Surgery: light – thermal – and electrical application – Light – thermal – and electrical application – Electrical energy applicator
Reexamination Certificate
1999-11-30
2001-03-13
Evanisko, George R. (Department: 3737)
Surgery: light, thermal, and electrical application
Light, thermal, and electrical application
Electrical energy applicator
C607S125000, C607S126000
Reexamination Certificate
active
06201994
ABSTRACT:
BACKGROUND OF THE INVENTION
The present invention relates generally to implantable electrical leads and more particularly implantable single pass cardiac pacing leads.
It has long been a goal to provide a single cardiac lead which will reliably sense and pace both the atrium and ventricles of a human heart. The simplest approach to providing such lead is simply to add one or more electrodes to the body of a ventricular pacing lead spaced from the distal end of the lead a distance appropriate to locate the added electrodes in the atrium. Such leads are disclosed in U.S. Pat. No. 3,903,897 issued to Woollons and U.S. Pat. No. 3,825,015 issued to Berkovits. While such leads have been proven to sense reliably in the atrium and are currently used in conjunction with VDD pacemakers, their ability to reliably pace the atria is less than might be desired.
Over the years, numerous designs have been proposed and tested which attempted to provide for reliable positioning of the atrial electrodes on a single pass lead adjacent the tissue of the atria in order to allow for reliable cardiac pacing. These approaches have included the provision of active fixation electrodes for use in the atrium as disclosed in U.S. Pat. No. 4,402,329 issued to Williams and U.S. Pat. No. 4,497,326 issued to Curry and the provision of expandable or extendable arms as in U.S. Pat. No. 3,865,118 issued to Bures and U.S. Pat. No. 4,386,615 issued to Sowton.
One of the most common proposals for locating an electrode in the atrium in the context of a single pass lead is the provision of pre-formed loops, coils, or other laterally extending curves formed in the lead body to assist in maintaining an electrode located thereon adjacent the tissue of the atrium. Such leads include U.S. Pat. No. 5,628,778 issued to Kruse et al., U.S. Pat. No. 4,401,126 issued to Reenstierna and U.S. Pat. No. 4,627,439 issued to Harris.
It has also been suggested that an atrial electrode may be stabilized by provision of pre-formed curves, loops or coils proximal to the electrode, intended to be located in the superior vena cava. Such leads are disclosed in U.S. Pat. No. 4,394,866 issued to Hughes and U.S. Pat. No. 5,628,779 issued to Bornzin et al. and in the article “Toward Optimizing a Preshaped Catheter and System Parameters to Achieve Single Lead DDD Pacing”, by Brownlee et al., published in
Pace,
May 1997, Part I, pp. 1354-1358.
SUMMARY OF THE INVENTION
The present invention is directed toward the provision of a workable single pass lead which is easy to implant, and provides an opportunity for reliably pacing the right atrium in conjunction with providing stimulus or cardioversion/defibrillation pulses to a second location in or near the heart and toward a method of using the lead.
The present invention accomplishes these goals by means of a lead configured to allow simultaneous location of a pacing and/or defibrillation electrode at the right ventricular apex or elsewhere and location of atrial stimulation electrodes in the superior vena cava. In this context, as reflected in the article “Penetration of Atrial Myocardium into the Vena Cavae”, by Schwartzman et al., Published in
Pace,
April 1997, Part II, p. 1202 it should be understood that stimulable tissue from the atrium may extend up to 3 centimeters into this superior vena cava. This fact offers unique opportunities in the context of single pass AV pacing leads and is employed by the present invention to provide an improved, easy to use single-pass lead. The superior vena cava remains relatively motionless during the beating of the heart, the motion of the heart. As such it is possible to locate an atrial electrode using non-active fixation mechanisms such as loops or coils in a stable location in the superior vena cava with substantially greater success than employing these mechanisms located adjacent the wall of the right atrium. A lead according to one embodiment of the present invention can therefore be provided with a series of laterally extending loops or coils sized to maintain the lead located in the superior vena cava, hereafter referred to as “fixation curves” and may be provided with one or more electrodes mounted along the fixation curves in positions such that at least one of the electrodes will be in contact with the tissue of the superior vena cava in a position which allows for reliable atrial pacing.
In a preferred embodiment of the invention, order to further reduce the likelihood of displacement, the lead body may further be provided with a series of curves extending laterally to a lesser extent than the fixation curves, hereafter referred to as “stretch curves”, located proximally and/or distally to the fixation curves in order to prevent tensile forces applied to the lead proximally and/or distally to the fixation curves from dislodging the atrial pacing electrodes. In a preferred embodiment, the lead body may also be made more flexible and pliant proximal and distal to the portion to be located in the superior vena cava.
The lead may carry one or more atrial pacing electrodes for location in the superior vena cava in conjunction with one or more additional pacing electrodes for location in the right ventricle or elsewhere. Additionally or alternatively, the lead may carry cardioversion defibrillation electrodes adapted to be located in the right ventricle, superior vena cava or coronary sinus. Preferably, the lead body distal to the fixation curves is of sufficient length to extend past the desired location of the atrial pacing electrode to the desired location of the ventricular or other pacing electrode and/or cardioversion/defibrillation electrodes.
In several embodiments discussed herein, the lead is typically implanted by first locating the right ventricular pacing electrode in its desired location and subsequently locating the atrial pacing electrode or electrodes in the superior vena cava. This may be accomplished by inserting an internal stylet to straighten the lead body and passing the lead through the vascular system until the ventricular electrode is at its desired location. thereafter withdrawing the internal stylet and moving the lead body distally to allow the fixation curves on the lead body to be displayed in the right atrium, distal to the end of the stylet. The lead may the be pulled proximally to place the atrial pacing electrodes in their desired locations in the superior vena cave After location of the electrodes in the superior vena cava, the stylet is withdrawn completely and the lead is anchored at its site of venous insertion in connection with an implantable pulse generator in a conventional fashion. Alternatively, the lead body may be straightened by means of a guide catheter through which the lead is passed to the desired location of the ventricular pacing electrode, with the guide catheter moved proximally and the lead moved distally to allow the fixation curves to be displayed in the right atrium, followed by the lead being pulled proximally to locate the atrial pacing electrodes in the superior vena cava as discussed above. Location of the lead in embodiments in which the lead is provided with one or more electrodes for location in the coronary sinus, right atrium elsewhere may be accomplished in an analogous fashion.
REFERENCES:
patent: 3729008 (1973-04-01), Berkovits
patent: 3825015 (1974-07-01), Berkovits
patent: 3865118 (1975-02-01), Bures
patent: 3903897 (1975-09-01), Woollons et al.
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patent: 4402330 (1983-09-01), Lindemans
patent: 4497326 (1985-02-01), Curry
patent: 4506680 (1985-03-01), Stokes
patent: 4567901 (1986-02-01), Harris
patent: 4627439 (1986-12-01), Harris
patent: 4934381 (1990-06-01), MacGregor
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patent: 5282844 (1994-02-01),
Bonner Matthew D.
Warman Eduardo N.
Duthler Reed A.
Evanisko George R.
Medtronic Inc.
Patton Harold R.
Wolde-Michael Girma
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