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: 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: 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: Methods and systems for removing an object, such as a lead, from formed tissue are provided. Specifically, a lead removal sleeve is configured to engage patient formed tissue at a dilation engagement point. The lead removal sleeve is configured to dilate the formed tissue around a lead, while providing an inner lumen with clearance for the lead to move within the sleeve. It is an object of the lead removal sleeve to support the formed tissue, and even forces of the formed tissue, with a structure of the sleeve as the lead is removed from a patient. The methods and systems are well suited for use in cardiac pacing or defibrillator lead explant procedures.

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: 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: Methods, devices and systems for separating an implanted object, such as a lead attached to a cardiac conduction device, from formed tissue within a blood vessel are provided. The methods, devices and systems for separating a lead from the tissue relate to dilating the tissue surrounding the lead from underneath the tissue and/or between the lead and the tissue.

Abstract: Device and method for capturing guidewires inside blood vessels. The disclosed device enables retrieval of guidewires that need to be pulled from the body at a different location than the guidewire entering location, such as guidewires that have entered in a retrograde direction.

Abstract: Embodiments of a balloon biasing laser catheter are provided. In some embodiments, the laser catheter may include a distal tip that extends from the distal end of the catheter from a point near the light guide aperture. The distal tip may be disposed at the periphery of the catheter. In some embodiments, a balloon may be disposed between the light guide aperture and the distal tip, such that the a light guide extending from the aperture may be disposed proximate with the distal tip having the balloon in between. A retaining wire may be coupled with the distal tip and slidably coupled with the light guide. The retaining wire may keep the light guide biased relatively parallel with the distal tip and/or the catheter body when the balloon is inflated. The light guide may include a guidewire lumen the extends to the distal end of the distal tip.

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: 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: Expandable laser catheters for utilizing laser energy to remove obstructions from body passages are described. 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, as described herein.

Abstract: Embodiments of the present invention comprise a fiber optic guidewire having a hypotube with a plurality of openings that provide variable stiffness and tracking characteristics between at least one proximal segment and one distal segment of the guidewire. In some embodiments, the guidewire further comprises a mandrel disposed within the hypotube, the mandrel cooperating with the optical fibers to permit the distal end of the hypotube to be shaped as desired by a user. Methods of manufacturing and using the guidewire are also disclosed.

Abstract: A lead locking device has a lead insertion member having a proximal end and a distal end and has a lead engaging assembly. The lead insertion member defines a lumen extending along a longitudinal axis between the distal end and the proximal end of the lead engaging assembly. A mandrel disposed in the lumen of the lead engaging assembly extends along substantially the entire length of the lumen and protrudes beyond the most proximal end of the lead insertion member. The mandrel includes a distal portion in slidable contact with at least a portion of the lead engaging assembly. The lead engaging assembly has a first configuration while being inserted into a lumen of a lead and a second configuration while engaging the lead from within the lumen of the lead. The lead engaging member has at least two expansion jaws that, in the first configuration, define a substantially cylindrical body.

Abstract: Embodiments of the present invention comprise a fiber optic guidewire having a hypotube with a plurality of openings that provide variable stiffness and tracking characteristics between at least one proximal segment and one distal segment of the guidewire. In some embodiments, the guidewire further comprises a mandrel disposed within the hypotube, the mandrel cooperating with the optical fibers to permit the distal end of the hypotube to be shaped as desired by a user. Methods of manufacturing and using the guidewire are also disclosed.

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: Methods of advancing a laser catheter across an occlusion are described. They may include the steps of advancing a guidewire through a first proximal lumen and a distal lumen of the catheter into a first region of the occlusion, retracting the guidewire from the distal lumen, and advancing a diagnostic device from a second proximal lumen of the catheter to examine the occlusion. The methods may also include retracting the diagnostic device from the distal lumen and advancing the guidewire through the distal lumen. The laser catheter may be activated to create a lumen through the occlusion.

Abstract: A catheter assembly is disclosed according to one embodiment of the invention. The assembly includes a catheter body, a housing and a detector. The catheter includes a distal tip, a proximal end, and a fiber optic extending between the proximal end and the distal tip. The housing may include a channel adapted to support at least a portion of the distal tip of the catheter. The may be detector disposed within the housing so as to be spaced a fixed distance from the distal tip of the catheter. Methods for providing and calibrating a catheter supported within housing are also disclosed according to other embodiments of the invention.

Abstract: The invention provides an apparatus having a tubular member for receiving an endocardial lead implanted within a patient's body. Disposed generally at a distal end of the tubular member is at least one blade or cutting surface. An adjustment mechanism moves the blade between retracted and extended positions to engage the cutting surface with the endocardial lead to cut the lead. Once severed, the cut portion of the lead remains within an inner channel of the tubular member and the apparatus and cut portion of the lead are removed from within the patient. Various embodiments include the blade pivotally connected to the distal end of the tubular member and activated by a wire adjustment mechanism. Others include a metallic wire for slicing through the lead. Still others include a pneumatically actuated adjustment mechanism that inflates to move the blade and engage the cutting surface with the lead.

Abstract: An optical sensor that provides lateral viewing while maintaining light polarization is disclosed according to one embodiment of the invention. The sensor includes a sensor body, at least one waveguide and at least one refractive optical element. The sensor body may includes proximal end and a distal end. The waveguide includes a proximal end coincident near the proximal end of the sensor body and a distal end coincident at a point near the distal end of the sensor body. The waveguide may include one or more fiber optic. The waveguide may be positioned within the sensor body. The refractive optical element may be positioned within the sensor near the distal end of the waveguide and may be configured to refract light received from the distal end of the waveguide outward from the sensor. The refractive optical element may include one or more prisms.