Surgery: light – thermal – and electrical application – Light – thermal – and electrical application – Electrical energy applicator
Reexamination Certificate
1999-10-19
2001-04-24
Evanisko, George R. (Department: 3762)
Surgery: light, thermal, and electrical application
Light, thermal, and electrical application
Electrical energy applicator
C600S585000, C606S129000
Reexamination Certificate
active
06223087
ABSTRACT:
BACKGROUND OF THE INVENTION
This invention relates generally to implantable medical leads, and more particularly to cardiac pacing leads and methods of their delivery.
As discussed in the article, “Atrial Septal Pacing: A method for Pacing Both Atria Simultaneously”, by Spencer et al. published in PACE, Vol. 29, November, 1997, pp. 2739-2745, it is possible to pace both atria with a single active fixation electrode appropriately located in the anterior portion of the right side of the atrial septum separating the right and left atria. However, using present lead technologies, accurate placement of a lead at this desired site, typically located adjacent and slightly above and anterior to the ostium of the coronary sinus can be relatively difficult. While delivery of cardiac pacing leads or other electrode catheters to desired locations within the heart by means of a deflectable or pre-curved guide catheter is known, typically the location of the lead to be so delivered must be determined flouroscopically. As the lead is to be placed while the heart is beating, placement even using a guide catheter is not as simple as would be desired.
SUMMARY OF THE INVENTION
The present invention is directed toward providing a reliable and easy to use mechanism for accurately locating an atrial pacing electrode in the atrial septum, adjacent and above the ostium of the coronary sinus. The present invention accomplishes this desired result by means of an active fixation atrial pacing lead delivered by means of a pre-curved or preferably a deflectable guiding catheter. The guiding catheter is provided with an internal lumen through which the atrial pacing lead is passed, which lumen exits laterally, proximal to the distal tip of the catheter. The distal portion of the catheter is pre-curved or deflectable into an S-shaped bend, having two generally coplanar curves, with a lateral exit aperture located along the outer portion of the more proximal of the two curves. The guiding catheter when so curved is configured so that when the distal tip of the guiding catheter is located in the coronary sinus, the distal end of the atrial lead may be advanced out of the lateral aperture of the guide catheter and embedded in the atrial septum at the desired location. Locating the distal end of the guide catheter in the coronary sinus both assists in proper location of the atrial pacing lead relative to the coronary sinus and in providing a stable platform, allowing the lead to be maintained in its desired location during the measurement of pacing and sensing thresholds and during placement of the electrode in the atrial septal tissue. After the atrial electrode is placed, the guide catheter is withdrawn over the lead, and the lead is coupled to an implantable cardiac pacemaker.
In a preferred embodiment, the guide catheter is configured so that it may be deflectable to first display only the more distally located of the two curves, facilitating placement of the guide catheter in the coronary sinus. The catheter then preferably may then be curved to also display the more proximal of the two curves, facilitating the exit of the atrial pacing lead adjacent to the desired location on the atrial septum. The catheter may be deflectable by any of the numerous presently known mechanisms for providing controlled variable curvature, including but not limited to the use of internal pull wires and the use of nested straight and pre-curved catheter tubes.
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“A trial Septal Pacing: A Method for Pacing Both Atria Simultaneously”, Spencer et al, PACE, vol.20(11), Nov. 1997, pp 2739-2745.
Duthler Reed A.
Evanisko George R.
Medtronic Inc.
Patton Harold R.
Wolde-Michael Girma
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