Surgery: light – thermal – and electrical application – Light – thermal – and electrical application – Electrical energy applicator
Reexamination Certificate
1998-08-17
2001-04-17
Schaetzle, Kennedy (Department: 3762)
Surgery: light, thermal, and electrical application
Light, thermal, and electrical application
Electrical energy applicator
C607S119000, C607S129000, C607S009000
Reexamination Certificate
active
06219581
ABSTRACT:
BACKGROUND OF THE INVENTION
The invention relates to a pacing electrode arrangement for a pacemaker.
Implanted pacemakers in connection with pacing electrodes, arranged on an intracardiac electrode catheter and positioned on the heart inside wall, have long been used for the treatment of various chronic arrhythmias. They are designed to stimulate the excitable cardiac tissue, thereby compensating defects in the body's own cardiac stimulus generating and conduction system.
The designs for pacemaker and associated electrodes have been improved more and more. Numerous technical solutions for attaching the electrode leads to the heart wall—in the ventricle as well as the atrium—have been discovered and essential practical improvements have actually been made, with the goal of ensuring good, long-term contact between the pacing electrode(s) and the heart tissue, so as to achieve simultaneously an energy-saving and secure stimulation.
Nevertheless, the dislocation of electrodes is still considered one of the most serious complications encountered in pacemaker therapy, which results in a worsening or a loss of contact with the heart to be stimulated on the inside wall and consequently increases the stimulus threshold considerably, thus leading to an increased current consumption of the pacemaker as well as a reduced life expectancy and, in the worst case, to the operational failure of this pacemaker. The technical development of attachment mechanisms (becoming ever more complicated and expensive) therefore still continues.
In addition to high production costs, these traditional electrode arrangements have the disadvantage of requiring a great deal of experience and expenditure for the implantation.
Also known are electrode arrangements, which are not intended for a permanent attachment in the ventricle or the atrium (so-called “floating” arrangements) and are easier to implant, are cheaper and require less knowledge for the implantation. These electrode arrangements are known primarily from implantable defibrillator arrangements, but are also used with pacemakers.
An early arrangement of this type is disclosed in the U.S. Pat. No. 3,915,714.
The European Patent Application EP 0 601 338 A1 describes an electrode system for an implanted defibrillator, comprising at least two intravascular positioned coil electrodes (spiral-type electrodes), held in place without special fasteners, simply because of their size. One of these large-surface defibrillation electrodes can be arranged specifically in the vena cava superior.
The European Patent Application EP-O 677 301-A1 discloses an electrode catheter for use with a defibrillator, which comprises an elongated, cylindrical electrode with a covering that can be moved along the electrode lead, thereby permitting a displacement of the effective electrode region. For example, the catheter can be adjusted such that a first electrode is positioned in the ventricle and that the electrode region, positioned through movement of the covering, is located in the vena cava superior.
In past clinical experiments, pacing electrodes that float in the heart could not ensure with sufficient certainty a reliable stimulation, given the available stimulus pulse voltage and making economic use of the limited battery capacity, to allow for a worthwhile practical operation.
Apart from the aforementioned practical problems, the traditional method of transmitting the stimulation pulses from an implanted pacemaker via electrodes installed in the wall to the excitable muscle tissue of the heart inside wall, in the lower region of the ventricle or the atrium, cannot lead to satisfactory results in a number of frequently occurring arrhythmias, owing to basic physiological considerations. This procedure is designed to stimulate regions in the lower hierarchical planes of the cardiac stimulus generating and conduction system. The procedure can require, for example, a technically involved two-chamber stimulation (in the atrium and ventricle), even for clinical pictures shaped by a sinus node defect, but where the remaining stimulus conduction system is for the most part intact.
The applicant's DE Patent Application 196 09 471.2 relates to an arrangement with preferably floating pacing electrodes of varied polarity, designed to produce a stimulus pulse field that is “focused” onto predetermined heart tissue regions.
SUMMARY OF THE INVENTION
It is the object of the invention to specify an improved electrode arrangement of the aforementioned generic type, which permits a pacemaker operation that is more reliable and better follows the physiological conditions with respect to the stimulus pulse localization, and which is easier to produce and can be positioned easily and safely.
This object is solved with a pacing electrode arrangement for stimulating the heart by means of an implantable pacemaker, comprising a first pacing electrode that is arranged in the vena cava superior and a second pacing electrode, arranged in the atrium or a vessel near the heart other than the vena cava superior, or arranged at a distance to the heart, such that the first and the second pacing electrode essentially enclose between them a predetermined, central region of the cardiac stimulus generating and conduction system, in particular the sinus node.
The invention comprises the idea of realizing an electrode arrangement for conducting the pacemaker stimulation pulses to the highest regions of the cardiac stimulus generating and conduction system—primarily the sinus node—so that a sinus node defect, for example, can be compensated easily by means of a precisely localized electric stimulation at the location of the defect.
In order to realize this idea, the suggested electrode arrangement uses a localization of the stimulus pulse field, generated from a single stimulation voltage, in the sinus node or any other central region of the stimulus generating system. The pacing electrodes used for this are arranged in blood vessels near the heart and optionally in the atrium, directly adjacent to this region (preferably without being secured there).
At least the first pacing electrode in the blood vessel near the heart is preferably arranged on an electrode lead that extends at least into the atrium and is designed to be placed without being secured, in particular to be floating.
In one preferred modification of this embodiment, the second pacing electrode is arranged on the electrode lead at such a distance to the first pacing electrode that it is positioned in the atrium following implantation.
The electrode lead furthermore can comprise one or even several electrode(s) that is (are) distally spaced apart from the first or second pacing electrode in such a way that the electrode(s) is (are) arranged in the ventricle after implantation. This (these) ventricle electrode(s) can function in particular as sensing electrode(s) for special arrhythmias—e.g. a complete AV block—but also as additional pacing electrode(s).
The first pacing electrode—or the electrode lead, if such is provided—in particular can have positioning means to adjust the predetermined position of the first pacing electrode in the vena cava superior and/or the second pacing electrode in the atrium.
To be specific, the first pacing electrode itself can be shaped in such a way that it occupies a predetermined position in the vena cava superior after implantation or, if necessary, also provides the atrium electrode with a predetermined position—insofar as it is mechanically connected to it in the embodiment having a joint electrode lead. This can be achieved, for example with a spiral design or a design containing a spiral segment, for which the spiral diameter approximately corresponds to the vessel inside diameter.
It is useful if the aforementioned positioning means is (are) designed as integral part(s) of the electrode lead and, in an embodiment with multiple adjustment options, comprise means for adjusting a predetermined curvature in the electrode lead after it is implanted.
As alternative or in addition to that, the positioning
Schaldach Max
Thong Tran
Biotronik Mess-und Therapiegeraete GmbH & Co. Ingenieurbuero Ber
Kinberg Robert
Schaetzle Kennedy
Spencer George H.
Venable
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