US20220249813A1 - Detachable balloon embolization device and methods - Google Patents

Abstract

A balloon embolization apparatus, system and method include a detachable balloon device mounted to the distal end of a catheter or microcatheter. The balloon device includes an elongated cannula having first and second axial lumens defined in the cannula, one lumen which allows for travel over a wire, an inflatable balloon disposed on the cannula, and a valve sleeve disposed between the balloon and the cannula. An inflation port on the cannula allows fluid to be introduced to the balloon via a channel in the catheter. The valve sleeve includes a vent offset from the inflation port in the cannula. The valve sleeve allows the introduced fluid to inflate the balloon, but prevents the fluid from escaping, thereby forming a check valve. Once inflated, the catheter is detached from the balloon apparatus. When the catheter is withdrawn, the balloon remains in place to allow for embolization.

Description

CROSS-REFERENCES TO RELATED APPLICATIONS
• This nonprovisional patent application claims priority to U.S. Provisional Patent Application No. 63/146,166, entitled “DETACHABLE BALLOON EMBOLIZATION DEVICE AND METHODS,” which was filed on Feb. 5, 2021, and which is pending, the entirety of which is incorporated by reference.
• A portion of the disclosure of this patent document contains material that is subject to copyright protection. The copyright owner has no objection to the reproduction of the patent document or the patent disclosure, as it appears in the U.S. Patent and Trademark Office patent file or records, but otherwise reserves all copyright rights whatsoever.
STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT
• None.
REFERENCE TO SEQUENCE LISTING OR COMPUTER PROGRAM LISTING APPENDIX
• None.
BACKGROUND
• The present invention relates generally to devices and methods for controlling the flow of blood in humans and animals, and more particularly to devices for embolization of blood vessels in general as well as specifically for embolization of aneurysms.
• Blood is moved throughout the body via the circulatory system via an intricate and complex network of blood vessels. By definition, arteries bring pumped blood from the heart to other organs and musculature, systematically branching into smaller and smaller branches akin to a tree, either to supply oxygenated blood (systemic circulation) or to move blood to get oxygenated in the lungs (pulmonary circulation). Conversely, veins return deoxygenated blood used by organs and musculature in the systemic circulation by progressively draining into larger veins until blood is returned to the heart; veins in the pulmonary circulation return blood which has been oxygenated in the lungs back to the heart.
• Due to various disease processes such as trauma, aneurysms, gastrointestinal bleeds, bleeding during procedures/surgeries (termed iatrogenic bleeding), tumors, or even to change physiologic or pathophysiologic flow for numerous other reasons, it is not uncommon for physicians to emergently or electively need to close down blood vessels, either temporarily or permanently. The severity and danger of a bleeding vessel depends on multiple factors, and the most dangerous include but are not limited to: larger size of the vessel, pressure in the vessel (arteries are more pressurized given pumping from the heart ventricles and their arterial wall structure), location of the vessel (i.e., bleeding artery in the brain is much more dangerous than in the arm), whether another structure can tamponade (or block and contain) the bleed to limit the blood that escapes from circulatory system, and finally depending on how well that person's body can thrombose the abnormal bleeding (i.e., can they clot properly, are they on blood thinners, etc.). Depending on those and other factors, bleeding can range from asymptomatic or mild discomfort all the way to hypotension to complete circulatory collapse, termed hypovolemic shock, which can ultimately lead to death.
• As previously mentioned, a common pathophysiology encountered in the vascular world is an aneurysm, which refers to an unnatural expansion or outpouching of an artery. The most feared and catastrophic complication of an aneurysm is the possibility that the enlarged/stretched wall of the aneurysm has weakened over time and ultimately ruptures. The two common morphologies of aneurysms are fusiform, which means that the entire circumference of the artery is enlarged, and saccular, which means that there is a focal outpouching in the artery.
• Medicine and surgery have been trying to combat minor bleeding to severe hemorrhaging for millennia. Medical treatments include volume resuscitation by giving fluids or even blood to replace the lost blood, giving medications such as inotropic agents to keep blood pressure up and prevent shock, giving agents to promote clotting, such as platelets and fresh frozen plasma, counteracting bleeding diatheses, correcting medications preventing clotting (typically known anticoagulants), providing bowel rest and giving proton pump inhibitors to minimize gastric acid secretion, and other various treatments. While this may work well for smaller bleeds, larger bleeds often need to be controlled mechanically to prevent further morbidity and mortality.
• Older, more traditional surgical methods of stopping bleeding include techniques such as holding pressure (if the bleeding is visible or close to the skin), clamping a vessel (i.e., cinching it down with a clamp temporarily or clip permanently), ligating (or tying off) a vessel with a suture, surgically repairing a vessel with a patch or sewing the bleeding site shut, or even surgically resecting the vessel from the body if needed. Many of the above are complex and challenging surgeries performed by vascular surgeons or trauma surgeons which entail obvious high risk depending on the vessel, the location, and the patient's state and other comorbidities. In the past few decades, newer methods to control bleeding have been created via open surgical, laparoscopic, or endoscopic surgical methods such as banding vessels with medical rubber bands or sclerosing (externally injecting with a medicine) certain vessels closed.
• Embolization refers to stopping blood flow in a vessel via a minimally invasive technique of entering the vessel and blocking flow from an internal, or endovascular, approach. The most common embolization is blocking flow in an artery, called an arterial embolization. For a typical arterial embolization, this technique involves first gaining access to the arterial system called catheterization. As opposed to most of the surgical methods described above, catheterization typically does not need general anesthesia and can be performed typically with moderate sedation. After the patient is sedated, a small amount of anesthetic such as lidocaine is given in the skin and a tiny incision is made. Either by palpating the vessel or typically now using ultrasound guidance, the artery is then accessed using a small needle. The most common arterial entry sites are the common femoral artery in the groin and the radial artery in the wrist. The entry needle is then exchanged over a wire for a small tube called a catheter, which is then navigating throughout the body using wires and contrast and seen in real-time using x-ray guidance called fluoroscopy. Once at the site of the bleed, various ingenious techniques and devices have been developed over time that are used to attempt to control and stop the bleeding.
• There are different reasons to perform embolization, and one common reason is to achieve tissue infarct for reasons such as tumor embolization, uterine fibroid embolization, and prostate artery embolization. In order to stop blood flow to abnormal tissue, the goal is to embolize as distally (far downstream) as possible to avoid the possibility of other blood source detouring around the embolization. For this purpose, tiny particles—just small enough to lodge into the tiniest vessel feeding the abnormal tissue—are generally injecting.
• Other complex vascular pathophysiology require blood flow to be closed down in various shapes, such as in arteriovenous malformations, high flow arteriovenous fistulas, amorphous endoleaks, or angiomyolipomas. In these cases, a smaller catheter called a microcatheter may be advanced to the site and liquid embolics such as surgical-grade glue, alcohol, or Onyx can be used along with other devices.
• However, for the majority of bleeding issues such as trauma, GI bleeds, and other large vessel bleeding from various causes, the goal is to simply stop the pressure head of the uncontrolled bleed, and to preserve flow to the downstream organ or musculature, in essence avoiding downstream tissue infarct. The exact site of embolization in a vessel is typically just proximal (before) the site of downstream bleeding, or oftentimes across the site of bleeding if it is felt that the cessation of flow at that location may change the hemodynamics such that “backdoor” bleeding from the other site may occur. Obviously, in these larger vessel embolizations, the question is whether it is safe to the body, based on risks and benefits, to shut down flow in that vessel. If so, this type of embolization is typically known as a “vessel sacrifice”. Generally, in this type of embolization, as opposed to using particles or liquid embolics, the goal is stopping the flow in that vessel at that exact site, and potentially continue to allow flow downstream to the intended target organ or musculature.
• Many techniques and devices have been developed over past few decades for vessel sacrifice. One of the first techniques was autologous clot embolization, which entailed taking blood from the patient's body, allowing it to form a thrombus (clot), and then injecting that back into the vessel via the catheter at that site. This is rarely if ever used today due to lack of control and inconsistency. Another older but still commonly used embolic is Gelfoam, a sponge-like material that can be cut up, rolled up, and/or mixed with liquid to create slurry or “torpedoes”, all while compressing it through the catheter or microcatheter to then allow it to expand in the blood vessel and obstruct flow. Over the course of a few weeks, the vessel then slowly recanalizes. This is therefore commonly used in the setting of trauma or postpartum hemorrhage. Both these first two embolization techniques are readily available, cheap, and fairly easy to learn, but both have the major issue of lack of control of where the final embolic may end up. This last point, that an embolic particle may move downstream with the flow of blood or otherwise migrate to an unintended location, is one of the most common and most immediate fears when performing an embolization. The complication is termed nontarget embolization.
• A few decades ago, embolic devices started expanding with the advent of embolization coils. Coils are fairly soft but generally memory-retentive metal that have the morphology and appearance of small wires. They are made to the size of the catheter or microcatheter being used, and ideally will build up into a “ball of yarn” at the intended embolization site and occlude flow. In their original iteration, the goal of coils was to create a matrix for the thrombotic cascade to occur, which means the coil was supposed to build a “scaffold” to attract platelets and thrombin, which would then start the clotting process. Coils come in many shapes and sizes (such as straight, helical, or tornado-shaped), and the original ones and subsequent versions come heathered with fibers or expanding gel attached to them to fill in the empty space and have the platelets and fibrin attach. Newer generations of coils have become softer, with more complex shapes, longer, thicker, more easily trackable through long microcatheters, and now have more control as they stay attached to the pushing wire of the coil until it is ready to be deployed. In many practices, these “detachable” coils have become the standard of care for vessel sacrifice due to their ease of use, controllability, and relative affordability.
• Similar and novel embolization devices have also sprung up over the past decade plus to compete and/or augment coil embolics. Vascular plugs are another broad category of embolics that were limited previously due to their larger profile that required very large catheters to deliver. In recent years, newer smaller vascular plugs are allowing delivery through smaller catheters and microcatheters. Additionally, there is increasing utilization for the aforementioned glue and Gelfoam in larger arteries in various circumstances. Overall, embolization has become the gold standard for nearly all types of vascular bleeding as it is generally more effective, quicker, and safer than opening the patient surgically, and has less overall risk.
• Similarly, minimally invasive endovascular embolization for aneurysms has essentially also replaced open surgical repair and clipping. For fusiform aneurysms, the gold standard now for most patients with aneurysms in larger, accessible arteries is generally repair with a stent graft (a metallic stent covered with an impermeable material) to exclude the enlarged and weakened segment. Stent graft exclusion of aneurysms can also be performed for saccular aneurysms, however, given the difficulty in maneuvering a large profile stent graft and given that typically the location of aneurysms in tortuous vessels and at branch points makes placing stent grafts not feasible for most saccular aneurysms. Therefore, stent grafts are mainly limited to larger arteries which are fairly straight. Despite advancements in stent grafts become smaller in profile and more flexible, limitations of stent grafts still remain today.
• Similarly, saccular aneurysm treatment has also evolved greatly over the past two decades. For many saccular aneurysms, coiling has become the gold standard. The key to successfully being able to embolize a saccular aneurysm lies in terms of the aneurysm location in relation to the vessel or branch point as well as in its morphology, especially depending on the size of the aneurysm neck. For “narrow” neck aneurysms, the goal of coils or other embolics will be to try to keep them in place without fear of the coil pack migrating out of the aneurysm.
• However, “wide neck” aneurysms still pose a conundrum for treatment given that there is no guarantee of the coil or other embolic staying in place within the intended aneurysm target, especially given that many of these aneurysms form in turbulent, high flow areas. Again, the fear is that there will be immediate or delayed nontarget embolization. In the body, this can mean stoppage of flow to a critical organ or limb, while in the brain it results in stroke or death.
• Additionally, a new category of aneurysm repair devices has entered the market in the past few years and are called “flow diverters.” These are similar to stent graft but have no impermeable covering around the metal struts; rather, they are configured such that the metal struts “bunch” in certain areas (ideally at the neck of the aneurysm) to divert flow away from the aneurysm rather than occlude the aneurysm from the inside. These are smaller and travel better than stent grafts, and thus their primary use is in the cerebral vasculature. Other recent devices coming to market include spherical mesh vascular plugs meant to sit inside and occlude flow in to saccular aneurysms as opposed to vessel sacrifice. Finally, for saccular aneurysms which are at branch points which cannot be stent-assisted coil embolized, other new devices in the design of scaffolds have recently come out to help keep coils inside challenging-anatomy aneurysms.
• Vessel embolization and aneurysm embolization mixes a good deal of art with science. Although ingenuity and creativity in advancing techniques has been astounding in the past 20 years, much of what the endovascular community can achieve is still limited by what products are commercially available and FDA-approved.
• While the aforementioned devices and techniques seem simple and elegant in theory, trying to achieve a perfect embolization is challenging and stressful. The planning and execution of either a large or a tiny aneurysm with high flow in a turbulent bifurcation in an aneurysm that may rupture or the thought that any tiny downstream nontarget embolization could result in catastrophic injury or death makes these some of the most challenging and rewarding endovascular cases.
• Many conventional solutions to embolization are thus problematic because they are hard to control and use, they do not consistently work, they require multiple coils, they have large profiles, they are hard to track, they leave streak artifacts, they have a high learning curve and/or they can be very expensive. New solutions to embolization devices and methods are needed to overcome these deficiencies.
• What is needed, then, are evolutionary improvements or even a completely new innovation in devices and methods for embolization of vessels as well as aneurysms.
BRIEF SUMMARY
• One aspect of the present disclosure provides a detachable embolization balloon device. The balloon apparatus includes a cannula with a guide wire lumen defined axially through the cannula and an inflation lumen defined partially axially through the cannula. A valve sleeve is disposed over the exterior of the cannula, and a balloon is disposed over the exterior of the valve sleeve. The valve sleeve and the balloon are sealed against the cannula at each end. The valve sleeve forms a check valve that allows inflation of the balloon via an inflation channel in the microcatheter, but prevents leakage of the inflation medium from the balloon once inflated.
• In some embodiments, the apparatus can be inserted via the distal end of a catheter through a vessel to the precise desired location, such as at the site of arterial bleeding or in an aneurysm. Once positioned, the balloon is inflated by passing a gas or liquid inflation medium through an inflation channel in the catheter and into the inflation lumen on the cannula.
• In some embodiments, the inflation medium travels through the inflation lumen on the cannula and out an inflation port defined in the cannula wall. The inflation medium then enters a plenum formed between the outer surface of the cannula and the inner surface of the valve sleeve, and eventually exits through a vent defined in the valve sleeve. The inflation medium is then trapped between the balloon and the valve sleeve, inflating the balloon to a desired size. Once inflated, the balloon apparatus releases from the distal tip of the catheter by a friction fit release mechanism, and the catheter can be withdrawn from the vasculature leaving the inflated balloon apparatus in place.
• In some embodiments, the balloon apparatus includes a first end and a second end. A first marker band is positioned on the first end, and a second marker band is positioned on the second end. The first and second markers comprise a radio-opaque material in some embodiments such that the location of the apparatus can be observed fluoroscopically in real time imaging during surgery, and the device can be guided to a precise location by observing the position of the marker bands using appropriate imaging equipment.
• In further embodiments, the present disclosure provides a system for embolization of an aneurysm. The system includes a microcatheter configured for detachable connection to a balloon device, and a balloon device detachably mounted on the distal end of the microcatheter for insertion into a patient's body. The microcatheter includes a guide wire lumen channel and a separate inflation channel. The inflation channel of the microcatheter is in fluid communication with an inflation lumen on the balloon device. When inflation medium such as a liquid or gas is introduced through the inflation channel in the microcatheter into the inflation lumen, the balloon device becomes inflated, thereby mechanically occluding the flow of blood in the aneurysm. The microcatheter may be easily detached from the balloon by simply pulling on the microcatheter, which causes the friction fit interface between the balloon and the microcatheter to release. This allows the inflated balloon to remain in position inside the body when the microcatheter is withdrawn.
• In some embodiments, the present disclosure provides a balloon embolization device configured to occlude flow mechanically, regardless of a patient's ability to naturally clot.
• In further embodiments, the present disclosure provides a balloon embolization device configured to occlude flow quickly upon inflation, but not irreversibly.
• In further embodiments, the present disclosure provides a balloon embolization device configured to achieve optimized aneurysm fill by conforming to the vessel lumen or aneurysm regardless of shape.
• In further embodiments, the present disclosure provides a balloon embolization device configured to be detachable and controllable for precise placement which stays in place.
• In further embodiments, the present disclosure provides a balloon embolization device configured to allow for recapture and repositioning for optimal placement.
• In further embodiments, the present disclosure provides a balloon embolization device configured to be mounted on a microcatheter, such as but not limited to a 2.7 Fr dual channel microcatheter configured for insertion along a guide wire.
• In further embodiments, the present disclosure provides a balloon embolization device configured to be quickly and easily deployed.
• In further embodiments, the present disclosure provides a balloon embolization device configured to have an easy and reliable detachment from the microcatheter following inflation.
• In further embodiments, the present disclosure provides a balloon embolization device configured to be soft upon insertion and prevent microcatheter overtravel or “kickout” during insertion.
• In further embodiments, the present disclosure provides a balloon embolization device configured to provide no artifact on follow-up imaging secondary to its lack of metal components.
• In further embodiments, the present disclosure provides a balloon embolization device configured to have a relatively low cost when compared to other embolization devices.
• A further objective of the present disclosure is to provide a balloon embolization device with a self-sealing configuration that will retain liquid or gas when inflated and detached from the catheter.
• Numerous other objects, advantages and features of the present disclosure will be readily apparent to those of skill in the art upon a review of the following drawings and description of a preferred embodiment.
BRIEF DESCRIPTION OF THE FIGURES
• FIG. 1 illustrates a perspective view of an embodiment of an uninflated balloon assembly positioned via a vascular catheter for embolization of a saccular aneurysm.
• FIG. 2 illustrates a perspective view of the embodiment of a balloon assembly ofFIG. 1 in an inflated state inside of a saccular aneurysm.
• FIG. 3 illustrates a plan view of an embodiment of a balloon embolization system with an inflatable balloon assembly detached from the distal end of a catheter.
• FIG. 4 illustrates a plan view of the embodiment of the balloon embolization system ofFIG. 3 with the inflatable balloon assembly attached to the distal end of the catheter.
• FIG. 5 illustrates a perspective view of an embodiment of a balloon embolization system including an inflatable balloon assembly attached to the distal end of a catheter.
• FIG. 6 illustrates a perspective view of an embodiment of a balloon embolization system including a detachable and inflatable balloon assembly detached from the distal end of a catheter.
• FIG. 7 illustrates a perspective view of an embodiment of a balloon embolization system including a detachable balloon assembly in an inflated state detached from the distal end of a catheter.
• FIG. 8 illustrates a perspective and a cross-sectional view of a cannula for use with a balloon assembly.
• FIG. 9 illustrates a perspective view of a valve sleeve for use with a balloon assembly.
• FIG. 10 illustrates a perspective view of a balloon for use with a balloon assembly.
• FIG. 11A illustrates an exploded perspective view of an embodiment of a detachable and inflatable balloon assembly for embolization of an aneurysm.
• FIG. 11B illustrates a perspective view of an embodiment of a detachable and inflatable balloon assembly for embolization of an aneurysm.
• FIG. 12 illustrates a cross-sectional view of an embodiment of a balloon embolization system including a detachable balloon assembly in an inflated state detached from a catheter.
• FIG. 13 illustrates a perspective view of an embodiment of a detachable balloon assembly in an inflated state.
• FIG. 14A illustrates a side view of an embodiment of a three-way connector and a tri-hub for use in a balloon embolization system.
• FIG. 14B illustrates a cutaway side view of an embodiment of a three-way connector and a tri-hub for use in a balloon embolization system.
• FIG. 15 illustrates a cutaway front view of an embodiment of a catheter for use with a balloon embolization system.
• FIG. 16A illustrates a perspective side view of an embodiment of a cannula for use with a embolization system.
• FIG. 16B illustrates a cross-sectional view of the cannula ofFIG. 16A.
• FIG. 17A illustrates a perspective view of an embodiment of a detachable and inflatable balloon assembly for embolization of an aneurysm.
• FIG. 17B illustrates an exploded view of the detachable and inflatable balloon assembly ofFIG. 17A.
• FIG. 17C illustrates a cutaway view of the detachable and inflatable balloon assembly ofFIG. 17A.
• FIG. 18 illustrates a perspective view of the detachable and inflatable balloon assembly ofFIG. 17A with a balloon.
• FIG. 19A illustrates a method of aneurysm embolization.
• FIG. 19B illustrates a continuation of the method ofFIG. 19A.
DETAILED DESCRIPTION
• While the making and using of various embodiments of the present invention are discussed in detail below, it should be appreciated that the present invention provides many applicable inventive concepts that are embodied in a wide variety of specific contexts. The specific embodiments discussed herein are merely illustrative of specific ways to make and use the invention and do not delimit the scope of the invention. Those of ordinary skill in the art will recognize numerous equivalents to the specific apparatus and methods described herein. Such equivalents are considered to be within the scope of this invention and are covered by the claims.
• In the drawings, not all reference numbers are included in each drawing, for the sake of clarity. In addition, positional terms such as “upper,” “lower,” “side,” “top,” “bottom,” etc. refer to the apparatus when in the orientation shown in the drawing. A person of skill in the art will recognize that the apparatus can assume different orientations when in use.
• The present invention provides a detachable balloon apparatus, methods and system for embolization of an aneurysm. The balloon apparatus can be detachably mounted to the distal end of a catheter, can be inserted through vasculature in a human or animal, can be positioned at a desired location, can be inflated with a fluid (e.g., a liquid or a gas), and can be easily detached from the catheter and remain in place to provide quick and safe embolization following removal of the catheter.
• Referring toFIG. 1 andFIG. 2, an introductory embodiment of a balloon embolization system is generally illustrated. Although the system shown in this embodiment is for treatment of asaccular aneurysm10, thesystem100 may be used to treat any type of spherical saccular aneurysm in both neurovascular and peripheral applications as well to embolize any cylindrical vessel including arteries and veins in both the peripheral and neurovascular territories.System100 includes acatheter14 inserted throughvasculature12 of a patient. Thecatheter14 includes a dual-lumen, or dual-channel configuration. Specifically, in some embodiments,catheter14 includes a 2.7 Fr microcatheter including a guide wire channel and an inflation channel defined on the interior of the catheter body. As is shown inFIG. 3, thecatheter14 is coupled to a Y-connector16 in some embodiments. As shown inFIG. 1, aballoon apparatus20 is positioned on the distal end of thecatheter14. Theballoon apparatus20 may be steered through thevasculature12 to ananeurysm10, inserted into the aneurysm cavity, and inflated via aballoon50, shown inFIG. 2. Theballoon50 fills with a fluid inflation medium and closely fits the interior space of theaneurysm10. Following inflation, theballoon apparatus20 may be quickly detached from thecatheter14, and the catheter may be withdrawn from thevasculature12, leaving theinflated balloon50 in place inside theaneurysm10.
• Referring toFIG. 3, an embodiment of aballoon embolization system100 is shown, including amicrocatheter14, a Y-connector16 positioned at a proximal end of themicrocatheter14, and aballoon apparatus20 positioned at the distal end of the microcatheter. Theballoon apparatus20 is detachable from themicrocatheter14. The Y-connector16 may include afirst channel17 and asecond channel18. In some embodiments, the distal end of themicrocatheter14 includes one or more plugs for providing a detachable connection to theballoon apparatus20. For example, in some embodiments,microcatheter14 includes afirst plug22 and asecond plug24 protruding from the distal end of themicrocatheter14. In other embodiments,microcatheter14 may include only one plug, or more than two plugs. In alternative embodiments, one plug, two plugs or more than two plugs protrude from theballoon apparatus20 and extend toward and into themicrocatheter14 in a reverse configuration.
• Referring further toFIG. 3, the first andsecond plugs22,24 interface with theballoon apparatus20 in a detachable configuration. Referring toFIG. 4, theballoon apparatus20 is mounted on the distal end of thecatheter14 at a detachable joint28. During use, theballoon apparatus20 may be easily separated from thecatheter14 at the detachable joint28 following inflation of theballoon apparatus20 simply by pulling slightly on themicrocatheter14 to release a friction fit.
• Referring toFIG. 5, an embodiment of aballoon embolization system100 is shown in greater detail. In some embodiments,balloon apparatus20 is attached tocatheter14 at a detachable joint28.Balloon apparatus20 includes an outer layer including aninflatable balloon50.Balloon apparatus20 includes an axialguide wire lumen34 defined through anelongated cannula30. Thesystem100 may be passed over aguide wire29 extending throughguide wire lumen34 and insidecatheter14. As shown inFIG. 5, in some embodiments, acatheter marker band26 is disposed on the distal end ofcatheter14. Similarly, afirst marker band60 and asecond marker band70 are disposed onballoon apparatus20. Each marker band includes a device visible under fluoroscopy and may be used to guide and place thecatheter14 andballoon device20. In some embodiments, each marker band comprises a metal material. In further embodiments one or more marker bands comprise polymer or metal-filled polymer material.
• Referring toFIG. 6, an embodiment of aballoon embolization system100 includes acatheter14 with adistal end15. Thedistal end15 of thecatheter14 includes a mechanical interface configured for detachably coupling with theballoon apparatus20. In some embodiments,catheter14 includes first and second axial channels defined through the interior of the catheter. Afirst plug22 is positioned on the first channel incatheter14, and asecond plug24 is positioned on the second channel incatheter14. First andsecond plugs22,24 each protrude from thedistal end15 ofcatheter14 towardballoon apparatus20. First and second plugs each include a central bore configured to allow passage of guide wire, liquid or gas. First plug22 is shorter in axial length thansecond plug24 in some embodiments.
• First plug22 is configured to fit inside an interior lumen incannula30 in an interference fit in some embodiments. As such,first plug22 may be received insideguide wire lumen34 in a friction fit whenballoon apparatus20 is installed on thedistal end15 ofcatheter14. In other embodiments,first plug22 does not engagecannula30 in a friction fit, but merely provides an alignment function that prevents rotation ofcannula30.
• Similarly,second plug24 may be received in a second lumen insidecannula30 in a friction fit.Second plug24 engages an inflation lumen incannula30 to provide passage of an inflation medium such as a liquid or gas intocannula30.Second plug24 thus provides a gas-tight interface betweencatheter14 andballoon device20.
• Referring toFIG. 7, an embodiment of aballoon embolization system100 is shown with aballoon apparatus20 inflated and detached from thedistal end15 ofcatheter14.Balloon apparatus20 includes anelongated cannula30 forming a base, or frame, of theballoon apparatus20. Avalve sleeve40 is positioned oncannula30, andballoon50 is positioned overvalve sleeve40. Whenballoon50 is inflated,balloon50 expands radially beyondvalve sleeve40. In some embodiments,balloon apparatus20 comprises three maincomponents including cannula30,valve sleeve40 andballoon50, shown in more detail inFIGS. 8-10. These components are arranged in a self-sealing configuration such that liquid or gas inflation medium is trapped insideballoon50, but may not leak from the balloon once inflated.
• Referring toFIG. 8, acannula30 comprises anelongated cylinder31 in some embodiments.Cannula30 is dimensioned with an outer diameter substantially the same as the outer diameter ofcatheter14 in some embodiments. In some embodiments,cannula30 includes an outer diameter of about 2.7 Fr. The outer diameter and axial length ofcannula30 may be tailored to fit specific applications. For example, to embolize a larger vessel or aneurysm,cannula30 may have a longer length, but for small aneurysms the axial length ofcannula30 may be shorter. In some embodiments, the balloon embolization system comprises a kit of various balloondevices including cannulas30 having different lengths and/or diameters that may be specifically matched to vessels and aneurysms of different sizes. In some embodiments,cannula30 comprises a metal material. In other embodiments,cannula30 comprises a polymer material.
• Referring further toFIG. 8,cannula30 includes afirst lumen34 defined axially through the cannula body.First lumen34 includes an inner diameter dimensioned to receive a guide wire of the types used for catheter insertion and steering and thus may be referred to as a guide wire lumen. In some embodiments, first lumen inner diameter is between about 0.8 mm and about 1.1 mm, however the inner diameter offirst lumen34 may vary depending on the application.First lumen34 is offset from the center axis ofcannula30 in some embodiments, as shown in the cross-sectional view ofFIG. 8.
• Referring further toFIG. 8,cannula30 includes asecond lumen32 defined axially partially throughcannula30.Second lumen32 includes ablind end39 in some embodiments. In other embodiments,second lumen32 is defined entirely throughcannula30 and is plugged at the distal end instead of being formed with a blind end.Second lumen32 includes an inflation lumen through which a fluid may be passed for inflatingballoon apparatus20.Second lumen32 may include the same inner diameter asfirst lumen34 in some embodiments, or may have a different diameter in other embodiments. Awall38 is defined insidecannula30 between first andsecond lumens34,32.Wall38 includes a wall thickness sufficient to prevent leakage of fluid into the guide wire lumen as the fluid passes into and throughsecond lumen32 in some embodiments. In some embodiments, a fluid may include a gas or a liquid. A gas may include a pressurized gas, and a liquid may include a pressurized liquid.
• As shown inFIG. 8, aninflation port36 is defined incannula30.Inflation port36 is in fluid communication withsecond lumen32 such that fluid traveling intosecond lumen32 may exitcannula30 throughinflation port36.Inflation port36 comprises one or more holes drilled or otherwise formed through the side wall ofcannula30. In some embodiments, a transversecylindrical recess37 is machined or formed incannula30 adjacent toinflation port36. Additionally, the cannula wall surroundinginflation port36 is chamfered in some embodiments. Such configuration provides a vacant space on the exterior surface ofcannula30 to allow accumulation of fluid to form in a local pocket to press against the inner wall ofvalve sleeve40 in some embodiments during inflation.
• Referring toFIG. 9,valve sleeve40 includes a tubular member shaped to fit closely on the outer surface ofcannula30.Valve sleeve40 comprises a resilient, elastomeric material that may stretch and/or compress when subjected to mechanical strain.Valve sleeve40 includes an inner sleeve diameter substantially equal to the outer diameter ofcannula30 in some embodiments.Valve sleeve40 comprises avent46 defined in the tubular wall of the sleeve.Vent46 may take any suitable shape, including but not limited to a slit, a flap, a hole or a plurality of openings.Vent46 allows inflation medium such as liquid or gas to enter and inflate theballoon50.
• Theinflation port36 ofcannula30 is located a first length L1 from the proximal end ofcannula30. Similarly, thevent46 onvalve sleeve40 is located a second length L2 from the proximal end ofvalve sleeve40. In some embodiments, whenvalve sleeve40 is installed oncannula30, vent46 is purposely axially misaligned (or axially offset) withinflation port36 such thatinflation port36 and vent46 are not located the same axial distance from the proximal end ofcannula30. In other words, in some embodiments, L1 is greater than L2. In other embodiments, L1 is less than L2. By positioning thevent46 at a different axial position relative toinflation port36,valve sleeve40 operates as a check valve that fits tight againstcannula30 thereby preventing fluid from inadvertently traveling back intosecond lumen32 viainflation port36. By varying the ratio of L1/L2, the balloon device may be “tuned” to achieve different inflation characteristics, such as required pressure for inflation. When fluid travels out ofinflation port36 toward the inner wall ofvalve sleeve40,valve sleeve40 slightly expands enough to permit the liquid or gas to travel inside a local plenum formed betweenvalve sleeve40 andcannula30 and pass throughvent46 to fill theballoon50. The positive pressure formed inside theballoon50 upon inflation further pressesvalve sleeve40 back againstcannula30, thereby maintaining the self-sealing check valve configuration.
• Referring toFIG. 10, an embodiment of aballoon50 is shown.Balloon50 includes abody52 comprising a resilient, elastomeric material.Balloon50 fits closely over the outer surface ofvalve sleeve40. When pressurized gas or liquid exits vent46,balloon50 becomes inflated.Balloon50 may include any suitable balloon device and material known known in the art for medical applications. The wall thickness ofballoon50 may be varied along its axial profile to provide different inflation shapes, sizes or inflation parameters. For example, in some embodiments,balloon50 includes a uniform wall thickness along its axial length. In other embodiments,balloon50 includes a higher or lower wall thickness in the middle axial position of theballoon50 between the opposite ends.
• Referring toFIG. 11A, an exploded view of an embodiment of aballoon apparatus20 is shown.Balloon apparatus20 includes acannula30, avalve sleeve40 and aballoon50. These three components are assembled by axially sliding thevalve sleeve40 over thecannula30, and sliding theballoon50 over thevalve sleeve40. The device may be assembled in any order. First andsecond marker bands60,70 are positioned external to the three main components at the proximal and distal ends ofcannula30 in some embodiments.Marker bands60,70 may be crimped, welded, fused or otherwise attached to the assembly to form a gas-tight seal at each end ofballoon apparatus20. As such, when fluid is introduced to theballoon apparatus20 to fillballoon50, the first andsecond marker bands60,70 hold tight against the components and prevent fluid from escaping at the proximal and distal ends of the device. This causesballoon50 to inflate in a toroidal shape aroundcannula30 in some embodiments, as shown inFIGS. 12 and 13.
• Valve sleeve40 andballoon50 may be sealed against each other and againstcannula30 at proximal and distal ends of the device using other suitable fastening means in various embodiments, including but not limited to mechanical sealing, adhesives, radio-frequency (RF) welding, crimping, or using an alternative fastener such as a wire or tape. Additionally, in some embodiments,valve sleeve40 andballoon50 may be integrally formed as a single elastomeric two-layer piece withvent46 defined therein. Referring toFIG. 11B, an embodiment of an assembledballoon apparatus20 is shown including first andsecond marker bands60,70 positioned at opposite ends of the device.
• Referring toFIG. 12, a partial cross-sectional view of an embodiment of aballoon apparatus20 and acatheter14 is shown.Catheter14 includes adistal end15 configured for a releasable attachment toballoon apparatus20. In some embodiments, afirst plug22 is installed in afirst channel18aincatheter14. First plug22 includes a hollow bore and aproximal end23 inserted intofirst channel18ain a press fit. Alternatively,first plug22 may be secured infirst channel18ausing a threaded engagement, a fastener or an adhesive. In further embodiments,first plug22 may be integrally formed or molded oncatheter14 as a unitary, one-piece construction. In some embodiments, asecond plug24 is installed in asecond channel17aincatheter14.Second plug24 includes a hollow bore and aproximal end25 inserted intosecond channel17ain a press fit. Alternatively,second plug24 may be secured insecond channel17ausing a threaded engagement, a fastener or an adhesive. In further embodiments,second plug24 may be integrally formed or molded oncatheter14 as a unitary, one-piece construction.
• First plug22 is received inguide wire lumen34 oncannula30. First plug22 includes a tapered distal end shaped to be inserted intoguide wire lumen34. In some embodiments,first plug22 entersguide wire lumen34, but does not form an interference fit. In other embodiments,first plug22 forms an interference fit betweencatheter14 andcannula30. First plug22 is identical tosecond plug24 in some embodiments.
• Second plug24 is received ininflation lumen32 oncannula30.Second plug24 includes a tapered distal end shaped to be inserted intoinflation lumen32 in a press fit. The tapered profile ofsecond plug24 includes an angle of about thirty degrees in some embodiments.
• First andsecond plugs22,24 may be secured in place using the radially compressive force applied bymarker band26 in some embodiments.
• In some embodiments,balloon50 when inflated extends axially on its distal and proximal ends beyondcannula30 such that the ends ofcannula30 are not exposed and do not press against tissue inside the aneurysm when theballoon50 is inflated.
• Referring toFIG. 13, in some embodiments,inflation port36 and vent46 are angularly offset with respect to each other. The angular offset provides additional self-sealing functionality, as the angular offset prevents backflow of fluid from theballoon50 back into theinflation cannula30. In some embodiments, the angular offset betweeninflation port36 and vent46 is about 180 degrees. In further embodiments, the angular offset is between zero degrees and 180 degrees. In further embodiments,inflation port36 and vent46 are both angularly offset and axially offset to provide enhanced self-sealing functionality. The degree of angular offset and the amount of axial offset betweenvent46 andinflation port36 are parameters that can be varied from device to device to fine tune inflation parameters such as fill rate and fill pressure.
• FIG. 14A depicts one embodiment of a three-way connector80. The three-way connector80 may be used in place of the Y-connector16 depicted inFIGS. 1-4. The three-way connector80 may include thefirst channel17 and thesecond channel18, similar to the first andsecond channels17,18 of the Y-connector16. The three-way connector80 may include athird channel81. In some embodiments, the three-way connector80 may include anend cap82a. Theend cap82amay be removably disposable on the end of achannel17,18,81. Theend cap82amay prevent an object from inadvertently entering achannel17,18,81. In some embodiments, the three-way connector80 may include awire cap82b. Thewire cap82bmay be selectively disposed on achannel17,18,81. Thewire cap82bmay include a wire (such as theguide wire29 or the nitinol wire (described below)) that may be inserted into thechannel17,18,81.
• In one embodiment, a tri-hub83 may be disposed on an end of the three-way connector80, as is illustrated inFIG. 14A. The tri-hub83 may include a channel through which thecatheter14 or thecannula30 may traverse. The tri-hub83 may include one ormore wings84 that may extend from the main body of the tri-hub83. Awing84 may allow a user to grip the tri-hub83 (or the tri-hub83-three-way connector80 assembly) to move or position the tri-hub83 (or the tri-hub83-three-way connector80 assembly).
• FIG. 14B depicts a cutaway view of an assembly of a three-way connector80 and a tri-hub83. As can be seen inFIG. 14B, the first, second, andthird channels17,18,81 may include hollow channels by which objects, fluids, or other items may traverse through the three-way connector80. The first, second, andthird channels17,18,81 may joint into amain channel85. In one embodiment, thecatheter14 may extend through themain channel85 and out the end of the tri-hub83 that is disposed distal from the three-way connector80.
• FIG. 15 depicts another embodiment of thecannula30. In this embodiment, thecannula30 may include thefirst lumen34 and thesecond lumen32. Thefirst lumen34 may include the guide wire lumen, and thesecond lumen32 may include the inflation lumen. Thecannula30 may include athird lumen90. Thethird lumen90 may include a deflation lumen. In some embodiments, thecatheter14 may include the first, second, andthird lumens34,32,90.
• FIG. 16A depicts one embodiment of thecannula30. Thecannula30 may include thefirst lumen34. Thecannula30 may include theinflation port36. Theinflation port36 may be located the first length L1 from the proximal end ofcannula30. Thecannula30 may include adeflation port92. Thedeflation port92 may be located a third length L3 from the proximal end of thecannula30.
• In some embodiments, as depicted inFIG. 16A, thedeflation port92 may include a pill shape. However, in other embodiments, thedeflation port92 may include other shapes such as an oval, circle, slit, rectangle, or other shape. In one or more embodiments, the third length L3 may be shorter than the first length L1 (as is shown inFIG. 16A). In certain embodiments, the third length L3 may be longer than the first length L1, shorter than the second length L2, or longer than the second length L2.
• FIG. 16B depicts one embodiment of thecannula30. Thecannula30 may include the first, second, andthird lumens34,32 (not shown), and90. Thecannula30 may include thewall38 defined inside thecannula30. Thecannula30 may include thedeflation port92 defined in thecannula30.Deflation port92 may be in fluid communication with thedeflation lumen90.Deflation port92 may include one or more holes drilled or otherwise formed through the side wall ofcannula30. In some embodiments, thedeflation port92 may be purposely axially misaligned (or axially offset) withinflation port36 orvent46.
• Thedeflation lumen90 may include adeflation mechanism94 disposed within thedeflation lumen90. Thedeflation mechanism94 may include a wire. The wire may include a heat-seat nickel titanium (nitinol) wire. The wire may include shape memory properties. The wire may include a preformedbend96. The preformedbend96 may run an entire length of the wire or only a portion of the wire. The preformedbend96 may align with thedeflation port92. In response to a transformation event, the preformedbend96 may bend further and cause at least a portion of thedeflation mechanism94 to extend through thedeflation port92 and engage or push against thevalve sleeve40. Thevalve sleeve40 may slightly expand enough to permit the fluid to travel from theinflation port36 and pass throughvent46 to fill theballoon50 or to permit fluid to travel from theballoon50 throughvent46. The fluid may then travel through thedeflation port92 to deflate theballoon50. In some embodiments the fluid may travel through theinflation port36 to deflate theballoon50.
• In some embodiments, the transformation event may include heating or cooling the wire to a predetermined temperature, manipulating the wire (e.g., twisting the wire, pushing the wire, or some other manipulation), or some other transformation event that may cause the preformedbend96 to extend through thedeflation port92. In response to the transformation event ceasing, the preformedbend96 may return to its shape at rest and no longer extend through thedeflation port92. This may cause thevalve sleeve40 to fit tightly to thecannula30 and seal theballoon50. Thevalve sleeve40 being activated, and thus opened, by thedeflation mechanism94 may enable thevalve sleeve40 to act as a failsafe such that once theballoon50 has been inflated and theballoon apparatus20 detached from thecatheter14, theballoon50 may retain its shape without leakage. In some embodiments, thedeflation lumen90 may include ablind end98. In some embodiments, thevalve sleeve40 may include a silicone embedded seal valve that may be disposed over theinflation port36 and act as a passive one-way valve.
• In one or more embodiments, thecatheter14 may include a 5 Fr catheter. The guide wire of theguide wire lumen34 may include a 0.035 inch guidewire. In one embodiment, theballoon50 may include a material coating or a micro-surfacing that may enhance endothelial wall inflammation.
• FIG. 17A depicts one embodiment of aballoon apparatus20. Theballoon apparatus20 may be similar to theballoon apparatuses20 ofFIGS. 1-13. As such, theballoon apparatus20 may include thefirst marker band60, thesecond marker band70, thecannula30, thesecond lumen32, thefirst lumen34, thevalve sleeve40, the vent46 (not depicted), or theinflation port36. In some embodiments, theballoon apparatus20 may include thethird lumen90, thedeflation port92, or other components discussed above in relation toFIGS. 15 and 16A-B.
• FIG. 17B depicts an exploded view of theballoon apparatus20 ofFIG. 17A.FIG. 17C depicts a cutaway perspective view of theballoon apparatus20 ofFIG. 17A. As can be seen fromFIG. 17C, thedeflation port92 may run along a portion of thethird lumen90.FIG. 18 depicts one embodiment of theballoon apparatus20 ofFIG. 17A with theballoon50 inflated. In some embodiments, theballoon apparatus20 may operate similarly to theballoon apparatus20 described above in relation toFIGS. 1-13. However, as discussed above in relation toFIGS. 15 and 16A-B, in response to a transformation event, the deflation mechanism94 (such as the nitinol wire) may further bend and push against thevalve sleeve40. This may allow a fluid disposed in theballoon50 to flow through thethird lumen90 or thesecond lumen32 and deflate theballoon50.
• FIG. 19A andFIG. 19B depict one embodiment of amethod100. Themethod100 may include a method of embolization. Themethod100 may include embolization of an aneurysm or a vessel, including but not limited to arterial, venous, lymphatic, or vascular malformation embolization. Themethod100 may include providing acatheter14, including adetachable balloon device20 disposed on adistal end15 of the catheter14 (step102). Themethod100 may include inserting thedetachable balloon device20 and thecatheter14 intovasculature12 of a patient and locating thedetachable balloon device20 in or near a target location (step104). Themethod100 may include introducing a fluid through thecatheter14 into thedetachable balloon device20, thereby inflating thedetachable balloon device20 and the target location (step106). Themethod100 may include sealing thedetachable balloon device20 during inflation such that the fluid becomes trapped inside the inflated detachable balloon device20 (step108). Themethod100 may include detaching thecatheter14 from the inflated detachable balloon device20 (step110). Themethod100 may include withdrawing thecatheter14 from thevasculature12 while leaving the detached and inflateddetachable balloon device20 at or near the target location inside the vasculature12 (step112). In some embodiments, one or more steps102-112 of themethod100 may be performed by one or more elements of the systems and apparatuses described above and may perform as described above.
• In one embodiment, thedetachable balloon device20 may include thecannula30. Thecannula30 may include a firstaxial lumen34 and a secondaxial lumen32. Thedetachable balloon device20 may include theballoon50, which may include a tubular balloon disposed on thecannula30. Thedetachable balloon device20 may include thevalve sleeve40. Thevalve sleeve40 may be disposed between thetubular balloon50 and thecannula30. Thevalve sleeve40 may include avent46. In some embodiments, thedetachable balloon device20 may be detachably secured to thecatheter14 in a friction fit.
• In certain embodiments, introducing the fluid through thecatheter14 into the detachable balloon device20 (step106) may include thevalve sleeve40 expanding to permit the fluid to travel inside a local plenum formed between thevalve sleeve40 and thecannula30. Step106 may include the fluid passing through thevent46 into thetubular balloon50.
• In one embodiment, sealing thedetachable balloon device20 during inflation (step108) may include forming a positive pressure inside thetubular balloon50. The positive pressure may further press thevalve sleeve40 against thecannula30. In some embodiments, the fluid inside thetubular balloon50 may create the positive pressure. In one or more embodiments, introducing the fluid through the catheter14 (step106) may include introducing a pressurized liquid or a gas through thecatheter14.
• In one embodiment, themethod100 may further include the step of manipulating a nickel titanium wire. The nickel titanium wire may be disposed in thecatheter14 and in alumen90 of thecannula30. Manipulating the wire may partially deflate the inflated detachable balloon device20 (e.g., by allowing the fluid to exit theballoon50 through the vent46).
• In some embodiments, the systems and methods disclosed herein provide a fullycompliant balloon50 capable of conforming to the morphology of a vascular structure into which theballoon50 is inflated. The balloon50 (along with theballoon apparatus20 theballoon50 is included with) has the ability to then safely detach from thecatheter14 delivery system. Theballoon50 may take the shape of the vessel oraneurysm10 to induce immediate, mechanical occlusion. Theballoon50 and other detachable portions of theballoon apparatus20 can detach while theballoon50 keeps its shape and radial strength due to the self-sealing nature of thedevice20. The systems and methods may provide for inflation, deflation, and reinflation of theballoon50 to be able to accurately position and reposition theballoon50 within theaneurysm10 or vessel.
• Thus, although there have been described particular embodiments of the present invention of new and useful balloon embolization devices, systems and methods, it is not intended that such references be construed as limitations upon the scope of this invention except as set forth in the Claims.

Claims (20)

What is claimed is:

1. A balloon embolization apparatus, comprising:

a cannula comprising

a guide wire lumen, and

an inflation lumen;

an inflation port defined in the cannula, wherein the inflation port is in fluid communication with the inflation lumen;

a balloon disposed on the cannula; and

a valve sleeve disposed between the balloon and the cannula, the valve sleeve defining a vent in fluid communication with the balloon,

wherein the vent is angularly and axially offset relative to the inflation port.

2. The apparatus ofclaim 1, further comprising:

a first marker band disposed around the balloon, the valve sleeve, and the cannula at a first end of the cannula; and

a second marker band disposed around the balloon, the valve sleeve, and the cannula at a second end of the cannula opposite the first end.

3. The apparatus ofclaim 2, wherein the first marker band and the second marker band each form a gas-tight seal between the balloon, the valve sleeve, and the cannula.

4. The apparatus ofclaim 2, wherein the first marker band and the second marker band each further include a device visible under fluoroscopy.

5. The apparatus ofclaim 1, wherein the balloon comprises an endothelial wall inflammation-enhancing material coating.

6. The apparatus ofclaim 1, wherein:

the cannula further includes a deflation lumen; and

the apparatus further includes a deflation port defined in the cannula, wherein the deflation port is in fluid communication with the deflation lumen.

7. A balloon embolization system, comprising:

a catheter including a distal end having a plug protruding from the catheter;

an inflatable balloon device detachably mounted to the catheter, wherein the inflatable balloon device includes a cannula having an axial lumen, wherein the plug is received in the axial lumen;

an inflation port defined in the cannula and in fluid communication with the axial lumen;

a balloon disposed on the cannula; and

a valve sleeve disposed between the balloon and the cannula, the valve sleeve defining a vent in fluid communication with the balloon,

wherein the vent is angularly and axially offset relative to the inflation port, and

wherein the inflatable balloon device is detachable from the catheter.

8. The apparatus ofclaim 7, wherein the cannula further comprises an inflation channel in fluid communication with the axial lumen via the plug.

9. The apparatus ofclaim 8, wherein the inflation channel is configured to receive at least one of a pressurized liquid or a pressurized gas for inflation of the balloon.

10. The apparatus ofclaim 9, further comprising:

a catheter marker band disposed on the catheter; and

a first balloon marker band and a second balloon marker band, wherein the first and second balloon marker bands are disposed on the inflatable balloon device.

11. The apparatus ofclaim 7:

wherein the cannula further includes a deflation lumen; and

further comprising

a deflation port defined in the cannula and in fluid communication with the deflation lumen, and

a wire disposed in the deflation lumen, wherein the wire includes a preformed bend disposed proximate the deflation port.

12. The apparatus ofclaim 11, wherein the preformed bend of the wire is configured to engage the valve sleeve in response to a transformation event.

13. The apparatus ofclaim 12, wherein:

the wire comprises a nickel titanium wire; and

the transformation event comprises heating the wire to a predetermined temperature.

14. A method of embolization, comprising:

(a) providing a catheter including a detachable balloon device disposed on a distal end of the catheter;

(b) inserting the detachable balloon device and the catheter into vasculature of a patient and locating the detachable balloon device in or near a target location;

(c) introducing a fluid through the catheter into the detachable balloon device, thereby inflating the detachable balloon device at the target location;

(d) sealing the detachable balloon device during inflation such that the fluid becomes trapped inside the inflated detachable balloon device;

(e) detaching the catheter from the inflated detachable balloon device; and

(f) withdrawing the catheter from the vasculature while leaving the detached and inflated detachable balloon device at or near the target location inside the vasculature.

15. The method ofclaim 14, wherein the detachable balloon device comprises:

a cannula with a first axial lumen and a second axial lumen;

a tubular balloon disposed on the cannula; and

a valve sleeve disposed between the tubular balloon and the cannula, wherein the valve sleeve includes a vent.

16. The method ofclaim 15, wherein the detachable balloon device is detachably secured to the catheter in a friction fit.

17. The method ofclaim 15, wherein introducing the fluid through the catheter into the detachable balloon device comprises:

the valve sleeve expanding to permit the fluid to travel inside a local plenum formed between the valve sleeve and the cannula; and

the fluid passing through the vent into the tubular balloon.

18. The method ofclaim 17, wherein sealing the detachable balloon device during inflation comprises forming a positive pressure inside the tubular balloon that further presses the valve sleeve against the cannula.

19. The method ofclaim 14, wherein introducing the fluid through the catheter comprises introducing at least one of:

a pressurized liquid; or

a gas.

20. The method ofclaim 14, further comprising manipulating a nickel titanium wire disposed in the catheter, thereby partially deflating the inflated detachable balloon device.

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