Abstract: Medical devices are described herein. More particularly, the disclosure relates to catheters useful in the treatment of bodily passages, such as an airway, sinus cavity, or sinus passage. The disclosure also relates to methods of treating bodily passages. An exemplary catheter comprises an elongate member having a first balloon and a second balloon.

Abstract: A method of manufacturing a catheter can include assembling an inner balloon within a separate outer balloon. The inner and outer balloons can each be open on opposing longitudinal ends and have a central radially expandable portion, and proximal and distal reduced diameter portions on opposite longitudinal end portions of the balloon. The method can further include bonding a portion of an inner surface of the outer balloon proximal reduced diameter portion to a portion of an outer surface of the inner balloon proximal reduced diameter portion and bonding a distal end portion of an elongate catheter shaft to a proximal portion of the bonded inner and outer balloons.

Abstract: Balloon catheters, and methods of treatment therewith, are provided including an inflatable first balloon at least partially enclosed by an expandable second balloon that has holes. The annular space between the first balloon and the second balloon is configured to promote delivery of the fluid evenly through holes in the second balloon to avoid problems of underloading and/or overloading. Preferably, the annular space is in communication with the holes, and the annular space is configured to receive and then to release and distribute the fluid via the holes in a substantially uniform manner such that even amounts of fluid are released in the distal and proximal holes. The first balloon may have various configurations including being tapered relative to the second balloon. The second balloon may also be tapered accordingly. The device may also include raised portions disposed in the annular space and configured to define channels having various configurations.

Abstract: The invention relates generally to devices and methods for local delivery of therapeutic agents to the wall of a bodily lumen with minimal shearing damage to the therapeutic agents, more specifically to the wall of a blood vessel following atherectomy. A preferred delivery mechanism comprises a balloon, or double balloon, though any distal catheter design may be used to reduce shear stress and to conserve and/or isolate the therapeutic substance.

Abstract: A balloon catheter comprises a shaft having a proximal end and a distal end. An inflatable member is disposed adjacent the distal end of the shaft. The inflatable member has an inner inflatable member and an outer inflatable member disposed around the inner inflatable member. The inflatable members have different compliant properties.

Abstract: A balloon catheter includes a balloon support member having a hollow axial lumen and open distal end for allowing passage of a guidewire therethrough, a balloon disposed around the balloon support member, and an annular balloon seal disposed proximate to a distal end of the balloon catheter. The seal defines a central passageway for allowing passage therethrough of a guidewire extending out the distal end of the balloon support member, and is configured to form a substantially fluid tight seal around each of a plurality of guidewires having different outer diameters.

Abstract: A balloon catheter for delivering a therapeutic and/or diagnostic agent to tissue is described including an outer balloon having a wall with an opening therethrough and an inner surface, an inner balloon disposed in the outer balloon, enclosing an inflation chamber and having an outer surface defining a space between the outer surface of the inner balloon and the inner surface of the outer balloon, a catheter having a first lumen in fluid communication with the space between the inner balloon and the outer balloon for supplying the agent thereto, and a second lumen through which fluid is supplied to the inflation chamber for inflating the inner balloon to urge the agent out of the opening in the outer balloon, wherein the outer balloon and/or the inner balloon comprise at least one protrusion for directing the agent formed by an inner balloon wall and/or the outer balloon wall.

Abstract: A balloon catheter system is provided. The catheter includes a first balloon disposed around a second balloon which is movable within the first balloon.

Abstract: A balloon catheter or stent delivery system for medical treatment of a patient has a proximal hub, a balloon, and an improved shaft design. The catheter shaft has a rapid-exchange configuration, and a tubular outer body that includes a hypotube extending from the catheter proximal end to a position at or near a proximal leg of the balloon. An inner tubular body defines a guidewire lumen extending from a distal guidewire port at the catheter distal end to a proximal port located at a position between the balloon and the hub. A distal leg of the balloon is directly or indirectly affixed to the inner body, and a proximal leg of the balloon is affixed to the distal end of the outer body. The hypotube has an aperture for accepting the inner body proximal end, and a circumferential cut pattern. The cut pattern adds flexibility, and may extend from the hypotube distal end to a position proximal of the proximal guidewire port.

Abstract: A method for injecting a therapeutic agent into a target tissue, the method comprising: (a) providing an expandable member; (b) positioning said expandable member in proximity to the target tissue; (c) Introducing the therapeutic agent into the expandable member until a desired pressure is achieved; and (d) creating a plurality of small apertures in the expandable member.

Abstract: A balloon catheter, including an outer shaft with a distal end and a fluid line, an inner part located distal anterior to its distal end, as well as a balloon that can be inflated under the influence of a fluid that has been pressurized by the fluid line, that is fastened fluid-tight onto the distal end section of the outer shaft with a first fastening zone at its proximal end, and fluid-tight onto inner part with a second fastening zone at its distal end, whereby the balloon, on at least one of its two ends is designed without cone and with essentially unvarying thin wall thickness, the balloon is provided on at least one of its two ends with respectively one twist anterior to its fastening zone, and a second balloon is placed above the first balloon and is also provided with a twist on at least one of its two ends anterior to the fastening zone, that is directed in the opposite direction of the twist of the first balloon end that is positioned underneath.

Abstract: A catheter includes a first expandable membrane having a first pressurization limit and a second expandable membrane, having a second pressurization limit, wherein the second pressurization limit is greater than the first pressurization limit, the first expandable membrane defines a cooling chamber, the second expandable membrane being disposed around the first expandable membrane to define an junction therebetween. The catheter includes a coolant injection lumen in fluid communication with the at least one fluid inlet port and the cooling chamber, and a primary coolant return lumen in fluid communication with the at least one fluid outlet port and the cooling chamber. The coolant injection tube, the cooling chamber, and the primary coolant return lumen define a first fluid pathway. The catheter further includes a secondary coolant return lumen in fluid communication with the at least one fluid outlet port and the junction. The junction and the secondary coolant return lumen define a second fluid pathway.

Abstract: A fluid delivery system including a first balloon and a second balloon at least partially positioned within the first balloon, wherein the second balloon has an inner surface, an outer surface, and at least one micro-needle extending outwardly from the outer surface of the second balloon. The delivery system can further include a fluid source in communication with at least one of the micro-needles of the second balloon.

Abstract: The present invention relates generally to dilatation balloon catheters and systems used for expansion against an obstruction within a body vessel or channel, or to deliver devices such as, but not limited to, stents and therapeutic agents to sites within vascular or tubular channel systems of the body.

Abstract: Catheter balloon assemblies (10) for delivering a therapeutic agent to a body vessel are provided, as well as related methods of manufacturing and methods of treatment. The catheter balloon assemblies may include a concentrically disposed dual balloon assembly at the distal portion of the catheter having an inner balloon (44), a porous outer balloon (42) concentrically arrayed around the inner balloon and a catheter shaft (30) adapted to deliver a therapeutic agent to the body vessel through the apertures in the outer balloon. Radial outward expansion of the inner balloon may urge the outer balloon into contact with the wall of a body vessel, where the therapeutic agent may be delivered from the catheter shaft through apertures in the outer balloon directly to the wall of the body vessel.

Abstract: A self sealing inflatable article including an inflatable body portion and a neck portion having an opening, a ring member supporting the opening of the article and a plug member for sealing the opening wherein at least a portion of the body portion of the article is invaginated through the opening of the article with the plug member associated with the invaginated portion.

Abstract: A balloon catheter for delivering a therapeutic and/or diagnostic agent to tissue is described including an outer balloon having a wall with an opening therethrough and an inner surface, an inner balloon disposed in the outer balloon, enclosing an inflation chamber and having an outer surface defining a space between the outer surface of the inner balloon and the inner surface of the outer balloon, a catheter having a first lumen in fluid communication with the space between the inner balloon and the outer balloon for supplying the agent thereto, and a second lumen through which fluid is supplied to the inflation chamber for inflating the inner balloon to urge the agent out of the opening in the outer balloon, wherein the outer balloon and/or the inner balloon comprise at least one protrusion for directing the agent.

Abstract: A combination dilatation and drug delivery device includes a flexible catheter, a drug delivery sheath mounted to a distal end region of the catheter and a dilatation balloon also mounted to the catheter and contained within a compartment formed by the sheath. The sheath is radially expandable by supplying a liquid therapeutic agent to the compartment under a moderate pressure. The dilatation balloon is expandable by providing a dilatation fluid to the balloon under a much higher pressure. The sheath can be formed of a highly elastic material or can be made quite thin, and in either case is mounted independently of the dilatation balloon. Thus when radially expanded, the sheath is moved into a conforming contact with surrounding vascular tissue. The conforming contact protects tissue and the therapeutic agent from exposure to blood, and more effectively confines the therapeutic agent to the intended treatment area.

Abstract: A multi-layer inflatable balloon cuff may be adapted to seal a patient's trachea when associated with an endotracheal tube. The outer layer and the inner layer of the balloon cuff may have different material properties that may enhance a cuff's mechanical pressure seal by reducing wrinkles or folds that may form against a patient's tracheal walls.

Abstract: The disclosure is directed to catheter devices and methods for controlled application of irradiation to tissue adjacent a body site, such as cavity after removal of tissue, e.g. cancer. The catheter device includes an inflatable balloon having at least two layers. The inflatable balloon has an expansion of more than 25% and less than 200% when inflated from the un-inflated condition to a turgid condition, preferably more than 50% and less than 150%. In the turgid condition the polymeric material(s) of the balloon layers are at or near the elastic limit of the balloon layer material. The balloon may contain or be formed of or be coated with radiopaque material to facilitate positional or symmetry verification.

Abstract: The disclosure is directed to catheter devices and methods for controlled application of irradiation to tissue adjacent a body site, such as cavity after removal of tissue, e.g. cancer. The catheter device includes an inflatable balloon having at least two layers. The inflatable balloon has an expansion of more than 25% and less than 200% when inflated from the un-inflated condition to a turgid condition, preferably more than 50% and less than 150%. In the turgid condition the polymeric material(s) of the balloon layers are at or near the elastic limit of the balloon layer material. The balloon may contain or be formed of or be coated with radiopaque material to facilitate positional or symmetry verification.

Abstract: The present invention generally relates to an intraluminal catheter device for use in angioplasty and delivery of a therapeutic agent. Particularly, the present invention is directed to a catheter having an expandable member having a therapeutic agent disposed thereon and a fibrous matrix covering for delivering a therapeutic agent and methods of using the same.

Abstract: An expandable medical balloon useful for treatment at a vessel bifurcation, the balloon having at least one expanded state, the balloon having at least one inner layer and at least one outer layer, the outer layer having at least one cavity therein through which the inner layer protrudes when the balloon is in its at least one expanded state, and methods of making and using the same.

Abstract: The present invention relates to a catheter assembly that can deliver a therapeutic composition. The catheter assembly can include an outer balloon with openings for releasing the therapeutic composition. When the catheter assembly is in its contracted state, the openings are closed, and the assembly retains the therapeutic composition. When the catheter assembly is in its dilated state, the openings are open, and the therapeutic composition is released. The present invention also includes methods of making and using such a catheter assembly.

Abstract: A medical catheter assembly including either a reinforced balloon bolster or the combination of a balloon bolster and a wire-basket bolster. According to one embodiment, the medical catheter assembly is a low-profile replacement PEG device comprising a feeding tube, an external bolster, an end cap and an internal bolster. The internal bolster comprises a first expandable structure and a second expandable structure. In one embodiment, the first expandable structure is a balloon and the second expandable structure comprises reinforcing members. In another embodiment, the first expandable structure is a balloon and the second expandable structure is a wire basket bolster. The feeding tube has a feeding lumen and an inflation lumen, extending parallel longitudinally. The external bolster is fixed to the external end of the feeding tube and has a feeding lumen aligned with that of the tube and an inflation lumen aligned with that of the tube.

Abstract: The present invention relates to a pharmaceutical composition for intravascular delivery of a therapeutic agent, such as paclitaxel, rapamycin, or an analog thereof. The composition includes the therapeutic agent and a biocompatible solvent, such as glycofurol. The composition can aid tissue penetration by the therapeutic agent. A catheter assembly that protects the pharmaceutical composition from the surroundings can be used for its intravascular delivery.

Abstract: There is disclosed a drug eluting balloon catheter assembly provided with a balloon formed of an inner balloon member of non-compliant material and an outer balloon member of a compliant material and which is provided with holes therein for eluting a drug or other fluid. In use, the outer balloon member is biased by contraction onto the inner balloon member thereby keeping the holes therein normally sealed closed and minimizing dead space in the device.

Abstract: Methods and devices for bonding a balloon assembly, such as a balloon assembly including an inner balloon and an outer balloon, to a catheter shaft are disclosed. In some cases, a proximal waist of the inner balloon may be bonded to an interior surface of an outer tubular member of the catheter shaft and a proximal waist of the outer balloon may be bonded to an exterior surface of the outer tubular member. In other cases, the proximal waist of the inner balloon may be bonded to a reduced diameter portion of the outer tubular member of the catheter shaft and the proximal waist of the outer balloon may be bonded to the outer tubular member, such as a non-reduced outer diameter portion of the outer tubular member.

Abstract: Catheter balloons (10) for delivering a bioactive (260) to a body vessel in a greater amount and/or more quickly are provided, as well as related methods of treatment. The catheter balloon may include a dual balloon assembly at the distal portion (300) of the catheter having an inner balloon (44), an outer balloon (42) with apertures (43) concentrically arrayed around the inner balloon, and a catheter shaft (30) adapted to deliver a carrier (270) through the apertures of the outer balloon. The bioactive is disposed on a portion of at least one of the inner and outer balloon surfaces. Radial outward expansion of the inner balloon urges the outer balloon into contact with the wall of the body vessel. The carrier is introducible within the catheter shaft to pass through the annular lumen (242) between the balloons and through the apertures of the outer balloon. The carrier interacts with the bioactive in order to release a therapeutically effective amount of drug to the wall of the body vessel.

Abstract: Catheter balloon assemblies (10) for delivering a therapeutic agent to a body vessel are provided, as well as related methods of manufacturing and methods of treatment. The catheter balloon assemblies may include a concentrically disposed dual balloon assembly at the distal portion of the catheter having an inner balloon (44), a porous outer balloon (42) concentrically arrayed around the inner balloon and a catheter shaft (30) adapted to deliver a therapeutic agent to the body vessel through the apertures in the outer balloon. Radial outward expansion of the inner balloon may urge the outer balloon into contact with the wall of a body vessel, where the therapeutic agent may be delivered from the catheter shaft through apertures in the outer balloon directly to the wall of the body vessel.

Abstract: A balloon catheter may comprise a primary inflation balloon and a secondary inflation balloon located to one side of the primary inflation balloon. The secondary balloon comprises a first portion and a second portion, the first portion located closer to the primary balloon. The second portion has a greater size than the first portion, and a portion of the second portion extends outwardly beyond the first portion and overhangs the first portion. In some embodiments, a cross-sectional shape of the secondary balloon in an inflated state comprises a mushroom shape.

Abstract: Medical devices for delivering a bioactive agent and methods of use thereof are provided. The device includes a balloon having micro-needles for delivery of the bioactive agent.

Abstract: The invention relates generally to devices and methods for local delivery of therapeutic agents to the wall of a bodily lumen with minimal shearing damage to the therapeutic agents, more specifically to the wall of a blood vessel following atherectomy. A preferred delivery mechanism comprises a balloon, or double balloon, though any distal catheter design may be used to reduce shear stress and to conserve and/or isolate the therapeutic substance.

Abstract: Balloon catheters, and methods of treatment therewith, are provided including an inflatable first balloon at least partially enclosed by an expandable second balloon that has holes. The annular space between the first balloon and the second balloon is configured to promote delivery of the fluid evenly through holes in the second balloon to avoid problems of underloading and/or overloading. Preferably, the annular space is in communication with the holes, and the annular space is configured to receive and then to release and distribute the fluid via the holes in a substantially uniform manner such that even amounts of fluid are released in the distal and proximal holes. The first balloon may have various configurations including being tapered relative to the second balloon. The second balloon may also be tapered accordingly. The device may also include raised portions disposed in the annular space and configured to define channels having various configurations.

Abstract: Balloon catheters, and methods of treatment therewith, are provided including an inflatable first balloon at least partially enclosed by an expandable second balloon that has holes. The annular space between the first balloon and the second balloon is configured to promote delivery of the fluid evenly through holes in the second balloon to avoid problems of underloading and/or overloading. Preferably, the annular space is in communication with the holes, and the annular space is configured to receive and then to release and distribute the fluid via the holes in a substantially uniform manner such that even amounts of fluid are released in the distal and proximal holes. The first balloon may have various configurations including being tapered relative to the second balloon. The second balloon may also be tapered accordingly. The device may also include raised portions disposed in the annular space and configured to define channels having various configurations.

Abstract: Multiple-balloon catheters, and methods of treatment therewith, are provided including an inflatable inner balloon at least partially enclosed by an expandable outer balloon that has holes. The annular space between the inner balloon and the outer balloon is configured to promote delivery of the fluid evenly through holes in the outer balloon to avoid problems of underloading and/or overloading. Preferably, the annular space is in communication with the holes, and the annular space is configured to receive and then to release and distribute the fluid via the holes in a substantially uniform manner such that even amounts of fluid are released in the distal and proximal holes. The inner balloon may have various configurations including being tapered relative to the outer balloon. The outer balloon may also be tapered accordingly. The device may also include raised portions disposed in the annular space and configured to define channels having various configurations.

Abstract: Multi-balloon catheter structures that are able to move with respect to one another may provide superior compliance in tortuous passages to, for example, perform angioplasty and/or expand stents. Two or more balloons may be inflated to equal pressures. A length of the balloons may be sufficiently longer than a length of a stent to accommodate axial movement of the balloons. One or more balloons may be lubricous or carry a lubricant.

Abstract: An endoscope device comprises: an endoscope including an insertion portion and a first balloon attached to a distal end of the insertion portion; and an insertion guide that is to be covered on the insertion portion to guide insertion of the insertion portion, the insertion guide comprising a second balloon on its distal end, wherein the insertion portion or the insertion guide is fixed in a body cavity by expanding the first balloon or the second balloon, respectively, wherein the first balloon and the second balloon are substantially equal to each other in friction resistance against the body cavity when they are expanded.

Abstract: A balloon catheter, including an outer shaft with a distal end and a fluid line, an inner part located distal anterior to its distal end, as well as a balloon that can be inflated under the influence of a fluid that has been pressurized by the fluid line, that is fastened fluid-tight onto the distal end section of the outer shaft with a first fastening zone at its proximal end, and fluid-tight onto inner part with a second fastening zone at its distal end, whereby the balloon, on at least one of its two ends is designed without cone and with essentially unvarying thin wall thickness, the balloon is provided on at least one of its two ends with respectively one twist anterior to its fastening zone, and a second balloon is placed above the first balloon and is also provided with a twist on at least one of its two ends anterior to the fastening zone, that is directed in the opposite direction of the twist of the first balloon end that is positioned underneath.

Abstract: An integrated guiding device has a tube and a corewire within the tube and a torque coupler. The torque coupler can couple the rotational motion of the tube with the rotational motion of the corewire. The wire can be moved longitudinally at least some amount relative to the tube. The device can further comprise a functional medical structure, such as an embolism protection structure. The device can be used in medical procedures, such as less invasive procedures within the cardiovascular system. Improved fiber based embolism protection devices comprise fiber bundles that are twisted prior to delivery.

Abstract: Devices and methods for balloon delivery of rapamycin and other hydrophobic compounds to the wall of blood vessels. Balloon catheters, such as those used for balloon angioplasty, are modified with the addition of a reservoir of dry micelles, disposed at a suitable location within the balloon or catheter. The reservoir may be installed within the angioplasty balloon, within a lumen in communication with the angioplasty balloon, either as a loose or packed powder or as a film coating. The micelle preparation is reconstituted and the micelles are mobilized when the aqueous solution used to inflate the balloons is injected into the catheter. The micelles are infused into tissue surrounding the balloon when pressurized fluid within the balloon leaks through the wall of the balloon.

Abstract: An enteral feeding unit that reduces the occurrence of gastro-esophogeal-pharynegal reflux during feeding includes an automatable feeding pump with a feedback sensor for sensing a relative pressure in a patient's stomach and esophagus, and a regulator system for controlling and monitoring feeding rate to the patient as a function of the relative gastro-esophageal pressure. The system includes a stomach probe that provides a fluid-tight closure of the esophagus. The stomach probe includes a tampon-bladder for watertight closure of the esophagus, in which the tampon-bladder is formed of flexible and/or elastic material. At least an inner cavity of the bladder is provided for the reception of a fluid medium.

Abstract: An introducer assembly (10) includes a balloon catheter (12) for deploying a medical device (19) in a body lumen or for dilating a body lumen at a range of diameters from a minimum deployment diameter to a maximum deployment diameter. The balloon catheter includes an outer balloon (42) and an inner balloon (40) located within the outer balloon (42). The outer balloon (42) has an unstretched diameter equivalent to the minimum deployment diameter and the inner balloon (40) has an unstretched diameter equivalent to the maximum deployment diameter. The outer balloon (42) is made of an elastic material able to stretch from the minimum deployment diameter to the maximum deployment diameter, while the inner balloon (40) is preferably of an non-compliant material.

Abstract: A multiple cuff system is disclosed which has more than one cuff some of which may be perforated or permeable in any degree or made of porous materials to let in situ delivery of different drugs, and especially local anesthetics to the target tissues that are the tissues in touch or within the vicinity of the inflated cuff. The local anesthetics suitable to be delivered via the cuff are also introduced. The preferred method for application of the multiple cuffed ETT during surgical operations, can overcome the emergence reactions commonly encountered during lighter levels of anesthesia.

Abstract: The present invention provides a cardiac vascular occlusion system which includes inner and outer guide catheters and an occluding member disposed on the inner catheter. The occluding member may be deployed from a compressed to an expanded position to limit retrograde blood flow in a body lumen. The occluding member may be used when injecting a contrast agent into the body lumen.

Abstract: There is disclosed a drug eluting balloon catheter assembly provided with a balloon formed of an inner balloon member of non-compliant material and an outer balloon member of a compliant material and which is provided with holes therein for eluting a drug or other fluid. In use, the outer balloon member is biased by contraction onto the inner balloon member thereby keeping the holes therein normally sealed closed and minimizing dead space in the device.

Abstract: The present disclosure generally provides a multiple balloon assembly used as part of the distal region of a medical device that is capable of delivering a therapeutic agent into a body vessel having bodily fluid. The multiple balloon assembly comprises an inner balloon and an outer balloon. The outer balloon further comprises a proximal taper region, a middle region, and a distal taper region. The inflation of the inner balloon causes the middle region of the outer balloon to contact the inner wall of the body vessel, thereby, occluding the flow of fluid through the body vessel. The proximal taper region and the distal taper region are configured such that they do not touch the inner wall of the body vessel. One of the distal taper and proximal taper regions has a plurality of apertures configured to allow for the therapeutic agent to be delivered into the body vessel at a predetermined rate.

Abstract: A drug delivery catheter and method are provided for delivering drugs to a targeted region of a lumen include drug-laden microcapsules provided within a porous catheter balloon with an effective pore size that prevents free-flow of the microcapsules through the porous wall of the balloon. The microcapsules are frangible under the influence of increased pressure within the balloon. In an alternative embodiment, the microcapsules may be mechanically ruptured by compression between the outer porous balloon and optional, inner, non-porous balloon. The drug is emitted from the microcapsules through the balloon pores and against the targeted luminal surface.

Abstract: A dual balloon catheter apparatus for controlling postpartum hemorrhage in uterine or vaginal cavities or hemorrhage in other body cavities, comprising: (1) a catheter having an inflation lumen and a deflation lumen; (2) a first inflatable balloon in fluid communication with the inflation lumen; and (3) a second inflatable balloon encompassing the first balloon and in fluid communication with the deflation lumen. A first fluid inflation medium can be introduced from an external fluid source through the inflation lumen to inflate the first balloon, so as to apply a substantially even pressure along a substantial portion of a uterine cavity to reduce or eliminate bleeding along such inner surface. The second inflatable balloon functions to confine any first fluid inflation medium that escapes (e.g., by leakage or rupture) from the first balloon, and to discharge such medium through the deflation lumen.

Abstract: A system for delivery of a stent dilatable by means of a balloon, including a multilumen polymeric catheter having at least two balloons at the input end, where the distal balloon can expand an eccentric stent mounted on it, and the proximal balloon of smaller diameter has, at least, two radiopaque labels (markers) and has a capability of accurate orientation of the stent in an artery lumen.