Abstract: A seal adapted for use with medical devices is provided. The medical device may be a lead having a distal tip adapted for implantation on or about the heart and for connection to a system for monitoring or stimulating cardiac activity. The lead assembly in one embodiment includes an atraumatic tip. A seal is provided within the lead tip assembly, which prevents or limits further entry of fluids through the lead tip. The lead may be a left ventricular lead with a hemostasis mechanism provided therewithin.

Abstract: A lead for monitoring or stimulating cardiac activity is provided. The lead is adapted for implantation on or about the heart within the coronary vasculature and for connection to a signal generator. The lead body has one or more electrodes associated therewith. The lead is constructed and arranged so that when it is implanted, the electrodes are housed in the coronary vasculature and urged into intimate contact a vessel wall. A method for implanting the lead into the coronary vasculature is also provided, the method comprising the steps of inserting a stylet into the lead, inserting the lead into the coronary sinus, advancing the lead from the coronary sinus toward the toward the left atrium and into a coronary vein, removing the stylet, and sensing and pacing the heart.

Abstract: A lead for monitoring or stimulating cardiac activity is provided. The lead is adapted for implantation on or about the heart within the coronary vasculature and for connection to a signal generator. The lead body has one or more electrodes associated therewith. The lead is constructed and arranged so that when it is implanted, the electrodes are housed in the coronary vasculature and urged into intimate contact a vessel wall. A method for implanting the lead into the coronary vasculature is also provided, the method comprising the steps of inserting a stylet into the lead, inserting the lead into the coronary sinus, advancing the lead from the coronary sinus toward the toward the left atrium and into a coronary vein, removing the stylet, and sensing and pacing the heart.

Abstract: A lead having an atraumatic tip is adapted for implantation on or about the heart within the coronary vasculature and for connection to a signal generator. The lead is constructed and arranged so that when it is implanted, the electrodes are housed in the coronary vasculature and are biased toward a vessel wall by a preformed biased portion. Near the distal end, the lead has an optional tapered portion and a flexible portion, where the flexible portion is more flexible than the biased portion.

Abstract: A catheter assembly for cannulating a heart vessel includes a guide handle having proximal and distal ends, a lumen open at least at the distal end of the guide handle, and a stop member disposed within the lumen at a distal end of the guide handle. A catheter of the assembly has a proximal end disposed within the lumen of the guide handle and a preformed distal end. The catheter is longitudinally displaceable within the guide handle to adjust an exposed length of the distal end of the catheter. The stop member is engagable with the proximal end of the catheter to prevent the proximal end of the catheter from passing out of the guide handle. A locking mechanism within the guide handle to selectably prevents and permit axial rotation between the guide handle and catheter while permitting longitudinal displacement of the catheter within the guide handle.

Abstract: A catheter assembly includes an outer catheter member having a distal flexible end. An inner catheter member is movably disposed within the outer catheter member. Optionally, a handle assembly is coupled with the outer catheter member and the inner catheter member, where the handle assembly is adapted to slide the inner catheter member relative to the outer catheter member.

Abstract: An apparatus and method for allowing cardiac signals to be sensed and pacing pulse vectors to be delivered between two or more electrodes. In one embodiment, cardiac signals are sensed and pacing pulse vectors are delivered between least one of a first left ventricular electrode and a second left ventricular electrode. Alternatively, cardiac signals are sensed and pacing pulse vectors are delivered between different combinations of the first and second left ventricular electrodes and a first supraventricular electrode. In addition, cardiac signals are sensed and pacing pulse vectors are delivered between different combinations of the first and second left ventricular electrode, the first supraventricular electrode and a conductive housing. In an additional embodiment, a first right ventricular electrode is used to sense cardiac signals and provide pacing pulses with different combinations of the first and second left ventricular electrodes, the first supraventricular electrode and the housing.

Abstract: An apparatus and method for allowing cardiac signals to be sensed and pacing pulse vectors to be delivered between two or more electrodes. In one embodiment, cardiac signals are sensed and pacing pulse vectors are delivered between least one of a first left ventricular electrode and a second left ventricular electrode in a left ventricular region. In an additional embodiment, cardiac signals are sensed and pacing pulse vectors are delivered between different combinations of the first left ventricular electrode and a second left ventricular electrode in a left ventricular region and a first supraventricular electrode in a right atrial region. In addition, the housing of the apparatus is conductive so as to allow cardiac signals to be sensed and pacing pulse vectors to be delivered between different combinations of the first left ventricular electrode, the second left ventricular electrode, the first supraventricular electrode and the housing.

Abstract: A seal adapted for use with medical devices is provided. The medical device may be a lead having a distal tip adapted for implantation on or about the heart and for connection to a system for monitoring or stimulating cardiac activity. The lead assembly in one embodiment includes an atraumatic tip. A seal is provided within the lead tip assembly, which prevents or limits further entry of fluids through the lead tip. The lead may be a left ventricular lead with a hemostasis mechanism provided therewithin.

Abstract: An improved guidewire for assisting in implantation of a cardiac lead includes three sections. The most distal zone is sufficiently floppy to prevent trauma to the vessel walls through which the guidewire and lead are inserted. An intermediate zone is generally stiffer and has a cross-section less than or equal to the cross-section of the distal zone. The third zone is stiffer yet and is joined to the intermediate zone by a shoulder. The shoulder cooperates with protrusions on the lead to transfer forces between the guidewire and lead. A finishing wire having temporary locking means to lock the finishing wire to the lead is employed to remove the guide catheter without moving the lead from its desired location. Lubricious coatings are also provided to reduce friction between the lead and guidewire.

Abstract: An improved guidewire for assisting in implantation of a cardiac lead includes three sections. The most distal zone is sufficiently floppy to prevent trauma to the vessel walls through which the guidewire and lead are inserted. An intermediate zone is generally stiffer and has a cross-section less than or equal to the cross-section of the distal zone. The third zone is stiffer yet and is joined to the intermediate zone by a shoulder. The shoulder cooperates with protrusions on the lead to transfer forces between the guidewire and lead. A removal wire having temporary locking means to lock the removal wire to the lead is employed to remove the guide catheter without moving the lead from its desired location. Lubricious coatings are also provided to reduce friction between the lead and guidewire.

Abstract: A seal adapted for use with medical devices is provided with a lead having a distal tip electrode. The distal tip of the lead is adapted for implantation on or about the heart and for connection to a system for monitoring or stimulating cardiac activity. The lead can include a fixation helix for securing the electrode to cardiac tissue. The lead assembly can alternatively include an open lumen lead tip. A seal is provided within the lead tip assembly such that the seal is expanded to prevent or limit further entry of fluids through the lead tip. The seal includes an expandable matrix, such as a hydrogel. The seal is formed on or within the lead when the lead and the seal comes into contact with a fluid and expands. The seal is also formed as a plug which is deployed through the medical device, and expands as the plug absorbs fluid. A housing incorporating the seal can also be attached to a portion of the medical device to provide the seal.

Abstract: A seal adapted for use with medical devices is provided with a lead having a distal tip electrode. The distal tip of the lead is adapted for implantation on or about the heart and for connection to a system for monitoring or stimulating cardiac activity. The lead can include a fixation helix for securing the electrode to cardiac tissue. The lead assembly can alternatively include an open lumen lead tip. A seal is provided within the lead tip assembly such that the seal is expanded to prevent or limit further entry of fluids through the lead tip. The seal includes an expandable matrix, such as a hydrogel. The seal is formed on or within the lead when the lead and the seal comes into contact with a fluid and expands. The seal is also formed as a plug which is deployed through the medical device, and expands as the plug absorbs fluid. A housing incorporating the seal can also be attached to a portion of the medical device to provide the seal.

Abstract: A body implantable lead for placement in a selected coronary vein includes a resilient retention structure for inhibiting displacement of the lead because of heart beat action, breathing or other body movement. The retention structure includes a plurality of resilient projections that are attached to the lead body and which are adapted to project at a predetermined acute angle to the axis of the lead body when unconstrained. Prior to being routed through the vascular system, the projections can be bonded to the lead body to provide a low profile with a biodegradable adhesive. Following exposure to body fluids, the adhesive dissolves, releasing the projections so that they can engage the walls of the vein in which the lead is disposed.

Abstract: Expandable electrodes for intravascular leads permit the electrodes to be placed and retained in the vasculature of the left side of the heart. Such electrodes can be in the form of a balloon, an expandable wire coil, or other expandable shapes.

Abstract: An apparatus for fixing a cardiac lead in place within the vasculature of the heart includes a coil having a normal helical shape and a stylet for holding the coil straight during insertion of the coil through a lumen of the lead. Upon retraction of the stylet, the coil returns to its helical shape along with the lead, forcing portions of the lead into contact with the vessel wall.

Abstract: An apparatus for positioning a cardiac lead in the vasculature of the heart includes a guide catheter, a sleeve and a guidewire. The guide catheter has an inflatable balloon at its distal end and a central lumen open distally to the exterior of the catheter for injection of dye or advancement of a guidewire through the guide catheter and past its distal end. The guide sleeve replaces the guide catheter once the guidewire is in position so that a lead can be advanced over the guidewire with the sleeve.

Abstract: The present invention is a torque handle for use in inserting and positioning a pacing lead and guide wire, such as within a coronary vein. The torque handle is a handle with a lumen extending therethrough. A first clamping arrangement is located on the handle and receives the guide wire therethrough. A second clamping arrangement is also located on the handle. The second clamping arrangement sized to receive the body of the lead therethrough. In use, the physician determines whether torque is to be transmitted along the lead, the guide wire or both. Torque is transmitted by clamping or loosening the designated clamping arrangement around the lead, the guide wire or both, and then rotating the handle. As the handle is rotated, torque is transmitted along the length of the clamped lead or guide wire or both.

Abstract: An intravenous lead for use with a cardiac device for implantation in the coronary venous system of the heart includes a lead body that is adapted to be routed through the vascular system into the coronary sinus with the distal end portion of the lead placed in the great cardiac vein or branch vein. The lead body includes a fixation member disposed just proximal of its tip. The fixation member comprises a radially expandable polymeric matrix that incorporates an osmotic agent so that when placed in a aqueous medium it will swell. Thus, when placed in a cardiac vein, the swelling of the fixation member will anchor the lead against longitudinal displacement due to body motion, blood flow and the beating action of the heart.

Abstract: An elongated monopolar or bipolar coronary vein lead having a reduced outer diameter and especially adapted to be advanced into a selected coronary vein for delivering a pacing signal to a predetermined region of a patient's heart, such as the left ventricle. A method of using the lead for pacing a patient's heart in the treatment of heart failure is also described. The method for pacing the heart includes advancing the coronary vein lead through both the coronary sinus and into a selected coronary vein of a patient's heart, connecting the lead to an electrical pacing source and applying electrical stimulation to a particular chamber of the patient's heart via the implanted lead. The lead includes a flexible tip and transition ring that enhances the ability to guide the lead through the coronary veins.