Abstract: The invention provides a cardiac rhythm management system which includes a tachyarrhythmia detection and classification circuit programmed to detect and classify a tachyarrhythmia, a biologic therapy delivery device configured to deliver or regulate an expression cassette suitable for terminating or preventing atrial fibrillation (AF), and a control circuit coupled to the tachyarrhythmia detection and classification circuit and the biologic therapy delivery device. Also provided is an implantable medical device for use in a body having a cardiovascular system, which includes an implantable device body including at least a cardiovascular portion configured to be in the cardiovascular system, and an expression cassette incorporated into the cardiovascular portion of the implantable device body, the expression cassette selected to express a gene product that terminates or prevents AF. Further provided are methods which employ particular expression cassettes to prevent, inhibit or treat AF.

Abstract: An epicardial pacing lead including a flexible, elongated lead body. The epicardial pacing lead has a proximal end and a distal end. An electrode is coupled to the lead body near the distal end. A housing is coupled to the lead body proximal to the electrode. A platform is at least partially encompassed by the housing. The platform includes at least four tines. Each tine is adapted for engagement with the epicardium and includes an upper section extending outwardly from the platform and a lower section extending distally at an angle to the upper section.

Abstract: An implantable medical device that includes a body that includes a proximal end portion configured to be at least partially received by an apparatus, and a distal end portion; a stimulating electrical element at the distal end portion of the body; a stimulating contact at the proximal end portion of the body, wherein the stimulating contact is positioned such that, when received by the apparatus, at least a portion of the apparatus is capable of electrically coupling to the stimulating contact; a stimulating conductor that electrically couples the stimulating electrical element to the stimulating contact; a conductive body, wherein the conductive body is not utilized for application of stimulation; a conductive body contact, wherein the conductive body is electrically connected to the conductive body contact. Systems that include devices are also disclosed.

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: Implantable cardioverter-defibrillators (ICDs) are disclosed that are entirely implantable subcutaneously with minimal surgical intrusion into the body of the patient and provide distributed cardioversion/defibrillation and pace/sense electrodes for delivery of cardioversion/defibrillation shock and pacing therapies across the heart when necessary. At least two hermetically sealed housings forming first and second hermetically sealed housings coupled together by a cable support first, second and, optionally, third cardioversion/defibrillation electrodes. The relatively bulky high voltage battery and high voltage capacitors, and circuitry powered by a low voltage power source for detecting a tachyarrhythmia, charging the high voltage capacitor, and discharging the high voltage capacitor to provide a cardioversion/defibrillation shock are distributed between the first and second hermetically sealed housings.

Abstract: The invention is directed to devices for two minimally invasive therapeutic procedures, particularly for patients with congestive heart failure. One procedure involves providing a valve to form a passageway through the patient's left ventricular wall at the apex of the patient's heart and configured to advance instruments through the valved passageway to connect the valve leaflets of the patient's heart valve, e.g. the mitral valve, in a “Bow-Tie” configuration to prevent or minimize regurgitation through the valve. The second procedure is directed to a pacing lead with a housing and a pacing lead implanting device which are configured to pass through a trocar in the patient's chest and implanting the pacing lead on an exposed epicardial region of the patient's heart wall. The pacing lead has a penetrating electrode which is secured within the heart wall. One or both procedures may be performed on a patient with CHF.

Abstract: The present invention is of an electrode comprising an electrode substrate, wherein the electrode substrate has an electrode side and a back side; a conductive material layer disposed on the back side of the electrode substrate; and an insoluble electroactive material disposed on the electrode side of the electrode substrate. The electrode substrate can be a conductive substrate or a non-conductive substrate. In an embodiment wherein the substrate is a non-conductive substrate, the electrode can include vias which extend from the electrode substrate backside to the electrode side of the substrate. In some embodiments, the electroactive material is zinc and the conductive material is silver. The present invention provides an electrode with improved current distribution and high capacity, which can provide higher current and/or higher voltage. In addition, the present invention provides a dermal patch, which includes a higher powered, high capacity electrode with uniform current distribution.

Abstract: An implantable lead having an elongated lead body that includes an electrical conductor extending between a distal end of the lead body and a proximal end of the lead body is disclosed. The lead further includes an electrode formed at the distal end of the lead body, the electrode being coupled to the electrical conductor and one or more passive fixation mesh sections coupled to the distal end of the lead body that promotes tissue over growth.

Abstract: Electrical cardiac therapy devices including electrode assemblies having openings for receiving an electrode insertion tool, and methods of inserting such electrode assemblies. The opening(s) are defined on the electrode assemblies to allow an insertion tool to be coupled to the electrode assembly and then used to push the electrode assembly into place.

Abstract: Electrical cardiac therapy devices including electrode lead assemblies having first and second insertion tool receivers. The insertion tool receivers may be attached to an electrode and/or an electrode cover assembly. A lead assembly having first and second insertion tool receivers may be used in conjunction with an insertion tool having means, such as tines, for coupling with the insertion tool receivers. A lead assembly system may include both an insertion tool and a lead assembly. A treatment system further includes an implantable housing along with the lead assembly and insertion tool.

Abstract: Electrical cardiac therapy devices including electrode lead assemblies having appendages coupled to an electrode. The appendage may take the form of a riser and a head having various characteristics. A further embodiment may include a cover and/or other features coupling the electrode to the riser. A lead may be provided for electrical coupling to the electrode. The lead may couple to the electrode exclusive of the riser and head. An implantable housing containing electrical circuitry for using the electrode to stimulate cardiac activity is also illustrated.

Abstract: An implantable subcutaneous cardiac device includes at least two subcutaneous electrodes adapted for placement external to a heart beneath the skin of a patient. The device further includes an arrhythmia detector that detects a sustained tachyarrhythmia of the heart and a pulse generator that delivers anti-tachycardia pacing pulses to the subcutaneous electrodes in response to detection of a sustained tachyarrhythmia. The pacing pulses preferably have waveforms devoid of any exponential voltage decay and include rounded or substantially constant portions to minimize pain.

Abstract: Electrical cardiac therapy devices including electrode assemblies having openings for receiving an electrode insertion tool, and methods of inserting such electrode assemblies. The opening(s) are defined on the electrode assemblies to allow an insertion tool to be coupled to the electrode assembly and then used to push the electrode assembly into place.

Abstract: The lead body of a medical lead comprises a distal end portion carrying at least one electrode for placement in the pericardial sac of a human heart. The distal end portion of the lead body includes a multi-turn section having opposed ends, opposing forces applied to the ends tending to flatten the multi-turn section, the multi-turn section being thereby adapted to be retained within the pericardial sac. The turns of the multi-turn section may become progressively smaller from one end of the section to the other end of the section. The multi-turn section may have, in a relaxed state thereof, a generally conical, helical configuration. The at least one electrode may be carried adjacent to the end of the multi-turn section having the larger turns. Alternatively, the at least one electrode may be carried adjacent to the end of the multi-turn section having the smaller turns.

Abstract: Terminating supraventricular arrhythmias through parasympathetic nerve stimulation. The method comprises detecting a supraventricular arrhythmia, stimulating a parasympathetic nerve and determining whether the supraventricular arrhythmia terminated or worsened. Various exemplary methods include delivering one or more stimulation pulses during postinspiration and/or in response to one or more cardiac events.

Abstract: Electrical cardiac therapy devices including lead electrode assemblies for implantation into a patient comprising an electrode having a first face and a second face, and an appendage extending opposite the second face of the electrode, the appendage including an eyelet for securing an insertion device thereto. The assembly may further include an electrode frame assembly to which the appendage may be attached. Alternatively, the appendage may be formed as part of a molded electrode frame assembly. A backing piece may be provided between the electrode frame assembly and the electrode. The frame assembly may cover a portion of a front side of the electrode. Further embodiments include an electrode lead assembly including an appendage with an eyelet and an electrode insertion tool adapted to engage the eyelet.

Abstract: An expandable intravascular medical device comprises an arcuate spring configured to be expanded into contact with the inner surface of a blood vessel. Another medical device comprises an electrode support structure, e.g., a non-tubular arcuate structure or a cylindrical member, and a plurality of resilient spring loops laterally extending from the support structure. The contact created between the loops and a blood vessel is sufficient to anchor the medical device within the blood vessel. In another embodiment, the medical device comprises an elongated member and two resilient spring arms extending distally from the elongated member. The arms are configured to be laterally moved towards each other to place the medical device in a collapsed geometry, and configured to be laterally moved away from each into contact with an inner surface of a blood vessel to place the medical device an expanded geometry.

Abstract: A system for treating the heart includes a cardiac harness associated with a cardiac rhythm management devise which includes at least electrodes and a power source. The cardiac harness applies a compressive force on the heart during diastole and systole. The electrodes will deliver an electrical shock to the heart for defibrillation and/or can be used for pacing/sensing. The cardiac harness and electrodes are delivered and implanted on the heart by minimally invasive access.

Abstract: A medical electrical lead to conduct electrical stimulation and/or signals between an electrical stimulator and a heart site includes an elongated lead body extending to a proximal connector for attachment to the electrical stimulator. An electrode head at the distal end includes an electrode tip member for fixation to the heart and an electrode backing member fixed to the lead body is releasably attachable to the electrode tip member for transmission of electrical signals between the heart and the electrical stimulator. The electrode tip member may include a first non-conductive base with an outwardly projecting tip electrode and a first mounting member projecting oppositely away from the non-conductive base. The electrode backing member includes a second non-conductive base and a second mounting member thereon adapted for mounting engagement with the first mounting member for selectively releasably but firmly integrating the electrode tip member and the electrode backing member.

Abstract: An implantable cardiac system has a master pacing unit and a remote satellite pacing unit. The master pacing unit is electrically coupled to a right side of a patient's heart via a lead assembly. The satellite pacing unit is a leadless device mounted on the left side of the patient's heart and is wirelessly controlled by the master pacing unit. The satellite pacing unit is affixed to the heart by one or more mounting members. The base of the satellite unit case has a gel-like material which facilitates adhesion of the pacing unit to the heart tissue. The gel-like material promotes tissue growth to hold the pacing unit in place on the heart. The gel-like material may be composed of polyvinlpyrrolidone and may contain a steroid, such as dimethyl sulfoxide (DMSO), or dexamethazone sodium phosphate.

Abstract: Methods and devices for implanting pacing electrodes or other apparatus, or for delivering substances, to the heart of other tissues within the body. A guided tissue penetrating catheter is inserted into a body lumen (e.g., blood vessel) or into a body cavity or space (e.g., the pericardial space) and a penetrator is advanced from the catheter to a target location. In some embodiments, a substance or an apparatus (such as an electrode) may be delivered through a lumen in the penetrator. In other embodiments, a guidewire may be advanced through the penetrator, the penetrating catheter may then be removed and an apparatus (e.g., electrode) may then be advanced over that guidewire. Also disclosed are various implantable electrodes and electrode anchoring apparatus.

Abstract: Apparatus and techniques to address the problems associated with lead migration, patient movement or position, histological changes, neural plasticity or disease progression. Disclosed are techniques for implanting a lead having therapy delivery elements, such as electrodes or drug delivery ports, within a vertebral or cranial bone so as to maintain these elements in a fixed position relative to a desired treatment site. The therapy delivery elements may thereafter be adjusted in situ with a position control mechanism and/or a position controller to improve the desired treatment, such as_electrical stimulation and/or drug infusion to a precise target. The therapy delivery elements may be positioned laterally in any direction relative to the targeted treatment site or toward or away from the targeted treatment site. A control system maybe provided for open- or closed-loop feedback control of the position of the therapy delivery elements as well as other aspects of the treatment therapy.

Abstract: A system for treating the heart includes a cardiac harness associated with a cardiac rhythm management devise which includes at least electrodes and a power source. The cardiac harness applies a compressive force on the heart during diastole and systole. The electrodes will deliver an electrical shock to the heart for defibrillation and/or can be used for pacing/sensing. The cardiac harness and electrodes are delivered and implanted on the heart by minimally invasive access.

Abstract: Methods and apparatus for cardiac pacing, cardioversion and defibrillation rely on delivering ultrasonic or other vibrational energy in combination with electrical energy to the heart, usually after the onset of an arrhythmia. A vibrational transducer and suitable electrical contacts may be combined in a single housing or distributed among various housings, and will usually be implantable so that the vibrational transducer can be directed at a target portion of the heart. Alternatively, external systems comprising the vibrational transducer and electrical contacts are also described.

Abstract: The invention is directed to techniques for electrode placement around a heart. A harness having one or more attachment sites may be secured around the heart, and electrodes may be secured at the attachment sites as desired by the physician for the patient. The electrodes may be, for example, pacing and sensing electrodes, defibrillation electrodes, or any combination thereof. The harness holds the electrodes in place and also impedes the progress of ventricular dilation. The electrodes attached to the harness may be used for any of several purposes, such as cardiac resynchronization, selective defibrillation, measurement of impedance, pacing and cardioversion.

Abstract: During fabrication of an electrical medical lead, a cut end of a stranded wire conductor is subjected to electrical current sufficient to heat and weld the strands together upon discharge of a high voltage between the cut end and a ground metal plate formed of a material of the stranded wire conductor. The discharge of weld energy between the stranded wire cut end and the ground plate induces heat in the wire strands at the stranded wire cut end and the ground plate sufficient to transfer conductive material from the ground plate to fuse the wire strands together. The fusing inhibits unraveling of the wire strands at the fused cut end, whereby the insertion of the stranded wire cable through a lead body lumen and the connection of the fused stranded wire cut end to a further lead component, e.g., a proximal lead connector element or distal electrode, is facilitated.

Abstract: A system for treating the heart includes a cardiac harness associated with a cardiac rhythm management devise which includes at least electrodes and a power source. The cardiac harness applies a compressive force on the heart during diastole and systole. The electrodes will deliver an electrical shock to the heart for defibrillation and/or can be used for pacing/sensing. The cardiac harness and electrodes are delivered and implanted on the heart by minimally invasive access.

Abstract: A system for treating the heart includes a cardiac harness associated with a cardiac rhythm management devise which does not have a lead system. The cardiac harness applies a compressive force on the heart during diastole and systole, and the cardiac rhythm management devise will deliver an electrical shock to the heart for defibrillation and/or can be used for pacing/sensing. The cardiac harness and cardiac rhythm management devise are both delivered and implanted by minimally invasive access.

Abstract: A system for treating the heart includes a cardiac harness associated with a cardiac rhythm management devise which includes at least electrodes and a power source. The cardiac harness applies a compressive force on the heart during diastole and systole. The electrodes will deliver an electrical shock to the heart for defibrillation and/or can be used for pacing/sensing. The cardiac harness and electrodes are delivered and implanted on the heart by minimally invasive access.

Abstract: A system for treating the heart includes a cardiac harness associated with a cardiac rhythm management devise which includes at least electrodes and a power source. The cardiac harness applies a compressive force on the heart during diastole and systole. The electrodes will deliver an electrical shock to the heart for defibrillation and/or can be used for pacing/sensing. The cardiac harness and electrodes are delivered and implanted on the heart by minimally invasive access.

Abstract: A system for treating the heart includes a cardiac harness associated with a cardiac rhythm management devise which includes at least electrodes and a power source. The cardiac harness applies a compressive force on the heart during diastole and systole. The electrodes will deliver an electrical shock to the heart for defibrillation and/or can be used for pacing/sensing. The cardiac harness and electrodes are delivered and implanted on the heart by minimally invasive access.

Abstract: A disposable internal defibrillator paddle providing for a more economical and easier defibrillation procedure than non disposable paddles. The disposable paddle contains: (a) a handle attached to a shaft attached to a spoon, the spoon having a receiving unit, and the handle, the shaft, and the spoon are all made of non conducting material; and (b) an electrode plate attaching onto the receiving unit of the spoon.

Abstract: An epicardial electrode which is suitable, in particular, for use with a cardiac stimulation device, comprises an electrode body which has a stimulation surface adapted to bear against the cardiac tissue and to stimulate a part of the heart, that is to say a partial region of the heart, and at least one fixing element for fixing the stimulation surface to the cardiac tissue. The at least one fixing element is adapted for engagement into the cardiac tissue. The epicardial electrode can be secured to the outside and in particular to the outer skin of the cardiac muscle (epicardium) without being sewn to the cardiac muscle like a patch electrode. Only the fixing element has to be brought into engagement with the cardiac tissue.

Abstract: Implantable cardioverter-defibrillators (ICDs) are disclosed that are entirely implantable subcutaneously with minimal surgical intrusion into the body of the patient and provide distributed cardioversion/defibrillation and pace/sense electrodes for delivery of cardioversion/defibrillation shock and pacing therapies across the heart when necessary. At least two hermetically sealed housings forming first and second hermetically sealed housings coupled together by a cable support first, second and, optionally, third cardioversion/defibrillation electrodes. The relatively bulky high voltage battery and high voltage capacitors, and circuitry powered by a low voltage power source for detecting a tachyarrhythmia, charging the high voltage capacitor, and discharging the high voltage capacitor to provide a cardioversion/defibrillation shock are distributed between the first and second hermetically sealed housings.

Abstract: Instruments for thermally-mediated treatment of a patient's lower esophageal sphincter (LES) to induce an injury healing response to thereby populate the extracellular compartment of walls of the LES with collagen matrices to altere the biomechanics of the LES to provide an increased intra-esophageal pressure for preventing acid reflux. A preferred embodiment is a bougie-type device for trans-esophageal introduction that carries conductive electrodes for delivering Rf energy to walls of the LES (i) to induce the injury healing response or (ii) to “model” collagenous tissues of the LES by shrinking collagen fibers therein.

Abstract: A device for treating atrial fibrillation includes a pad which houses the distal end of an electrode which is adapted to deliver a substantially uniform shock gradient to an atrial surface of a postoperative cardiac patient, if atrial fibrillation is detected. The device also includes a catheter for delivering anti-arrhythmic and/or anesthetic drugs to the pad. After a treatment period, the device may be removed by pulling the electrode and the pad, if the pad is not bioabsorbable, into the catheter and then pulling the catheter through the patient's chest wall.

Abstract: A surgical electrode has an anchor which is constrained by a coating made from a bioabsorbable material. The anchor may have a barbed harpoon-like shape designed to enhance the retention strength of the anchor.

Abstract: One embodiment of the present invention provides a lead electrode assembly for subcutaneous implantation including an electrode; a riser coupled to the electrode; and a head coupled to the riser.

Abstract: This invention relates to implantable heart sack that can be equipped with pacemaker leads and/or defibrillation leads for the treatment of cardiomyopathy, hypertrophic cardiomyopathy, tachycardia, bradycardia, ventricular fibrillation, atrial fibrillation etc. The hear sack was prepared from biocompatible, biostable, implantable polyetherurethane, polycarbonateurethane, silicone, polysiloxaneurethane, polyfluoroethylene, or hydrogenated poly(styrene-butadiene) copolymer. The heart sack is equipped with attached sutures to make it easier to attach onto the heart. The heart sack can be made semipermeable or perforated to have numerous holes. The heart sack can be reinforce with fiber or filament. Ordinary pacemaker leads can be attached to the inner side of the heart sack.

Abstract: An epicardial electrode according to the invention which is suitable, in particular, for use with a cardiac stimulation device, comprises an electrode body which has a stimulation surface adapted to bear against the cardiac tissue and to stimulate a part of the heart, that is to say a partial region of the heart, and at least one fixing element for fixing the stimulation surface to the cardiac tissue. The at least one fixing element is adapted for engagement into the cardiac tissue. The epicardial electrode according to the invention can be secured to the outside and in particular to the outer skin of the cardiac muscle (epicardium) without being sewn to the cardiac muscle like a patch electrode. Only the fixing element has to be brought into engagement with the cardiac tissue.

Abstract: Electrical cardiac therapy devices including electrode assemblies having openings for receiving an electrode insertion tool, and methods of inserting such electrode assemblies. The opening(s) are defined on the electrode assemblies to allow an insertion tool to be coupled to the electrode assembly and then used to push the electrode assembly into place.

Abstract: A manipulator joined to a distal end of a delivery system shaft includes a plurality of arms and a collar. A proximal portion of each of the arms is joined to the shaft and a distal portion of each of the arms is joined to the collar such that the collar is substantially aligned with a lumen of the shaft. The lumen and the collar slideably and rotatably engage a medical electrical lead while a plurality of control wires, adapted to manipulate the manipulator, join to each of the plurality of manipulator arms in proximity to the distal end of the shaft.

Abstract: A pericardial augmentation apparatus and method for electrically assisting the normal contraction of the heart. The invention comprises placing a mesh material apparatus over the heart within the pericardial space. Embedded in the apparatus is a plurality of electrode nodules that are synchronized to stimulate and assist in the normal contraction of the heart. The mesh of the device is adaptable to fit any size or shape heart and can be self-secured or sutured to the pericardium.

Abstract: An electrode device for myocardial and the like comprises an electrode device body with elasticity; the electrode parts provided in a tip part of the electrode device body or a portion adjacent the tip part of the electrode device body, having a prevention part for missing the electrode parts; and the grip parts provided so as to nip the electrode device body so that it can avoid fear of infection disease and heart failure and connect the electrode device from an epimyocardium side

Abstract: An epicardial electrode (10) includes a generally parallelepiped flexible body (12). The epicardial electrode has an electrode element (22) attached to the center of a first side (14) for conveying electrical stimulation to cardiac muscle, and a lead (24) attached to the flexible body at a lead side (18). The lead has at least an insulated cathode conductor (26) electrically coupled to the electrode element. The epicardial electrode also has two pairs of prongs (31-34), electrically insulated from the electrode element, for anchoring the epicardial electrode to the heart. The tip (41-44) of each prong is dull. The flexible body has two elongate holes (51-52) on opposite sides of the flexible body sized to accept rods of a tool for flexing the epicardial electrode.

Abstract: An electrode for use in stimulating an individual is provided. The electrode includes a conductive element that is at least partially made of a conductive material. The conductive element has an outer edge and has at least one aperture within the outer edge.

Abstract: Medical electrical leads adapted to be implanted within the body, and particularly such leads having at least one distal electrode affixed at a site of a body organ, particularly the epicardium of the heart, employing a light-activated adhesive fixation, and methods and systems for accessing the site, applying the distal electrode to the site, and activating the light-activated adhesive. The lead is preferably implanted by performing a thoracoscopy of the thorax of the patient to visualize the site of the epicardium through a thoracoscope and to provide a pathway to the site of the epicardium. While viewing the site of the epicardium through the thoracoscope, the electrode head is inserted through the provided pathway to apply the plate against the site of the epicardium, and the light-activated adhesive is exposed to a predetermined bandwidth of light to adhere the plate to the epicardium.

Abstract: A unitary subcutaneous implantable cardioverter-defibrillator is disclosed which has a long thin housing in the shape of a patient's rib. The housing contains a source of electrical energy, a capacitor, and operational circuitry that senses the presence of potentially fatal heart rhythms. Provided on the housing are cardioversion/defibrillation electrodes located to deliver electrical cardioversion-defibrillation energy when the operational circuitry senses a potentially fatal heart rhythm. The unitary subcutaneous implantable cardioverter-defibrillator does not have a transvenous, intracardic, epicardial, or subcutaneous electrode.

Abstract: The methods and apparatus for lead placement on a surface of the heart are employed using an elongated body having proximal and distal end portions. The body defines a lead receiving passageway extending between a proximal inlet and a distal outlet for receiving a lead therethrough for contact with the heart surface. The elongated body is adapted for insertion between a pericardium and an epicardial surface. At least a portion of the body may have a non-circular cross-sectional shape adapted to retain the body orientation between the pericardium and the epicardial surface.

Abstract: An implantable cardioverter defibrillator (ICD) system includes an internal electrode placed in the right ventricle of the heart, and a flexible array (that includes a plurality of electrodes) placed over a significant portion of the heart. Defibrillation shocks are applied between the internal electrode in the ventricle and the electrodes in the flexible array. Because the electrodes in the flexible array surround a significant portion of the heart, the array functions as a quasi-Faraday cage and is thus capable of confining a significant portion of the defibrillation shock field to the heart itself. As a result, defibrillation shocks are less likely to activate extracardiac muscle(s) and/or nerve tissue(s) within the surrounding chest. Application of the shocks is thus less painful to the patient.