Surgery – Instruments – Electrical application
Reexamination Certificate
2001-10-09
2003-10-21
Peffley, Michael (Department: 3739)
Surgery
Instruments
Electrical application
Reexamination Certificate
active
06635056
ABSTRACT:
BACKGROUND OF THE INVENTION
1. Field of the Invention
The invention relates generally to an electrophysiological (“EP”) apparatus and method for providing energy to biological tissue and, more particularly, to a radio frequency (“RF”) ablation apparatus for controlling the flow of current through biological tissue so that the depth and continuity of ablation lesions may be controlled.
2. Description of the Related Art
The heart beat in a healthy human is controlled by the sinoatrial node (“S-A node”) located in the wall of the right atrium. The S-A node generates electrical signal potentials that are transmitted through pathways of conductive heart tissue in the atrium to the atrioventricular node (“A-V node”) which in turn transmits the electrical signals throughout the ventricle by means of the His and Purkinje conductive tissues. Improper growth, remodeling, or damage to, the conductive tissue in the heart can interfere with the passage of regular electrical signals from the S-A and A-V nodes. Electrical signal irregularities resulting from such interference can disturb the normal rhythm of the heart and cause an abnormal rhythmic condition referred to as “cardiac arrhythmia.”
While there are different treatments for cardiac arrhythmia, including the application of anti-arrhythmia drugs, in many cases ablation of the damaged tissue can restore the correct operation of the heart. Such ablation can be performed percutaneously, a procedure in which a catheter is introduced into the patient through an artery or vein and directed to the atrium or ventricle of the heart to perform single or multiple diagnostic, therapeutic, and/or surgical procedures. In such case, an ablation procedure is used to destroy the tissue causing the arrhythmia in an attempt to remove the electrical signal irregularities or create a conductive tissue block to restore normal heart beat. Successful ablation of the conductive tissue at the arrhythmia initiation site usually terminates the arrhythmia or at least moderates the heart rhythm to acceptable levels. A widely accepted treatment for arrhythmia involves the application of RF energy to the conductive tissue.
In the case of atrial fibrillation (“AF”), a procedure published by Cox et al. and known as the “Maze procedure” involves the formation of continuous atrial incisions to prevent atrial reentry and to allow sinus impulses to activate the entire myocardium. While this procedure has been found to be successful, it involves an intensely invasive approach. It is more desirable to accomplish the same result as the Maze procedure by use of a less invasive approach, such as through the use of an appropriate EP catheter system providing RF ablation therapy. In this therapy, transmural ablation lesions are formed in the atria to prevent atrial reentry and to allow sinus impulses to activate the entire myocardium. In this sense transmural is meant to include lesions that pass through the atrial wall or ventricle wall from the interior surface (endocardium) to the exterior surface (epicardium).
There are two general methods of applying RF energy to cardiac tissue, unipolar and bipolar. In the unipolar method a large surface area electrode; e.g., a backplate, is placed on the chest, back or other external location of the patient to serve as a return. The backplate completes an electrical circuit with one or more electrodes that are introduced into the heart, usually via a catheter, and placed in intimate contact with the aberrant conductive tissue. In the bipolar method, electrodes introduced into the heart have different potentials and complete an electrical circuit between themselves. In both the unipolar and the bipolar methods, the current traveling between the electrodes of the catheter and between the electrodes and the backplate enters the tissue and induces a temperature rise in the tissue resulting in ablation.
During ablation, RF energy is applied to the electrodes to raise the temperature of the target tissue to a lethal, non-viable state. In general, the lethal temperature boundary between viable and non-viable tissue is between approximately 45° C. to 55° C. and more specifically, approximately 48° C. Tissue heated to a temperature above 48° C. for several seconds becomes permanently non-viable and defines the ablation volume. Tissue adjacent to the electrodes delivering RF energy is heated by resistive heating which is conducted radially outward from the electrode-tissue interface. The goal is to elevate the tissue temperature, which is generally at 37° C., fairly uniformly to an ablation temperature above 48° C., while keeping both the temperature at the tissue surface and the temperature of the electrode below 100° C. In clinical applications, the target temperature is set below 70° C. to avoid coagulum formation. Lesion size has been demonstrated to be proportional to temperature.
A basic RF ablation system for forming linear lesions includes a catheter carrying a plurality of electrodes, a backplate and an RF generator adapted to provide RF signals to the electrodes to establish bipolar or unipolar current flow. In one such ablation system, as described in U.S. Pat. No. 6,200,314, RF signals having a constant amplitude and a controllable phase angle are supplied to each electrode. A backplate is maintained at a reference voltage level in relation to the amplitude of the RF signals. The power control system controls the relative phase angles of the RF signals to establish a voltage potential between the electrodes. Current thus flows between the electrodes and between the electrodes and the backplate to produce linear lesions. In order to establish the phase difference between RF signals, the system requires a programmable logic array and a controllable frequency source. The logic array receives phase control signals from a microprocessor and controls the frequency source accordingly.
In other, less complex RF ablation systems, such as those described in U.S. Pat. Nos. 5,810,802 and 6,001,093, a controller electrically couples an indifferent electrode, i.e., backplate, and each of several electrodes to a single RF source through a network of switches. Depending on the setting of its associated switch, an electrode may be set to either an energy emitting polarity, an energy receiving polarity or neither (inactive). Using the switches, the system may be configured so that current flows between the electrodes or between the electrodes and the backplate. The system, however, does not provide for simultaneous unipolar and bipolar operation, thus lesion depth and continuity characteristics may be inadequate. Moreover, since power to all electrodes is supplied by a single source, any type of power control using temperature feedback may prove ineffective. Specifically, any power adjustments resulting from the operating conditions of one electrode, e.g., lower power due to an overheated electrode, necessarily affect the operating conditions of the remaining electrodes. This too can lead to inadequate lesion depth and continuity characteristics.
In other ablation systems having a generator with a limited number of output channels power delivery to some electrodes is not controllable. For example, as shown schematically in
FIG. 13
, for a six channel generator outputting power signals P
1
-P
6
used in conjunction with a twelve band electrode catheter, every other electrode may be individually controlled while the remaining electrodes are maintained at a reference ground. Such a system has inherent problems with respect to temperature feedback power control. For example, if the temperature at electrode E
2
increases above an acceptable threshold level, heat at electrode E
2
is reduced by reducing the current flowing to it from adjacent electrodes E
1
and E
3
. To accomplish this, power to electrode E
1
may be shut off or reduced. If, however, the temperature at electrode E
2
remains above the threshold, then the power to electrode E
3
may have to be shut off or reduced. In this case little if any current flows between electrodes E
1
-E
2
and e
Hall Jeffrey A.
Kadhiresan Veerichetty A.
Kasischke Kathryn
Wood David S.
Cardiac Pacemakers Inc.
Fulwider Patton Lee & Utecht LLP
Peffley Michael
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