Patent Publication Number: US-2010113964-A1

Title: Determining intercardiac impedance

Description:
BACKGROUND OF THE DISCLOSURE 
     The present disclosure relates to determining intercardiac impedance. In particular, it relates to determining complex intercardiac impedance to detect various cardiac functions. 
     SUMMARY OF THE DISCLOSURE 
     The present disclosure relates to an apparatus, system, and method for determining intercardiac impedance to detect various cardiac functions. In one or more embodiments, the method for determining complex intercardiac impedance involves providing an adjustable direct current signal, modulating the adjustable direct current signal to produce a modulated signal, propagating the modulated signal across a myocardium, detecting an outputted modulated signal from the myocardium, and using at least one circuit to reduce the influence of process noise (aggressors) in the outputted modulated signal. 
     In one or more embodiments, the at least one circuit performs the steps comprising amplifying the outputted modulated signal to produce a second outputted modulated signal, wherein the second outputted modulated signal has a signal of interest that is amplified at a higher frequency than the process noise (aggressors); demodulating the second outputted modulated signal to produce a third outputted modulated signal, wherein the third outputted modulated signal has the signal of interest demodulated to a lower frequency and the process noise (aggressors) becomes modulated to a higher frequency; and passing the third outputted modulated signal through an integrator to produce a fourth outputted modulated signal, wherein the fourth outputted modulated signal has the signal of interest retained and the process noise (aggressors) filtered out. 
     In one or more embodiments, the amplitude and phase of the fourth outputted modulated signal indicate the complex impedance of the myocardium. In addition, changes in the complex impedance patterns of the myocardium provide indication of various cardiac functions and an ischemic event. Also, changes in patterns sensed by a combination of correlated sensors for specific regions of the heart provide indication of various cardiac functions and an ischemic event. 
     In one or more embodiments, the direct current signal is adjustable. Additionally, in some embodiments, the modulated signal has a nominal frequency of approximately 4 kilo Hertz to prevent interference with functions of other implanted devices. 
     In one or more embodiments, the method for determining intercardiac impedance may further comprise the steps of generating a signal when an ischemic event is indicated, where the signal contains an alert message; and transmitting the signal. 
     In one or more embodiments, the apparatus, system, and/or method is employed with at least one implantable medical device (IMD). In some embodiments, the at least one implantable medical device (IMD) is a cardiac pacemaker. In other embodiments, the at least one implantable medical device (IMD) is an implantable cardioverter defibrillator (ICD). 
     In one or more embodiments, a system is used for determining intercardiac impedance. The system comprises a signal generator for providing an adjustable direct current signal, a modulator for modulating the adjustable direct current signal to produce a modulated signal, at least one electrode for propagating the modulated signal across a myocardium, at least one sensor for detecting an outputted modulated signal from the myocardium; and at least one circuit to reduce the influence of process noise (aggressors) in the outputted modulated signal. 
     In one or more embodiments, at least one circuit comprises an amplifier for amplifying the outputted modulated signal to produce a second outputted modulated signal, wherein the second outputted modulated signal has a signal of interest that is amplified at a higher frequency than the process noise (aggressors); a demodulator for demodulating the second outputted modulated signal to produce a third outputted modulated signal, wherein the third outputted modulated signal has the signal of interest demodulated to a lower frequency and the process noise (aggressors) becomes modulated to a higher frequency; and an integrator for passing the third outputted modulated signal through to produce a fourth outputted modulated signal, wherein the fourth outputted modulated signal has the signal of interest retained and the process noise (aggressors) filtered out, wherein the amplitude and phase of the fourth outputted modulated signal indicate the complex impedance of the myocardium. 
     In one or more embodiments, at least one electrode is a left ventricular tip (LVTIP) electrode, and the at least one sensor is a right ventricular coil (RVCOIL) sensor. In some embodiments, the at least one electrode is a left ventricular tip (LVTIP) electrode, and the at least one sensor is a right ventricular ring (RVRING) sensor. In other embodiments, the at least one electrode is a right ventricular tip (RVTIP) electrode, and the at least one sensor is a right ventricular ring (RVRING) sensor. In some embodiments, the at least one electrode is a left ventricular tip (LVTIP) electrode, and the at least one sensor is a left superior vena cava coil (SVCCOIL) sensor. In other embodiments, the at least one electrode is a right ventricular tip (RVTIP) electrode, and the at least one sensor is a superior vena cava coil (SVCCOIL) sensor. 
     In one or more embodiments, the system for determining intercardiac impedance may further comprise a signal generator for generating a signal when an ischemic event is indicated, where the signal contains an alert message; and a transmitter for transmitting the signal. 
     In one or more embodiments, a system is used for determining intercardiac impedance. The system comprises a signal generator means for providing an adjustable direct current signal; a modulator means for modulating the adjustable direct current signal to produce a modulated signal; at least one electrode means for propagating the modulated signal across a myocardium; at least one sensor means for detecting an outputted modulated signal from the myocardium; and at least one circuit means for reducing the influence of process noise (aggressors) in the outputted modulated signal. 
     In one or more embodiments, the at least one circuit means comprises an amplifier means for amplifying the outputted modulated signal to produce a second outputted modulated signal, wherein the second outputted modulated signal has a signal of interest that is amplified at a higher frequency than the process noise (aggressors); a demodulator means for demodulating the second outputted modulated signal to produce a third outputted modulated signal, wherein the third outputted modulated signal has the signal of interest demodulated to a lower frequency and the process noise (aggressors) becomes modulated to a higher frequency; and an integrator means for passing the third outputted modulated signal through to produce a fourth outputted modulated signal, wherein the fourth outputted modulated signal has the signal of interest retained and the process noise (aggressors) filtered out, wherein amplitude and phase of the fourth outputted modulated signal indicate the complex impedance of the myocardium. 
     In one or more embodiments, the system for determining intercardiac impedance may further comprise a signal generator means for generating a signal when an ischemic event is indicated, where the signal contains an alert message; and a transmitter means for transmitting the signal. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
       These and other features, aspects, and advantages of the present disclosure will become better understood with regard to the following description, appended claims, and accompanying drawings where: 
         FIG. 1  is an illustration of a myocardium containing sensors for determining intercardiac impedance in accordance with at least one embodiment of the present disclosure. 
         FIG. 2  is a schematic circuit diagram for determining intercardiac impedance in accordance with at least one embodiment of the present disclosure. 
         FIG. 3  is a graphical representation of the stimulation current (Istim) in the time domain in accordance with at least one embodiment of the present disclosure. 
         FIG. 4  is a graphical representation of modulated signal V 1  in the time domain in accordance with at least one embodiment of the present disclosure. 
         FIG. 5  is a graphical representation of outputted modulated signal V 2  in the time domain in accordance with at least one embodiment of the present disclosure. 
         FIG. 6  is a graphical representation of outputted modulated signal VA in the time domain in accordance with at least one embodiment of the present disclosure. 
         FIG. 7  is a graphical representation of outputted modulated signal VA′ in the time domain in accordance with at least one embodiment of the present disclosure. 
         FIG. 8  is a graphical representation of outputted modulated signal VB in the time domain in accordance with at least one embodiment of the present disclosure. 
         FIG. 9  is a graphical representation of outputted modulated signal Vout in the time domain in accordance with at least one embodiment of the present disclosure. 
         FIG. 10  is a graphical representation of the stimulation current (Istim) in the frequency domain in accordance with at least one embodiment of the present disclosure. 
         FIG. 11  is a graphical representation of modulated signal V 1  in the frequency domain in accordance with at least one embodiment of the present disclosure. 
         FIG. 12  is a graphical representation of outputted modulated signal V 2  in the frequency domain in accordance with at least one embodiment of the present disclosure. 
         FIG. 13  is a graphical representation of outputted modulated signal VA in the frequency domain in accordance with at least one embodiment of the present disclosure. 
         FIG. 14  is a graphical representation of outputted modulated signal VA′ in the frequency domain in accordance with at least one embodiment of the present disclosure. 
         FIG. 15  is a graphical representation of outputted modulated signal VB in the frequency domain in accordance with at least one embodiment of the present disclosure. 
         FIG. 16  is a graphical representation of outputted modulated signal Vout in the frequency domain in accordance with at least one embodiment of the present disclosure. 
     
    
    
     DETAILED DESCRIPTION 
     The methods and apparatus disclosed herein provide an operative system for determining intercardiac impedance. Specifically, this system allows for determining complex intercardiac impedance to detect various cardiac functions including, but not limited to, contractility, capture detection, atrium-ventricle optimization, right ventricular function, left ventricular function, cardiac output (stroke volume), and right to left ventricular synchronization. In addition, this system allows for the monitoring of complex intercardiac impedance for the detection of ischemia, which is related to myocardial tissue viability. Ischemia is an absolute or relative shortage of blood supply to an organ, which causes tissue damage because of the lack of oxygen and nutrients to the affected tissue. 
     The present disclosure describes a system comprising an implantable medical device (IMD) that includes an intercardiac impedance measurement circuit. Implantable medical devices (IMDs) are devices that are designed to be implanted into a patient. Examples of implantable medical devices to be utilized with this system include, but are not limited to, cardiac pacemakers, implantable cardioverter defibrillators (ICDs), and other devices that include a combination of pacing and defibrillation including cardiac resynchronization therapy. These implantable devices are typically used to treat patients using electrical therapy. In addition, these devices may include electrical leads connected to sensors located on the myocardium that are used to monitor electrical signals. 
     The intercardiac impedance measurement circuit employed by this system is adapted to be coupled to implantable electrodes/sensors in order to obtain an intercardiac impedance signal between the electrodes/sensors. The amplitude and phase of the intercardiac impedance signal indicate the complex impedance of the myocardium. The complex impedance of the myocardium can be used to detect various cardiac functions. 
     The complex impedance of the myocardium typically fluctuates in a corresponding pattern with the beating of the heart. Changes in the complex impedance patterns of the myocardium can indicate reduced oxygen and blood flow to the myocardium and, thus, provide a method for an immediate indication of an acute ischemic event (acute myocardial infarction (AMI)). The system of the present disclosure monitors the impedance of the heart and, thus, is able to detect possible ischemia of the myocardium. In addition, changes in the patterns sensed by a combination of correlated sensors for specific regions of the heart may provide indication of various cardiac functions and/or an ischemic event. In the event that an ischemic event is detected, the system may cause a signal, which is carrying an alert message, to be generated and transmitted directly to the patient or sent through telemetry links to a monitoring receiver. Various telemetry methods and systems may be employed by the system of the present disclosure. 
     In the following description, numerous details are set forth in order to provide a more thorough description of the system. It will be apparent, however, to one skilled in the art, that the disclosed system may be practiced without these specific details. In the other instances, well known features have not been described in detail so as not to unnecessarily obscure the system. 
       FIG. 1  contains an illustration of a myocardium  110  containing electrodes and/or sensors for determining intercardiac impedance in accordance with at least one embodiment of the present disclosure. In this illustration, a human heart  110  is depicted as having electrodes and/or sensors ( 130 ,  135 ,  140 ,  145 ,  150 ,  155 ,  160 , and  165 ) located at various points on the myocardium  110 . 
     Also depicted in this figure is an implantable medical device (IMD)  100  that is in electrical communication with a patient&#39;s heart  110  by the use of at least three electrical leads ( 115 ,  120 , and  125 ). Right ventricular lead  115  has at least a superior vena cava (SVC) coil electrode/sensor  130 , a right ventricular coil (RVCOIL) electrode/sensor  140 , a right ventricular ring (RVRING) electrode/sensor  145 , and/or a right ventricular tip (RVTIP) electrode/sensor  150 . In addition, right atrial lead  120  has at least a right atrial tip (RATIP) electrode/sensor  135  and/or a right atrial ring (RARING) electrode/sensor  170 . Additionally, coronary sinus lead  125  has at least a left ventricular tip (LVTIP) electrode/sensor  165 , multiple left ventricular (LV) electrodes/sensors (not shown in figure), a left atrial ring (LARING) electrode/sensor, and/or a left atrial coil (LACOIL) electrode/sensor. 
     In one or more embodiments, the system of the present disclosure is able to obtain an intercardiac impedance signal between at least one electrode and at least one sensor. In at least one embodiment, a right ventricle coil (RVCOIL) sensor  140  may detect an impedance signal that originated from left ventricle tip (LVTIP) electrode  165 . In some embodiments, a right ventricular ring (RVRING) sensor  145  may detect an impedance signal that originated from the left ventricle tip (LVTIP) electrode  165 . In one or more embodiments, a right ventricular ring (RVRING) sensor  145  may detect an impedance signal that originated from the right ventricular tip (RVTIP) electrode  150 . These three specific signal paths each indicate an impedance signal that is proportional to blood flow, and provide a first derivative that is an indication of cardiac contractility. In addition, a change in complex impedance pattern for any of these particular signal paths can indicate that the portion of the heart the path crosses has been affected by ischemia. Thus, the various combinations of electrodes and sensors that are employed by this system provide comprehensive vector coverage of the heart. 
     In one or more embodiments, the disclosed system allows for determining intercardiac impedance to detect various cardiac functions including, but not limited to, contractility, capture detection, atrium-ventricle optimization, right ventricular function, left ventricular function, cardiac output (stroke volume), and right to left ventricular synchronization. A single impedance signal path can indicate various cardiac functions as well as the presence of ischemia of the corresponding region of the heart  110  that the signal path crosses. 
     In one or more embodiments, for example, an impedance signal path from a right ventricular tip (RVTIP) electrode  150  to a superior vena cava coil (SVCCOIL) sensor  130  can detect various cardiac functions of the right side of the heart  110 . In another example, an impedance signal path from a right atrial tip (RATIP) electrode  135  to the superior vena cava coil (SVCCOIL) sensor  130  can also detect various cardiac functions of the right side of the myocardium  110 . In an additional example, an impedance signal path from a left ventricular tip (LVTIP) electrode  165  to a superior vena cava coil (SVCCOIL) sensor  130  can detect various cardiac functions of the left side of the heart  110 . In yet another example, an impedance signal patch from a right atrial ring (RARING) electrode  160  to a superior vena cava coil (SVCCOIL) sensor  130  can detect various cardiac functions of the left side of the heart  110 . 
     In other embodiments of this system, the system may employ more or less electrodes and/or sensors than are illustrated in  FIG. 1 . Also, in alternative embodiments, electrodes and/or sensors may be placed at other locations of the myocardium  110  than are shown in the  FIG. 1 . 
       FIG. 2  contains a schematic circuit diagram  200  for determining intercardiac impedance in accordance with at least one embodiment of the present disclosure. In this figure, a stimulation current (Istim), which is a direct current (DC) signal, is first generated. The stimulation current (Istim) is adjustable. In one or more embodiments, the stimulation current (Istim) is adjustable at discrete values between approximately 500 nano amperes and approximately 10 microamperes. In alternative embodiments, the stimulation current (Istim) may be adjustable at various other ranges. The current is generated by switching a programmable resistor in series with a supply. Alternatively, the stimulation current (Istim) may be generated by other means including, but not limited to, various signal generators. 
     The stimulation current (Istim) is then modulated  220  at a nominal frequency of approximately 4 kilo Hertz (KHz) by a modulator  250  to produce modulated signal V 1 . The nominal frequency of approximately 4 KHz prevents interference with functions of other implanted devices. The modulation of the stimulation current (Istim) allows for the stimulation and measurement circuitry to be isolated from the direct current (DC) potentials on the lead pathway. In alternative embodiments, the signal is modulated at various other frequencies. In one or more embodiments of this system, the signal is modulated into a square wave. However, in alternative embodiments, the signal can be modulated into, but not limited to, a sinusoid, or pulses. 
     The modulated signal V 1  is then propagated from at least one electrode located on the myocardium through the myocardium  210 . At least one sensor located on the myocardium  210  senses the outputted modulated signal V 2 . The outputted modulated signal V 2  is combined with process noise (aggressors)  230 . The resultant signal that contains the impedance signal of the heart with process noise (aggressors)  230  is outputted modulated signal VA. The resultant outputted modulated signal VA is then passed through at least one circuit  290  to reduce the influence of process noise (aggressors)  230  in the outputted modulated signal VA. 
     In the at least one circuit  290 , the outputted modulated signal VA is amplified through an amplifier  240  to produce outputted modulated signal VA′. Outputted modulated signal VA′ has a signal of interest that is amplified at a higher frequency than the process noise (aggressors)  230  within the signal. Outputted modulated signal VA′ is then demodulated  280  by demodulator  250  to produce outputted modulated signal VB. Outputted modulated signal VB has a signal of interest that is demodulated to a lower frequency and its process noise (aggressors)  230  becomes modulated to a higher frequency. 
     In one or more embodiments, a feedback loop  270  is employed to reduce errors that result from the low bandwidth of the amplifier  240  and to set the gain. In the circuit, outputted modulated signal VB is passed through an integrator  260  to produce outputted modulated signal Vout. The integrator  260  stabilizes the feedback loop  270  and acts as a low pass filter. In one or more embodiments of the system, an additional resistor-capacitor (RC) low pass filter is included at the output of the at least one circuit  290  to further isolate the signal of interest. 
     The resultant signal of interest of the outputted modulated signal Vout indicates the impedance of the area of the myocardium that the signal passed through. If demodulator  250  is clocked in phase with the simulation current (Istim), the real impedance is measured from outputted modulated signal Vout. Alternatively, if the demodulator  250  is clocked at - 90  degrees with respect to the stimulation current (Istim), the imaginary part of the impedance is measured from the outputted modulated signal Vout. 
       FIG. 3  contains a graphical representation of the stimulation current (Istim) in the time domain in accordance with at least one embodiment of the present disclosure. In this figure, the stimulation current (Istim) is depicted as a direct current (DC) signal.  FIG. 4  illustrates a graphical representation of modulated signal V 1  in the time domain in accordance with at least one embodiment of the present disclosure. In this figure, the stimulation current (Istim) is shown to have been modulated at approximately 4 kHz into a square wave. 
       FIG. 5  illustrates a graphical representation of outputted modulated signal V 2  in the time domain in accordance with at least one embodiment of the present disclosure. In this figure, the reactive outputted modulated signal V 2  is depicted has having a shift in phase versus  FIG. 4 . The amount of shift in phase of the signal is related to the amount of the reactive component of the impedance of the signal.  FIG. 6  is a graphical representation of outputted modulated signal VA in the time domain in accordance with at least one embodiment of the present disclosure. In this figure, the outputted modulated signal VA includes process noise (aggressors). 
       FIG. 7  shows a graphical representation of outputted modulated signal VA′ in the time domain in accordance with at least one embodiment of the present disclosure. This figure shows the resultant amplified signal, which is the outputted modulated signal VA′.  FIG. 8  contains a graphical representation of outputted modulated signal VB in the time domain in accordance with at least one embodiment of the present disclosure. In this figure, the resultant demodulated signal, outputted modulated signal VB, is depicted.  FIG. 9  illustrates a graphical representation of outputted modulated signal Vout in the time domain in accordance with at least one embodiment of the present disclosure. This figure shows the resultant signal, outputted modulated signal Vout, after it has passed through an integrator. 
       FIG. 10  contains a graphical representation of the stimulation current (Istim) in the frequency domain in accordance with at least one embodiment of the present disclosure. In this figure, the stimulation current (Istim) signal  1010  is shown.  FIG. 11  shows a graphical representation of modulated signal V 1  in the frequency domain in accordance with at least one embodiment of the present disclosure. In this figure, the signal of interest  1110  of modulated signal V 1  has been modulated to a carrier frequency, “fchop”. This frequency is chosen to be outside the bandwidth of typical aggressors, which include environmental noise. 
       FIG. 12  is a graphical representation of outputted modulated signal V 2  in the frequency domain in accordance with at least one embodiment of the present disclosure. In this figure, it is evident that the modulated signal of interest  1210  of outputted modulated signal V 2  has a lower signal amplitude than the modulated signal of interest  1110  of modulated signal V 1 , which is depicted in  FIG. 11 .  FIG. 13  contains a graphical representation of outputted modulated signal VA in the frequency domain in accordance with at least one embodiment of the present disclosure. This figure shows the inclusion of aggressors  1320  with the modulated signal of interest  1310  in outputted modulated signal VA. 
       FIG. 14  shows a graphical representation of outputted modulated signal VA′ in the frequency domain in accordance with at least one embodiment of the present disclosure. In this figure, it is shown that the outputted modulated signal VA′ has a modulated signal of interest  1410  that is amplified at a higher frequency than the aggressors  1420 .  FIG. 15  illustrates a graphical representation of outputted modulated signal VB in the frequency domain in accordance with at least one embodiment of the present disclosure. This figure shows that outputted modulated signal VB has a signal of interest  1510  that is demodulated to a lower frequency and has aggressors  1520  that are modulated to a higher frequency. This figure also depicts the low pass filter of the integrator that outputted modulated signal VB will be passed through to produce outputted modulated signal Vout. 
       FIG. 16  is a graphical representation of outputted modulated signal Vout in the frequency domain in accordance with at least one embodiment of the present disclosure. In this figure, it is shown that the outputted modulated signal Vout has a signal of interest  1610  that is retained and aggressors  1620  that have been filtered out by an integrator acting as a low pass filter. 
     Although certain illustrative embodiments and methods have been disclosed herein, it can be apparent from the foregoing disclosure to those skilled in the art that variations and modifications of such embodiments and methods can be made without departing from the true spirit and scope of the art disclosed. Many other examples of the art disclosed exist, each differing from others in matters of detail only. Accordingly, it is intended that the art disclosed shall be limited only to the extent required by the appended claims and the rules and principles of applicable law.