Abstract: A prosthesis for insertion into a lumen to limit restenosis of the lumen. The prosthesis carries restenosis-limiting drugs which elute after the device is positioned in the lumen.

Abstract: A stabilized electrophysiology catheter (4) includes a main body portion (16) and a flexible tip portion (18). A plurality of electrodes (24, 26) are positioned along the tip portion. The tip portion includes a main section (20) and a pre-curved, offset, reverse-angle anchor section (22) at its distal end. The anchor section is shaped to engage with and anchor to a coronary opening, typically the coronary sinus opening (48) in the right atrium or a pulmonary vein opening (82) in the left atrium, for stabilized mapping and ablation of the right atrium or the left atrium. A manipulator wire (36) is used to radially deflect the tip portion in a first direction (40). When introduced through the superior vena cava (46), the tip portion forms a generally J-shape. When introduced through the inferior vena cava (54), the tip portion is deflected more than 360.degree..

Abstract: A prosthesis for insertion into a lumen to limit restenosis of the lumen. The prosthesis carries restenosis-limiting drugs which elute after the device is positioned in the lumen.

Abstract: Multifunction and radial deflection wires (66, 64) extend from a catheter shaft (8) and into a handle (4). The multifunction wire is pulled and pushed longitudinally and is rotated about its axis to change the stiffness of and to laterally deflect the tip portion (12). A curve size manipulator (32) on the handle body (24) moves the multifunction wire longitudinally but does not hinder its rotational movement. Rotation of a lateral deflection manipulator (38) on the handle causes the proximal end (70) of the multifunction wire to rotate about its own axis; the free longitudinal movement of the proximal end is unhindered. Any initial corkscrewing or other deflection of the tip portion can be removed at assembly by rotating the proximal end (68) of the radial deflection wire. The longitudinal movement of the manipulators can be limited by movable stops (120).

Abstract: An intraluminal stent comprising fibrin is capable of reducing the incidence of restenosis at the site of vascular injury such as that produced by an angioplasty procedure.

Abstract: Intraluminal stents and methods of manufacturing intraluminal stents are disclosed in which the stents have a plurality of recesses in the body of the stent, at least some of the recesses preferably providing a plurality of passageways between the inner and outer surfaces of the stent. The preferred stents are constructed of films on support structures having spaced apart elements, with the films having a thickness of between about 25 micrometers and about 400 micrometers. The stent can also be treated with an antithrombotic or a thrombolytic substance and, in some cases, the stents can incorporate therapeutic agents for delivery. The methods of manufacturing stents include forming the films using a solid particulate material that can be substantially removed after the film is formed, thereby forming the recesses and corresponding passageways described above. In preferred methods, the solid particulate material is soluble in a solvent in which the film is substantially insolvent.

Abstract: A method for making a medical balloon catheter in a single molding operation employs a parison which is molded and biaxially oriented by the use of first and second pressurization stages. The starting material is in the form of a tubular parison with a reduced diameter portion which is made of a biaxial orientable polyamide or polyetheramide material. The resulting balloon can be attached to a catheter that includes a tapered or stepped distal end without further shaping or modification of the balloon ends.

Abstract: A method of predicting critical points in patient respiration includes monitoring at least one characteristic of a respiratory effort waveform of a patient to detect a respiratory event. A refractory period is defined that includes a hard refractory period during which time the respiratory event cannot be responded to and a soft refractory period following the hard refractory period. The respiratory event outside of the refractory period is detected as a function of a first set of predetermined parameters for the monitored at least one characteristic and the respiratory event within the soft refractory period is detected as a function of a second set of predetermined parameters for the monitored at least one characteristic. The respiratory event may be inspiration onset and the characteristic of the respiratory effort waveform monitored is at least one of slope and amplitude.

Abstract: A catheter and method of making the same, including an elongated tube structure having a proximal end and at least one preset curved portion proximate a distal end. The preset curved portion includes a first material located generally along an outer surface of the preset curved portion and a second material located generally along an inside surface of the preset curved portion. The first material preferably has a greater stiffness than the second material, so that the catheter is capable of assuming a generally straight configuration without plastic deformation.

Abstract: Balloon catheters are prepared to include body affecting chemicals within microcapsules on the exterior of the balloon either alone or with a stent. The coating releases from the balloon when the balloon is inflated into contact with the lumen to be treated. The device provides accurate placement of the dosage required at the location in need of treatment. A sheath may be employed over the balloon and microcapsules to prevent the microcapsules from being rubbed off during delivery through a body lumen. The catheters are especially useful in balloon angioplasty procedures.

Abstract: A prosthesis for insertion into a lumen to limit restenosis of the lumen. The prosthesis carries restenosis-limiting drugs which elute after the device is positioned in the lumen.

Abstract: A medical device having a surface graft matrix comprising carboxyl-functional groups located on the device, the surface graft matrix comprising an outer portion; and one or more biomolecules covalently coupled to the surface graft matrix, wherein a majority of the biomolecules are located in the outer portion of the surface graft matrix. The surface graft matrix can also be loaded with a pharmaceutical agent.

Abstract: A a blood-contacting medical device with improved biocompatibility. The device is coated with a layer of water-soluble heparin, overlaid by a porous polymeric coating through which the heparin can elute. The inclusion of a porous polymer in intimate contact with a heparin on the device controls the administration of heparin following implantation or other blood contact. The adhesion of the coating and the rate at which the heparin is delivered can be controlled by the selection of an appropriate bioabsorbable or biostable polymer.

Abstract: A prosthesis for insertion into a lumen to limit restenosis of the lumen. The prosthesis carries restenosis-limiting drugs which elute after the device is positioned in the lumen.

Abstract: A prosthesis for insertion into a lumen to limit restenosis of the lumen. The prosthesis carries restenosis-limiting drugs which elute after the device is positioned in the lumen.

Abstract: An intraluminal stent comprising fibrin is capable of reducing the incidence of restenosis at the site of vascular injury such as that produced by an angioplasty procedure.

Abstract: A method for making an intravascular stent by applying to the body of a stent a solution which includes a solvent, a polymer dissolved in the solvent and a therapeutic substance dispersed in the solvent and then evaporating the solvent. The inclusion of a polymer in intimate contact with a drug on the stent allows the drug to be retained on the stent during expansion of the stent and also controls the administration of drug following implantation. The adhesion of the coating and the rate at which the drug is delivered can be controlled by the selection of an appropriate bioabsorbable or biostable polymer and the ratio of drug to polymer in the solution. By this method, drugs such as dexamethasone can be applied to a stent, retained on a stent during expansion of the stent and elute at a controlled rate.

Abstract: To minimize the incidence and consequences of device related infection that occur after prosthetics implants of neuro-muscular stimulating devices, an infection resistant intra-muscular lead has been developed and is disclosed herein. Infection incidence has been decreased by using biomaterials able to release antibacterial drugs (gentamicin) at a controlled rate for the first 3-6 weeks after implant.

Abstract: This invention relates to an intraluminal stent having a lumen-wall contacting surface and a lumen-exposed surface wherein the stent comprises a first polymer composition comprising fibrin and wherein the stent is suitable to deliver virus to the wall of a lumen of the body. The invention also relates to methods for making the stent and to methods for delivering nucleic acid to cells accessible from a wall of a body lumen.

Abstract: A method for delivering a therapeutic substance to a body lumen utilizing an intravascular stent having a coating comprising a polymer and a therapeutic substance in a solid/solid solution with the polymer. The coating comprises a first coating layer nearer the stent body having a first concentration of therapeutic substance overlaid by a second porous coating layer having a second lesser concentration of therapeutic substance. The inclusion of a porous polymer coating layer on the stent helps retain the therapeutic substance on the stent during expansion of the stent and also controls the administration of the therapeutic substance following implantation. By this method, drugs such as dexamethasone can be applied to a stent, retained on a stent during expansion of the stent and elute at a controlled rate.