Abstract: A medical device, such as a catheter shaft, having an inner lumen defined by a layer of polymer coating, and a method for forming such a medical device. In some embodiments, the method generally includes the steps of applying a polymer coating to an elongated mandrel, and constructing the remainder of the catheter shaft body around the polymer coated mandrel. In some embodiments, the polymer coating layer is made from water dispersible polymer or water soluble polymer.

Abstract: An apparatus and system for removing an obstruction from a body lumen simultaneously mechanically dislodges the obstruction, macerates the obstruction, and aspirates the effluent caused thereby. The maceration is effected by directing pressurized fluid to the obstruction, while the obstruction is dislodged by a tip portion formed on the end of a guidewire. The apparatus includes a flexible catheter having at least two channels individually accommodating fluid flow paths towards and away from the obstruction. The guidewire may be disposed in either of the channels or a third channel formed in the flexible catheter. The apparatus also includes a drive unit for rotating the guidewire. The drive unit may be an external drive unit, such as an electrical motor, or may include drive elements formed on the guidewire within a drive chamber, across which the fluid flows and imparts energy against the drive elements to cause rotation of the guidewire.

Abstract: A mouthguard for allowing medical instruments to be passed into a patient includes an integrally formed or removable locking device. The locking device includes one or more mechanisms for preventing the movement of a guidewire or other medical devices during a surgical procedure.

Abstract: An improved Optical Coherence Domain Reflectometry (OCDR) system is provided. One embodiment of this OCDR system outputs a detector signal carrying image depth information on multiple modulation frequencies, where each modulation frequency corresponds to a different image depth. The image depth information from the detector signal may be resolved by tuning to the desired modulation frequency. Another system for imaging body tissue uses multiple frequency modulators such that the light beam does not travel from an optical fiber to free space.

Abstract: A stent-graft endoprosthesis is provided. The graft is a non-textile graft made from biocompatible polymers. The biocompatible compatible polymers include poly-para-xylylene polymeric material. The stent is also coated with a poly-para-xylylene polymeric material. The graft is formed by vacuum vapor deposition of diradicals forming the poly-para-xylylene material. The stent is also coated with the poly-para-xylylene material by vacuum vapor deposition.

Abstract: A medical lead and method of treating a patient are provided. The medical lead comprises an electrically insulative membrane, a resilient spring element associated with the insulative membrane, and at least one electrode associated with the insulative membrane. The spring layer is configured to urge that insulative membrane into an expanded geometry. The medical lead is configured to be collapsed into a compact form for percutaneous delivery into the patient, thereby obviating the need to perform an invasive surgical procedure on the patient. The patient can be treated by placing the medical lead into a collapsed state by applying a compressive force to the medical lead, percutaneously delivering the collapsed medical lead into the patient adjacent tissue to be treated, and placing the medical lead into an expanded state by releasing the compressive force.

Abstract: Embolic protection filters and methods of making and using such devices are disclosed. An illustrative method of making a device for filtering embolic debris from a body may include the steps of molding a filter assembly that includes a distal tip and a filter portion, forming a plurality of apertures within the filter portion, and coupling a support member to the filter assembly that is adapted to shift the filter portion between a collapsed configuration and an expanded configuration.

Abstract: The present invention relates to methodology of and apparatus for accurately positioning devices for performing endoscopic cannulation, papillotomy and sphincterotomy and similar procedures. The sphincterotome with a steerable or adjustable distal segment of the present invention allows the physician to control the position of the distal tip of the device independently of the endoscope and adjust for inconsistencies in the device and the anatomy. According to one embodiment of the present invention, a threaded portion of a cable assembly cooperates with a torque transmission element and a cog to enable the operator to rotate a cutting wire into a desired position relative to the catheter. Alternate embodiments allow the operator to fix the depth of a needle knife while allowing, if desired, accurate rotational positioning of the associated catheter. Threaded stabilizing elements, pivot elements and a steering wire may be used together or individually to accomplish these features.

Abstract: An intravascular pump, which may be a left ventricle assist device, comprising a wall defining a pumping chamber, the wall support by struts, the struts attached to or part of an actuation system to move the wall from an expanded position to a contracted position and back to operated the pump, the actuation system may be electrically activated shape memory alloy struts, electroactive polymeric struts, or may be a balloon, struts attached to a slidable member or other suitable system.

Abstract: A system for treating tissue includes a source of conductive and/or magnetic beads, a first member, e.g., a catheter or cannula, coupled to the source of magnetic beads, and a second member, e.g., a catheter or cannula, carrying a magnet on its distal end. The system is used for ablating or otherwise treating tissue within a target tissue region including a blood vessel contacting or passing therethrough. Magnetic beads are introduced into the target tissue region, e.g., using the first member, and a magnetic field is generated within the target tissue region, e.g., using the second member, to cause the magnetic beads to migrate towards a wall of the vessel. Energy is delivered into the target tissue region, e.g., to heat tissue therein, and the magnetic beads may attenuate or enhance treatment of tissue adjacent to the vessel.

Abstract: The present invention pertains to devices for causing cold-induced necrosis or apoptosis. The present invention includes a cryo therapy apparatus including a core member; a cryoplasty tube coupled to the core member, the cryoplasty tube having a proximal end and a distal end; wherein the distal end includes a coil disposed about at least a portion of the tubular sheath, the coil including at least one opening; an outer tube disposed over at least a portion of the cryoplasty tube; and a cooling member disposed over the coil and coupled to the outer tube. A method of causing cold-induced necrosis is also disclosed.

Abstract: A needle is guided to a target along a pre-determined needle insertion trajectory. A method that utilizes a fluoroscope can be used to locate the target. The target can be an internal structure within the human body. A device can be used with the fluoroscope to aim and insert a needle or sharp probe along the predetermined trajectory to the target. By using the device with the fluoroscope, a user can receive real time visual confirmation of contact between the needle and the target.

Abstract: The present invention is directed to a medical device, such as an endoscopic device, configured to be loaded into a channel of an endoscope prior to insertion of the endoscope into a body, and a method of performing an operative procedure with an endoscopic device. The endoscopic device comprises an elongate member for insertion into the channel of the endoscope, wherein a length of the elongate member is greater than a length of the channel of the endoscope. The endoscopic device also comprises a distal assembly connected to a distal portion of the elongate member and operable to perform an endoscopic operation, wherein the distal assembly has an open configuration and a closed configuration with a profile larger than a diameter of the channel of the endoscope, wherein the distal assembly is adapted to be exterior to the channel when the endoscope is inserted into the body.

Abstract: Elongate medical devices such as guidewires can be formed from a core wire and a preformed distal cap that is configured to fit over a distal end of the core wire. The distal cap can be attached using a variety of techniques. In particular, the distal cap can be attached to the core wire using laser welding.

Abstract: A catheter includes a shaft having a distal end, an expandable member secured to the distal end, and an anchoring device slidably positioned distal to the expandable member. The anchoring device having a delivery configuration and a deployed configuration. By way of one example, the anchoring device may comprise a shaped (e.g., helical) wire, the anchoring device having a cross-sectional dimension that allows it to secure itself inside a pulmonary vein when in its deployed configuration.

Abstract: An intravascular guidewire having an articulating distal section for improved maneuverability beyond a lesion or other protrusion within a body lumen. An elongated core wire having an actuatable stop disposed thereon is adapted to have a reduced profile in a first position, and an enlarged profile in a second position. The actuatable stop can be adapted to expand by any number of means, including a spring coil, a polymeric tube or a mesh sleeve. In one particular embodiment, the actuatable stop comprises a distal section of a tubular member having a plurality of circumferentially disposed openings adapted to permit a plurality of struts disposed therebetween to expand in an outward direction when compressed axially.

Abstract: A connection joint (20) is described that is formed by inserting a plastic connector (10) into the end of a silicone tube (14). The connector includes a plurality of barbs (12). A reinforcing agent (16) is placed between each of the barbs (12) of the connector (10). An adhesive (18) is injected between the tube (14), the reinforcing agents (16) and the connector (10). The adhesive (18) is then cured at a predetermined temperature for a predetermined time in order to solidify the connection joint (20).

Abstract: Distal protection filter retrieval devices and methods of retrieving a distal protection filter. A filter retrieval catheter may comprise an inner tube, an outer tube disposed over the inner tube, an annular lumen disposed between the inner tube and the outer tube, and a tapered member coupled to the lumen. The tapered member may be movable between a first position for passing a lesion and a second position retrieving a filter.

Abstract: Medical devices and methods of manufacturing medical devices at least partially from linear elastic materials. The manufacturing methods may include cold-forming and/or low-temperature heat setting to construct medical devices.

Abstract: An apparatus and method for molding balloon catheters is disclosed. The balloon may be molded by providing a polymeric tube within a mold having an interior cavity in the shape of the desired balloon. Microwave energy, which may be generated by a gyrotron, may then be directed toward the mold, to heat the polymeric material without heating the mold. Once heated, pressurized fluid may be injected into the tube to blow the polymeric material against the interior cavity whereupon the material can cool to form the balloon or can be further heatset by additional microwave energy and be cooled to form the balloon. In accordance with one embodiment, microwave energy can also be used without a mold to form a medical device. A polymer extrusion apparatus is disclosed utilizing a microwave energy for heating polymer feedstock material within the extruder tip and die unit just prior to formation of the extrudate product.