Abstract: The present invention is a lead for use in connection with a myocardial lead attachment system of the type having an anchor for engaging the heart and a tether extending from the anchor. The lead includes a lead body having a proximal end, a distal end and a lumen for accepting the tether. A tapered tip is separate from the lead and positioned adjacent the distal end of the lead. The tip has a longitudinal through-hole for accepting the tether.

Abstract: A cardiac rhythm management system includes a lead assembly for intracardiac mapping, pacing, and drug delivery. The lead assembly includes an implantable endocardial lead having a proximal end for connection to an implantable cardiac rhythm management device and a distal end for disposal in an intracardiac region. The lead includes a pacing-sensing electrode and a drug delivery device, both located at or near the distal end. A lumen is within and extends throughout the lead, with an opening at or near the proximal end and another opening at or near the distal end. The lumen provides for access to the intracardiac region by a steerable stylet and a hollow needle, one at a time. The steerable stylet allows for electrophysiological mapping of the intracardiac region. The hollow needle allows for delivery of chemical, biochemical, and/or biological substance to the intracardiac region.

Abstract: Implantable cardiac monitoring and stimulation devices and methods using cardiac leads employ coated fixation arrangements. The coating, such as an expanded polytetrafluoroethylene, reduces exit block by reducing the tissue response to the fixation arrangement, decreasing the amount of fibrotic tissue, and reducing exit block. An epicardial lead may include a lead body with one or more electrical conductors with associated insulators and an electrode assembly situated at the distal end. The electrode assembly includes an electrode having an active fixation arrangement such as a helical fixation element. The fixation arrangement is completely or partially coated with a fluoropolymer or has a sleeve on some or all of the active fixation arrangement. The coating or sleeve may include a steroid or other pharmacological eluting arrangement disposed on the active fixation arrangement.

Abstract: A myocardial lead attachment system for securing a distal end of a lead within a myocardium of a patient's heart. The system includes a lead body, an anchor mechanism formed of a bioabsorbable or biodegradable polymer for engaging a surface of the patient's heart and a surface feature formed on a portion of the lead body for promoting formation of scar tissue around said portion of the lead body.

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: The present invention is a myocardial lead attachment system and method for securing a distal end of a lead within the myocardium of a patient's heart. The system includes an anchor, a tether coupled at a distal end to the anchor and a lead body. The lead body has a proximal end, a distal end, and a lumen extending therethrough for receiving the tether. A fixation mechanism is at the distal end of the lead body, and is adapted to collapse to a first configuration during implantation and deploy to a second configuration after implantation.

Abstract: The present invention is a myocardial lead attachment system for securing a distal end of a lead within a myocardium of a patient's heart. The system includes an anchor, a tether coupled to the anchor, and a delivery instrument for receiving and advancing the anchor through a tract in the heart from a proximal entrance site to a distal exit site in such a manner that the tether extends proximally from the anchor through the tract. The delivery instrument includes a needle having a distal tip and a nest. The nest is positioned proximal to the distal tip and is sized to receive the anchor. The delivery instrument further includes an ejection mechanism for ejecting the anchor from the nest.

Abstract: A connector for connecting to an energy source such as a pulse generator for a cardiac stimulator system. The connector assembly includes a pin, at least one ring and a sleeve composed of an insulative hard polymer molded between the pin and ring such that the sleeve provides electrical insulation between the pin and ring and mechanically couples the pin and ring.

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 for placement of cardiac monitoring and stimulation leads. A lead is advanced into a myocardium of the patient's heart through a lead introducing system, and an electrode is implanted within the myocardium. The method may include gaining access with a cannula from an outer chest wall to the myocardium. Space is created in the myocardium using the lead introduction system. Aspects include eluting a steroid from the lead and into the myocardium, affixing the lead into myocardial tissue using an active fixation mechanism, such as a helical coil, and stabilizing the lead by suturing, clipping, stapling, or other method. A dilating sheath may be used to create a space within the myocardium sufficient in size to accommodate an implantable myocardial electrode. The system may include an implantation depth indicator such as a shoulder, a cuff, or a skirt on the lead.

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: 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 cardiac rhythm management system provides an endocardial cardiac rhythm management lead with an at least partially dissolvable coating at least partially on insulating portions of the lead body at or near its distal end. Upon dissolution, the coating promotes tissue ingrowth to secure the lead in place within fragile vascular structures or elsewhere. Dissolution of one such coating releases a therapeutic agent, such as a steroid that modifies the fibrotic scar tissue content of tissue ingrowth, such that the resulting bond between the tissue and the lead is weak, so that the lead can be easily extracted if desired. One such lead includes an insulating elongate body carrying at least. The lead also includes an at least partially dissolvable coating on an insulating portion of the peripheral distal lead surface. The coating provides one or more of a rough surface, a porous surface, or a swollen surface after being exposed to an aqueous substance.

Abstract: A medical electrical lead employs a load bearing sleeve arrangement. A medical electrical lead includes an outer sleeve, having proximal and distal ends, and is formed of a first material. At least one electrical conductor is situated within the outer sleeve and extends between the proximal and distal ends of the outer sleeve. At least one electrode is electrically coupled to the electrical conductor. A load bearing sleeve extends between the proximal and distal ends of the outer sleeve. The load bearing sleeve is formed of a second material different from the first material. The load bearing sleeve offers resistance to axial loading forces applied to the lead. The load bearing sleeve can be coextensive with the outer sleeve or extend along at least the majority of the length of the outer sleeve.

Abstract: A lead assembly includes insulative tubing with at least one tine coupled thereto, and a lumen extends through the tubing. The tine has a first position that extends away from the exterior of the tubing, and a second compressed position. In the second compressed position, the tine at least partially compresses the lumen.

Abstract: A connector for connecting to an energy source such as a pulse generator for a cardiac stimulator system. The connector assembly includes a pin, at least one ring and a sleeve composed of an insulative hard polymer molded between the pin and ring such that the sleeve provides electrical insulation between the pin and ring and mechanically couples the pin and ring.

Abstract: A unitary lead body of a medical electrical lead is formed of a flexible material and has a substantially cylindrical shape. An outer surface of the unitary lead body defines an outer surface of the lead, thereby obviating the need for a separate outer surface or sheath. The unitary lead body includes one or more longitudinally extending cavities defining a number of lumens. One or more electrical conductors are disposed within at least one of the lumens. One or more electrodes are respectively coupled to the electrical conductors. The unitary lead body is preferably formed by use of an extrusion process.

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 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.