Patent Description:
This section of this document introduces information about and/or from the art that may provide context for or be related to the subject matter described herein and/or claimed below. It provides background information to facilitate a better understanding of the various aspects of the that which is claimed below. This is a discussion of "related" art. That such art is related in no way implies that it is also "prior" art. The related art may or may not be prior art. The discussion in this section of this document is to be read in this light, and not as admissions of prior art.

An electrocardiogram ("ECG") graphs voltage acquired from a person's body over time. The voltages represent electrical activity of the heart. To acquire the voltages, electrodes are placed at selected points on the person's body. It is desirable to establish a strong physical contact and electromagnetic coupling between each of the electrodes and the person's body. The strong physical contact and electromagnetic coupling are desirable because they promote good data acquisition that improves the accuracy of the ECG.

One measure of the strength of the contact and the coupling is "contact impedance". There inherently exists an impedance at the interface between the electrode and the skin and this impedance is called the contact impedance. A low contact impedance is desirable because it indicates a strong physical contact and electromagnetic coupling. Conversely, a high impedance is undesirable and may even indicate a "lead-off" condition. A lead-off condition is a condition in which the electrode has become detached from the person's body to the point it no longer adequately acquires the voltages.

Many ECG monitors therefore monitor the contact impedance of the various electrodes during the ECG procedure. If a contact impedance exceeds some predetermined threshold, the ECG monitor may presume it indicates that a lead is off and issue an alarm. An attendant or technician, upon detecting the alarm, may then check to make sure there are no detached electrodes and, if there are, then reattach them.

<CIT> is directed to systems and methods for evaluating the quality of electrode contact with a skin surface.

<CIT> relates generally to an electrophysiological device comprising an electrical impedance detector, and more particularly to an electrophysiological device comprising a Zero-Power Lead-off Detector.

Illustrative embodiments of the subject matter claimed below will now be disclosed. In the interest of clarity, not all features of an actual implementation are described in this specification. It will be appreciated that in the development of any such actual embodiment, numerous implementation-specific decisions must be made to achieve the developers' specific goals, such as compliance with system-related and business-related constraints, which will vary from one implementation to another. Moreover, it will be appreciated that such a development effort, even if complex and time-consuming, would be a routine undertaking for those of ordinary skill in the art having the benefit of this disclosure.

While the invention is susceptible to various modifications and alternative forms, the drawings illustrate specific examples herein described in detail by way of example. It should be understood, however, that the description herein of specific examples is not intended to limit the invention to the particular forms disclosed, but on the contrary, the intention is to cover all modifications, equivalents, and alternatives falling within the spirit and scope of the invention as defined by the appended claims.

As alluded to above, ECG monitors may monitor contact impedance to determine whether a lead-off condition has occurred. The contact impedance has both a resistive component and a capacitive component. However, known monitoring techniques only use the resistive component of the contact impedance. There is an underlying assumption that when the resistive component is high the capacitive component is low and vice versa. Under this assumption, the case in which both the resistive component and the capacitive component are high then overall contact impedance is also high. This is not always correct.

If the resistive component is low and the capacitive component is low, the overall contact impedance is low and performance is high. When the resistive component is low and the capacitive component is low, or when the resistive component is high and the capacitive component is high, the overall contact impedance can be low and therefore good for performance. In some cases, when the resistive component is high and the capacitive component is low it is possible that the contact impedance may get high enough to degrade performance. Thus, the underlying assumption mentioned above can lead to undesirable false alarms for the presence of a lead-off condition.

The presently disclosed technique includes a determination of the capacitive component of the contact impedance that can be combined with the resistive component to obtain a more accurate measure of a contact impedance. Although the presently disclosed technique determines the resistive component in the course of determining the capacitive component, this is not always necessary. The resistive component may be determined in any manner known to the art. One suitable technique is disclosed in <CIT> ("the '<NUM> patent"). By operating on a contact impedance including both the resistive and capacitive elements, a more accurate determination of whether a lead-off condition is present can be made. This, in turn, may reduce the occurrence of false alarms.

Turning now to the drawings, <FIG> illustrates an ECG procedure <NUM> in accordance with the present disclosure. In <FIG>, a patient <NUM> is undergoing the ECG procedure <NUM> being administered using the ECG system <NUM>. The ECG system <NUM> comprises an ECG monitor <NUM>, a plurality of electrical leads <NUM>, and a plurality of ECG electrodes <NUM> (only one indicated). There need not be a <NUM>:<NUM> correspondence between the ECG electrodes <NUM> and the electrical leads <NUM> as is shown in <FIG>. The ECG electrodes <NUM> are ostensibly attached to the patient <NUM> and connected to the ECG monitor <NUM> via the electrical leads <NUM>.

As used herein, the term "ostensibly attached" means that the ECG electrodes <NUM> are intended to physically contact and electromagnetically couple to the body of the patient <NUM> sufficiently to acquire suitable ECG data during the ECG procedure <NUM>. However, as described above, it is possible that one or more of the ECG electrodes <NUM> may become detached from the body of the patient <NUM> to a problematical degree. The present disclosure is directed to a technique by which the ECG monitor <NUM> may determine whether a high-impedance or even lead-off condition is present. In such a situation, while it is intended that the ECG electrodes <NUM> are to be attached, one or more may be detached. The term "ostensibly attached" describes this situation.

The implementation of the ECG electrodes <NUM> and the electrical leads <NUM> will depend on the configuration of the ECG system <NUM> in a manner that will become apparent to those skilled in the art having the benefit of this disclosure. For example, the ECG electrodes <NUM> may be, without limitation, a flat, paper-thin sticker or a self-adhesive circular pad. The electrical leads <NUM> may be, again without limitation, limb leads, augmented limb leads, precordial (or chest) leads, or some combination of these. One common configuration, and one with which the currently disclosed technique may be practiced, is a <NUM> electrode, <NUM> lead configuration to measure <NUM> voltages across a person's body. One example of what the <NUM> electrodes may measure is set forth in Table <NUM> below. Note that the nomenclature used in Table <NUM> may differ from that used conventionally to prevent confusion and make consistent with other nomenclature used below.

The ECG monitor <NUM> includes, in this particular example, at least a sensor interface <NUM>, a processor-based control unit <NUM>, a memory <NUM>, and an alarm generator <NUM>. In some embodiments, the memory <NUM> and alarm generator <NUM> may be incorporated into the processor-based control unit <NUM>. Although not necessary to practice the technique disclosed herein, the ECG monitor <NUM> also includes a display <NUM>. The display <NUM> may be used to present a user interface ("Ul", not separately shown) through which a user may interact with the ECG monitor <NUM>. The various components of the ECG monitor <NUM> may communicate with one another over a bus system <NUM>.

The display <NUM> may be any suitable type of display known to the art. The display may be, for example and without limitation, a Light Emitting Diode ("LED") display, a Liquid Crystal Display ("LCD"), an electroluminescent display, or even a cathode-ray tube display. The display <NUM> may be a touch screen in some embodiments and may not be in other embodiments. Embodiments in which the display <NUM> is a touch screen may be used to present a Graphical User Interface ("GUI"). In embodiments in which the display <NUM> is not a touch screen, the UI may include mechanical means, such as buttons and/or switches, to interface with a user. Regardless of whether the display <NUM> includes a touch screen, various embodiments may also employ a variety of peripheral input devices (not shown) as a part of the Ul. Examples of such peripheral input devices include, without limitation, pointing devices such a mouse, trackpad, or track ball and keyboards.

As with the display <NUM> and the Ul, the technique disclosed herein also admits wide variation in the implementation of the alarm generator <NUM>. The alarm generator <NUM> may be, for example, an audio speaker to broadcast an audio alarm. In other examples, the alarm generator <NUM> may include a light, such as an LED, to provide a visual alarm. Note that, in some embodiments, a visual alarm may be presented on the display <NUM> through the UI such that the alarm generator <NUM> may be omitted. Furthermore, such a visual alarm may include a display of the contact impedance demonstrating that it exceeds a threshold as is discussed below.

The sensor interface <NUM> receives data from the ECG electrodes <NUM> over the leads <NUM> and then conditions that data for use and handling by the rest of the ECG monitor <NUM>. The sensor interface <NUM> may include, for example, one or more electrical connectors (not separately shown) the receive(s) and/or mates with one or more electrical connectors (also not separately shown) that may comprise a part of the electrical leads <NUM>. The sensor interface <NUM> may also include electrical circuitry and electronic components for conditioning the received data. As those in the art having the benefit of this disclosure will appreciate, the precise makeup of the sensor interface <NUM> in any given embodiment will be implementation specific. Factors for consideration may include, without limitation, the quantity, quality, form, and format of the received data.

Those in the art having the benefit of this disclosure will also appreciate that the ECG monitor <NUM> will typically include other components not separately shown. For example, the ECG monitor <NUM> may include a battery, a connection to a power supply such as an electrical grid, or both. Similarly, the ECG monitor <NUM> may also include mechanical buttons or switches for a user to interact with the ECG monitor <NUM> during use as mentioned above. However, these and other features of the ECG monitor <NUM> not germane to the practice of the technique disclosed herein have been omitted for the sake of clarity and to promote an understanding of that which is claimed below.

<FIG> conceptually illustrates one particular implementation of the processor-based control unit <NUM>. In the illustrated embodiment, the processor-based controller <NUM> is dedicated to performing the functional aspects of the technique disclosed herein. However, in alternative embodiments, the processor-based control unit <NUM> may also more generally perform all control functions for the ECG monitor <NUM> in addition to the technique disclosed herein. For example, in some embodiments, the processor-based control unit <NUM> may present a user interface (not separately shown) to a user on the display <NUM> by executing a set of user interface ("UI") instructions <NUM> residing in memory <NUM> as shown in <FIG>.

As those in the art having the benefit of this disclosure will appreciate, the term "processor" is understood in the art to have a definite connotation of structure. A processor may be hardware, software, or some combination of the two. In the illustrated embodiment of <FIG>, the processor <NUM> is a programmed hardware processor, such as a controller, a microcontroller or a Central Processing Unit ("CPU"). However, in alternative embodiments, the processor <NUM> may be a Digital Signal Processor ("DSP"), a processor chip set, an Application Specific Integrated Circuit ("ASIC"), an appropriately programmed Electrically Programmable Read-Only Memory ("EPROM"), an appropriately programmed Electrically Erasable, Programmable Read-Only Memory ("EEPROM"), a logic circuit, etc..

The processor <NUM> executes machine executable instructions <NUM> residing in the memory <NUM> to perform the functionality of the technique described herein. The instructions <NUM> may be embedded as firmware in the memory <NUM> or encoded as routines, subroutines, applications, etc. The memory <NUM>, as well as the memory <NUM> in embodiments where they differ, may include Read-Only Memory ("ROM"), Random Access Memory ("RAM"), or a combination of the two. They will typically be installed memory but may be removable. They may be primary storage, secondary, tertiary storage, or some combination thereof implemented using electromagnetic, optical, or solid-state technologies.

Accordingly, in the illustrated embodiment, the processor-based control unit <NUM> performs the software-implemented functionality of the presently disclosed technique. More particularly, the processor <NUM> executes the instructions <NUM>, both shown in <FIG>, to perform the programmed functionality in which the ECG monitoring process includes a determination of the capacitive component of the contact impedance. The capacitive component can then be combined with the resistive component to get a more accurate measure of a contact impedance.

Referring now to <FIG> and <FIG> collectively, in some embodiments, the processor-based control unit <NUM> performs the method <NUM> during the ECG procedure <NUM>. The method <NUM> begins by monitoring (at <NUM>) the ECG electrodes <NUM> ostensibly electrically connected to the body of the patient <NUM>. As described above, during the ECG procedure <NUM>, the ECG electrodes <NUM> are presumed to be attached but it is possible that one or more of the ECG electrodes <NUM> may have become detached. Thus, the ECG electrodes <NUM> are, for purposes of the presently disclosed technique, considered to be "ostensibly connected".

The method <NUM> continues by determining (at <NUM>) the respective contact impedance for each of the ECG electrodes <NUM> as electrical currents are driven through them in a predetermined pattern. As discussed above, the predestined pattern includes both values and sequencing. Each respective contact impedance includes a resistive component and a capacitive component. One method for determining the capacitive component will be discussed further below. As mentioned above, the resistive component may be determined in any manner known to the art, such as is disclosed in the '<NUM> patent.

The method <NUM> also ascertains (at <NUM>) whether any of the determined respective contact impedances for the ECG electrodes <NUM> exceeds a predetermined threshold. The measure of the predetermined threshold may vary depending how closely any given implementation wishes to monitor the ECG procedure <NUM> for lead-off conditions. In particular, an alarm is issued when the resistive component of the contact impedance is high and the capacitive component is low. Thus, some embodiments may set the predetermined threshold at greater than 4MΩ and less than 5nF, for example.

If (at <NUM>) any of the determined respective contact impedances exceeds the predetermined threshold, an alarm is issued. The alarm may be, for example, an audio alarm, a visual alarm, or a combination of the two. The alarm may be issued by the alarm generator <NUM> at the direction of the processor-based control unit <NUM> or, in some embodiments, the processor-based control unit <NUM> itself.

Thus, the presently disclosed technique provides a method for a determining the capacitive component of a contact impedance for each of a plurality of ECG electrodes during an ECG procedure. The capacitive component can then be combined with the resistive component to get a more accurate measure of a contact impedance. The technique also provides an ECG system for performing such a method during an ECG procedure. In some aspects, the presently disclosed technique also provides a computer-readable medium (e.g., the memory <NUM> or the memory <NUM>) encoded with instructions perform such a method.

One particular way in which the capacitive component of a contact impedance can be determined will now be disclosed. The capacitive component is non-linear and behaves non-linearly in the face of changes in voltage. <FIG> illustrates the change in a voltage over time t as it reaches a steady state, direct current ("DC") value A at point <NUM>. The quantity τ represents the time at which the curve has settled enough that the contact impedance may be determined for purposes of determining a lead-off condition.

The voltage is an exponential function f(t) that can be represented as: <MAT>.

Since the curve in <FIG> is exponential, the quantity τ can be calculated from three samples of the curve shown in <FIG>. For a sample period: <MAT>.

The contact impedance Z(x) for the three samples n to n+<NUM> may be represented by Equations (<NUM>)-(<NUM>): <MAT> <MAT> <MAT>.

The quantity τ can then be calculated as follows. First, the difference between Z(n + <NUM>) and Z(n) and between Z(n + <NUM>) and Z(n + <NUM>) are taken: <MAT> <MAT>.

A quantity q is then represented as: <MAT>.

Substituting Equations (<NUM>) and (<NUM>) and reducing yields: <MAT>.

Note that Equation (<NUM>) is independent of n. Next, define x as follows: <MAT>.

Substituting Equation (<NUM>) into Equation (<NUM>) using x and reducing yields: <MAT>.

And solving Equation (<NUM>) for τ yields: <MAT>.

Substituting Equation (<NUM>) for q: <MAT>.

From the determined value for τ, the value for the DC voltage A can also then be determined. Using the equations above: <MAT> <MAT>.

Thus, instead of waiting for the voltage to reach a steady state DC voltage A, three samples of the voltage may be taken during the transition caused by changing a driving current as discussed below. From these three samples of the voltage in transition, both τ and A can be determined.

<FIG> is a conceptual diagram of selected portions of the ECG system <NUM>' in accordance with the present disclosure. The ECG system <NUM>', as discussed above relative to ECG system <NUM>, includes a plurality of ECG electrodes <NUM><NUM>-<NUM><NUM>. There theoretically may be any number of electrodes greater than or equal to three. Those in the art having the benefit of this disclosure, however, will realize that there are practical limitations on the number of electrodes. Each of the ECG electrodes <NUM><NUM>-<NUM><NUM> is attached to the patient <NUM>. In the embodiment of <FIG>, in contrast, the ECG system <NUM>' is configured with six electrodes in which ECG electrodes <NUM><NUM>-<NUM><NUM> may be the right leg, right arm, left arm, and left leg leads and ECG electrodes <NUM><NUM>-<NUM><NUM> may be any of the other voltage leads.

Although the number of electrodes in the embodiment of <FIG> is six, other embodiments may have other numbers of electrodes. Some embodiments may have as many as <NUM> electrodes, for example, as in the embodiment of <FIG> in which there are <NUM> ECG electrodes <NUM>. The present disclosure may be readily extrapolated by those skilled in the art having the benefit of this disclosure to any other number of electrodes. In theory, the technique disclosed herein may be applied to any number of electrodes so long as that number exceeds or is equal to three.

Each ECG electrode <NUM><NUM>-<NUM><NUM> may be represented by its resistive and capacitive components as well as an offset voltage. Thus, in <FIG>, ECG electrode <NUM><NUM> is represented by a resistance R<NUM> in parallel with a capacitance C<NUM>, both in series with an offset voltage Vos; the ECG electrode <NUM><NUM> is represented by a resistance R<NUM> in parallel with a capacitance C<NUM>, both in series with an offset voltage Vos; and so forth down to ECG electrode <NUM><NUM>, which is represented by a resistance R<NUM> in parallel with a capacitance C<NUM>, both in series with an offset voltage Uos. The resistances Rd5-Rd0 represent the line resistances of the individual leads to the ECG electrodes <NUM><NUM>-<NUM><NUM>.

Each ECG electrode <NUM><NUM>-<NUM><NUM> is associated with and electrically coupled to a respective current source I<NUM>-I<NUM> as shown, excepting only the ECG electrode <NUM><NUM>. The current sources I<NUM>-I<NUM> may be direct current ("DC") sources. The current sources I<NUM>-I<NUM> each drive or inject a respective current i<NUM>-i<NUM> through each respective ECG electrode <NUM><NUM>-<NUM><NUM> in a predetermined pattern as will be described below. The current sources I<NUM>-I<NUM> driving the current i<NUM>-i<NUM> through each respective ECG electrode <NUM><NUM>-<NUM><NUM> generates a respective voltage Vx1-Vx5 that is sensed at the points x<NUM>-x<NUM>. Each of the sensed voltages Vx1-Vx5 is converted to digital by a respective analog-to-digital converter ("A/D") for input to the processor-based control unit <NUM> to implement the functionality described herein.

The ECG electrode <NUM><NUM> receives a current i<NUM> from operational amplifier <NUM> driven by the voltage output <NUM> of averaging circuit ("AVG CKT") <NUM>. The output <NUM> of the averaging circuit <NUM> is the average of the three voltages Vx3-Vx5 at points x<NUM>-x<NUM> across the ECG electrodes <NUM><NUM>-<NUM><NUM>. The voltage output <NUM> may be a Wilson average voltage as described in <CIT>, entitled "Detecting Saturation in an Electrocardiogram Neutral Drive Amplifier,". The resistance value of the resistors R in the averaging circuit <NUM> may be, for example, in the range of <NUM> kΩ to <NUM> kΩ.

For purposes of the following description of how the capacitive component C<NUM>-C<NUM> of the contact impedance for each ECG electrode <NUM><NUM>-<NUM><NUM> may be determined. The following description therefor assumes a configuration for the ECG system <NUM>' in which there are six ECG electrodes. However, as discussed above, the value of ECG electrodes may vary depending upon the configuration of the ECG system <NUM>'. Those in the art having the benefit of this disclosure will be able to readily adapt the following discussion for those configurations in which there are numbers of ECG electrodes other than six.

The technique assumes that the ECG system <NUM>' is operating and has reached a steady state or that the steady state values have been determined using τ is described above. This includes the current sources I<NUM>-I<NUM> each driving a respective initial current i<NUM>-i<NUM> through each respective ECG electrode <NUM><NUM>-<NUM><NUM> and the operational amplifier <NUM> driving the initial current i<NUM> through ECG electrode <NUM><NUM>. The initial states of the voltages Vx0-Vx5 across the electrodes <NUM><NUM>-<NUM><NUM> sensed at points x<NUM>-x<NUM> in <FIG> may be represented by equations (<NUM>)-(<NUM>): <MAT> <MAT> <MAT> <MAT> <MAT> <MAT>.

In equations (<NUM>)-(<NUM>), Vb is the voltage across the body of the patient <NUM> and Vos is the offset voltage of the respective ECG electrode <NUM>. The contact impedances Z<NUM>-Z<NUM> and the current i<NUM> is represented by equations (<NUM>)-(<NUM>), in which s=jω, the Laplace variable that represents frequency ω=<NUM>πf. <MAT> <MAT>.

After capturing the initial state of the ECG system <NUM>', the technique makes a first pass in which certain, but not all, of the currents i<NUM>-i<NUM> are changed. More particularly, one of the ECG electrodes <NUM><NUM>-<NUM><NUM> is selected as a first reference ECG electrode for the first pass. Theoretically, the ECG electrode <NUM><NUM> could be selected as the reference ECG electrode. However, because its driving current i<NUM> is dependent on the voltages Vx5-Vx3, the current i<NUM> is less easily controlled.

In the first phase, the injected current ij for the reference ECG electrode <NUM> is kept the same while the injected current for the remaining ECG electrodes <NUM> is changed. In this example, for illustrative purposes, the ECG Electrode <NUM><NUM> is selected, and so the injected current i<NUM> remains unchanged. The injected currents i<NUM> and i<NUM>-i<NUM> are then changed to i<NUM>'and i<NUM>'-i<NUM>', which change i<NUM> to i<NUM>'. For example, the injected currents might be "flipped". This causes the voltages Vx0-Vx1 and Vx3-Vx5 to transition as shown in <FIG> and discussed above to Vx0'-Vx1' and Vx3'-Vx5'. Note that Rd and Vos for each respective ECG electrode <NUM> will remain unchanged.

Accordingly, after the injected currents i<NUM> and i<NUM>-i<NUM> are changed, the voltages Vx0'-Vx5' may be represented as equations (<NUM>)-(<NUM>). Note that in equation (<NUM>), the injected current i<NUM> remains unchanged relative to equation (<NUM>) because the ECG electrode <NUM><NUM> has been selected as the first reference ECG electrode. <MAT> <MAT> <MAT> <MAT> <MAT> <MAT>.

The contact impedances Z<NUM>-Z<NUM> in equations (<NUM>)-(<NUM>) are represented by equation (<NUM>) and the current i<NUM>' is represented by equation (<NUM>). Note, however, that, in application of equation (<NUM>), i<NUM>'=i<NUM> as described above.

The initial voltage Vx2 across the first reference ECG electrode <NUM><NUM> is subtracted from the initial voltages Vx0-Vx1 and Vx3-Vx5 across the ECG electrodes <NUM><NUM>-<NUM><NUM> and <NUM><NUM>-<NUM><NUM>. <MAT> <MAT> <MAT> <MAT> <MAT>.

Next, the voltage Vx2' across the first reference ECG electrode <NUM><NUM> from the first pass is subtracted from the initial voltages Vx0-Vx1 and Vx3-Vx5' across the ECG electrodes <NUM><NUM>-<NUM><NUM> and <NUM><NUM>-<NUM><NUM> from the first pass. <MAT> <MAT> <MAT> <MAT> <MAT>.

Equations (<NUM>)-(<NUM>) are then subtracted from equations (<NUM>)-(<NUM>), respectively. <MAT> <MAT> <MAT> <MAT> <MAT>.

Equations (<NUM>)-(<NUM>) can be rewritten as equations (<NUM>)-(<NUM>), where <MAT> Vxj and <MAT>. <MAT> <MAT> <MAT> <MAT> <MAT>.

In equations (<NUM>)-(<NUM>), Δ Vxj are based on measurements, Δixj are controlled values, Rdj are circuit constants, and Zj are unknowns that can be solved for based on the above systems of equations. If the measurement <MAT> is done after the system is stabilized or settled, the resistance value, Rj can be calculated: <MAT>.

However, if one captures a sample before changing the current sources (e.g., the initial state described above), Vxj(t=<NUM>-), and three samples after changing the current source, Vxj(t=<NUM> Ts, <NUM> Ts, <NUM> Ts), where Ts is the time between samples, then the time constant τj=RjCj, can be determined as discussed above relative to equations (<NUM>)-(<NUM>). This is because each Δ Vxj-Δ Vx2 (or other reference ECG electrode) is of the exponential function set forth in equation (<NUM>). There are multiple ways to solve for τ, the description above is just one way in which this may be done.

Once τj and Rj are determined, the capacitive component Cj can be found from equation (<NUM>).

Thus, the complete solution for the total impedance capacity including both resistive and capacitive components can be resolved from equation (<NUM>).

The technique as disclosed to this point has determined the total contact impedance for each of the ECG electrodes <NUM><NUM>-<NUM><NUM> and <NUM><NUM>-<NUM><NUM>. The total contact impedance for the ECG electrode <NUM><NUM> has not yet been determined because it was selected as the first reference ECG electrode for the first pass. More particularly, as the reference ECG electrode, the injected current i<NUM> for the ECG electrode <NUM><NUM> remained constant and was not changed. Since the technique determines the capacitive component of the contact impedance from the transition in the voltage as the injection current changes, and since there is no such transition in Vx2, the capacitive component of the contact impedance Z<NUM> cannot be found in the first pass.

Consequently, a second pass is made to determine Z<NUM>. In this second pass, a second reference ECG electrode is selected. Since the point is to determine the contact impedance of the first reference ECG electrode, the second reference ECG electrode is different from the first reference ECG electrode. For purposes of illustration, this discussion will select ECG electrode <NUM><NUM> as the second reference electrode for the second pass.

The injected currents i<NUM>'-i<NUM>' are therefore changed again while, this time, the injected current i<NUM>' remains unchanged. The change to the injected currents i<NUM>'-i<NUM>' needs to be significant enough to achieve a non-trivial change in i<NUM>'. A non-trivial change, in this context, would be one sufficient large so that the transition from Vx0' to Vx0" yields good results in the determinations to follow. The nature and amount of this non-trivial change will be implementation specific in a manner that will become apparent to those skilled in the art having the benefit of this disclosure. However, in general i<NUM>-i<NUM> should be set so that i<NUM>≠<NUM>.

Once the currents are changed, the value for τ is again determined as discussed relative to <FIG> above. The process laid out relative to <FIG> above can then be repeated to determine Z<NUM> (including the capacitive component C<NUM>) using Z<NUM> as the second reference. Note that this will result in a second set of equations based on new values for the quantities in Eqs. (<NUM>)-(<NUM>). Some embodiments may also repeat the process to determine Z<NUM>-Z<NUM> and Z<NUM>-Z<NUM> again. However, this is not necessary as these quantities have already been determined. At this point, each of Z<NUM>-Z<NUM> has been determined, each determined Z<NUM>-Z<NUM> including the capacitive component thereof.

Note that, as mentioned above, the presently disclosed embodiment determines the contact impedance Zj for each of six ECG electrodes. The technique may be readily adapted to any number of ECG electrodes given the disclosure presented herein. Thus, the technique is readily adaptable to, for instance, the <NUM> electrode, <NUM> lead configuration described above.

Accordingly, in at least one aspect, the presently disclosed technique includes the method <NUM> in <FIG>. The method <NUM> may be performed by, for example, the processor-based control unit <NUM> of the ECG system <NUM> in <FIG>. The method <NUM> may therefore be a software-implemented method in these embodiments.

The method <NUM> includes determining (at <NUM>) a respective resistive component for each respective contact impedance of each respective ECG electrode of a plurality of monitored ECG electrodes (e.g., ECG electrodes <NUM><NUM>-<NUM><NUM>) ostensibly electrically connected to a human body (e.g., the body of patient <NUM>) and determining (at <NUM>) a respective capacitive component (e.g., Cj) for each respective contact impedance (e.g., Z<NUM>-Z<NUM>) of each respective ECG electrode. The presently disclosed embodiment determines the resistive component in the course of determining the capacitive component. However, this is not necessary in all embodiments. The resistive component may be determined (at <NUM>) in any suitable manner known to the art. Furthermore, determining (at <NUM>) the resistive component may also be determined either before or after the capacitive component is determined (at <NUM>).

Determining (at <NUM>) a respective capacitive component for each respective contact impedance begins, in this particular embodiment, by selecting (at <NUM>) a first reference ECG electrode from among the plurality of ECG electrodes. The remainder of the ECG electrodes becoming non-reference ECG electrodes. In the example set forth above, the first reference ECG electrode is ECG electrode <NUM><NUM> and ECG electrodes <NUM><NUM>-<NUM><NUM> and <NUM><NUM>-<NUM><NUM> are non-reference ECG electrodes.

Next, the respective contact impedance for each of the non-reference ECG electrodes is determined (at <NUM>) from a first transition from a respective first ECG electrode voltage to a respective second ECG electrode voltage as a plurality of electrical currents driven through the ECG electrodes change, each respective contact impedance including a resistive component and a capacitive component. In the example above, the respective contact impedances are Z<NUM>-Z<NUM> and Z<NUM>-Z<NUM>; the first ECG electrode voltages are Vx0-Vx1 and Vx3-Vx5; the second ECG electrode voltages are Vx0'-Vx1' and Vx3'-Vx5'; and the driven electrical currents are i<NUM> and i<NUM>-i<NUM> that change to i<NUM>' and i<NUM>'-i<NUM>'.

The method <NUM> then proceeds by selecting (at <NUM>) a second reference ECG electrode from among the ECG electrodes, the second reference ECG electrode being different from the first reference ECG electrode, the rest of the ECG electrodes becoming second non-reference ECG electrodes. In the example described above, the second reference ECG electrode is ECG electrode <NUM><NUM>. Note that the second reference ECG electrode is different from the first so that the contact impedance of the first reference ECG electrode may be determined.

The method <NUM> then concludes by determining (at <NUM>) the respective contact impedance for the non-reference ECG electrode previously identified as the first reference electrode from a second transition from a respective second ECG electrode voltage to a respective third ECG electrode voltage as the electrical currents driven through the ECG electrodes changes, the respective contact impedance including a resistive component and a capacitive component.

Returning to <FIG>, once the complete contact impedance, including both resistive and capacitive components, is known for each of the ECG electrodes, the ECG electrodes can be used to more accurately monitor the ECG procedure <NUM>. The disclosure uses the complete contact impedance to monitor for lead-off conditions as was discussed above. If a lead-off condition is detected, then an alarm can be sounded to alert nearby personnel that attention is needed. Table <NUM> sets forth monitored conditions for contact impedance and whether those conditions lead to an alarm.

Whether a determined resistive or capacitive component is "high" or "low" is determined by comparing the value thereof against a threshold. The value for the threshold may vary by implementation and embodiment as discussed above. However, on one particular embodiment, a high resistive component is one that is greater than 4MΩ and a low capacitive component is one that is less than 5nF.

Accordingly, and still referring to <FIG>, when the processor-based control unit <NUM> determines that the resistive component is high and the capacitive component is low for any particular ECG electrode <NUM>, a signal is provided to the alarm generator <NUM>. The alarm generator <NUM> then issues an alarm, whether aural, visual, or both. Note from Table <NUM> that the presently disclosed technique does not trigger a false alarm when the resistive component is high and the capacitive component is high. The presently disclosed technique is furthermore capable of distinguishing between that false alarm condition and a true alarm condition because the actual value of the capacitive component of the contact impedance is known. The presently disclosed technique may therefore forego lead-off false alarms that may be experienced in other, conventional ECG monitoring systems.

The foregoing outlines the features of several embodiments so that those of ordinary skill in the art may better understand various aspects of the present disclosure. Those of ordinary skill in the art should appreciate that they may readily use the present disclosure as a basis for designing or modifying other processes and structures for carrying out the same purposes and/or achieving the same advantages of various embodiments introduced herein.

Although the subject matter has been described in language specific to structural features or methodological acts, it is to be understood that the subject matter of the appended claims is not necessarily limited to the specific features or acts described above. Rather, the specific features and acts described above are disclosed as example forms of implementing at least some of the claims.

Various operations of embodiments are provided herein. The order in which some or all of the operations are described should not be construed to imply that these operations are necessarily order dependent. Alternative ordering will be appreciated having the benefit of this description. Further, it will be understood that not all operations are necessarily present in each embodiment provided herein. Also, it will be understood that not all operations are necessary in some embodiments.

It will be appreciated that layers, features, elements, etc., depicted herein are illustrated with particular dimensions relative to one another, such as structural dimensions or orientations, for example, for purposes of simplicity and ease of understanding and that actual dimensions of the same differ substantially from that illustrated herein, in some embodiments. Moreover, "exemplary" is used herein to mean serving as an example, instance, illustration, etc., and not necessarily as advantageous. As used in this application, "or" is intended to mean an inclusive "or" rather than an exclusive "or". In addition, "a" and "an" as used in this application and the appended claims are generally be construed to mean "one or more" unless specified otherwise or clear from context to be directed to a singular form. Also, at least one of A and B and/or the like generally means A or B or both A and B. Furthermore, to the extent that "includes", "having", "has", "with", or variants thereof are used, such terms are intended to be inclusive in a manner similar to the term "comprising". Also, unless specified otherwise, "first," "second," or the like are not intended to imply a temporal aspect, a spatial aspect, an ordering, etc. Rather, such terms are merely used as identifiers, names, etc. for features, elements, items, etc. For example, a first element and a second element generally correspond to element A and element B or two different or two identical elements or the same element.

Claim 1:
A method, comprising:
monitoring a plurality of Electrocardiogram, "ECG", electrodes ostensibly electrically connected to a human body, wherein each ECG electrode is associated with and electrically coupled to a respective current source, except one ECG electrode which receives a current from an operational amplifier driven by a voltage output from an averaging circuit, the current sources being configured to each drive or inject a respective current through each respective ECG electrode;
determining the respective contact impedance for each of the ECG electrodes as a plurality of electrical currents is driven through the ECG electrodes in a predetermined pattern, each respective contact impedance including a resistive component and a capacitive component; and
ascertaining whether any of the determined resistive components of the contact impedances exceed a predetermined first threshold, and ascertaining whether any of the determined capacitive components of the contact impedances exceed a predetermined second threshold; and
if, for any particular ECG electrode, the determined resistive component of the contact impedance is higher than the predetermined first threshold and the capacitive component of the contact impedance is lower than the predetermined second threshold, issuing an alarm.