Abstract: A debulking catheter includes an advancer for advancing a tissue-removing clement, and a linear-force indicator. The linear-force indicator provides feedback to the user based on an amount of linear force being applied to the advancer.

Abstract: A tissue-removing catheter for removing tissue in a body lumen includes an elongate body having an axis, and proximal and distal end portions spaced apart from one another along the axis. The elongate body is sized and shaped to be received in the body lumen. A handle is mounted to the proximal end portion of the elongate body. The handle includes a housing enclosing components operable to cause rotation of the elongate body. A tissue-removing element is mounted on the distal end portion of the elongate body. An inner liner is received within the elongate body and defines a guidewire lumen. An advancer is mounted on the handle and is movable relative to the housing. A guide tube is mounted in the handle and is coupled to the advancer such that movement of the advancer relative to the housing causes movement of the guide tube.

Abstract: A tool has an outer assembly, which includes a deployment tube, extending around, and moveable with respect to an inner assembly of the tool; the inner assembly includes a single pull wire and a distal member configured to engage an end of an implantable medical device. The deployment tube includes an articulating segment located just proximal to an enlarged distal-most portion, which contains the device and the distal member. Relatively soft and stiff sections of a composite sidewall define the articulating segment and extend alongside one another, such that, when the pull wire is actuated, the composite sidewall causes bending of the segment in two directions. A handle assembly of the tool includes a control member for the pull wire, and may further include a flushing subassembly that has a connector port located at an end of the handle assembly that is opposite a proximal port of the handle.

Abstract: A tissue-removing catheter for removing tissue in a body lumen includes an elongate body and a tissue-removing element mounted on a distal end portion of the elongate body. The tissue-removing element is configured to remove the tissue as the tissue-removing element is rotated by the elongate body within the body lumen. An inner liner is received within the elongate body. The inner liner defines a guidewire lumen. The inner liner isolates an interior of the guidewire lumen from the elongate body and tissue-removing element such that rotational forces are not transferred from the elongate body and tissue-removing element to the interior of the guidewire lumen when the elongate body and tissue-removing element are rotated during removal of tissue from the body lumen.

Abstract: A tissue-removing catheter includes a torque sensor that senses torque from a motor acting on a component of the catheter. A linear force sensor senses a linear force from the advancer acting on a component of the catheter. A controller is in operative communication with the motor, the torque sensor, and the linear force sensor. The controller controls a speed of the motor based on the sensed torque and the sensed linear force during operation of the tissue-removing catheter. The linear force sensor may sense linear force imparted on a liner of the catheter.

Abstract: A tissue-removing catheter may be configured to remove tissue in a body lumen. The tissue-removing catheter may include an elongate body sized and shaped to be received in the body lumen. The tissue-removing catheter also may include a tissue-removing element mounted on a distal end portion of the elongate body. The tissue-removing element may be configured to remove the tissue as the tissue-removing element is rotated by the elongate body within the body lumen. The tissue-removing catheter may further include a motor operatively engaging the elongate body for driving rotation of the elongate body and the tissue-removing element. The tissue-removing catheter additionally may include a controller operatively connected to the motor and configured to perform a torque response routine to control a speed of the motor based on a set PWM value of the motor and a detected current applied to the motor during rotation of the elongate body and tissue-removing element.

Abstract: A tissue-removing catheter for removing tissue in a body lumen includes an elongate body having an axis. A handle is mounted to a proximal end portion of the elongate body. A tissue-removing element is mounted on a distal end portion of the elongate body. An inner liner is received within the elongate body and defines a guidewire lumen. An advancer is mounted on the handle and is movable relative to the housing. The inner liner is coupled to the advancer at a proximal end portion of the inner liner such that movement of the advancer causes a corresponding movement of the inner liner to exert a push force on the tissue-removing element to advance the tissue-removing element and a pull force on the tissue-removing element to retract the tissue-removing element for moving the tissue-removing element relative to the handle.

Abstract: A tissue-removing catheter for removing tissue in a body lumen includes an elongate body having an axis, and proximal and distal end portions spaced apart from one another along the axis. The elongate body is sized and shaped to be received in the body lumen. A handle is mounted to the proximal end portion of the elongate body. The handle includes a housing enclosing components operable to cause rotation of the elongate body. A tissue-removing element is mounted on the distal end portion of the elongate body. An inner liner is received within the elongate body and defines a guidewire lumen. An advancer is mounted on the handle and is movable relative to the housing. A guide tube is mounted in the handle and is coupled to the advancer such that movement of the advancer relative to the housing causes movement of the guide tube.

Abstract: A debulking catheter includes an advancer for advancing a tissue-removing element, and a linear-force indicator. The linear-force indicator provides feedback to the user based on an amount of linear force being applied to the advancer.

Abstract: The present disclosure provides a tissue-removing catheter for removing tissue in a body lumen. The tissue-removing catheter includes an elongate drive member and a tissue-removing element. The elongate drive member has proximal and distal ends with a length and a longitudinal axis extending between the proximal and distal ends. The elongate drive member is sized and shaped to be received in the body lumen and rotates about its longitudinal axis. The elongate drive member further includes first and second longitudinal portions. The first longitudinal portion is proximal to and stiffer than the second longitudinal portion. The tissue-removing element is operatively coupled to the distal end of the elongate drive member and rotates by the elongate drive member to remove the tissue in the body lumen.

Abstract: A tool has an outer assembly, which includes a deployment tube, extending around, and moveable with respect to an inner assembly of the tool; the inner assembly includes a single pull wire and a distal member configured to engage an end of an implantable medical device. The deployment tube includes an articulating segment located just proximal to an enlarged distal-most portion, which contains the device and the distal member. Relatively soft and stiff sections of a composite sidewall define the articulating segment and extend alongside one another, such that, when the pull wire is actuated, the composite sidewall causes bending of the segment in two directions. A handle assembly of the tool includes a control member for the pull wire, and may further include a flushing subassembly that has a connector port located at an end of the handle assembly that is opposite a proximal port of the handle.

Abstract: A tissue-removing catheter for removing tissue in a body lumen includes an elongate body and a tissue-removing element mounted on a distal end portion of the elongate body. The tissue-removing element is configured to remove the tissue as the tissue-removing element is rotated by the elongate body within the body lumen. An inner liner is received within the elongate body. The inner liner defines a guidewire lumen. The inner liner isolates an interior of the guidewire lumen from the elongate body and tissue-removing element such that rotational forces are not transferred from the elongate body and tissue-removing element to the interior of the guidewire lumen when the elongate body and tissue-removing element are rotated during removal of tissue from the body lumen.

Abstract: A tissue-removing catheter for removing tissue in a body lumen includes an elongate body and a tissue-removing element mounted on a distal end portion of the elongate body. The tissue-removing element is configured to remove the tissue as the tissue-removing element is rotated by the elongate body within the body lumen. An inner liner is received within the elongate body. The inner liner defines a guidewire lumen. The inner liner isolates an interior of the guidewire lumen from the elongate body and tissue-removing element such that rotational forces are not transferred from the elongate body and tissue-removing element to the interior of the guidewire lumen when the elongate body and tissue-removing element are rotated during removal of tissue from the body lumen.

Abstract: A tissue-removing catheter for removing tissue in a body lumen includes an elongate body having an axis and proximal and distal end portions spaced apart from one another along the axis. A tissue-removing element is mounted on the distal end portion of the elongate body. The tissue-removing element is configured to remove the tissue as the tissue-removing element is rotated by the elongate body within the body lumen. A motor operatively engages the elongate body for driving rotation of the elongate body and tissue-removing element mounted on the elongate body. A controller is operatively connected to the motor and configured to perform a torque response routine to control a speed of the motor based on a set PWM value of the motor and a detected current applied to the motor during rotation of the elongate body and tissue-removing element.

Abstract: A tissue-removing catheter for removing tissue in a body lumen includes a tube extending axially along the catheter. A junction box housing is located at a distal end of the tube. An elongate body extends distally from the junction box housing. The elongate body is sized and shaped to be received in the body lumen. A gear assembly is disposed in the junction box housing. The gear assembly engages the elongate body for rotating the elongate body. A tissue-removing element is mounted on a distal end portion of the elongate body. The tissue-removing element is configured to remove the tissue as the tissue-removing element is rotated by the elongate body within the body lumen.

Abstract: A tissue-removing catheter for removing tissue in a body lumen includes an elongate body having an axis, and proximal and distal end portions spaced apart from one another along the axis. The elongate body is sized and shaped to be received in the body lumen. A tissue-removing element is mounted on the distal end portion of the elongate body. The tissue-removing element is configured to remove the tissue as the tissue-removing element is rotated by the elongate body within the body lumen. An inner liner is received within the elongate body and defines a guidewire lumen. The inner liner is coupled to the tissue-removing element at a distal end portion of the inner liner. A coupling assembly is disposed in the tissue-removing element for coupling the inner liner to the tissue-removing element. The coupling assembly includes a bushing attached directly to the distal end portion of the inner liner.

Abstract: A tissue-removing catheter for removing tissue in a body lumen includes a catheter body assembly having an axis and proximal and distal end portions spaced apart from one another along the axis. At least a portion of the catheter body assembly is sized and shaped to be received in the body lumen. A handle is mounted to the proximal end portion of the catheter body assembly and operable to cause rotation of the catheter body assembly. The handle includes internal handle components that interface with the catheter body assembly. The internal handle components provide at least four interface locations spaced axially along the catheter body assembly. A tissue-removing element is mounted on the distal end portion of the catheter body assembly. The tissue-removing element is configured to remove the tissue as the tissue-removing element is rotated by the catheter body assembly within the body lumen.

Abstract: A method of removing tissue in a body lumen includes advancing a tissue-removing catheter over a guidewire in the body lumen to position a distal end of the catheter adjacent the tissue and a proximal end portion of the catheter outside of the body lumen. The catheter includes an elongate body, a tissue removing element mounted on a distal end portion of the elongate body, and an inner liner disposed within the elongate body. The inner liner defines a guidewire lumen in which the guidewire is disposed during the advancement of the catheter. The method further includes rotating the elongate body and tissue-removing element of the catheter to remove the tissue. Detecting wear of the inner liner caused by the elongate body contacting the inner liner during use.

Abstract: The present disclosure provides a tissue-removing catheter that includes an elongate body, a tissue-removing element, and an inner liner. The elongate body has proximal and distal end portions spaced apart from one another along an axis and is sized and shaped to be received in a body lumen. The tissue-removing element rotates by the elongate body to remove tissue. The inner liner is received within the elongate body, defines a guidewire lumen, and isolates an interior of the guidewire lumen from the elongate body and tissue-removing element, preventing torsional force from transferring from the elongate body and tissue-removing element to the interior of the guidewire lumen. The inner liner includes a distal end margin that may have a construction different from a construction of a second portion of the inner liner proximal of the distal end margin. The distal end margin may be more flexible than the second portion.

Abstract: A tissue-removing catheter for removing tissue in a body lumen includes an elongate catheter body. A tissue-removing element is operatively coupled to a distal end portion of the elongate catheter body. The tissue-removing element has a central axis. The tissue-removing element is configured to be rotated about its central axis to remove tissue from the body lumen. A distal end portion of the tissue-removing element includes a distal end face at a distal-most end of the tissue-removing element. The distal end face has a perimeter and a diameter extending through the central axis. Diametrically opposite points on the perimeter lie in a plane that is oblique to the central axis of the tissue-removing element.