Surgery – Diagnostic testing – Structure of body-contacting electrode or electrode inserted...
Reexamination Certificate
2001-01-16
2003-03-11
Cohen, Lee (Department: 3739)
Surgery
Diagnostic testing
Structure of body-contacting electrode or electrode inserted...
C600S374000, C607S116000, C607S119000, C607S122000, C607S123000
Reexamination Certificate
active
06532378
ABSTRACT:
BACKGROUND OF THE INVENTION
The present invention is directed toward a pulmonary artery catheter and more particularly, toward a left pulmonary artery catheter which records activity in the left atrium.
A catheter placed in the pulmonary artery for measuring cardiac pressure, and thermal dilution (for calculating cardiac output) is well known in the art and has been used commercially for more than the last twenty years. More recently, oxygen sensors have been used on the catheter to measure oxygen content of the blood, and even more recently, defibrillation electrodes have been added to a pulmonary artery catheter to aid in cardioversion in patients with atrial or ventricular fibrillation or tachycardia, who are otherwise being monitored by a pulmonary artery catheter.
An atrial cardioversion catheter as disclosed, for example, in U.S. Pat. No. 5,571,159 to Alt contains electrodes in the right atrium for pacing the heart, as well as for recording a ventricular spike on which to trigger the defibrillating shock. A ventricular defibrillation catheter in the pulmonary artery has been described in U.S. Pat. No. 5,403,351 to Saksena.
Pulmonary artery catheters known in the art and which are used today do not embody a plurality of electrodes purposefully placed which could assist in the diagnosis of electrophysiological disorders of the heart, such as the disease of atrial fibrillation.
Atrial fibrillation is a disorganized electrical disorder of the upper chambers of the heart. It was once thought to be a disease of aging, relatively benign, and untreatable. However, the number of people exhibiting this disease is quite large, and the effects of the disease are quite profound. Atrial fibrillation presently affects over 2 million Americans, and this number is increasing with the aging of the population. It is the leading cause of stroke in the U.S.; doubles the mortality from heart disease; and leads to reduced heart function, and hence, a diminished lifestyle and serious morbidity and mortality. Thus, over the last several years, atrial fibrillation is a heart condition which has moved to the forefront in terms of both research, and clinically applied therapies. Research in the area of recording and defining electrophysiological properties and anatomic locations of the tissue generating this atrial arrhythmia has been shown in publications by co-inventor Saksena. (See Am. J. Cardiology 1999, 83:187-193.)
Basic electrophysiological (EP) recording of the heart consists of “mapping” the timing of the activation of the various cells as very low voltage electrical activity conducts through the heart. To do this, various catheters with a plurality of recording electrodes are placed at various locations within the heart. In a basic study, catheters are placed in the high right atrium, the area around the atrial-ventricle node, and the apex of the right ventricle. These placements allow the physician to measure the conduction training from the top of the heart to the bottom, primarily in the right atrium and right ventricle. To measure conduction “cross-ways”, or laterally across the heart, a catheter, generally with ten electrodes, is placed in the coronary sinus, a vessel which goes around the back side of the upper heart.
Recent research has shown that left atrial electrical activity is an important factor in the diagnosis of the origin of atrial fibrillation. Regional atrial mapping of different right and left atrial regions or very “focal” mapping of left sided electrical patterns from inside the atrium is helpful. However, putting a catheter inside the left side of the heart is not easy, and is associated with risk of death or clot formation resulting in stroke or paralysis in patients with or without atrial fibrillation. Thus, keeping catheters out of the cavity of the left atrium is highly desirable and preferred for simplicity of technique. The current methods of puncturing a hole in the septum between atria and inserting a recording catheter inside the left atrium is not routine, is risky, and is fairly undesirable.
SUMMARY OF THE INVENTION
The present invention is designed to overcome the deficiencies of the prior art discussed above. It is an object of the present invention to provide a catheter which has a number of electrodes placed on a pulmonary artery catheter used for the primary purpose of recording atrial activity, and, more specifically, activity of the left atrium, but can also be used for recording activity in the right atrium.
It is another object of the present invention to provide a catheter for atrial mapping and a method of recording regional left atrial activation patterns for spontaneous and induced electrical activity in the heart.
It is a further object of the present invention to provide a catheter for defibrillating or cardioverting the heart.
In accordance with the illustrative embodiments demonstrating features and advantages of the present invention, there is provided a catheter for indirect left atrial mapping from the left pulmonary artery and for mapping the superior interatrial septum, the superior left atrium, and the lateral left atrium. In addition, these recordings can detect early electrical activity in the right and left superior pulmonary veins. Recordings can also be obtained from the right pulmonary artery, the right interatrial septum, and the superior right atrium. The catheter essentially includes an elongated flexible member with a distal end and a proximal end. Located at the distal end is a balloon and an array of mapping electrodes. Located at the proximal end is a manifold to which various ports are attached. The ports may be used, for example, to secure connectors for the electrodes.
In a second embodiment of the present invention the catheter has the same structure as the catheter in the first embodiment but differs in that interspersed within the array of mapping electrodes are defibrillation electrodes. Located proximally of the array of mapping electrodes is an array of defibrillation electrodes and two sense electrodes.
In a third embodiment of the present invention the catheter has the same structure as the catheter in the first embodiment but differs in that an array of defibrillation electrodes are located between the balloon and the array of mapping electrodes. Located proximally of the array of mapping electrodes is an array of defibrillation electrodes and two sense electrodes.
REFERENCES:
patent: 3995623 (1976-12-01), Blake et al.
patent: 4721115 (1988-01-01), Owens
patent: 4951682 (1990-08-01), Petre
patent: 5403351 (1995-04-01), Saksena
patent: 5443074 (1995-08-01), Roelandt et al.
patent: 5571159 (1996-11-01), Alt
patent: 5653734 (1997-08-01), Alt
patent: 5697965 (1997-12-01), Griffin, III
patent: 6141576 (2000-10-01), Littmann et al.
Saksena et al., “Electrophysiology and Endocardial Mapping of Induced Atrial Fibrillation in Patients with Spontaneous Atrial Fibrillation,” The American Journal of Cardiology, vol. 83, pp. 187-193, Jan. 15, 1999.
Griffin, III Joseph C.
Saksena Sanjeev
Cohen Lee
EP MedSystems, Inc.
Lehrer Norman E.
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