Abstract: The present invention provides a guidewire assist tool for use in providing a smooth back loading of a guide wire through an intravascular blood pump such as a VAD, LVAD or RVAD. Such devices typically have large apertures or windows, e.g., outlet apertures located proximally of an impeller. The guidewire assist tool temporarily fills the windows to allow the guidewire to smoothly translate past the windows. Once the guidewire tip has translated past the apertures or windows, the guidewire assist tool may be removed.

Abstract: A rotational atherectomy device includes a drive shaft, a cutter mechanism coupled to the drive shaft and configured to cut occlusive material from a lesion, and a multi-stage macerator coupled to the drive shaft and configured to macerate cut occlusive material into a fine slurry. Successive stages of the multi-stage macerator macerate the cut occlusive material into successively smaller particles, which are moved proximally through a lumen of a sheath of the device that surrounds the drive shaft proximal to the macerator. The device may include a movable cutter mechanism guard that is passively rotatable between a first position in which it covers the cutter mechanism and a second position in which it exposes the cutter mechanism. One or more features of the device may limit a depth to which the cutter mechanism is able to cut the occlusive material to reduce a likelihood of undesirable tissue dissection.

Abstract: A rotational atherectomy device includes a drive shaft, a cutter mechanism coupled to the drive shaft and configured to cut occlusive material from a lesion, and a multi-stage macerator coupled to the drive shaft and configured to macerate cut occlusive material into a fine slurry. Successive stages of the multi-stage macerator macerate the cut occlusive material into successively smaller particles, which are moved proximally through a lumen of a sheath of the device that surrounds the drive shaft proximal to the macerator. The device may include a movable cutter mechanism guard that is passively rotatable between a first position in which it covers the cutter mechanism and a second position in which it exposes the cutter mechanism. One or more features of the device may limit a depth to which the cutter mechanism is able to cut the occlusive material to reduce a likelihood of undesirable tissue dissection.

Abstract: The present disclosure generally relates to methods, devices and systems relating to applying drugs or therapeutic agents to biological conduits, e.g., vascular lumens. More specifically, the present invention comprises enhancing the uptake of drugs or therapeutic agents encapsulated in microbubbles in combination with ultrasound energy as well as applying drugs or therapeutic agents in a cyclic manner using a pulse generator that may be matched in frequency with a patient's blood pulsing.

Abstract: Various embodiments of the systems, methods and devices are provided comprising angioplasty to break up calcification or other tissue in occlusive areas within a blood vessel. The various embodiments disclosed comprise pressure pulse periods designed to break up calcified occlusive material through a cyclically stretching of the vessel walls without damaging the vessel wall tissue.

Abstract: Various embodiments of the systems, methods and devices are provided comprising angioplasty to break up calcification or other tissue in occlusive areas within a blood vessel. The various embodiments disclosed include pressure pulse periods designed to break up calcified occlusive material through a cyclically stretching of the vessel walls without damaging the vessel wall tissue.

Abstract: A rotational atherectomy device includes a drive shaft, a cutter mechanism coupled to the drive shaft and configured to cut occlusive material from a lesion, and a multi-stage macerator coupled to the drive shaft and configured to macerate cut occlusive material into a fine slurry. Successive stages of the multi-stage macerator macerate the cut occlusive material into successively smaller particles, which are moved proximally through a lumen of a sheath of the device that surrounds the drive shaft proximal to the macerator. The device may include a movable cutter mechanism guard that is passively rotatable between a first position in which it covers the cutter mechanism and a second position in which it exposes the cutter mechanism. One or more features of the device may limit a depth to which the cutter mechanism is able to cut the occlusive material to reduce a likelihood of undesirable tissue dissection.

Abstract: The present disclosure generally relates to methods, devices and systems relating to applying drugs or therapeutic agents to biological conduits, e.g., vascular lumens. More specifically, the present invention comprises enhancing the uptake of drugs or therapeutic agents encapsulated in microbubbles in combination with ultrasound energy as well as applying drugs or therapeutic agents in a cyclic manner using a pulse generator that may be matched in frequency with a patient's blood pulsing.

Abstract: The present system is directed in various embodiments to methods, devices and systems for sensing, measuring and evaluating compliance in a bodily conduit. In other embodiments, the methods, devices and systems sense, measure, determine, display and/or interpret compliance in a bodily conduit and/or a lesion within the bodily conduit. In all embodiments, the sensing, measuring, determining, displaying and/or interpreting may occur before, during and/or after a procedure performed within the bodily conduit. An exemplary conduit comprises a blood vessel and an exemplary procedure comprises a vascular procedure such as atherectomy, angioplasty, stent placement and/or biovascular scaffolding.

Abstract: The present disclosure generally relates to methods, devices and systems relating to applying drugs or therapeutic agents to biological conduits, e.g., vascular lumens. More specifically, the present invention comprises enhancing the uptake of drugs or therapeutic agents encapsulated in microbubbles in combination with ultrasound energy as well as applying drugs or therapeutic agents in a cyclic manner using a pulse generator that may be matched in frequency with a patient's blood pulsing.

Abstract: Various embodiments of the systems, methods and devices are provided comprising angioplasty to break up calcification or other tissue in occlusive areas within a blood vessel. The various embodiments disclosed comprise pressure pulse periods designed to break up calcified occlusive material through a cyclically stretching of the vessel walls without damaging the vessel wall tissue.

Abstract: A rotational atherectomy system is disclosed, comprising: an elongated, flexible spin-to-open drive shaft having a distal end for insertion into a vasculature of a patient and having a proximal end opposite the distal end remaining outside the vasculature of the patient; a concentric or eccentric abrasive element, preferably a solid crown, attached to the drive shaft proximate the distal end of the drive shaft; an electric motor rotatably coupled to the proximal end of the drive shaft, the electric motor being capable of rotating the drive shaft in a spin-to-open direction; and control electronics for monitoring and controlling the rotation of the electric motor. When an obstruction at the distal end is detected by the applied torque and/or current reaching a predetermined maximum allowed level and with the drive shaft opened to a maximum allowed outer diameter, power to the motor is eliminated.

Abstract: The present disclosure generally relates to methods, devices and systems relating to applying drugs or therapeutic agents to biological conduits, e.g., vascular lumens. More specifically, the present invention comprises enhancing the uptake of drugs or therapeutic agents encapsulated in microbubbles in combination with ultrasound energy as well as applying drugs or therapeutic agents in a cyclic manner using a pulse generator that may be matched in frequency with a patient's blood pulsing.

Abstract: The present system is directed in various embodiments to methods, devices and systems for sensing, measuring and evaluating compliance in a bodily conduit. In other embodiments, the methods, devices and systems sense, measure, determine, display and/or interpret compliance in a bodily conduit and/or a lesion within the bodily conduit. In all embodiments, the sensing, measuring, determining, displaying and/or interpreting may occur before, during and/or after a procedure performed within the bodily conduit. An exemplary conduit comprises a blood vessel and an exemplary procedure comprises a vascular procedure such as atherectomy, angioplasty, stent placement and/or biovascular scaffolding.

Abstract: A rotational atherectomy system is disclosed, comprising: an elongated, flexible spin-to-open drive shaft having a distal end for insertion into a vasculature of a patient and having a proximal end opposite the distal end remaining outside the vasculature of the patient; a concentric or eccentric abrasive element, preferably a solid crown, attached to the drive shaft proximate the distal end of the drive shaft; an electric motor rotatably coupled to the proximal end of the drive shaft, the electric motor being capable of rotating the drive shaft in a spin-to-open direction; and control electronics for monitoring and controlling the rotation of the electric motor. When an obstruction at the distal end is detected by the applied torque and/or current reaching a predetermined maximum allowed level and with the drive shaft opened to a maximum allowed outer diameter, power to the motor is eliminated.

Abstract: The present invention is directed in various methods, devices and systems relating to providing a balloon on a sheath in combination with orbital atherectomy in order reduce the number of steps in the procedure. In certain embodiments, the balloon comprises adjunctive low pressure balloon for prevention of vessel trauma during dilatation.

Abstract: An immersion mold for a medical device balloon. The mold has a cavity adapted to receive a hollow parison expandable therein to form the balloon. The cavity has a length, a first end, a second end, and a cavity wall with inner and outer surfaces. The mold form cavity wall is provided with one or a plurality of through-holes along the length thereof to facilitate entrance and egress of a heated fluid.

Abstract: An immersion mold for a medical device balloon. The mold has a cavity adapted to receive a hollow parison expandable therein to form the balloon. The cavity has a length, a first end, a second end, and a cavity wall with inner and outer surfaces. The mold form cavity wall is provided with one or a plurality of through-holes along the length thereof to facilitate entrance and egress of a heated fluid.

Abstract: A balloon catheter that comprises an inner shaft, a balloon and a sleeve that defines a lumen. A portion of the inner shaft is positioned within the lumen and the balloon is engaged to the sleeve at least two engagement points.

Abstract: A balloon catheter that comprises an inner shaft, a balloon and a sleeve that defines a lumen. A portion of the inner shaft is positioned within the lumen and the balloon is engaged to the sleeve at least two engagement points.