Abstract: A dilatation balloon formed with at least one layer, the layer including at least one polymeric material and at least one material which is a heating medium, the heating medium sensitive to an electromagnetic field.

Abstract: Medical devices and methods for making and using medical devices are disclosed. An example medical device may include an elongate inner member having a guidewire lumen extending therethrough. An outer member may be disposed about the inner member. An inflation lumen may be formed between the inner member and the outer member. The medical device may be configured to have a first stiffness when the inflation lumen is free of inflation media and a second stiffness different from the first stiffness when inflation media is disposed within the inflation lumen. In addition, the inner member may include a collapsible region that is configured to deflect radially inward when inflation media is disposed within the inflation lumen.

Abstract: A catheter for delivering a stent includes an outer tube having a proximal end, a distal end and a wall defining a lumen; an inner tube disposed within the outer tube and defining a lumen for a guidewire, wherein a portion of a length of the inner tube is wrapped around with a spiral-shaped wire; a balloon sealingly connected to the inner tube and the outer tube adjacent the distal ends thereof, the balloon defining an interior volume and having an exterior surface; and a marker made from a wire of a highly radiopaque and ductile material, wherein the wire is wrapped in a plurality of at least partially overlapping layers such that the marker is flexible along the length of the catheter.

Abstract: Medical devices and methods for making and using the same are disclosed. An example medical device may include a fixed wire balloon catheter. An example fixed wire balloon catheter may include a core wire. An inner tubular member may be attached to the core wire. The inner tubular member may have a plurality of slots formed therein. A catheter shaft may be disposed about the inner tubular member. An inflation lumen may be defined between the catheter shaft and the core wire. A balloon may be coupled to the catheter shaft. The balloon may have a distal portion. A crossing tip may be coupled to the distal portion of the balloon.

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 used for treatment of complex vasculature, such as a bifurcated aneurysm, is provided with an inflatable balloon at a distal portion thereof. The shape, location and material of the inflatable balloon are selected such that when inflated, the balloon conforms to the shape of the complex vasculature, or at least a portion thereof, without appreciably deforming the vessel walls. In this manner, the balloon can be used to control flow in the vasculature, for example occluding a selected branch of the vasculature during introduction of material in order concentrate the material and minimize its disbursement by blood flow.

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: A dilatation catheter for delivering a therapeutic agent within a body lumen having a wall with a thickness is provided having a balloon having a flexible wall including a polymer with dispersed nanotubes and pores configured to close below a predefined pressure and to open at or above a predefined pressure. In some embodiments, an actuator is provided to controllably inflate the balloon with a fluid at a pressure sufficient to bring the flexible wall of the balloon into contact with at least a portion of the wall of the body lumen but below the predefined pressure, and to controllably increase the pressure of the fluid within the inflated balloon to at least the predefined pressure at a rate and with a force sufficient to deliver the therapeutic agent from the pores and through at least a portion of the thickness of the wall of the body lumen.

Abstract: The present invention relates to a catheter comprising a balloon (10, 30) and at least one pharmaceutically active substance. To enable more accurate dosing of the pharmaceutically active substance, the pharmaceutically active substance is disposed in a reservoir (15, 35) inside the balloon (10, 30) or on the balloon (10, 30), wherein a wall (14, 32, 34) that closes the reservoir toward the outside comprises at least one predetermined breaking point (16). Furthermore, a system for applying an intraluminal endoprosthesis, preferably a stent, in a body cavity, and simple and cost-effective methods for manufacturing the catheter and the system are described.

Abstract: A medical balloon having a resistance to circumferential tearing comprises a substantially cylindrical portion disposed between first and second tapered portions that have a decreasing cross-sectional area along a length thereof away from the cylindrical portion. The substantially cylindrical portion includes first and second end portions and a midsection disposed therebetween. The midsection includes a first region having a first resistance to tearing and a second region having a second lower resistance to tearing, where the second region extends about only a portion of the circumference of the cylindrical portion and does not extend beyond the midsection.

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: Medical devices for delivering a bioactive agent(s) and methods of use thereof are provided.

Abstract: A catheter balloon is configured to improve its fold-in or collapsing behavior. The catheter balloon has a balloon body portion, a first tapered end portion and a second tapered end portion. The balloon body portion has a substantially cylindrical shape in an expanded state. The first tapered end portion is formed at a first end of the balloon body portion. The first tapered end portion includes a first predetermined embossment. The second tapered end portion is formed at a second end of the balloon body portion. The second tapered end portion includes a second predetermined embossment. The balloon body portion is formed free of a predetermined embossment. In other words, the balloon body portion is formed without folds so that there is only predetermined folding on the conical end portions for inducing the folding of the balloon body portion in a predetermined direction upon collapsing.

Abstract: A rectal balloon apparatus has a shaft with a fluid passageway extending therethrough. A balloon is affixed over an end of the shaft such that the fluid passageway communicates with an interior of the balloon. The balloon has a laterally flat surface thereon when inflated. The laterally flat surface of the balloon has a longitudinal groove formed thereon. The balloon having a pair of bulges formed thereon when the balloon is inflated. A ring is affixed to the shaft adjacent the balloon. The shaft has a plurality of holes formed thereon opening to an interior of the balloon.

Abstract: Balloon catheter comprises a shaft having a proximal end, a distal end, and an inflation lumen extending therein, and a balloon on the shaft which has an interior in fluid communication with the inflation lumen. The balloon is formed of a blend of polymeric materials comprising a transparent amorphous nylon having a Shore D duromcter hardness of not less than 77D and being not more than about 40% by weight of the blend, and a polyamide or a polyether block amide having a Shore D duromcter hardness of no more than 73D. An increase in radial diameter of the balloon above nominal pressure for one atmosphere of pressure is no greater than 0.025 mm/atm. A guidewire catheter is also provided.

Abstract: A balloon of a balloon catheter including, in its folded state, a central, inflatable body portion having an outer peripheral wall surface and a plurality of hollow lobes being wrapped around the outer peripheral wall surface and being in fluid communication with the inflatable body portion the lobes including free end portions defining gaps therebetween.

Abstract: A catheter including an outer conduit and an inner conduit movably disposed therein. The distal tip of the inner conduit extends beyond the distal tip of the outer conduit. An inflatable balloon has a first margin attached to the distal tip of the outer conduit, and a second margin attached to the portion of the inner conduit extending beyond the distal tip of the outer conduit. The balloon includes a middle portion, an inflatable distal side portion having at least one tapering part and an inflatable proximal side portion having at least one tapering portion. The length of proximal side portion is equal to or larger than the length of the middle portion. The distal end portion of the balloon is capable of intussuscepting upon proximal movement of the inner conduit within the outer conduit. The catheter includes an inflation/deflation port for introducing and removal of inflating fluid.

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: The present invention relates to medical devices that can be placed in bodily conduits. The invention particularly relates to balloons and catheters using such balloons for administering treatments to widen constricted passages, deliver therapeutic agents, deliver endoprosthesis' or perform other medical procedures. The balloon catheter can include an expandable balloon disposed adjacent a distal end of an elongated catheter shaft. The balloon can be constructed of a novel absorbable biomaterial.

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: The invention relates to multi-layer medical balloons. In one aspect, a medical device includes an inflatable balloon. The inflatable balloon includes a first layer including a material having a first modulus of elasticity, and a second layer adjacent the first layer, the second layer including a material having a second modulus of elasticity that differs from the first modulus of elasticity by at least about 2,000 psi. A cutting element is carried by the balloon.

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: Catheters, balloons, and methods of manufacturing balloons for balloon catheters using lasers are disclosed. A catheter with a shaft sized for use with a 0.014 inch guide wire includes a polymeric balloon having a body portion with an inflated outer diameter of more than 6 millimeters. An inflatable balloon includes an inflated outer diameter to inner waist diameter ratio of 12.5 to 1. An inflatable polymeric balloon that has a body portion with two regions that have different molecular orientations is also provided. A method of processing an elongate polymeric material includes heating a portion of the polymeric material with a laser while longitudinally stretching the portion of the polymeric material. A method of manufacturing a balloon includes heating and longitudinally stretching a first and second portion of an elongate polymeric tube to form first and second end portion. The remaining body portion is radially expanded to form the balloon.

Abstract: A medical device such as a catheter, stent or balloon, is formed by depositing a radiation curable composition on a form made of ice or wax. The deposited composition may be cured by irradiation, suitably with UV light. Complex structures can be built up if the deposition or curing is achieved imagewise. Compositions which photocure to polyester, polyamide or polyimide may be employed. A particular structure is a balloon for a rapid exchange catheter which has a guide wire lumen passing through the balloon cone walls.

Abstract: A non-compliant fiber-reinforced medical balloon comprises a first fiber layer and a second fiber layer embedded in a continuous matrix of thermally-weldable polymer material defining a barrel wall, cone walls and neck walls. The fibers of the first fiber layer run substantially parallel to one another and substantially parallel to the longitudinal axis. The fibers of the first fiber layer have a pattern of different lengths and are divisible into a first group and a second group based on length. Each fiber of the first group begins in the neck wall at one end of the balloon, extends continuously in the longitudinal direction and terminates in the neck wall at the opposite end of the balloon. Substantially all of the fibers of the first group have a generally uniform length. Each fiber of the second group begins in the cone wall at one end of the balloon, extends continuously in the longitudinal direction and terminates in the cone wall at the opposite end of the balloon.

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 radiopaque balloon with a composite wall having a radiopaque adhesive affixing inner and outer layers of the balloon. The radiopaque adhesive provides a radiographic image of the balloon wall with or without the use of a radiopaque contrast media to inflate the balloon. A radiographically fainter image is provided as the balloon is inflated with well-defined edges of a balloon image, and the total radiopacity of the balloon does not change as the balloon is inflated. Also, a method of imaging a balloon wall and a method of imaging a radiopaque adhesive between two layers of a balloon wall are provided.

Abstract: A medical device such as a tube or a balloon including wall structure with multiple layers. The wall structure can distribute stress, resulting in reduced defect propagation and failure.

Abstract: A multi-layered balloon is provided where each layer is formed such that each layer is made from tubing that optimizes the inner wall stretch thus providing maximum balloon strength. The high pressure, multi-layer balloon is provided with layers that allow for slipping, such that the balloon has a very high pressure rating and toughness, yet excellent folding characteristics. Methods for producing such multi-layer balloons using existing balloon forming equipment are also provided. The multi-layer balloons can have alternating structural and lubricating layers, or layers with low-friction surfaces. The multi-layer balloons are preferably manufactured using a variety of methods including nesting, co-extrusion, or a combination of nesting and co-extrusion. The multi-layer balloons have balloon layers having substantially similar, or the same, high degree of biaxial orientation of their polymer molecules such that each balloon layer of the multi-layer balloon will fail at approximately the same applied pressure.

Abstract: An interventional catheter for angioplasty and the like, comprising a catheter tube including an outer tubular member, an inner tubular member disposed within the lumen of the outer tubular member, and a balloon attached to the distal end of the outer tubular member and the distal end of the inner tubular member. The outer tubular member includes a first portion having a first stiffness and a second portion having a second stiffness less than the first stiffness. The inner tubular member has an inner surface having a first coefficient of friction and an outer surface having a second coefficient of friction greater than the first coefficient of friction.

Abstract: A balloon catheter that comprises an inner shaft, a balloon and a sleeve that defines a lumen. A portion of the inner shaft is positioned within the lumen and the balloon is engaged to the sleeve at least two engagement points.

Abstract: Tracheal ventilation device, particularly a tracheal tube, which seals the trachea in a substantially air-tight manner. The device includes a cuff that blocks the trachea below the glottis and is traversed by a ventilation cannula. The cuff is larger in its filled, freely displaceable, unrestricted state than in its filled state positioned in the trachea. The cuff is of a flexible soft film material and lies against the trachea by means of its folds. The device is adapted to the morphology of a child's larynx and is available in finely graded sizes.

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: A dual-layer dilatation balloon, and a process of making such balloon, which includes an inner layer that includes a plasticizer and a polymer selected from the group consisting of a polyamide, a copolymer thereof, and a combination thereof, and an outer layer that includes an ethylene-propylene rubber. The dual-layer balloon optionally further includes a stent disposed on the balloon. The stent is optionally a drug-eluting stent.

Abstract: Disclosed is a resin composition for balloons, which is excellent in gas permeation resistance and hydrolysis resistance (acid resistance), while having an excellent balance among flexibility, mechanical strength and elastic recoverability. Also disclosed is a balloon made of such a resin composition for balloons. Specifically disclosed is a resin composition for balloons, which is characterized by containing an isobutylene block copolymer (A) having a polymer block (a) mainly composed of isobutylene and a polymer block (b) mainly composed of an aromatic vinyl monomer. This resin composition for balloons is also characterized in that the polymer block (b) is 10-40% by weight of the weight of the isobutylene block copolymer (A).

Abstract: The present invention provides a balloon which achieves diameters greater than 6 mm for securement to a catheter. The balloon includes an elastomeric generally hollow pressure expandable body which exhibits essentially radial symmetry and constant length when expanded under an internally applied minimum working pressure from an uninflated state.

Abstract: A perfusion guidewire is disclosed. The perfusion guidewire includes an elongate core member and a collapsible sheath tightly wrapped around at least the distal portion of the elongate core member such that the wrapped sheath is folded upon itself, forming a plurality of layers of material in a radial direction from the longitudinal axis of the elongate core member. The wrapped sheath is tightly wrapped about the elongate core member such that the wrapped sheath and elongate core member travel as a unit during navigation within the blood vessel of the body of a patient. The wrapped sheath is expandable to a larger diameter in order to allow a perfusate to pass through the lumen of the sheath.

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: The present invention provides a balloon having a non-uniform thickness that is adapted to facilitate folding of the balloon. The balloon comprises at least one relatively thin section formed between inner and outer surfaces of the balloon, and at least one relatively thick section formed between the inner and outer surfaces. The balloon may be formed from a balloon preform that similarly comprises at least one relatively thin section and at least one relatively thick section. The shape of the balloon preform may be formed, for example, by extrusion. The balloon preform may be placed in a balloon mold having a substantially cylindrical interior surface, and blow-molded to form the finished balloon configuration. The balloon comprises a non-uniform thickness, while comprising a substantially cylindrical outer diameter both after removal from the balloon mold and in an inflated state.

Abstract: Inflatable medical devices and methods for making and using the same are disclosed. The inflatable medical devices can be medical balloons. The balloons can be configured to have a through-lumen or no through-lumen and a wide variety of geometries. The device can have a high-strength, non-compliant, fiber-reinforced, multi-layered wall. The inflatable medical device can be used for angioplasty, kyphoplasty, percutaneous aortic valve replacement, or other procedures described herein.

Abstract: A coated medical device adapted for introduction into a passage or vessel of a patient is provided. The medical device is preferably an implantable balloon with a bioactive deposited or within the balloon. The balloon can further include a hydrophilic material positioned between the balloon and a bioactive material posited on the balloon.

Abstract: The invention relates to a balloon catheter in which the balloon is mounted on the end of the catheter in a manner that creates a recess or pocket between the catheter wall and balloon wall. The recess or pocket opens toward the proximal end of the catheter. The rigid end of an introducer element or finger is received in the recess to attach it to the catheter. The distal end of the catheter, with the end of the introducer element in the recess, is inserted and positioned within the bowel by manipulating the introducer element or finger. After the catheter is properly positioned in the bowel, the introducer element or finger is withdrawn, detaching it from the catheter as the end of the introducer element slides out of the recess and then out of the bowel. The balloon is inflated prior to or after the withdrawal of the introducer element to anchor the end of the catheter in position within the bowel.

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 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: A distal protection device captures debris during vascular procedures. In order to reduce the profile of the device, the thickness of the distal protection element is reduced in one or both of the end regions, either by reducing the thickness of filaments which form the distal protection element, or by removing portions of those filaments altogether. Various methods of reducing the thickness of the end regions and different profiles that can be created by the reduction are disclosed.

Abstract: A dilatation balloon for use in combination with a catheter device, the balloon having a waist, cone and body portion and having a first layer formed from a first polymeric composition, the balloon having a second layer disposed on at least a portion of the first layer, the second layer formed from a second polymeric composition which is crosslinked on at least a portion of the dilatation balloon, and methods of making and using the same.

Abstract: Medical devices, for example, those that have balloons, and methods of making the devices are described. For example, in some embodiments, a medical device includes an elongated shaft, and an inflatable balloon carried by the shaft. The balloon includes a first recessed channel, a second recessed channel, a third recessed channel, and a fourth recessed channel, wherein the first recessed channel is spaced from the second recessed channel by a first distance, the third recessed channel is spaced from the fourth recessed channel by the first distance, and the second recessed channel is spaced from the third recessed channel by a second distance different than the first distance.

Abstract: An intraluminal catheter device having an expandable member formed of a matrix of fiber elements, the expandable member including a hydrogel polymer having a therapeutic agent incorporated therein. The hydrogel polymer can be coated on the fiber elements in a co-axial configuration. The fiber elements may also have a second coating including a protective substance surrounding the hydrogel polymer having a therapeutic agent therein. The matrix of fiber elements can be formed by electrospinning. A process of delivering a therapeutic agent to a target site includes providing an intraluminal catheter device having an expandable member formed of a matrix of fiber elements, the expandable member including a hydrogel polymer having a therapeutic agent dispersed therein, and advancing the catheter device at a desired treatment site.

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: The present invention relates to medical devices for dilating or enlarging strictures or narrowed regions of body vessels. Specifically, the present invention relates to a high pressure dilation balloon catheter that includes an elongate shaft extending between a proximal end and a distal end, the proximal end being adapted for attachment to a source of inflation fluid, and a first lumen extending through the shaft adapted for the passage of the inflation fluid; and a balloon disposed on the distal end of the shaft and having a balloon body extending between a proximal end and a distal end of the balloon.