Abstract: A method of creating a simulated aorta patterned from a natural aorta and having a preselected amount of compliance is disclosed. The dimensions of a simulated aortic root patterned according to the dimensions of a natural aorta are first selected and a mold provided. The amount of circumferential compliance desired in the simulated aorta is then selected, based on natural circumferential compliancies. A material such as silicone rubber formed of an elastomer and a filler is used to form the aorta, the durometer of the material being varied by varying the relative amount of the components, to provide the selected amount of circumferential compliance in a simulated aorta having the selected dimensions. The aorta is then formed curing the material in the mold for about 24 hours. Groups of simulated aortas so produced, sometimes having different sizes and/or compliancies are also disclosed. A method of testing non-stented valves using the aortas is included.

Abstract: An electrocautery instrument is provided with a hollow electrode having a source of conductive fluid coupled to a proximal end thereof. Conductive fluid is communicated through said electrode and expelled out of the distal end thereof during electrocautery, forming a “virtual electrode.” The infused conductive liquid conducts the RF electrocautery energy away from the conductive electrode, thereby displacing the region of thermal generation and reducing the extent of burns and perforations caused by conventional electrocautery electrodes. In one embodiment, the electrode is partially disposed within and extends distally out of a retractable suction tube, such that smoke and fluid are aspirated from the electrocautery site. When the suction tube is fully advanced. the electrode is concealed therein, enabling suction without electrocautery to be performed.

Abstract: Deposition of a pyrocarbon coating of precise thickness onto one or more substrates being levitated along with a bed of particles in a fluidized bed coating enclosure is accomplished by varying the amount of hydrocarbon supplied to the bed as a part of an upward levitating flow to compensate for changes which are detected in the size of the fluidized bed. Increases and decreases in the size of the bed are detected by monitoring either the differential pressure above and below the bed or the weight of the bed, and compensating changes are made to return the bed to its desired size by changing the flow rate of hydrocarbon. For example, when a growth in bed size is detected that is not attributable to an aberration in either particle supply or withdrawal, the amount of hydrocarbon being supplied to the bed is decreased so as to cause the size of the bed to gradually return to its desired value.

Abstract: An electro-stimulation device includes a pair of electrodes for connection to at least one location in the body that affects or regulates the heartbeat. The electro-stimulation device both electrically arrests the heartbeat and stimulates the heartbeat. A pair of electrodes are provided for connection to at least one location in the body that affects or regulates the heartbeat. The pair of electrodes may be connected to an intravenous catheter for transvenous stimulation of the appropriate nerve. A first switch is connected between a power supply and the electrodes for selectively supplying current from the power supply to the electrodes to augment any natural stimuli to the heart and thereby stop the heart from beating. A second switch is connected between the power supply and the electrodes for selectively supplying current from the power supply to the electrodes to provide an artificial stimulus to initiate heartbeating.

Abstract: A left atrium ablation catheter (4), including a sheath (8) and a deflectable electrophysiology catheter (10) housed within the sheath, is used to ablate coronary tissue at a target site within the left atrium (LA) of a heart. The electrophysiology catheter has ablation electrodes (24) along the tip (10). The ablation catheter is introduced into the right atrium (RA) through either the superior vena cava (SVC) or the inferior vena cava (IVC). The distal open end of the sheath is guided through a punctured hole in the interatrial septum and into the left atrium. The distal end (20) of the sheath is either precurved or is steerable so the electrode tip can be directed to the coronary target site in the left atrium. The electrode tip is sized and configured to create the desired lesion at the target site without movement of the electrode tip.

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 closed container is filled through a metal fill port which is then sealed with a rigid metal ball press fitted into the port passageway.

Abstract: A left atrium ablation catheter (4), including a sheath (8) and a deflectable electrophysiology catheter (10) housed within the sheath, is used to ablate coronary tissue at a target site within the left atrium (LA) of a heart. The electrophysiology catheter has ablation electrodes (24) along the tip (10). The ablation catheter is introduced into the right atrium (RA) through either the superior vena cava (SVC) or the inferior vena cava (IVC). The distal open end of the sheath is guided through a punctured hole in the interatrial septum and into the left atrium. The distal end (20) of the sheath is either precurved or is steerable so the electrode tip can be directed to the coronary target site in the left atrium. The electrode tip is sized and configured to create the desired lesion at the target site without movement of the electrode tip.

Abstract: An electrophysiology catheter (2) includes a handle (4) and a catheter shaft (6) having a flexible tip portion (22) with one or more electrodes (26, 28). A radial deflection wire (42) connects the tip portion to a first manipulator (10) at the handle to radially deflect the tip portion to a curved shape. A multifunction wire (60) extends from a second manipulator (11) at the handle to the tip portion. The second manipulator slides the multifunction wire longitudinally to position the distal end (64) of the multifunction wire along the multifunction lumen (38). The distal end of the multifunctional wire and the multifunction lumen are configured to provide interfering torquing surfaces (68, 70) so that when a third manipulator (12) rotates or torques the proximal end (62) of the multifunctional wire, the torquing force exerted between the interfering torquing surface causes lateral deflection of the radially curved tip portion.

Abstract: Mulifunction 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). The longitudinal positions of the abutment faces (126, 128) of the stops preferably change according to their longitudinal (distal or proximal) orientation.

Abstract: An implantable sensing device includes a sensing element and a mounting element. The mounting element has a first end and a second end with a longitudinal axis therethrough. The sensing element is positioned at the first end of the mounting element with the mounting element having a length that is adjustable along the longitudinal axis. The mounting element includes a sleeve having a first open end and a second open end with the longitudinal axis therethrough. The sensing element is positioned in the second open end and includes a lead body connected thereto extending through the second open end. The sleeve includes an outer sleeve member coupled for adjustment along the longitudinal axis with respect to an inner sleeve member. Further, the mounting element may include a flexible element about the first open end extending outwardly relative to the longitudinal axis and a flange element extending outwardly relative to the longitudinal axis from at least a portion of the second end.

Abstract: A stent for implantation in a body vessel in which a cylindrical stent body coiled from a generally continuous wire with a zig-zag structure is provide with attachment of the wire ends to an adjacent coil.

Abstract: A method for operating an implantable therapy system to conserve energy includes providing an implantable sensing device that generates a signal as a function of a physiological parameter of a patient during a treatment period. The signal is monitored during at least portions of the treatment period to detect a physiological event for use in controlling therapy of the patient during the treatment period. Energy consumption by the sensing device is terminated during the treatment period for at least portions of the treatment period when signal monitoring is not performed. Another method for operating an implantable therapy system for conserving energy includes providing an implantable component for performance of a function during a treatment period for the therapy system. The implantable component is operable in at least a first state during the treatment period and a second state outside of the treatment period; the first state using more energy than the second state.

Abstract: A medical device comprising a catheter and a balloon-expandable stent having a small initial diameter, flexibility along its longitudinal axis prior to expansion, a large expanded diameter, and rigidity after expansion. Local strain on the stent material is minimized, as and after the balloon is inflated. More particularly, the sent has rotation joints having minimal strain during stent expansion. The stent is substantially the same length before and after expansion and, being flexible longitudinally when constrained, is easy to deliver.

Abstract: A steerable electrophysiology catheter includes a shaft having a distal ablation segment with one or more electrodes coupled to a source of electrical energy by a connector extending through the shaft. The distal ablation segment of the shaft is movable between a collapsed configuration sized for percutaneous introduction into the patient and/or endoluminal delivery to the target site and an expanded configuration, in which the distal ablation segment forms a substantially continuous surface transverse to the shaft axis for engaging the heart tissue and creating a linear lesion thereon. The catheter includes one or more force element(s) positioned to apply an axial force between the distal and proximal ends of the ablation segment. The force element(s) provide a sufficiently uniform force against the distal ablation segment to establish continuous contact pressure between the electrodes and the patient's heart tissue.

Abstract: A precurved cardiac introducer sheath (4) includes an elongate, hollow body having main and tip portions (24, 22). The tip portion includes first through fifth segments (26, 28, 30, 32, 34). The first, second, and third segments lie in a first plane (36) while the fourth and fifth segments lie in a second plane (38) oriented at a second angle (37) of about .+-.10 to 170.degree. to the first plane. The second segment defines an arc extending along a first, included angle of about 90-110.degree. while the fourth segment defines an arc extending along a third, included angle of about 90-140.degree. . The first, third, and fifth segments are preferably generally straight segments. The precurved introducer sheath is preferably configured to direct the electrophysiology catheter (18) directly at the posterior region (52) of the left atrium (40). The precurved introducer sheath is preferably housed within an outer introducer sheath (46) having a radially deflectable distal end (46), or a fixed distal curve.

Abstract: An electrochemical cell and electrode assembly in which an alkali metal anode and a cathode assembly are wound together in a unidirectional winding having substantially straight sides such that the winding will fit into a prismatic cell. The anode and cathode are arranged in the winding to provide for even utilization of reactive material during cell discharge by placing cathode and anode material in close proximity throughout the electrode assembly in the proportions in which they are utilized. The winding also contributes to even utilization of reactive material by employing multiple tabs on the cathode assembly to ensure that cathode material is evenly utilized throughout the electrode assembly during cell discharge and also so that connections to the tabs are readily made.

Abstract: An implantable medical device has an electrode lead having an outer surface of a polymeric material which has been treated in an inert gas atmosphere by a glow discharge to deposit a monomer substance thereon to produce an outer surface lower in resistance to movement within the body tissue of a patient than untreated material.

Abstract: An electrophysiology catheter (2) includes a handle (4) and a catheter shaft (6) having a flexible tip portion (22) with one or more electrodes (26, 28). A radial deflection wire (42) connects the tip portion to a first manipulator (10) at the handle to radially deflect the tip portion to a curved shape. A multifunction wire (60) extends from a second manipulator (11) at the handle to the tip portion. The second manipulator slides the multifunction wire longitudinally to position the distal end (64) of the multifunction wire along the multifunction lumen (38). The distal end of the multifunctional wire and the multifunction lumen are configured to provide interfering torquing surfaces (68, 70) so that when a third manipulator (12) rotates or torques the proximal end (62) of the multifunctional wire, the torquing force exerted between the interfering torquing surface causes lateral deflection of the radially curved tip portion.

Abstract: A device useful for localized delivery of a therapeutic material is provided. The device includes a structure including a porous material; and a water-insoluble salt of a therapeutic material dispersed in the porous material. The water-insoluble salt is formed by contacting an aqueous solution of a therapeutic salt with a heavy metal water-soluble salt dispersed throughout a substantial portion of the porous material. The porous material can be made of a polymer other than fibrin with fibrin incorporated into the pores, which can be the only layer of polymeric material on the medical device (e.g., stent). A new method for preparing a porous polymer material on a medical device.