Abstract: A system for delivering and implanting a radially expandable endoluminal prosthesis within a body lumen (e.g., blood vessel). The system comprises a) an introducer/dilator assembly, and b) a delivery catheter/loader assembly. The introducer/dilator assembly comprises an elongate tubular introducer sheath which may be provided with a valving assembly mounted on the proximal end thereof. Such valving assembly may incorporate i) a hemostatic valve, ii) a first sealing valve and iii) a second sealing valve, positioned in series, to prevent leakage of body fluid out of the proximal end of the introducer and to permit two or more elongate members (e.g., catheters, guidewires) having differing outer diameters to be inserted through the introducer without leakage of body fluid therefrom. A dilator, which has regionalized differences in stiffness, is initially deployable within the lumen of the introducer to facilitate advancement of the introducer to its desired location within the body.

Abstract: The device for blocking (e.g., embolizing) the side branches of an anatomical passageway under endoscopic guidance. The device comprises an elongate catheter body having a side branch blocking apparatus, such as an embolization catheter, disposed therein and further incorporating an endoscope (e.g., an angioscope). The incorporated endoscope is useable to A) visually locate side branches which emanate from the anatomical passageway and b) visually observe the operation of the side branch blocking apparatus. Also disclosed are methods for utilizing a device of the forgoing character, including methods for performing in situ embolization of the side branches of a vein, under angioscopic visualization. The endoscopic component of the device may also be utilized to visually observe the use and/or effect of one or more separate device, such as valvulotome(s) used for cutting venous valves located within the lumen of a vein.

Abstract: An axi-symmetric injection nozzle has an inner body with a tapered bore, an adjustment screw, and an outer tube. A seat lip is machined on the outside perimeter of the outer extremity of the inner body. A head lip is machined on the outer perimeter of the adjustment screw head which engages the tapered bore in the outer extremity of the inner body. When the adjustment screw is tightened the head lip swages the seat lip radially outward, contacting the inner surface of the outer tube to form a fluid seal between inner body and outer tube. Further flexural deflection of the thin cylindrical section of inner body containing seat lip in a radially outward direction by tightening adjustment screw not only closes the annular passage between the inner body and the outer tube but wedges the seat lip against the outer tube forcefully to elastically deflect the outer tube radially and establish a pre-load tensile stress in the outer extremity of outer tube.

Abstract: Stented tubular grafts of expanded, sintered polytetrafluoroethylene (PTFE). The stented PTFE grafts of the present invention include an integrally stented embodiment, an externally stented embodiment, and an internally stented embodiment. In each embodiment, the stent may be either self-expanding or pressure-expandable. Also, in each embodiment, the stent may be coated or covered with a plastic material capable of being affixed (e.g., heat fused) to PTFE. Manufacturing methods are also disclosed by the individual components of the stented grafts are preassembled on a mandrel and are subsequently heated to facilitate attachment of the PTFE layer(s) to one another and/or to the stent. Optionally, the stented graft may be post-flexed and post-expanded following it's removal from the mandrel to ensure that the stented graft will be freely radially expandable and/or radially contractible over it's full intended range of diameters.

Abstract: A storage and dispensing apparatus for a springy guide wire used in medical procedures includes a coiled tubular portion defined by elongate tubing with a bore for receiving the guide wire. A ring section includes a tangential portion of the tubing defining an open end from which the guide wire may be dispensed. Adjacent to the tangential portion, the tubing defines a pair of spaced apart openings from which the guide wire respectively exits and reenters the tubing. Intermediate the pair of openings the tubing defines a curved external surface across which the guide wire runs externally of the tubing and is manually accessible for advancing and retracting movements impelled by a user's thumb, for example. The guide wire defines a pair of gentle S-shaped bends adjacent to the ends of the externally-exposed curved section, which bends cause the guide wire to engage sufficiently with the storage and dispensing apparatus to resist self-ejection.

Abstract: A guide wire dispenser which is used to introduce a guide wire into the body using one hand. The dispenser utilizes a trigger grip configuration which is arranged in combination with a thumb access platform to provide accurate single-handed control of guide wire delivery to the body. A dual trigger configuration is also disclosed which provides the capability to dispense a guide wire from two different nozzles in a single device.

Abstract: A ventricular assist device includes a pair of valved conduits and a pumping portion connected by these conduits into the circulatory system of a host patient. The pumping portion and valved conduits are constructed and configured to minimize the number of material-surface transitions which blood must cross in flowing through the device. Also, the valved conduits include porcine xenograft valves, which are externally supported by stenting structure located outside of the blood-contacting flow path of the device. A flexible shape-retaining inner wall member of the valved conduits is impervious to blood, but defines a porous inner surface on which a stable biological interface may form. Also, this inner wall member is shaped with sinuses which do not replicate either the porcine sinuses from which the xenograft valves were taken, or human aortic sinuses.

Abstract: A female electrical connector (164') is carried on an electrical cable (24') including plural electrical conductors (28'). The female connector includes an insulative housing (34a', 34b') defining a blind cavity (36') therewithin and an axial opening outwardly from the cavity. The housing carries a printed circuit board (166) carrying plural wire-like contacts (40') which individually connect with the conductors of the electrical cable. The wire-like contacts extend into the cavity of the connector for deflecting in spring-like contact with electrical contacts (60) carried by a male connector (20) when the latter is inserted into the cavity of the female connector. A comb feature (50') of the female connector is formed by a strong end wall (138') of the blind cavity and in a respective one of plural slots (48') of the comb feature movably receives a free end portion (46') of each one of the plural wire-like contacts.

Abstract: An engine structure and mechanism that operates on various combustion processes in a two-stroke-cycle without supplemental cooling or lubrication comprises an axial assembly of cylindrical modules and twin, double-harmonic cams that operate with opposed pistons in each cylinder through fully captured rolling contact bearings. The opposed pistons are double-acting, performing a two-stroke engine power cycle on facing ends and induction and scavenge air compression on their outside ends, all within the same cylinder bore. The engine includes a novel intake/exhaust valve configuration, a novel combustion chamber configuration and a novel external piston rod alignment structure comprising a cam follower assembly including a pair of needle roller bearings riding in longitudinal grooves machined in the cam follower body.

Abstract: A double lumen tubing which is adapted for use as a catheter. Both lumens of the double lumen tubing have equal cross-sectional areas to provide equivalent flow volumes through each lumen. The lumen wall which divides the outer tubular wall into the two lumens has a central arcuate portion which is shaped to allow insertion of relatively large guidewires through the lumen while at the same time maintaining equivalent cross-sectional areas for each lumen. Resistance to kinking is increased by varying external diameters of each lumen to increase the wall thickness of the tubing in selected areas and by varying the thickness of the wall that divides both lumens at the two joints where the wall meets the tubular wall.

Abstract: A system for monitoring and controlling a temperature of a heating element in a thermodilution catheter to maintain it within safe physiological limits includes a calibration circuit, a device for controlling the supply of power to the system, a relay between the calibration circuit and the heating element for switching power therebetween, a transistorized voltage detecting circuit for determining whether power has been supplied to the calibration circuit, and a device responsive to transistorized voltage detecting circuit to remove power from the system. Also, a method for monitoring and controlling a temperature of a thermodilution catheter-mounted heating element including providing a calibration circuit, switching a supply of power to either the calibration circuit or the heating element, monitoring the supply of power to the calibration circuit, and removing power from either the calibration circuit or the heating element in response to the monitored power at the calibration circuit.

Abstract: A catheter with several independent lumens extending longitudinally through the catheter for accepting probes and for introducing fluid through the catheter and into a body cavity is disclosed. The cathater outer body has a cross-sectional maximum outer dimension. The first lumen is circular in cross-section, and has a cross-sectional dimension of approximately half the maximum outer dimension of the catheter body. The first lumen is capable of accepting various probes, as well as allowing simultaneous fluid flow through the lumen. The second lumen is crescent-shaped in cross-section and occupies at least a quarter of an arc around the cross-section of the catheter body. The large cross-section of the second lumen allows for a high fluid flow rate through the lumen. The third lumen allows for inflation of an inflation balloon (when present), and the fourth lumen allows for the passing of a portion of an instrument along the length of the lumen.

Abstract: A method for improving the radial enlargeability and other properties of tape-reinforced tubular vascular graft formed of sintered fluoropolymer(s), such as expanded, sintered PTFE. Broadly, the method comprises the step of radially shrinking the reinforcement tape layer of the graft, or the entire tape-reinforced graft, after sintering thereof. Such radial shrinkage of the reinforcement tape layer, or of the entire graft, renders the graft subsequently radially enlargeable by more than 5%, without tearing or breaking of the reinforcement tape layer of the graft. Radially enlargeable grafts of the present invention may be combined with various types of stents or anchoring systems, to form endovascular graft devices which are transluminally insertable and implantable within the lumen of a host blood vessel.

Abstract: A continuous cardiac output monitor includes a general-purpose monitoring console with local display and communication facilities, and a module removably interfacing with the console to configure the latter for performing continuous cardiac output monitoring. The module includes a switch-mode high efficiency power amplifier for providing electrical heating power at a selected voltage, frequency, and wave form to a heating element of a continuous cardiac output monitoring catheter, which catheter at a distal end portion thereof is immersed in the blood flow of a patient. The catheter effects a temperature transient in the patient's blood flow by the controlled application of electrical resistance heating utilizing electrical power from the power amplifier, and this temperature transient is sensed and used to derive a value for the patient's cardiac output.

Abstract: A method and system for calibrating and controlling the withdrawal of a fluid, such as blood, from a fluid source, such as a blood vessel, includes a fluid pump, a pressure sensor, a flow rate sensor, and a microprocessor based flow control subsystem. The flow control subsystem optimizes the flow rate by sensing zero flow rate pressure within the subject, making a plurality of periodic flow path pressure measurements and extrapolating a calibration flow rate curve. A control curve is generated by utilizing the zero-flow rate pressure point, the slope of the calibration curve, and an empirically predetermined pressure. The blood pump is then operated at a maximum speed that is limited by the flow control curve to maximize flow without occlusion or collapse of the blood vessel during blood withdrawal. The method and system of the invention is particularly applicable to automated apheresis systems.

Abstract: An engine structure and mechanism that operates on various combustion processes in a two-stroke-cycle without supplemental cooling or lubrication comprises an axial assembly of cylindrical modules and twin, double-harmonic cams that operate with opposed pistons in each cylinder through fully captured rolling contact bearings. The opposed pistons are double-acting, performing a two-stroke engine power cycle on facing ends and induction and scavenge air compression on their outside ends, all within the same cylinder bore. The engine includes a control system which utilizes twin barrel cams with adjustable axial and angular positions enabling independent compression ratio and port phasing variation during operation. The engine control system comprises one or more electrohydraulic servos to set and maintain the axial and angular relationships of the cams either at extreme positions or controlled to particular positions and schedules thereof utilizing instantaneous piston position feedback information.

Abstract: A catheter for monitoring heart function comprises a catheter tube having a plurality of lumens. The catheter includes an inflatable balloon at a distal tip of the catheter tube for positioning the catheter in a wedged position within a pulmonary artery within the heart of a patient. Dual injectate ports are formed in a side wall of the catheter tube. Each port communicates with a respective injectate lumen carried in the catheter tube. When inserted into the heart of a patient, either the first or second injectate port is positioned within the desired distance from the tricuspid valve for thermodilution depending upon the size of the heart. Thermodilution to obtain cardiac output and/or right heart ejection fraction is implemented by injecting injectate through the lumen associated with the port properly positioned relative the tricuspid valve and discharged through the corresponding port.

Abstract: A catheter with several independent lumens extending longitudinally through the catheter for accepting probes and for introducing fluid through the catheter and into a body cavity is disclosed. The catheter outer body has a cross-sectional maximum outer dimension. The first lumen is circular in cross-section, and has a cross-sectional dimension of approximately half the maximum outer dimension of the catheter body. The first lumen is capable of accepting various probes, as well as allowing simultaneous fluid flow through the lumen. The second lumen is crescent-shaped in cross-section and occupies at least a quarter of an arc around the cross-section of the catheter body. The large cross-section of the second lumen allows for a high fluid flow rate through the lumen. The third lumen allows for inflation of an inflation balloon (when present), and the fourth lumen allows for the passing of a portion of an instrument along the length of the lumen.

Abstract: Methods and devices for separating leukocytes from a leukocyte contaminated blood fraction by use of a rotating membrane filter apparatus. The invention includes methods/devices for preparing substantially leukocyte free platelet concentrate for therapeutic use. The devices of the invention include a rotating membrane filter apparatus for leukocyte separation as well as tubing harness/component systems (FIGS. 2a, 2b, 2c) useable in connection with automated apheresis instruments.

Abstract: Polymer blends having improved torque transmitting properties are disclosed. The polymer blends include polyetherurethane and a concentration of polyetherester sufficient to provide the polymer blend with a 37.degree. C. dynamic torque value greater than 40% of the polymer blend's 25.degree. C. dynamic torque value. The polymer blend can be thermally processed to form small diameter tubing suitable for general purpose catheters requiring both a high degree of maneuverability and sufficient resiliency to avoid tissue perforation.