Abstract: A torqueable hollow device, such as a hollow guidewire device, with a pre-determined fixed distal tip is disclosed for removing occlusive material and passing through occlusions, stenosis, thrombus, plaque, calcified material, and other materials in a body lumen, such as a coronary artery. The hollow guidewire generally comprises an elongate, tubular guidewire body that has an axial lumen. A mechanically moving core element is positioned at or near a distal end of the tubular guidewire body and extends through the axial lumen. Actuation of the core element (e.g., oscillation, reciprocation, and/or rotation) creates a passage through the occlusive or stenotic material in the body lumen.

Abstract: A steerable distal support system for accessing stenosis, partial occlusions, or complete occlusions within a body lumen. The steerable distal support system generally includes an elongate member that comprises a proximal portion, a more flexible intermediate portion and a deflectable distal tip. The deflectable distal tip is at a distal end of the elongate body to facilitate directionality and positioning of the steerable distal support system to the target site. Optionally, an expandable centering assembly may be disposed on the steerable support assembly to center and anchor the steerable support assembly within the body lumen.

Abstract: A controller system includes a device configured to cross an occlusion or stenosis and a control unit. The occlusion-crossing device has an axial lumen and a drive shaft extending through the axial lumen. The control unit is coupled to the device. The control unit has a processor which produces a variable sound and a variable visual display in response to a load measurement on the drive shaft. The load may be measured by a change in current in a motor which drives the shaft. This change in current is then converted to a frequency for variable sound and to a visual display indicative of the load. The load status on the motor may be divided into discrete load levels and correspondingly indicated by discrete levels in the feedback sound frequency and the visual display. This system may be used to monitor and facilitate crossing vascular total occlusions during percutaneous interventions.

Abstract: A guidewire controller system includes a guidewire device and a control unit. The guidewire device has an axial lumen and a drive shaft extending through the axial lumen. The control unit is coupled to the guidewire device. The control unit has a processor which produces a variable sound in response to a load measurement on the drive shaft. The load may be measured by a change in current in a motor which drives the shaft. This change in current is then converted to a frequency for variable sound.

Abstract: A deflectable and torqueable hollow guidewire device is disclosed for removing occlusive material and passing through occlusions, stenosis, thrombus, plaque, calcified material, and other materials in a body lumen, such as a coronary artery. The hollow guidewire generally comprises an elongate, tubular guidewire body that has an axial lumen. A mechanically moving core element is positioned at or near a distal end of the tubular guidewire body and extends through the axial lumen. Actuation of the core element (e.g., oscillation, reciprocation, and/or rotation) creates a passage through the occlusive or stenotic material in the body lumen.

Abstract: Systems and methods for crossing stenosis, partial occlusions, or complete occlusions within a body lumen. The systems generally include an elongate member such as a hollow guidewire that houses a rotatable and translatable drive shaft. The drive shaft typically has a distal portion that is advanced to create a path in the occlusive material that is large enough to allow the hollow guidewire to cross the occlusive material.