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: Disclosed herein, among other things, are high surface area electrodes and methods of making the same. In an embodiment, the invention includes a method of increasing the surface area of an electrode of an implantable medical device including immersing the electrode in an electrolyte solution and oxidatively removing material from the surface of the electrode. In an embodiment, the invention includes a method of increasing the surface area of an electrode of an implantable medical device including immersing the electrode in an electrolyte solution and applying an oscillating electrical potential. In an embodiment, the invention includes a method of manufacturing an implantable stimulation lead including welding an electrode to a conductor and increasing the surface area of the electrode by oxidatively removing a portion of the electrode surface. Other aspects and embodiments are provided herein.

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: 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 medical electrical lead for transvascularly stimulating a nerve, muscle or other tissue from an adjacent vessel is described. The lead includes an expandable distal portion having one or more spirals for securing and stabilizing the lead within the vessel.

Abstract: A medical electrical lead for transvascularly stimulating a nerve, muscle or other tissue from an adjacent vessel is described. The lead includes a bifurcated distal portion including a first elongate member forming a first spiral and a second elongate member forming a second spiral. The spirals can be in parallel or serial alignment with one another.

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: The present invention relates to the regional delivery of therapeutic agents for the treatment of vascular diseases wherein regional delivery refers to delivery of a therapeutically effective amount of the therapeutic agent to an area of the vessel that includes not only afflicted tissue but non-afflicted tissue at the periphery of the afflicted tissue as well.

Abstract: The present invention provides an implantation system for delivering and securing a sensor in a patient's pulmonary artery. In general, the implantation system includes a pulse generator, a catheter, and a sensor coupled to the distal end of the catheter. The sensor is wireless and is adapted to communicate with the pulse generator or an external device.

Abstract: The invention relates to systems, devices, and methods for detecting infections associated with implantable medical devices. In an embodiment, the invention includes a method of detecting infection in a patient including measuring a physiological parameter using a chronically implanted sensor at a plurality of time points and evaluating the physiological parameter measurements to determine if infection is indicated. In an embodiment, the invention includes an implantable medical device including a first chronically implantable sensor configured to generate a first signal corresponding to a physiological parameter and a controller disposed within a housing, the controller configured to evaluate the first physiological parameter signal to determine if an infection is indicated. Other embodiments are also included herein.

Abstract: A lead for implanting into the epicardium includes a pair of tissue anchors coupled to a tissue engaging member, forming an anchor mechanism. The tissue anchors include electrodes coupled to conductors extending from the tissue engaging member. The tissue anchors are movable from a low profile configuration to an implanting configuration in which the tissue anchors are angled away from the tissue engaging member. A device for implanting the lead includes one or more lumens, including a lead lumen and a vacuum lumen terminating at a distal opening in the device. Suction is applied at the distal opening through the vacuum lumen to draw an epicardial bleb. The anchor mechanism of the lead is withdrawn proximally past the bleb, causing the tissue anchors to pierce the epicardium. The device is then withdrawn proximally over the conductors.

Abstract: A splint assembly includes an elongate body. An active fixation fastener is coupled substantially adjacent to a distal end of the elongate body. The splint assembly includes at least one flange coupled to the elongate body proximal the active fixation fastener. In one option, a stop of the at least one flange projects outside of an outer perimeter of the elongate body. In another option, the active fixation fastener is spaced from the at least one flange where the active fixation fastener and the at least one flange pull at least one heart chamber toward a substantially unexpanded shape when in an implanted condition within the heart an artery or a vein. In yet another option, the elongate body includes a predetermined curvature along at least a portion of the elongate body between the active fixation fastener and the at least one flange.

Abstract: A cardiac management implantable device that has an intravascular device body, and one or more chemical sensors coupled with the intravascular device body. A drug eluting substance is disposed at a location including at least one of on, directly adjacent, or near the one or more chemical sensors, where the drug eluting substance prevents fibrotic growth on the one or more chemical sensors.

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.