Intermedics Inc.

Sulzer Intermedics, Inc.

Paul R Spehr

James E Machek

Edward A Schroeppel

Elmar R Fischer, Sr

Richard E Phillips, Jr

Stephen L Goldman

Yves Verboven

Mark M Frankovich

Benjamin D Pless

James E Sluetz

Mark A White

David R Erickson

Arthur J Foster

John A Schmidt

A lead assembly adapted for endocardial fixation to a human heart is provided. The lead assembly includes a lead body that has a proximal end provided with a connector for electrical connection to a cardiac stimulator. The cardiac stimulator may be a pacemaker, a cardioverter/defibrillator, or a sensing instrument. The distal end of the lead body is connected to a tubular electrode housing. The lead body consists of one or more noncoiled conductor cables surrounded by a coextensive insulating sleeve. Each conductor cable consists of a conducting element covered by a coextensive insulating sleeve. The conducting element may be a single filament wire or a plurality of individual conductor wires. In contrast to conventional leads, the lead body of the present invention does not require coiled conductor wires. Lead body diameters of 1.04 mm or smaller are possible.

Cardiac lead with minimized inside diameter of sleeve

An electrode for a cardiac lead and method of making the same are provided. The electrode includes an electrode member and a coating applied to the electrode member. A method of fabricating a high impedance cardiac lead electrode is provided. The method includes the steps of providing an electrode member and coating a first portion of the electrode member with an electrically insulating material and placing a tubular mask or shield over the electrode. Portions of the insulating material are removed to expose selected areas of the electrode. The second or exposed portion enhances the impedance of the electrode, resulting in power savings and extended life spans for implantable stimulation and sensing devices. Exemplary materials for the coating includes diamond-like carbon and sapphire.

Method for making cardiac leads with zone insulated electrodes

An implantable defibrillation lead with steerable characteristics, allowing the lead to be more easily placed within the coronary sinus. The lead comprises an elongated lead body having a proximal end and a distal end. Adjacent the distal end, there is an electrode, preferably a coiled defibrillation electrode placed on the exterior of the elongated lead body. The distal end of the lead body has a permanent set or bend. A torque tube, extending through a lumen in the lead body from the proximal end of the lead to an anchor block adjacent the distal end of the lead, can be rotated by a physician to orient the bend in the lead. A cable passes through the torque tube from the proximal end of the lead through the anchor block to the distal end of the lead. This cable is affixed to a wall of the lumen, preferably in the direction of the bend. Pulling on the cable temporarily changes the bend in the distal end of the lead.

Steerable coronary sinus defibrillation lead

An electrode for a cardiac lead and method of making the same are provided. The electrode includes an electrode member and a coating applied to the electrode member. The coating is composed of an electrically insulating material and covers a first portion of the exterior of the electrode member while leaving a preselected second portion thereof exposed. The second or exposed portion enhances the impedance of the electrode, resulting in power savings and extended life spans for implantable stimulation and sensing devices. Exemplary materials for the coating includes diamond-like carbon and sapphire.

Cardiac lead with zone insulated electrodes

A cardiac stimulator lead is provided that includes a lead body that has a connector for coupling to a cardiac stimulator and a flexible insulating sleeve that has a first outer diameter. An electrode is coupled to the insulating sleeve. A conductor wire is coupled between the connector and the electrode. An annular seat is coupled to the lead body and is composed of a thermally-sensitive shape-memory polymeric material whereby the seal is deformable in situ from a temporary shape with a second outer diameter to a permanent shape with a third outer diameter that is greater than the second outer diameter. A shape-memory polymeric suture sleeve may be included that can tightly clamp the lead sleeve in situ.

Cardiac lead with shape-memory structure

A cardiac lead is provided that is capable of deforming in situ to accommodate difficult myocardial structures. The lead includes a connector for coupling to a cardiac stimulator and a flexible tubular sleeve coupled to the connector. The sleeve is composed of a thermally-sensitive shape-memory polymeric material and is deformable in situ into a permanent shape. An electrode is coupled to the sleeve and a conductor wire is coupled to the connector and to the first electrode.

Implantable cardiac lead with multiple shape memory polymer structures

Various endocardial lead assemblies are disclosed that may be particularly useful for placement within the coronary sinus. The lead assemblies may have open ends or closed ends. Lead assemblies having closed ends may be implanted using conventional implantation procedures. Lead assemblies have open ends may be implanted by first locating a stylet within the patient's body and, then, inserting the lead into the patient's body along the stylet. Each disclosed lead assembly uses one or more stents which expand to contact the inner surface of a body vessel once the lead has been properly positioned. Thus, the stents fix the lead at the desired location. Additionally, the stents may be used as electrodes for pacing and/or sensing.

Implantable endocardial lead assembly having a stent

A cardiac lead is provided that includes a connector for connecting to a cardiac stimulator and a flexible sleeve coupled to the connector. The sleeve has a first segment, a second segment and a jacket coupling the first segment and the second segment. The jacket is composed of a shape-memory polymeric material which deforms diametrically in situ to selectively disconnect the first segment from the second segment. An electrode is coupled to the sleeve and a conductor is disposed in the sleeve and coupled to the connector and the electrode for conveying electrical signals. The breakaway function of the jacket allows removal of all but a small portion of the lead without dissection of fibrous tissue.

Breakaway structure for body implantable medical device

A lead assembly adapted for endocardial fixation to a human heart is provided. The lead assembly includes a lead body that has a proximal end provided with a connector for electrical connection to a cardiac stimulator. The cardiac stimulator may be a pacemaker, a cardioverter/defibrillator, or a sensing instrument. The distal end of the lead body is connected to a tubular electrode housing. The lead body consists of a noncoiled conductor cable surrounded by a coextensive insulating sleeve. In contrast to conventional leads, the lead body of the present invention does not require coiled conductor wires or an internal lumen. Manipulation of the lead body is via an external guide tube. Lead body diameters of 0.25 mm or smaller are possible.

Small cable endocardial lead with exposed guide tube

Cardiac pacemaker cable lead

Various endocardial lead assemblies are disclosed that may be particularly useful for placement within the coronary sinus. One lead assembly includes an open-ended electrode that may be implanted in a patient by passing it along a previously implanted stylet. Another disclosed embodiment combines an open-ended electrode with one or more flow passages that improve blood flow through the body vessel in the area of the implanted electrode. Yet another disclosed embodiment uses an electrode that has flow passages but no opening. This electrode provides improved blood flow in the area of the electrode but may be implanted using conventional methods.

Endocardial lead assembly

A lead assembly includes a proximal end that has a connector for electrical connection to a cardiac stimulator, such as a pacemaker, a cardioverter/defibrillator, or a sensing instrument. The lead assembly includes an elongated proximal tubular portion that extends distally from the connector. The distal end of the proximal tubular portion is provided with a branch assembly that is joined distally to two elongated distal lead branches. The distal branches are provided, respectively, with lead tips that each function as electrodes for transferring electrical signals from and/or to the myocardium. The branch assembly includes structure for enabling a surgeon to selectively manipulate the distal branches using a single stylet passed through a single lumen in the proximal tubular portion.

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Lake Jackson, TX, United States of America

Paul R Spehr