Abstract:
A method for scaling the impedance measured during the course of an electrophysiology study accounts for impedance drifts. By scaling the impedance there is greater assurance that previously recorded positional information can be used to accurately relocate an electrode at a prior visited position. The scale factor may be based upon a mean value across several sensing electrodes. Alternatively, the scale factor may be calculated specifically with respect to an orientation of a dipole pair of driven electrodes.

Description:
CROSS-REFERENCE TO RELATED APPLICATIONS 
     This application is a continuation of U.S. application Ser. No. 11/227,580, filed 15 Sep. 2005, now allowed, which is hereby incorporated by reference as though fully set forth herein. 
    
    
     BACKGROUND OF THE INVENTION 
     a. Field of the Invention 
     This invention relates to systems for positioning and mapping electrophysiology catheters and ablation catheters in the heart of a patient. The invention further relates to methods for error correction in electrocardiograph signals. 
     b. Background Art 
     U.S. Pat. No. 5,697,377 (the &#39;377 patent) and U.S. Pat. No. 5,983,126 (the &#39;126 patent) to Wittkampf disclose a system for determining the position or location of a catheter in the heart. The &#39;377 patent and the &#39;126 patent are hereby incorporated herein by reference in their entirety. In the Wittkampf system, current pulses are applied to orthogonally placed patch electrodes placed on the surface of the patient. These surface electrodes are used to create axis specific electric fields within the patient. The Wittkampf references teach the delivery of small amplitude, low current pulses supplied continuously at three different frequencies, one on each axis. Any measurement electrode placed in these electric fields (for example within the heart) measures a voltage that varies depending on the location of the measurement electrode between the various surface electrodes on each axis. The voltage across the measurement electrode in the electric field in reference to a stable positional reference electrode indicates the position of the measurement electrode in the heart with respect to that reference. Measurement of the difference in voltage over the three separate axes gives rise to positional information for the measurement electrode in three dimensions. 
     Although the Wittkampf system is both safe and effective there are several factors that can result in errors in the position of the measurement electrode. Some factors previously identified as sources of impedance modulation include the cardiac cycle and respiration. Both of these sources also cause actual physical movement of an electrode in addition to direct impedance effects. Mitigations to these modulators to enhance stability of electrode positional measurements include low pass filtering, cardiac cycle triggering, and respiration compensation. One factor not previously addressed is the tendency of biologic impedance to change over time. Changes in biologic impedance are attributable to changes in cell chemistry, for example, due to saline or other hydration drips in the patient, dehydration, or changes in body temperature. 
     If the biologic impedance changes over a longer term (i.e., minutes or hours), then apparent shifts of the measured locations of electrodes may occur. If an internal cardiac electrode is used as a reference electrode, these shifts may be negligible, since they are manifest as a scale factor change of only a few percent. For example, a 2 percent change with respect to a fixed reference 4.0 centimeters away will represent an error of 0.8 millimeters, which is generally considered acceptable. However, if it is desired to use an external body surface electrode as a fixed reference, and eliminate the requirement of a fixed intra-cardiac electrode reference, then 2 percent may represent an intolerable error source. For example, if the reference electrode is an “apparent” 40 cm from a mapping electrode, the error due to a 2% impedance drift would be 8 millimeters. The term “apparent” is used because while the actual distance to the reference electrode may be somewhat less, the intervening biologic of lung and muscle tissue is higher than that of blood, such that it scales to a larger distance. 
     The information included in this Background section of the specification, including any references cited herein and any description or discussion thereof, is included for technical reference purposes only and is not to be regarded subject matter by which the scope of the invention is to be bound. 
     BRIEF SUMMARY OF THE INVENTION 
     The present invention addresses the problem of biologic impedance changes and the effect on measurement of the position of an electrode within a patient by continuously calculating a scale factor to apply to impedance measurements throughout the course of a procedure. Changes in biologic impedance attributable to changes in cell chemistry, for example, due to saline or other hydration drips in the patient, dehydration, or changes in body temperature, can thus be accounted for and a more accurate positional reading for a measurement electrode may be obtained. 
     In one form, the invention may be understood as a method for scaling impedance measurements in an electrophysiology study. A first dipole is driven along a first axis to create an electric field across a patient&#39;s body. A biologic impedance encountered by the electric field with respect to a surface sensor is measured. The mean of the absolute value of the measured biologic impedance is calculated continuously as a function of time Pm(t). An initial calculated mean of the absolute value of the at least one measured biologic impedance is saved as Pa. An impedance measurement between a measurement electrode and a reference electrode is then multiplied by the ratio of Pa/Pm(t) to scale the impedance measurement and account for any drift. This scaling calculation may be performed by software controlling an electrophysiology study or ablation system. The invention may further break the scale factors into component scales with respect to a plurality of dipole axes that may be driven. In this instance, separate measurements for each axis are measured and the scale factor is represented by Pa(i)/Pm(t,i), where (i) indicates the axis of measurement. 
     Other features, details, utilities, and advantages of the present invention will be apparent from the following more particular written description of various embodiments of the invention as further illustrated in the accompanying drawings and defined in the appended claims. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         FIG. 1  is a schematic diagram of a system for performing a cardiac electrophysiology examination or ablation procedure wherein the location of one or more electrodes can be determined and recorded. 
         FIGS. 2A-2D  are schematic diagrams of dipole pairs of driven surface electrodes. 
         FIG. 3  is a table indicating the surface electrodes used as sensors when a particular dipole pair of surface electrodes is driven. 
         FIG. 4  is a schematic diagram of biologic impedance drift portrayed as an electrical circuit. 
     
    
    
     DETAILED DESCRIPTION OF THE INVENTION 
     One of the primary goals of cardiac electrophysiology mapping is to locate with some certainty the position of an electrode within a cardiac cavity. An electric navigation field is created within a patient&#39;s body on each of the three principal axes by driving a constant current. If the impedances measured in the body are constant, then the potentials on each axis measured at a location, with respect to a reference electrode at a static location, will remain at a constant potential over time. Thus, if a location site is marked in the heart, one may return to that site with a catheter electrode in the future and be confident that if the measured navigation potentials, or impedance, are the same as before, the anatomic location is the same. 
       FIG. 1  depicts a schematic diagram of an exemplary electrophysiology mapping or ablation system. The patient  11  is depicted as an oval for clarity. Three sets of surface electrodes (e.g., patch electrodes) are shown applied to a surface of the patient  11  along an X-axis, a Y-axis, and a Z-axis. The X-axis surface electrodes  12 ,  14  are applied to the patient along a first axis, such as on the lateral sides of the thorax region of the patient (e.g., applied to the patient&#39;s skin underneath each arm) and may be referred to as the Left and Right electrodes. The Y-axis electrodes  18 ,  19  are applied to the patient along a second axis generally orthogonal to the X-axis, such as along the sternum and spine of the patient in the thorax region and may be referred to as the Chest and Back electrodes. The Z-axis electrodes  16 ,  22  are applied along a third axis generally orthogonal to both the X-axis and the Y-axis, such as along the inner thigh and neck regions of the patient, and may be referred to as the Left Leg and Neck electrodes. The heart  10  lies between these pairs of surface electrodes. An additional surface reference electrode (e.g., a “belly patch”)  21  provides a reference and/or ground electrode for the system  8 . The belly patch electrode  21  is an alternative to a fixed intra-cardiac electrode  31 . It should also be appreciated that in addition, the patient  11  will have most or all of the conventional electrocardiogram (ECG) system leads in place. This ECG information is available to the system although not illustrated in the  FIG. 1 . 
     A representative catheter  13  with a single, distal measurement electrode  17  is also depicted in  FIG. 1 . The catheter  13  may also have additional electrodes in addition to the measurement electrode  17 . A fixed reference electrode  31  may be attached to a heart wall on an independent catheter  29 . In many instances, a coronary sinus electrode or other fixed reference electrode  31  in the heart  10  can be used as a reference for measuring voltages and displacements. For calibration purposes the reference electrode  31  remains stationary on the wall of the heart during the course of the procedure. 
     Each surface electrode is independently connected to a multiplex switch  24 . Pairs of the surface electrodes are selected by software running on a computer  20 , which couples the surface electrodes  12 ,  14 ,  16 ,  18 ,  19 ,  21 ,  22  to a signal generator  25 . A first pair of surface electrodes, for example, the Z-axis electrodes  18 ,  19 , is excited by the signal generator  25 . The exited electrodes generate an electric field in the body of the patient  11  and the heart  10 . This electrode excitation process occurs rapidly and sequentially as alternate sets of patch electrodes are selected and one or more of the unexcited surface electrodes are used to measure voltages. During the delivery of a current pulse, the unexcited surface electrodes  12 ,  14 ,  16 , and  22  are referenced to either the reference electrode  31  or the belly patch  21  and respective voltages are measured across one or more of these unexcited electrodes. In this way, the surface electrodes are divided into driven and non-driven electrode sets. 
     While a pair of electrodes is driven by the current generator  25 , the remaining, non-driven electrodes may be used as references to synthesize the orthogonal drive axes. A low pass filter  27  processes the voltage measurements to remove electronic noise and cardiac motion artifact from the measurement signals. The filtered voltage measurements are transformed to digital data by the analog to digital converter  26  and transmitted to the computer  20  for storage under the direction of software. This collection of voltage measurements is referred to herein as the “patch data.” The software has access to each individual voltage measurement made at each surface electrode during each excitation of each pair of surface electrodes. The patch data is used to determine a relative location in three dimensions (X, Y, Z) of the measurement electrode  17 . Potentials across each of the six orthogonal surface electrodes may be acquired for all samples except when a particular surface electrode pair is driven. Sampling while a surface electrode acts as a source or sink in a driven pair is normally avoided as the potential measured at a driven electrode during this time will be skewed by the electrode impedance and the effects of high local current density. 
     Generally, three nominally orthogonal electric fields are generated by a series of driven and sensed electric dipoles in order to realize catheter navigation in a biological conductor. Alternately, these orthogonal fields can be decomposed and any pairs of surface electrodes can be driven as dipoles to provide effective electrode triangulation. Additionally, such nonorthogonal methodologies add to the flexibility of the system and the ability to localize biologic impedance compensation. For any desired axis, the potentials measured across an intra-cardiac electrode  17  resulting from a predetermined set of drive (source-sink) configurations are combined algebraically to yield the same effective potential as would be obtained by simply driving a uniform current along the orthogonal axes. 
     Thus, any two of the surface electrodes  12 ,  14 ,  16 ,  18 ,  19 ,  22  may be selected as a dipole source and drain with respect to a ground reference, e.g., the belly patch  21 , while the unexcited electrodes measure voltage with respect to the ground reference. The measurement electrode  17  placed in the heart  10  is exposed to the field from a current pulse and is measured with respect to ground, e.g., the belly patch  21 . In practice the catheters within the heart may contain multiple electrodes and each electrode potential may be measured. As previously noted, at least one electrode may be fixed to the interior surface of the heart to form a fixed reference electrode  31 , which is also measured with respect to ground. Data sets from each of the surface electrodes and the internal electrodes are all used to determine the location of the measurement electrode  17  within the heart  10 . After the voltage measurements are made, a different pair of surface electrodes is excited by the current source and the voltage measurement process of the remaining patch electrodes and internal electrodes takes place. The sequence occurs rapidly on the order of 100 times per second. To a first approximation the voltage on the electrodes within the heart bears a linear relationship with position between the patch electrodes that establish the field within the heart. Correction factors, e.g., to compensate for respiration, may be applied to the raw location information to improve the accuracy of the location value. 
     When operating with constant currents during an electrophysiology study, the potentials created with respect to any reference will be a function of the intervening impedance. This concept is represented schematically in  FIG. 4 . A catheter  13  with a distal measurement electrode  17  is placed within the heart  10  of the patient  11 . A set of orthogonal surface electrodes  12 ,  14 ,  16 ,  18 ,  19 ,  22  are alternately paired as drive electrodes while the remaining, unexcited electrodes may function as sensor electrodes. The electric potential generated by a dipole pair of electrodes may be measured at a measurement electrode in the body and the path of current through the body between the driven surface electrode and the distal measurement electrode  17  on the catheter may be understood simply as a circuit. For example, as shown in  FIG. 4 , when the Left Leg electrode  18  is driven as a source, a circuit  30  is created between the Left Leg electrode  18  and the measurement electrode  17  on the catheter  13  within the heart  10 . The body tissue between the skin at the Left Leg electrode  12  and the heart  10  acts primarily as a resistive impedance and can be viewed functionally as a resistor  32 . However, due to changes in body chemistry during a procedure, the value of this resistor  32  may drift. Therefore, the resistor  32  may be more accurately viewed as a variable resistor as depicted. It should be apparent that if the tissue impedance changes, then the voltage data and thus positional data for each electrode, including a reference electrode, e.g., the belly patch electrode  21 , will similarly drift. 
     To the extent that intervening impedances change after a study begins and sites have been marked, attempts to place the measurement electrode at previously visited locations may not be consistent with earlier marked sites. To the extent that the impedance change for a given pair of drive surface electrode dipoles is tracked by unexcited surface electrodes used as sensors, these data may be used to correct the drift on each driven dipole. This is best done by using the surface electrode patches as sensors in the time slices when they are un-driven. Two exemplary methods are discussed herein to account for and correct any potential drift. The first method assumes that the bio-impedance changes are essentially homogeneous. Thus all driven dipoles change by the same percentage and averaging of all the patch data returns a single impedance index. The second method does not make this assumption and computes an index for each axis. 
     A first method for biologic impedance scaling assumes that any biologic impedance changes are essentially homogenous within the body, that all dipoles change by the same percentage, and that averaging of all surface electrode data will provide a single, accurate impedance index. The method uses the Neck, Left, Right, Chest, and Back surface electrode patches as sensors when they are not being driven. The Left Leg electrode is not generally used for sensing because sensed potentials on it tend to be very small. For pairings of the driven surface electrode excluding the Left Leg, there are thus three potential sense patches that contribute data. In the case of driven pairings including the Left Leg, four surface electrode patches are available as sensors. The mean of the absolute values of the measured impedance at the surface electrode sensors is obtained continuously as a function of time. This mean value may be denoted as Pm(t). Immediately after the a study begins, the initial value of Pm(t) is saved as an initial value Pa. On every subsequent sample, all of the measurement electrode data is multiplied by the ratio Pa/Pm(t). The three dimensional impedance measurements are thereby scaled to account for any drift over time. 
     To illustrate, a study begins and, assuming there are no errors due to unconnected surface electrodes, the surface electrodes are each sensed during their un-driven phases and averaged to yield a Pa of 10.0 ohms, which is saved in the software on the computer  20 . Assume an important site is marked with a measurement electrode on a catheter in the heart at a site with the impedance coordinates of (1.0, 2.0, 10.0) ohms with respect to a belly patch reference electrode  21 . These impedance coordinates are translated for the user using a nominal scale factor to yield positional coordinates of (25, 50, 400) millimeters. Suppose, due to a saline drip or other factors, an hour later the patient&#39;s biologic impedance has lowered by 2%. Without compensation, a return visit by a catheter electrode to the marked anatomic site would now show up at coordinates of (24.5, 49.0, 392.0) millimeters, a drift of 8 millimeters. However, the same biologic impedance drift will be registered on the data sensed by the surface electrodes. For example, Pm(t) will now read 9.8 ohms. Therefore, scaling the catheter electrode coordinate data by Pa/Pm(t), or 1.0204, will ensure the catheter electrode is positioned at its original and correct location. 
     A second method for scaling biologic impedance shifts according to the present invention is generally the same as in the prior embodiment, except that separate scale factors are maintained for each axis or pair of driven electrode dipoles. While it is generally found that biologic impedance drifts are essentially homogeneous, this method may be preferred in the event that biologic impedance drifts are not homogeneous throughout the measurement space. In this instance a value, Pm(i,t), the mean of the absolute values of the measured impedance of each of the dipole combinations as a function of time, can be calculated. In this method, Pm(i,t) for each dipole pair are computed, where “i” is the dipole number, or “Impedance Number,” by averaging the impedance measurements at the surface electrodes on a dipole basis. Notably, not all of the undriven surface electrodes need be averaged to optimally determine the axial impedance for each dipole. Thus, the initial value of patch impedance, Pa(i), and subsequent values of patch impedance, Pa(i,t), may be measured for each dipole by averaging only the electrode data per the table of  FIG. 3  for that dipole. 
     As shown in  FIG. 3 , the measured impedance for a first dipole Xa-Ya (0) between the Left electrode and the Back electrode may be obtained by averaging the Right electrode (Xb) and the Neck electrode (Za) data. This dipole is depicted in  FIG. 2A . Similarly, the measured impedance for a second dipole Xa-Yb (1) between the Left electrode and the Chest electrode may also be obtained by averaging the Right electrode (Xb) and the Neck electrode (Za) data. This dipole is depicted in  FIG. 2B . The measured impedance for a third dipole Xb-Ya (2) driven between the Right electrode and the Back electrode may be obtained by averaging the Left electrode (Xb) and the Chest electrode (Yb) data. This dipole is depicted in  FIG. 2C . The measured impedance for a fourth dipole Xb-Yb (3) driven between the Right electrode and the Chest electrode may be obtained by averaging the Left electrode (Xb), the Back electrode (Ya) and the Neck electrode (Yb) data together. This dipole is depicted in  FIG. 2D . The measured impedance for a fifth dipole Za-Ya (4) driven between the Neck electrode and the Back electrode may be obtained by averaging the Left electrode (Xa) and the Right electrode (Xb) data together. Finally, the measured impedance for a sixth dipole is Zb-Ya (5) driven between the left Leg electrode and the Back electrode may be optimally obtained by recoding data for the Chest electrode (Xa) only. 
     It should be noted that while biologic impedance scaling will have the greatest effect when correcting impedance changes when a body surface electrode is used as a reference electrode, such scaling may also be applied to cases where an intra-cardiac reference electrode is used. There is simply less error to correct for in the latter case. 
     Although various embodiments of this invention have been described above with a certain degree of particularity, or with reference to one or more individual embodiments, those skilled in the art could make numerous alterations to the disclosed embodiments without departing from the spirit or scope of this invention. All directional references (e.g., proximal, distal, upper, lower, upward, downward, left, right, lateral, front, back, top, bottom, above, below, vertical, horizontal, clockwise, and counterclockwise) are only used for identification purposes to aid the reader&#39;s understanding of the present invention, and do not create limitations, particularly as to the position, orientation, or use of the invention. Connection references (e.g., attached, coupled, connected, and joined) are to be construed broadly and may include intermediate members between a collection of elements and relative movement between elements unless otherwise indicated. As such, connection references do not necessarily infer that two elements are directly connected and in fixed relation to each other. It is intended that all matter contained in the above description or shown in the accompanying drawings shall be interpreted as illustrative only and not limiting. Changes in detail or structure may be made without departing from the basic elements of the invention as defined in the following claims.