Abstract: The invention provides a method of manufacturing a system for treating a vascular condition. A catheter including an inflatable balloon is provided. A stent is positioned over the balloon. An adhesive material is applied between an inner surface of the stent and an outer surface of the balloon. The adhesive material is heated to above a melting point of the adhesive material. The adhesive material is cooled to below a melting point of the adhesive material to provide an adhesive bond that retains the stent to the catheter during vascular delivery, wherein the stent is released from the balloon following inflation and deflation of the balloon at a treatment site.

Abstract: A method for the treatment of a stenosis or an occlusion in a blood vessel in which an occlusive device is first delivered and activated at a site distal to the occlusion to at least partially occlude the vessel. A therapy catheter is then introduced to treat the occlusion and a debris removal device is delivered to aspirate debris from the vessel. The present invention eliminates the need for a separate irrigation catheter and irrigation fluid which allows the procedure to be performed quickly and efficiently, and is especially useful in the removal of occlusion from saphenous vein grafts, the coronary and carotid arteries, arteries above the aortic arch and vessels of similar size and pressure.

Abstract: The present invention provides a stent for delivering drugs to a vessel in a body, including a stent framework with a plurality of reservoirs formed therein, a drug polymer positioned in the reservoirs, and a polymer layer positioned on the drug polymer. The present invention also provides a method of manufacturing a drug-polymer stent and a method of treating a vascular condition using the drug-polymer stent.

Abstract: A balloon catheter includes an inflation shaft and an elongated guidewire shaft. A relatively short, distal portion of the guidewire shaft is attached to, or enveloped within, a distal portion of the inflation shaft. A proximal portion of the guidewire shaft is detached from and independent of a proximal portion of the inflation shaft. The detached portion of the guidewire shaft contains perforations at pre-determined points along its length that define removable segments thereof. The removable segments remain attached to the guidewire shaft under normal conditions, but may be torn away from the guidewire shaft to provide access to a guidewire within a guidewire lumen thereof.

Abstract: A catheter and guide wire exchange system including a catheter having a guide wire lumen with a guide way extending along the length of a stiffened proximal shaft portion, and a guide member slidably disposed about the proximal shaft for directing a guide wire into or out of the guide way and the guide wire lumen. The guide member may be slid along the proximal shaft portion and the guide wire in zipper-like fashion so that the guide wire is contained within the guide wire lumen distal to the guide member and with the guide wire and catheter being separated proximal of the guide member.

Abstract: A catheter for emitting radiation is disclosed, comprising a catheter shaft and an x-ray unit attached to the distal end of the catheter shaft. The x-ray unit comprises an anode and a cathode coupled to an insulator to define a vacuum chamber. The cathode is preferably a field emission cathode of graphite or graphite coated with titanium carbide, for example. The anode is preferably tungsten and the insulator is preferably pyrolytic boron nitride. The x-ray unit is preferably coupled to a voltage source through a coaxial cable. The anode is preferably a heavy metal such as tungsten. The cathode may also be a ferroelectric material. The x-ray unit can have a diameter less than about 4 mm and a length less than about 15 mm. Methods of use of the catheter are also disclosed. The catheter of the present invention can be used to irradiate the site of an angioplasty procedure to prevent restenosis. It can also be used to treat other conditions in any vessel, lumen or cavity of the body.

Abstract: Methods for coating a stent according to the invention include mixing a plurality of compounds to form a solution and applying the solution to a stent frame. The solution is dried on the stent frame to substantially evaporate solvent(s). In one embodiment, the solution includes at least one therapeutic agent, a poly(□-caprolactone) polymer, and a tetrahydrofurane solvent. In another embodiment, the solution includes a Resten-NG therapeutic agent, at least one polymer, and at least one solvent including methanol. In yet another embodiment, the solution includes a podophyllotoxin therapeutic agent, at least one poly(n-butylmethacrylate-co-vinylacetate) polymer, and at least one solvent.

Abstract: A balloon catheter includes a one-piece shaft and a guidewire track for use of a guidewire that runs along an outer surface of the one-piece shaft adjacent to a longitudinal central axis of the one-piece shaft. The one-piece shaft has an inflation lumen formed therein. The one-piece shaft is formed to include a substantially C-shaped cross section, which has two endpoints and forms the guidewire track. The dimensions of the wall thicknesses between the inflation lumen and the guidewire track may be varied to help maintain the guidewire track and the gap between the endpoints of the C-shaped cross section such that a guidewire is maintained on the guidewire track and does not traverse the gap. In addition, a reinforcement may be included in the single lumen shaft to maintain the integrity of the guidewire track.

Abstract: A low profile catheter valve comprises a movable sealer portion positioned within the inflation lumen of a catheter. The sealer portion forms a fluid tight seal with the inflation lumen by firmly contacting the entire circumference of a section of the inflation lumen. The sealer portion may be positioned proximally of a side-access inflation port on the catheter, to establish an unrestricted fluid pathway between the inflation port and an inflatable balloon on the distal end of the catheter. As desired, the clinician may move the sealer portion to a position distal of the inflation port, thereby preventing any fluid from being introduced into or withdrawn from the balloon via the inflation port.

Abstract: The present invention provides a system for treating a vascular condition, which includes a catheter; a stent coupled to the catheter, the stent including a stent framework; a phenoxy primer coating operably disposed on the stent framework; and a drug-polymer coating disposed on the phenoxy primer coating. The present invention also provides a drug-coated stent and a method of manufacturing a drug-coated stent.

Abstract: A cathode for a miniature X-ray device includes an insulating shell, a cathode and an anode. The cathode includes a focusing cup formed into an end. The focusing cup can include a thin metal layer that conforms to an inner surface of the cathode. An emitting material having a low work function, such as diamond, is deposited directly onto the internal surface of the focusing cup. The anode has a flat receiving surface for collecting electrons emitted from the anode. An interior coating is applied as a circumferential belt on the interior surface of the insulating shell. The interior coating, formed of a negative secondary emission yield material, extends lengthwise in the region of the cathode to an anode gap, covering the region of the insulating shell most likely to be subject to stray electrons emitted from the cathode.

Abstract: A mold for forming medical balloons and the balloons formed therefrom are disclosed. The mold has a generally cylindrical inner molding surface for forming a working length of the balloon, and generally cylindrical outer molding surfaces at either end of the mold for forming shafts of the balloon. Joining these outer and inner molding surfaces are taper molding regions composed of two generally conical molding surfaces oriented at two different angles from a longitudinal axis of the mold. A balloon resulting from a manufacturing process using a mold according to the present invention reflects the geometry of the mold and has a unique concave taper profile and a well-defined working length.

Abstract: A filter for filtering micro-emboli from a patient's blood during an angioplasty procedure is disclosed which comprises a plurality of curved wires connected to a rod between a first connector fixed with respect to the rod and a second connector slidingly mounted on the rod. Two layers of filter material are connected to opposite sides of the wires, and each layer includes perforations which are offset from the perforations in the other layer. When the rod and the wires are disposed within a catheter, the inner wall of the catheter compresses the wires toward the rod and when the rod is extended from the catheter, the wires resume their curved shape and pull the sliding connector along the rod toward the fixed connector.

Abstract: An over-the-wire catheter provides substantially shadow-free delivery of radiation to a body lumen by having a treatment region wherein a guidewire tube and a radiation source tube form a parallel double helix configuration. When a radiation source is inserted into the radiation source tube and a guidewire is present in the guidewire tube, no portion of the treatment site will be obscured from all radiation emitted by the radiation source because, within the treatment region, the guidewire and the radiation source are not in a conventional, axially parallel configuration. Optionally, a balloon may be mounted about or adjacent the treatment region of the catheter, the balloon providing centering and/or dilatation functions.

Abstract: A process for forming a heat weld between a catheter shaft and a surrounding balloon comprises selecting an elongate catheter shaft formed of thermoplastic polymeric material that is opaque to red and near-infrared light, and selecting a balloon formed of thermoplastic polymeric material that is transparent or translucent to red and near-infrared light. While a neck of the balloon is fitted in close contact around a distal portion of the catheter shaft, a laser beam of red and near-infrared light is applied through the balloon neck to impinge on the underlying opaque distal shaft, which is heated thereby. Heat from the shaft is conducted into the surrounding balloon neck so that adjacent annular portions of both components melt and mix. The molten materials are allowed to cool, forming a secure weld joint between the neck and the shaft. The process yields strong, flexible bonds between balloons and catheter shafts that may be selected from a wide variety of materials.

Abstract: A medical device for stenting within a patient's vascular system is a low profile fixed-wire balloon catheter. The balloon is not attached directly to the wire-like structure of the catheter, providing a degree of independent rotation therebetween.

Abstract: A catheter to be used without a guidewire which includes a support wire shaft formed of metal, a balloon mounted on a distal portion of the catheter, and an inflation shaft for inflating the balloon, wherein a core wire may be interchangeably inserted into the support wire shaft when the catheter is within a human body to change the stiffness and improve control thereof.

Abstract: A catheter to be used without a guidewire which includes a support wire shaft formed of metal, a balloon mounted on a distal portion of the catheter, and an inflation shaft for inflating the balloon, wherein a core wire may be interchangeably inserted into the support wire shaft when the catheter is within a human body to change the stiffness and improve control thereof. In one embodiment, the portion of the support wire shaft that extends just proximal of, through and distal of the balloon is formed entirely of a metal wound coil. The flexibility characteristics of this support wire shaft can be controlled by varying the pitch of the wound coil and the thickness of the wire or ribbon it is made from. An overjacket is also provided on the metal wound coil portion to hold pressure within the inflation lumen and provide a suitable material for bonding a distal end of the balloon to the support wire shaft.

Abstract: An endolumenal prosthesis delivery assembly includes an endolumenal prosthesis which is delivered to a desired location within a body lumen by used of first and second delivery members. The first delivery member has a prosthesis coupler that is adapted to removeably engage the prosthesis during delivery to the desired location and to release the prosthesis and implant it at the desired location. The second delivery member has an anchor on its distal end portion which is adapted to secure the second delivery member within the body lumen distally of the desired location for stenting. Once the second delivery member is anchored, the first delivery member is slideably advanced over the second delivery member until the prosthesis is positioned at the desired location. The anchor along the second delivery member according to this assembly is either an expandable member, such as a balloon, or is otherwise adapted to engage the body lumen wall, such as by use of suction or other mechanical means.

Abstract: A guidewire apparatus for use during percutaneous catheter interventions such as angioplasty or stent deployment. A protection element comprising a filter or an occluder is mounted near the distal end of a steerable guidewire, which guides a therapeutic catheter. The guidewire apparatus comprises a hollow shaft movably disposed about a core wire. The shaft and core wire control relative displacement of the ends of the protection element, causing transformation of the protection element between a deployed configuration and a collapsed configuration. The protection element is freely rotatable about the guidewire apparatus. A tracking member disposed adjacent the distal end of the guidewire apparatus can be used to guide the device along another guidewire. Thrust bearings may be employed to facilitate unlimited rotation of the steerable guidewire within the protection element, especially while the protection element is retained in the collapsed configuration.