Abstract: A tissue-removing catheter includes a cutter having an axial cavity and an opening extending from the axial cavity through the cutter to allow tissue removed from the body lumen by the annular cutting edge to pass proximally through the opening. A cutter driveshaft defines a tissue-transport passage extending longitudinally therein and in communication with the axial cavity of the cutter. A screw blade extends longitudinally within the tissue-transport passage and includes an external helical thread for transporting removed tissue proximally within the tissue-transport passage as the screw blade rotates about its axis. The cutter driveshaft having a distal end portion operatively coupled to the cutter for driving rotation of the cutter.

Abstract: A cleaning device for cleaning a catheter lumen of a tissue removal catheter has a flushing chamber with distal and proximal seals and an inlet port. The proximal seal is a duckbill seal that includes a pair of opposing duckbill members that slidingly accept the distal end portion of a catheter body to form a seal about the catheter body proximal to a proximal opening in of the catheter lumen. Fluid is directed in the inlet port, into the flushing chamber, into proximal opening in the catheter body, and through the catheter lumen to discharge tissue contained in the catheter lumen. In some embodiments, the cleaning device is preloaded on the catheter body. The cleaning device can have an internal stop that engages with an external stop on the catheter body when the cleaning device is positioned in an operative position.

Abstract: A tissue-removing catheter includes a cutter having an axial cavity and an opening extending from the axial cavity through the cutter to allow tissue removed from the body lumen by the annular cutting edge to pass proximally through the opening toward a tissue-transport passage of a catheter body. A screw blade extends longitudinally within the interior passage of the catheter body includes an external helical thread for transporting removed tissue proximally within the tissue-transport passage as the screw blade rotates about its axis. A cutter driveshaft extends longitudinally within a driveshaft passage of the screw blade and is rotatable about its axis relative to the screw blade. The cutter driveshaft having a distal end portion operatively coupled to the cutter for driving rotation of the cutter.

Abstract: A tissue-removing catheter includes a cutter having an axial cavity and an opening extending from the axial cavity through the cutter to allow tissue removed from the body lumen by the annular cutting edge to pass proximally through the opening. A cutter driveshaft defines a tissue-transport passage extending longitudinally therein and in communication with the axial cavity of the cutter. A screw blade extends longitudinally within the tissue-transport passage and includes an external helical thread for transporting removed tissue proximally within the tissue-transport passage as the screw blade rotates about its axis. The cutter driveshaft having a distal end portion operatively coupled to the cutter for driving rotation of the cutter.

Abstract: A tissue-removing catheter includes a cutting element. A radially innermost portion of the leading radial wall of a raised element of the cutting element may be spaced a radial distance from the longitudinal axis that is less than 66% of the radius of the annular cutting edge. The cutting element may be extendable through the window during operation such that as the cutting element is being rotated about its longitudinal axis, less than an entire radial portion of the leading radial wall passes through the window. A plurality of abrading members may be formed on at least the central portion of the inner surface of the cutting element to abrade hardened tissue as the cutting element is rotating about its longitudinal axis. A radially outermost portion of the leading radial edge of the raised element may be spaced apart radially from an inner surface of the cutting element.

Abstract: A tissue-removing catheter for removing tissue from a body lumen includes an elongate catheter body configured for insertion into the body lumen and a tissue-removing element. A side opening in the distal portion of the catheter body is defined by opposite first and second side edges, a proximal edge extending between the first and second side edges, and a distal edge opposite the proximal edge and extending between the first and second side edges. The side opening window has a longitudinal axis extending between the distal and proximal edges. The tissue-removing element is configured to move between a tissue-removing position, in which the tissue-removing element is exposed through the side opening window, and a neutral position, in which the tissue-removing element is positioned inside the distal portion of the catheter. The distal edge is asymmetric about the longitudinal axis of the side opening window.

Abstract: A tissue-removing catheter includes a cutting element. A radially innermost portion of the leading radial wall of a raised element of the cutting element may be spaced a radial distance from the longitudinal axis that is less than 66% of the radius of the annular cutting edge. The cutting element may be extendable through the window during operation such that as the cutting element is being rotated about its longitudinal axis, less than an entire radial portion of the leading radial wall passes through the window. A plurality of abrading members may be formed on at least the central portion of the inner surface of the cutting element to abrade hardened tissue as the cutting element is rotating about its longitudinal axis. A radially outermost portion of the leading radial edge of the raised element may be spaced apart radially from an inner surface of the cutting element.

Abstract: Drive shafts having helical blades and methods of making are disclosed. In one method a helical auger blade is formed by twisting or sculpting a heated polymer tube which has been placed over a cylindrical drive shaft. In another method a drive shaft is placed within a helical winding and heat is applied to melt polymer which has been coated over one or both of the drive shaft and helical winding.

Abstract: Drive shafts having helical blades and methods of making are disclosed. In one method a helical auger blade is formed by twisting or sculpting a heated polymer tube which has been placed over a cylindrical drive shaft. In another method a drive shaft is placed within a helical winding and heat is applied to melt polymer which has been coated over one or both of the drive shaft and helical winding.

Abstract: A tissue-removing catheter includes a cutter. The catheter also includes a longitudinal force-transmitting member extending along a catheter body and being longitudinally movable relative to the catheter body. A distal end portion of the longitudinal force-transmitting member is operatively connected to a distal longitudinal portion of a cutter housing such that distal movement of the longitudinal force-transmitting member relative to the catheter body and the cutter imparts pivoting of the distal longitudinal portion to its open position to expose the cutter.

Abstract: A tissue-removing catheter includes a cutter. The catheter also includes a longitudinal force-transmitting member extending along a catheter body and being longitudinally movable relative to the catheter body. A distal end portion of the longitudinal force-transmitting member is operatively connected to a distal longitudinal portion of a cutter housing such that distal movement of the longitudinal force-transmitting member relative to the catheter body and the cutter imparts pivoting of the distal longitudinal portion to its open position to expose the cutter.

Abstract: A rotatable cutter for a tissue-removing catheter includes a central hub, flutes spaced apart from one another around the circumference of the central hub, and arcuate cutting members. Each cutting member includes an arcuate cutting edge extending along an arc length of the cutting member for cutting tissue as the cutter is rotated. A raised element of each cutting member has a leading cutting edge at a leading end of the distal cutting member for cutting tissue as the cutter is rotated. A clearance portion of each cutting member is recessed, relative to the longitudinal axis of the cutter, from the raised element and extends from the raised element to a trailing end of the cutting member to provide clearance for the leading cutting edge of an adjacent and opposing distal cutting member.

Abstract: A catheter for removing tissue from a body lumen include's a rotatable cutter. The cutter includes an annular cutting tip at the distal end portion of the cutter for removing tissue from the body lumen. An axial cavity is defined by an interior surface of the cutter and extends proximally from the annular cutting tip toward the proximal end portion of the cutter. An eccentric opening extends from the central cavity through the cutter to allow tissue removed from the body lumen by the annular cutting tip to pass proximally through the eccentric opening toward an interior passage of the catheter body. The offset opening is offset from the longitudinal axis of the cutter.

Abstract: A tissue-removing catheter for removing tissue from a body lumen includes an elongate catheter body configured for insertion into the body lumen and a tissue-removing element. A side opening in the distal portion of the catheter body is defined by opposite first and second side edges, a proximal edge extending between the first and second side edges, and a distal edge opposite the proximal edge and extending between the first and second side edges. The side opening window has a longitudinal axis extending between the distal and proximal edges. The tissue-removing element is configured to move between a tissue-removing position, in which the tissue-removing element is exposed through the side opening window, and a neutral position, in which the tissue-removing element is positioned inside the distal portion of the catheter. The distal edge is asymmetric about the longitudinal axis of the side opening window.

Abstract: A cleaning device for a medical instrument including a flushing chamber, the flushing chamber having a lumen sized and configured to accept a distal end portion of the medical instrument during a cleaning process. The flushing chamber has an inlet port and an outlet port. Proximal and distal sealing members of the flushing chamber seal about the medical instrument when the instrument is inserted into the lumen of the flushing chamber.

Abstract: A tissue-removing catheter for removing tissue from a body lumen includes a tissue-removing element. The tissue-removing element may be coupled to a first longitudinal body portion of the catheter body. The first longitudinal body portion may be rotatable along its length and relative to a second longitudinal body portion to adjust the angular position of the first longitudinal body portion relative to the second longitudinal body portion. An angular-positioning mechanism may be operatively connected to the tissue-removing element for rotating the tissue-removing element relative to the second longitudinal body portion about a rotational axis to adjust an angular tissue-removing position of the tissue-removing element, relative to the longitudinal axis of the body lumen, from a first angular tissue-removing position to a second angular tissue-removing position offset from the first angular tissue-removing position.

Abstract: A catheter includes a tissue-removing element and a tissue-containment chamber configured to receive tissue removed by the tissue-removing element. The tissue-containment chamber has a tissue-removing opening for use in removing tissue from the chamber. A closure component is associated with the tissue-removing opening for selectively opening and closing the opening.

Abstract: A rotatable cutter for a tissue-removing catheter includes a central hub, flutes spaced apart from one another around the circumference of the central hub, and arcuate cutting members. Each cutting member includes an arcuate cutting edge extending along an arc length of the cutting member for cutting tissue as the cutter is rotated. A raised element of each cutting member has a leading cutting edge at a leading end of the distal cutting member for cutting tissue as the cutter is rotated. A clearance portion of each cutting member is recessed, relative to the longitudinal axis of the cutter, from the raised element and extends from the raised element to a trailing end of the cutting member to provide clearance for the leading cutting edge of an adjacent and opposing distal cutting member.

Abstract: A catheter for removing tissue from a body lumen includes a rotatable cutter. The cutter includes an annular cutting tip at the distal end portion of the cutter for removing tissue from the body lumen. An axial cavity is defined by an interior surface of the cutter and extends proximally from the annular cutting tip toward the proximal end portion of the cutter. An eccentric opening extends from the central cavity through the cutter to allow tissue removed from the body lumen by the annular cutting tip to pass proximally through the eccentric opening toward an interior passage of the catheter body. The offset opening is offset from the longitudinal axis of the cutter.

Abstract: A cleaning device for a medical instrument including a flushing chamber, the flushing chamber having a lumen sized and configured to accept a distal end portion of the medical instrument during a cleaning process. The flushing chamber has an inlet port and an outlet port. Proximal and distal sealing members of the flushing chamber seal about the medical instrument when the instrument is inserted into the lumen of the flushing chamber.