Abstract: A balloon catheter for dilation of stenotic tissue within a tubular member of the body such as a blood vessel provides fluid flow such as blood flow through the balloon while it is being inflated and after it has been inflated. For valvuloplasty applications or for predilitation prior to a TAVI procedure the balloon is placed across the stenotic aortic valve leaflets and inflated to push the leaflets aside to create a greater blood flow area or allow improved subsequent passage of the large TAVI catheter across the stenotic aortic valve leaflets. As the balloon is inflated in diameter, it is required to reduce in length; this length reduction causes a braided inner tubing to also reduce in length. The braided inner tube is thereby required it to increase in diameter during the balloon inflation and create a suitably large blood flow path through the inner tubing.

Abstract: A method of manufacturing a balloon catheter involves applying a first application liquid, which contains a hydrophilic coating material, to the outer periphery of a balloon which is disposed on an elongated catheter and is held in an expanded state; folding the balloon; and applying a second application liquid, which contains the hydrophilic coating material, to the balloon with the balloon folded.

Abstract: A drug eluting balloon device is disclosed, comprising a balloon and a sheath disposed around the balloon, the sheath comprising a plurality of drug delivery areas. When the sheath is in a first position, the drug delivery areas are in the form of pockets adapted to contain a therapeutic agent. When the sheath is expanded, the pockets invert into protrusions in order to deliver the therapeutic agent. In an alternative embodiment, the pockets are adapted to be pushed outwardly upon inflation of the balloon. The device may further comprise a fluid or shape memory material to force the pockets outwardly.

Abstract: The invention generally relates to carbon nanotube based drug delivery methods, devices, and compositions. More particularly, the invention relates to controlled drug delivery using anchored carbon nanotube arrays.

Abstract: In one aspect, the present invention provides composite coatings for implantable or insertable medical devices. These composite coatings comprise (a) an inorganic portion and (b) a polymeric portion that comprises a poly(vinyl pyrrolidone) (PVP) block.

Abstract: A method of fabrication of a medical balloon, and a balloon device useful for various medical balloon procedures, such as gastrointestinal, vascular, reproductive system, urinary system and pulmonary applications. At least two layers of a thermoplastic film are sealed at their peripheral edges and heat sealed at one or more locations inside an area enclosed by the sealed edges at predetermined locations, in one implementation of the balloon device. Such configuration enables the balloon to articulate to a desired shape upon inflation, with the desired shape being selected to accommodate a specific medical application.

Abstract: A non-compliant medical balloon, where the non-compliant medical balloon may be changed from a deflated state to an inflated state by increasing pressure within the balloon, is made with a first fiber layer, a second fiber layer over said first fiber layer such that the fibers of the first fiber layer and the fibers of the second fiber layer form an angle and a binding layer coating the first fiber layer and said second fiber layer. The interior surface area of the non-compliant medical balloon remains unchanged when the balloon changes from a deflated state to an inflated state.

Abstract: Multilayer balloon for a catheter comprises a first layer made of a first polymer material having a first Shore durometer hardness, a second layer made of a second polymer material having a second Shore durometer hardness greater than the first Shore durometer hardness, wherein the second layer is an inner layer relative to the first layer, and a third layer made of a third polymer material having a third Shore durometer hardness less the first Shore durometer hardness, wherein the third layer is an inner layer relative to the second layer. Method of making a multilayer balloon for a catheter and a balloon catheter are also provided.

Abstract: A method of increasing blood flow through an obstructed blood vessel includes providing an expandable member substantially made of a mesh having a plurality of interstices. The expandable member is inserted into the blood vessel, positioned within the blood vessel with the proximal member end upstream of the distal member end and the member body located radially adjacent at least a portion of an obstruction, and expanded to bring at least a portion of the member body into contact with the obstruction. An outward radial force is exerted on the obstruction to dislodge at least one fragment from the obstruction and to enhance blood flow through the blood vessel past the obstruction. The at least one fragment is passed through at least one interstice of the member body in the radial direction, and is selectively retained within the expandable member.

Abstract: A catheter balloon and method involves extruded tubing with multiple layers of different durometer values, selected such that the blow up ratio (BUR) at the balloon's inner surface is increased. In one method a two stage blow mold process uses a small radius initial stage where radial growth is limited, followed by a second stage to a final dimension. A single stage blow mold process is also disclosed where the materials and processing are selected to approach the elongation to failure limit of the material. The single stage approach is preferably followed by a modified post-expansion heat set treatment to promote greater axial strength, leading to a preferred failure mode in the axial rather than radial direction.

Abstract: A balloon carries a drug in drug-carrying regions, wherein the drug-carrying regions protect the drug during delivery through a patient's vasculature. Once at a target site, the balloon expands, causing the drug-carrying regions to expose the drug to the target site. One drug eluting balloon device includes a longitudinal sheath that defines an interior space having a balloon disposed therein. When the balloon expands, at least one push element at least partially inverts at least one pocket formed on an outer surface of the sheath. This inversion causes a drug contained within the at least one pocket to be released to the target site. In another embodiment, a plurality of bands is provided, each band made of material having a different resistance to elongation. Upon expansion, the bands invert to expose a drug provided on a surface of the bands.

Abstract: A method of increasing blood flow through an obstructed blood vessel includes providing an expandable member substantially made of a mesh having a plurality of interstices. The expandable member is inserted into the blood vessel, positioned within the blood vessel with the proximal member end upstream of the distal member end and the member body located radially adjacent at least a portion of an obstruction, and expanded to bring at least a portion of the member body into contact with the obstruction. An outward radial force is exerted on the obstruction to dislodge at least one fragment from the obstruction and to enhance blood flow through the blood vessel past the obstruction. The at least one fragment is passed through at least one interstice of the member body in the radial direction, and is selectively retained within the expandable member.

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 present invention relates to balloon catheters for treating a luminal system of a patient. Specifically, the invention relates to catheters having a flexible membrane positioned at a distal portion of the catheter, the flexible membrane retained in a substantially unexposed conformation prior to deployment. Preferably the flexible membrane is capable of delivering a therapeutic agent to a localized environment when deployed to an exposed conformation.

Abstract: A non-shortening catheter balloon having a longitudinal axis and an inflatable balloon able to be affixed to a catheter shaft is provided. The balloon has an uninflated length which remains relatively unchanged upon inflation and is formed of least two helically oriented wrapped passes of balloon materials at a balanced force angle. Methods of making this balloon are also provided.

Abstract: Disclosed is an expandable transluminal sheath, for introduction into the body while in a first, small cross-sectional area configuration, and subsequent expansion of at least a part of the distal end of the sheath to a second, enlarged cross-sectional configuration. The sheath is configured for use in the vascular system and has utility in the introduction and removal of implant delivery catheters. The access route is through the femoral arteries and the iliac arteries into the aorta. The distal end of the sheath is maintained in the first, low cross-sectional configuration during advancement to the arteries into the aorta. The distal end of the sheath is subsequently expanded using a radial dilatation device, which is removed prior to the introduction of implant delivery catheters. In an exemplary application, the sheath includes a supported proximal end, a supported distal end, and a collapsible center section.

Abstract: A catheter having shaft segments which are joined together by a strong bond providing a low profile shaft section with a flexibility transition and/or a compositional transition. A balloon catheter embodying features of the invention has a distal tip member and a coupling band member surrounding a junction of an inner tubular member of the shaft, and has a gradual change in bending stiffness along a distal end section of the shaft which extends distally from a location within the balloon interior. Another catheter embodying features of the invention has shaft segments joined together by a diagonal seam.

Abstract: A catheter balloon with integral non-distending regions having a plurality of layers which wind around the balloon material and overlap to form an angle of between 45 and 90 degrees relative to each other upon inflation, and methods of making the non-distending regions are provided.

Abstract: This invention is generally related to catheters for insertion into a body cavity, duct or vessel, and more particularly to a tip or plug for a catheter. The catheter tip is constructed and arranged to form a seal on the end portion of the catheter tube, while a sleeve secured or formed integrally to the tip cooperates with the catheter tube to form a first balloon that encapsulates the tip of the catheter and a second balloon that positions the catheter within the body cavity, duct or vessel.

Abstract: Catheter or guidewire mounted automatic vessel occlusion and fluid dispersion devices that expand to occlude or partially occlude a vessel when a fluid is flowing in the catheter or guidewire, and that automatically collapse when fluid flow is stopped. Each occlusion device has an elastic skeleton covered with a flexible cover coupled thereto and may have a hole(s) or openings in its distal or proximal end thereof to allow controlled flow through the desired end of the occlusion device. The fluid may be a flush fluid for enabling or improving the performance of imaging devices and image enhancing fluids, of treatment fluids for localized treatment of a vessel or tissues in communication with the vessel and/or of the transmission of energy to the vessel wall and adjacent tissues. Various embodiments are disclosed.

Abstract: A multilayer balloon catheter is formed to have an inner layer and an outer layer, where the outer layer is adapted to resist shredding and premature rupture. The outer layer is formed of a material having a glass transition temperature that is lower than the transition or melting temperature of the inner layer. By forming the balloon on a mold at a temperature between the glass transition temperature of the outer layer and the glass transition or melting temperature of the inner layer, the outer layer will undergo a thermal relaxation that will alleviate some of the axial orientation of the polymer chains that develop during the formation of the multilayer balloon. This relaxation leads to a resistance to shredding when the balloon is expanded during operation.

Abstract: Embodiments of the invention provide swallowable devices, preparations and methods for delivering drugs and other therapeutic agents within the GI tract. Some embodiments provide a swallowable device such as a capsule for delivering drugs into the intestinal wall or other GI lumen. The device comprises a capsule sized to be swallowed and pass through the intestinal tract. The capsule can include at least one guide tube, one or more tissue penetrating members positioned in the guide tube, a delivery member, an actuating mechanism and a release element. The release element degrades upon exposure to various conditions in the intestine so as to release and actuate the actuating mechanism. Embodiments of the invention are particularly useful for the delivery of drugs which are poorly absorbed, tolerated and/or degraded within the GI tract.

Abstract: Medical devices for delivering a bioactive agent and methods of use thereof are provided. The medical devices include micro-needles integrated within a balloon of a catheter. The balloon can include dimples, cavities or a variable thickness membrane in which the micro-needles are integrated.

Abstract: A safety catheter includes a flexible, multi-lumen shaft having an outer diameter, a distal tip, a proximal catheter end with a drain end and a proximal inflation end. The multi-lumen shaft defines a drain lumen, a distal hollow balloon portion, at least one inflation lumen, and a drainage port. A hollow stretch valve is coaxially disposed in the inflation or drainage lumen, or both, has a fixed portion within the inflation or drainage lumen, or both, and prevents fluid from passing through the drainage port in a steady state and has a sliding portion slidably disposed within the inflation or drainage lumen, or both, such that, in a stretched state when the proximal catheter end is stretched, the sliding portion slides within the inflation or drainage lumen, or both to permit fluid to pass through the balloon drainage port and/or wall of the catheter.

Abstract: Disclosed is an expandable transluminal sheath, for introduction into the body while in a first, collapsed cross-sectional configuration, subsequent expansion of at least a part of the distal end of the sheath to a second, enlarged cross-sectional configuration, and subsequent removal in a third, collapsed cross-sectional configuration. The sheath is configured for use in the vascular system and has utility in the introduction and removal of implant delivery catheters. The access route is through the femoral arteries and the iliac arteries into the aorta. The distal end of the sheath is maintained in the first, collapsed cross-sectional configuration during advancement to the arteries into the aorta. The distal end of the sheath is then expanded using a radial dilatation device, which is removed prior to the introduction of implant delivery catheters. The distal end of the sheath is subsequently reduced to a diametrically small size for removal.

Abstract: A balloon catheter includes a balloon which is both of high strength and radiopaque. The balloon includes an outer strengthened layer which includes a strengthening element at least partially embedded within the layer. Concentrically within the strengthened layer there is a radiopaque layer which includes a high concentration of radiopaque material distributed in the radiopaque layer. The strengthened layer acts as a support to the radiopaque layer which is otherwise be unable to withstand the pressure to which the balloon is normally inflated for deployment and in the course of a medical procedure. The structure provides a high strength radiopaque balloon with a relatively thin balloon wall optimizing balloon flexibility and wrappability. There is also disclosed a method of making a balloon which uses an internal support layer in a raw tubing which is then removed following formation of a balloon.

Abstract: The invention provides a balloon catheter formed with a plurality of depressions. The balloon is coated with a matrix incorporating a therapeutic substance, which fills the depressions. When the balloon is expanded within a body lumen, the therapeutic substance may diffuse into the lumen wall, or all or a portion of the coating transfers to the lumen wall. A lattice frame may surround the balloon, applied prior to coating if the coating is to transfer, operative to maintain a more linear balloon profile during inflation, promoting more even transfer pressure. A contrast dye is incorporated into the transferred coating, enabling ready location and inspection of the treated lumen area.

Abstract: A balloon catheter includes a balloon having a plurality of layers. The inner layer acts as a support layer to the outer layer. Embedded within the outer layer is a plurality of particles or pellets which in one embodiment provide roughening of the outer surface of the balloon. The particles or pellets, particularly in conjunction with an inner support layer, ensure maintenance of the roughened outer surface of the balloon during inflation of the balloon. In another embodiment, the particles or pellets may be radiopaque and/or echogenic with or without creating surface roughening of the balloon.

Abstract: A medical balloon for a balloon catheter is described. The balloon has at least a first layer made from a first material and a second layer made from a second material, said first and second layers being in overlying relationship with one another and being integral with one another; wherein the first layer has a softening or melting temperature which is higher than a softening or melting temperature of the second layer. A method of forming the medical balloon is also described, including locating a raw tubing in a mold; preheating and inflating the raw tubing so as to cause it to stretch; heating the raw tubing to soften or melt the second layer; setting the inflated raw tubing to form the medical balloon; and cooling the set balloon.

Abstract: A balloon catheter assembly comprises a balloon having attached to or in its wall one or more filar elements, extending from one end of the balloon to the other. The filar elements are made of a material which is at least as flexible as the material forming the walls of the balloon. In the event of circular burst of the balloon, the filar element(s) prevent disconnection of the material of the balloon into two or more separate pieces. The filar element(s) become attached to or in the material of the balloon wall when the raw material is inflated to the shape of a mold. The filar elements may comprise a natural fiber, a synthetic fiber or a metal wire.

Abstract: A balloon including a laminated film of at least two layers including a polyamide elastomer layer and a polyamide layer wherein the polyamide elastomer layer is formed at the inner side of the polyamide layer and a molecular weight distribution of the polymers as a whole of the balloon (weight-average molecular weight Mw/number-average molecular weight Mn) ranges from 3 to 10.

Abstract: Balloon catheter comprises an elongate catheter shaft having a proximal section, a distal section, and an inflation lumen, and a multilayer balloon on the distal section of the shaft. The multilayer balloon comprises a first layer made of a first polymer material having a first Shore durometer hardness, a second layer made of a second polymer material having a second Shore durometer hardness lower than the first shore durometer hardness, wherein the second layer is an inner layer relative to the first layer, and an outer-most layer made of a third polymer material having a third Shore durometer hardness lower than the second Shore durometer hardness.

Abstract: Balloon catheter comprises an elongate catheter shaft having a proximal section, a distal section, and an inflation lumen, and a multilayer balloon on the distal section of the shaft. The multilayer balloon comprises at least a first layer and a second layer having a combined wall thickness and an outer-most layer. The first layer is made of a first polymer material having a first maximum blow-up-ratio. The second layer is made of a second polymer material having a second maximum blow-up-ratio greater than the first maximum blow-up-ratio and the second layer is an inner layer relative to the first layer. The at least first and second layers define a compliance less than that of a single layer balloon made of the first polymer material with a wall thickness equal to the combined wall thickness. The outer-most layer is made of a third polymer material.

Abstract: A non-compliant medical balloon may be changed from a deflated state to an inflated state by increasing pressure within the balloon. The non-compliant medical balloon is composed of randomly oriented fibers forming an angle. The angle remains substantially unchanged when the balloon changes from a deflated state to an inflated state.

Abstract: A catheter assembly may comprise a guide catheter, a balloon catheter with a steering balloon and a stabilizing balloon and a guide wire. The stabilizing balloon secures the balloon catheter to the guide catheter while the steering balloon secures the catheter assembly to the vessel wall. In another embodiment, the balloon catheter has three balloons engaged to the exterior surface, a steering balloon, a stabilizing balloon and an anchoring balloon.

Abstract: A non-compliant medical balloon, where the non-compliant medical balloon may be changed from a deflated state to an inflated state by increasing pressure within the balloon, is made with a first fiber layer, a second fiber layer over said first fiber layer such that the fibers of the first fiber layer and the fibers of the second fiber layer form an angle and a binding layer coating the first fiber layer and said second fiber layer. The interior surface area of the non-compliant medical balloon remains unchanged when the balloon changes from a deflated state to an inflated state.

Abstract: A balloon catheter having a multi-layered balloon which has a first layer and at least a second layer, and which has noncompliant limited radial expansion beyond the nominal diameter of the balloon. By selecting the polymeric materials forming the balloon layers, and arranging and radially expanding the multiple layers of the balloon in accordance with the invention, a balloon is provided having an improved low compliance, preferably in combination with high flexibility and softness.

Abstract: Multilayer balloon for a catheter comprising at least a first layer, a second layer, and a third layer having a combined wall thickness. The first layer is made of a first polymer material having a first maximum blow-up-ratio. The second layer is made of a second polymer material having a second maximum blow-up-ratio greater than the first maximum blow-up-ratio. The second layer is an inner layer relative to the first layer. The third layer is made of a third polymer material having a third maximum blow-up-ratio greater than the second maximum blow-up-ratio. The third layer is an inner layer relative to the second layer. The at least first, second, and third layers define a compliance less than that of a single layer balloon made of the first polymer material with a wall thickness equal to the combined wall thickness.

Abstract: A catheter assembly comprising a first polymer, a second polymer and a first weld region. The first polymer forms a balloon having a first waist. The second polymer forms a catheter shaft. The first waist is positioned about a portion of the catheter shaft thereby forming the first weld region. The first weld region comprises a first weld and a second weld which engage the first waist to the catheter shaft. The first weld has a first longitudinal position and the second weld has a second longitudinal position, where the first longitudinal position is different from the second longitudinal position.

Abstract: A method of increasing blood flow through an obstructed blood vessel includes providing an expandable member substantially made of a mesh having a plurality of interstices. The expandable member is inserted into the blood vessel, positioned within the blood vessel with the proximal member end upstream of the distal member end and the member body located radially adjacent at least a portion of an obstruction, and expanded to bring at least a portion of the member body into contact with the obstruction. An outward radial force is exerted on the obstruction to dislodge at least one fragment from the obstruction and to enhance blood flow through the blood vessel past the obstruction. The at least one fragment is passed through at least one interstice of the member body in the radial direction, and is selectively retained within the expandable member.

Abstract: A non-compliant medical balloon may be changed from a deflated state to an inflated state by increasing the internal pressure within the balloon. The balloon comprises a balloon layer having an outer surface, the balloon layer including a base layer, a first reinforcing layer and a second reinforcing layer. The base layer is formed of a polymer material. The first reinforcing layer is one of either a plurality of discrete inelastic fibers oriented substantially parallel to the long axis of the balloon and a first layer of textile fabric material, the textile fabric material being one of a woven, knitted, braided and non-woven fabric. The second reinforcing layer is one of either at least one inelastic fiber wrapped around the circumference of the balloon substantially transverse to the long axis of the balloon and a second layer of textile fabric material, the textile fabric material being one of a woven, knitted, braided and non-woven fabric.

Abstract: Medical devices and methods of making medical devices are described. In some embodiments, a medical device includes a member having a first portion with a first wall thickness, and a second portion with a second wall thickness, wherein the first portion is circumferentially rotated.

Abstract: Medical systems and methods including balloons having nanotubes are disclosed. In some embodiments, a medical system includes an elongated shaft, and an expandable balloon carried by the shaft and including nanotubes. The medical system is capable of cooling the balloon to less than about 37° C. In some embodiments, a method includes providing a medical device having an elongated shaft, and an expandable balloon carried by the elongated shaft and including nanotubes; and cooling the balloon to less than about 37° C.

Abstract: A non-compliant medical balloon is formed with a first fiber layer including a first fiber and a second fiber layer over said first fiber layer. The first fiber is substantially parallel to a longitudinal axis of the non-compliant medical balloon.

Abstract: A method of increasing blood flow through an obstructed blood vessel includes providing an expandable member substantially made of a mesh having a plurality of interstices. The expandable member is inserted into the blood vessel, positioned within the blood vessel with the proximal member end upstream of the distal member end and the member body located radially adjacent at least a portion of an obstruction, and expanded to bring at least a portion of the member body into contact with the obstruction. An outward radial force is exerted on the obstruction to dislodge at least one fragment from the obstruction and to enhance blood flow through the blood vessel past the obstruction. The at least one fragment is passed through at least one interstice of the member body in the radial direction, and is selectively retained within the expandable member.

Abstract: Methods and devices for perfusing a blood vessel during the entire course of an end-to-side or end-to-end anastomosis procedure. One method can be used to form an end-to-side anastomosis of a saphenous vein graft to a coronary artery during an off-pump, beating heart, coronary artery bypass graft. In this example, the distal end of an elongate tube carrying a saphenous vein graft is advanced into an arteriotomy distal to an occlusion in the coronary artery. Perfusing blood flow is provided through the tube to the coronary artery, the vein graft is advanced over the tube to the arteriotomy and sutured completely to the coronary artery. The elongate tube can be retracted through the now secured vein graft, and the coronary artery supplied again from the proximal end of the vein graft. Some tubular devices include a reversibly expandable distal region, to form a seal between the inserted tube and the coronary artery being perfused, to prevent blood flow into the surgical field.

Abstract: There is provided a method of making a balloon having a differential thickness. The method uses a raw tube composed of a thermoplastic polymer which is placed in an asymmetrical mold. The tube is preheated in the mold to a temperature sufficient to soften the material of the tube and inflated with a gas to generally uniformly stretch the material of the tube while allowing the tube to retract lengthwise, thus forming a balloon. The resulting completed balloon has a differential wall thickness wherein the upper region has a thickness of from about 15 to about 30 micrometers and the lower region has a thickness of from about 5 to about 15 micrometers.

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: Medical device polymeric tubing segments suitable for forming catheter shafts or as balloon parisons are formed with discrete regions having different orientation relative to each other. Wall thickness may also be varied of the length of the segment.

Abstract: A catheter assembly comprises at least one catheter shaft and a balloon. The catheter shaft comprises a substantially cylindrical portion and at least one tapered portion. The tapered portion forms an angle with the cylindrical portion of about 1 degree to about 25 degrees. At least one of the waists of the balloon is sealingly engaged to the tapered portion.