Surgery – Diagnostic testing – Cardiovascular
Reexamination Certificate
2000-10-13
2003-06-10
Dolinar, Andrew M. (Department: 3747)
Surgery
Diagnostic testing
Cardiovascular
C604S103010
Reexamination Certificate
active
06577895
ABSTRACT:
FIELD OF THE INVENTIONS
The inventions described below relate to the field of diagnostic medical devices. Specifically the inventions relate to a device and method for diagnosing whether ablation of a portion of the pulmonary vein will eliminate atrial fibrillation originating in the pulmonary vein.
BACKGROUND OF THE INVENTIONS
Atrial fibrillation (AF) is a form of heart disease that afflicts millions of people. It is a condition in which the normal contraction of the heart is interrupted, primarily by abnormal and uncontrolled action of the atria of the heart. The heart has four chambers: the right atrium, right ventricle, the left ventricle, the left atrium. The right atrium pumps de-oxygenated blood from the vena cava to the right ventricle, which pumps the blood to the lungs, necessary for return flow of de-oxygenated blood from the body. The right atrium contracts to squeeze blood into the right ventricle, and expands to suck blood from the vena cava. The left atrium pumps oxygenated blood from the pulmonary veins (returning from the lungs), necessary for flow of oxygenated blood from the lungs. The left atrium contracts to squeeze blood into the left ventricle, which then pumps the blood into the aorta and thence to the entire body, and expands to suck blood from the pulmonary veins. The contractions of the atria normally occur in a controlled sequence with the contractions of the other chambers of the heart. When the left atrium or the right atrium fails to contract, contracts out of sequence, or contracts ineffectively, blood flow within the heart is disrupted. The disruption of the normal rhythm of contraction is referred to as an arrhythmia. The arrhythmia, known as atrial fibrillation, can cause weakness of the heart due to reduced ventricular filling and reduced cardiac output. Stroke due to clot formation in a poorly contracting atria (which may lead to brain damage and death), and even other life threatening ventricular arrhythmias can also occur.
There is a broad spectrum of situations which fall under the broad heading of AF. For example, in older patients where there is substantial heterogeneity in the conduction within the atrial tissue, the patient is said to have the tissue substrate for AF such that any trigger will result in maintaining AF. In younger patients, the tissue may have more homogeneous conduction and be less likely to have sustained AF. In the younger patient it may be the often reoccurrence of a premature depolarizing tissue which acts as a trigger that causes the clinical manifestation of problematic episodes of AF. Clearly, there is a continuous spectrum of degrees of triggered AF and conduction heterogeneity which acts as a substrate for this arrhythmia, and it is appropriate that a number of medical therapies are being developed to treat and diagnose this disease.
Atrial fibrillation can be treated by atrial ablation. There are two general approaches for providing ablative therapy to the heart for the treatment of atrial fibrillation. These shall be called the long linear ablative lesion approach, and the focal ablation approach.
In the long linear lesion approach, the heart tissue is killed along a linear pathway. The cardiac electrophysiologist does this to segment the heart into regions which are too small to sustain atrial fibrillation. Such an approach is very similar to performing the Maze procedure using radiofrequency, microwave, and ultrasound ablative energy sources on the end of catheters. In the Maze procedure, a number of incisions are made with a scalpel in an attempt to terminate inappropriate accessory pathways.
In the focal ablation approach, the heart tissue is killed at a single site. The cardiac electrophysiologist attempts to ablate the region of the heart that prematurely depolarizes, and which has been described as acting as a trigger for the initiation of atrial fibrillation. Recently, ablation of the junction of the pulmonary veins and the left atrium has been performed. Such ablations remove the possibility of triggers for AF initiating within the pulmonary veins, or at the region near the junction of the veins with the left atrial tissue. Such ablations may also remove disturbances introduced into the conduction pathway by the heterogeneity of the junction region anatomy.
SUMMARY
Focal ablation of the region within or adjacent to the pulmonary vein to terminate atrial fibrillation with different energy transfer techniques such as RF ablation, laser ablation, ultrasound ablation, cryoablation, and microwave ablation causes damage to the tissue which may affect the viability of the tissue. While the ablation reliably eliminates the source of atrial fibrillation, the concomitant damage to the pulmonary vein may give rise to side effects such as stenosis of the treated pulmonary vein. Confirming that ablation of a target pulmonary vein would produce the desired result of stopping the atrial fibrillation would therefore be a highly beneficial procedure. The devices and methods describe below allow testing of the pulmonary veins to determine whether or not ablation would be effective in terminating atrial fibrillation. The devices and methods include a catheter having an expandable balloon attached to the distal end of the catheter. The balloon has pores on the distal end of the balloon for administering a fluid into the target pulmonary vein. The fluid inhibits the electrical impulses in the target pulmonary vein. Once the electrical impulses of the target pulmonary vein have been inhibited then it can be determined whether or not the atrial fibrillation has ceased occurring. If the atrial fibrillation has been eliminated, then ablation or other therapy is appropriate. Thus, the devices and methods described herein limit unnecessary treatment of a pulmonary vein.
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BioCardia, Inc.
Crockett K. David
Crockett & Crockett
Dolinar Andrew M.
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