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: 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 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.

Abstract: In at least one embodiment of the present invention a balloon catheter is provided. The balloon catheter comprises a shaft having a lumen formed therethrough. Connected to the shaft is an inflatable balloon. The inflatable balloon has a balloon wall defining a balloon interior surface and a balloon exterior surface that is opposite the interior surface. In fluid communication with the balloon wall is the lumen for inflating the balloon to define an inflated state and for collapsing the balloon to define a deflated state. The balloon wall is textured in the deflated state such that the balloon interior surface is spatially registered with the balloon exterior surface. The balloon in the inflated state is tensioned to have a surface roughness substantially less than a surface roughness of the balloon in the deflated state.

Abstract: A balloon catheter comprises an outer shaft having a distal end, an inner shaft situated therein to form an annular fluid line and projecting beyond the distal end of the outer shaft, and a balloon which is dilatable under the influence of a fluid introduced through the fluid line under pressure. At its proximal end the balloon is attached in a fluid-tight manner to the distal end region of the outer shaft at a first attachment zone, and at its distal end is attached in a fluid-tight manner to the distal end region of the inner shaft at a second attachment zone. Between the attachment zones, in the undilated state the balloon is placed in longitudinal folds along its length. The balloon, at least at its distal end, has an untapered design with a thin wall thickness (d) which is essentially unchanged over the length of the balloon, and the longitudinal folds extend into the attachment zone at that location.

Abstract: A stent deployment device is provided with a tapered balloon wrap to protect the edge of a crimped stent during stent deployment. The balloon is wrapped unevenly so that the distal end is looser and has a wider circumference than the proximal end of the balloon. With a stent crimped upon such a balloon, the distal balloon end billows out and covers the distal edge of the stent. This shielding billow prevents the stent edge from becoming damaged or causing harm if the stent is distally impacted while traversing body vessels on the way to the deployment site.

Abstract: An expandable medical device having a static state and at least one expanded state, the expandable medical device in the static state including at least one first inner layer and at least one second outer layer, the outer layer having an inner surface and an outer surface, the outer layer having a closed lattice in the inner surface or the outer surface of the outer layer, wherein the lattice is open when the expandable medical device is in the at least one expanded state, and methods of making the same.

Abstract: Balloon catheters and methods of making and using the same. A balloon catheter may include a catheter shaft and a balloon coupled thereto. A traction member may be coupled to the balloon catheter adjacent the balloon and may extend along a portion or all of the length of the balloon. The traction member can improve traction between the balloon and a target site.

Abstract: The present invention provides a mechanism by which the physical properties of diseased blood vessel walls can be manipulated to achieve an effective vessel lumen diameter for a prolonged period of time. The methods and devices of the present invention selectively isolate and treat the medial or adventitial layers of these diseased blood vessels. The invention is based on the delivery of proteolytic enzymes and crosslinking agents via specialized delivery devices to a select layer of the diseased blood vessel wall. By isolating and treating these layers of the artery, collagen degrading and collagen crosslinking agents can be delivered so as to affect the diameter of the blood vessels and control blood flow therein.

Abstract: A balloon catheter is provided that may be used to dilate hardened regions of a stenosis. The balloon catheter is provided with one or more dilation elements that extend along a surface of a balloon. Each dilation element is connected to an outer surface of the balloon by a connector. The connector is sufficiently sized and designed to undergo stress-induced plastic deformation incurred during blow molding so that a significant portion of each of the dilation elements does not become absorbed into the wall of the final blow molded balloon, thereby maintaining the structural integrity of each of the dilation elements.

Abstract: Balloon catheters and methods of making and using the same. A balloon catheter may include a catheter shaft and a balloon coupled thereto. A traction member may be coupled to the balloon catheter adjacent the balloon and may extend along a portion or all of the length of the balloon. The traction member can improve traction between the balloon and a target site.

Abstract: A balloon catheter with dilation elements and method of fabricating thereof is provided that may be used to dilate and/or cut hardened regions of a body vessel. The balloon catheter is provided with dilation elements that extend along a surface of a balloon. One or both ends of the dilation element is inserted through corresponding apertures formed in the balloon neck. After inserting the one or both ends through the corresponding apertures, the ends are bonded into the material of the catheter shaft and the balloon.

Abstract: This invention relates to a method of providing a coating on a medical device, especially a dilatation balloon, which improves the durability of the balloon.

Abstract: A balloon catheter comprises a catheter body, a balloon at a distal end of the catheter body, and a guidewire tube within the balloon and separate from the catheter body. A catheter may be introduced over a guidewire by passing the guidewire through a guidewire lumen in the guidewire tube. No guidewire lumen is provided within the catheter body.

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: The present invention relates to compositions which are suitable for selective filling or selective coating of folds of a folded balloon, and especially relates to compositions of a contrast agent and an active agent in a solvent for filling of folds of a folded catheter balloon as well as to methods for selective filling or selective coating of folds of a folded catheter balloon and to filled or coated folded catheter balloons which can be obtained according to one of these methods.

Abstract: A method of delivering an arteriogenic factor. The factor is delivered in a medically effective manner to structurally enlarge an existing blood vessel. A distal portion of a catheter can be advanced to an existing blood vessel to deliver the arteriogenic factor.

Abstract: A predetermined arrangement of differentially lubricious areas on a balloon catheter for controlling against unexpected movement of a stent carried thereon when in situ in the body.

Abstract: A shunt includes a first occlusion assembly and a second occlusion assembly. The first occlusion assembly includes a first occlusion fluid conduit that carries an inflation fluid from a fluid source to a first balloon of the shunt. The second occlusion assembly includes a second occlusion fluid conduit that carries an inflation fluid from a fluid source to a second balloon of the shunt. The first occlusion assembly includes a first color and the second fluid assembly includes a second color, distinct from the first color. The distinctive colorings of the first and second occlusion fluid conduits remain visible within an operative field during an endarterectomy procedure and allow a user to distinguish the first occlusion assembly from the second occlusion assembly during the procedure.

Abstract: A method for manufacturing a balloon catheter assembly includes forming a balloon from a polymer selected from the group consisting of polyamide, polyether block amide, and polyethylene terephthalate, forming a plurality of pores in the polymer, and mounting the balloon onto a catheter shaft. The shaft is configured to supply a fluid to the balloon to inflate the balloon, and the pores are configured to prevent the fluid from passing through the balloon.

Abstract: A balloon catheter having wires situated between an outer layer and a surface of a balloon is described. Each wire may be confined within an interior space of a pocket or encapsulated within a sheath. The pocket includes the outer layer and the balloon surface. The outer layer and balloon surface are unattached to allow the wire to slidably fit between therewithin. The pocket is selectively bonded to the balloon. The sheath includes a preformed shape that completely circumscribes the wire along the longitudinal and radial directions of the wire. The confined and encapsulated feature of the wires enable the wires to be atraumatic and remain spaced apart during treatment of calcification of a lesion.

Abstract: A balloon catheter and a method of making the balloon catheter, having a balloon which is bonded to an elongated shaft, and which has a first layer and a second layer and an improved bond between the balloon and the shaft. One aspect of the invention is directed to a balloon in which the balloon first layer includes eUHMWPE and has at least a section that has been oxidized with a chromic acid solution to provide improved bondability.

Abstract: An elastically distensible folding member is disclosed. The folding member can be formed with a wall that is substantially shaped as a tube when the folding member is in a relaxed (i.e. unstressed) state. The tubular shaped folding member defines a tube axis and can have an axially aligned slit that extends through the wall. The folding member can be used to cover an incising element that is attached to the balloon and positioned in the lumen of the tubular folding member. During balloon inflation, the folding member can be deformed to expose the tip of the incising element to allow for a tissue incision.

Abstract: The present invention provides apparatus and methods for facilitating folding of a balloon before, during or after a medical procedure. In a first embodiment, the apparatus generally comprises at least one catheter shaft member, a balloon disposed on a distal region of the catheter shaft member, and at least one folding member disposed along at least a proximal region of the balloon. The folding member may comprise at least one radially-outward projecting member integrally formed with or attached to the balloon, or an internally-formed groove in the balloon, which is adapted to promote twisting of the balloon to reduce the profile of the balloon in the deflated state. Optionally, biasing members may be disposed between the folding member and an adjacent portion of the balloon to promote folding of the balloon in a clockwise or counter-clockwise direction.

Abstract: This disclosure relates to medical devices and related methods. In some embodiments, the methods include applying a material to the balloon and then removing the material from one or more regions of the balloon.

Abstract: Apparatus and method are provided for treatment of a bifurcation of a body lumen. The apparatus includes an elongated catheter body having a proximal end and a distal end. A balloon is associated with the distal end of the balloon catheter. The balloon includes a main vessel balloon for treating a main vessel of the bifurcation, and a branch vessel balloon for treating a branch vessel of the bifurcation. The branch vessel balloon includes an accordion configuration capable of being expanded from an unexpanded collapsed accordion configuration to an expanded accordion configuration extending into the branch vessel.

Abstract: A guidewire lumen for a catheter includes a tubular member. At least a portion of the tubular member is formed of a compound comprising a polymer and particles or fibers. The particles or fibers can reduce a friction coefficient of the portion of the tubular member while having minimal to no adverse effects with respect to bondability, flexibility, and processability.

Abstract: A balloon catheter method of providing same, wherein a balloon catheter defines one or more indentations which provide improved flexibility to at least a portion of the catheter shaft and/or improved folding and rewrapping characteristics to the balloon.

Abstract: A balloon catheter having a balloon with a porous polymer layer and one or more filamentary members which are on or in the porous polymer layer and which form ridges protruding outwardly from a surface of the balloon in the inflated configuration. In a presently preferred embodiment, the balloon has a wingless noninflated configuration.

Abstract: A particle-removing medical device includes an outer, hollow tube having a tube distal end and a porous braided structure having a distal part and a proximal part. Structure, housed within the tube and having a distal end positioned distally of the tube distal end, is used to move the braided structure from a contracted condition to an expanded condition by moving the distal ends of the tube and the structure towards one another. The braided structure is constructed to inhibit particles from moving completely through the braided structure when in the expanded condition.

Abstract: A balloon for a catheter and a method of making the balloon, having a layer of a porous polymeric material with a modified outer surface and a lubricious coating bonded to the modified outer surface. In one embodiment, the modified outer surface is formed by a polymer impregnated in the porous polymeric material, and the subsequently applied lubricious coating bonds to the impregnating polymer. In another embodiment, the modified outer surface is formed by a functionality deposited on the porous polymeric material which bonds to the subsequently applied lubricious coating. The modified outer surface provides an improved strong bond between the lubricious coating and the balloon, for improved catheter performance.

Abstract: The invention features a method for triggering release of a drug from a hydrogel polymer to tissue at a desired location of the body using a catheter. A portion of the catheter is coated on its outer surface with a polymer having the capacity to incorporate a predetermined substantial amount of drug which is immobilized in the polymer until released by a triggering agent or condition that is different from physiological conditions. Upon contact with a triggering agent or condition, the polymer reacts, e.g., swells or contracts, such that the drug is delivered to the desired body tissue. A balloon catheter is shown in which the hydrogel is carried on the exterior surface of the balloon.

Abstract: Embodiments of the present invention are directed to a method and apparatus for accurate positioning of a dual balloon catheter. In one embodiment of the present invention, a first balloon provides an anchoring point. In one embodiment, the first balloon has protrusions to help secure its position. In one embodiment, once the first balloon is inflated, it provides a fixed position relative to which a second balloon is accurately positioned in the treatment region. In another embodiment, a second balloon imparts a radial force. In another embodiment, a second balloon imparts an axial force, using the first balloon as an anchor against which the force is applied. The force may be applied in a forward or a backward direction. In yet another embodiment, a second balloon imparts a rotational force, using the first balloon as an anchor against which the force is applied.

Abstract: A balloon catheter comprises a catheter body, a balloon at a distal end of the catheter body, and a guidewire tube within the balloon and separate from the catheter body. A catheter may be introduced over a guidewire by passing the guidewire through a guidewire lumen in the guidewire tube. No guidewire lumen is provided within the catheter body.

Abstract: The present invention provides improved devices, methods, and kits for inhibiting restenosis and hyperplasia after intravascular intervention. In particular, the present invention provides controlled radiosensitizer delivery in combination with ionizing radiation to selected locations within a patient's vasculature to reduce and/or inhibit restenosis and hyperplasia rates with increased efficacy. In one embodiment, the combination radiation and radiosensitizer delivery catheter for inhibiting hyperplasia comprises a catheter body having a proximal end and distal end, an ionizing radiation source coupleable to the catheter body for applying a radiation dose to a body lumen, and a porous material, matrix, membrane, banier, coating, infusion lumen, stent, graft, or reservoir for releasing an radiosensitizer to the body lumen.

Abstract: An intravascular catheter with micro spines that penetrate arterial wall to delivery drug or mechanical injury to the vessel wall inducing a “stent” like healing process in the vessel.

Abstract: A catheter balloon formed of a polymeric material such as expanded polytetrafluoroethylene (ePTFE) bonded to a second layer formed of a low tensile set polymer and/or impregnated with a low tensile set polymer. In a presently preferred embodiment, the low tensile set polymer is a silicone-polyurethane copolymer elastomer or a diene polymer elastomer. The low tensile set polymer has high strength, low modulus, high elongation, and low tensile set. The diene or silicone-polyurethane has a low tensile set, which facilitates deflation of the balloon to a low profile deflated configuration. One aspect of the invention provides improved attachment of the diene to the ePTFE. In one embodiment, the second layer is formed of a diene mixed with a bonding promoter such as a vulcanizing agent which is covalently bonded to the diene.

Abstract: A balloon catheter and a method of making the balloon catheter, having a balloon which is bonded to an elongated shaft, and which has a first layer and a second layer and an improved strong bond between the balloon and the shaft. One aspect of the invention is directed to a balloon in which the balloon first layer has at least a section with a gas plasma-etched or chemical solution-etched surface for improved bondability. Another aspect of the invention is directed to a balloon in which the balloon first layer has a proximal end section bonded to an outer surface of the shaft and the balloon second layer has a proximal end section bonded to an inner surface of the shaft, and, in one embodiment, at least a section of the balloon first layer has a gas plasma-etched or chemical solution-etched surface.

Abstract: A balloon catheter having a balloon disposed upon an elongate shaft near a relatively rigid distal insertion tip, a fluid lumen for fluid communication with a body cavity and an inflation lumen for fluid communication with the balloon. The balloon holds the catheter tip within a body cavity such as the stomach for long-term enteral feeding. The balloon is configured such that upon inflation, the balloon distends distally to cover the distal tip thus insulating it from sensitive anatomy.

Abstract: A dimensionally stable and growth controlled inflatable member formed by adding a multifunctional agent to a soft polymer to form a compound, extruding an inflatable member from the compound, and crosslinking the compound. The inflatable member is configured to be formed-in-place with a body lumen. Preferably, the inflatable member is blown to a working diameter prior to use and then heated to the glass transition temperature of the polymer to shrink the diameter of the blown inflatable member back to about the nominal diameter of the tubing. In another embodiment, the invention is a dimensionally stable and growth controlled inflatable member comprising longitudinal zones of crosslinked material symmetrically spaced about the circumference of the inflatable member and a uniform working diameter. Preferably, there are three or more longitudinal zones that run the working length of the inflatable member.

Abstract: An angioplasty balloon catheter and method of making and using the same. The balloon catheter may include a catheter shaft and a balloon coupled to the shaft. The balloon may include one or more cutting edges or member and may include one or more wings. The wings may include an undulating surface.

Abstract: The present invention relates to an appliance for cannulation of a blood vessel with a cannula which, after introduction into the vessel, is in fluidic communication with the vessel. At least one means is also provided to permit a controlled division of the blood into a first subsidiary stream which leaves the vessel through the cannula, and a second subsidiary stream which continues to flow through the vessel.

Abstract: The present invention provides a mechanism by which the physical properties of diseased blood vessel walls can be manipulated to achieve an effective vessel lumen diameter for a prolonged period of time. The methods and devices of the present invention selectively isolate and treat the medial or adventitial layers of these diseased blood vessels. The invention is based on the delivery of proteolytic enzymes and crosslinking agents via specialized delivery devices to a select layer of the diseased blood vessel wall. By isolating and treating these layers of the artery, collagen degrading and collagen crosslinking agents can be delivered so as to affect the diameter of the blood vessels and control blood flow therein.

Abstract: The present invention relates to a tracheal ventilating device, especially a tracheal tube or tracheal cannula which obturates the trachea as hermetically as possible for ventilating a patient, the device comprising a cuffed balloon which blocks the trachea below the glottis and through which a ventilating cannula is passed, with the cuffed balloon when filled or inflated and freely unfolded without any limitation, being larger than when placed in the trachea in an inflated state, and being made from a soft flexible foil material. To intubate a patient with said device as gently as possible at low pressures over a long period of time and with a low risk of infection, the invention suggests that the draped fold of the cuffed balloon should rest on the trachea and be designed in such a way that the loop created at the dead end of a fold has a small diameter which inhibits the free flow of secretion through the loop of said fold.

Abstract: Desired portions of a balloon may be marked by varying the texture of the surface. Marking the balloon facilitates positioning of the balloon on a catheter and facilitates positioning a medical device on the balloon.

Abstract: The present invention relates to a balloon catheter for positioning a stent, including a tubular basic body with a proximal end and a distal end, and at least one lumen extending in between, a balloon close to the distal end which is connected to the lumen, and a stent crimped around the balloon, wherein a filling body of elastic material is arranged inside the balloon and has a size corresponding to at least the dimensions of the stent in compressed state, where the filling body is compressed by the stent in the compressed state.

Abstract: A method and expandable device for thermally affecting tissue in which there is a fluid conduit. An expandable element includes a wall defining an inner volume. The wall has a tissue contact region which is non-coaxial with the longitudinal axis of the fluid conduit. The tissue contact region is operable to have a first contact surface area and a second contact surface area in which the second contact surface area is larger than the first contact surface area. A port is formed through the wall and is in fluid communication with the fluid conduit.

Abstract: Desired portions of a balloon may be marked by varying the texture of the surface. Marking the balloon facilitates positioning of the balloon on a catheter and facilitates positioning a medical device on the balloon.

Abstract: Embodiments of the present invention are directed to a method and apparatus for accurate positioning of a dual balloon catheter. In one embodiment of the present invention, a first balloon provides an anchoring point. In one embodiment, the first balloon has protrusions to help secure its position. In one embodiment, once the first balloon is inflated, it provides a fixed position relative to which a second balloon is accurately positioned in the treatment region. In another embodiment, a second balloon imparts a radial force. In another embodiment, a second balloon imparts an axial force, using the first balloon as an anchor against which the force is applied. The force may be applied in a forward or a backward direction. In yet another embodiment, a second balloon imparts a rotational force, using the first balloon as an anchor against which the force is applied.

Abstract: A hydraulically expandable medical device for insertion into an obstruction in a blood vessel, comprising a hydraulically expandable tube having a clover leaf shape in its relaxed, deflated, position; and longitudinal ridges attached to the expandable tube and harbored in the clover leaf shape, the expandable tube adapted to be inflated and expanded with fluid, thereby pushing the elongated ridges outwardly into the obstruction material.

Abstract: Methods for forming low profile balloons for use with a catheter by providing a polymeric tube, removing material from the outer surface of the polymeric tube around at least one of its end portions, and inflating a region of the polymeric tube between the two end portions to form the balloon. Low profile balloons having end portions with an outer diameter below 30 mils are also disclosed.