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: Methods and devices for an optical assembly for a laser generator comprise: a laser source producing a first beam of light and an optical assembly. The optical assembly comprises a prism. The prism has a bottom surface configured to receive a first beam at an incoming angle of incidence relative to a first surface normal, and a hypotenuse surface configured to transmit, at an exit angle relative to a second surface normal, a second beam having a second aspect ratio. The optical assembly further comprises a plano-convex lens configured to transmit the second beam to a coupler. The coupler comprises a first coupling plane at a first distance from the plano-convex lens and a second coupling plane at a second distance from the plano-convex lens. The combination of the prism and the plano-convex lens is configured to change the beam divergence, so that the first coupling plane has a third aspect ratio and the second coupling plane has a fourth aspect ratio.

Abstract: A device for extending a lead according to an embodiment of the present disclosure includes a body, wherein the body is elongated and includes at least two apertures; a first filament loop comprising a filament, the filament extending along the inner surface of the body and through at least one of the at least two apertures, the first filament loop extending outside the outer surface of the body; a second filament loop extending outside the outer surface of the body; the first and second filament loops arranged so as to receive therethrough a lead, the first and second filament loops being tightenable about the lead in a manner that grips the lead between the first and second filament loops and an outer surface of the lead; and a tether coupled to the lead via one or more of the body, the first filament loop, and the second filament loop.

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 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: 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: The present disclosure relates generally to devices, methods and systems for laser generators, and more specifically, to laser generators having an optical assembly, which allows fiber optic catheters to couple to laser generators while delivering laser beams.

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: 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: A device for extending a lead according to some embodiments includes a body, a tubular member coupled to the body, the tubular member comprising an outer surface, wherein the outer surface is sized to insert into an inner lumen of a lead, the tubular member is movable between a first configuration in which the tubular member slides into the lead, and a second configuration in which at least a portion of the tubular member expands to engage an inner surface of the lead; and, an actuation mechanism operatively coupled to the tubular member, the actuation mechanism configured to move the tubular member between the first configuration and second configuration.

Abstract: Methods and systems for separating an object, such as a lead, from formed tissue are provided. Specifically, a tissue slitting device is configured to engage patient formed tissue at a slitting engagement point. While the object is subjected to a first traction force, the tissue slitting device is caused to move further into the engaged tissue and slit the tissue past the point of engagement. The slitting device 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 methods and systems are well suited for use in cardiac pacing or defibrillator lead explant procedures.

Abstract: A device for extending a lead according to some embodiments includes a body, a tubular member coupled to the body, the tubular member comprising an outer surface, wherein the outer surface is sized to insert into an inner lumen of a lead, the tubular member is movable between a first configuration in which the tubular member slides into the lead, and a second configuration in which at least a portion of the tubular member expands to engage an inner surface of the lead; and, an actuation mechanism operatively coupled to the tubular member, the actuation mechanism configured to move the tubular member between the first configuration and second configuration.

Abstract: The present disclosure relates to a system and method for providing laser energy through a catheter towards a second end portion of the catheter. Based on a characteristic of the laser energy multiple types of ablation therapy may be implemented. A first ablation therapy is directed at the target site when the laser energy at the second end portion of the laser energy delivery system has a first characteristic. A second ablation therapy is directed at the target site when the laser energy at the second end portion of the laser energy delivery system has a second characteristic. The first ablation therapy may be an optical ablation therapy wherein the laser energy is directed at the target site as optical energy and the second ablation therapy may be a pressure wave ablation therapy wherein pressure waves are directed at the target site as pressure wave energy.

Abstract: Methods and systems for separating an object, such as a lead, from formed tissue are provided. Specifically, a tissue slitting device is configured to engage patient formed tissue at a slitting engagement point. While the object is subjected to a first traction force, the tissue slitting device is caused to move further into the engaged tissue and slit the tissue past the point of engagement. The slitting device 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 methods and systems are well suited for use in cardiac pacing or defibrillator lead explant procedures.

Abstract: A device for removing an implanted object from a body vessel includes an actuator having an elongated sheath extending therefrom, the elongated sheath including a proximal portion and a distal portion. A tubular outer member has a proximal end attached to the distal portion of the elongated sheath, with a ramped surface at a distal end of the tubular outer member which constricts a diameter of a bore formed in the tubular outer member. A tubular inner member is located within the tubular outer member, the tubular inner member including a proximal end operably connected to the actuator and a distal end opposite the proximal end, the distal end of the tubular inner member including a plurality of resiliently flexible blades positioned to interact with the ramped surface of the tubular outer member such that the ramped surface is operable to deflect the resiliently flexible blades radially inwardly as the tubular inner member is advanced distally within the tubular outer member.