A new apparatus,
algorithm, and method (all called Invention) are introduced herein to support navigation and placement of an
intravascular catheter using the
electrical conduction system of the heart (ECSH) and control electrodes placed on the patient's
skin. According to the present Invention, an
intravascular catheter can be guided both in the arterial and venous systems and positioned at different desired locations in the vasculature in a number of different clinical situations. The
catheter is connected to the apparatus using, for example, sterile extension cables, such that the apparatus can measure the electrical activity at the tip of the
catheter. Another
electrode of the apparatus is placed for reference on the patient's
skin. In one embodiment of the present Invention, a control
electrode is placed on the patient's chest over the manubrium of the sternum below the presternal notch. In this case, if a
catheter is inserted in the venous
system, for example in the basilic
vein, the Invention will indicate if the tip of the catheter navigates from the
insertion point in the basilic
vein into the subclavian
vein on the same side, into the subclavian vein counter laterally, into the
jugular vein, into the
superior vena cava, into the cavoatrial junction (CAJ), into the
right atrium (RA), into the right
ventricle (RV), or into the
inferior vena cava (IVC). For the same location of a control
electrode, if a catheter is inserted in the arterial
system, the Invention will indicate when the tip of the catheter is navigating into the arch of the
aorta, into the
right coronary artery, into the left
circumflex artery, or into the left
ventricle (LV). In another embodiment of the present Invention, a control electrode can be placed on the sternum over the xiphoid process. In one embodiment of the present invention, a catheter can be inserted in the arterial systems by arterial radial, brachial or axillary access. In another embodiment of the present Invention, a catheter may be inserted into either the arterial or the venous systems by femoral or saphenous access. In one aspect of the present Invention, navigation maps are introduced for different locations in the vasculature which allow for easy identification of the location of the catheter tip. In another aspect of the present Invention, a novel
algorithm is introduced to compute a navigation
signal in real time using electrical signals from the tip of the catheter and from control electrodes. In another aspect of the present Invention, a novel
algorithm is introduced to compute in
real time navigation parameters from the navigation
signal computes according to the present Invention. In another aspect of the present Invention, a method is introduced which makes use of the navigation
signal to allow for placing an
intravascular catheter at a desired location in the vasculature relative to the ECSH and to the control electrodes placed on the
skin. In another aspect of the present Invention, the electrical signals obtained from control electrodes and from the tip of the catheter may be generated by the natural ECSH, e.g., the sino-atrial node (SAN), by artificial (implanted) pacemakers or by electrical generators external to the body. In yet another aspect of the Invention, an apparatus is introduced which supports
data acquisition required by the computation of a navigation signal according to the present Invention.