A platform device for material excision or removal from vascular structures for either handheld or stereotactic table use may comprise a work element or elements configured to selectively open and close at least one articulable beak or scoopula configured to penetrate and remove intra-vascular materials or obstructions, or follow a central lumen of another device or over a wire in a longitudinal direction. Flush and vacuum tissue transport mechanisms may be incorporated. A single tube or an inner sheath and an outer sheath which may be co-axially disposed relative to a work element may be configured to actuate a beak or beaks or scoopulae and provisions for simultaneous beak or scoopula closing under rotation may be incorporated.

Devices and methods for the treatment of chronic total occlusions are provided. One disclosed embodiment comprises a method of facilitating treatment via a vascular wall defining a vascular lumen containing an occlusion therein. The method includes providing a first intravascular device having a distal portion with a concave side, inserting the first device into the vascular lumen, positioning the distal portion in the vascular wall, and orienting the concave side of the distal portion toward the vascular lumen.

A device (1, 30, 40, 50, 60) for denuding a vein comprises a vein denuding head (3) operatively attached to an elongated catheter member (2) and configured for transluminal delivery and deployment in the vein. The vein denuding head comprises a helical coil (4) that is self-adjustable from an uncoiled delivery configuration suitable for transluminal delivery within the catheter member and a coiled deployed configuration having a diameter greater than the vein to be denuded that circumferentially engages an internal lumen of the vein when deployed. The helical coil has an abrasive surface configured to circumferentially denude the internal lumen of the vein when the coil is moved axially along the body lumen in the coiled configuration. The helical coil may be a single helical coil element.

Dual-access site catheter systems with a blade or scoring functionality entering through a first access site and a balloon functionality for manipulating or driving the blade or scoring functionality through a different site. The blade or scoring functionality also sometimes provides needle or fluid delivery functionality to an atherosclerotic lesion.

A tissue-removing catheter for removing tissue in a body lumen includes an elongate body sized and shaped to be received in the body lumen. A handle is mounted at a proximal end portion of the catheter and is operable to cause rotation of 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. A guidewire lumen extends through the elongate body from a distal end of the catheter to an intermediate location on the catheter spaced distally from the proximal end portion of the catheter. The guidewire lumen is configured to receive a guidewire such the catheter can be removed from the body lumen by pulling the catheter along the guidewire without removing the guidewire from the body lumen.

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.

Devices and methods for the treatment of chronic total occlusions are provided. One disclosed embodiment comprises a method of facilitating treatment via a vascular wall defining a vascular lumen containing an occlusion therein. The method includes providing a first intravascular device having a distal portion with a concave side, inserting the first device into the vascular lumen, positioning the distal portion in the vascular wall, and orienting the concave side of the distal portion toward the vascular lumen.

A device for manipulating tissue at a vessel includes an elongated member having a proximal end and a distal end, a guide member at the distal end of the elongated member, the guide member having a blunt distal tip for engagement against an interior wall of the vessel, and a tissue cutting device at the distal end of the elongated member, wherein the tissue cutting device has a sharp tip that is proximal to the blunt distal tip of the guide member.

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 and coupled to a handle at a proximal end of the inner liner. 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 and torsional 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 operation of the tissue-removing catheter.

An atherectomy system includes a handle and a drive motor that is adapted to rotate a drive cable extending through the handle and operably coupled to an atherectomy burr. A control system is adapted to regulate operation of the drive motor, including providing the drive motor with a high frequency pulse width modulation (PWM) drive signal in order to operate the drive motor. The control system monitors a motor performance parameter such as motor speed or motor torque, and when the motor performance parameter approaches a limit of a performance range, the control system adds a low frequency PWM signal to the high frequency PWM drive signal, thereby causing the drive motor to produce a tactile signal that signals to the user that the motor performance parameter is approaching the limit of the performance range.