Body Tissue Depolarization Evaluation System

Physiological waveform processors are known to the prior art for such purposes as detecting the occurrence of a particular waveform characteristic. For example, such devices have been used to detect the occurrence of an R-wave or a QRS complex within an ECG.

Typical prior art devices of the type described recognize that the slope or slew rate of the waveform characteristic of interest often differs from that of the remainder of the waveform. When the characteristic of interest has a greater slew rate than other waveform characteristics, a mere comparison of the derivative of the waveform signal against a reference value can reliably detect the occurrence of the characteristic of interest. In an environment where noise or other extraneous signals are likely to be present, a second criterion may be employed to reduce the probability of a false indication of the waveform characteristic of interest.

A prior art device which employs the slope or slew rate of a waveform to detect the occurrence of a particular waveform characteristic is shown in U.S. Pat. No. 3,878,833, issued Apr. 22, 1975, for Physiological Waveform Detector. The referenced patent includes an embodiment which detects the occurrence of the QRS complex in the ECG waveform essentially by comparing the derivative of the waveform signal with a reference signal and determining whether the derivative signal exceeds the reference signal for a predetermined period of time. Thus, two criteria are employed to detect the QRS complex: namely, magnitude and duration. The magnitude criterion distinguishes between the QRS complex and other portions of the ECG as well as low frequency artifacts and noise. The duration criterion distinguishes between the QRS complex and muscle spikes, pacemaker pulses and other high frequency artifacts.

Prior art devices of the type disclosed in the referenced patent can detect a QRS complex in an ECG and other waveform characteristics within other waveforms. The process of detection by comparison with a reference value, however, merely gives an indication of the occurrence of the characteristic of interest without any indication as to the parameters of that characteristic. Further, the criteria employed by this prior art device may not be the most reliable or desirable to establish the occurrence of the characteristic. For example, in determining whether or not a cardiac pacing lead is properly placed, peak-to-peak amplitude and slew rate may be far more valuable than the magnitude and duration of a waveform characteristic.

A signal processor which establishes peak-to-peak amplitude between a waveform signal peak and the next successive peak as well as the slew rate of the waveform signal between successive waveform signal peaks is disclosed in United States Patent Application Ser. No. 180,710, filed Aug. 25, 1980, for Physiological Waveform Processor which is co-owned with the present invention. This system determines the maximum peak-to-peak amplitude of the waveform signal and its associated slew rate. The occurrence of a particular waveform characteristic is detected by comparing the maximum peak-to-peak amplitude and its associated slew rate against reference values. If the reference values are satisfied, the system may then indicate that the waveform characteristic has, in fact, occurred. For example, comparison of the maximum peak-to-peak amplitude, and its associated slew rate, against reference values may be employed to detect the occurrence of a QRS complex in an ECG waveform, as in a sense amplifier or cardiac pacemaker, or to check the lead placement for a cardiac pacemaker. However, this system requires that that portion of the waveform being processed that has the maximum peak-to-peak amplitude also has the greatest merit or probability that it is the characteristic of interest. In fact, a noise spike may have a higher peak-to-peak amplitude than other portions of the waveform being processed. Such a noise spike would not likely be detected as a QRS complex as a result of filtering and the slew rate comparison. However, if detected, it could prevent a detection of the QRS complex as a result of its higher peak-to-peak amplitude. Thus, this latter mentioned system can reliably give an indication that it has detected as QRS complex but may not always reliably detect that complex. Further, it is limited to a detection of those complexes having the highest peak-to-peak amplitude in the waveform.

The present invention provides an evaluation system for waveforms of physiological origin. The waveform is evaluated by identifying excursions in the waveform signal (that portion of the signal between waveform peaks) and evaluating identified excursions in accordance with a preselected plurality of merit criteria. If those criteria include peak-to-peak amplitude and slew rate, for example, an excursion may have a higher merit even though it has a lower peak-to-peak amplitude. Thus, a noise spike having the highest peak-to-peak amplitude within the waveform being evaluated can be rejected as not satisfying the merit criteria because of inadequate duration while the evaluation system does evaluate a waveform characteristic or excursion of lower peak-to-peak amplitude as satisfying the merit criteria. Accordingly, the certainty of detection of the desired characteristic is enhanced over the prior art systems described above. Also, the system of the present invention is more versatile than prior art systems in that it does not depend on identifying a maximum in one of its merit criteria.

In a preferred embodiment, the system of the present invention is implemented in conjunction with a body implantable stimulator of the type having a stimulation delivering and depolarization sensing lead system. The evaluation system may form a part of the stimulator, as the sense amplifier of a cardiac pacemaker, or, alternatively, may be employed to check lead placement for the purpose of threshold evaluation and/or compatibility of the lead placement with the sensitivity of the stimulator. An input connects the lead system to a digitizer which digitizes depolarization signals sensed by the lead system. A computing system identifies excursions in the digitized depolarization signals and evaluates identified excursions in accordance with a preselected plurality of merit criteria. An output is connected to the computing system for giving an indication of at least that excursion having the highest merit that satisfies the merit criteria. For the purpose of this specification and claims, the term "excursion" is intended to embrace that portion of a waveform lying between two changes in slope of the waveform and further includes "notched" and "tailing" portions of the waveform, as defined below. The term "merit" embraces the relative reliability of the parameters of a particular waveform characteristic or excursion as establishing that a particular characteristic or excursion is that characteristic it is desired to detect. For example, an excursion of higher merit is a more reliable indication of the occurrence of a particular characteristic than is an excursion of lower merit. Among the merit criteria that may be employed in evaluating identified excursions are excursion slew rate, excursion peak-to-peak amplitude, excursion duration and, for excursion subsequent to a first excursion satisfying the merit criteria, the relative peak-to-peak amplitude and the time of occurrence following the first evaluated excursion that satisfies the merit criteria.

FIG. 1 is a graph that illustrates the merit concept underlying the present invention.

FIG. 2 shows a waveform that illustrates the application of the merit system shown graphically in FIG. 1.

FIG. 3 illustrates, the block diagram form, an implementation of the present invention.

Referring now to FIG. 1, there is shown a graph that illustrates the merit concept of the present invention. FIG. 1 is a plane Cartesian coordinate system having peak-to-peak amplitude as the abcissa and slew rate as the ordinate. The waveform characteristic to which the graph of FIG. 1 is directed is the QRS complex.

FIG. 1 defines a region above it and to its right that has higher merit in the detection of the QRS complex than the region to its left and below it. That is, an excursion whose parameters fall within the region above and to the right of line 1 is a more reliable indicator that that excursion is, or is a part of, the QRS complex than an excursion whose parameters fall below or to the left of the line 1. Line 2 similarly defines a region of merit, that region having a higher merit than the region defined by the line 1 while the line 3 defines a region of yet higher merit. As described to this point, the points labeled A and C in FIG. 1 fall within the same merit region while the Point B falls within a higher merit region. Of course, other merit criteria beyond slew rate and peak-to-peak amplitude may be employed to evaluate a particular excursion.

With reference to FIG. 2, there is shown a waveform in which the amplitude of the first three negative excursions is indicated by the Arrows A, B and C. These three excursions represent the Points A, B and C in FIG. 1. That is, the first negative excursion (A) has a higher slew rate and lower amplitude than the third negative excursion (C) while the second negative excursion (B) has both a higher slew rate and peak-to-peak amplitude than either of the other two negative excursions of the waveform discussed to this point. As noted above, applying the merit criteria of slew rate and peak-to-peak amplitude results in the negative excursion whose amplitude is indicated at B having a higher merit. The remaining portion of the waveform illustrated in FIG. 2 is discussed below.

The above discussion focuses on the down slope or negative sloped portion of a waveform as an excursion. However, an excursion can be defined to be the up slope of a waveform, the down slope of a waveform, or both. A single slope implementation is here preferred for ease of implementation with the down slope being the most prominent single slope in the majority of QRS complexes and, thus, the slope of choice. However, the term "excursion" is intended to embrace an up slope excursion, a down slope excursion, and a double slope excursion as well as excursions having notches and trailing excursions, as discussed below.

In addition to slew rate and peak-to-peak amplitude, other merit criteria may be employed in evaluating an excursion. Among these are excursion duration which will generally fall within a range having lower and upper limits which are expected of the characteristic of interest, the QRS complex, for example. Other merit criteria that may be employed include relative amplitude and timing of an excursion relative to a first excursion that satisfies the merit criteria. For example, within the context of heart depolarizations, a subsequent excursion of greater peak-to-peak amplitude that satisfies the same merit criteria as an earlier excursion and which occurs within a preselected period of time following the first excursion is determined to have a higher merit (that is a better reliability as an indicator of the QRS complex). In this context, desirable merit criteria are an excursion slew rate greater than 0.1 volts per second, an excursion peak-to-peak amplitude greater than 1.0 millivolts, an excursion duration greater than 3 milliseconds but no greater than 30 milliseconds and, for subsequent excursions following a first excursion that satisfies these merit criteria, a greater relative peak-to-peak amplitude and the occurrence of the subsequent excursion within a preselected interval, 200 milliseconds, for example. Thus, assuming excursions having the amplitudes indicated at A, B and C in FIG. 2, and that each satisfy at least the merit criteria of Region 1 of FIG. 1, Excursion A would be evaluated as satisfying these criteria as would Excursion B. Indeed, Excursion B would be evaluated as the excursion of highest merit under either the criteria of Region 1 set out above or the higher merit criteria of Region 2. However, Excursion C would not satisfy the Region 1 criteria because it is a subsequent excursion not greater in peak-to-peak amplitude than the last occurring excursion that satisfied those criteria. Also, If either Excursion B or C occurred after the preselected interval following Excursion A, those excursions would not satisfy the merit criteria.

FIG. 3 illustrates a block diagram of a preferred implementation of the present invention. A lead system 10 which forms a part of a body implantable body stimulator includes a stimulation delivering and depolarization sensing lead system. Depolarization signals sensed by the lead system are amplified by an amplifier 11 and applied as an analog input to an analog to digital converter 12. The digitized depolarization signals are connected as an input to a processor which includes a computing system for identifying excursions in the digitized depolarization signals and for evaluating identified excursions in accordance with a preselected plurality of the merit criteria discussed above. The processor 13 is connected to an output 14, the output 14 giving an indication of at least that excursion having the highest merit that satisfies the merit criteria. In a preferred embodiment, the output gives an indication of the first evaluated excursion satisfying the merit criteria and excursions evaluated subsequent to the first indicated excursion having greater merit than the last indicated excursion. The output may be in the form of a display to display the peak-to-peak amplitude of indicated excursions. In this instance, the display may be employed to check the placement of the lead system 10 or to evaluate the probable response of a body stimulator to be connected to the lead system. In this instance, connection of a body stimulator to the lead system may be at the terminal 15. Preferably, the display will be digital or an analog printing with the excursion of highest merit identified. Alternatively, elements 11-14 of FIG. 3 may be employed as a sense amplifier of a cardiac pacemaker to identify the occurrence of a QRS complex in an ECG waveform.

Implementation of the preferred embodiment illustrated in FIG. 3 may be by any suitable components. For example, in an external system for evaluation of lead placement and pacemaker response, a National Semiconductor ADC0808 analog digital converter may be employed for element 12 while a NCS 800 microprocessor may be employed to implement the processor 13. With these components, a program listing that may be employed to implement the present invention in the manner described above is attached hereto as Table I. However, other programming may be employed without departing from the scope of the present invention.

Obviously, many modifications and variations of the present invention are possible in light of the above teachings. For example, one set of merit criteria may be established the satisfaction of which is indicated by the present invention in accordance with the above discussion. Alternatively, two or more merit criteria may be established, each having differing merit. Implementations employing either of these approaches are embraced within the present invention. In addition, excursions having a notch such as that excursion having an amplitude indicated at D in FIG. 2 may be treated as a single excursion, provided the timing and other characteristics of the notch satisfy established design parameters. For example, the notch should occur within 15 milliseconds following the beginning of the down slope and be small compared to the overall excursion peak-to-peak amplitude. Additionally, down slopes that trail off as indicated by the down slope whose amplitude is indicated at F in FIG. 2 may be treated as a "routine" down slope for the purposes of the present invention taking the peak-to-peak amplitude of the down slope to be that amplitude of the down slope at a predetermined period of time following the beginning of the down slope, 30 milliseconds, for example. Further, the processor 13 may operate on a real time basis or, alternatively, may include a memory for storage of digitized depolarization signals for later processing, as desired. The program listing that may be employed to implement the present invention in the manner described above is attached hereto as Table I. However, other programming may be employed without departing from the scope of the present invention. It is therefore to be understood that, within the scope of the appended claims, the invention may be practiced otherwise than as specifically described. ##SPC1## ##SPC2##