Abstract: Angiogenesis in cardiac and other tissues is promoted by the transmural delivery of angiogenic factors such as VEGF, FGF, EGF, and PDGF, through blood vessels and other body lumens into the surrounding tissue. Usually, the angiogenic factor is delivered using a catheter having infusion parts at its distal end. Optionally, the distal end of the catheter is radially expanded to engage the infusion parts directly against the blood vessel wall.

Abstract: A radially expansible lumenal prosthesis comprises one or more body segments which include struts and hinge regions between the struts. Certain of the hinge regions are weakened relative to others so that the expansion characteristics of the prosthesis may be programmed. In particular, by distributing the weakened hinge regions circumferentially about the body segment, uniform expansion of the prosthesis can be improved, even when the prosthesis is only partially deployed.

Abstract: A balloon catheter assembly (2) includes a catheter (8) having a catheter shaft (10) with a balloon (12) at its distal end. A sleeve assembly (16) has a diametrically expanding balloon enlargement sleeve (18) at its distal end sized to be positionable over the balloon when the balloon is deflated. The enlargement sleeve can expand from a relaxed condition, at which it is placed over the deflated balloon, to an expanded condition surrounding the fully inflated balloon. The enlargement sleeve is sufficiently thick when expanded for an enlarged dilatation of the vessel when the balloon is reinflated. The enlargement sleeve can be made of elastic or substantially inelastic material; it can also include a porous matrix material with a drug interspersed therein so the drug is applied topically when the vessel is redilated.

Abstract: The invention provides methods and devices for delivering low level radiation to inhibit neointimal hyperplasia following angioplasty or other intravascular procedures. In an exemplary method, a balloon is inflated within a stenosed region of a blood vessel to produce a treated region. The balloon is then deflated and a radioactive source within a sleeve is aligned over the deflated balloon. The balloon is again inflated at the treated region to engage the sleeve having the radioactive source against the blood vessel within the treated region for from 1 to 40 minutes to deliver a sufficient dose of radiation to inhibit neointimal hyperplasia.

Abstract: Sleeve catheters having an interactive device near their distal ends are provided for introduction while disposed over conventional interventional and imaging catheters. Exemplary interactive devices on the sleeve catheters include ultrasonic imaging arrays, drug delivery lumens, and the like. The sleeve catheters are most commonly used with angioplasty catheters, stent placement catheters, atherectomy catheters, and the like.

Abstract: The invention provides methods and devices for delivering low level radiation to inhibit neointimal hyperplasia following angioplasty or other intravascular procedures. In an exemplary method, a balloon is inflated within a stenosed region of a blood vessel to produce a treated region. The balloon is then deflated and a radioactive source within a sleeve is aligned over the deflated balloon. The balloon is again inflated at the treated region to engage the sleeve having the radioactive source against the blood vessel within the treated region for from 1 to 40 minutes to deliver a sufficient dosage of radiation to inhibit neointimal hyperplasia.

Abstract: The catheter system comprises a balloon catheter having a removable hub. The hub is removed to permit loading of a sleeve catheter over the proximal end of the balloon catheter. The removable hub includes both a circumferential seal for preventing leakage of inflation medium from the hub and a mechanical interlock for axially securing the hub to the balloon catheter.

Abstract: An intravascular catheter provides fluid infusion tubes over a balloon surface to form isolated reservoir pockets for delivering drugs intraluminally. The fluid infusion tubes will be arranged in a network which, upon balloon expansion, defines the isolated reservoir pockets between adjacent tubes. In one embodiment, the drug infusion tubes are formed as part of an expansible sleeve which is positioned over a separate balloon catheter for expansion. In another embodiment, the infusion tubes are disposed over a balloon of a balloon catheter.

Abstract: A catheter for delivering self-expanding stents and other helical prostheses comprises a catheter body having a rotatable barrel at its distal end. The helical prosthesis is received within a helical channel on the rotatable barrel and covered with a retractable cover. Optionally, the channel includes a split membrane for covering the helical stent and preventing direct engagement by the stent against the cover. As the cover is retracted, the stent deploys radially outward and engages an inner wall of the lumen in which it is being deployed. Uncoiling or unwinding of the stent is accommodated by rotation of the barrel so that the stent is not dragged against the inner luminal wall potentially damaging said wall.

Abstract: Methods and apparatus for deburring and rounding edges and polishing surfaces of radially expansible lumenal prostheses, such as stents and grafts, are provided. A stent (2) is mounted onto a polishing apparatus (58) and a flowable abrasive slurry is extruded through the apparatus in abrading contact with inner and outer surfaces (28, 29) and circumferential openings (30) in the stent. To polish the cut surfaces (32) and edges (34, 36) surrounding the openings, the abrasive slurry is introduced into an inner lumen (26) of the stent and extruded radially outward through the openings. The inner and outer wall surfaces 28, 29 are preferably pre-polished prior to cutting the slot pattern (i.e., openings 30) in the stent.

Abstract: A catheter for use in combination with a balloon angioplasty catheter for delivering stents and other intraluminal prostheses comprises a tubular catheter body having a radially expansible portion. The stent is disposed over the radially expansible portion, and structure is provided for retaining the stent on the tubular body prior to deployment. The retaining structure may be active, i.e., requiring the user to retract retaining elements, such as axial members, sheaths, or the like. Alternatively, the retaining structure may be passive, wherein balloon expansion results in release of the prosthesis from the retaining structure. Particular methods for fluoroscopically positioning stents using such delivery catheters, for delivering two or more stents using such delivery catheters, and for overexpanding the ends of the stents for anchoring them in place, are also described.

Abstract: Restenosis in recanalized blood vessels is inhibited by delivering tissue factor pathway inhibitor (TFPI) intramurally at a target site within the blood vessel. Usually, TFPI is delivered using a catheter having infusion ports at its distal end. Optionally at the distal end of the catheter is radially expanded to engage the infusion ports directly against the blood vessel wall.

Abstract: Catheter systems comprising a base catheter and a sleeve catheter are modified to have reduced sliding friction therebetween. The sleeve catheter is received over the base catheter, and an inner luminal surface of the sleeve catheter or outer surface of the base catheter is modified to have surface irregularities to reduce sliding friction. Preferably, the surface irregularities are circumferentially spaced-apart V-spaced peaks. Such peaks may be formed by fabricating tubular catheter bodies in an extrusion tool having a mold or die with correspondingly shaped V-shaped grooves therein. Alternatively, the surface irregularities may be imparted using a mold or mandrel which is placed over or in a tubular catheter body, where the desired geometry is transferred by heating the catheter.

Abstract: An intravascular catheter provides means for infusing an agent into a treatment site in a body lumen and means for deploying the infusing means adjacent the treatment site which operate independently of one another. In a first embodiment, a flexible catheter body has an expansion member attached to its distal end in communication with an inflation passage, and an infusion array disposed about the expansion member in communication with one or more delivery passages. In a second embodiment, the infusion array is a separate component and slidably received over the expansion member, which may be a balloon dilatation catheter. In both embodiments, the infusion array includes a plurality of delivery conduits having laterally oriented orifices. The delivery conduits may be extended radially from the catheter body to contact a treatment site by expanding the expansion member with an inflation fluid.

Abstract: A guide catheter includes a tubular body having a proximal end and a distal end. A pressure or other sensor is disposed at or near the distal end of the body, preferably having an active surface thereof disposed away from the direction of blood flow when the catheter is present in a particular blood vessel, such as the aorta adjacent to a coronary ostium.

Abstract: Type-A (operational) and type-B (non-operational) syringes (2A, 2B), used for double-blind clinical tests, are constructed so the type-B syringe mimics the operation of the type-A syringe while avoiding the delivery of anything into the patient. Each syringe includes an injector (4), a fluid connector (12) coupling the exit port (10) of the injector to a discharge port (14) to which a catheter or needle cannula is connected, a valve (18) positioned along the fluid connector, and a dumping reservoir (24) mounted to the valve. The type-A valve fluidly couples the exit port to the discharge port in both purging and infusion positions. The type-B valve couples the exit port to the discharge port in the purging position, but couples the exit port to the dumping reservoir in the infusion position. The infusate is directed through the catheter and into the patient when in the infusion position with the type-A valve but is directed into the dumping reservoir with the type-B valve.

Abstract: A balloon catheter assembly (2) includes a catheter (8) having a catheter shaft (10) with a balloon (12) at its distal end. A sleeve assembly (16) has a diametrically expanding balloon enlargement sleeve (18) at its distal end sized to be positionable over the balloon when the balloon is deflated. The enlargement sleeve can expand from a relaxed condition, at which it is placed over the deflated balloon, to an expanded condition surrounding the fully inflated balloon. The enlargement sleeve is sufficiently thick when expanded for an enlarged dilatation of the vessel when the balloon is reinflated. The enlargement sleeve can be made of elastic or substantially inelastic material; it can also include a porous matrix material with a drug interspersed therein so the drug is applied topically when the vessel is redilated.

Abstract: An intravascular catheter provides means for infusing an agent into a treatment site in a body lumen and means for deploying the infusing means adjacent the treatment site which operate independently of one another. In a first embodiment, a flexible catheter body has an expansion member attached to its distal end in communication with an inflation passage, and an infusion array disposed about the expansion member in communication with one or more delivery passages. In a second embodiment, the infusion array is a separate component and slidably received over the expansion member, which may be a balloon dilatation catheter. In both embodiments, the infusion array includes a plurality of delivery conduits having laterally oriented orifices. The delivery conduits may be extended radially from the catheter body to contact a treatment site by expanding the expansion member with an inflation fluid.

Abstract: A catheter sleeve includes a radially expansible distal region having a plurality of axial blood perfusion lumens or channels formed thereon. The catheter sleeve may be introduced over a conventional angioplasty balloon catheter with the expansible region lying over the balloon. When the balloon of the angioplasty catheter is expanded, the perfusion lumens will provide a flow path for blood around the expanded balloon. Optionally, the catheter sleeve may further include drug infusion lumens over the radially expansible region. In this way, drugs can be delivered over prolonged periods while the underlying angioplasty balloon is inflated and blood flows through the lumens or channels to perfuse the distal myocardium.

Abstract: A radially expansible lumenal prosthesis comprises a plurality of body segments which are joined by universal articulation structures. Each universal articulation structure consists of a serpentine ring and two pairs of beam members. By joining adjacent body members to the serpentine ring using beam members, an articulated connection is provided while permitting radial expansion of all components. Optionally, linear elements within the body segment or segments may be protected and/or anchored by loop structures joined to or between longitudinal elements of the terminal body segments.