Difibrillation electrodes and implantation
First Claim
1. A method for surgical implantation of an electrode in a patient for use in defibrillating the patient'"'"'s heart, which comprises:
- selecting an electrical lead having at its distal end a defibrillation electrode composed of a multiplicity of fine, elongate, juxtaposed, individual, flexible conductive fibers each having an uncoated, relatively smooth surface layer of carbon derivative of substantially uniform thickness along substantially an entire length of each of said fibers to provide an overall electrode effective electrical surface area which is a cumulative effect of each surface area of the individual fibers and considerably greater than the geometric surface area of the electrode, for implantation in the patient'"'"'s body;
puncturing a preselected site in the chest/abdominal wall of the patient for insertion of the flexible fiber electrode and lead therein; and
inserting the flexible fiber electrode and lead through the puncture site, and maneuvering the inserted fiber electrode into position within the patient'"'"'s body to encompass a portion of the ventricular mass of the heart for electrical stimulation of the ventricles when the electrode is energized, while viewing the maneuvering externally on a visual internal body scanner.
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Accused Products
Abstract
An electrical lead has a cardioverting/defibrillating electrode composed of a multiplicity of tiny flexible elongate metallic fibers, for implantation in a patient. One embodiment of the lead is implanted by puncturing the chest/abdominal wall of the patient and inserting the lead, fiber electrode first, into the body through the puncture site followed by maneuvering the lead by endoscopy to position the electrode adjacent the epicardium of the heart for electrical interaction with the ventricles. The fibers may be interwoven to form a thin tube prestressed to assume a flat spiral shape to permit it to be straightened with a stiffening wire for maneuvering to return to its flat spiral shape after proper positioning and removal of the wire. In other embodiments, the lead has multiple conductors electrically connected to respective electrodes arranged on the lead for positioning transvenously relative to selected regions of the heart. For ventricular fibrillation, the arrangement is such that one electrode is positioned in the right ventricle and another in either the subclavian vein or pulmonary artery at the left side of the heart when the lead is fully implanted. For atrial fibrillation, the arrangement is such that one electrode is positioned in the right ventricle and another in the pulmonary artery adjacent the left atrium when the lead is fully implanted. The fibers of the electrode have a surface layer composed of electrically conductive carbon which may include a substance to inhibit thrombosis, inflammation and/or coagulation at the exposed surface of the electrode when the lead is implanted in the patient'"'"'s body.
221 Citations
31 Claims
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1. A method for surgical implantation of an electrode in a patient for use in defibrillating the patient'"'"'s heart, which comprises:
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selecting an electrical lead having at its distal end a defibrillation electrode composed of a multiplicity of fine, elongate, juxtaposed, individual, flexible conductive fibers each having an uncoated, relatively smooth surface layer of carbon derivative of substantially uniform thickness along substantially an entire length of each of said fibers to provide an overall electrode effective electrical surface area which is a cumulative effect of each surface area of the individual fibers and considerably greater than the geometric surface area of the electrode, for implantation in the patient'"'"'s body; puncturing a preselected site in the chest/abdominal wall of the patient for insertion of the flexible fiber electrode and lead therein; and inserting the flexible fiber electrode and lead through the puncture site, and maneuvering the inserted fiber electrode into position within the patient'"'"'s body to encompass a portion of the ventricular mass of the heart for electrical stimulation of the ventricles when the electrode is energized, while viewing the maneuvering externally on a visual internal body scanner. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9)
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10. A method for defibrillating the heart of a patient, comprising the steps of:
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implanting in the patient an electrical lead having a proximal end and a distal end, and having at its distal end a flexible electrode composed of conductive fibers each having an uncoated carbon surface, and in which the carbon surface of substantially each of the fibers is impregnated to bond with molecules of a substance selected to inhibit growth of fibrotic connective tissue at each impregnated surface of the electrode exposed to blood and tissue when implanted in the patient'"'"'s body, positioning the implanted electrode relative to the patient'"'"'s heart for use in defibrillating the heart when the electrode is energized with a defibrillating electrical waveform, and electrically connecting the proximal end of the lead to a source of said defibrillating electrical waveform. - View Dependent Claims (11, 12, 13, 14, 15)
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16. A lead assembly for use in defibrillating the heart of a patient in which the lead assembly is to be implanted, comprising:
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an electrically conductive lead wire having a proximal end and a distal end, a flexible stimulating electrode composed of a multiplicity of fine, elongate, electrically conductive fibers each having an uncoated carbon surface of substantially uniform thickness over substantially its entire length, the electrode being electrically connected to the distal end of the lead wire for implantation in the patient'"'"'s body and adapted, when the electrode is implanted at a selected site in the patient'"'"'s body and the proximal end of the lead wire is connected to a defibrillator, to accept electrical energization of sufficient magnitude to defibrillate the heart, and a substance incorporated into the carbon surface of the fibers of the electrode in a molecular bond with and not a coating of the carbon surface to impede the growth of fibrotic connective tissue at a surface of the electrode exposed to blood and tissue when implanted in the patient'"'"'s body. - View Dependent Claims (17, 18, 19)
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20. An implantable lead for use in cardioversion or defibrillation of a human heart, comprising:
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an elongate electrical conductor, and an electrode electrically connected to the conductor, the electrode including; a multiplicity of juxtaposed, fine, uninsulated, elongate, individual, flexible metallic fibers each of a diameter considerably smaller than its length, and of sufficient number to provide an overall effective electrically conductive surface area formed by individual surfaces of the multiplicity of fibers considerably greater than the outer geometrical surface area encompassing the electrode and capable of being non-destructively energized by electrical waveforms of magnitude and other characteristics suitable to defibrillate a human heart, and maintaining means for holding the multiplicity of fibers in a flexible configuration having a shape and size selected according to an intended location of the electrode when the lead is implanted for use in cardioversion or defibrillation of the heart. - View Dependent Claims (21, 22, 24, 25, 26)
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27. An implantable lead for use in cardioversion or defibrillation of a human heart, comprising:
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an elongate electrical conductor, and an electrode electrically connected to the conductor, the electrode including; a multiplicity of individual, flexible metallic fibers each of a diameter considerably smaller than its length, each fiber having a surface layer composed of a substantially isotropic electrically conductive carbon derivative, to provide an overall effective electrically conductive surface area formed by the individual surfaces of the multiplicity of fibers considerably greater than the outer geometrical surface area encompassing the electrode, and maintaining means for holding the multiplicity of fibers in a flexible configuration having a shape and size selected according to an intended location of the electrode when the lead is implanted for use in cardioversion or defibrillation of the heart. - View Dependent Claims (23, 28, 29, 30)
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31. The implantable lead of claim 301, wherein:
said fibers are arranged in multi-strand bundles, each strand being composed of said alloy and having a diameter in a range from about 10 to about 30 microns, and a plurality of said bundles are braided to form said electrode.
Specification