Surgery: light – thermal – and electrical application – Light – thermal – and electrical application – Electrical energy applicator
Reexamination Certificate
1999-03-26
2001-01-23
Evanisko, George R. (Department: 3762)
Surgery: light, thermal, and electrical application
Light, thermal, and electrical application
Electrical energy applicator
Reexamination Certificate
active
06178356
ABSTRACT:
BACKGROUND OF THE INVENTION
I. Field of the Invention
This invention relates generally to a cardiac pacing lead designed for placement in a left coronary vein, and more particularly to such a lead employing tines for holding the distal end portion of the pacing lead in place.
II. Discussion of the Prior Art
Cardiac pacemakers for treating bradycardia commonly employ pacing leads for connecting an electrical pulse generator to excitable cardiac tissue, usually within the heart's right ventricle. Such leads have one or more electrodes proximate the distal end thereof and also commonly employ tines located just distal of the tip electrode for holding that electrode in contact with endocardial tissue in the right ventricle. The tines engage the trabeculae, resisting movement of the lead tip due to body movement and/or contractions of the heart muscle itself.
More recently, researchers have found that cardiac stimulation can have a beneficial effect in treating patients suffering from congestive heart failure (CHF). By properly controlling the AV interval of the pacemaker, a sick heart may be made to pump more efficiently. Pacing therapy for the treatment of CHF, however, often requires the ability to stimulate the left ventricle, either alone or in conjunction with right ventricular stimulation. Current methods for achieving left ventricular pacing require placement of an epicardial lead, via thoracotomy or a thoracoscopic approach. Because of the usual poor condition of CHF patients, both of these procedures are “high risk” due to the trauma of the surgery itself and the need for general anesthesia. To obviate the need for a thoracotomy, left ventricular access (LVA) leads have been developed that may be introduced through the coronary sinus and then advanced through the coronary veins so that the lead's stimulating tip electrode can be positioned on the surface of the left ventricle near the apex of the heart.
Those skilled in the art knowing the anatomical configuration and dimensions of the coronary veins on the left side of the heart can appreciate that a lead to be routed therethrough must be of a relatively small diameter as compared to a conventional pacing lead adapted for placement in the right ventricle. As such, a means must be provided for at least temporarily anchoring the electrode at a desired selected location until fibrotic attachment and resulting lead stabilization occurs. Heart motion and respiratory motion as well as blood flow or other body movement are typical mechanisms for lead dislodgement. The problem is also deemed to be more acute in CHF patients due to the dilated condition of CHF hearts.
It can be seen, then, that a need exists for a pacing lead that can readily be advanced through the coronary sinus and thence through a coronary vein on the left side of the heart and having an anchoring structure for maintaining the electrode at a desired site notwithstanding heart motion, respiratory motion blood flow and other body movement.
SUMMARY OF THE INVENTION
The present invention comprises an implantable lead for placement in a selected coronary vein. It includes a lead body with at least one electrode carried thereon at a distal portion thereof and an elongated conductor contained within the lead body electrically joining a terminal pin at a proximal end of the lead body to the electrode at its distal end. To temporarily anchor the distal end portion of the lead body within the selected coronary vein until such time that fibrosis can be relied upon for retention, the lead includes a plurality of resilient passive retention structures attached at one end to the lead body and adapted to project at a predetermined acute angle to an axis of the lead body when the resilient retention structures are unconstrained. The retention structures are designed to conform to the anatomy and provide retention by producing a slight amount of friction against the vessel wall. The retention structures can be constructed of a resorbable material that can be either molded as part of the lead or attached to the lead body by a collar or similar technique. The structure can be temporarily adhered to the lead body in part or in total. Partial adhesion allows parts of the retention structure to be fixed to lead body for a short period of time to, for example, provide a low profile during lead insertion. The biodegradable adhesive is used to temporarily constrain the retention structure to lie against the lead body until released by the action of body fluids on the biodegradable adhesive following placement of the electrode at the desired site. Total adhesion with a resorbable adhesive allows the lead body to be separated from the retention structure if an attempt is made at a latter date to extract the lead. Alternatively, the retention structure itself can be designed to break away during an extraction procedure.
The resorbable material can be a material such as polydioxanone, polyglactin or poliglecaprone.
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Chastain Stuart A.
Liu Lili
Tockman Bruce A.
Westlund Randy W.
Cardiac Pacemakers Inc.
Evanisko George R.
Nikolai Mersereau & Dietz, P.A.
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