Abstract: A collapsible medical device and associated methods for occluding an abnormal opening in, for example, a body organ, wherein the medical device is shaped from a heat treatable metal fabric. The metal fabric is formed from a plurality of metal strands and is heat treated within a mold in order to substantially set a desired shape of the device. The medical device includes a fastener for attaching to the end of a guide wire or delivery catheter, wherein the shape of the medical device is formed such that the fastener is attached to the metal fabric within a recess formed in the shape of the medical device. A medical device having a preselected shape is delivered through a catheter or the like for deployment in a desired channel or opening in a patient's body. The medical device may be shaped, for example, to occlude an ASD, PDA, or a VSD.

Abstract: The present invention provides a method of forming a medical device and medical devices which can be formed in accordance with the method. In one embodiment, the method includes the steps of a) providing a metal fabric formed of a plurality of strands formed of a metal which can be heat treated to substantially set a desired shape; b) deforming the metal fabric to generally conform to a surface of a molding element; c) heat treating the metal fabric in contact with the surface of the molding element to substantially set the shape of the fabric in its deformed state; and d) removing the metal fabric from contact with the molding element. The resulting metal fabric will define a medical device which can be collapsed for passage through a catheter or the like for deployment in a channel of a patient's body. Medical devices made in accordance with this method can have varying structures.

Abstract: In one embodiment, the present invention provides a mechanical thrombus maceration device which includes a flexible shaft adapted to be guided along a vascular path and rotated within a vascular channel; a rotor affixed to the shaft adjacent the distal end thereof for rotation therewith; drive means for rotating the shaft; and a rotor housing within which the rotor rotates. The rotor housing of this embodiment comprises a generally cylindrical wall substantially surrounding the rotor and having at least one port formed therein, the port or ports being positioned about the housing such that when a fluid (e.g. blood) is ejected through the ports within a vascular channel, the housing will tend to deflect toward one side of the vascular channel to permit the device to be steered during deployment.

Abstract: The present invention provides a safe, reliable means of breaking down a thrombus with rotating blades into particles which are fine enough to be left in the vascular system without any significant risk of forming additional thrombi. The thrombectomy device also includes ports to ensure that the rotating blades of the device do not directly contact the walls of the vessel, but rather remain substantially centered within the vessel.

Abstract: The present invention provides a snare for intravascular use having an elongate proximal member and a loop-shaped distal segment oriented at an angle to the adjacent portion of the proximal member. The snare may be formed of a superelastic shape memory alloy, which permits the distal segment to be collapsed for passage through a catheter and yet automatically open into its original, unrestrained configuration upon emerging from the distal tip of the catheter.

Abstract: A medical catheter introducer and hemostasis valve assembly consists of a sheath having an elongated tube defining a conduit, a housing disposed at the proximal end of the sheath and further defining a conduit and an orifice, and a flexible elongated dilator sized for insertion through the hub and sheath conduit. The dilator has a tapered distal tip end and defines an axial conduit and an annular ridge having distally- and proximally-directed inclined surfaces. The sheath, when assembled with the dilator, has its distal end immediately adjacent the proximally-directed inclined surface of the ridge. A hemostasis valve for sealing the conduit is disposed in alignment with the conduit, and defines an aperture for passage of dilator and ridge therethrough in sealing engagement, into the conduit, and seals when the dilator is removed. The valve has a housing defining an orifice of a first diameter, and a valve element of a second diameter, greater than the first diameter.

Abstract: The present invention provides a combined needle and dilator comprising a needle having a head with an outer diameter greater than the outer diameter of the body of the needle and a dilating sheath carried about the needle and abutting the rearward needle portion of the needle head. The dilating sheath has a front portion with an outer diameter substantially equal to the outer diameter of the needle head to define, with the head, a generally smooth surface; a body portion with an outer diameter greater than that of the front portion; and a tapered portion disposed between the front and body portions. The tapered portion has an outer surface smoothly merging into the outer surfaces of the front portion and the body portion.

Abstract: A device for performing percutaneous puncture treatment of a patient includes an elongate radiolucent plastic handle with a central portion and two opposite elongated end portions. A hollow radiopaque needle has a hub at its proximal end which is releasably mounted in the central portion of the handle so that the needle is perpendicular to an axis through the end portions. The distal end of the needle has a puncturing tip. An internal fluid passage in the needle is open to the tip and the hub so that fluid may be drained from a patient's body through the passage when the needle is inserted in the patient's body. The needle and central portion of the handle are aligned under a field of view of a fluoroscope. The handle is held by the grips which are outside of the field of view of the fluoroscope. While the doctor continuously monitors progress of the needle on the fluoroscope, the puncturing tip is inserted through the skin and moved to an internal location for aspiration of fluid.