Abstract: Methods facilitate inserting a cardiac lead into a patient's vasculature. A cardiac lead system includes a cardiac lead having a lumen, and a guide member displaceable within the lumen. The guide member includes a guide wire extension that extends distal to the elongated body of the guide member. The guide wire extension is dimensioned to pass through an external distal opening of the cardiac lead lumen. Engagement of stop features or a stop mechanism of the cardiac lead system provides a push point for advancing the cardiac lead system through the patient's anatomy.

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: Methods and systems provide for anchoring implantable medical device inside a bodily vessel. An anchoring structure can include a stent-like structure to which the IMD is attached. The stent-like structure is positioned at a desired location in the bodily vessel. The stent-like structure can be repositioned based on a measurement from the IMD. The IMD can include outwardly extending fins over which tissue can fibrose to affix the IMD to a wall of the bodily vessel. The stent-like structure can be made of a bio-absorbable material. The IMD can be attached to a stent-like structure by leads, by being lodged in a recessed diaphragm, by being embedded in mesh of the stent-like structure, or other methods. The stent-like structure can be balloon deployable to allow for controlled positioning and anchoring. The anchoring structure can include a vena cava filter.

Abstract: A delivery system and method for delivering a right ventricular lead into a right ventricle includes a delivery device having an inflatable balloon at a distal end. The device is inserted into the venous system, the balloon is inflated and the device is floated along a blood flow path within the venous system through the heart and into the pulmonary artery. The lead is delivered into the right ventricle using the device. In one embodiment, the device is a catheter that facilitates placement of a guide wire into the right ventricle for delivery of the lead. The catheter is then removed and the lead is inserted into the right ventricle over the guide wire.

Abstract: A delivery system and method for delivering a pulmonary artery lead into a pulmonary artery includes a delivery device having an inflatable balloon at a distal end. The device is inserted into the venous system, the balloon is inflated and the device is floated along a blood flow path within the venous system through the heart and into the pulmonary artery. The lead is delivered into the pulmonary artery using the device. In one embodiment, the device is a catheter that facilitates placement of an implantation catheter and/or a guide wire into the pulmonary artery for delivery of the lead. In another embodiment, the lead is mounted over the catheter. In yet another embodiment, the delivery device is formed at the distal end of the lead.

Abstract: Implantable cardiac monitoring and stimulation methods and devices with epicardial leads having sensor feedback. A fixed or extendable/retractable sensor may be displaceable within the lead's lumen and configured to sense the presence of an anatomical feature or physiological parameter of cardiac tissue in proximity with the lead body's distal end. The sensor may include an ultrasonic sensing element, a perfusion sensor, a photoplethysmographic sensor, or a blood oximetry sensor. Methods of determining suitability for implanting a lead involve the steps of accessing an epicardial surface of the heart, and moving the cardiac lead to an implant site at the epicardial surface. A transmitted signal is directed at the implant site. A reflected signal is received, indicative of the presence of a blood vessel at the implant site. A determination may be made to determine whether the implant site is suitable or unsuitable based on the reflected signal.

Abstract: A peel-away sheath for a catheter includes at least one weakened area in a non-longitudinal pattern, such as a helical pattern, along the length of the sheath. One embodiment of a catheter sheath includes a tube having at least one pull wire integrally located within its wall. Another embodiment of a catheter sheath includes a tube having at least one integral lumen within its wall. The integral lumen may house a filling material. One embodiment of a catheter may include a first sheath which is positioned within a second sheath, with each of the first and second sheaths having at least one weakened area along its length. A reinforcing guide for a guide catheter includes a tube having a lumen with a diameter at least as large as the guide catheter diameter. The reinforcing guide includes a gap with a width which is less than the guide catheter diameter.

Abstract: A method of manipulating a catheter assembly involves providing an inner catheter member movably disposed within an outer catheter member. At least a distal end portion of the inner catheter member has a stiffness greater than that of at least a distal end portion of the outer catheter member. The distal end portion of the outer catheter member includes a deflectable distal end. The method further involves advancing the inner catheter member through the outer catheter member toward the deflectable distal end of the outer catheter member, and longitudinally displacing the distal end portion of the inner catheter member relative to the deflectable distal end of the outer catheter member to alter a shape of the deflectable distal end.

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. 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 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 system and method facilitates inserting a cardiac lead into a patient's vasculature. The cardiac lead system includes a cardiac lead having a lumen, and a guide member displaceable within the lumen. The guide member includes a guide wire extension that extends distal to the elongated body of the guide member. The guide wire extension is dimensioned to pass through an external distal opening of the cardiac lead lumen. Engagement of stop features or a stop mechanism of the cardiac lead system provides a push point for advancing the cardiac lead system through the patient's anatomy.

Abstract: A guiding catheter for use in medical procedures includes a flexible shaft with one or more audio transducers and a distal tip. An audio signal may be sent to one or more of the transducers and a reflected signal is received at one or more transducers. The reflected signal is used to detect the presence of an anatomical structure to assist in navigating the catheter to its destination. In another arrangement, the transducer can be used passively to detect physical characteristics of the heart such as sound, subsonic energy or temperature, that indicate relative proximity of a destination vessel.

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: A hemostasis valve for use in introducing an over-the-wire medical lead into a patient's vascular system comprises a housing with a passageway, the passageway including an elastomeric pierceable seal member interposed therein and a resilient, annular tip surrounding a distal end of the housing where the tip has a central opening that is sized to receive a tubular connector terminal at the proximal end of the medical lead for dripping the end of the lead and sealing the lead's tubular connector terminal in the passageway of the housing.

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 hemostasis valve for use in introducing an over-the-wire medical lead into a patient's vascular system comprises a housing with a passageway, the passageway including an elastomeric pierceable seal member interposed therein and a resilient, annular tip surrounding a distal end of the housing where the tip has a central opening that is sized to receive a tubular connector terminal at the proximal end of the medical lead for dripping the end of the lead and sealing the lead's tubular connector terminal in the passageway of the housing.

Abstract: A system and method for navigating coronary vasculature involves use of a guide catheter system which includes a guide catheter, a navigator catheter longitudinally displaceable within the guide catheter, and a deflection arrangement provided at a distal end of the navigator catheter. The guide catheter is advanced to at least a patient's coronary sinus ostium, and the navigator catheter is extended from the guide catheter to a location proximate or within an angled vein distal to the coronary sinus ostium. Using the deflection arrangement, a guide wire passing through the navigation catheter is directed into the angled vein. A lead having an open lumen is advanced over the guide wire to direct the lead to an implant site within the angled vein.

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 device 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 peel-away sheath for a catheter includes at least one weakened area in a non-longitudinal pattern, such as a helical pattern, along the length of the sheath. One embodiment of a catheter sheath includes a tube having at least one pull wire integrally located within its wall. Another embodiment of a catheter sheath includes a tube having at least one integral lumen within its wall. The integral lumen may house a filling material. One embodiment of a catheter may include a first sheath which is positioned within a second sheath, with each of the first and second sheaths having at least one weakened area along its length. A reinforcing guide for a guide catheter includes a tube having a lumen with a diameter at least as large as the guide catheter diameter. The reinforcing guide includes a gap with a width which is less than the guide catheter diameter.