Abstract: The invention provides systems and methods for mixing of therapeutic agents before and/or during the localized application of the therapeutic agents. Most preferably, the present invention provides systems and methods for mixing of therapeutic agents before and/or during administration of the agents within a biological lumen. Various embodiments of the present invention comprise systems and methods for inducing a mixing state in the therapeutic agents, thereby inducing and/or maintaining homogeneity of the agents before and/or during localized delivery.

Abstract: The present invention is directed in various methods, devices and systems relating to systems and methods for measuring and calculating a biological conduit's, e.g., a blood vessel, inner diameter, the opposition force of the conduit's wall on an expanding balloon disposed therein and the conduit and/or lesion compliance to the expanding balloon.

Abstract: An atherectomy device may include a handle having a rotational drive mechanism therein, a drive shaft operably coupled to the drive mechanism and having an abrasive element arranged at a distal end thereof, the drive shaft comprising a first portion and a second portion, wherein the first portion comprises a spin-to-close profile and the second portion comprises a spin-to-open profile.

Abstract: The invention relates generally to devices and methods for local delivery of therapeutic agents to the wall of a bodily lumen with minimal shearing damage to the therapeutic agents, more specifically to the wall of a blood vessel following atherectomy. A preferred delivery mechanism comprises a balloon, or double balloon, though any distal catheter design may be used to reduce shear stress and to conserve and/or isolate the therapeutic substance.

Abstract: The invention provides a system, device and method for localized application of therapeutic substances within a biological conduit. One embodiment comprises a rotational atherectomy device having a flexible, elongated, rotatable, drive shaft having a lumen and with an eccentric enlarged abrading head having at least one application hole attached therethrough and in communication with a therapeutic agent delivery sheath and an operator-controlled actuator. The therapeutic substances may then spray radially outwardly from the application hole(s) on the eccentric abrading head during and/or after high-speed rotation of the head. Another embodiment comprises compartments in the abrading head that hold therapeutic agent(s) for release during high-speed rotation. In each case, the therapeutic substance(s) is delivered with radial forces resulting from high-speed orbital rotation of the eccentric abrading head, driving the therapeutic substance(s) into the conduit wall.

Abstract: The invention provides a system, device and method for localized application of therapeutic substances within a biological conduit after the lumen wall has been scored by an eccentric scoring head. One embodiment comprises radial scoring with the eccentric scoring head, with a therapeutic agent coated balloon inflated distal to the scoring and dragged proximally through the scoring. Another embodiment comprises inflation of two anchor balloons on either side of scoring with subsequent inflation of a therapeutic agent coated balloon therebetween which causes the distance between anchor balloons to increase, thus stretching the scoring crevices while applying the agent therein with subsequent closure of crevices on deflation of anchor and application balloons. Another embodiment comprises an inflated anchor balloon with a threaded scoring device wherein the scoring members are coated with agent and rotation of the threaded device enables travel in the proximal direction away from anchor balloon.

Abstract: The invention provides systems and methods for mixing of therapeutic agents before and/or during the localized application of the therapeutic agents. Most preferably, the present invention provides systems and methods for mixing of therapeutic agents before and/or during administration of the agents within a biological lumen. Various embodiments of the present invention comprise systems and methods for inducing a mixing state in the therapeutic agents, thereby inducing and/or maintaining homogeneity of the agents before and/or during localized delivery.

Abstract: The invention relates generally to devices and methods for local delivery of therapeutic agents to the wall of a bodily lumen with minimal shearing damage to the therapeutic agents, more specifically to the wall of a blood vessel following atherectomy. A preferred delivery mechanism comprises a balloon, or double balloon, though any distal catheter design may be used to reduce shear stress and to conserve and/or isolate the therapeutic substance.

Abstract: The invention provides a system, device and method for localized application of therapeutic substances within a biological conduit. One embodiment comprises a rotational atherectomy device having a flexible, elongated, rotatable, drive shaft having a lumen and with an eccentric enlarged abrading head having at least one application hole attached therethrough and in communication with a therapeutic agent delivery sheath and an operator-controlled actuator. The therapeutic substances may then spray radially outwardly from the application hole(s) on the eccentric abrading head during and/or after high-speed rotation of the head. Another embodiment comprises compartments in the abrading head that hold therapeutic agent(s) for release during high-speed rotation. In each case, the therapeutic substance(s) is delivered with radial forces resulting from high-speed orbital rotation of the eccentric abrading head, driving the therapeutic substance(s) into the conduit wall.

Abstract: An atherectomy device is disclosed, with a clutch between the motor and the drive shaft. The clutch includes two plates that rely on frictional to transmit torque from one plate to the other. The clutch has an attractive magnetic normal force that holds the plates together. For relatively low torques, as is the case during normal use, a static frictional torque holds the plates together, and the plates spin together without slipping. For relatively high torques, as occurs when the distal end of the drive shaft encounters an obstacle and stops abruptly, the high torque exceeds the maximum possible static frictional torque, and the plates slip. When slipping, the plates transmit a kinetic frictional torque that is low enough to avoid damage to the patient or to the atherectomy device. In some cases, the torque levels associated with a stoppage of the drive shaft distal end are chosen to mimic those of a known atherectomy device, in which a gas-driven turbine is clutchlessly attached to the drive shaft.

Abstract: A balloon blowing process which involves radial expansion of an extruded tubing segment which has been subjected to a stretching step prior to radial expansion, the process utilizing an internal pressure and a temperature which together cause at least a portion of the tubing to expand to an interior diameter (ID) which is greater than the interior diameter of the extruded segment prior to extrusion.