Abstract: Guidance to an operator to more accurately position electrodes upon a segmented heart model (SGM). The SGM is included in a map panel on a display screen. A catheter advanced into a beating heart supports one or more electrodes. During a single beat of the heart, an image is obtained with darkened portions corresponding to locations of the electrodes. The image is presented in the same map panel as the SGM. The current location of the electrodes is confirmed relative to the SGM, either manually or through automated software algorithms. EP data is captured that represents electrophysiological signals of the beating heart at the current location for each of the electrodes. A signal processing algorithm is applied to the captured EP data in view of the confirmed current location of the electrodes to result in a calculation that is mapped at the confirmed location of the electrodes.

Abstract: A method for making an encapsulated stent includes providing a first seamless unsintered ePTFE tube, providing a second seamless sintered ePTFE tube, positioning a self-expanding stent between the first and second ePTFE tubes to form an assembly, and joining the first ePTFE tube to the second ePTFE tube through openings in a wall of the stent by applying first pressure, and then heat, to the assembly.

Abstract: A catheter assembly for use in accessing a vasculature of a patient during renal replacement or other therapies is disclosed. In one embodiment, the catheter assembly includes a catheter body that defines first and second lumens. The catheter body defines a distal tip region that includes a venous lateral opening that is in fluid communication with the first lumen and includes a distal-facing portion. The distal tip region further includes an arterial lateral opening that is in fluid communication with the second lumen, includes a distal-facing portion, and is substantially un-staggered with respect to the venous lateral opening. A distal end opening is defined on the distal tip region and is sized to pass a fluid therethrough. In one embodiment, the distal end opening is in fluid communication with a third lumen of the catheter body that can withstand high fluid flow rates associated with power injection of contrast media.

Abstract: A medical device for creating a fistula in a patient has a catheter including a first lumen and a second lumen for forming a fistula inside a body organ of a patient is disclosed. The second lumen may be capable of fluid communication with an internal bolster, wherein the internal bolster is attachable to the catheter near the distal end and is at least partially filled with a liquid. An external bolster may be adjustably attachable to the catheter outside the patient. Methods of use of medical devices according to the present invention are also disclosed. In one aspect of a method of use, at least a portion of the liquid within an internal bolster may be removed. Such a process may substantially collapse the internal bolster for removal of the medical device.

Abstract: A split-tip catheter for placement within the vasculature of a patient and for use in hemodialysis or other suitable procedures is disclosed. In one embodiment, the split-tip catheter includes a catheter body that defines a first lumen and a second lumen. The catheter body further comprises a split distal region, including a venous segment that defines a distal portion of the first lumen and an arterial segment that defines a distal portion of the second lumen. The venous segment includes a recess extending proximally of a nose portion; and a lateral opening in fluid communication with the first lumen. The arterial segment is separate from the venous segment and is removably seatable in the recess provided by the venous segment such that it “nests” therein. The arterial segment also includes a lateral opening in fluid communication with the second lumen.

Abstract: The present invention is directed to an active handle assembly for use in a bidirectional steerable surgical instrument having a deflectable distal end. Typically, the surgical instrument includes a handle component which the user manipulates to cause a distal end of the instrument to deflect. The distal end comprises an end tip portion of a shaft which extends outwardly from the handle. A control mechanism is disposed within the handle and extends through the shaft for selectively controlling the direction and degree of deflection at the distal end. For example, one exemplary control mechanism uses control or steering wires to deflect the distal end. The active counterforce mechanism according to the present invention is designed to be used in combination with the control mechanism and provides a force which counters the return to center force generated by the deflection of the shaft at the distal end thereof.

Abstract: An introducer for providing intravascular access to a patient is disclosed, and includes a dilator and sheath that are configured to prevent peelback, or “fishmouthing,” of the sheath during introducer advancement. In one embodiment, the introducer comprises a dilator including a distal tapered region, and a sheath including an inner bore that receives the dilator such that a portion of the tapered region of the dilator extends from the sheath distal end. A distal outer surface of the sheath includes a first curved portion defined by a first radius and extending proximally from the distal end of the sheath to a first end point, and a second curved portion defined by a second radius and extending proximally from the first end point to a second end point. Additionally, an interference fit is established between the dilator tapered region and the sheath distal end to further prevent sheath end deformation.

Abstract: An implantable medical device is described, including a filtering element and radially expandable structure. In one variation, the filtering element may include a pluralit of filaments attached to the structure, the filaments being joined together at a proximal en thereof. The filtering element may include strut members and a hub attached to the proxima end of the filaments. The filaments may be made of suture material. In another variation, the filtering element may include a filter with a plurality of legs, the filter being attached to the support structure via a plurality of filaments.

Abstract: A vascular implant delivery device is disclosed and can include a body and a syringe attachment formed in the body. Further, the device can include an outer sheath extending from the body. The outer sheath can include a distal end that can be configured to receive a vascular implant. The device can also include at least three implant support structures that can extend radially inward from the distal end of the outer sheath. The implant support structures can be configured to support and guide a vascular implant moving through the outer sheath. Additionally, the device can include an inner carrier catheter slidably disposed within the outer sheath.

Abstract: An angioplasty balloon is disclosed and can include a body having a first end and a second end. An inflatable portion can be established between the first end and the second end. Moreover, a first reinforcing member can be wound around the body from the first end to the second end over the inflatable portion. Further, the first reinforcing member can be wound at a first winding angle with respect to a longitudinal axis. The first winding angle is in a range of fifteen degrees to forty-five degrees (15°-45°).

Abstract: A stent graft is disclosed and can include a stent and a graft engaged with the stent. The graft can include an inner surface and an outer surface. Further, at least one of the inner surface and the outer surface can include a plurality of protrusions as viewed in cross section extending through a longitudinal axis.

Abstract: A method for extracting a tissue sample includes altering the pressure inside the lumen of a cannula to facilitate extraction of a tissue sample from the cannula. One aspect of the invention includes a biopsy apparatus comprising a valve for controlling the pressure inside the lumen of the cannula. In one variation, the pressure/vacuum generating device is connected to a cannula with a closed distal end and an orifice located on a circumferential surface of said cannula. A cutting sheath is slidably disposed over said cannula. The valve may be provided between the pressure/vacuum generating device and the cannula to control the pressure within the lumen of the cannula.

Abstract: A hemodialysis catheter, including an elongate body with an outer wall enclosing an arterial lumen and a venous lumen, and a method of making same. A loop extends from a distal end of the body and defines an enclosed opening. An arterial inlet in fluid communication with the arterial lumen, and a venous outlet in fluid communication with the venous lumen, are positioned on the loop.

Abstract: A fluid line connector to establish fluid communication with a conventional male luer fitting. The fluid line connector includes a housing with a hub member having a proximal opening adapted to receive a distal portion of the male luer fitting, a threaded profile circumscribing the proximal opening, and a cam member. The cam member engages the threaded surface of the male luer fitting collar to prevent inadvertent disengagement of the male luer fitting from the housing.

Abstract: An electrophysiology (EP) system includes an interface for operator-interaction with the results of code executing therein. A template model can have channels positioned or repositioned thereupon by the user to define a set-up useful in rapid catheter positioning. Mapping operations can be performed without the requirement for precise catheter location determinations. A map module coordinates EP data associated with each selected channel and its associated position on the template model to provide this result, and can update the resulting map in the event that the channel or location is changed. Messaging and other dynamic features enable synchronized presentation of a myriad of EP data. Additional systems and methods are disclosed herein.

Abstract: An implantable medical device including an expandable stent with an amorphous fluoropolymer coating, and methods of coating the stent. The amorphous fluoropolymer coating may be optically transparent and resistant to chemical corrosion.

Abstract: A multi-lumen catheter configured for insertion into the vasculature of a patient for fluid infusion into or fluid aspiration from the patient is disclosed. The multi-lumen catheter includes one or more cross sectionally variable lumens, wherein the cross sectional area of the lumen(s) may be selectively increased, particularly during fluid infusion, in order to enable relatively greater fluid flow rate therethrough. In one embodiment, the multi-lumen catheter includes a deformable first septum for providing an increased cross sectional area for a lumen under high flow rate pressurization, such as power injection. A deformable second septum also deforms to allow for first septum deformation and additionally provides an urging force to restore the first septum to an un-deformed state once lumen pressurization has ceased. In another embodiment, a bi-positional septum is used to selectively increase the cross sectional area of a lumen of the catheter during power injection.

Abstract: Apparatus for delivering a medicament through an artificial airway connected to a patient ventilation/aspiration system without breaking the ventilation circuit comprises a manifold with an interior chamber communicating with first, second and third ports. The manifold is structured and arranged to maintain an uninterrupted ventilation pathway between the first and second ports and to provide a travel path for a suction catheter between the second and third ports, the second port being adapted for connection to the artificial airway. The apparatus further includes a catheter assembly, including a catheter with a lumen, positioned within a protective sleeve and slidable through a distal end fixture connected to the third port. The catheter assembly is structured and arranged to permit advancement of the distal end of the catheter through the manifold and artificial airway. A syringe and a suction control valve are interchangeably connectable to the proximal end of the catheter assembly.

Abstract: Two-way, three-position and one-way, two-position slit valves in cardiovascular access catheters with closed distal ends have slit geometries configured to overcome adhesion between opposed abutting slit faces, when pressure differentials are applied between the interior and the exterior of the catheter. Portions of the slit are oriented at a non-zero angle relative to the longitudinal axis of the catheter causing shear forces to be generated in abutting slit faces. Shear forces arise from tangential, radial, or longitudinal stresses generated in the catheter body. Slit geometries are planar or curved or include multiple end-to-end connected slit subsections. If a slit partially circumscribes a portion of the adjacent outer wall of the catheter body, restraint to outward and inward movement on that portion is reduced. Slit valves are configured to open inwardly to aspirate fluids, to open outwardly to infuse fluids, or both.

Abstract: A kit for treating effusion, such as pleural effusion, comprises at least one tray including a plurality of indentations configured to receive one or more components used to insert a chest tube into a patient's pleural cavity, at least one dressing kit including supplies for applying a dressing to the patient's skin surrounding an inserted chest tube, and at least one drainage kit including one or more components for receiving fluid drained from the patient's pleural cavity.