Pacesetter, Inc.

Ventritex, Inc.

Drew A Hoffmann

M Elizabeth Bush

Benjamin D Pless

Peter A Altman

Matthew G Fishler

Eric Steven Fain

Eric Falkenberg

Dean F Carson

M Dean Matthews

Michael B Sweeney

Steven M Mitchell

Pedro G Medrano

An implantable cardiac device and method provides for monitoring a progression or regression in heart disease during an extended time period. A sensor generates an electrogram signal representing electrical activity of a patient's heart. From the generated electrogram signal, a processor determines morphology measurements wherein the morphology measurements indicate a progression or regression in the heart disease. The morphology measurements are stored in a memory during the extended period of time. A telemetry circuit transmits the stored morphology measurements to an external receiver for retrieval or display. The morphology measurements may be of electrogram intrinsic activity or evoked response activity characteristics.

Implantable cardiac device for and method of monitoring progression or regression of heart disease by quantifying morphological features

A method for treating arrhythmias which includes the steps of detecting an arrhythmia, and, in response to detection of the arrhythmia, delivering electrical energy to a targeted part of myocardial tissue in such a manner as to create a transient conduction block in the targeted part of the myocardial tissue without causing permanent damage to the targeted part of the myocardial tissue. The electrical energy can be continuous or pulsed RF, or continuous or pulsed DC. The detected arrhythmia can be atrial fibrillation, atrial flutter, ventricular fibrillation, or other type of arrhythmia. The targeted part of the myocardial tissue constitutes a critical part of the reentrant pathway or reentrant circuit required to sustain the detected arrhythmia. The electrical energy is preferably delivered via a catheter-based electrode which is in direct contact with the targeted part of the myocardial tissue, for either a prescribed period of time or until the arrhythmia is no longer detected (i.e., is terminated). In the former case, the prescribed period of time can be either sufficient to ensure that the arrhythmia can no longer be sustained, or sufficient to ensure that the arrhythmia is organized well enough to be terminated with additional low energy cardioversion/defibrillation therapy (such as a biphasic shock or pulse train). In a first alternative embodiment of the method of the present invention, a shock (or other form of cardioversion or defibrillation therapy) can be delivered, and then, if necessary (e.g., if it is detected that the fibrillation has not been terminated), electrical energy can be delivered to a targeted part of the myocardial tissue in order to create a transient conduction block in the targeted part of the myocardial tissue. In a second alternative embodiment of the method of the present invention, electrical energy is delivered to a targeted part of the myocardial tissue in order to create a first transient conduction block in the targeted part of the myocardial tissue, then a shock (or other form of cardioversion or defibrillation therapy) can be delivered, and then, if necessary (e.g., if it is detected that the fibrillation has not been terminated), electrical energy can again be delivered to the targeted part of the myocardial tissue in order to create a second transient conduction block in the targeted part of the myocardial tissue. The method is preferably carried out by using an automatic implantable defibrillator.

Method of using electrical energy to produce temporary conduction block for defibrillation and cardioversion

Method of using electrical energy to produce temporary conduction block

An extractable lead and method for chronic blood contacting use. The new lead contains a hydrogel coating having a thickness increase greater than 10% when hydrated. A thick coating is used to provide a shear layer so that the coating tears during extraction, either at the coating/lead interface, between layers of the coating itself, or at the coating/tissue interface. Furthermore, because of the flexibility of such a thick coating, contracture of any fibrous capsule that may have formed is not a problem during extraction, since instead of contracting onto the lead, it contracts onto the flexible coating which can be extracted out of the tight capsule.

Explantable lead

A method for making a co-radial, multi-polar coiled cable lead. The method includes the steps of attaching a first end of a coated cable to a mandrel using a first end fixture. The coated cable comprises one or more cable strands, where each strand is made from one or more filaments. After the first end of the cable is attached to the mandrel, the cable is wound around the mandrel to form a coiled cable. A second end of the coiled cable is then attached to the mandrel using a second end fixture to retain the coiled cable under tension. Second stage processing is then performed on the coiled cable so that the end fixtures may be subsequently removed from the coiled cable without the coiled cable unwinding. After the second stage processing is complete, the coiled cable can be used in the manufacture of an implantable lead.

Co-radial, multi-polar coiled cable lead and method for making the same

A lead system for use with an implantable pacemaker/cardioverter/defibrillator. The lead system includes a securable pace/sense electrode positioned between the distal tip of the lead and the tricuspid valve. The distal tip of the lead is positioned at the apex of the right ventricle and may or may not be secured there by a second fixation means such as a screw tip or tines. The securable pace/sense electrode allows the defibrillation electrode to be accurately positioned by the patient's surgeon and maintained in intimate contact with the septum wall of the patient's heart, thereby reducing defibrillation thresholds; it provides a sense signal from the region of the His bundle or AV node, which can be used with other electrodes to distinguish between various arrhythmias; and it provides more physiologic pacing leading to greater cardiac output.

Lead with septal defibrillation and pacing electrodes

An implantable defibrillator lead having an improved integrated bipolar defibrillation electrode is disclosed. The defibrillation electrode is electrically connected to the lead conductor at the distal end, and has an increased surface area portion at the distal end, for bipolar sensing with a right ventricular pacing electrode.

Lead having an integrated defibrillation/sensing electrode

A body implantable electrode with rate controlled drug delivery is disclosed. A body implantable lead is provided for the delivery of stimulation energy to a desired body site includes a drug dispenser carried by the lead which retains a drug to be dispensed at least adjacent the desired body stimulation site. The drug may be one which is intended to counter thrombus formation, fibrosis, inflammation or arrhythmias, for example. The drug may be in liquid or powder form retained in a reservoir carried by the lead. The reservoir is formed as a pump which controls dispensing of the drug using a fluid drawing agent such as a salt.

Implantable cardiac electrode with rate controlled drug delivery

A lead for use with an implantable cardioverter/defibrillator system is disclosed. In the preferred embodiment, the lead combines a right ventricular endocardial electrode, a superior vena cava electrode and one or more atrial sensing electrodes on a single catheter lead. The distal end of the lead is transvenously implanted, typically through an incision in the cephalic or subclavian vein. The proximal end of the lead is then tunneled below the fascia to the location of the pulse generator. Ventricular sensing and/or pacing electrode(s) may also be included at the distal end of the combined lead to provide ventricular intracardiac electrogram sensing and bradycardia pacing.

Cardiac defibrillation lead having defibrillation and atrial sensing

An improved endocardial lead for electrocardial stimulation includes a sleeve that has a face surface. A conductor fitted into the sleeve, such that a distal end of the conductor passes completely through the sleeve, past the face surface, is electrically and mechanically connected to the face surface of the sleeve by mechanical means, e.g. crimping, and/or through the application of heat, e.g. welding or brazing. An electrode is integrated with the sleeve along an outer sleeve surface. A highly reliable, redundant joint is thereby provided between the sleeve and the conductor that secures the conductor against movement and therefore minimizes stress placed on the conductor, preventing fatigue to the conductor at the joint. A sleeve made in accordance with the present invention provides the narrowest and shortest possible conductor/electrode joint to minimize impact on the patient, while at the same time providing an endocardial lead that has excellent electrical properties, mechanical stability, and ease of manufacture, and that may be made from any desired material to thereby take advantage of new and/or improved materials.

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Los Gatos, CA, United States of America

Drew A Hoffmann