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: Lead tip removal is accomplished by first stabilizing an area around the lead tip attachment site in the heart wall. A balloon located at the tip of the lead when inflated expands substantially perpendicular to the lead, stabilizing the area around the lead tip. Upon further inflation, the balloon expands substantially parallel with the lead, causing the lead tip to pull away from the heart wall. In another embodiment, a sheath is inserted over the lead and advanced to the heart wall. A passive or active stabilization device is attached to the sheath tip to stabilize the area around the lead tip. In another embodiment, a balloon is located at the tip of the sheath that, when inflated, expands substantially perpendicular to the lead, stabilizing the area around the lead tip. The lead tip is removed with less force due to the stabilization provided to the lead tip area.

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 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 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 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: Catheter devices for ablation and removal of occlusions from blood vessels and methods of using the same are provided. Catheter devices are useful to ablate, cut, dislodge, and otherwise remove occlusions within a blood vessel that may limit or prevent proper circulation. Distal features of the catheter devices comprise arrangements of laser ablative or mechanical cutting features that generally provide enhanced surface areas and cutting functions. Spiral or helical arrangements are provided to aid in cutting operations.

Abstract: Various embodiments of an offset catheter are provided. In some embodiments, an offset catheter includes a guidewire tube and a catheter coupled with an elastic and/or compressible rib. The compressible rib provides an offset or separation between the catheter and the guidewire tube in its resting state. The rib has an initial resting state, but may be forced into a compressed state. When released from the compressed state, the rib returns to its resting state. An offset catheter may be compressed and slid through a sheath. When the offset catheter emerges from the sheath, the distal tip will return to its resting state providing an operation offset.

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: A system is provided to determine whether an insulating layer of an implanted lead is damaged.

Abstract: Snaring systems and methods involve engaging objects such as pacemaker pacing leads within a patient. Physicians can use snaring systems having loops, tags, and roller mechanisms to remove a pacing leads from a patient. For example, snaring systems can be inserted through a jugular access site, engaged with a pacemaker pacing lead, and withdrawn through the jugular access site so as to remove a portion of the pacing lead. Lead extraction techniques can be employed to further dislodge the pacing lead from the patient.

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 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: Laser energy delivery devices and methods are provided. A laser energy delivery device for providing treatment to a subject may include a coupling adapted to couple to a laser energy generator. A sheath is coupled to the coupling, the sheath including a distal end adapted to be disposed in the subject. A plurality of transport members are carried by the coupling and the sheath, the plurality of transport members being adapted to receive laser energy at the coupling, transmit laser energy through the sheath, and deliver laser energy to the subject. A sensor is adapted to detect transmission of laser energy through at least one of the plurality of transport members.

Abstract: Various embodiments of an eccentric balloon catheter are disclosed. In some embodiments, an eccentric balloon catheter includes an eccentrically positioned guidewire tube, with an interior lumen, that extends at least a portion of the length of the catheter body. Optical fibers may extend the length of the catheter body and may also be eccentrically positioned within the catheter body. An inflatable balloon may be positioned within a window within the catheter body near the distal end of the catheter. When inflated, the balloon and catheter may slide relative to one another. When used within a vessel, an inflated balloon may press against a vessel wall and bias the catheter toward an opposite vessel wall.

Abstract: A system 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. Pulsed aspiration systems are further provided, the pulsed aspiration systems operable to remove ablated, cut, or dislodged material without excessive or unnecessary removal of blood and fluid.

Abstract: A device for extending a lead according to an embodiment of the present disclosure includes a body having proximal and distal ends, the distal end having first and second apertures, the body having an inner lumen, the first and second apertures extending from an outside of the body to the inner lumen; a filamentous element extending out of the first aperture and into the second aperture to form a filament loop extending from the body; a tightening mechanism configured to twist the filamentous element to compress a lead body between the filament loop and the body; and a tether coupled to body and configured to extend further proximally than a proximal-most end of the lead body when the lead body is compressed between the filament loop and body, the tether further configured to transfer at least a portion of a tension force applied to the tether to the lead body.

Abstract: A light-diverting catheter tip is provided according to embodiments disclosed herein. The light-diverting catheter tip may be coupled with the distal tip of a laser catheter and divert at least a portion of the light exiting the distal tip of the laser catheter such that the spot size of the laser beam on an object after exiting the catheter tip is larger than the spot size of the light entering the catheter without the catheter tip. The catheter tip may be removably coupled with the catheter or constructed as part of the catheter. In other embodiments, the catheter tip may conduct fluid and/or divert fluid at the tip of the laser catheter.

Abstract: A catheter system to ablate target matter within a mammalian body using light energy is described. The system may include an open-ended catheter tip through which a liquid light guide medium flows to the target matter, where at least a portion of the liquid light guide medium exiting the catheter tip creates a fluid optical channel to transmit the light energy from the catheter tip to the target matter. The system may also include a catheter lumen whose distal end includes the open-ended catheter tip, a light source to generate the light energy, and a liquid light guide medium source fluidly coupled to the catheter lumen. The liquid light guide medium source may include a reservoir of the liquid light guide medium that includes a magnesium chloride solution or a lactated Ringer's solution.

Abstract: An endovascular device monitoring system is provided that determines, based on movement of the endovascular device past a selected reference location, at least one of a movement rate of a endovascular device and position of a distal end of a endovascular device in a body of a patient.