Abstract: The present disclosure relates to a system and method for coordinated laser delivery and imaging during an interventional procedure. A method may include activating an imaging source to provide a pulsed imaging signal and activating a laser source to provide a pulsed laser signal while the imaging source remains activated. The method may include coordinating the pulsed laser signal and the pulsed imaging signal to output each pulse of the pulsed laser signal and each pulse of the pulsed imaging signal in non-overlapping time windows. A system may include a controller in communication with the laser source and the imaging source for coordinating the output of the laser signal and the imaging signal.

Abstract: A method and device for local delivery of water-soluble or water-insoluble therapeutic agents to the surface of a normal or diseased body lumen is disclosed. An expandable structure of a medical disposable device, such as a balloon of a balloon catheter, is coated with an amphiphilic polymer coating comprising a therapeutic agent and an amphiphilic polymer or co-polymer. The medical disposable device is inserted into a body lumen, and expanded to contact the amphiphilic polymer coating against the body lumen. The total solubility of the polymer or co-polymer in vivo prevents any embolic hazard associated with the amphiphilic polymer coating.

Abstract: In some embodiments, without limitation, the invention comprises a catheter having an elongated housing with a channel disposed therein. A laser delivery member is movable and at least partially disposed within the channel. A ramp is disposed within the housing at an angle to its central axis and proximate to its distal end. The ramp is adapted to move the distal end of the laser delivery member outwardly from the central axis of the housing. A guidewire biases the distal end of the laser delivery member generally inwardly toward the central axis of the housing. In some embodiments, without limitation, the offset of the central axis of the tip of the laser delivery member from the central axis of the housing is determined by adjusting the extent to which the laser delivery member travels on the ramp, and disposition of the laser delivery member on the guidewire maintains the offset tip substantially parallel to the central axis of the housing.

Abstract: The present disclosure relates generally to coating medical devices. In particular, the present disclosure provides materials and methods for coating a portion of a balloon catheter with a pharmaceutical agent using electrodeposition techniques. Although angioplasty and stenting can be effective methods for treating vascular occlusions, restenosis remains a pervasiveness problem. Therefore, coating portions of a balloon catheter with a pharmaceutical agent that inhibits restenosis can reduce the likelihood of restenosis.

Abstract: Embodiments of the present invention include a laser catheter that includes a catheter body, a light guide, and a distal tip that extends beyond the exit aperture of the light guide. In some embodiments, an imaging device is disposed on the distal tip such that the imaging device is distal relative to the exit aperture of the light guide. In some embodiments, the imaging device can be gated to record images during and or slightly beyond periods when the laser catheter is not activated.

Abstract: Lead extraction is the removal of one or more leads from inside the heart utilizing a lead removal catheter having a tubular sheath that is placed in the blood vessel, either subclavian or femoral. The sheath of the lead removal catheter may accidentally tear or perforate the blood vessel as it is advanced over the lead toward the heart. Such an occurrence must be dealt with quickly to prevent harm to the patient or subject. An expandable member, such as a balloon, attached to the exterior of the sheath of a lead removal catheter can be deployed temporarily adjacent the perforation in the vessel wall. Inflation of the balloon not only stops (or substantially stops) the bleeding, but, upon inflation, the balloon may include one or more channels that allow blood to continue to flow through the channel(s) until the blood vessel perforation can be repaired.

Abstract: Devices for removing implanted objects from body vessels are provided. A device includes a sheath assembly having a cutting tip. The cutting tip includes a cutting surface that is adapted to cut tissue coupled to an implanted object as the cutting tip rotates. The sheath assembly further includes an outer shield carried outside of the cutting tip. The outer shield includes a distal opening, and the outer shield is translatable relative to the cutting tip from a first position to a second position and vice versa. In the first position the cutting surface of the cutting tip is disposed within the outer shield, and in the second position the cutting tip extends through the distal opening and the cutting surface is at least partially disposed outside of the outer shield.

Abstract: The present disclosure relates generally to the use of medical devices for the treatment of vascular conditions. In particular, the present disclosure provides devices and methods for using electrically-induced pressure waves created within a sheath to disrupt vascular blockages via the sheath and/or a tip at the end of the sheath.

Abstract: Systems and methods for separating an object such as a pacing lead from a patient tissue involve a flexible and torqueable shaft having an internal lumen sized to receive the object, and a hard separating mechanism for separating the object from the tissue. Typically the shaft and separating mechanism are advanced along or toward the object, and the separating mechanism is contacted with the tissue. The shaft is rotated to effect separation between the object and the tissue. The systems and methods are well suited for use in cardiac pacing or defibrillator lead explant procedures.

Abstract: The present disclosure relates generally to the use of medical devices for the treatment of vascular conditions. In particular, the present disclosure provides devices and methods for using electrically-induced pressure waves to disrupt vascular blockages. The present disclosure not only provides devices and methods for using electrically-induced pressure waves to disrupt vascular blockages, but the present disclosure also provides devices and method for assisting the guidewire in penetrating an occlusion, devices and method for using a sealable valve in the tip of the balloon catheter to reduce the overall size and diameter of the balloon catheter, thereby allowing the balloon catheter to penetrate smaller size blood vessels and devices. Given the persistence of coronary artery disease (CAD) and peripheral artery disease (PAD), there remains a need for improved therapeutic methods designed not only to reduce vascular blockages in the short term, but also to prevent future complications such as restenosis.

Abstract: Methods and devices for separating an implanted object, such as a pacemaker lead, from tissue surrounding such object in a patient's vasculature system. Specifically, the tissue separating device includes a handle, an elongate sheath and a circular cutting blade that may extend from the distal end of the sheath upon actuating the handle. The elongate sheath, particularly its distal end, includes a non-uniform wall thickness having one or more thicker portions in the outer sheath, particularly the outer cam member, and/or one or more thicker portions in an inner member disposed radially inward of the blade.

Abstract: The present disclosure relates generally to the use of medical devices for the treatment of vascular conditions. In particular, the present disclosure provides devices and methods for using laser-induced pressure waves to disrupt vascular occlusions. The present disclosure not only provides devices and methods for using laser-induced pressure waves to disrupt vascular occlusions or portions thereof, but the present disclosure also provides devices and methods for disrupting calcium in the media and/or intima layer of an arterial wall.

Abstract: Methods and devices for separating an implanted object, such as a pacemaker lead, from tissue surrounding such object in a patient's vasculature system. Specifically, the surgical device includes a handle, an elongate inner sheath and a circular cutting blade that extends from the distal end of the sheath upon actuating the handle. The circular cutting blade is configured to engage the tissue surrounding an implanted lead and cut such tissue in a coring fashion as the surgical device translates along the length of the lead, thereby allowing the lead, as well as any tissue remaining attached to the lead, to enter the device's elongate shaft. The surgical device has a barrel cam cylinder in the handle assembly that imparts rotation of the blade and a separate cam mechanism in the tip of outer sheath assembly that imparts and controls the extension and retraction of the blade.

Abstract: Methods and systems for separating an object, such as a lead, from formed tissue are provided. Specifically, a tissue slitting apparatus is configured to engage formed tissue at a slitting engagement point. While the object is subjected to a first traction force, the tissue slitting apparatus is caused to move further into the engaged tissue and slit the tissue past the point of engagement. The slitting apparatus causes the tissue to separate along an axial direction of the length of the formed tissue and releases at least some of the force containing the object. The slitting apparatus is supported by a distal end support device configured to lock onto the lead. While supported, a slitting element of the apparatus places fibers of the formed tissue under tension and performs a lifting cut operation. The methods and systems are well suited for use in cardiac pacing or defibrillator lead explant procedures.

Abstract: Embodiments include a catheter system comprising an elongated housing having a housing channel disposed between a first proximal end and a first distal end. The first distal end includes a ramp, having an inclining proximal section and an apex section, and a nose section. The catheter system further includes a rail wire channel in communication with the ramp but not the nose section and a laser delivery member being at least partially disposed within the housing channel and movable therein. In some embodiments, the catheter system includes a rail wire fixedly attached to and terminating at the first distal end of the elongated housing, wherein the rail wire extends through the rail wire channel, and wherein the laser delivery member is slidably coupled to the rail wire.

Abstract: A system and devices for ablation and removal of occlusions from blood vessels is provided. Laser cutting systems and mechanical cutting systems are provided in catheter devices, the cutting systems operable to ablate, cut, dislodge, and otherwise remove occlusions within a blood vessel that may limit or prevent proper circulation. Catheter systems comprise distal end features adapted to cut and remove at least portions of an occlusion that generally correspond to dimensions of an inner lumen of a catheter.

Abstract: A dilation balloon is wrapped in one or more patterns with a wire or braided material having diamond abrasive or other abrasive material bonded thereto. The wire or braided material is vibrated in one or more ways to enhance the cutting action of the wire abrasive. The wire abrasive may be vibrated using high, low, or even ultrasonic waves transmitted to the wire abrasive via local or remote methods. Alternatively, the dilation balloon may be dilated with a contrast media that exhibits a high absorption to laser light. The contrast material is lazed with a laser fiber or fibers inserted into the balloon interior, creating a substantial shockwave that vibrates the balloon and assists in the cracking or abrading of the surrounding plaque in contact with the dilation balloon. The cutting balloon may employ the abrasive coated wires described above or cutting blades.

Abstract: A system can include a microprocessor executable controller configured, based on one or more of total fiber active area of a laser catheter, imaging information regarding the target and/or non-target endovascular structure(s), target endovascular structure characterization information, current location and/or orientation of a distal tip of the laser catheter, and area of contact of the distal tip with the target and/or non-target endovascular structure to select at least one of a fiber active area for each optical channel, a number of optical channels, a configuration of fibers in an optical channel, an optical channel to be irradiated, and an ordering of optical channel irradiation.

Abstract: Methods and devices for separating an implanted object, such as a pacemaker lead, from tissue surrounding such object in a patient's vasculature system. Specifically, the surgical device includes a handle, an elongate inner sheath and a circular cutting blade that extends from the distal end of the sheath upon actuating the handle. The circular cutting blade is configured to engage the tissue surrounding an implanted lead and cut such tissue in a coring fashion as the surgical device translates along the length of the lead, thereby allowing the lead, as well as any tissue remaining attached to the lead, to enter the device's elongate shaft. The surgical device has a barrel cam cylinder in the handle assembly that imparts rotation of the blade and a separate cam mechanism in the tip of outer sheath assembly that imparts and controls the extension and retraction of the blade.

Abstract: The present disclosure relates to methods and systems for removing a vascular obstruction in a subject using a combination of thrombolytic and laser ablation therapy. Treatment methods include positioning a catheter adjacent to an obstruction within a vessel of a subject. A portion of the obstruction may be ablated by delivering laser energy through the optical fibers to the distal end of the catheter, where the optical fibers are exposed, and circulating a fluid containing one or more thrombolytic agents to a remaining portion of the obstruction for a predetermined amount time. Fluid containing one or more thrombolytic agents capable of dissolving a remaining portion of the obstruction may be circulated through the fluid delivery lumen and removed through the fluid removal lumen.