Abstract: A coated implantable medical device 10 includes a structure 12 adapted for introduction into the vascular system, esophagus, trachea, colon, biliary tract, or urinary tract; at least one layer 18 of a bioactive material posited on one surface of structure 12; and at least one porous layer 20 posited over the bioactive material layer 18 posited on one surface of structure (12) and the bioactive-material-free surface. Preferably, the structure 12 is a coronary stent. The porous layer 20 is comprised of a polymer applied preferably by vapor or plasma deposition and provides a controlled release of the bioactive material. It is particularly preferred that the polymer is a polyamide, parylene or a parylene derivative, which is deposited without solvents, heat or catalysts, merely by condensation of a monomer vapor. Also disclosed is the method of manufacture of the device 10, as well as a method of using it in medical treatments.

Abstract: An improved prosthesis assembly for placement at an aneurysm in the bifurcated lumen of the aorta and the common iliac arteries extending therefrom. The prosthesis assembly includes a single lumen graft or a bifurcated lumen graft having a main body and ipsilateral and contralateral limbs extending therefrom. The main body and ipsilateral and contralateral limbs each have a spring assembly about their orifices for conforming that portion of the graft to the wall of the vessel lumen. The main body spring assembly has an improved barb with first and second attachment arms for securely anchoring the spring assembly to the vessel wall. The improved barb includes two forms of mechanical attachment such as, for example, a helical coil body positioned around a spring assembly arm and, secondly, a bonding material such as, for example, solder for fixedly attaching the coil and spring assembly arm.

Abstract: A coated implantable medical device 10 includes a structure 12 adapted for introduction into the vascular system, esophagus, trachea, colon, biliary tract, or urinary tract; at least one layer 18 of a bioactive material positioned over the structure 12; and at least one porous layer 20 positioned over the bioactive material layer 18. Preferably, the structure 12 is a coronary stent, and the bioactive material is at least one of heparin, dexamethasone or a dexamethasone derivative. The device 10 includes layers 18 and 22 of heparin and dexamethasone, the layer 22 of dexamethasone being positioned above the layer 18 of heparin. The layers of bioactive material also can be individual materials or a combination of different materials. Unexpectedly, the more soluble heparin markedly promotes the release of the less soluble dexamethasone above it. The porous layer 20 is composed of a polymer applied by vapor or plasma deposition and provides a controlled release of the bioactive material.

Abstract: A papillotome (10) including a multi-lumen inner member tube (11) with an outer member tube (16) positioned around the proximal portion thereof with a spacing therebetween for limiting the radial expansion of the inner member tube so that the elastic limit of the inner member tube is not exceeded. The material of and the spacing between the inner and outer member tubes is selected so as to longitudinally distribute the radial expansion of the inner member tube from a fixed or partial attachment of the inner and outer member tubes.

Abstract: A pulsed Doppler probe 10 for monitoring blood flow within a blood vessel 12 includes a sheath 17 and a plurality of electrically conductive wires 26 extending through the sheath 17. The wires 26 have distal ends 28 to which an ultrasonic transducer 18 is operatively connected. The transducer 18 has an operative surface 20, and the probe 10 also includes a means 22 for fixing the orientation of the operative surface 20 with respect to at least one of a longitudinal axis 38 of the sheath 17, and the orientation fixing means 22, or with respect to the distal ends 28 of the electrically conductive wires 26. The orientation fixing means 22 includes an epoxy material 24 encasing the ultrasonic transducer 18, shaped to include a cylindrically concave surface 30. The probe 10 further includes a mesh band 44 of at least one of an absorbable material and an inert material adapted to encircle the blood vessel 12.

Abstract: A minimally invasive medical device (10, 23, 31, 40, 41, 46, 49) for providing a selected and controlled radiation dosage to the vascular system of a patient. The device includes an outer sheath (15) with an inner elongated member (55) slidably disposed in the passage (59) of the outer sheath. The inner elongated member has an expandable distal portion (11) of spring wires (12, 13) looped about a distal end 14 of the inner elongated member. The inner elongated member also includes a proximal portion (17) extending from the proximal end (58) of the outer sheath for extending and withdrawing the expandable distal portion from the distal end (56) of the outer sheath. The spring wires of the expandable distal portion include a radiation source (18) alloyed with or disposed around the spring wires. The inner elongated member also alternatively includes a catheter (60) with an inflatable balloon (38) forming the expandable distal portion thereof.

Abstract: An intravascular medical device having a structure shaped and sized for introduction into the vascular system of a patient including a base material and a coating of a thrombolytic agent on the base material. The thrombolytic agent advantageously dissolves or breaks up the formation of thrombus on the surface of the structure when placed in the vascular system of a patient. The intravascular medical device also includes a antithrombogenic agent for inhibiting the formation of thrombus on the surface of the medical device. The method of treating a medical device with a thrombolytic agent includes providing a base material for the medical device along with a thrombolytic agent. The base material is dipped into the thrombolytic agent and then removed to allow the thrombolytic agent to dry on the surface thereof. The dipping and drying steps are repeated to increase the concentration or quantity of the thrombolytic agent on the device.

Abstract: A minimally invasive intravascular medical device for providing a radiation treatment in a body passageway such as a coronary vessel of the vascular system. The device includes a flexible elongated member having distal and proximal portions. The distal portion is percutaneously insertable into a vessel and includes a distal end that is directable through the vessel to the treatment site. A radiation source is attached about the distal portion for delivering a radiation treatment to the walls a vessel having a stent positioned thereagainst. The distal portion of the elongated member includes a wire coil positioned about the tapered distal end of a mandril wire. The combination of the wire coil and the tapered distal end of the mandril wire provides variable flexibility to the distal portion of the device. The distal portion also has a predetermined curvature for directing the distal end of the device through the vessel.

Abstract: A catheter, system, and method for selectively ablating prostatic tissue about the prostatic urethra. The catheter includes an elongated member having distal, proximal, and intermediate portions, the intermediate portion being shaped and sized for intimate contact with the prostatic urethra. The distal and proximal portions of the catheter include fixation and cooling balloons having an annular recess therein for positioning the internal and external sphincters therein and for maintaining the longitudinal position of the catheter in the prostatic urethra. A thermally conducted, heat-emitting element is positioned in the intermediate portion for producing a thermally conductive heat distribution to ablate the prostatic tissue. The catheter also includes irrigation and aspiration passageways therein for communicating with the interior of the distal and proximal cooling balloons.

Abstract: A system and method for producing volumetric conductive hyperthermia for the treatment of a cancerous tumor in a patient. The location and volume of the tumor are determined with the aid of a CT scanning system, and an array of probes each containing a heat-emitting element is formed by interstitial implantation in the tumor in a predetermined pattern for volumetric heating using a template for guiding the probes into parallel alignment in the tumor. The template is affixed with respect to the patient's body and with respect to the imaging plane of the CT scanning system. After implantation, the probes are connected to a manifold which is in turn connected to an external control system capable of independently controlling the probes while monitoring various analog and digital values representative of system performance.

Abstract: An epidural catheter is disclosed having a durable and a flexible segment joined together. The flexible segment is inserted into a patient with the use of a well-known needle which is removed by passing the needle over the outside of the catheter. The flexible segment is atraumatic to the surrounding tissue. The flexible segment includes a plastic tube surrounded by a wire coil for pushing the tube into a passageway of the tissue. The distal end of the plastic tube and wire coil are joined to prevent unwinding of the coil when extracted. The tightly coupled wire coil also permits the flexible portion to be easily inserted into the passageway of the tissue. The durable segment joined to the flexible segment includes a stainless steel tube with a flat wire coil surrounding a length of the tube. The stainless steel tube permits fluid at an elevated pressure to pass through the hollow passageway therein without rupturing. The flat wire coil prevents kinking of the semi-rigid stainless steel tube.

Abstract: Method and apparatus are disclosed for thermally destroying a layer of an organ such as the mucosal layer of the gallbladder. The apparatus includes a catheter having an elongated member having a plurality of lumens therein. At the distal end of the elongated member is an electrode for emitting radiofrequency current to the mucosal layer. Also at the distal end is a capacitive balloon electrode surrounding the current-emitting electrode for containing an electrolyte solution and for distributing the radiofrequency current to the mucosal layer. The balloon electrode is expanded with the electrolyte solution to conform and make contact with the mucosal layer. The electrolyte solution has a resistivity significantly less than the resistivity of the gallbladder wall, as well as the gallbladder bile, to cause a concentrated power deposition in the mucosal layer.