Ventritex, Inc.

Pacesetter, Inc.

M Elizabeth Bush

Benjamin D Pless

Drew A Hoffmann

Peter A Altman

Craig E Mar

Eric Steven Fain

Paul M Paspa

Dean F Carson

Steven M Mitchell

M Dean Matthews

Michael B Sweeney

D Scott Romkee

Pedro G Medrano

William D Miner, Ii

Stanley D McEtchin

Frank M Fischer

Intracardiac lead for compliant fixation of a distal end of the lead to cardiac tissue. A fixation helix is disposed at the distal end of the lead. The fixation helix has a first end rigidly attached to the compliant fixation device and a second end that is sharpened to facilitate insertion of the fixation helix into cardiac tissue. The fixation helix can be designed to provide for either electrically active or inactive fixation. Once the lead is implanted in the cardiac tissue, the compliant fixation device, connecting the lead with the fixation helix, reduces the amount of lead movement that is transferred to the patient's tissue at the site of implantation of the fixation helix and reduces those forces from lead movement that could cause dislodgment of the fixation helix. The compliant fixation device thereby decreases the amount of irritation to the cardiac tissue, lessens the possibility of fibrous tissue growth around the area of the fixation helix, decreases the chance of dislodgment of the fixation helix, and reduces the possibility of perforation of the cardiac wall or tamponade of the pericardial sac.

Intracardiac lead having a compliant fixation device

A continuous sheath of open-celled porous plastic, preferably ePTFE, is used on the outside of an implantable lead, extending along the lead body and the electrodes, in such a way that the lead is isodiametric along its length, and is very strong in tension as is required for lead removal. Because the plastic is open-celled, when the pores are filled with saline, the lead can deliver defibrillation energy through the pores in the plastic. Pore size is chosen to discourage tissue ingrowth while allowing for defibrillation energy delivery through it.

Medical lead and method of making and using

A method for defibrillating a patient's heart with an implantable defibrillator having defibrillation synchronized to the fibrillation waveform is disclosed. The defibrillator is used to detect fibrillation in a patient's heart, monitor at least two far-field fibrillation voltages across at least three spaced-apart electrodes while the high voltage capacitors are charging, then deliver a high energy shock during a period of ventricular fibrillation when the absolute values of the peak and trough voltages exceed a threshold based on a desired percentage greater than a running average of the absolute values of the peaks and troughs of the fibrillation voltages monitored during and after capacitor charging. The shock is then delivered synchronous with the next significant cardiac complex. The defibrillator also includes a safety timer so that if the threshold is not reached within a specified safe time limit, the high energy shock will be delivered without further delay.

Method and apparatus for delivering defibrillation shocks with improved

An implantable lead for use with an implantable pacemaker/cardioverter/defibrillator. Since irradiation from a radioisotope source is capable of inhibiting the growth of hyperproliferating cells as compared with normal cells, a radioisotope material which is incorporated into the lead can be used to decrease the rate of fibrotic growth. The radioisotope may be located inside the lead, alloyed into the metal from which the lead electrode or conductor is made, molded into rubber portions of the lead, or coated onto the conductor or electrode's surface. Beta emitting radioisotopes would be best suited as a radioactive material because of their comparatively short range of action within human tissue.

Implantable lead modified to reduce tissue ingrowth

An implantable suture sleeve for use with an implantable lead with a pacemaker/cardioverter/defibrillator lead. Since irradiation from a radioisotope source is capable of inhibiting the growth of hyperproliferating cells as compared with normal cells, a radioisotope material which is incorporated into the lead can be used to decrease the rate of fibrotic growth. The radioisotope may be located inside the suture sleeve, alloyed into or coated onto the metal from which a wire or coil within the suture sleeve is made, or molded into the rubber of the suture sleeve. Beta emitting radioisotopes having a half-life between 1 and 100 days would be best suited as the radioactive material due to their comparatively short range of action within human tissue, and because of their comparatively short half-life.

Implantable suture sleeve modified to reduce tissue ingrowth

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

The present invention is directed toward providing a composite lead body design for pacing and defibrillation leads. This lead body design improves the lead crush resistance in the lead segment that is implanted in the patient's clavicular region, while maintaining good fatigue resistance in the lead segment implanted in the heart. The clavicular segment has a generally flat profile. By flattening the clavicular segment proximal to the venous entry site, the lead will have a lower profile. Also, by substantially co-aligning the conductors within the clavicular segment, the crush resistance of the lead is significantly improved.

Crush resistant implantable lead

A defibrillator having a housing for enclosing and containing defibrillation pulse generator circuitry, particularly adapted to allow for ease of manufacture and use. At least one surface of the housing is electrically conductive and may be connected to the defibrillation pulse generator circuitry for delivering defibrillating energy to the heart. The defibrillator is provided with two case-activating setscrew blocks isolated from two contacts. By tightening the first setscrew onto its contact, the can is activated and is positive for defibrillation. By tightening the second setscrew instead, the can is activated and is negative for defibrillation. Tightening neither setscrew maintains the inactive status of the can. By using this system, various electrode configurations can be used as required to provide the optimum system for a given patient. The defibrillator generator housing is preferably implanted in the left pectoral region proximate the heart with the conductive surface facing the heart. Other implantable electrodes are discharged against the defibrillator generator housing electrode.

Cardiac defibrillator having selectable polarity case

A defibrillation insulating device prevents current from directly shunting through the blood pool from the right ventricular defibrillation electrode to a superior vena cava electrode and vice versa. This forces current to flow through the heart muscle, thus increasing the current density throughout the heart, to depolarize the majority of the cardiac tissue with a minimum of energy.

Nonshunting endocardial defibrillation lead

A pulse generator having a housing for enclosing and containing pulse generator defibrillation circuitry, particularly adapted to allow for ease of manufacture and use, is disclosed. At least one surface of the housing is electrically conductive and connected to the pulse generator circuitry for delivering defibrillating energy to the heart. The defibrillator is provided with a case activating lead connector cavity having two connector blocks. By plugging in a lead with a pin long enough to contact the only first connector block, the lead becomes active. Using a plug with a longer pin to contact both blocks activates the can. To use neither a lead in the case activating port, nor an active can, a plug with a short or nonconductive pin may be used to plug the cavity without activating the can. By using this system, various electrode configurations can be used as required to provide the optimum system for a given patient. The pulse generator housing is preferably implanted in the left pectoral region proximate the heart with the conductive surface facing the heart. Other implantable electrodes are discharged against the pulse generator housing electrode.

Pulse generator with case that can be active or inactive

An implantable defibrillator lead comprises a flexible core onto which is wound helically wound coils to form an electrode. These electrode coils are partially encapsulated by a flexible matrix which holds them in their wrapped position around the core. Due to its coiled coil structure, this electrode provides improved flexibility, and can be used endocardially, intravascularly, epicardially, or subcutaneously. The electrode may function alternately as a defibrillation electrode and as a sensing electrode in a lead with a separate pacing electrode.

Method of making flexible defibrillation electrode

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.

Growing community of inventors

Fremont, CA, United States of America

M Elizabeth Bush