lumen configured to receive at least one of a guidewire, an elongate body, an expandable body, or a coagulation fluid;
(iii-1) a proximal end including a proximal hub;
(iii-2) a proximal portion that passes through the proximal hub of the first catheter;
(iii-3) an intermediate portion passing through the lumen of the first catheter;
(iii-4) a distal portion extending distally relative to the distal end of the first catheter;
(iii-5) a distal portion passing through the proximal neck or proximal neck assembly of the balloon;
(iii-6) a distal portion that passes through the central cavity or interior volume of the balloon;
(iii-7) a distal portion that engages or passes through a distal neck or distal neck assembly within the balloon; and
(iii-8); a second catheter including an open distal end;
(iv) the balloon can be expanded by passage of a fluid through the first catheter into a central void or interior volume of the balloon;
After the balloon is expanded, the second catheter can be moved forward or backward while keeping the expanded balloon fixed in place;
After expansion of the balloon, including before or after advancing the tip of the second catheter, one or more of the first elongate body, the expandable body, a coagulation fluid, a solution containing a drug or therapeutic agent, or a solution or suspension containing embolic particles can be disposed through the lumen of the second catheter and into the biological space adjacent to the balloon;
After expansion of the balloon, the second catheter can be pulled back until a distal tip of the second catheter is disposed within the central void or interior volume of the balloon, and one or more of the first elongate body, the expandable body, or the coagulation fluid can be passed through the lumen of the second catheter and disposed within the central void or interior volume of the balloon;
The first catheter can be separated from the expanded balloon;
the first and second catheters can be removed from the patient leaving the balloon and the one or more of the first elongate body, the expandable body, or the coagulation fluid within the patient;
a second medical device comprising:
(i) a distal portion including a first elongate body or an expandable body;
(ii) a proximal portion comprising a second elongate body or delivery system;
Including,
after placement of the first elongate or expandable body of the second medical device within the unfilled portion of the aneurysm lumen adjacent the expanded balloon of the first medical device, contacting at least a portion of the first elongate or expandable body of the second medical device with at least a portion of the wall of the aneurysm adjacent the expanded balloon of the first medical device;
after placement of the first elongate body or expandable body of the second medical device into the unfilled portion of the aneurysm lumen adjacent the expanded balloon of the first medical device, but prior to separation of the first elongate body or expandable body of the second medical device and the second elongate body of the second medical device, the second medical device may be removed from the patient;
the first elongate body or the expandable body can be separated from the second elongate body;
A method of reducing blood flow within a saccular aneurysm in a human patient using two or more medical devices, wherein after separation of a first elongate body or an expandable body from a second elongate body, the second elongate body can be removed from the patient while leaving the first elongate body or the expandable body within the patient.
[Aspect 3]
3. The method of claim 1 or 2, wherein after expansion of the balloon of the first medical device and prior to retraction of the second catheter of the first medical device into the central void or interior volume of the expanded balloon of the first medical device, a solution containing a fluoroscopy contrast agent, a drug or therapeutic agent, a coagulation fluid, or a combination thereof, is injected through the lumen of the second catheter of the first medical device and into the lumen of the aneurysm adjacent to the expanded balloon of the first medical device.
[Aspect 4]
The method of aspect 3, wherein a syringe or other suitable delivery system is used to inject the fluoroscopic contrast agent, the drug, the therapeutic agent, the coagulation fluid, or a combination thereof.
[Aspect 5]
5. The method of aspect 3 or 4, wherein the second catheter of the first medical device is advanced within the aneurysm while maintaining the position of the balloon of the first medical device prior to injecting a fluoroscopic contrast agent, a drug, a therapeutic agent, a coagulation fluid, or a combination thereof, through the lumen of the shaft of the second catheter of the first medical device and into the lumen of the aneurysm adjacent the expanded balloon of the first medical device.
[Aspect 6]
The method of aspect 1 or 2, further comprising injecting a coagulation fluid from the proximal end of the first catheter of the first medical device, through the lumen of the first catheter of the first medical device, and into the central void or interior volume of the expanded balloon of the first medical device prior to separating the expanded balloon of the first medical device from the first catheter of the first medical device.
[Aspect 7]
The method of any one of aspects 1-6, wherein the expanded balloon is configured to contact at least 100%, 90%, 80%, 70, 60%, 50%, 40%, 30%, 20%, 10%, or 5% of the area of the luminal surface of the aneurysm.
[Aspect 8]
7. The method of any one of claims 1-6, wherein the expanded balloon is configured to fill at least 100%, 90%, 80%, 70%, 60%, 50%, 40%, 30%, 20%, 10%, or 5% of the volume of the aneurysm lumen.
[Aspect 9]
The method of any one of aspects 1-8, wherein the maximum diameter or tertiary diameter of the second medical device is equal to or less than the maximum diameter of the portion of the aneurysm not filled by the expanded balloon of the first medical device.
[Aspect 10]
The method of any one of aspects 1-8, wherein the maximum or tertiary diameter of the first elongate or expandable body of the second medical device ranges from a value equal to a maximum diameter of an expanded balloon of the first medical device to a value 20% greater than a maximum diameter of a portion of the aneurysm not filled by the expanded balloon of the first medical device.
[Aspect 11]
The method of any one of aspects 1-10, wherein the maximum or tertiary diameter of the first elongate or expandable body of the second medical device is 1, 2, 3, 4, 5, 6, 7, 8, 9, or 10 mm greater than the maximum diameter of the portion of the aneurysm that is not filled by the expanded balloon of the first medical device.
[Aspect 12]
The method of any one of aspects 1-11, wherein after placement within the aneurysm lumen, at least a portion of the first elongate body or expandable body of the second medical device applies force to the walls of the aneurysm and the walls of the expanded balloon of the first medical device.
[Aspect 13]
13. The method of aspect 12, wherein the force of the first elongate body or the expandable body on the wall of the expanded balloon pushes the expanded balloon towards the aneurysm neck.
[Aspect 14]
Aspect 14. The method of any one of aspects 1-13, wherein the maximum or tertiary diameter of the first elongate or expandable body of the second medical device is equal to or greater than the maximum diameter of the expanded balloon.
[Aspect 15]
The method of any one of aspects 1-14, wherein the maximum or tertiary diameter of the first elongate or expandable body of the second medical device ranges from a value equal to a maximum diameter of the expanded balloon of the first medical device to a value 50% greater than the maximum diameter of the expanded balloon of the first medical device.
[Aspect 16]
The method of any one of aspects 1-14, wherein the maximum or tertiary diameter of the first elongate or expandable body of the second medical device is 1, 2, 3, 4, 5, 6, 7, 8, 9, or 10 mm greater than the maximum diameter of the expanded balloon of the first medical device.
[Aspect 17]
The method of any one of aspects 9-11, wherein after being positioned within the central void or interior volume of the expanded balloon, the first elongate or expandable body of the second medical device exerts a force on the wall of the expanded balloon of the first medical device.
[Aspect 18]
18. The method of aspect 17, wherein the force on the wall of the expanded balloon of the first medical device is outward.
[Aspect 19]
19. The method of any one of the preceding aspects, wherein the volume of the first elongate body or expandable body of the second medical device disposed within the central void or interior volume of the expanded balloon fills 5-75% of the volume of the central void or interior volume of the expanded balloon.
[Aspect 20]
The volume of the first elongate body or expandable body of the second medical device disposed within the central void or interior volume of the expanded balloon is 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49, 50, 51, 52, 53, 54, 55, 56, 57, 58, 59, 60, 61, 62, 63, 64, 65, 66, 67, 68, 69, 70, 71, 72, 73, 74, 75, 76, 77, 78, 79, 80, 81, 82, 83, 84, 85, 86, 87, 88, 89, 90, 91, 92, 93, 94, 95, 96, 97, 98, 99, 100, 101, 102, 103, 104, 105, 106, 107, 108, 109, 1109, 1110, 112, 113, 114, 115, 116, 117, 118, 120, 1 , 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49, 50, 51, 52, 53, 54, 55, 56, 57, 58, 59, 60, 61, 62, 63, 64, 65, 66, 67, 68, 69, 70, 71, 72, 73, 74, or 75% of the total.
[Aspect 21]
21. The method of any one of aspects 1-20, wherein the volume of the first elongate body or expandable body of the second medical device disposed within the lumen of the aneurysm fills 5-75% of the volume of the aneurysm that is not filled by the expanded balloon.
[Aspect 22]
The volume of the first elongate body or expandable body of the second medical device disposed within the lumen of the aneurysm is 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49, 50, 51, 52, 53, 54, 55, 56, 57, 58, 59, 60, 61, 21. The method of any one of the preceding claims, wherein the method satisfies 3, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49, 50, 51, 52, 53, 54, 55, 56, 57, 58, 59, 60, 61, 62, 63, 64, 65, 66, 67, 68, 69, 70, 71, 72, 73, 74, or 75%.
[Aspect 23]
The method of any one of aspects 1-22, wherein the distal portion of the second catheter of the first medical device comprises a radiopaque portion, ring or marker that is clearly visible under fluoroscopy, and fluoroscopy is used to monitor the position of the distal portion of the second catheter of the first medical device relative to the position of the distal portion of the balloon of the first medical device as the second catheter of the first medical device moves.
[Aspect 24]
24. The method of any one of aspects 1-23, wherein the distal portion of the balloon of the first medical device comprises a radiopaque portion, ring or marker that is clearly visible under fluoroscopy, and fluoroscopy is used to monitor the position of the distal portion of the second catheter of the first medical device relative to the position of the distal portion of the balloon of the first catheter as the second catheter of the first medical device moves.
[Aspect 25]
25. The method of any one of claims 1-24, wherein at least a portion of the distal telescoping structure of the first medical device comprises a radiopaque portion, ring or marker that is clearly visible under fluoroscopy, and fluoroscopy is used to monitor the position of a distal portion of the second catheter of the first medical device relative to the position of the distal telescoping structure of the first medical device as the second catheter of the first medical device moves.
[Aspect 26]
The method of any one of aspects 1-25, wherein at least a portion of the first elongate body or expandable body of the second medical device is formed from a material that is radiopaque and clearly visible under fluoroscopy, and fluoroscopy is used to monitor the placement and position of the first elongate body or expandable body of the second medical device.
[Aspect 27]
The method of any one of aspects 1-26, wherein the second catheter of the first medical device includes one, two, or more radiopaque portions, rings, or markers, and fluoroscopy is used to monitor the position of the second catheter of the first medical device relative to the position of the first elongate body or expandable body of the second medical device.
[Aspect 28]
28. The method of any one of aspects 1-27, wherein a distal portion of the first catheter of the first medical device comprises a radiopaque marker that is clearly visible under fluoroscopy, and fluoroscopy is used to monitor separation of the expanded balloon of the first medical device from the first catheter of the first medical device.
[Aspect 29]
29. The method of any one of aspects 1-28, wherein a proximal portion of the balloon of the first medical device comprises a radiopaque marker that is clearly visible under fluoroscopy, and fluoroscopy is used to monitor separation of the expanded balloon of the first medical device from the first catheter of the first medical device.
[Aspect 30]
30. The method of any one of aspects 23-29, wherein the radiopaque portion, ring, or marker comprises platinum, iridium, gold, tungsten, or a combination thereof.
[Aspect 31]
The method of any one of embodiments 1 to 30, wherein the wall of the aneurysm is damaged or ruptured.
[Aspect 32]
The method of any one of aspects 1 to 30, wherein the wall of the aneurysm is not damaged or ruptured.
[Aspect 33]
Aspects 1-33. The method of any one of aspects 1-32, wherein the distal neck or distal neck assembly of the second catheter of the first medical device and the balloon of the first medical device are coupled by a friction fit, and the second catheter of the first medical device and the expanded balloon of the first medical device are separated by applying axial tension to the coupling.
[Aspect 34]
34. The method of aspect 33, wherein the distal neck or distal neck assembly of the second catheter of the first medical device and the balloon of the first medical device are joined by an elastomeric valve.
[Aspect 35]
The method of aspect 34, wherein the elastomeric valve serves to reduce blood flow through a central void or interior volume of the expanded balloon of the first medical device after removal of the second catheter of the first medical device from the patient.
[Aspect 36]
Aspects 1-36. The method of any one of aspects 1-35, wherein the proximal neck or proximal neck assembly of the first catheter of the first medical device and the balloon of the first medical device are coupled by a friction fit, and the first catheter of the first medical device and the expanded balloon of the first medical device are separated by applying axial tension to the coupling.
[Aspect 37]
37. The method of aspect 36, wherein the proximal neck or proximal neck assembly of the first catheter of the first medical device and the balloon of the first medical device are joined by an elastomeric tubular segment.
[Aspect 38]
Aspects 1-36. The method of any one of aspects 1-35, wherein the first catheter of the first medical device and the balloon of the first medical device are coupled by a mechanical latch, a portion of the mechanical latch being joined to a distal end of the first catheter and a second portion of the mechanical latch being joined to a proximal neck or proximal neck assembly of the balloon of the first medical device.
[Aspect 39]
40. The method of aspect 38, wherein the proximal neck of the balloon of the first medical device is the second portion of the mechanical latch.
[Aspect 40]
40. The method of aspect 38 or 39, wherein two portions of the mechanical latch engage or are operably coupled when the second catheter of the first medical device passes through the mechanical latch.
[Aspect 41]
41. The method of aspect 40, wherein the second catheter of the first medical device is removed from the mechanical latch to separate or operatively separate the mechanical latch and the two portions of the mechanical latch.
[Aspect 42]
42. The method of aspect 41, wherein the first catheter of the first medical device and the expanded balloon of the first medical device are separated.
[Aspect 43]
A method according to any one of aspects 1 to 42, wherein the first catheter of the first medical device and the proximal neck or proximal neck assembly of the balloon of the first medical device are joined by adhesive, glue, or solder, and a portion of the proximal neck or proximal neck assembly of the balloon of the first medical device is eroded by electrolysis.
[Aspect 44]
44. The method of aspect 43, wherein the first catheter of the first medical device and the expanded balloon of the first medical device are separated following erosion of a proximal neck or portion of a proximal neck assembly of the balloon of the first medical device.
[Aspect 45]
A method according to any one of aspects 1 to 35, wherein the first catheter of the first medical device and the proximal neck or proximal neck assembly of the balloon of the first medical device are joined by adhesive, glue, or solder, and a distal portion of the first catheter of the first medical device, a portion of the proximal neck or proximal neck assembly of the balloon of the first medical device, or a portion of the bond between the distal portion of the first catheter of the first medical device and the proximal neck or proximal neck assembly of the balloon of the first medical device is melted by heating.
[Aspect 46]
The method of claim 45, wherein the first catheter of the first medical device and the expanded balloon of the first medical device are pulled apart after melting of the distal portion of the first catheter of the first medical device, a portion of the proximal neck or proximal neck assembly of the balloon of the first medical device, or a portion of the bond between the distal portion of the first catheter of the first medical device and the proximal neck or proximal neck assembly of the balloon of the first medical device.
[Aspect 47]
Aspect 147. The method of any one of aspects 1-46, wherein the balloon is deflated or compressed prior to placement within the aneurysm lumen.
[Aspect 48]
The method of any one of aspects 1 to 2, wherein the expanded balloon of the first medical device occupies a portion of the lumen of the aneurysm and reduces blood flow from the parent vessel into the lumen of the aneurysm.
[Aspect 49]
3. The method of aspect 1 or 2, comprising pulling an expanded balloon of the first medical device toward the neck of the aneurysm to obstruct the neck of the aneurysm and reduce blood flow to the aneurysm.
[Aspect 50]
50. The method of aspect 49, comprising pulling an expanded balloon of the first medical device toward the neck of the aneurysm prior to placing the first elongate or expandable body within the lumen of the aneurysm.
[Aspect 51]
The method of aspect 49, further comprising the step of: after positioning the first elongate or expandable body within the lumen of the aneurysm and after separating the first catheter of the first medical device from the expanded balloon of the first medical device, pulling the expanded balloon of the first medical device toward the aneurysm neck.
[Aspect 52]
Aspect 52. The method of any one of aspects 1-51, wherein the expanded balloon of the first medical device fills at least a portion of the lumen of the aneurysm and a portion of the lumen of the adjacent artery.
[Aspect 53]
Aspects 1-53. The method of any one of aspects 1-52, wherein the first elongate body or the expandable body of the second medical device is flexible, the second elongate body of the second medical device is flexible, or the first elongate body and the second elongate body of the second medical device are flexible.
[Aspect 54]
Aspect 53. The method of any one of aspects 1-52, wherein the first catheter of the first medical device is flexible, the second catheter of the first medical device is flexible, or the first catheter and the second catheter of the first medical device are flexible.
[Aspect 55]
Aspect 1, wherein the balloon of the first medical device is detachable.
[Aspect 56]
Aspect 56. The method of any one of aspects 1-55, wherein the balloon of the first medical device is deflated or compressed prior to expansion.
[Aspect 57]
Aspect 57. The method of any one of aspects 1-56, wherein the fluid used to expand the balloon of the first medical device is water, saline, a fluoroscopy contrast agent, or a combination thereof.
[Aspect 58]
58. The method of any one of aspects 1-57, wherein a solution comprising a fluoroscopic contrast agent is injected under fluoroscopy through the second catheter of the first medical device, into the hub of the second catheter of the first medical device, and into the lumen of the aneurysm adjacent the distal tip of the second catheter of the first medical device prior to expansion of the balloon of the first medical device.
[Aspect 59]
59. The method of any one of aspects 1-58, wherein a solution comprising a fluoroscopic contrast agent is injected under fluoroscopy through the second catheter of the first medical device, into the hub of the second catheter of the first medical device, and into the lumen of the aneurysm adjacent the distal tip of the second catheter of the first medical device after expansion of the balloon of the first medical device but prior to separation of the expanded balloon of the first medical device and the first catheter of the first medical device.
[Aspect 60]
60. The method of any one of aspects 1-59, wherein a solution comprising a fluoroscopic contrast agent is injected under fluoroscopy through the second catheter of the first medical device, into the hub of the second catheter of the first medical device, and into the lumen of the aneurysm adjacent the distal tip of the second catheter of the first medical device after separation of the expanded balloon of the first medical device and the first catheter of the first medical device.
[Aspect 61]
Aspect 61. The method of any one of aspects 1-60, further comprising providing a first medical device and one or more second medical devices.

Aspects and embodiments relating to the method of treating the left atrial appendage as disclosed herein:
[Aspect 1]
(a) determining a maximum left atrial appendage neck diameter, a minimum left atrial appendage width, a minimum left atrial appendage depth, and a minimum left atrial appendage height; and
The diameter of the inflated balloon is smaller than the minimum left atrial appendage width.
selecting a first medical device including a balloon having an expanded balloon diameter less than the minimum left atrial appendage depth, and an expanded balloon diameter including any retention mechanism less than the minimum left atrial appendage height;
(b) placing a balloon of a first medical device within the lumen of the left atrial appendage;
(c) withdrawing the third catheter of the first medical device while holding the first catheter and balloon of the first medical device fixed in place until the retention structure of the balloon of the first medical device expands and brings a portion of the retention structure into contact with the wall of the left atrial appendage;
(d) optionally applying axial tension on the first catheter after expansion of the retention structure to ensure attachment of the retention structure to the wall of the left atrial appendage;
(e) withdrawing the third catheter of the first medical device while holding the first catheter and balloon of the first medical device fixed in place until the balloon of the first medical device is exposed;
(f) delivering a fluid medium through the first lumen to a central void or interior volume of the balloon of the first medical device such that the expanded balloon assumes an expanded configuration filling a portion of the left atrial appendage lumen;
(g) pulling back the second catheter of the first medical device while maintaining the position of the expanded balloon of the first medical device until a distal tip of the second catheter of the first medical device is within a central void or interior volume of the expanded balloon of the first medical device;
(h) delivering a first elongate or expandable body of the second medical device from the proximal end of the second catheter of the first medical device, through the lumen of the second catheter of the first medical device, and into a central void or interior volume of the expanded balloon of the first medical device;
(i) separating the first elongate body or expandable body of the second medical device from the second elongate body of the second medical device and removing the second elongate body from the patient while leaving the first elongate body or expandable body of the second medical device within the left atrial appendage lumen;
(j) optionally repeating steps (h) and (i) until a desired percentage of the volume of the unfilled portion of the left atrial appendage lumen adjacent the expanded balloon of the first medical device is filled with the first elongate body or the first expandable body;
(k) separating the expanded balloon of the first medical device from the first catheter of the first medical device and removing the first and second catheters of the first medical device from the patient while leaving the expanded balloon and the one or more first elongate bodies or first expandable bodies of the first medical device in the patient;
a first medical device comprising:
(i) (i-1) a distal region, a proximal region generally opposite the distal region, an intermediate region transitioning from the distal region to the proximal region, a first axis extending proximally-distally between the proximal and distal regions, and a second axis perpendicular to the first axis;
(i-2) a wall having an outer surface and an inner surface, the inner surface defining a central void or interior volume, the wall extending generally continuously from a proximal region through an intermediate region to a distal region;
(i-3) an opening in the wall in the proximal region that allows the passage of fluid from the first catheter into the central cavity or interior volume of the balloon and also allows the passage of a portion of the second catheter into the central cavity or interior volume of the balloon;
(i-4) an opening in the wall of the distal region that allows passage of a portion of the second catheter into the central cavity or interior volume of the balloon;
(i-5) proximal neck or proximal neck assembly;
(i-6) a distal neck or a distal neck assembly; and
(i-7) a pleated and folded balloon configured for permanent implantation within a human patient comprising a self-expanding metal retention structure, wherein after expansion, a diameter of at least a portion of the self-expanding metal retention structure is equal to or greater than a diameter of the expanded balloon;
(ii) defining a first lumen for permitting passage of fluid from a proximal end of the first catheter to a distal end of the first catheter and into a central void or interior volume of the balloon;
(ii-1) a proximal end including a proximal hub;
(ii-2) a proximal portion passing through the proximal hub of the third catheter;
(ii-3) a central portion passing through the lumen of the third catheter;
(ii-4) a distal portion extending distally relative to the distal end of the third catheter; and
(ii-5) a first catheter including a distal portion operably coupled or joined to a proximal neck or proximal neck assembly of the balloon;
(iii) defining a second lumen configured to receive at least one of a guidewire, an elongate body, an expandable body, or a coagulation fluid;
(iii-1) a proximal end including a proximal hub;
(iii-2) a proximal portion that passes through the proximal hub of the first catheter;
(iii-3) an intermediate portion passing through the lumen of the first catheter;
(iii-4) a distal portion extending distally relative to the distal end of the first catheter;
(iii-5) a distal portion passing through the proximal neck or proximal neck assembly of the balloon;
(iii-6) a distal portion that passes through the central cavity or interior volume of the balloon;
(iii-7) a distal portion that engages or passes through a distal neck or distal neck assembly within the balloon; and
(iii-8); a second catheter including an open distal end;
(iv) partially defining a third lumen for permitting passage of fluid from the proximal end of the third catheter to the distal end of the third catheter, the third catheter being configured to compress a retention structure of a balloon of the first medical device;
(iv-1) a proximal end including a proximal hub;
(iv-2); a third catheter including an open distal end;
Including,
(v) the third catheter of the first medical device can be moved forward or backward while the first catheter, the third catheter, and the balloon of the first medical device are fixed in place;
the balloon can be expanded by passage of fluid through the first catheter into a central void or interior volume of the balloon;
After the balloon is expanded, the second catheter can be moved forward or backward while keeping the expanded balloon fixed in place;
After expansion of the balloon, including before or after advancing the tip of the second catheter, one or more of the first elongate body, the expandable body, a coagulation fluid, a solution containing a drug or therapeutic agent, or a solution or suspension containing embolic particles can be disposed through the lumen of the second catheter and into the biological space adjacent to the balloon;
After expansion of the balloon, the second catheter can be pulled back until a distal tip of the second catheter is disposed within the central void or interior volume of the balloon, and one or more of the first elongate body, the expandable body, or the coagulation fluid can be passed through the lumen of the second catheter and disposed within the central void or interior volume of the balloon;
The first catheter can be separated from the expanded balloon;
the first and second catheters can be removed from the patient leaving the balloon and the one or more of the first elongate body, the expandable body, or the coagulation fluid within the patient;
a second medical device comprising:
(i) a distal portion including a first elongate body or an expandable body;
(ii) a proximal portion comprising a second elongate body or delivery system;
Including,
contacting at least a portion of the first elongate or expandable body of the second medical device with at least a portion of a wall of the expanded balloon of the first medical device after placement of the first elongate or expandable body of the second medical device within the expanded balloon of the first medical device;
after placement of the first elongate body or expandable body of the second medical device within the central void or interior volume of the expanded balloon of the first medical device, but prior to separation of the first elongate body or expandable body of the second medical device and the second elongate body of the second medical device, the second medical device can be removed from the patient;
the first elongate body or the expandable body can be separated from the second elongate body;
A method of reducing blood flow in the left atrial appendage of a human patient using two or more medical devices, wherein after separation of a first elongate body or an expandable body from a second elongate body, the second elongate body can be removed from the patient while leaving the first elongate body or the expandable body in the patient.
[Aspect 2]
The method of aspect 1, wherein after expansion of the balloon of the first medical device and prior to retraction of the second catheter of the first medical device into the central void or interior volume of the expanded balloon of the first medical device, a solution containing a fluoroscopic contrast agent, a drug or therapeutic agent, a coagulation fluid, or a combination thereof is injected through the lumen of the second catheter of the first medical device and into the lumen of the left atrial appendage adjacent to the expanded balloon of the first medical device.
[Aspect 3]
The method of aspect 2, wherein a syringe or other suitable delivery system is used to inject the fluoroscopic contrast agent, the drug, the therapeutic agent, the coagulation fluid, or a combination thereof.
[Aspect 4]
4. The method of aspect 2 or 3, further comprising advancing a second catheter of the first medical device within the left atrial appendage while maintaining the position of the balloon of the first medical device prior to injecting a fluoroscopic contrast agent, a drug, a therapeutic agent, a coagulation fluid, or a combination thereof, through the lumen of the shaft of the second catheter of the first medical device and into the lumen of the left atrial appendage adjacent the expanded balloon of the first medical device.
[Aspect 5]
The method of aspect 1 or 2, further comprising injecting a coagulation fluid from the proximal end of the second catheter of the first medical device, through the lumen of the second catheter of the first medical device, and into the central void or interior volume of the expanded balloon of the first medical device prior to separating the expanded balloon of the first medical device from the first catheter of the first medical device.
[Aspect 6]
The method of any one of aspects 1-5, wherein the inflated balloon is configured to contact at least 100%, 90%, 80%, 70, 60%, 50%, 40%, 30%, 20%, 10%, or 5% of the area of the luminal surface of the left atrial appendage.
[Aspect 7]
The method of any one of aspects 1-5, wherein the inflated balloon is configured to fill at least 100%, 90%, 80%, 70%, 60%, 50%, 40%, 30%, 20%, 10%, or 5% of the volume of the lumen of the left atrial appendage.
[Aspect 8]
The method of any one of aspects 1-7, wherein the maximum or tertiary diameter of the first elongate or expandable body of the second medical device is equal to or less than the maximum diameter of the expanded balloon of the first medical device.
[Aspect 9]
The method of any one of aspects 1-7, wherein the maximum or tertiary diameter of the first elongate or expandable body of the second medical device ranges from a value equal to a maximum diameter of the expanded balloon of the first medical device to a value 50% greater than the maximum diameter of the expanded balloon of the first medical device.
[Aspect 10]
The method of any one of aspects 1-9, wherein the maximum overall or tertiary diameter of the first elongate or expandable body of the second medical device is 1, 2, 3, 4, 5, 6, 7, 8, 9, or 10 mm greater than the maximum diameter of the expanded balloon of the first medical device.
[Aspect 11]
The method of any one of aspects 8-10, wherein after being positioned within the central void or interior volume of the expanded balloon, the first elongate or expandable body of the second medical device exerts a force on the wall of the expanded balloon of the first medical device.
[Aspect 12]
12. The method of aspect 11, wherein the force on the wall of the expanded balloon of the first medical device is outward.
[Aspect 13]
13. The method of any one of the preceding aspects, wherein the volume of the first elongate body or expandable body of the second medical device disposed within the central void or interior volume of the expanded balloon fills 5-75% of the volume of the central void or interior volume of the expanded balloon.
[Aspect 14]
The volume of the first elongate body or expandable body of the second medical device disposed within the central void or interior volume of the expanded balloon is 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49, 50, 51, 52, 53, 54, 55, 56, 57, 58, 59, 60, 61, 62, 63, 64, 65, 66, 67, 68, 69, 70, 71, 72, 73, 74, 75, 76, 77, 78, 79, 80, 81, 82, 83, 84, 85, 86, 87, 88, 89, 90, 91, 92, 93, 94, 95, 96, 97, 98, 99, 100, 101, 102, 103, 104, 105, 106, 107, 108, 109, 1109, 1110, 112, 113, 114, 115, 116, 117, 118, 120, 1 , 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49, 50, 51, 52, 53, 54, 55, 56, 57, 58, 59, 60, 61, 62, 63, 64, 65, 66, 67, 68, 69, 70, 71, 72, 73, 74, or 75% of the total.
[Aspect 15]
The method of any one of aspects 1-14, wherein the distal portion of the second catheter of the first medical device comprises a radiopaque portion, ring or marker that is clearly visible under fluoroscopy, and fluoroscopy is used to monitor the position of the distal portion of the second catheter of the first medical device relative to the position of the distal portion of the balloon of the first medical device as the second catheter of the first medical device moves.
[Aspect 16]
16. The method of any one of aspects 1-15, wherein the distal portion of the balloon of the first medical device comprises a radiopaque portion, ring or marker that is clearly visible under fluoroscopy, and fluoroscopy is used to monitor the position of the distal portion of the second catheter of the first medical device relative to the position of the distal portion of the balloon of the first catheter as the second catheter of the first medical device moves.
[Aspect 17]
The method of any one of aspects 1-16, wherein at least a portion of the distal telescoping structure of the first medical device comprises a radiopaque portion, ring or marker that is clearly visible under fluoroscopy, and fluoroscopy is used to monitor the position of a distal portion of the second catheter of the first medical device relative to the position of the distal telescoping structure of the first medical device as the second catheter of the first medical device moves.
[Aspect 18]
The method of any one of aspects 1-17, wherein at least a portion of the first elongate body or expandable body of the second medical device is formed from a material that is radiopaque and clearly visible under fluoroscopy, and fluoroscopy is used to monitor the placement and position of the first elongate body or expandable body of the second medical device.
[Aspect 19]
The method of any one of aspects 1-18, wherein the second catheter of the first medical device includes one, two, or more radiopaque portions, rings, or markers, and fluoroscopy is used to monitor the position of the second catheter of the first medical device relative to the position of the first elongate body or expandable body of the second medical device.
[Aspect 20]
20. The method of any one of aspects 1-19, wherein a distal portion of the first catheter of the first medical device comprises a radiopaque marker that is clearly visible under fluoroscopy, and fluoroscopy is used to monitor separation of the expanded balloon of the first medical device from the first catheter of the first medical device.
[Aspect 21]
21. The method of any one of aspects 1-20, wherein a proximal portion of the balloon of the first medical device comprises a radiopaque marker that is clearly visible under fluoroscopy, and fluoroscopy is used to monitor separation of the expanded balloon of the first medical device from the first catheter of the first medical device.
[Aspect 22]
22. The method of any one of aspects 15-21, wherein the radiopaque portion, ring, or marker comprises platinum, iridium, gold, tungsten, or a combination thereof.
[Aspect 23]
23. The method of any one of aspects 1-22, wherein the distal neck or distal neck assembly of the second catheter of the first medical device and the balloon of the first medical device are coupled by a friction fit, and the second catheter of the first medical device and the expanded balloon of the first medical device are separated by applying axial tension to the coupling.
[Aspect 24]
24. The method of aspect 23, wherein the distal neck or distal neck assembly of the second catheter of the first medical device and the balloon of the first medical device are joined by an elastomeric valve.
[Aspect 25]
25. The method of aspect 24, wherein the elastomeric valve serves to reduce blood flow through a central void or interior volume of the expanded balloon of the first medical device after removal of the second catheter of the first medical device from the patient.
[Aspect 26]
26. The method of any one of aspects 1-25, wherein the proximal neck or proximal neck assembly of the first catheter of the first medical device and the balloon of the first medical device are coupled by a friction fit, and the first catheter of the first medical device and the expanded balloon of the first medical device are separated by applying axial tension to the coupling.
[Aspect 27]
27. The method of aspect 26, wherein the proximal neck or proximal neck assembly of the first catheter of the first medical device and the balloon of the first medical device are joined by an elastomeric tubular segment.
[Aspect 28]
26. The method of any one of aspects 1-25, wherein the first catheter of the first medical device and the balloon of the first medical device are coupled by a mechanical latch, a portion of the mechanical latch being joined to a distal end of the first catheter and a second portion of the mechanical latch being joined to a proximal neck or proximal neck assembly of the balloon of the first medical device.
[Aspect 29]
30. The method of aspect 28, wherein the proximal neck of the balloon of the first medical device is the second portion of the mechanical latch.
[Aspect 30]
30. The method of aspect 28 or 29, wherein two portions of the mechanical latch engage or are operably coupled when the second catheter of the first medical device passes through the mechanical latch.
[Aspect 31]
31. The method of aspect 30, wherein the second catheter of the first medical device is removed from the mechanical latch to separate or operatively separate the mechanical latch and the two portions of the mechanical latch.
[Aspect 32]
32. The method of aspect 31, wherein the first catheter of the first medical device and the expanded balloon of the first medical device are separated.
[Aspect 33]
The method of any one of aspects 1-32, wherein the first catheter of the first medical device and the proximal neck or proximal neck assembly of the balloon of the first medical device are joined by adhesive, glue, or solder, and a portion of the proximal neck or proximal neck assembly of the balloon of the first medical device is eroded by electrolysis.
[Aspect 34]
34. The method of aspect 33, wherein the first catheter of the first medical device and the expanded balloon of the first medical device are separated following erosion of a proximal neck or portion of a proximal neck assembly of the balloon of the first medical device.
[Aspect 35]
26. The method of any one of aspects 1-25, wherein the first catheter of the first medical device and the proximal neck or proximal neck assembly of the balloon of the first medical device are joined by adhesive, glue, or solder, and a distal portion of the first catheter of the first medical device, a portion of the proximal neck or proximal neck assembly of the balloon of the first medical device, or a portion of the bond between the distal portion of the first catheter of the first medical device and the proximal neck or proximal neck assembly of the balloon of the first medical device is melted by heating.
[Aspect 36]
The method of claim 35, wherein the first catheter of the first medical device and the expanded balloon of the first medical device are pulled apart after melting of the distal portion of the first catheter of the first medical device, a portion of the proximal neck or proximal neck assembly of the balloon of the first medical device, or a portion of the bond between the distal portion of the first catheter of the first medical device and the proximal neck or proximal neck assembly of the balloon of the first medical device.
[Aspect 37]
Aspect 37. The method of any one of aspects 1 to 36, wherein the balloon is deflated or compressed prior to placement within the lumen of the left atrial appendage.
[Aspect 38]
2. The method of aspect 1, wherein the expanded balloon of the first medical device occupies a portion of the lumen of the left atrial appendage and reduces blood flow from the right atrium to the lumen of the left atrial appendage.
[Aspect 39]
Aspect 39. The method of any one of aspects 1-38, wherein the expanded balloon of the first medical device fills at least a portion of the lumen of the left atrial appendage and a portion of the lumen of the adjacent left atrium.

[Aspect 40]
Aspect 40. The method of any one of aspects 1-39, wherein the self-expanding retention structure is bonded to the distal neck of the balloon of the first medical device.
[Aspect 41]
The method of any one of aspects 1-40, wherein the first elongate body or the expandable body of the second medical device is flexible, the second elongate body of the second medical device is flexible, or the first elongate body and the second elongate body of the second medical device are flexible.
[Aspect 42]
42. The method of any one of aspects 1-41, wherein the first catheter of the first medical device is flexible, the second catheter of the first medical device is flexible, the third catheter of the first medical device is flexible, or the first catheter, the second catheter, and the third catheter of the first medical device are flexible.
[Aspect 43]
Aspect 1, wherein the balloon of the first medical device is detachable.
[Aspect 44]
Aspect 44. The method of any one of aspects 1-43, wherein the balloon of the first medical device is deflated or compressed prior to expansion.
[Aspect 45]
Aspect 45. The method of any one of aspects 1-44, wherein the fluid used to expand the balloon of the first medical device is water, saline, a fluoroscopy contrast agent, or a combination thereof.
[Aspect 46]
46. The method of any one of the preceding aspects, wherein a solution comprising a fluoroscopic contrast agent is injected under fluoroscopy through the second catheter of the first medical device, into the hub of the second catheter of the first medical device, and into the lumen of the left atrial appendage adjacent the distal tip of the second catheter of the first medical device prior to expansion of the retention structure.
[Aspect 47]
47. The method of any one of aspects 1-46, wherein a solution comprising a fluoroscopic contrast agent is injected under fluoroscopy through the second catheter of the first medical device, into the hub of the second catheter of the first medical device, and into the lumen of the left atrial appendage adjacent the tip of the second catheter of the first medical device after expansion of the retention structure of the balloon of the first medical device but prior to expansion of the balloon of the first medical device.
[Aspect 48]
48. The method of any one of aspects 1-47, wherein a solution comprising a fluoroscopic contrast agent is injected under fluoroscopy through the second catheter of the first medical device, into the hub of the second catheter of the first medical device, and into the lumen of the left atrial appendage adjacent the distal tip of the second catheter of the first medical device after balloon expansion of the first medical device but after separation of the expanded balloon of the first medical device and the first catheter of the first medical device.
[Aspect 49]
49. The method of any one of aspects 1-48, wherein a solution comprising a fluoroscopic contrast agent is injected under fluoroscopy through the second catheter of the first medical device, into the hub of the second catheter of the first medical device, and into the lumen of the left atrial appendage adjacent the distal tip of the second catheter of the first medical device after separation of the inflated balloon of the first medical device and the first catheter of the first medical device.
[Aspect 50]
50. The method of any one of the preceding aspects, wherein a solution comprising a fluoroscopic contrast agent is injected under fluoroscopy through the third catheter of the first medical device, into a hub of the third catheter of the first medical device, and into the lumen of the left atrial appendage adjacent the distal tip of the third catheter of the first medical device prior to expansion of the retention structure.
[Aspect 51]
51. The method of any one of aspects 1-50, wherein a solution comprising a fluoroscopic contrast agent is injected under fluoroscopy through the third catheter of the first medical device, into the hub of the third catheter of the first medical device, and into the lumen of the left atrial appendage adjacent the distal tip of the third catheter of the first medical device after expansion of the retention structure of the balloon of the first medical device but after expansion of the balloon of the first medical device.
[Aspect 52]
52. The method of any one of aspects 1-51, wherein a solution comprising a fluoroscopic contrast agent is injected under fluoroscopy through the third catheter of the first medical device, into a hub of the third catheter of the first medical device, and into the lumen of the left atrial appendage adjacent the distal tip of the third catheter of the first medical device after expansion of the balloon of the first medical device but prior to separation of the expanded balloon of the first medical device and the first catheter of the first medical device.
[Aspect 53]
53. The method of any one of aspects 1-52, wherein a solution comprising a fluoroscopic contrast agent is injected under fluoroscopy through the third catheter of the first medical device, into a hub of the third catheter of the first medical device, and into the lumen of the left atrial appendage adjacent the distal tip of the third catheter of the first medical device after separation of the inflated balloon of the first medical device and the first catheter of the first medical device.
[Aspect 54]
Aspect 54. The method of any one of aspects 1-53, further comprising providing a first medical device and one or more second medical devices.

Aspects and embodiments relating to the method of treating paravalvular leak with a detachable balloon catheter as disclosed herein:
[Aspect 1]
(a) determining a diameter and length of a segment of the paravalvular leak pathway to be treated, and selecting a first medical device including a balloon having an expanded diameter equal to or greater than the diameter of the selected segment of the paravalvular leak pathway, and an expanded length such that when the balloon of the first medical device is expanded, the balloon can occupy at least a portion of the lumen of the paravalvular leak pathway;
(b) placing a balloon of a first medical device within the lumen of the paravalvular leak pathway;
(c) delivering a fluid medium through the first lumen into the interior volume of the balloon of the first medical device such that the expanded balloon assumes an expanded configuration filling a portion of the lumen of the paravalvular leak pathway and contacting at least a portion of a wall of the paravalvular leak pathway;
(d) pulling back the second catheter of the first medical device while maintaining the position of the expanded balloon of the first medical device until a distal tip of the second catheter of the first medical device is within a central void or interior volume of the expanded balloon of the first medical device;
(e) delivering a first elongate or expandable body of the second medical device from the proximal end of the second catheter of the first medical device, through the lumen of the second catheter of the first medical device, and into a central void or interior volume of the expanded balloon of the first medical device;
(f) separating the first elongate body or expandable body of the second medical device from the second elongate body of the second medical device and removing the second elongate body from the patient while leaving the first elongate body or expandable body of the second medical device within the patient;
(g) repeating steps (e) and (f) until a desired percentage of the central void or interior volume of the expanded balloon of the first medical device is filled with the first elongate body or first expandable body;
(h) separating the expanded balloon of the first medical device from the first catheter of the first medical device and removing the first and second catheters of the first medical device from the patient while leaving the expanded balloon of the first medical device and the one or more first elongate bodies or first expandable bodies of the second medical device in the patient;
a first medical device comprising:
(i) (i-1) a distal region, a proximal region generally opposite the distal region, an intermediate region transitioning from the distal region to the proximal region, a first axis extending proximally-distally between the proximal and distal regions, and a second axis perpendicular to the first axis;
(i-2) a wall having an outer surface and an inner surface, the inner surface defining a central void or interior volume, the wall extending generally continuously from a proximal region through an intermediate region to a distal region;
(i-3) an opening in the wall in the proximal region that allows the passage of fluid from the first catheter into the central cavity or interior volume of the balloon and also allows the passage of a portion of the second catheter into the central cavity or interior volume of the balloon;
(i-4) an opening in the wall of the distal region that allows passage of a portion of the second catheter into the central cavity or interior volume of the balloon;
(i-5) a proximal neck or a proximal neck assembly; and
(i-6) a pleated and folded balloon configured for permanent implantation in a human patient, the balloon comprising a distal neck or distal neck assembly;
(ii) defining a first lumen for permitting passage of fluid from a proximal end of the first catheter to a distal end of the first catheter and into a central void or interior volume of the balloon;
(ii-1) a proximal end including a proximal hub; and
(ii-2) a first catheter including a distal portion operably coupled or joined to a proximal neck or proximal neck assembly of the balloon;
(iii) defining a second lumen configured to receive at least one of a guidewire, an elongate body, an expandable body, or a coagulation fluid;
(iii-1) a proximal end including a proximal hub;
(iii-2) a proximal portion that passes through the proximal hub of the first catheter;
(iii-3) an intermediate portion passing through the lumen of the first catheter;
(iii-4) a distal portion extending distally relative to the distal end of the first catheter;
(iii-5) a distal portion passing through the proximal neck or proximal neck assembly of the balloon;
(iii-6) a distal portion that passes through the central cavity or interior volume of the balloon;
(iii-7) a distal portion that engages or passes through a distal neck or distal neck assembly within the balloon; and
(iii-8); a second catheter including an open distal end;
Including,
(iv) the balloon can be expanded by passage of a fluid through the first catheter into a central void or interior volume of the balloon;
After expansion of the balloon, the second catheter can be moved forward or backward while keeping the expanded balloon fixed in place;
After expansion of the balloon, including before or after advancing the tip of the second catheter, one or more of the first elongate body, the expandable body, a coagulation fluid, a solution containing a drug or therapeutic agent, or a solution or suspension containing embolic particles can be disposed through the lumen of the second catheter and into the biological space adjacent to the balloon;
After expansion of the balloon, the second catheter can be pulled back until a distal tip of the second catheter is disposed within the central void or interior volume of the balloon, and one or more of the first elongate body, the expandable body, or the coagulation fluid can be passed through the lumen of the second catheter and disposed within the central void or interior volume of the balloon;
The first catheter can be separated from the expanded balloon;
the first and second catheters can be removed from the patient leaving the balloon and the one or more of the first elongate body, the expandable body, or the coagulation fluid within the patient;
a second medical device comprising:
(i) a distal portion including a first elongate body or an expandable body;
(ii) a proximal portion comprising a second elongate body or delivery system;
Including,
contacting at least a portion of the first elongate or expandable body of the second medical device with at least a portion of a wall of the expanded balloon of the first medical device after placement of the first elongate or expandable body of the second medical device within the expanded balloon of the first medical device;
after placement of the first elongate body or expandable body of the second medical device within the central void or interior volume of the expanded balloon of the first medical device, but prior to separation of the first elongate body or expandable body of the second medical device and the second elongate body of the second medical device, the second medical device can be removed from the patient;
the first elongate body or the expandable body can be separated from the second elongate body;
A method of reducing blood flow in a paravalvular leak pathway in a human patient using two or more medical devices, wherein after separation of a first elongate body or an expandable body from a second elongate body, the second elongate body can be removed from the patient while leaving the first elongate body or the expandable body in the patient.
[Aspect 2]
The method of aspect 1, further comprising injecting a coagulation fluid from the proximal end of the second catheter of the first medical device, through the lumen of the second catheter of the first medical device, and into the central void or interior volume of the expanded balloon of the first medical device prior to separating the expanded balloon of the first medical device from the first catheter of the first medical device.
[Aspect 3]
The method of aspect 1 or 2, wherein after being positioned within the central void or interior volume of the expanded balloon, the first elongate or expandable body of the second medical device exerts a force on the wall of the expanded balloon of the first medical device.
[Aspect 4]
The method of aspect 3, wherein the force on the wall of the expanded balloon of the first medical device is outward.
[Aspect 5]
The method of any one of aspects 1-4, wherein the maximum diameter or tertiary diameter of the second medical device is equal to the maximum diameter of the expanded balloon.
[Aspect 6]
The method of any one of aspects 1-4, wherein the maximum or tertiary diameter of the first elongate or expandable body of the second medical device ranges from a value equal to a maximum diameter of the expanded balloon of the first medical device to a value 50% greater than the maximum diameter of the expanded balloon of the first medical device.
[Aspect 7]
The method of any one of aspects 1-4, wherein the maximum overall or tertiary diameter of the first elongate or expandable body of the second medical device is 1, 2, 3, 4, 5, 6, 7, 8, 9, or 10 mm greater than the maximum diameter of the expanded balloon of the first medical device.
[Aspect 8]
Aspect 8. The method of any one of aspects 1-7, wherein the volume of the one or more first elongate bodies or expandable bodies of the second medical device fills 5-75% of the volume of the central void of the expanded balloon.
[Aspect 9]
8. The method of any one of claims 1-7, wherein the volume of the first elongate body or expandable body of the second medical device fills 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49, 50, 51, 52, 53, 54, 55, 56, 57, 58, 59, 60, 61, 62, 63, 64, 65, 66, 67, 68, 69, 70, 71, 72, 73, 74, or 75% of the volume of the central void of the expanded balloon.
[Aspect 10]
The method of any one of aspects 1-9, wherein the distal portion of the second catheter of the first medical device comprises a radiopaque portion, ring or marker that is clearly visible under fluoroscopy, and fluoroscopy is used to monitor the position of the distal portion of the second catheter of the first medical device relative to the position of the distal portion of the balloon of the first medical device as the second catheter of the first medical device moves.
[Aspect 11]
The method of any one of aspects 1-10, wherein the distal portion of the balloon of the first medical device comprises a radiopaque portion, ring or marker that is clearly visible under fluoroscopy, and fluoroscopy is used to monitor the position of the distal portion of the second catheter of the first medical device relative to the position of the distal portion of the balloon of the first catheter as the second catheter of the first medical device moves.
[Aspect 12]
The method of any one of aspects 1-11, wherein at least a portion of the distal telescoping structure of the first medical device comprises a radiopaque portion, ring or marker that is clearly visible under fluoroscopy, and fluoroscopy is used to monitor the position of a distal portion of the second catheter of the first medical device relative to the position of the distal telescoping structure of the first medical device as the second catheter of the first medical device moves.
[Aspect 13]
The method of any one of aspects 1-12, wherein at least a portion of the first elongate body or expandable body of the second medical device is formed from a material that is radiopaque and clearly visible under fluoroscopy, and fluoroscopy is used to monitor the placement and position of the first elongate body or expandable body of the second medical device.
[Aspect 14]
The method of any one of aspects 1-13, wherein the second catheter of the first medical device comprises one, two, or more radiopaque portions, rings, or markers, and fluoroscopy is used to monitor the position of the second catheter of the first medical device relative to the position of the first elongate body or expandable body of the second medical device.
[Aspect 15]
15. The method of any one of aspects 1-14, wherein a distal portion of the first catheter of the first medical device comprises a radiopaque marker that is clearly visible under fluoroscopy, and fluoroscopy is used to monitor separation of the expanded balloon of the first medical device from the first catheter of the first medical device.
[Aspect 16]
16. The method of any one of aspects 1-15, wherein a proximal portion of the balloon of the first medical device comprises a radiopaque marker that is clearly visible under fluoroscopy, and fluoroscopy is used to monitor separation of the expanded balloon of the first medical device from the first catheter of the first medical device.
[Aspect 17]
17. The method of any one of aspects 10-16, wherein the radiopaque portion, ring, or marker comprises platinum, iridium, gold, tungsten, or a combination thereof.
[Aspect 18]
18. The method of any one of aspects 1-17, wherein the distal neck or distal neck assembly of the second catheter of the first medical device and the balloon of the first medical device are coupled by a friction fit, and the second catheter of the first medical device and the expanded balloon of the first medical device are separated by applying axial tension to the coupling.
[Aspect 19]
20. The method of aspect 18, wherein the distal neck or distal neck assembly of the second catheter of the first medical device and the balloon of the first medical device are joined by an elastomeric valve.
[Aspect 20]
The method of aspect 19, wherein the elastomeric valve serves to reduce blood flow through a central void or interior volume of the expanded balloon of the first medical device after removal of the second catheter of the first medical device from the patient.
[Aspect 21]
21. The method of any one of aspects 1-20, wherein the proximal neck or proximal neck assembly of the first catheter of the first medical device and the balloon of the first medical device are coupled by a friction fit, and the first catheter of the first medical device and the expanded balloon of the first medical device are separated by applying axial tension to the coupling.
[Aspect 22]
22. The method of aspect 21, wherein the proximal neck or proximal neck assembly of the first catheter of the first medical device and the balloon of the first medical device are joined by an elastomeric tubular segment.
[Aspect 23]
21. The method of any one of aspects 1-20, wherein the first catheter of the first medical device and the balloon of the first medical device are coupled by a mechanical latch, a portion of the mechanical latch being joined to a distal end of the first catheter and a second portion of the mechanical latch being joined to a proximal neck or proximal neck assembly of the balloon of the first medical device.
[Aspect 24]
24. The method of aspect 23, wherein the proximal neck of the balloon of the first medical device is the second portion of the mechanical latch.
[Aspect 25]
25. The method of aspect 23 or 24, wherein two portions of the mechanical latch engage or are operably coupled when the second catheter of the first medical device passes through the mechanical latch.
[Aspect 26]
26. The method of aspect 25, wherein the second catheter of the first medical device is removed from the mechanical latch to separate or operably separate the mechanical latch and the two portions of the mechanical latch.
[Aspect 27]
27. The method of aspect 26, wherein the first catheter of the first medical device and the expanded balloon of the first medical device are separated.
[Aspect 28]
21. The method of any one of aspects 1-20, wherein the first catheter of the first medical device and the proximal neck or proximal neck assembly of the balloon of the first medical device are joined by adhesive, glue, or solder, and a portion of the proximal neck or proximal neck assembly of the balloon of the first medical device is eroded by electrolysis.
[Aspect 29]
30. The method of aspect 28, wherein the first catheter of the first medical device and the expanded balloon of the first medical device are separated following erosion of a proximal neck or a portion of a proximal neck assembly of the balloon of the first medical device.
[Aspect 30]
21. The method of any one of aspects 1-20, wherein the first catheter of the first medical device and the proximal neck or proximal neck assembly of the balloon of the first medical device are joined by adhesive, glue, or solder, and a distal portion of the first catheter of the first medical device, a portion of the proximal neck or proximal neck assembly of the balloon of the first medical device, or a portion of the bond between the distal portion of the first catheter of the first medical device and the proximal neck or proximal neck assembly of the balloon of the first medical device is melted by heating.
[Aspect 31]
The method of claim 30, wherein the first catheter of the first medical device and the expanded balloon of the first medical device are pulled apart after melting of the distal portion of the first catheter of the first medical device, a portion of the proximal neck or proximal neck assembly of the balloon of the first medical device, or a portion of the bond between the distal portion of the first catheter of the first medical device and the proximal neck or proximal neck assembly of the balloon of the first medical device.
[Aspect 32]
Aspects 1-32. The method of any one of aspects 1-31, wherein the first elongate body or the expandable body of the second medical device is flexible, the second elongate body of the second medical device is flexible, or the first elongate body and the second elongate body of the second medical device are flexible.
[Aspect 33]
Aspect 33. The method of any one of aspects 1-32, wherein the first catheter of the first medical device is flexible, the second catheter is flexible, the third catheter of the first medical device is flexible, or the first catheter and the second catheter of the first medical device are flexible.
[Aspect 34]
Aspect 34. The method of any one of aspects 1-33, wherein the balloon of the first medical device is detachable.
[Aspect 35]
Aspect 35. The method of any one of aspects 1-34, wherein the balloon of the first medical device is deflated or compressed prior to expansion.
[Aspect 36]
Aspect 36. The method of any one of aspects 1-35, wherein the fluid used to expand the balloon of the first medical device is water, saline, a fluoroscopy contrast agent, or a combination thereof.
[Aspect 37]
37. The method of any one of aspects 1-36, wherein a solution comprising a fluoroscopic contrast agent is injected under fluoroscopy through the second catheter of the first medical device, into the hub of the second catheter of the first medical device and into the lumen of the aortic chamber or heart chamber adjacent the distal tip of the second catheter of the first medical device prior to expansion of the balloon of the first medical device.
[Aspect 38]
38. The method of any one of aspects 1-37, wherein a solution comprising a fluoroscopic contrast agent is injected under fluoroscopy through the second catheter of the first medical device, into the hub of the second catheter of the first medical device, and into the lumen of the aortic chamber or heart chamber adjacent the distal tip of the second catheter of the first medical device after expansion of the balloon of the first medical device but prior to separation of the expanded balloon of the first medical device and the first catheter of the first medical device.
[Aspect 39]
39. The method of any one of aspects 1-38, wherein a solution comprising a fluoroscopic contrast agent is injected under fluoroscopy through the second catheter of the first medical device, into the hub of the second catheter of the first medical device, and into the lumen of the aortic chamber or heart chamber adjacent the distal tip of the second catheter of the first medical device after separation of the inflated balloon of the first medical device and the first catheter of the first medical device.
[Aspect 40]
Aspects 40. The method of any one of aspects 1-39, further comprising providing a first medical device and one or more second medical devices.

Aspects and embodiments relating to the method of treating a biological conduit as disclosed herein:
[Aspect 1]
(a) determining a diameter and length of a segment of a biological conduit to be treated and selecting a first medical device including a balloon having an expanded diameter equal to or greater than the diameter of the selected segment of the biological conduit and an expanded length such that, when the balloon of the first medical device is expanded, the balloon can occupy at least a portion of the lumen of the biological conduit;
(b) placing a balloon of a first medical device within the lumen of the biological conduit;
(c) delivering a fluid medium through the first lumen into an interior volume of the balloon of the first medical device such that the expanded balloon assumes an expanded configuration filling a portion of the lumen of the biological conduit and contacting at least a portion of a wall of the biological conduit;

(d) pulling back the second catheter of the first medical device while maintaining the position of the expanded balloon of the first medical device until a distal tip of the second catheter of the first medical device is within a central void or interior volume of the expanded balloon of the first medical device;
(e) delivering a first elongate or expandable body of the second medical device from the proximal end of the second catheter of the first medical device, through the lumen of the second catheter of the first medical device, and into a central void or interior volume of the expanded balloon of the first medical device;
(f) separating the first elongate body or expandable body of the second medical device from the second elongate body of the second medical device and removing the second elongate body from the patient while leaving the first elongate body or expandable body of the second medical device within the patient;
(g) repeating steps (e) and (f) until a desired percentage of the central void or interior volume of the expanded balloon of the first medical device is filled with the first elongate body or first expandable body;
(h) separating the expanded balloon of the first medical device from the first catheter of the first medical device and removing the first and second catheters of the first medical device from the patient while leaving the expanded balloon of the first medical device and the one or more first elongate bodies or first expandable bodies of the second medical device in the patient;
a first medical device comprising:
(i) (i-1) a distal region, a proximal region generally opposite the distal region, an intermediate region transitioning from the distal region to the proximal region, a first axis extending proximally-distally between the proximal and distal regions, and a second axis perpendicular to the first axis;
(i-2) a wall having an outer surface and an inner surface, the inner surface defining a central void or interior volume, the wall extending generally continuously from a proximal region through an intermediate region to a distal region;
(i-3) an opening in the wall in the proximal region that allows the passage of fluid from the first catheter into the central cavity or interior volume of the balloon and also allows the passage of a portion of the second catheter into the central cavity or interior volume of the balloon;
(i-4) an opening in the wall of the distal region that allows passage of a portion of the second catheter into the central cavity or interior volume of the balloon;
(i-5) a proximal neck or a proximal neck assembly; and
(i-6) a pleated and folded balloon configured for permanent implantation in a human patient, the balloon comprising a distal neck or distal neck assembly;
(ii) defining a first lumen for permitting passage of fluid from a proximal end of the first catheter to a distal end of the first catheter and into a central void or interior volume of the balloon;
(ii-1) a proximal end including a proximal hub; and
(ii-2) a first catheter including a distal portion operably coupled or joined to a proximal neck or proximal neck assembly of the balloon;
(iii) defining a second lumen configured to receive at least one of a guidewire, an elongate body, an expandable body, or a coagulation fluid;
(iii-1) a proximal end including a proximal hub;
(iii-2) a proximal portion that passes through the proximal hub of the first catheter;
(iii-3) an intermediate portion passing through the lumen of the first catheter;
(iii-4) a distal portion extending distally relative to the distal end of the first catheter;
(iii-5) a distal portion passing through the proximal neck or proximal neck assembly of the balloon;
(iii-6) a distal portion that passes through the central cavity or interior volume of the balloon;
(iii-7) a distal portion that engages or passes through a distal neck or distal neck assembly within the balloon; and
(iii-8); a second catheter including an open distal end;
Including,
(iv) the balloon can be expanded by passage of a fluid through the first catheter into a central void or interior volume of the balloon;
After the balloon is expanded, the second catheter can be moved forward or backward while keeping the expanded balloon fixed in place;
After expansion of the balloon, including before or after advancing the tip of the second catheter, one or more of the first elongate body, the expandable body, a coagulation fluid, a solution containing a drug or therapeutic agent, or a solution or suspension containing embolic particles can be disposed through the lumen of the second catheter and into the biological space adjacent to the balloon;
After expansion of the balloon, the second catheter can be pulled back until a distal tip of the second catheter is disposed within the central void or interior volume of the balloon, and one or more of the first elongate body, the expandable body, or the coagulation fluid can be passed through the lumen of the second catheter and disposed within the central void or interior volume of the balloon;
The first catheter can be separated from the expanded balloon;
the first and second catheters can be removed from the patient leaving the balloon and the one or more of the first elongate body, the expandable body, or the coagulation fluid within the patient;
a second medical device comprising:
(i) a distal portion including a first elongate body or an expandable body;
(ii) a proximal portion comprising a second elongate body or delivery system;
Including,
contacting at least a portion of the first elongate or expandable body of the second medical device with at least a portion of a wall of the expanded balloon of the first medical device after placement of the first elongate or expandable body of the second medical device within the expanded balloon of the first medical device;
after placement of the first elongate body or expandable body of the second medical device within the central void or interior volume of the expanded balloon of the first medical device, but prior to separation of the first elongate body or expandable body of the second medical device and the second elongate body of the second medical device, the second medical device can be removed from the patient;
The first elongate body or the expandable body can be separated from the second elongate body;
A method of reducing the flow of bodily fluid within a biological conduit of a human patient using two or more medical devices, wherein after separation of a first elongate body or an expandable body from a second elongate body, the second elongate body can be removed from the patient while leaving the first elongate body or the expandable body within the patient.
[Aspect 2]
The method of aspect 1, wherein after expansion of the balloon of the first medical device and prior to retraction of the second catheter of the first medical device into the central void or interior volume of the expanded balloon of the first medical device, a solution containing a fluoroscopy contrast agent, a drug or therapeutic agent, a coagulation fluid, or a combination thereof, is injected through the lumen of the second catheter of the first medical device and into the biological conduit adjacent to the expanded balloon of the first medical device.
[Aspect 3]
The method of aspect 2, wherein a syringe or other suitable delivery system is used to inject a fluoroscopic contrast agent, a drug, a therapeutic agent, a coagulation fluid, or a combination thereof, through a lumen of the shaft of the second catheter of the first medical device and into the biological conduit adjacent the expanded balloon of the first medical device.
[Aspect 4]
4. The method of aspect 2 or 3, further comprising advancing a second catheter of the first medical device within the biological conduit while maintaining the position of the balloon of the first medical device prior to injecting a fluoroscopic contrast agent, a drug, a therapeutic agent, a coagulation fluid, or a combination thereof, through a lumen of the shaft of the second catheter of the first medical device and into the biological conduit adjacent the expanded balloon of the first medical device.
[Aspect 5]
The method of aspect 1 or 2, further comprising injecting a coagulation fluid from the proximal end of the second catheter of the first medical device, through the lumen of the second catheter of the first medical device, and into the central void or interior volume of the expanded balloon of the first medical device prior to separating the expanded balloon of the first medical device from the first catheter of the first medical device.
[Aspect 6]
The method of any one of aspects 1-5, wherein after being positioned within the central void or interior volume of the expanded balloon, the first elongate or expandable body of the second medical device exerts a force on the wall of the expanded balloon of the first medical device.
[Aspect 7]
7. The method of embodiment 6, wherein the force on the wall of the expanded balloon of the first medical device is outward.
[Aspect 8]
The method of any one of aspects 1-7, wherein the maximum diameter or tertiary diameter of the second medical device is equal to the maximum diameter of the expanded balloon.
[Aspect 9]
The method of any one of aspects 1-7, wherein the maximum or tertiary diameter of the first elongate or expandable body of the second medical device ranges from a value equal to a maximum diameter of an expanded balloon of the first medical device to a value 50% greater than a maximum diameter of an expanded balloon of the first medical device.
[Aspect 10]
The method of any one of aspects 1-7, wherein the maximum overall or tertiary diameter of the first elongate or expandable body of the second medical device is 1, 2, 3, 4, 5, 6, 7, 8, 9, or 10 mm greater than the maximum diameter of the expanded balloon of the first medical device.
[Aspect 11]
Aspect 11. The method of any one of aspects 1-10, wherein the volume of the one or more first elongate bodies or expandable bodies of the second medical device fills 5-75% of the volume of the central void or interior volume of the expanded balloon.
[Aspect 12]
The volume of the first elongate body or expandable body of the second medical device is 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49, 50, 51, 52, 53, 54, 55, 56, 57, 58, 59, 60, 61, 62, 63, 64, 13. The method of any one of the preceding aspects, wherein the method satisfies 6, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49, 50, 51, 52, 53, 54, 55, 56, 57, 58, 59, 60, 61, 62, 63, 64, 65, 66, 67, 68, 69, 70, 71, 72, 73, 74, or 75%.
[Aspect 13]
13. The method of any one of aspects 1-12, wherein the expanded balloon is configured to contact at least 100%, 90%, 80%, 70, 60%, 50%, 40%, 30%, 20%, 10%, or 5% of the area of the luminal surface of the selected biological conduit.
[Aspect 14]
15. The method of any one of the preceding aspects, wherein the expanded balloon is configured to fill at least 100%, 90%, 80%, 70%, 60%, 50%, 40%, 30%, 20%, 10%, or 5% of the lumen volume of the selected segment of the biological conduit.
[Aspect 15]
The method of any one of aspects 1-14, wherein the distal portion of the second catheter of the first medical device comprises a radiopaque portion, ring or marker that is clearly visible under fluoroscopy, and fluoroscopy is used to monitor the position of the distal portion of the second catheter of the first medical device relative to the position of the distal portion of the balloon of the first medical device as the second catheter of the first medical device moves.
[Aspect 16]
16. The method of any one of aspects 1-15, wherein the distal portion of the balloon of the first medical device comprises a radiopaque portion, ring or marker that is clearly visible under fluoroscopy, and fluoroscopy is used to monitor the position of the distal portion of the second catheter of the first medical device relative to the position of the distal portion of the balloon of the first catheter as the second catheter of the first medical device moves.
[Aspect 17]
The method of any one of aspects 1-16, wherein at least a portion of the distal telescoping structure of the first medical device comprises a radiopaque portion, ring or marker that is clearly visible under fluoroscopy, and fluoroscopy is used to monitor the position of a distal portion of the second catheter of the first medical device relative to the position of the distal telescoping structure of the first medical device as the second catheter of the first medical device moves.
[Aspect 18]
The method of any one of aspects 1-17, wherein at least a portion of the first elongate body or expandable body of the second medical device is formed from a material that is radiopaque and clearly visible under fluoroscopy, and fluoroscopy is used to monitor the placement and position of the first elongate body or expandable body of the second medical device.
[Aspect 19]
The method of any one of aspects 1-18, wherein the second catheter of the first medical device includes one, two, or more radiopaque portions, rings, or markers, and fluoroscopy is used to monitor the position of the second catheter of the first medical device relative to the position of the first elongate body or expandable body of the second medical device.
[Aspect 20]
20. The method of any one of aspects 1-19, wherein a distal portion of the first catheter of the first medical device comprises a radiopaque marker that is clearly visible under fluoroscopy, and fluoroscopy is used to monitor separation of the expanded balloon of the first medical device from the first catheter of the first medical device.
[Aspect 21]
21. The method of any one of aspects 1-20, wherein a proximal portion of the balloon of the first medical device comprises a radiopaque marker that is clearly visible under fluoroscopy, and fluoroscopy is used to monitor separation of the expanded balloon of the first medical device from the first catheter of the first medical device.
[Aspect 22]
22. The method of any one of aspects 15-21, wherein the radiopaque portion, ring, or marker comprises platinum, iridium, gold, tungsten, or a combination thereof.
[Aspect 23]
23. The method of any one of aspects 1-22, wherein the distal neck or distal neck assembly of the second catheter of the first medical device and the balloon of the first medical device are coupled by a friction fit, and the second catheter of the first medical device and the expanded balloon of the first medical device are separated by applying axial tension to the coupling.
[Aspect 24]
24. The method of aspect 23, wherein the distal neck or distal neck assembly of the second catheter of the first medical device and the balloon of the first medical device are joined by an elastomeric valve.
[Aspect 25]
The method of aspect 24, wherein the elastomeric valve acts to reduce the flow of biological fluid through a central void or interior volume of the expanded balloon of the first medical device after removal of the second catheter of the first medical device from the patient.
[Aspect 26]
26. The method of any one of aspects 1-25, wherein the proximal neck or proximal neck assembly of the first catheter of the first medical device and the balloon of the first medical device are coupled by a friction fit, and the first catheter of the first medical device and the expanded balloon of the first medical device are separated by applying axial tension to the coupling.
[Aspect 27]
27. The method of aspect 26, wherein the proximal neck or proximal neck assembly of the first catheter of the first medical device and the balloon of the first medical device are joined by an elastomeric tubular segment.
[Aspect 28]
26. The method of any one of aspects 1-25, wherein the first catheter of the first medical device and the balloon of the first medical device are coupled by a mechanical latch, a portion of the mechanical latch being joined to a distal end of the first catheter and a second portion of the mechanical latch being joined to a proximal neck or proximal neck assembly of the balloon of the first medical device.
[Aspect 29]
30. The method of aspect 28, wherein the proximal neck of the balloon of the first medical device is the second portion of the mechanical latch.
[Aspect 30]
30. The method of aspect 28 or 29, wherein two portions of the mechanical latch engage or are operably coupled when the second catheter of the first medical device passes through the mechanical latch.
[Aspect 31]
31. The method of aspect 30, wherein the second catheter of the first medical device is removed from the mechanical latch to separate or operatively separate the mechanical latch and the two portions of the mechanical latch.
[Aspect 32]
32. The method of aspect 31, wherein the first catheter of the first medical device and the expanded balloon of the first medical device are separated.
[Aspect 33]
26. The method of any one of aspects 1-25, wherein the first catheter of the first medical device and the proximal neck or proximal neck assembly of the balloon of the first medical device are joined by adhesive, glue, or solder, and a portion of the proximal neck or proximal neck assembly of the balloon of the first medical device is eroded by electrolysis.
[Aspect 34]
34. The method of aspect 33, wherein the first catheter of the first medical device and the expanded balloon of the first medical device are separated following erosion of a proximal neck or a portion of a proximal neck assembly of the balloon of the first medical device.
[Aspect 35]
26. The method of any one of aspects 1-25, wherein the first catheter of the first medical device and the proximal neck or proximal neck assembly of the balloon of the first medical device are joined by adhesive, glue, or solder, and a distal portion of the first catheter of the first medical device, a portion of the proximal neck or proximal neck assembly of the balloon of the first medical device, or a portion of the bond between the distal portion of the first catheter of the first medical device and the proximal neck or proximal neck assembly of the balloon of the first medical device is melted by heating.
[Aspect 36]
The method of claim 35, wherein the first catheter of the first medical device and the expanded balloon of the first medical device are pulled apart after melting of the distal portion of the first catheter of the first medical device, a portion of the proximal neck or proximal neck assembly of the balloon of the first medical device, or a portion of the bond between the distal portion of the first catheter of the first medical device and the proximal neck or proximal neck assembly of the balloon of the first medical device.
[Aspect 37]
The method of any one of aspects 1-36, wherein the first elongate body or the expandable body of the second medical device is flexible, the second elongate body of the second medical device is flexible, or the first elongate body and the second elongate body of the second medical device are flexible.
[Aspect 38]
The method of any one of aspects 1-37, wherein the first catheter of the first medical device is flexible, the second catheter of the first medical device is flexible, or the first catheter and the second catheter of the first medical device are flexible.
[Aspect 39]
Aspect 1, wherein the balloon of the first medical device is detachable.
[Aspect 40]
Aspects 40. The method of any one of aspects 1-39, wherein the balloon of the first medical device is deflated or compressed prior to expansion.
[Aspect 41]
Aspect 41. The method of any one of aspects 1-40, wherein the fluid used to expand the balloon of the first medical device is water, saline, fluoroscopy contrast, or a combination thereof.
[Aspect 42]
42. The method of any one of aspects 1-41, wherein a solution comprising a fluoroscopic contrast agent is injected under fluoroscopy through the second catheter of the first medical device, into a hub of the second catheter of the first medical device, and into a lumen of the biological conduit adjacent the distal tip of the second catheter of the first medical device prior to expansion of the balloon of the first medical device.
[Aspect 43]
43. The method of any one of aspects 1-42, wherein a solution comprising a fluoroscopic contrast agent is injected under fluoroscopy through the second catheter of the first medical device, into a hub of the second catheter of the first medical device, and into the lumen of the biological conduit adjacent the distal tip of the second catheter of the first medical device after balloon expansion of the first medical device but prior to separation of the expanded balloon of the first medical device and the first catheter of the first medical device.
[Aspect 44]
44. The method of any one of aspects 1-43, wherein a solution comprising a fluoroscopic contrast agent is injected under fluoroscopy through the second catheter of the first medical device, into a hub of the second catheter of the first medical device, and into the lumen of the biological conduit adjacent the distal tip of the second catheter of the first medical device after separation of the expanded balloon of the first medical device and the first catheter of the first medical device.
[Aspect 45]
Aspect 45. The method of any one of aspects 1-44, further comprising providing a first medical device and one or more second medical devices.

Aspects and embodiments relating to methods of treating biological spaces as disclosed herein:
[Aspect 1]
(a) determining a diameter and length of a biological space to be treated and selecting a first medical device including a balloon having an expanded diameter equal to or greater than the diameter of the selected biological space and an expanded length such that, when the balloon of the first medical device is expanded, the balloon can occupy at least a portion of the biological space;
(b) placing a balloon of a first medical device within the biological space;
(c) delivering a fluid medium through the first lumen into a central void or interior volume of the balloon of the first medical device such that the expanded balloon assumes an expanded configuration filling a portion of the biological space and contacting at least a portion of a wall of the biological space;
(d) pulling back the second catheter of the first medical device while maintaining the position of the expanded balloon of the first medical device until a distal tip of the second catheter of the first medical device is within a central void or interior volume of the expanded balloon of the first medical device;
(e) delivering a first elongate or expandable body of the second medical device from the proximal end of the second catheter of the first medical device, through the lumen of the second catheter of the first medical device, and into a central void or interior volume of the expanded balloon of the first medical device;
(f) separating the first elongate body or expandable body of the second medical device from the second elongate body of the second medical device and removing the second elongate body from the patient while leaving the first elongate body or expandable body of the second medical device within the patient;
(g) repeating steps (e) and (f) until a desired percentage of the central void or interior volume of the expanded balloon of the first medical device is filled with the first elongate body or first expandable body;
(h) separating the expanded balloon of the first medical device from the first catheter of the first medical device and removing the first and second catheters of the first medical device from the patient while leaving the expanded balloon of the first medical device and the one or more first elongate bodies or first expandable bodies of the second medical device in the patient;
a first medical device comprising:
(i) (i-1) a distal region, a proximal region generally opposite the distal region, an intermediate region transitioning from the distal region to the proximal region, a first axis extending proximally-distally between the proximal and distal regions, and a second axis perpendicular to the first axis;
(i-2) a wall having an outer surface and an inner surface, the inner surface defining a central void or interior volume, the wall extending generally continuously from a proximal region through an intermediate region to a distal region;
(i-3) an opening in the wall in the proximal region that allows the passage of fluid from the first catheter into the central cavity or interior volume of the balloon and also allows the passage of a portion of the second catheter into the central cavity or interior volume of the balloon;
(i-4) an opening in the wall of the distal region that allows passage of a portion of the second catheter into the central cavity or interior volume of the balloon;
(i-5) a proximal neck or a proximal neck assembly; and
(i-6) a pleated and folded balloon configured for permanent implantation in a human patient, the balloon comprising a distal neck or distal neck assembly;
(ii) defining a first lumen for permitting passage of fluid from a proximal end of the first catheter to a distal end of the first catheter and into a central void or interior volume of the balloon;
(ii-1) a proximal end including a proximal hub; and
(ii-2) a first catheter including a distal portion operably coupled or joined to a proximal neck or proximal neck assembly of the balloon;
(iii) defining a second lumen configured to receive at least one of a guidewire, an elongate body, an expandable body, or a coagulation fluid;
(iii-1) a proximal end including a proximal hub;
(iii-2) a proximal portion that passes through the proximal hub of the first catheter;
(iii-3) an intermediate portion passing through the lumen of the first catheter;
(iii-4) a distal portion extending distally relative to the distal end of the first catheter;
(iii-5) a distal portion passing through the proximal neck or proximal neck assembly of the balloon;
(iii-6) a distal portion that passes through the central cavity or interior volume of the balloon;
(iii-7) a distal portion that engages or passes through a distal neck or distal neck assembly within the balloon; and
(iii-8); a second catheter including an open distal end;
Including,
(iv) the balloon can be expanded by passage of a fluid through the first catheter into a central void or interior volume of the balloon;
After the balloon is expanded, the second catheter can be moved forward or backward while keeping the expanded balloon fixed in place;
After expansion of the balloon, including before or after advancing the tip of the second catheter, one or more of the first elongate body, the expandable body, a coagulation fluid, a solution containing a drug or therapeutic agent, or a solution or suspension containing embolic particles can be disposed through the lumen of the second catheter and into the biological space adjacent to the balloon;
After expansion of the balloon, the second catheter can be pulled back until a distal tip of the second catheter is disposed within the central void or interior volume of the balloon, and one or more of the first elongate body, the expandable body, or the coagulation fluid can be passed through the lumen of the second catheter and disposed within the central void or interior volume of the balloon;
The first catheter can be separated from the expanded balloon;
the first and second catheters can be removed from the patient leaving the balloon and the one or more of the first elongate body, the expandable body, or the coagulation fluid within the patient;
a second medical device comprising:
(i) a distal portion including a first elongate body or an expandable body;
(ii) a proximal portion comprising a second elongate body or delivery system;
Including,
contacting at least a portion of the first elongate or expandable body of the second medical device with at least a portion of a wall of the expanded balloon of the first medical device after placement of the first elongate or expandable body of the second medical device within the expanded balloon of the first medical device;
after placement of the first elongate body or expandable body of the second medical device within the central void or interior volume of the expanded balloon of the first medical device, but prior to separation of the first elongate body or expandable body of the second medical device and the second elongate body of the second medical device, the second medical device can be removed from the patient;
the first elongate body or the expandable body can be separated from the second elongate body;
A method of reducing the flow of a biological fluid in a biological space of a human patient using two or more medical devices, wherein after separation of a first elongate body or an expandable body from a second elongate body, the second elongate body can be removed from the patient while leaving the first elongate body or the expandable body within the patient.
[Aspect 2]
The method of aspect 1, wherein after expansion of the balloon of the first medical device and prior to retraction of the second catheter of the first medical device into the central void or interior volume of the expanded balloon of the first medical device, a solution containing a fluoroscopic contrast agent, a drug or therapeutic agent, a coagulation fluid, or a combination thereof, is injected through the lumen of the second catheter of the first medical device into the biological space adjacent to the expanded balloon of the first medical device.
[Aspect 3]
The method of aspect 2, wherein a syringe or other suitable delivery system is used to inject a fluoroscopic contrast agent, a drug, a therapeutic agent, a coagulation fluid, or a combination thereof, through a lumen of the shaft of the second catheter of the first medical device and into the biological space adjacent to the expanded balloon of the first medical device.
[Aspect 4]
4. The method of aspect 2 or 3, further comprising advancing a second catheter of the first medical device within the biological space while maintaining the position of the balloon of the first medical device prior to injecting a fluoroscopic contrast agent, a drug, a therapeutic agent, a coagulation fluid, or a combination thereof, through a lumen of the shaft of the second catheter of the first medical device and into the biological space adjacent the expanded balloon of the first medical device.
[Aspect 5]
The method of aspect 1 or 2, further comprising injecting a coagulation fluid from the proximal end of the second catheter of the first medical device, through the lumen of the second catheter of the first medical device, and into the central void or interior volume of the expanded balloon of the first medical device prior to separating the expanded balloon of the first medical device from the first catheter of the first medical device.
[Aspect 6]
The method of any one of aspects 1-5, wherein after being positioned within the central void or interior volume of the expanded balloon, the first elongate or expandable body of the second medical device exerts a force on the wall of the expanded balloon of the first medical device.
[Aspect 7]
7. The method of embodiment 6, wherein the force on the wall of the expanded balloon of the first medical device is outward.
[Aspect 8]
The method of any one of aspects 1-7, wherein the maximum diameter or tertiary diameter of the second medical device is equal to the maximum diameter of the expanded balloon.
[Aspect 9]
The method of any one of aspects 1-7, wherein the maximum or tertiary diameter of the first elongate or expandable body of the second medical device ranges from a value equal to a maximum diameter of the expanded balloon of the first medical device to a value 50% greater than the maximum diameter of the expanded balloon of the first medical device.
[Aspect 10]
The method of any one of aspects 1-7, wherein the maximum overall or tertiary diameter of the first elongate or expandable body of the second medical device is 1, 2, 3, 4, 5, 6, 7, 8, 9, or 10 mm greater than the maximum diameter of the expanded balloon of the first medical device.
[Aspect 11]
Aspect 11. The method of any one of aspects 1-10, wherein the volume of the one or more first elongate bodies or expandable bodies of the second medical device fills 5-75% of the volume of the central void or interior volume of the expanded balloon.
[Aspect 12]
The volume of the first elongate body or expandable body of the second medical device is 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49, 50, 51, 52, 53, 54, 55, 56, 57, 58, 59, 60, 61, 62, 63, 64, 65, 66, 67, 68, 69, 70, 71, 72, 73, 74, 75, 76, 77, 78, 79, 80, 81, 82, 83, 84, 85, 86, 87, 88, 89, 90, 91, 92, 93, 94, 95, 96, 97, 98, 99, 100, 101, 102, 103, 104, 105, 106, 107, 108, 109, 110, 111, 112, 113, 114, 115, 116, 117, 118, 120, 121, 122, 133, 1 13. The method of any one of the preceding aspects, wherein the method satisfies 6, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49, 50, 51, 52, 53, 54, 55, 56, 57, 58, 59, 60, 61, 62, 63, 64, 65, 66, 67, 68, 69, 70, 71, 72, 73, 74, or 75%.
[Aspect 13]
13. The method of any one of the preceding aspects, wherein the expanded balloon is configured to contact at least 100%, 90%, 80%, 70, 60%, 50%, 40%, 30%, 20%, 10%, or 5% of the area of the luminal surface of the selected biological space.
[Aspect 14]
15. The method of any one of the preceding aspects, wherein the expanded balloon is configured to fill at least 100%, 90%, 80%, 70%, 60%, 50%, 40%, 30%, 20%, 10%, or 5% of the volume of the lumen of the selected segment of the biological space.
[Aspect 15]
The method of any one of aspects 1-14, wherein the distal portion of the second catheter of the first medical device comprises a radiopaque portion, ring or marker that is clearly visible under fluoroscopy, and fluoroscopy is used to monitor the position of the distal portion of the second catheter of the first medical device relative to the position of the distal portion of the balloon of the first medical device as the second catheter of the first medical device moves.
[Aspect 16]
16. The method of any one of aspects 1-15, wherein the distal portion of the balloon of the first medical device comprises a radiopaque portion, ring or marker that is clearly visible under fluoroscopy, and fluoroscopy is used to monitor the position of the distal portion of the second catheter of the first medical device relative to the position of the distal portion of the balloon of the first catheter as the second catheter of the first medical device moves.
[Aspect 17]
The method of any one of aspects 1-16, wherein at least a portion of the distal telescoping structure of the first medical device comprises a radiopaque portion, ring or marker that is clearly visible under fluoroscopy, and fluoroscopy is used to monitor the position of a distal portion of the second catheter of the first medical device relative to the position of the distal telescoping structure of the first medical device as the second catheter of the first medical device moves.
[Aspect 18]
The method of any one of aspects 1-17, wherein at least a portion of the first elongate body or expandable body of the second medical device is formed from a material that is radiopaque and clearly visible under fluoroscopy, and fluoroscopy is used to monitor the placement and position of the first elongate body or expandable body of the second medical device.
[Aspect 19]
The method of any one of aspects 1-18, wherein the second catheter of the first medical device includes one, two, or more radiopaque portions, rings, or markers, and fluoroscopy is used to monitor the position of the second catheter of the first medical device relative to the position of the first elongate body or expandable body of the second medical device.
[Aspect 20]
20. The method of any one of aspects 1-19, wherein a distal portion of the first catheter of the first medical device comprises a radiopaque marker that is clearly visible under fluoroscopy, and fluoroscopy is used to monitor separation of the expanded balloon of the first medical device from the first catheter of the first medical device.
[Aspect 21]
21. The method of any one of aspects 1-20, wherein a proximal portion of the balloon of the first medical device comprises a radiopaque marker that is clearly visible under fluoroscopy, and fluoroscopy is used to monitor separation of the expanded balloon of the first medical device from the first catheter of the first medical device.
[Aspect 22]
22. The method of any one of aspects 15-21, wherein the radiopaque portion, ring, or marker comprises platinum, iridium, gold, tungsten, or a combination thereof.
[Aspect 23]
23. The method of any one of aspects 1-22, wherein the distal neck or distal neck assembly of the second catheter of the first medical device and the balloon of the first medical device are coupled by a friction fit, and the second catheter of the first medical device and the expanded balloon of the first medical device are separated by applying axial tension to the coupling.
[Aspect 24]
24. The method of aspect 23, wherein the distal neck or distal neck assembly of the second catheter of the first medical device and the balloon of the first medical device are joined by an elastomeric valve.
[Aspect 25]
The method of aspect 24, wherein the elastomeric valve acts to reduce the flow of biological fluid through a central void or interior volume of the expanded balloon of the first medical device after removal of the second catheter of the first medical device from the patient.
[Aspect 26]
26. The method of any one of aspects 1-25, wherein the proximal neck or proximal neck assembly of the first catheter of the first medical device and the balloon of the first medical device are coupled by a friction fit, and the first catheter of the first medical device and the expanded balloon of the first medical device are separated by applying axial tension to the coupling.
[Aspect 27]
27. The method of aspect 26, wherein the proximal neck or proximal neck assembly of the first catheter of the first medical device and the balloon of the first medical device are joined by an elastomeric tubular segment.
[Aspect 28]
26. The method of any one of aspects 1-25, wherein the first catheter of the first medical device and the balloon of the first medical device are coupled by a mechanical latch, a portion of the mechanical latch being joined to a distal end of the first catheter and a second portion of the mechanical latch being joined to a proximal neck or proximal neck assembly of the balloon of the first medical device.
[Aspect 29]
30. The method of aspect 28, wherein the proximal neck of the balloon of the first medical device is the second portion of the mechanical latch.
[Aspect 30]
30. The method of aspect 28 or 29, wherein two portions of the mechanical latch engage or are operably coupled when the second catheter of the first medical device passes through the mechanical latch.
[Aspect 31]
31. The method of aspect 30, wherein the second catheter of the first medical device is removed from the mechanical latch to separate or operatively separate the mechanical latch and the two portions of the mechanical latch.
[Aspect 32]
32. The method of aspect 31, wherein the first catheter of the first medical device and the expanded balloon of the first medical device are separated.
[Aspect 33]
26. The method of any one of aspects 1-25, wherein the first catheter of the first medical device and the proximal neck or proximal neck assembly of the balloon of the first medical device are joined by adhesive, glue, or solder, and a portion of the proximal neck or proximal neck assembly of the balloon of the first medical device is eroded by electrolysis.
[Aspect 34]
34. The method of aspect 33, wherein the first catheter of the first medical device and the expanded balloon of the first medical device are separated following erosion of a proximal neck or portion of a proximal neck assembly of the balloon of the first medical device.
[Aspect 35]
26. The method of any one of aspects 1-25, wherein the first catheter of the first medical device and the proximal neck or proximal neck assembly of the balloon of the first medical device are joined by adhesive, glue, or solder, and a distal portion of the first catheter of the first medical device, a portion of the proximal neck or proximal neck assembly of the balloon of the first medical device, or a portion of the bond between the distal portion of the first catheter of the first medical device and the proximal neck or proximal neck assembly of the balloon of the first medical device is melted by heating.
[Aspect 36]
The method of claim 35, wherein the first catheter of the first medical device and the expanded balloon of the first medical device are pulled apart after melting of the distal portion of the first catheter of the first medical device, a portion of the proximal neck or proximal neck assembly of the balloon of the first medical device, or a portion of the bond between the distal portion of the first catheter of the first medical device and the proximal neck or proximal neck assembly of the balloon of the first medical device.
[Aspect 37]
The method of any one of aspects 1-36, wherein the first elongate body or the expandable body of the second medical device is flexible, the second elongate body of the second medical device is flexible, or the first elongate body and the second elongate body of the second medical device are flexible.
[Aspect 38]
The method of any one of aspects 1-37, wherein the first catheter of the first medical device is flexible, the second catheter of the first medical device is flexible, or the first catheter and the second catheter of the first medical device are flexible.
[Aspect 39]
Aspect 1, wherein the balloon of the first medical device is detachable.
[Aspect 40]
Aspects 40. The method of any one of aspects 1-39, wherein the balloon of the first medical device is deflated or compressed prior to expansion.
[Aspect 41]
Aspect 41. The method of any one of aspects 1-40, wherein the fluid used to expand the balloon of the first medical device is water, saline, fluoroscopy contrast, or a combination thereof.
[Aspect 42]
42. The method of any one of the preceding aspects, wherein a solution comprising a fluoroscopic contrast agent is injected under fluoroscopy through the second catheter of the first medical device, into a hub of the second catheter of the first medical device and into the biological space adjacent to the distal tip of the second catheter of the first medical device prior to expansion of the balloon of the first medical device.
[Aspect 43]
43. The method of any one of aspects 1-42, wherein a solution comprising a fluoroscopic contrast agent is injected under fluoroscopy through the second catheter of the first medical device, into a hub of the second catheter of the first medical device, and into the biological space adjacent to the distal tip of the second catheter of the first medical device after balloon expansion of the first medical device but prior to separation of the expanded balloon of the first medical device and the first catheter of the first medical device.
[Aspect 44]
44. The method of any one of aspects 1-43, wherein a solution comprising a fluoroscopic contrast agent is injected under fluoroscopy through the second catheter of the first medical device, into a hub of the second catheter of the first medical device, and into the biological space adjacent to the distal tip of the second catheter of the first medical device after separation of the expanded balloon of the first medical device and the first catheter of the first medical device.
[Aspect 45]
Aspect 45. The method of any one of aspects 1-44, further comprising providing a first medical device and one or more second medical devices.

It is also understood that the apparatus and method of the present disclosure can be embodied in the form of various embodiments, only a few of which have been illustrated and described. The disclosure herein can be embodied in other specific forms without departing from its spirit or essential characteristics. The described embodiments are to be considered in all respects as illustrative and not restrictive, the scope of the invention being, accordingly, indicated by the foregoing description rather than by the appended claims. All changes that come within the meaning and range of equivalency of the claims are to be embraced within their scope.

Claims (37)

a distal region, a proximal region generally opposite the distal region, an intermediate region transitioning from the distal region to the proximal region, a first axis extending proximally-distally between the proximal region and the distal region, and a second axis perpendicular to the first axis;
a wall having an outer surface and an inner surface and extending generally continuously from said proximal region through said intermediate region to said distal region;
a central cavity defined by the inner surfaces of the walls;
a proximal opening in the wall at the proximal region that allows the passage of fluid into the central cavity of the balloon; and a distal opening in the wall at the distal region, the balloon configured for permanent implantation within a biological space.
a first proximal end coupled to a first proximal hub;
a first catheter including: a first distal end; and a first distal portion operably coupled to the proximal opening of the balloon;
a second proximal end coupled to a second proximal hub;
a second proximal portion passing through the first proximal hub of the first catheter;
a second catheter including: a second distal portion passing through the proximal opening, the central void, and the distal opening of the balloon; and a second distal end that is open;
a detachable assembly for joining the balloon to the first catheter , comprising:
a tubular male structure coupled to the first distal end of the first catheter to form a first assembly defining a lumen of a first detachable assembly, the tubular male structure including at least one movable arm having a distal tab projecting radially outward from an outer surface thereof;
a tubular female structure coupled to the proximal neck of the balloon to form a second detachable assembly, the second detachable assembly defining a lumen for the second detachable assembly extending from the female proximal end to the female distal end;
Body; and
a shaft of the second catheter, in a first configuration, the first assembly can be fixed to the second assembly, and in a second configuration, the first assembly is free to move relative to the second assembly;
a removable assembly including:
Including,
when the removable assembly is in an engaged configuration, at least a portion of the distal tab of the at least one movable arm of the tubular male structure extends distally beyond at least a portion of the female distal end of the tubular female structure and the distal tab of the at least one movable arm of the tubular male structure extends radially beyond at least a portion of the female outer surface of the tubular female structure, thereby retaining the tubular male structure within the tubular female structure .
1. A medical device for placement in a biological space, comprising:
the first catheter defines, together with the second catheter, a first lumen that allows a fluid to pass from the first proximal end to the first distal end of the first catheter and into the central cavity of the balloon;
the passage of the liquid through the first lumen to the central cavity causes the balloon to expand from a compressed configuration to an expanded configuration;
the second catheter defines a second lumen configured to receive one or more second medical devices, the second lumen including a braided metal wire assembly or a braided metal wire assembly;
After expansion of the balloon, the second catheter is actuated to move forward or backward while the first catheter and the balloon remain in a fixed position;
after expansion of the balloon, operating the second catheter to move forward until the second distal end of the second catheter is located within the biological space such that at least one of the one or more second medical devices is capable of passing through the second lumen of the second catheter into the biological space adjacent the balloon;
operatively moving the second catheter rearwardly until the second distal end of the second catheter is located within the central cavity of the balloon such that, after expansion of the balloon, at least one of the one or more second medical devices can pass through the central cavity of the balloon via the second lumen of the second catheter;
after expansion of the balloon and passage of all or a portion of the one or more second medical devices through the second lumen of the second catheter into the central cavity of the balloon, the first catheter is operative to separate from the balloon, and the first catheter and the second catheter are operative to be removed from the biological space while the balloon and all or a portion of the one or more second medical devices remain in the biological space.
Medical devices. The medical device of claim 1, wherein the balloon wall comprises a single layer of polymer. The medical device of claim 2, wherein the single layer of polymer comprises a continuous layer of polymer. The medical device of claim 2, wherein the single layer of polymer comprises a discontinuous layer of polymer. The medical device of any one of claims 1 to 4, wherein the balloon further comprises a proximal neck and a distal neck. The medical device of claim 1, wherein at least a portion of the balloon wall comprises two or more polymer layers. The medical device of claim 1, wherein the balloon wall comprises a single layer of metal. The medical device of claim 7, wherein the single layer of metal comprises a continuous layer of metal. The medical device of claim 7, wherein the single layer of metal comprises a discontinuous layer of metal. The medical device of any one of claims 7 to 9, wherein the metal monolayer comprises gold or an alloy thereof. The medical device according to any one of claims 7 to 9, wherein the metal monolayer comprises platinum or an alloy thereof. The medical device of claim 1, wherein the wall of the balloon includes one or more outer layers or coatings and one or more inner layers or coatings. The medical device of claim 12, wherein the one or more outer layers or coatings and the one or more inner layers or coatings comprise one or more polymers. The medical device of claim 1, wherein the wall of the balloon comprises an inner layer comprising a metal and an outer layer or coating comprising a polymer. The medical device of claim 14, wherein the polymer is a metal whose inner layer containing the metal does not conduct current to the outer surface of the balloon. The medical device of claim 14 or 15, wherein the thickness of the outer layer or coating is 0.1 to 100 μm. The medical device according to any one of claims 1 to 16, comprising an expandable metal retention structure, wherein after the expandable metal retention structure and the balloon are expanded, the retention structure diameter of the expandable metal retention structure portion is equal to or greater than the diameter of the balloon. a third catheter;
a third inner surface of the third catheter and a first outer surface of the first catheter defining a third lumen configured to receive the first catheter, the second catheter, and at least a portion of the expandable metallic retention structure;
The third catheter comprises:
a third proximal end coupled to a third proximal hub; and a third distal end passing over at least a portion of the expandable metal retention structure and holding the expandable metal retention structure in a compressed retained shape until the third catheter is withdrawn;
Including,
20. The medical device of claim 17, wherein withdrawal of the third catheter expands the expandable metallic retention structure from the compressed retention configuration to an expanded retention configuration. The medical device according to any one of claims 1 to 18, wherein the first catheter can be separated from the balloon by pulling the first catheter and the balloon apart. The medical device according to any one of claims 1 to 18, wherein the second catheter can be separated from the balloon by pulling the second catheter and the balloon apart. The medical device according to any one of claims 1 to 18, wherein the first catheter and the second catheter can be separated from the balloon by pulling apart the assembly of the first catheter and the second catheter and the balloon. The medical device according to any one of claims 1 to 21, wherein a portion of the first distal end of the first catheter and a portion of the proximal neck of the balloon combine to form a mechanical attachment between the first catheter and the balloon, the mechanical attachment being configured to engage when the second catheter passes through an attachment site of the mechanical attachment and to disengage when the second catheter is removed from the attachment site of the mechanical attachment. The medical device of claim 1, wherein the second catheter can be separated from the balloon by pulling the second catheter and the balloon apart. 24. The medical device of claim 23, wherein the first assembly can be separated from the second assembly by withdrawing the shaft of the second catheter from within the lumen of the first detachable assembly of the tubular male structure and pulling the first catheter and the balloon apart as the detachable assembly changes from an engaged configuration to a disengaged configuration. a detachable assembly for joining the balloon to the first catheter, the detachable assembly including a first tubular structure coupled to a proximal neck of the balloon and configured to frictionally fit with the first distal end of the first catheter;
19. The medical device of claim 17 or 18, wherein when the balloon is expanded within an artery, vein, left atrial appendage, aneurysm, biological conduit, or other blood-containing or biological space, and at least a portion of the outer surface of the balloon or a portion of the outer surface of the expandable metal retention structure attached to the balloon contacts at least a portion of a wall of an artery, vein, left atrial appendage, aneurysm, biological conduit, or other blood-containing or biological space, the first catheter can be separated from the assembly of the proximal neck of the balloon and the first tubular structure by pulling the assembly of the first catheter and the proximal neck of the balloon and the first tubular structure apart. a detachable assembly for joining the balloon to the first catheter, the detachable assembly including a first tubular structure coupled to a proximal neck of the balloon and configured to frictionally fit with the first distal end of the first catheter;
19. The medical device of claim 17 or 18, wherein when the balloon is expanded within an artery, vein, left atrial appendage, aneurysm, biological conduit, or other blood-containing or biological space, and at least a portion of the outer surface of the balloon or a portion of the outer retention surface of the expandable metal retention structure attached to the balloon contacts at least a portion of a wall of an artery, vein, left atrial appendage, aneurysm, biological conduit, or other blood-containing or biological space, the first catheter can be separated from the assembly of the proximal neck of the balloon and the first tubular structure by pulling the first catheter and the first assembly of the proximal neck of the balloon and the first tubular structure apart. a detachable assembly for joining the balloon to the first catheter, the detachable assembly including a first tubular structure coupled to the first distal end of the first catheter and configured to frictionally engage a proximal neck of the balloon;
19. The medical device of claim 17 or 18, wherein when the balloon is expanded within an artery, vein, left atrial appendage, aneurysm, biological conduit, or other blood-containing or biological space, and at least a portion of the outer surface of the balloon or a portion of the outer surface of the expandable metal retention structure attached to the balloon contacts at least a portion of a wall of an artery, vein, left atrial appendage, aneurysm, biological conduit, or other blood-containing or biological space, the detachable assembly of the first catheter and first tubular structure and the balloon can be separated from the proximal neck of the balloon by pulling the assembly of the first catheter and first tubular structure and the balloon apart. a detachable assembly for joining the balloon to the second catheter;
the detachable assembly includes one or more elastomeric valves attached to the distal neck or distal neck assembly of the balloon;
the one or more elastomeric valves are configured to frictionally fit with the second distal end of the second catheter;
28. The medical device of any one of claims 1 to 27, wherein when the balloon is expanded within an artery, vein, left atrial appendage, aneurysm, biological conduit, or other blood-containing space or biological space, and at least a portion of the outer surface of the balloon or a portion of an outer retention surface of an expandable metallic retention structure attached to the balloon contacts at least a portion of a wall of an artery, vein, left atrial appendage, aneurysm, biological conduit, or other blood-containing space or biological space, the second catheter can be separated from the balloon by pulling the second catheter and the balloon apart. The medical device according to any one of claims 1 to 28, wherein the wall of the first catheter is continuous and the wall of the segment of the second catheter passing through the central cavity of the balloon includes a second segment opening for the fluid to flow out of the second lumen of the second catheter. The medical device according to any one of claims 1 to 29, wherein the second proximal hub of the second catheter is proximal to the first proximal hub of the first catheter, a portion of the second catheter passes through the first lumen of the first catheter, and the second distal end of the second catheter is distal to the first distal end of the first catheter. The medical device of claim 1, wherein the one or more second medical devices include an elongate body comprising a metal coil, a metallic coil, a polymer coil, a composite coil of metal and polymer, a coiled polymer wire, a coiled metal wire, a coiled metallic wire, a composite wire coil of metal and polymer, a polymer strand, a metal strand, a metallic strand, a composite strand of metal and polymer, a vascular coil, or a combination thereof. The medical device of claim 1, wherein the one or more second medical devices further comprise a polymer strand assembly, a composite metal and polymer wire or strand assembly, a coiled metal wire assembly, a coiled metallic wire assembly, a coiled polymer strand assembly, a composite coiled metal and polymer structure, a metal strand assembly, a metallic strand assembly, a composite metal and polymer strand assembly, a composite metal and polymer braided wire assembly, a braided polymer strand assembly, a composite metal and polymer braided strand assembly, a metal mesh assembly, a metal mesh assembly, a composite metal and polymer mesh assembly, a woven polymer strand assembly, a woven metal and polymer strand assembly, or a combination thereof. 10. The medical device of claim 1, wherein the one or more second medical devices comprise an expandable body comprising an expansion assembly of a metal coil, a metallic coil, a polymer coil, a composite coil of metal and polymer, a coiled polymer wire, a coiled metal wire, a coiled metallic wire, a composite wire coil of metal and polymer, a polymer strand, a metal strand, a metallic strand, a composite strand of metal and polymer, an assembly of metal wires, an assembly of metallic wires, an assembly of polymer strands, an assembly of composite wires or strands of metal and polymer, an assembly of coiled metal wires, an assembly of coiled metallic wires, an assembly of coiled polymer strands, a composite coiled structure of metal and polymer, an assembly of polymer strands, an assembly of metal strands, an assembly of metallic strands, an assembly of composite strands of metal and polymer, an assembly of composite braided wires of metal and polymer, an assembly of braided polymer strands, an assembly of composite braided strands of metal and polymer, an assembly of metal mesh, an assembly of metal mesh, an assembly of composite mesh of metal and polymer, an assembly of woven polymer strands, an assembly of woven metal and polymer composite strands, or combinations thereof. The medical device of claim 1, wherein the one or more second medical devices include a balloon support structure comprising beads, balls, microspheres, a bioabsorbable material, an adhesive, a glue, a solidified polymer, a solidified foam, or a combination thereof. The medical device of any one of claims 1 to 34, wherein the first proximal hub of the first catheter includes a port for injecting a fluid into the first lumen. The medical device of any one of claims 1 to 35, wherein the second proximal hub of the second catheter is configured for injection of a fluid into the second lumen. The medical device of claim 5, wherein at least a portion of the proximal neck, the distal neck, or both the proximal neck and the distal neck includes a layer of radiopaque metal.