Heart sound sensing to reduce inappropriate tachyarrhythmia therapy

A method and device for detecting a cardiac event that includes sensing cardiac electrical signals representative of electrical activity of a heart of a patient, detecting the cardiac event in response to the sensed cardiac signals, determining an indication of signal reliability corresponding to the sensed cardiac signals as being one of a reliable signal and a not reliable signal, and switching operation of the device between a first mode of determining whether the sensed signal is one of treatable and not treatable and a second mode of determining whether the sensed signal is one of treatable and not treatable in response to the determined indication of signal reliability.

FIELD OF THE DISCLOSURE

This disclosure relates to medical devices and, more particularly, to medical devices that delivery therapy to terminate tachyarrhythmias.

BACKGROUND

Medical devices, such as implantable cardioverter-defibrillators, provide therapeutic electrical stimulation to the heart in order to terminate tachyarrhythmia, such as tachycardia or fibrillation. The electrical stimulation may include signals such as pulses or shocks for pacing, cardioversion or defibrillation. In some cases, the medical device may sense intrinsic depolarizations of the heart, detect tachyarrhythmia based on the intrinsic depolarizations, and control delivery of electrical stimulation to the heart if tachyarrhythmia is detected based on the intrinsic depolarizations.

Medical devices sense cardiac electrical signals and deliver therapeutic stimulation via electrodes. Implantable pacemakers, cardioverters, defibrillators, or pacemaker-cardioverter-defibrillators are typically coupled to one or more intracardiac leads that carry electrodes for cardiac sensing and delivery of therapeutic stimulation. The cardiac electrical signals sensed via the electrodes may be referred to as a cardiac electrogram (EGM). In some systems, electrodes positioned outside the heart, for example in subcutaneous or submuscular locations are used to sense electrocardiogram (ECG) signals. The cardiac electrical signals include depolarizations and other intrinsic electrical activity of the heart.

In some cases, a medical device delivers therapeutic electrical stimulation, such as a defibrillation pulse, when the stimulation is not required. Delivery of such therapy by a medical device is often due to misinterpretation of the cardiac EGM (or ECG) as indicating a rapid or unstable ventricular tachycardia or ventricular fibrillation. In some cases, the medical device detects a rapid ventricular tachycardia or ventricular fibrillation when the cardiac rhythm is in fact stable, or otherwise not requiring a defibrillation pulse, such as sinus tachycardia (ST), supraventricular tachycardia (SVT), or rapid atrial tachycardia/atrial fibrillation (AT)/(AF) conducted to the ventricles, or a hemodynamically stable ventricular tachycardia (VT). In some cases, the medical device misinterprets T-waves in the cardiac EGM as R-waves, which is referred to as T-wave over-sensing (TWOS), and may cause the medical device to interpret the cardiac rhythm as having a higher ventricular rate than the actual rate. In some cases, the medical device over-senses R-waves due to non-physiological or non-cardiac signals in the cardiac EGM, which may be the result of electromagnetic interference (EMI), EGM clipping, lead fracture, or muscle noise, as examples. Implantable medical devices that detect the cardiac EGM via implantable medical leads may be susceptible to oversensing due to non-physiological or non-cardiac signals in the cardiac EGM.

DETAILED DESCRIPTION

The techniques described in this disclosure allow a medical device to use a heart sound signal to reduce inappropriate delivery of tachyarrhythmia therapy. Analysis of heart sound signals may reduce inappropriate delivery of therapy because heart sounds provide complementary information that can be used to corroborate EGM based decisions when the EGM signal is reliable. In addition, heart sounds are not susceptible to the same noise sources or other misinterpretation issues as EGMs. For example, the heart sound sensor may be more immune to noise that negatively effects EGMs, such as EMI, lead fracture, and muscle noise. As such, heart sound signals may be relied upon for therapy decisions when the EGM signal is determined to be unreliable.

In general, heart sounds are associated with mechanical vibrations of a patient's heart and the flow of blood through the heart and, thus, are highly correlated with pressure gradients across heart valves and blood pressure. Heart sounds are not only due to vibrations of and pressure within the heart, but may be due to the whole cardiohemic system, e.g., blood, heart, great arteries, etc. Heart sounds recur with each cardiac cycle and are separated and classified according to the activity associated with the vibration. The first heart sound is referred to as “S1,” and can be thought of as the vibrational sound made by the heart during closure of the atrioventricular (AV) valves, i.e., the mitral valve and tricuspid valve. The second heart sound is referred to as “S2,” and results from the closure of the semilunar valves, i.e., the pulmonary and aortic valves. The S2heart sound can be thought of as marking the beginning of diastole. The third and fourth heart sounds are referred to as “S3” and “S4,” respectively, and can be conceptualized as related to filling of the ventricles during diastole. S3is due to rapid filling of the ventricles and can occur when the ventricular wall is not relaxed when a large volume of blood flows into the ventricle from the atria. S4is caused by blood rapidly filling into the ventricles from the atria due to atrial contraction.

The described techniques may enhance specificity with minimal impact on sensitivity. In particular, the described techniques may successfully withhold an incorrect EGM based decision that a rhythm is treatable with a therapy, such as defibrillation, and not withhold a correct EGM based decision that a rhythm is a treatable ventricular tachycardia (VT) or ventricular fibrillation (VF).

Additionally, a heart sound sensor, such as a piezoelectric sensor or other acoustic sensor, may be easy to implement with an implantable medical device (IMD), e.g., on a lead or within a housing of the IMD. Enclosing the sensor within the housing of the IMD may provide additional protection for the sensor.

FIG. 1is a conceptual diagram illustrating an example system10that detects heart sounds to reduce inappropriate delivery of tachyarrhythmia therapy to patient14. In particular, system10determines whether a cardiac rhythm of patient14is treatable based, at least in part, on detected heart sounds of the patient. In some examples, system10may first determine whether a cardiac rhythm is treatable or non-treatable based on a cardiac EGM. The system then determines whether the EGM signal is reliable. Based on the EGM reliability, the system selects a heart sound analysis algorithm to confirm the rhythm determination based on monitored heart sounds of patient14. For example, if the EGM is found unreliable, e.g. due to noise corruption or oversensing, detection of heart sounds and analysis of heart sound data is performed independent of the EGM signal. If the EGM signal is found reliable, acquisition and analysis of heart sound data is performed dependent on the EGM signal, e.g. using EGM-gated ensemble averaging. Based on detected heart sounds, system10may confirm a tachyarrhythmia detection and deliver the therapy to patient14, or deny the detection and withhold the therapy. Determining whether a rhythm is treatable or non-treatable based on both EGM and heart sounds may reduce inappropriate delivery of tachyarrhythmia therapy to patient14.

System10includes implantable medical device (IMD)16, which is connected to leads18,20, and22, and communicatively coupled to a programmer24. IMD16senses electrical signals attendant to the depolarization and repolarization of heart12, e.g., a cardiac EGM, via electrodes on one or more of leads18,20and22or a housing of IMD16. IMD16also delivers therapy in the form of electrical signals to heart12via electrodes located on one or more leads18,20, and22or a housing of IMD16, such as pacing, cardioversion and/or defibrillation pulses. IMD16also includes, or is coupled to via one or more of leads18,20and22, one or more heart sound sensors (not shown inFIG. 1). IMD16may similarly include or be coupled to other sensors, such as one or more accelerometers, for detecting other physiological parameters of patient14, such as activity or posture.

In some examples, programmer24takes the form of a handheld computing device, computer workstation, or networked computing device that includes a user interface for presenting information to and receiving input from a user. A user, such as a physician, technician, surgeon, electrophysiologist, or other clinician, may interact with programmer24to communicate with IMD16. For example, the user may interact with programmer24to retrieve physiological or diagnostic information from IMD16. A user may also interact with programmer24to program IMD16, e.g., select values for operational parameters of the IMD.

In some embodiments programmer24may be coupled to a server via a communication network to enable a user to interact with programmer24remotely using a computing device coupled to the server. Examples of such a system and network configuration including IMD16and programmer24are described in the above-referenced U.S. Publication No. 2010/0331903.

IMD16and programmer24communicate via wireless communication. Examples of communication techniques may include, for example, low frequency or radiofrequency (RF) telemetry, but other techniques are also contemplated. In some examples, programmer24may include a programming head that may be placed proximate to the patient's body near the IMD16implant site in order to improve the quality or security of communication between IMD16and programmer24. IMD16is shown in a right pectoral implant position inFIG. 1, but may alternatively be implanted in a left pectoral position. In other examples, programmer24may be located remotely from IMD16, and communicate with IMD16via wireless distance telemetry or a network.

As will be described in greater detail, IMD16may deliver or withhold therapeutic stimulation or “therapy” to patient14for terminating a tachyarrhythmia of heart12based, at least in part, on heart sounds. Examples of tachyarrhythmias include ventricular tachycardia and ventricular fibrillation. Examples of therapeutic stimulation to terminate tachyarrhythmia include pacing, e.g., anti-tachycardia pacing (ATP), cardioversion shocks and defibrillation shocks.

The techniques for reducing inappropriate therapy based on heart sounds are primarily described herein as being performed by IMD16, e.g., by a processor of IMD16. In other examples some or all of the functions ascribed to IMD16or a processor thereof may be performed by one or more other devices, such as programmer24, or a processor thereof. For example, programmer24may process heart sound and/or EGM signals received from IMD16to determine whether a therapy should be delivered to terminate a tachyarrhythmia, and control whether IMD16delivers the therapy. Furthermore, although described herein with respect to an IMD, in other examples, the techniques described herein may be performed by or implemented in an external medical device, which may be coupled to a patient via percutaneous or transcutaneous leads.

FIG. 2is a conceptual diagram illustrating IMD16and leads18,20, and22of system10in greater detail. In the illustrated example, bipolar electrodes40and42are located adjacent to a distal end of lead18advanced into the right ventricle (RV)28of heart12. In addition, bipolar electrodes44and46are located adjacent to a distal end of lead20shown advanced into a cardiac vein30via the coronary sinus in the right atrium (RA)26. Lead20is used for sensing EGM signals and delivering therapy in the left ventricle (LV)32. Bipolar electrodes48and50are located adjacent to a distal end of lead22, positioned in the RA26.

In the illustrated example, electrodes40,44and48take the form of ring electrodes, and electrodes42,46and50may take the form of extendable helix tip electrodes optionally mounted retractably within insulative electrode heads52,54and56, respectively. Leads18,20,22also include elongated electrodes62,64,66, respectively, which may take the form of a coil. Each of the electrodes40,42,44,46,48,50,62,64and66is electrically coupled to a respective conductor within the lead body of its associated lead18,20,22, and thereby coupled to circuitry within IMD16.

In some examples, IMD16includes one or more housing electrodes, such as housing electrode4illustrated inFIG. 2, which may be formed integrally with an outer surface of hermetically-sealed housing8of IMD16or otherwise coupled to housing8. In some examples, housing electrode4is defined by an uninsulated portion of an outward facing portion of housing8of IMD16. Other division between insulated and uninsulated portions of housing8may be employed to define two or more housing electrodes. In some examples, a housing electrode comprises substantially all of housing8.

As described in further detail with reference toFIG. 3, housing8encloses a signal generator that generates therapeutic stimulation, such as cardiac pacing, cardioversion and defibrillation pulses, as well as a sensing module for sensing electrical signals attendant to the depolarization and repolarization of heart12. Housing8may also enclose a heart sound sensor that generates an electrical signal based on sensed heart sounds. The heart sound sensor may be enclosed within housing8. Alternatively, the heart sound sensor may be integrally formed with an outer surface of housing8, carried on a lead coupled to IMD16, such as one or more leads18,20and22, or be a remote sensor that wirelessly communicates with IMD16, programmer24, or any other device described herein.

IMD16senses electrical signals attendant to the depolarization and repolarization of heart12via any of electrodes4,40,42,44,46,48,50,62,64and66. IMD16may sense such electrical signals via any bipolar combination of electrodes40,42,44,46,48,50,62,64and66. Furthermore, any of the electrodes40,42,44,46,48,50,62,64and66may be used for unipolar sensing in combination with housing electrode4.

In some examples, IMD16delivers pacing pulses via bipolar combinations of electrodes40,42,44,46,48and50to produce depolarization of cardiac tissue of heart12. In some examples, IMD16delivers pacing pulses via any of electrodes40,42,44,46,48and50in combination with housing electrode4in a unipolar configuration. Furthermore, IMD16may deliver cardioversion or defibrillation pulses to heart12via any combination of elongated electrodes62,64,66, and housing electrode4.

The illustrated numbers and configurations of leads18,20, and22and electrodes are merely examples. Other configurations, i.e., number and position of leads and electrodes, are possible. In some examples, system10may include an additional lead or lead segment having one or more electrodes positioned at different locations in the cardiovascular system for sensing and/or delivering therapy to patient14. For example, instead of or in addition to intracardiac leads18,20and22, system10may include one or more epicardial or subcutaneous leads not positioned within the heart. As another example, system10may include an additional lead that carries a heart sound sensor positioned such that signals generated by the heart sound sensor include heart sounds. In some embodiments, a device for sensing cardiac electrical signals, heart sounds, and delivering cardioversion/defibrillation pulses in response to treatable tachyarrhythmia detection is a subcutaneous system including housing electrodes and/or subcutaneous leads and electrodes without the use of transvenous leads, electrodes or other sensors. An example of such a system is generally disclosed in commonly-assigned U.S. Pat. No. 7,904,153 (Greenhut et al.), hereby incorporated herein by reference in its entirety.

FIG. 3is a block diagram illustrating an example configuration of IMD16. In the illustrated example, IMD16includes a processor70, memory72, signal generator74, sensing module76, telemetry module78, heart sound analysis module80(also referred to herein as (heart sound analyzer”), heart sound sensor82and activity and/or posture sensor84. Memory72includes computer-readable instructions that, when executed by processor70, causes IMD16and processor70to perform various functions attributed to IMD16and processor70herein. The computer-readable instructions may be encoded within memory72. Memory72may include any volatile, non-volatile, magnetic, optical, or electrical computer-readable storage media, such as a random access memory (RAM), read-only memory (ROM), non-volatile RAM (NVRAM), electrically-erasable programmable ROM (EEPROM), flash memory, or any other digital computer-readable media with the sole exception being a transitory propagating signal.

Processor70may include any one or more of a microprocessor, a controller, a digital signal processor (DSP), an application specific integrated circuit (ASIC), a field-programmable gate array (FPGA), or equivalent discrete or analog logic circuitry. In some examples, processor70may include multiple components, such as any combination of one or more microprocessors, one or more controllers, one or more DSPs, one or more ASICs, or one or more FPGAs, as well as other discrete or integrated logic circuitry. The functions attributed to processor70herein may be embodied as software, firmware, hardware or any combination thereof. Generally, processor70controls signal generator74to deliver stimulation therapy to heart12of patient14according to a selected one or more of therapy programs or parameters, which may be stored in memory72. As an example, processor70may control signal generator74to deliver electrical pulses with the amplitudes, pulse widths, frequency, or electrode polarities specified by the selected one or more therapy programs.

Signal generator74is configured to generate and deliver electrical stimulation therapy to patient12. As shown inFIG. 3, signal generator74is electrically coupled to electrodes4,40,42,44,46,48,50,62,64, and66, e.g., via conductors of the respective leads18,20, and22and, in the case of housing electrode4, within housing8. For example, signal generator74may deliver pacing, defibrillation or cardioversion pulses to heart12via at least two of electrodes4,40,42,44,46,48,50,62,64, and66. In other examples, signal generator74delivers stimulation in the form of signals other than pulses, such as sine waves, square waves, or other substantially continuous time signals.

Signal generator74may include a switch module (not shown) and processor70may use the switch module to select, e.g., via a data/address bus, which of the available electrodes are used to deliver the electrical stimulation. The switch module may include a switch array, switch matrix, multiplexer, or any other type of switching device suitable to selectively couple stimulation energy to selected electrodes.

Electrical sensing module76monitors electrical cardiac signals from any combination of electrodes4,40,42,44,46,48,50,62,64, and66. Sensing module76may also include a switch module which processor70controls to select which of the available electrodes are used to sense the heart electrical activity, depending upon which electrode combination is used in the current sensing configuration. Sensing module76may include one or more sensing channels, each of which may comprise an amplifier, for sensing different cardiac electrical signals. Some sensing channels may sense events, such as R-waves or P-waves, and provide indications of the occurrences of such events to processor70. One or more other sensing channels may provide the signals to an analog-to-digital converter, for conversion into a digital signal for processing or analysis by processor70.

For example, sensing module76may comprise one or more narrow band channels, each of which may include a narrow band filtered sense-amplifier that compares the signal to a threshold. If the filtered and amplified signal is greater than the threshold, the narrow band channel indicates that a certain electrical cardiac event, e.g., depolarization, has occurred, i.e. “sensed”. Processor70then uses that sensed event in measuring frequencies of the sensed events for detecting tachyarrhythmias.

In one example, at least one narrow band channel may include an R-wave or P-wave amplifier. In some examples, the R-wave and P-wave amplifiers may take the form of an automatic gain controlled amplifier that provides an adjustable sensing threshold as a function of the measured R-wave or P-wave amplitude. Examples of R-wave and P-wave amplifiers are described in U.S. Pat. No. 5,117,824 (Keimel et al.).

In some examples, sensing module76includes a wide band channel which may comprise an amplifier with a relatively wider pass band than the narrow band channels. Signals from the electrodes that are selected for coupling to this wide-band amplifier may be converted to multi-bit digital signals by an analog-to-digital converter (ADC) provided by, for example, sensing module76or processor70. Processor70may analyze the digitized versions of signals from the wide band channel. Processor70may employ digital signal analysis techniques to characterize the digitized signals from the wide band channel to, for example, detect and classify the patient's heart rhythm.

Processor70may detect and classify the patient's heart rhythm based on the cardiac electrical signals sensed by sensing module76employing any of numerous signal processing methodologies. For example, processor70may maintain escape interval counters that may be reset upon sensing of R-waves by sensing module76. The value of the count present in the escape interval counters when reset by sensed depolarizations may be used by processor70to measure the durations of R-R intervals, which are measurements that may be stored in memory72. Processor70may use the count in the interval counters to detect a tachyarrhythmia, such as ventricular fibrillation or ventricular tachycardia. A portion of memory72may be configured as a plurality of recirculating buffers, capable of holding series of measured intervals, which may be analyzed by processor70to determine whether the patient's heart12is presently exhibiting atrial or ventricular tachyarrhythmia.

In some examples, processor70may determine that tachyarrhythmia has occurred by identification of shortened R-R interval lengths. Generally, processor70detects tachycardia when the interval length falls below 360 milliseconds (ms) and fibrillation when the interval length falls below 320 ms. These interval lengths are merely examples, and a user may define the interval lengths as desired, which may then be stored within memory72. A stored interval length may need to be detected for a certain number of consecutive cycles, for a certain percentage of cycles within a running window, or a running average for a certain number of cardiac cycles, as examples. The number of intervals required to meet tachycardia or fibrillation detection is referred to as a “number of intervals to detect” or NID and may be expressed as the number of intervals meeting the detection interval length out of a consecutive number of intervals, e.g. 8 out of 10 intervals.

A tachyarrhythmia detection method may include any suitable tachyarrhythmia detection algorithms. For example, EGM morphology may be considered in addition to or instead of interval length for detecting tachyarrhythmias. In one example, processor70may utilize all or a subset of the rule-based detection methods described in U.S. Pat. No. 5,545,186 (Olson, et al.) and U.S. Pat. No. 5,755,736 (Gillberg et al.), both of which patents are incorporated herein by reference in their entireties. However, other tachyarrhythmia detection methodologies may also be employed by processor70.

Generally, processor70detects a treatable tachyarrhythmia, such as VF, based on the EGM, e.g., the R-R intervals and/or morphology of the EGM, and selects a therapy to deliver to terminate the tachyarrhythmia, such as a defibrillation pulse of a specified magnitude. The detection of the tachyarrhythmia may include a number of phases or steps prior to delivery of the therapy, such as first phase, sometimes referred to as detection, in which a number of consecutive or proximate R-R intervals satisfies a first number of intervals to detect (NID) criterion, a second phase, sometimes referred to as confirmation, in which a number of consecutive or proximate R-R intervals satisfies a second, more restrictive NID criterion. Tachyarrhythmia detection may also include confirmation based on EGM morphology or other sensors subsequent to or during the second phase. Again, in some cases, processor70may mistakenly classify the patient's heart rhythm as a treatable tachyarrhythmia, e.g., as a result of a noisy EGM.

To avoid or reduce delivery of therapy in response to a mistakenly classified EGM, IMD16also includes heart sound sensor82and heart sound analyzer80. Heart sound sensor82generates an electrical signal representative of heart sounds of patient14, and may be implemented as a piezoelectric sensor, a microphone, an accelerometer, or other type of acoustical sensor. In some examples, heart sound sensor82may comprise more than one sensor. For example, heart sound sensor82may comprise multiple accelerometer devices.

In the illustrated example, heart sound sensor82is enclosed within housing8of IMD16. In some examples, heart sound sensor82may be formed integrally with an outer surface of housing8. In other examples, heart sound sensor82is located on a lead that is coupled to IMD16or may be implemented as a remote sensor that wirelessly communicates with IMD16. In any case, heart sound sensor82is electrically or wirelessly coupled to circuitry contained within housing8of IMD16.

Heart sound analyzer80receives the electrical signal generated by heart sound sensor82. In one example, heart sound analyzer80processes the sensor signal to detect heart sounds, classifies the detected heart sounds as either normal or abnormal, and generates an indication that the heart rhythm of the patient is either treatable or non-treatable based on the classification of one or more of the detected heart sounds. In one example, heart sound analyzer80processes the sensor signal to generate an envelope signal independent of EGM or ECG signals, applies an algorithm that uses an adaptively decaying threshold to detect heart sounds within the envelope signal, extracts heart sound features from the detected heart sounds, and classifies the detected heart sounds as normal or abnormal based on the heart sound features. In another example, heart sound analyzer80processes the sensor signal to generate an ensemble averaged heart sound signal using a cardiac electrical signal, e.g. the EGM signal, for selecting and aligning heart sound signal intervals, then extracts the heart sound features from the ensemble averaged signal. The operation of heart sound analyzer80in an EGM-dependent or EGM-independent manner is controlled based on a determination of the reliability of the EGM signal by processor70. The operation of heart sound analyzer80in accordance with these example methods is described in greater detail with respect toFIGS. 4-10. In any case, the heart sound based indication of a treatable or non-treatable rhythm may be output to processor70, which may allow or withhold the a tachyarrhythmia therapy based on the indication.

In some examples, IMD16performs these steps prior to delivering any therapy, such as anti-tachycardia pacing (ATP), to the heart of the patient. In other examples, IMD16analyzes heart sounds or other aspects of the heart sound signal during delivery of pacing pulses, e.g., ATP. For example, IMD16may classify the cardiac rhythm as treatable or non-treatable based on whether the delivery of pacing pulses results in heart sounds that are classified as normal, and selectively deliver or withhold therapy, such as cardioversion or defibrillation, based on the classification. In some examples, IMD16delivers the electrical pulses, e.g., ATP, during confirmation phase of tachyarrhythmia detection. In other examples, IMD16may deliver ATP to the patient in response to heart sound analyzer80indicating that the heart rhythm is treatable based on an analysis of unpaced heart sounds.

Although processor70and heart sound analyzer80are illustrated as separate modules inFIG. 3, processor70and heart sound analyzer80may be incorporated in a single processing unit. Heart sound analyzer80, and any of its components discussed in greater detail below, may be a component of or module executed by processor70.

Furthermore, the components of and functionality provided by a heart sound analyzer80are described herein with respect to examples in which heart sound analyzer80is located within IMD16. However, it is understood that any one or more heart sound analyzers80may be individually or collectively provided by any one or more devices, such as IMD16and programmer24or another computing device communicatively coupled to programmer24, to individually or collectively provide the functionality described herein. Programmer24may receive signals generated by heart sound sensor4from IMD16in embodiments in which programmer24includes a heart sound analyzer.

As illustrated inFIG. 3, IMD16may also include an activity and/or posture sensor84. Activity and/or posture sensor84may, for example, take the form of one or more accelerometers, or any other sensor for detecting activity, e.g., body movement or footfalls, or posture. In some examples, activity and/or posture sensor84may comprises a three-axis accelerometer. In some examples, heart sound sensor82and activity and/or posture sensor84may comprise one or more common accelerometers.

Telemetry module78includes any suitable hardware, firmware, software or any combination thereof for communicating with another device, such as programmer24(FIG. 1). Under the control of processor70, telemetry module78may receive downlink telemetry from and send uplink telemetry to programmer24with the aid of an antenna, which may be internal and/or external. In some examples, processor70may transmit cardiac signals, e.g., EGM signals, acquired by sensing module76and/or signals generated by heart sound sensor82to programmer24. Processor70may also generate and store marker codes indicative of different cardiac events that sensing module76or heart sound analyzer80detects, and transmit the marker codes to programmer24. An example IMD with marker-channel capability is described in U.S. Pat. No. 4,374,382 (Markowitz), hereby incorporated herein by reference in its entirety. Information which processor70may transmit to programmer24via telemetry module78may also include indications of treatable rhythms, indications of EGM reliability and use of heart sound signals for detecting or confirming a tachyarrhythmia, and indications of non-treatable rhythms in which the EGM based analysis indicated that the rhythm was treatable and the heart sound analysis indicated that the rhythm was non-treatable. Such information may be included as part of a marker channel with an EGM.

FIG. 4is a block diagram illustrating an example configuration of heart sound analyzer80. As illustrated inFIG. 4, heart sound analyzer80may include a heart sound analysis selector86responsive to an EGM reliability signal85received from processor70. The heart sound analyzer80may further include an ensemble averaging module88, an envelope extractor90, heart sound detector92, heart sound feature module94, classification module96, and indication module98.

In one embodiment, selector86enables one of ensemble averaging module88and envelope extractor90in response to the EGM reliability signal85. Processor70determines if the EGM signal (or ECG in some embodiments) is reliable for rhythm determination. This determination may be made based on a signal-to-noise analysis, suspected oversensing or other EGM/ECG signal reliability or acceptability criteria. Example methods for detecting oversensing or noise corruption of a cardiac electrical activity signal that may be implemented in the techniques disclosed herein for determining EGM reliability are generally disclosed in U.S. Pat. No. 7,783,354 (Gunderson), U.S. Pat. No. 7,831,304 (Cao et al.), U.S. Pat. No. 7,904,153 (Greenhut, et al.), and U.S. Publication No. 2011/0186247 (Cao, et al), all of which references are hereby incorporated herein by reference in their entirety.

If the EGM signal is determined to be reliable for rhythm detection, heart sound analysis may be used to determine if an EGM-based ventricular tachyarrhythmia detection is stable or not. A stable rhythm is considered “non-treatable”. If a heart sound signal indicates regular mechanical activity associated with the electrical activity and without significantly diminished hemodynamic function, a tachyarrhythmia therapy, particularly a shock therapy, is not necessary. On the other hand, if the heart sound signal indicates irregular mechanical activity dissociated with the electrical activity or significantly diminished hemodynamic function, it is desirable to treat the unstable rhythm. An unstable rhythm is considered “treatable”.

If the EGM is reliable, ensemble averaging module88receives a signal from heart sound sensor82and is enabled to compute an ensemble average of the heart sound signal over an averaging interval selected from multiple cardiac cycles. The averaging interval is established during each cardiac cycle using the EGM signal. For example, the heart sound signal may be sampled over an averaging interval that begins upon an EGM sensed R-wave and ends a programmed time interval after the sensed R-wave, e.g. 400 ms. Thus, the heart sound signal analysis performed by heart sound analyzer80involving ensemble averaging is dependent on a reliable EGM signal for setting the averaging interval on a beat-by-beat basis (which may include consecutive or non-consecutive beats).

Ensemble averaging module88may sample the heart sound signal received from the sensor, e.g. at a sampling rate of 256 Hz, and filter the signal before performing ensemble averaging. Ensemble averaging module88may filter the heart sound signal, for example by bandpass filter having a passband of approximately 40 Hz to approximately 90 Hz, to attenuate respiration artifact or other non-cardiac signal artifact. The sampled and filtered signals obtained during the averaging interval over multiple cardiac cycles are then aligned and averaged to obtain an ensemble average of the heart sound signal.

The number of cardiac cycles used for computing the ensemble average may vary and may depend on the NID, signal-to-noise ratio of the heart sound signal, or other factors. The selector86may be configured to select the ensemble averaging method for analyzing heart sounds as well as set the averaging interval and number of cardiac cycles used by ensemble averaging module88based on information received from processor70and/or memory72, such as a programmed NID, detected heart rate, or whether initial detection or redetection is taking place. Details regarding parameters controlling ensemble averaging will be described further in conjunction withFIGS. 7 and 8.

Ensemble averaging module88computes an ensemble average of the heart sound signal from which heart sound feature module94extracts features used to classify the averaged heart sound signal as normal or abnormal. The ensemble averaged signal may be used directly or additional processing may be performed by heart sound feature module94for extracting feature values. In some embodiments, the ensemble averaged signal may be smoothed and an envelope of the ensemble averaged signal may be determined from which the heart sound feature module94extracts heart sound features. Examples of heart sound ensemble averaged signals and envelope signals derived therefrom are presented inFIGS. 9 and 10.

If the EGM reliability signal85indicates that the EGM signal is unreliable for rhythm detection, the selector86enables envelope extractor90to extract an envelope of the heart sound signal independent of a cardiac electrical activity signal, i.e. independent of an EGM (or ECG) signal. If the EGM is unreliable due to noise, undersensing or oversensing, the EGM signal cannot be relied upon for establishing ensemble averaging windows. As such, if the EGM signal is unreliable, heart sound analyzer80is enabled to perform heart sound analysis independent of the EGM signal. Heart sound analyzer80and processor70may make a tachyarrhythmia detection and therapy decision independent of the EGM signal.

Envelope extractor90receives an electrical signal from heart sound sensor82. The electrical signal may be digitized and parsed into segments of predetermined length. As an example, the electrical signal generated by heart sound sensor82may be sampled at a 256 Hertz (Hz) rate and parsed into segments including 100 or more sample points. Generally, envelope extractor90processes the received signal to extract an envelope, i.e., generate an envelope signal from the received signal.

In some examples, envelope extractor90band pass filters, rectifies, and smoothes the sensor signal before extracting the envelope signal. For example, envelope extractor90may include a high pass filter, e.g., a 40 Hz high pass filter, and a low pass filter, such as a 70 Hz low pass filter, to remove unwanted signal components from the heart sound sensor signal. In some examples a first order infinite impulse response (IIR) high pass filter with a cutoff frequency of 40 Hz and a third order IIR low pass filter with a cutoff frequency of 70 Hz may be used. In some examples, analog filtering of the heart sound sensor signal may additionally or alternatively be performed prior to digitization of the signal and receipt by envelope extractor90. As discussed above, IMD16may include analog-to-digital conversion circuitry.

Envelope extractor90may also, in some examples, include rectification circuitry and circuitry that sums the rectified signal with left-shifted and right-shifted rectified signals in order to smooth the rectified signal. In this manner, envelope extractor may approximately apply an analytic function transform to the signal for envelope extraction. In other examples, envelope extractor90may use other methods to generate the envelope signal, such as the normalized Shannon Energy, true Hilbert transform, or rectifying the derivative of the signal followed by moving window integration of the rectified derivative. In such examples, envelope extractor90extracts or generates the envelope signal of the processed signal, i.e., the band pass filtered, rectified, and smoothed signal. Extraction of the envelope signal may further include application of a box-car filter, such as a 16 point box-car filter, to the band pass filtered, rectified, and smoothed signal. Envelope extractor90outputs the envelope signal to heart sound detector92.

Heart sound detector92utilizes an algorithm to detect heart sounds within the envelope signal. Since the EGM signal is unavailable for parsing the heart sound envelope signal into cardiac cycles to differentiate the expected timing of particular heart sounds, such as S1, S2etc., within the cardiac cycle, the heart sound detector92is configured to detect when heart sounds corresponding to cardiac cycle events are occurring. Generally, heart sound detector92identifies the local maximums of the envelope signal. In order to identify the local maximums that correspond to heart sounds, heart sound detector92may utilize an adaptively decaying threshold. The adaptively decaying threshold is determined based on the running average of detected heart sound amplitudes, the running average of the envelope signal amplitude, and the mean heart sound-to-heart sound interval. Heart sound detector92compares the envelope signal to the adaptively decaying threshold to identify the local maximums. Heart sound detector92may store markers, referred to as “heart sound markers,” for the identified local maximums within memory72or provide the heart sound markers directly to heart sound feature module94. An example algorithm for detecting heart sounds within an envelope signal is described in detail in the above-incorporated U.S. Publication No. 2010/0331903, incorporated herein by reference init's entirety.

Heart sound feature module94extracts features of the detected heart sounds (received from module92) or from the ensemble averaged signal(s) (received from module88). Heart sound feature module94may extract the same or different heart sounds from an ensemble averaged signal than from the envelope signal received from heart sound detector92. The heart sound features extracted from the ensemble averaged signal are used primarily for indicating whether a tachyarrhythmia detected based on the reliable EGM signal is treatable or non-treatable rhythm. The heart sound features extracted from the heart sound detector signal may be used to detect a heart rate or a tachyarrhythmia independent of EGM signals when the EGM signal is unreliable and may additionally be used to establish if the heart rhythm is treatable or non-treatable.

As such, heart sound features extracted from the ensemble averaged signal may be primarily correlated to hemodynamic function or surrogates of a hemodynamic measure. An example of heart sound features that may be extracted from an ensemble averaged signal include the S1amplitude. Additionally or alternatively, heart sound features extracted from the ensemble averaged signal may be used to determine whether the electrical activity and the mechanical activity of the heart is associated or dissociated based on time intervals measured between features of the EGM signal and features of the ensemble averaged signal. For example, a time interval from the beginning or end of the EGM-based averaging interval to a heart sound feature may be measured.

Heart sound features extracted from the heart sound detector signal92may be related to cardiac cycle intervals for determining the heart rate and may additionally be related to hemodynamic function for determining if a detected fast heart rate is hemodynamically stable. Example heart sound features that may be extracted from the envelope signal include the mean period ratio (MPR) and matching score (MS) for a detected heart sound. These features may be used to detect a heart rhythm and may additionally be used to determine if the rhythm is hemodynamically stable when the EGM signal is unreliable.

The MPR for a detected heart sound is the period of the detected heart sound divided by the mean period of one or more template heart sounds. The MS may be determined using template matching schemes that compare detected heart sounds to template heart sounds, such as a wavelet template matching scheme or a “bounded template” matching scheme. An example wavelet template matching scheme is disclosed in commonly-assigned U.S. Pat. No. 6,393,316 (Gillberg), hereby incorporated herein by reference in its entirety. An example bounded template matching scheme is disclosed in a commonly-assigned and co-pending U.S. Patent Publication No. 2010/0185109 (Zhang, et al.), hereby incorporated herein by reference in its entirety.

In some examples, template heart sounds used for determining the MPR and MS may be example heart sounds that are loaded into heart sound feature module94. In other examples, template heart sounds may be heart sounds that were measured during a baseline interval of the patient. That is, the template heart sounds may be obtained from patient14during an identified or predetermined time period during which the patient is known to have a normal cardiac rhythm.

When receiving signals from heart sound detector92, heart sound feature module94may use a heart sound marker from heart sound detector92to center a window, e.g., a 48 point or sample window, at a detected heart sound and use the resulting segment of samples to determine the MPR and MS. For example, heart sound feature module94may determine the period of the band-pass filtered signal segment and use it to determine the MPR, and may compare the extracted envelope signal segment to a stored template to determine the MS. Heart sound feature module94may then provide the MPR and MS to classification module96.

When receiving an ensemble averaged signal from averaging module88, heart sound feature module94may detect a signal feature by peak detection, area estimation, signal width measurement or other aspects of the averaged signal. The onset, end or midpoint of the averaging interval may be used as a reference point for searching for aspects of the averaged signal to be measured as heart sound features.

Classification module96classifies determined heart sound features as either normal or abnormal based on comparisons between the feature values and reference or threshold values. Classification of the heart sound features as normal or abnormal may be based on whether the features, e.g., the S1amplitude, R-wave to S1time interval, MPR or MS values, are within a predetermined range, or above or below a predetermined threshold. When heart sound analyzer80is operating in an EGM-dependent mode, i.e. ensemble averaging module88is enabled, classification module will classify the ensemble averaged signal, which may represent two or more cardiac cycles. When heart sound analyzer80is operating in an EGM-independent mode, i.e. when envelope extractor90and heart sound detector92are enabled, classification module96classifies each detected heart sound individually.

Indication module98receives the classification information for the heart sound features from classification module96, and generates an indication whether the cardiac rhythm is treatable or non-treatable, e.g., whether to deliver or withhold a therapy scheduled to terminate a tachyarrhythmia, based on the received information. Indication module98may generate the indication based on one or more heart sound features obtained from a single ensemble averaged signal or multiple ensemble averaged signals when the EGM signal is reliable. Indication module98may generate the indication based on normal or abnormal classification of one or more heart sounds obtained from heart sound detector92.

As an example, indication module98may generate an indication that a rhythm detected as a tachyarrhythmia based on EGM analysis is treatable when a feature of the ensemble averaged signal presents greater than a threshold percentage change from a baseline ensemble averaged signal feature value. Indication module98generates an indication that the rhythm is non-treatable when a feature of the ensemble averaged signal presents less than a threshold change from the baseline value. Separation of treatable from non-treatable rhythms may be defined by a single threshold or two different thresholds, i.e. an abnormal threshold and a normal threshold.

In some cases, classification module may classify a feature value difference as “intermediate” when the difference falls between two thresholds defining treatable and non-treatable rhythms. For example, the feature value difference between an ensemble averaged signal and a baseline value may be intermediate a “normal” threshold and an “abnormal” threshold. In this case, indication module may give an indication of an “intermediate” rhythm status. The processor may then make a therapy delivery or therapy scheduling decision based on this information in addition to EGM signal information. The decision may be to immediately deliver therapy based on a severity of the EGM signal-based rhythm detection or withhold or delay a therapy pending additional analysis of the EGM and/or heart sound signals.

When classification module96provides indication module98the classifications of individual heart sounds detected by heart sound detector92, indication module98may generate an indication of a treatable or non-treatable rhythm based on a threshold number of heart sounds being classified as abnormal or normal. For example, if a threshold number of consecutive or proximate heart sounds, e.g., six of the last eight heart sounds or M out of N heart sounds, are classified as normal, indication module98generates an indication that a rhythm is non-treatable. In other examples, the threshold number may be a threshold number of abnormal heart sounds. In still other examples, classification module96may classify heart beats as normal or abnormal based on the classification of one or more heart sounds within each of the beats, and indication module may provide the indication as described based on a threshold number of normal or abnormal heart beats. Indication module98provides an indication to processor70, which selectively delivers therapy based on the heart sound based indication received from indication module98. This decision may be made independent of the EGM signal when the EGM signal is determined to be unreliable.

FIG. 5is a flow diagram100illustrating an example method for allowing or withholding a tachyarrhythmia therapy based on heart sound sensing. The example method is described with respect to IMD16and its components shown inFIG. 3, but in other examples may be practiced, at least in part, by another device, such as programmer24.

Flow chart100and other flow charts presented herein are intended to illustrate the functional operation of the device, and should not be construed as reflective of a specific form of software, firmware, or hardware necessary to practice the methods described. It is believed that the particular form of software, firmware and/or hardware will be determined primarily by the particular system architecture employed in the device and by the particular detection and therapy delivery methodologies employed by the device. Providing software. firmware and/or hardware to accomplish the described functionality in the context of any modern medical device system, given the disclosure herein, is within the abilities of one of skill in the art.

Methods described in conjunction with flow charts presented herein may be implemented in a non-transitory computer-readable medium that includes instructions for causing a programmable processor to carry out the methods described. The instructions may be implemented as one or more software modules, which may be executed by themselves or in combination with other software.

According to the illustrated example, processor70monitors an EGM signal at block102. More generally, a cardiac electrical activity signal is monitored which could be an EGM signal or an ECG signal. If the processor detects a fast rate (block104) based on measured intervals between cardiac electrical events, e.g. R-waves, the electrical signal is analyzed for reliability at block106. In some embodiments, a fast rate detected at block104may be a sensed heart rate above a detection rate that has not yet reached a required NID. For example a fast rate may be detected based on 3 consecutive beats shorter than a tachyarrhythmia detection interval or other criteria indicating a “concerning” rhythm state that does not yet meet VT or VF detection criteria. In other embodiments, a fast rate detection at block104may be detection of an SVT, VT or VF based on EGM interval-based or morphology based analysis.

EGM reliability analysis may include diagnostic algorithms for detecting lead-related noise, e.g. lead fracture or dislodgment, T-wave over sensing, EMI oversensing, or signal-to-noise ratio analysis. In some examples, EGM reliability monitoring may be performed continuously or periodically and whenever the EGM is deemed unreliable for rhythm detection, heart sound analyzer80enables envelope extractor at block116for detecting heart sounds and utilizing heart sound signals for rhythm detection and therapy decisions. In other examples, EGM reliability may be determined only after a concerning rhythm or tachyarrhythmia is already detected based on the EGM signal. If the EGM is unreliable, heart sound envelope extractor is enabled at block116.

In response to a reliable EGM signal indication at block106, the ensemble averaging module88is enabled at block108and computes an ensemble average of the heart sound signal sampled over the averaging interval for a selected number of cardiac cycles. In one embodiment, the number of cardiac cycles corresponds to a programmed NID. If an EGM analysis results in a tachyarrhythmia detection at block110, heart sound features are extracted from the ensemble averaged signal at block112. At block114, the heart sound feature(s) for the ensemble averaged signal are compared to respective threshold or baseline values. In one embodiment the S1amplitude is determined from the ensemble averaged signal and compared to a previously determined normal sinus rhythm (NSR) S1amplitude. If the S1amplitude is less than a predetermined percentage of the baseline value, the heart sound analysis confirms an unstable or treatable rhythm at block114. Heart sound analyzer80provides an indication that the rhythm is treatable to processor70. Processor70controls signal generator74to deliver a programmed therapy, e.g., a cardioversion or defibrillation shock, at block126.

If a heart sound feature measured from the ensemble averaged signal substantially matches a baseline NSR heart sound feature value, an indication of a non-treatable rhythm is provided. For example, if the S1amplitude (or other heart sound feature measured from the ensemble averaged signal) is greater than a predetermined percentage of the baseline NSR S1amplitude, heart sound analyzer80provides an indication that the rhythm is non-treatable. Processor70withholds the therapy at block115, e.g., does not control signal generator74to deliver the scheduled therapy. Processor70and analyzer80may then continue to monitor the EGM and heart sound signals, respectively (return to block102).

In response to a signal from processor70indicating the EGM is unreliable for rhythm detection, heart sound analyzer80is enabled to receive a raw signal from heart sound sensor82. Heart sound analyzer80may analyze the heart sound signal substantially continuously. At block116, heart sound envelope extractor90extracts the envelope signal of the sampled heart sound signal.

Envelope extractor90rectifies the filtered signal and smoothes the filtered signal to obtain an envelope signal from the filtered signal. In one example, envelope extractor90may smooth the filtered signal by summing together and averaging a left-shifted version of the signal, the initial signal, and a right-shifted version of the signal. Envelope extractor90may apply a boxcar filter to the resulting signal to extract the envelope signal. Generally, the number of points used in the boxcar filter may be dependent on the sampling rate. As one example, the boxcar filter may be a 16 point boxcar filter when the sample rate is approximately 256 Hz.

Other filters or signal processing techniques may be used to extract the envelope signal. In some examples, wavelet transforms may be used instead of or in addition to the bandpass filtering. Wavelet transforms may also allow automatic identification of the wavelet levels which contain heart sound information.

Heart sound detector92detects the occurrence of heart sounds in the envelope signal at block118. Heart sound detector detects the heart sounds independent of the EGM signal, which has been indicated as being unreliable. Generally, heart sound detector92identifies the local maximums of the envelope signal and may utilize an adaptively decaying threshold.

At block120, heart sound feature module94determines one or more heart sound features from each of the detected heart sounds based on the envelope signal and/or the filtered heart sound signal. Classification module96classifies each of the detected heart sounds as either normal or abnormal based on the heart sound features at block122. As an example, classification module96may compare heart sound feature values of a detected heart sound to a predetermined range of values. When the heart sound feature value(s) of the detected heart sound are within the predetermined range of values, classification module96may classify the detected heart sound as normal. However, if a heart sound feature value of the detected heart sound is not within the predetermined range of values, the detected heart sound may be classified as abnormal.

At block124, indication module98provides an indication to processor70of whether the heart rhythm is treatable or non-treatable based on the classification of one or more of the heart sounds. For example, indication module98may indicate that the heart rhythm is non-treatable when at least M of the last N heart sounds are classified as normal. Processor70allows or withholds a therapy based on the classification of the heart sounds, e.g., based on the indication from indication module98. If the indication is “non-treatable”, the process advances to block128to determine if the EGM signal is still unreliable, and if so, heart sound analysis continues using heart sound envelope extraction and heart sound detection at blocks116and118. If the indication is “treatable”, a therapy is delivered at block126.

The process shown by the flow diagram100, which may generally be performed by heart sound analyzer80and processor70, utilizes the EGM signal (or more generally cardiac electrical activity signal) when the EGM signal is identified as being reliable for computing an ensemble averaged heart sound signal over multiple cardiac cycles. A single set, i.e. one or more, heart sound features are derived from the ensemble averaged heart sound signal that represents the heart sound signal occurring over the multiple cardiac cycles. The single set of heart sound features from one ensemble averaged signal may be used to provide an indication of a treatable or a non-treatable rhythm. In contrast, when the EGM signal is identified as being unreliable, a set of (i.e. one or more) heart sounds is determined for each of the detected heart sounds individually so that each individually detected heart sound can be classified as abnormal or normal. Based on a count of the individually classified heart sounds, the heart sound analyzer provides an indication of a treatable or non-treatable rhythm. In other words, in the EGM-independent method, the heart sound features are determined on a beat-by-beat basis for classifying each beat whereas in the EGM-dependent method, heart sound features are determined from an ensemble average representing a group of beats.

FIG. 6is a flow diagram200illustrating an example method for establishing a baseline ensemble averaged heart sound signal and using the baseline signal for providing an indication of rhythm stability. The example method is described with respect to heart sound analyzer80and its components, and processor70, but it should be understood that the example method may be performed by any one or more devices, processors, or components described herein.

At block202, a baseline EGM morphology signal, e.g. a QRS signal morphology, is established by processor70using a digitized EGM signal from sensing module76. The baseline EGM morphology signal is established during a confirmed normal sinus rhythm, for example under the supervision of a clinician. At block204, the EGM signal and a heart sound signal are acquired during a slow heart rate (HR). A slow heart rate may be defined by a sustained series of R-R intervals longer than a tachyarrhythmia detection threshold or lower than a “concerning” rhythm threshold or normal HR upper limit (e.g., 90 bpm). During the slow heart rate, the EGM signal morphology is compared to the baseline EGM morphology to confirm NSR. Verification of NSR using EGM intervals and morphology may be done automatically by the IMD on a periodic basis or any time a low heart rate is sensed for enabling the establishing or updating of a baseline heart sound template.

Once a slow heart rate and NSR EGM signal morphology are verified (blocks204and206), a baseline ensemble average of the heart sound signal is established at block208. A feature or event of the EGM signal, such as a sensed R-wave, is used to set an ensemble averaging interval for each of multiple cardiac cycles. The heart sound signal is sampled and stored during each of the averaging intervals. The heart sound signals are then aligned based on the EGM-referenced averaging interval, and the signals are averaged together. Heart sound signal feature values may then be determined from the baseline ensemble averaged template for use as baseline or reference values during tachyarrhythmia detection and therapy decision-making. Additional details regarding establishing a baseline heart sound ensemble average will be described in conjunction withFIG. 7.

After establishing the baseline ensemble average heart sound signal, the EGM signal is monitored at block210until a fast rate is detected, i.e. RR intervals shorter than a tachyarrhythmia detection interval. As described previously in conjunction withFIG. 5, in some embodiments the EGM reliability is verified upon detecting a concerning rhythm (e.g. a rate that includes RR intervals shorter than a detection threshold but not yet satisfying NID criterion) before enabling the ensemble averaging module88. If a fast rate is detected at block210and the EGM is deemed reliable, the heart sound analyzer80enables ensemble averaging module88to determine a heart sound ensemble averaged signal at block212during the fast rate using the EGM signal to set averaging intervals and as a time reference for aligning heart sound signals in the same manner as used for establishing the baseline heart sound signal.

At block214, heart sound features are extracted from the ensemble averaged signal. In one example, the S1amplitude is extracted. In another example a time interval between an R-wave sense (which may correspond to the beginning of the averaging interval) and subsequent S1peak is measured. As such, heart sound features extracted from an ensemble averaged signal may include features of the heart sound signal, time intervals measured between features of the heart sound signal, and time intervals between features of the EGM signal or EGM-based averaging interval and the heart sound signal.

At block216, a percentage change or difference from the baseline ensemble averaged heart sound signal features established at block208is determined. For example, a percentage change may be determined as the difference between the feature value from the ensemble averaged signal during the fast rate and the corresponding feature value from the baseline ensemble averaged signal divided by the baseline feature value.

The percentage change in the heart sound feature value during the fast rate compared to the baseline value is compared to threshold ranges defined for discriminating between a stable rhythm and an unstable rhythm at block218. In response to the comparison, an indication of hemodynamic stability is provided at block220. In one embodiment, if the percentage change is large, e.g. represents more than approximately 80 to 90% change in the feature value, the indication module98of heart sound analyzer80provides an indication of an unstable or treatable rhythm at block220. This information may be used by processor70to detect a treatable rhythm based on both the EGM and heart sound signals and make a therapy delivery decision at block222to deliver a therapy, for example to deliver a cardioversion or defibrillation shock.

If the percentage change is small, e.g. represents less than approximately 10% to 20% change from the baseline feature value, the indication module96provides an indication of a stable rhythm at block220. The processor70may use this information to detect a non-treatable rhythm. The processor70may make a therapy decision at block222that includes withholding a shock therapy. The therapy decision may further include delivering an anti-tachycardia therapy to preempt deterioration to a hemodynamically unstable rhythm or to withhold all types of therapies.

In some embodiments, the change in the heart sound feature value may be intermediate to a threshold indicating a treatable rhythm and a threshold indicating a non-treatable rhythm. For example, if the change represents a decrease that falls between the two thresholds discriminating treatable and non-treatable rhythms, the indication module98may provide an intermediate indication. The processor70may use this intermediate indication in making therapy decisions at block222. For example, based on any combination of the indicated intermediate status, EGM-measured intervals, and EGM morphology analysis, the processor may determine an overall severity of the rhythm and select to deliver a shock therapy, withhold a shock therapy, deliver an anti-tachycardia pacing therapy, or post-pone a therapy to allow the rhythm to self-terminate and/or allow analysis of additional cardiac cycles of EGM and/or heart sound signal data or other physiological sensor signal data.

In other embodiments, a single threshold boundary may be defined for discriminating between hemodynamically stable and unstable rhythms. For example, if more than a 30% change (or other percentage change) in an ensemble averaged heart sound signal feature is detected, the rhythm may be indicated as being treatable.

FIG. 7is a flow chart300of a method for computing an ensemble averaged heart sound signal according to one embodiment. The EGM signal sensing is performed at block302for sensing R-waves and measuring RR intervals (RRIs). If the RRI is shorter than a tachyarrhythmia detection interval as determined at block304, the RRI is not used for ensemble averaging to obtain a baseline heart sound signal template or feature value. The process advances to the next R-wave at block308.

If the current RRI is longer than a tachyarrhythmia detection interval (block304), the EGM signal morphology for the R-waves defining the RR interval is examined at block306. A morphology matching score based on a wavelet analysis or other morphology analysis technique may be computed to determine a correlation score between the EGM signal morphology and a previously established NSR EGM signal template. If the EGM signal presents a high morphology matching score with the NSR template, the current RRI is used to update a running average of the RRI at block310. In one embodiment, a running average of the RRI is computed over four cardiac cycles though the running average may be computed using more or fewer RRIs.

The current RRI is then compared to the RRI running average at block312. If the difference between the current RRI and the RRI running average is less than an acceptance threshold, as determined at block314, the current RRI will be selected for use by the ensemble averaging module for inclusion in computing an ensemble average of the heart sound signal at block316. If the difference between the current RRI and the running average is greater than a beat acceptance threshold, the current RRI is rejected for use in computing a heart sound ensemble average. The process advances to block308to evaluate the next R-wave and next RRI.

At block316, an averaging interval is selected from the accepted RRI by identifying a fiducial point of the EGM signal, e.g. the point at which an R-wave is sensed or an R-wave peak. The averaging interval is defined relative to the fiducial point, and the heart sound signal is sampled during the averaging interval. In one embodiment, an averaging interval is selected as an interval beginning from an R-wave sense and extending a defined interval, e.g. 250 to 400 ms, thereafter. Any interval of time may be defined relative to any fiducial point or a combination of fiducial points identified from the leading or trailing R-wave defining the RRI.

If a required number (N) of averaging intervals have been selected from qualified RRIs, as determined at block318, the heart sound signals sampled over the N averaging intervals are aligned and averaged at block320to compute the heart sound ensemble average. From the ensemble average, baseline heart sound features are computed at block322and stored in IMD memory for use in comparing to heart sound features measured during a suspected tachyarrhythmia for use in indicating the stability of the heart rhythm. The required number of averaging intervals used for computing an ensemble average may vary between embodiments and may range from 2 to 12 intervals for example. The number of averaging intervals may depend on the signal to noise ratio of the heart sound signal, NID or other factors.

FIG. 8is a flow chart400of a method for determining ensemble averaged heart sound signal features for use in classifying a heart rhythm according to one embodiment. At block402, EGM signal sensing is enabled and if a fast rate is detected based on EGM interval analysis (block404), the EGM signal is evaluated for signal reliability at block406. If the EGM signal is determined to be unreliable, EGM-independent heart sound analysis is enabled at block408as described previously. The heart sound signal is sampled continuously and a heart sound signal envelope is extracted from which heart sounds are detected and used for indicating a treatable or non-treatable rhythm as described above.

If the EGM signal is deemed reliable, the RRI running average is updated at block410. In some embodiments, after detecting a fast rate, the RRI running average is updated on each beat without EGM morphology evaluation of the associated QRS signals for rejecting or accepting each RRI. The current RRI is compared to the running average RRI at block412. If the difference between the current RRI and the running average is greater than a beat acceptance threshold (block414), the current RRI is not used for selecting an ensemble averaging interval. The process advances to the next R-wave at block415.

If the current RRI meets acceptability criterion, the ensemble averaging interval is selected from the current RRI at block416. The averaging interval is based on a fiducial EGM signal point as a time interval reference point in the same manner as the selected averaging intervals used to establish a baseline ensemble averaged signal.

If a required number of averaging intervals has been selected (block418), the ensemble average is computed at block420. Otherwise, the process advances to the next sensed R-wave at block415to measure the next RRI. Once enough averaging intervals have been selected, the heart sound signals sampled over each averaging interval are aligned and averaged to compute the ensemble average. The required number of averaging intervals may be equal to or a proportion of the NID corresponding to the detected RRIs. In other embodiments, the required number may be based on a measured signal-to-noise ratio of the heart sound signal.

At block422, one or more heart sound features are determined from the ensemble averaged signal. These heart sound features are compared to the analogous baseline heart sound feature values for providing an indication of the stability of the heart rhythm. This indication of a treatable or non-treatable rhythm is used by processor70for making therapy delivery decisions as described above.

FIG. 9is an example recording500of an EGM signal502, raw heart sound signal506, and filtered heart sound signal508. In particular EGM signal502is used for sensing cardiac electrical events, such as R-waves504. EGM signal502in this example is a reliable EGM signal. Sensed R-waves504may be used in setting an ensemble averaging interval for averaging heart sound signals.

Raw heart sound signal506is the signal generated by a heart sound sensor and represents a signal that may be received by heart sound analyzer80. Signal508represents a band pass filtered version of raw signal506. Filtered signal508may be further processed by heart sound analyzer80for determining heart sound feature values. In particular, filtered signal508is used for determining an ensemble averaged signal.

FIG. 10is a depiction of an ensemble averaged heart sound signal600determined from the filtered signal508shown inFIG. 9. The time of 0 ms corresponds to the occurrence of an R-wave sense (not shown inFIG. 10) of EGM signal604. The ensemble averaged heart sound signal600is obtained by averaging the filtered signal508over 10 cardiac cycles in this example, beginning from the R-wave sense in each cycle and extending to 480 ms. The ensemble averaged signal600may be used directly for determining heart sound signal features or may be further processed by heart sound analyzer80. For example, the ensemble averaged signal600may be rectified and smoothed to obtain the heart sound signal envelope602. The heart sound signal features derived by heart sound feature module94may be determined from the ensemble averaged envelope signal602. In one embodiment, the S1peak amplitude606, shown here as having a magnitude of 0.36 mV, is determined from the ensemble averaged envelope signal602. While a particular averaging interval of 480 ms is used over 10 cardiac cycles in the example ofFIG. 10, it is recognized that any desired averaging interval and number of cardiac cycles may be used for enabling reliable determination of selected heart sound features used in the rhythm analysis.

Thus, a medical device system and associated methods have been presented in the foregoing description with reference to specific embodiments for using heart sound signals in discriminating between treatable and non-treatable cardiac rhythms and making therapy delivery decisions. It is appreciated that various modifications to the referenced embodiments may be made without departing from the scope of the disclosure as set forth in the following claims. For example, any of the techniques or processes described in conjunction with block diagrams and flow charts presented herein may be combined or functional blocks may be omitted or re-ordered in alternative embodiments. The description of the embodiments is illustrative in nature and, thus, variations that do not depart from the gist of the disclosure are intended to be within the scope of the disclosure.