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 drug delivery system incorporated into a cardiac device for delivering a dose of a drug to a patient upon detection of a particular medical condition. The cardiac device may be, for example, an implantable cardioverter/defibrillator, cardiac pacemaker, or combination device that communicates via a radio frequency link with a drug delivery device. The drug delivery device is preferably an electrically modulated transdermal drug delivery device for delivering the drug transdermally in accordance with a signal received from the cardiac device.

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 system and method for stimulating a human heart including a sensing module coupled through a lead to an electrode associated with a tissue of the human heart for sensing electrical activity of the heart. A controller module may be coupled to the sensing module. The controller module may select between a temporary stimulation therapy and a chronic stimulation therapy. Also included is a therapy module coupled to the controller, the therapy module communicating a plurality of anodic pulses to the heart through the lead when providing the temporary stimulation therapy. The amplitude, frequency, and duration of the anodic pulses may be varied, and biphasic pacing may also be used. The electrode may be a drug-eluting electrode for delivery of a drug. After an event occurs, the controller module may transition to the chronic stimulation therapy that may include cathodic stimulation.

Abstract: A helical element for insertion into tissue comprises a helical element having an insertion end, a protruding end and an open central area within the wire, rods, filaments, cables or the like that form the helix. The helical element has at least its insertion end covered by a cap of a water-soluble or water-dispersible composition. The cap is provided with a surface shape in a cross-section in which surface variations are present in the cross-section which create a surface orientation where a line from the center of the cross-section can intersect the surface, and a line perpendicular to said radius at a point of intersection with said surface forms four quadrants, three of said quadrants containing water-soluble or water-dispersible cap material. There is either a hollow area within the composition within the open central area or the material is more porous than the remaining material.

Abstract: A medical device for use with an implantable lead includes a force monitoring system coupled with the device. The force monitoring system monitors force placed on the medical device and/or the lead. Optionally the system compares the force with a preset limit, and notifies a user once the preset limit has been reached.

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 lead having an electrode assembly has a high impedance electrode. The high impedance electrode includes a partially insulated sleeve electrode or a wire filament. The high impedance electrode includes an exposed surface of less than 1.2 mm2. One or more eluting drugs are disposed adjacent to the high impedance electrode.

Abstract: A drug delivery system and method in which an implantable medical device communicates with and controls an external drug delivery device with low energy potential signals. The implantable device generates potential signals modulated with digitally encoded command information by operating a current source to cause corresponding electrical potentials that can be sensed at the skin surface by the external drug delivery device. The drug delivery device then demodulates the sensed potentials and decodes the digital data to extract command information therefrom to deliver a drug accordingly.

Abstract: A data logging system and method in which an implantable medical device transmits logged data to an external data logging device with low energy potential signals. The implantable device generates potential signals modulated with digitally encoded data by operating a current source to cause corresponding electrical potentials that can be sensed at the skin surface by the external data logging device. The data logging device then demodulates the sensed potentials to derive the digital data and stores the data in a data logging storage medium.

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 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 single-pass endocardial lead electrode adapted for implantation in, on or about the heart and for connection to a system for monitoring or stimulating cardiac activity includes a lead body which is adapted for implantation within a single chamber of the heart, or multiple chambers of the heart. The lead includes a first distal end electrode which has a first electrical conducting surface. The lead body also has a second electrode which has a second electrical conducting surface. The first and second electrodes are either passively or actively attached to the wall of the heart. The lead body also includes a curved portion which facilitates the positioning of the second electrode. The main lead body alternatively includes a recess into which an atrial lead body and an active fixation element attached to one end can travel from a recessed position to a position for fixation to the wall of the heart. The active fixation element can also be moved by turning the terminal pin.

Abstract: An implantable lead, being either a fixed or retractable/extendable lead, having a distal tip electrode is adapted for implantation on or about the heart and for connection to a system for monitoring or stimulating cardiac activity. The electrode includes a mechanical fastener such as a fixation helix for securing the electrode to cardiac tissue, which may or may not be electrically active. The implantable electrode with a helical tip includes an electrode which has a distal end and a proximal end. A helix is disposed within the electrode, where the helix is aligned along a radial axis of the electrode. The electrode further includes one or more of the following features: the helix having a coating of an insulating material on a surface of the helix, a porous conductive surface at a base of the helix, a porous conductive element at the end of the electrode having an insulating coating covering from 5-95% of the surface of the porous conductive element.

Abstract: A helical element for insertion into tissue comprises a helical element having an insertion end, a protruding end and an open central area within the wire, rods, filaments, cables or the like that form the helix. The helical element has at least its insertion end covered by a cap of a water-soluble or water-dispersible composition. The cap is provided with a surface shape in a cross-section in which surface variations are present in the cross-section which create a surface orientation where a line from the center of the cross-section can intersect the surface, and a line perpendicular to said radius at a point of intersection with said surface forms four quadrants, three of said quadrants containing water-soluble or water-dispersible cap material. There is either a hollow area within the composition within the open central area or the material is more porous than the remaining material.

Abstract: A cardiac lead introducing apparatus, the cardiac lead introducing apparatus having a sleeve with a peripheral surface, a first end and a second end, where the sleeve includes an opening extending from the first end to the second end and adapted to hold at least a portion of a cardiac lead. The cardiac lead introducing apparatus further includes a first slit extending from the peripheral surface to the opening and from the first end to the second end which permits the sleeve to separate so the cardiac lead can pass through the cardiac lead introducing apparatus without any longitudinal motion of the device with respect to the cardiac lead. In one embodiment, the diameter of the opening is smaller than the outer diameter of the cardiac lead which permits the cardiac lead to be held static within the introducing apparatus as the lead connector of the cardiac lead is inserted into the socket of an implantable pulse generator connector block.

Abstract: A drug delivery system incorporated into a cardiac device for delivering a dose of a drug to a patient upon detection of a particular medical condition. The cardiac device may be, for example, an implantable cardioverter/defibrillator, cardiac pacemaker, or combination device that communicates via a radio frequency link with a drug delivery device. The drug delivery device is preferably an electrically modulated transdermal drug delivery device for delivering the drug transdermally in accordance with a signal received from the cardiac device.

Abstract: A lead having an electrode assembly has a high impedance electrode. The high impedance electrode includes a partially insulated sleeve electrode or a wire filament. The high impedance electrode includes an exposed surface of less than 1.2 MM2. One or more eluting drugs are disposed adjacent to the high impedance electrode.

Abstract: A single-pass endocardial lead electrode adapted for implantation on or about the heart and for connection to a system for monitoring or stimulating cardiac activity including a lead body with a circumferential outer surface. The lead includes a first distal end electrode which has a first electrical conducting surface which is for positioning within the ventricle of the heart. The lead body also has a second electrode which has a second electrical conducting surface adapted for positioning within the atrium of the heart. Both of the first and the second electrodes are adapted for positioning and fixation to the wall. An active fixation element is used as part of the second electrode. The lead body also includes a curved portion which facilitates the positioning and fixing of the second electrode.

Abstract: A single-pass endocardial lead electrode adapted for implantation on or about the heart and for connection to a system for monitoring or stimulating cardiac activity includes a lead body with a circumferential outer surface. The lead includes a first distal end electrode which has a first electrical conducting surface. The lead body also has a second electrode which has a second electrical conducting surface. The second electrode is adapted for positioning and fixation to the wall of the atrium of the heart. A passive fixation element may be used as part of the second electrode. The lead body also includes a curved portion which facilitates the positioning and passive fixation of the second electrode.