Abstract: A medical device for removing material from a body vessel comprising a tube, a drive shaft extending through the tube, a stepped root mounted to the drive shaft, a rotatable screw having a distal and proximal end, the screw extending outward from the stepped root to form a helix with an edge, the rotatable screw having a tip and sharp outer cutting edges having a tapered diameter along its length to a minimum diameter at its distal end, and a generally cylindrical housing enclosing the sharp edge of the screw so that the tip of the screw extends outside the housing and enters the tissue, and the sharp edge, in cooperation with the housing, cuts the tissue. The housing has a leading inner edge so that the tissue is removed from the vessel as it enters the housing by cooperation of the screw and the leading inner edge.

Abstract: A one-piece balloon protector apparatus for a dilatation catheter. The disclosed protector comprises a unitary, planar element having two sets of longitudinal ribs, one set being disposed on a first planar face of the protector along a first edge and another set being disposed on the opposite planar face of the protector on the opposite edge. The protector is installed around a dilatation catheter balloon by placing the balloon on the protector and then coiling or wrapping the protector around the balloon. The two sets of ribs thus come come into contact an interlock with one another to secure the protector in a cylindrical configuration around the balloon.

Abstract: An improved balloon catheter is disclosed which is comprised of two jacketed spring coils placed end-to-end and joined by a linking element which contains a lumen communicating between the inflation lumens formed by the two spring coils. A side port entry to a guidewire lumen, which extends through the distal coil to the distal end of the catheter, is located in the transition region formed by the linking element. The linking element may include two polyimide tubes or may be a multilumen insert. The catheter is stiffened by a core wire which is bonded directly to the spring coils. A catheter comprised of a single spring coil with a side port entry in the coil is also disclosed, and a method and apparatus for crimping the coil to create the entry.

Abstract: A dilatation catheter having a balloon (20) of unique and novel configuration which enhances critical properties of the catheter. In at least one section (26), the balloon (20) has a substantially semi-circular cross section when in an uninflated, unwrapped condition. A groove (28) is formed in the resulting flat surface (30) of the balloon (20) accommodate an elongate guide wire lumen (40) and improves fold memory. The guide wire lumen (40) extends along and beside a distal section (23) of the catheter, and is bonded near its distal end into the groove (28) in the balloon (20). At the distal end of the groove (28), the balloon (20) is configured such that the guide wire lumen (40) passes through the balloon wall, such that the distal end of the lumen is disposed in the interior inflation chamber of the balloon (20). In this way, the guide wire (42) follows an essentially straight path in the region of the balloon (20).

Abstract: The present invention relates to over-the-wire PTCA balloon catheters (5), and more particularly, to a rapid exchange catheter with the guidewire lumen (50) at the distal tip. The present invention discloses a rapid exchange medical catheter having a wire guiding means external to the shaft (35) for slidably mounting over the guidewire (55), the wire guiding means being a short tubular member having a proximal end and a distal end extending proximally from the distal end of the shaft (35) and terminating before the distal end of the balloon therapy means.

Abstract: This invention relates to corporeal catheters. More particularly, this invention relates to an outer exchange catheter system comprising an outer catheter sheath and at least one steerable inner catheter having a control means, said outer catheter sheath extending less than the full length of each said inner catheter and being slidable thereover.

Abstract: The disclosed device relates to over-the-wire PTCA balloon catheters (5), and more particularly, to a rapid exchange catheter (5) for dilatation therapy. The rapid exchange medical catheter (5) has a wire guiding means external to the shaft (35) for slidably mounting over the guidewire (70), the wire guiding means being at least two loops (15) and having a guidewire loading attachment (20) between each pair of loops. The guidewire loading attachment consists of a snap ring (45) depending from a tubular member (55) defining a guidewire lumen (50). The guidewire loading attachment (20) snaps on to the shaft (35) through a slot (60) in the loading attachment (20), the slot (60) having a diameter less than that of the shaft (35) resulting in a compression fit. The loading attachment (20) is removed after loading the guidewire (70).

Abstract: An elastomeric compression unit forming a balloon protector for a catheter and a catheter system having the balloon protector are disclosed. The balloon protector is formed of an elastomeric tube, preferably silicone, lined with lubricious material. The lubricious lining may be a coating such as silicone or may be a Teflon.TM. tube. The Teflon.TM. tube is split longitudinally, so that the compressive forces of the protector are transmitted through it to the balloon. In the preferred embodiment, the split is made tangential to the inner surface of the Teflon.TM. tube. In the catheter system, the inner lumen is preferably non-compressible, or a stylet is inserted within it to preclude its compression.

Abstract: A tri-fold dilatation catheter balloon and a method for preparing the same. The disclosed balloon has a tri-fold configuration in which the longitudinal creases defined by three flaps of the balloon are softened to ensure symmetrical deflation of the balloon into its tri-fold form. The tri-fold configuration initially imparted to the balloon by drawing the balloon into an longitudinal interstitial channel defined by three substantially cylindrical pins arranged in a pyramid-type stack. While the balloon is secured within this channel, negative pressure is applied to an inflation lumen of the balloon to deflate the balloon. Negative pressure is maintained on the inflation lumen as the balloon is withdrawn from the interstitial channel, and continues to be maintained while the creases defined by the three tri-fold flaps are heated with a longitudinal heating element. This softens the balloon material in longitudinal creases, so that the same creases will tend form whenever the balloon is deflated.

Abstract: An improved balloon catheter is disclosed which is comprised of two jacketed spring coils placed end-to-end and joined by a linking element which contains a lumen communicating between the inflation lumens formed by the two spring coils. A side port entry to a guidewire lumen, which extends through the distal coil to the distal end of the catheter, is located in the transition region formed by the linking element. The linking element may include two polyimide tubes or may be a multilumen insert. The catheter is stiffened by a core wire which is bonded directly to the spring coils. A catheter comprised of a single spring coil with a side port entry in the coil is also disclosed, and a method and apparatus for crimping the coil to create the entry.

Abstract: A torque-transmitting structure such as a guidewire or catheter is formed of a generally flat band or wire twisted so that its longitudinal edge generally forms a helix. This twisted helical portion may be attached to a proximal shaft, and a tip member may be attached to the distal end of the helical portion. In some embodiments, the device is made of a single piece of wire, and in some embodiments, a spring coil may cover the helical portion. Where the device is a fixed wire balloon catheter, the helical portion may be attached to a proximal shaft, and the balloon mounted on the helical twisted wire, a plastic sheath encasing the main shaft and wire up to the balloon for inflation of the balloon. The helical guidewire may also be used in an over-the-wire balloon catheter.

Abstract: An inflation device is disclosed for inflation of a balloon of a balloon catheter. A housing defines a fluid-receiving reservoir in fluid communication with the balloon and an interior space for completely receiving a pressure gauge which accesses the fluid for measurement of the pressure within the system.The reservoir has a piston and threaded plunger extending from a proximal opening in the reservoir. The threaded plunger is selectively engaged by a biased rotatable arm on the housing. The piston and plunger are part of a syringe received within the reservoir, and the housing defines an aperture for visual readout of the level of liquid in the reservoir.The pressure gauge contains a Bourdon tube and further contains a gauge fluid in communication with the tube.

Abstract: A dilatation catheter compromising a torque-transmitting shaft, a flexible body surrounding the shaft, and an inflatable balloon having a proximal end mounted on the flexible body. The dilatation catheter also includes a tip spring having a proximal end fixedly mounted to the shaft proximal to the distal end of the balloon and a distal end fixedly attached to the distal tip of the shaft. The dilatation catheter further comprises a tip tube having a proximal end fixedly mounted to the shaft and a distal end exending through the distal end of the balloon, the distal end of the balloon being fixedly attached to the tip tube, the tip tube being sufficiently flexible and the proximal end being sufficiently removed from the distal end of the balloon so that rotation of the shaft causes rotation of the tip substantially without twisting the balloon and substantially reducing rotation of the tip spring where it contacts the vascular system.

Abstract: A self-sealing, penetrable, hemostasis valve for a catheter introducer or the like which comprises an elastomeric gasket member having first and second opposed faces adapted to be secured in a valve housing, wherein faces define generally concave surfaces to reduce the central thickness of the gasket member, and a pin hole or slits extending through the first and second opposed faces generally at or through the central region of the gasket member. The generally concave opposed face surfaces are molded to possess a pair of convex cusp-shaped surfaces, each lying in about one-half of the generally concave surfaces, each convex cusp having an edge thereof passing generally through the central region of reduced thickness. The pair of generally convex, cusp-shaped surfaces on the first face is disposed at a 90 degree angle to the pair of generally convex, cusp-shaped surfaces on the second face.

Abstract: A balloon catheter is disclosed having a catheter body and one or more loops external to the body and spaced from the balloon for insertion of a guidewire. A peelable sheath with a guidewiare lumen can instead be mounted exterior to the catheter body for holding the guidewire. The catheter body may optionally be reinforced with a stylet.