Abstract: This disclosure discusses various methods and devices for providing multiple types of indicators to be used with a sheath set. One type of indicator indicates the linear position and alignment of each of the sheaths within the sheath set, and another type of indicator indicates the rotational position and alignment of the sheaths. Both types of indicators may be included on the ends of the sheath set proximal to the user outside the patient's vasculature, thereby informing the user of the sheath set of the linear and rotational position and alignment of the ends of the inner and outer sheaths within the vasculature.

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 circular cutting blade is configured to engage the tissue surrounding an implanted lead and cut such tissue in a coring fashion as the 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 tissue separating device includes a cam mechanism at the distal portion of the sheath that allows the user of the device to more accurately control the extension and rotation of the cutting blade upon being actuated by the handle.

Abstract: Device and method for puncturing blood vessels while using fluoroscopy. The disclosed device enables improved needle orientation control and avoids direct exposure of the clinician's hand to X-ray during the puncturing procedure.

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: 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.

Abstract: A method and device for local delivery of a water-insoluble therapeutic agent to the tissue 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 a non-durable coating which comprises poly(HEMA) complexed with iodine and has a substantially water-insoluble therapeutic agent dispersed therein. The medical disposable device is inserted into a body lumen, and expanded to contact the non-durable coating against the body lumen and deliver the substantially water-insoluble therapeutic agent to the body lumen tissue.

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: Expandable laser catheters for utilizing laser energy to remove obstructions from body passages are described. In one embodiment, the laser catheter includes a shaftway having a distal end including a flexible portion configured in a series of radial folds. Multiple optical fibers, configured to transmit laser energy, extend along the shaftway and are attached to the flexible portion. An inflatable, ring-shaped balloon is attached to the catheter within the flexible portion. In use, the catheter is inserted into a body passage such as an artery, and advanced until the distal end is adjacent to an obstruction. The balloon is inflated to expand the flexible portion and to bring the optical fibers nearer the inner wall of the body passage. Laser energy is directed by the optical fibers toward targeted regions of the obstruction, As the catheter is advanced and the process repeated, a core is formed from the obstruction and contained within the flexible portion.

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: 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: 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: 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: The invention generally relates to method and apparatus for crossing an obstruction in a tubular member, and more particularly to a medical device method for crossing of a chronic occlusion in a subintimal or interstitial space of an artery.

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: 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: This disclosure discusses various methods and devices for capturing plaque that is to be removed from a blood vessel after the plaque has been separated from the blood vessel or remaining plaque.

Abstract: A catheter tip is provided according to various embodiments of the disclosure. The catheter tip may comprise a distal end, a proximal end, and tubular walls. The distal end includes a distal aperture with a distal inside diameter, and the proximal end includes a proximal aperture with a proximal inside diameter. The proximal inside diameter may be greater than the distal inside diameter. The proximal end comprises attachment means configured to couple the proximal end with a distal end of a laser catheter. The tubular walls may include at least an inside taper from the proximal end to the distal end such that the inner tubular walls generally taper from the proximal inside diameter to the distal inside diameter. Moreover, the tubular walls may be configured to direct at least a liquid medium, for example, a biocompatible solution, toward the distal aperture.