Patent ID: 12214208

DETAILED DESCRIPTION

FIG.1is a conceptual diagram illustrating an intracardiac pacing system10that may be used to sense cardiac electrical signals and motion signals induced by cardiac motion and flowing blood and provide pacing therapy to a patient's heart8. IMD system10includes a right ventricular (RV) intracardiac pacemaker14and may optionally include a right atrial (RA) intracardiac pacemaker12in some examples. Pacemakers12and14are transcatheter intracardiac pacemakers which may be adapted for implantation wholly within a heart chamber, e.g., wholly within the RV, wholly within the left ventricle (LV), wholly within the RA or wholly within the left atrium (LA) of heart8.

In the example ofFIG.1, pacemaker12is positioned along an endocardial wall of the RA, e.g., along the RA lateral wall or RA septum. Pacemaker14is positioned along an endocardial wall of the RV, e.g., near the RV apex though other locations are possible. The techniques disclosed herein are not limited to the pacemaker locations shown in the example ofFIG.1and other positions and relative locations in the heart8and from each other are possible. For example, a ventricular intracardiac pacemaker14may be positioned in the LV for and configured to detect cardiac motion signals and deliver atrial-synchronized ventricular pacing to the LV using the techniques disclosed herein.

Pacemakers12and14are reduced in size compared to subcutaneously implanted pacemakers and may be generally cylindrical in shape to enable transvenous implantation via a delivery catheter. In other examples, pacemakers12and14may be positioned at any other location inside heart8. For example, pacemaker12may be positioned outside or within the right atrium or left atrium to provide respective right atrial or left atrial pacing. Pacemaker14may be positioned within the right ventricle or left ventricle to provide respective right ventricular or left ventricular pacing and for sensing motion signals by a motion sensor within the ventricular chamber.

Pacemakers12and14are each capable of producing electrical stimulation pulses, e.g., pacing pulses, delivered to heart8via one or more electrodes on the outer housing of the pacemaker. RA pacemaker12is configured to sense a cardiac electrical signal from within the RA that may be used to produce an RA intracardiac electrogram (EGM) signal. RV pacemaker14is configured to deliver RV pacing pulses and sense an RV cardiac electrical signal using housing based electrodes for producing an RV EGM signal. The cardiac electrical signals may be sensed by the respective pacemaker12or14using the housing based electrodes that are also used to deliver pacing pulses to the respective RA or RV.

In some examples, a patient may only require RV pacemaker14for delivering ventricular pacing. In other examples, depending on individual patient need, RA pacemaker12may be required for delivering atrial pacing. The RV pacemaker14is configured to control the delivery of ventricular pacing pulses to the RV in a manner that promotes synchrony between the RA activation and the RV activation, e.g., by maintaining a target atrioventricular (AV) interval between atrial events and ventricular pacing pulses. That is, the RV pacemaker14controls RV pacing pulse delivery to maintain a desired AV interval between atrial activations (intrinsic or pacing-evoked) corresponding to atrial systole and ventricular pacing pulses delivered to cause ventricular depolarization.

According to the techniques described herein, atrial activations are detected by RV pacemaker14from a motion sensor signal that includes motion signals caused by ventricular and atrial events. For example, acceleration of blood flowing into the RV through the tricuspid valve16between the RA and RV caused by atrial activation, sometimes referred to as the “atrial kick,” is detected by RV pacemaker14from the signal produced by a motion sensor, for example an accelerometer, included in RV pacemaker14. Other motion signals detected by RV pacemaker14, such as motion caused by ventricular contraction, motion caused by ventricular relaxation, and motion caused by passive filling of the ventricle are described below in conjunction withFIG.4.

Atrial P-waves that are attendant to atrial depolarization are relatively low amplitude signals in the near-field RV cardiac electrical signal received by pacemaker14(e.g., compared to the near-field R-wave) and therefore can be difficult to reliably detect from the cardiac electrical signal acquired by RV pacemaker14. As such, atrial-synchronized ventricular pacing by RV pacemaker14may not be reliable when based solely on a cardiac electrical signal received by RV pacemaker14. According to the techniques disclosed herein, the RV pacemaker14includes a motion sensor, such as an accelerometer, and is configured to detect an atrial event corresponding to atrial mechanical activation or atrial systole using a signal from the motion sensor. Ventricular pacing pulses are synchronized to the atrial event that is detected from the accelerometer signal by setting a programmable atrioventricular (AV) pacing interval that controls the timing of the ventricular pacing pulse relative to the detected atrial systolic event. As described below, detection of the atrial systolic event used to synchronize ventricular pacing pulses to atrial systole may include detection of other cardiac event motion signals in order to positively identify the atrial systolic event.

A target AV interval may be a programmed value selected by a clinician and is the time interval from the detection of the atrial event until delivery of the ventricular pacing pulse. In some instances, the target AV interval may be started from the time the atrial systolic event is detected based on a motion sensor signal or starting from an identified fiducial point of the atrial event signal. The target AV interval may be identified as being hemodynamically optimal for a given patient based on clinical testing or assessments of the patient or based on clinical data from a population of patients. The target AV interval may be determined to be optimal based on relative timing of electrical and mechanical events as identified from the cardiac electrical signal received by RV pacemaker14and the motion sensor signal received by RV pacemaker14.

Pacemakers12and14may each be capable of bidirectional wireless communication with an external device20for programming the AV pacing interval and other pacing control parameters as well as mechanical event sensing parameters utilized for detecting ventricular mechanical events and the atrial systolic event from the motion sensor signal. Aspects of external device20may generally correspond to the external programming/monitoring unit disclosed in U.S. Pat. No. 5,507,782 (Kieval, et al.), hereby incorporated herein by reference in its entirety. External device20is often referred to as a “programmer” because it is typically used by a physician, technician, nurse, clinician or other qualified user for programming operating parameters in pacemakers12and14. External device20may be located in a clinic, hospital or other medical facility. External device20may alternatively be embodied as a home monitor or a handheld device that may be used in a medical facility, in the patient's home, or another location. Operating parameters, including sensing and therapy delivery control parameters, may be programmed into pacemakers12and14using external device20.

External device20is configured for bidirectional communication with implantable telemetry circuitry included in RV pacemaker14and RA pacemaker12(when present). External device20establishes a wireless radio frequency (RF) communication link22with RA pacemaker12and wireless RF communication link24with RV pacemaker14using a communication protocol that appropriately addresses the targeted pacemaker12or14. Communication links22and24may be established using an RF link such as BLUETOOTH®, Wi-Fi, Medical Implant Communication Service (MICS) or other communication bandwidth. In some examples, external device20may include a programming head that is placed proximate pacemaker12or14to establish and maintain a communication link, and in other examples external device20and pacemakers12and14may be configured to communicate using a distance telemetry algorithm and circuitry that does not require the use of a programming head and does not require user intervention to maintain a communication link. An example RF telemetry communication system that may be implemented in system10is generally disclosed in U.S. Pat. No. 5,683,432 (Goedeke, et al.), hereby incorporated herein by reference in its entirety.

External device20may display data and information relating to pacemaker functions to a user for reviewing pacemaker operation and programmed parameters as well as EGM signals transmitted from pacemaker14or pacemaker12, motion sensor signals acquired by pacemaker14, or other physiological data that is acquired by and retrieved from pacemakers12and/or14during an interrogation session.

It is contemplated that external device20may be in wired or wireless connection to a communications network via a telemetry circuit that includes a transceiver and antenna or via a hardwired communication line for transferring data to a remote database or computer to allow remote management of the patient. Remote patient management systems including a remote patient database may be configured to utilize the presently disclosed techniques to enable a clinician to review EGM, motion sensor, and marker channel data and authorize programming of sensing and therapy control parameters in RV pacemaker14, e.g., after viewing a visual representation of EGM, motion sensor signal and marker channel data.

Pacemaker12and pacemaker14may or may not be configured to communicate directly with each other. When pacemakers12and14are configured to communicate with each other, communication may be minimized in order to conserve battery life of the intracardiac pacemakers12and14. As such, communication may not occur on a beat-by-beat basis between the RA pacemaker12and RV pacemaker14for communicating when the other pacemaker is sensing cardiac events or when it is delivering pacing pulses. As disclosed herein, RV pacemaker14, however, is configured to detect atrial events as often as beat-by-beat from a motion sensor signal, without requiring communication signals from RA pacemaker12to provide atrial event detection for controlling atrial-synchronized ventricular pacing.

FIG.2Ais a conceptual diagram of the intracardiac RV pacemaker14shown inFIG.1. RV pacemaker14includes electrodes162and164spaced apart along the housing150of pacemaker14for sensing cardiac electrical signals and delivering pacing pulses. Electrode164is shown as a tip electrode extending from a distal end102of pacemaker14, and electrode162is shown as a ring electrode along a mid-portion of housing150, for example adjacent proximal end104. Distal end102is referred to as “distal” in that it is expected to be the leading end as pacemaker14is advanced through a delivery tool, such as a catheter, and placed against a targeted pacing site.

Electrodes162and164form an anode and cathode pair for bipolar cardiac pacing and sensing. In alternative embodiments, pacemaker14may include two or more ring electrodes, two tip electrodes, and/or other types of electrodes exposed along pacemaker housing150for delivering electrical stimulation to heart8and sensing cardiac electrical signals. Electrodes162and164may be, without limitation, titanium, platinum, iridium or alloys thereof and may include a low polarizing coating, such as titanium nitride, iridium oxide, ruthenium oxide, platinum black among others. Electrodes162and164may be positioned at locations along pacemaker14other than the locations shown.

Housing150is formed from a biocompatible material, such as a stainless steel or titanium alloy. In some examples, the housing150may include an insulating coating. Examples of insulating coatings include parylene, urethane, PEEK, or polyimide among others. The entirety of the housing150may be insulated, but only electrodes162and164uninsulated. Electrode164may serve as a cathode electrode and be coupled to internal circuitry, e.g., a pacing pulse generator and cardiac electrical signal sensing circuitry, enclosed by housing150via an electrical feedthrough crossing housing150. Electrode162may be formed as a conductive portion of housing150as a ring electrode that is electrically isolated from the other portions of the housing150as generally shown inFIG.2A. In other examples, the entire periphery of the housing150may function as an electrode that is electrically isolated from tip electrode164, instead of providing a localized ring electrode such as anode electrode162. Electrode162formed along an electrically conductive portion of housing150serves as a return anode during pacing and sensing.

The housing150includes a control electronics subassembly152, which houses the electronics for sensing cardiac signals, producing pacing pulses and controlling therapy delivery and other functions of pacemaker14as described below in conjunction withFIG.3. A motion sensor may be implemented as an accelerometer enclosed within housing150in some examples. The accelerometer provides a signal to a processor included in control electronics subassembly152for signal processing and analysis for detecting ventricular mechanical events and atrial systolic events for timing ventricular pacing pulses as described below.

Housing150further includes a battery subassembly160, which provides power to the control electronics subassembly152. Battery subassembly160may include features of the batteries disclosed in commonly-assigned U.S. Pat. No. 8,433,409 (Johnson, et al.) and U.S. Pat. No. 8,541,131 (Lund, et al.), both of which are hereby incorporated by reference herein in their entirety.

Pacemaker14may include a set of fixation tines166to secure pacemaker14to patient tissue, e.g., by actively engaging with the ventricular endocardium and/or interacting with the ventricular trabeculae. Fixation tines166are configured to anchor pacemaker14to position electrode164in operative proximity to a targeted tissue for delivering therapeutic electrical stimulation pulses. Numerous types of active and/or passive fixation members may be employed for anchoring or stabilizing pacemaker14in an implant position. Pacemaker14may include a set of fixation tines as disclosed in commonly-assigned, pre-grant publication U.S. 2012/0172892 (Grubac, et al.), hereby incorporated herein by reference in its entirety.

Pacemaker14may optionally include a delivery tool interface158. Delivery tool interface158may be located at the proximal end104of pacemaker14and is configured to connect to a delivery device, such as a catheter, used to position pacemaker14at an implant location during an implantation procedure, for example within a heart chamber.

FIG.2Bis a conceptual diagram of another example of RV pacemaker14. InFIG.2B, RV pacemaker14includes a proximal sensing extension165extending away from housing150and carrying a pair of sensing electrodes167and168. The proximal sensing extension165may be coupled to the housing150for positioning a return sensing electrode168or167which may be paired with distal electrode164at an increased inter-electrode distance compared to the inter-electrode spacing of housing-based electrodes162and164. The increased inter-electrode distance may facilitate sensing of far-field atrial signals such as P-waves attendant to atrial depolarization.

Alternatively, electrodes167and168may form a sensing electrode pair for sensing atrial P-waves. When distal end102is fixed along the RV apex, sensing extension165may extend toward the RA thereby positioning electrodes167and168nearer the atrial tissue for sensing far-field atrial P-waves. One electrode167may be coupled to sensing circuitry enclosed in housing150via an electrical feedthrough crossing housing150, and one electrode168may be coupled to housing150to serve as a ground electrode.

FIG.3is a schematic diagram of an example configuration of pacemaker14shown inFIG.1. Pacemaker14includes a pulse generator202, a sensing circuit204, a control circuit206, memory210, telemetry circuit208, motion sensor212and a power source214. Motion sensor212is implemented as an accelerometer in the examples described herein and may also be referred to herein as “accelerometer212.” Motion sensor212is not limited to being an accelerometer, however, and other motion sensors may be utilized successfully in pacemaker14for detecting cardiac motion signals according to the techniques described herein. Examples of motion sensors that may be implemented in pacemaker14include piezoelectric sensors and micro electro-mechanical systems (MEMS) devices.

Motion sensor212may be a multi-axis sensor, e.g., a two-dimensional or three-dimensional sensor, with each axis providing a signal that may be analyzed individually or in combination for detecting cardiac mechanical events. Motion sensor212produces an electrical signal correlated to motion or vibration of sensor212(and pacemaker14), e.g., when subjected to flowing blood and cardiac motion. Motion sensor212may be a one-dimensional, single axis accelerometer, two-dimensional or three-dimensional multi-axis accelerometer. One example of an accelerometer for use in implantable medical devices is generally disclosed in U.S. Pat. No. 5,885,471 (Ruben, et al.), incorporated herein by reference in its entirety. An implantable medical device arrangement including a piezoelectric accelerometer for detecting patient motion is disclosed, for example, in U.S. Pat. No. 4,485,813 (Anderson, et al.) and U.S. Pat. No. 5,052,388 (Sivula, et al.), both of which patents are hereby incorporated by reference herein in their entirety. Examples of three-dimensional accelerometers that may be implemented in pacemaker14and used for detecting cardiac mechanical events using the presently disclosed techniques are generally described in U.S. Pat. No. 5,593,431 (Sheldon) and U.S. Pat. No. 6,044,297 (Sheldon), both of which are incorporated herein by reference in their entirety. Other accelerometer designs may be used for producing an electrical signal that is correlated to motion imparted on pacemaker14due to ventricular and atrial events.

The various circuits represented inFIG.3may be combined on one or more integrated circuit boards which include a specific integrated circuit (ASIC), an electronic circuit, a processor (shared, dedicated, or group) and memory that execute one or more software or firmware programs, a combinational logic circuit, state machine or other suitable components that provide the described functionality.

Sensing circuit204is configured to receive a cardiac electrical signal via electrodes162and164by a pre-filter and amplifier circuit220. Pre-filter and amplifier circuit may include a high pass filter to remove DC offset, e.g., a 2.5 to 5 Hz high pass filter, or a wideband filter having a passband of 2.5 Hz to 100 Hz to remove DC offset and high frequency noise. Pre-filter and amplifier circuit220may further include an amplifier to amplify the “raw” cardiac electrical signal passed to analog-to-digital converter (ADC)226. ADC226may pass a multi-bit, digital electrogram (EGM) signal to control circuit206for use by atrial event detector circuit240in identifying ventricular electrical events (e.g., R-waves or T-waves) and/or atrial electrical events, e.g., P-waves. Identification of cardiac electrical events may be used in algorithms for detecting atrial systolic events from the motion sensor signal. The digital signal from ADC226may be passed to rectifier and amplifier circuit222, which may include a rectifier, bandpass filter, and amplifier for passing a cardiac signal to R-wave detector224.

R-wave detector224may include a sense amplifier or other detection circuitry that compares the incoming rectified, cardiac electrical signal to an R-wave detection threshold, which may be an auto-adjusting threshold. When the incoming signal crosses the R-wave detection threshold, the R-wave detector224produces an R-wave sensed event signal (R-sense) that is passed to control circuit206. In other examples, R-wave detector224may receive the digital output of ADC226for detecting R-waves by a comparator, morphological signal analysis of the digital EGM signal or other R-wave detection techniques. R-wave sensed event signals passed from R-wave detector224to control circuit206may be used for scheduling ventricular pacing pulses by pace timing circuit242and for use in identifying the timing of ventricular electrical events in algorithms performed by atrial event detector circuit240for detecting atrial systolic events from a signal received from motion sensor212.

Control circuit206includes an atrial event detector circuit240, pace timing circuit242, and processor244. Atrial event detector circuit240is configured to detect atrial mechanical events from a signal received from motion sensor212. As described below, one or more ventricular mechanical events may be detected from the motion sensor signal in a given cardiac cycle to facilitate positive detection of the atrial systolic event from the motion sensor signal during the ventricular cycle.

Control circuit206may receive R-wave sensed event signals and/or digital cardiac electrical signals from sensing circuit204for use in detecting and confirming cardiac events and controlling ventricular pacing. For example, R-wave sensed event signals may be passed to pace timing circuit242for inhibiting scheduled ventricular pacing pulses or scheduling ventricular pacing pulses when pacemaker14is operating in a non-atrial tracking ventricular pacing mode. R-wave sensed event signals may also be passed to atrial event detector circuit240for use in setting ventricular event detection windows and/or atrial event refractory periods, for example as shown and described in conjunction withFIG.6.

Atrial event detector circuit240receives a motion signal from motion sensor212and starts an atrial refractory period in response to a ventricular electrical event, e.g., an R-wave sensed event signal from sensing circuit204or delivery of a pacing pulse by pulse generator202. Atrial event detector circuit240determines if the motion sensor signal satisfies atrial mechanical event detection criteria outside of the refractory period. The motion sensor signal during the refractory period may be monitored by atrial event detector circuit240for the purposes of detecting ventricular mechanical events, which may be used for confirming or validating atrial systolic event detection and/or setting atrial systolic event detection control parameters as further described below, e.g., in conjunction withFIG.10. As such, ventricular mechanical event detection windows may be set during the atrial refractory period and may be set according to predetermined time intervals following identification of a ventricular electrical event. Atrial event detector circuit240may be configured to detect one or more ventricular mechanical events during respective ventricular event detection windows during the atrial refractory period. The timing and detection of the ventricular mechanical events may be used to update the atrial refractory period and/or an atrial systolic detection threshold amplitude and may be used to confirm detection of the atrial systolic event occurring subsequent to expected ventricular mechanical events.

Atrial event detector circuit240passes an atrial event detection signal to processor244and/or pace timing circuit242. Pace timing circuit242(or processor244) may additionally receive R-wave sensed event signals from R-wave detector224for use in controlling the timing of pacing pulses delivered by pulse generator202. Processor244may include one or more clocks for generating clock signals that are used by pace timing circuit242to time out an AV pacing interval that is started upon receipt of an atrial event detection signal from atrial event detector circuit240. Pace timing circuit242may include one or more pacing escape interval timers or counters that are used to time out the AV pacing interval, which may be a programmable interval stored in memory210and retrieved by processor244for use in setting the AV pacing interval used by pace timing circuit242.

Pace timing circuit242may additionally include a lower pacing rate interval timer for controlling a minimum ventricular pacing rate. For example, if an atrial systolic event is not detected from the motion sensor signal triggering a ventricular pacing pulse at the programmed AV pacing interval, a ventricular pacing pulse may be delivered by pulse generator202upon expiration of the lower pacing rate interval to prevent ventricular asystole and maintain a minimum ventricular rate.

Processor244may retrieve other programmable pacing control parameters, such as pacing pulse amplitude and pacing pulse width that are passed to pulse generator202for controlling pacing pulse delivery. In addition to providing control signals to pace timing circuit242and pulse generator202for controlling pacing pulse delivery, processor244may provide sensing control signals to sensing circuit204, e.g., R-wave sensing threshold, sensitivity, various blanking and refractory intervals applied to the cardiac electrical signal, and atrial event detection control signals to atrial event detector circuit240for use in detecting and confirming atrial systolic events, e.g., ventricular event detection windows, atrial refractory period, detection threshold amplitudes applied to the motion sensor signal, and any other atrial event detection criteria applied by circuitry included in atrial event detector circuit240.

The functions attributed to pacemaker14herein may be embodied as one or more processors, controllers, hardware, firmware, software, or any combination thereof. Depiction of different features as specific circuitry is intended to highlight different functional aspects and does not necessarily imply that such functions must be realized by separate hardware, firmware or software components or by any particular circuit architecture. Rather, functionality associated with one or more circuits described herein may be performed by separate hardware, firmware or software components, or integrated within common hardware, firmware or software components. For example, atrial systolic event detection from the motion sensor signal and ventricular pacing control operations performed by pacemaker14may be implemented in control circuit206executing instructions stored in memory210and relying on input from sensing circuit204and motion sensor212.

The operation of circuitry included in pacemaker14as disclosed herein should not be construed as reflective of a specific form of hardware, firmware and software necessary to practice the techniques described. It is believed that the particular form of software, hardware and/or firmware will be determined primarily by the particular system architecture employed in the pacemaker14and by the particular sensing and therapy delivery circuitry employed by the pacemaker14. Providing software, hardware, and/or firmware to accomplish the described functionality in the context of any modern pacemaker, given the disclosure herein, is within the abilities of one of skill in the art.

Pulse generator202generates electrical pacing pulses that are delivered to the RV of the patient's heart via cathode electrode164and return anode electrode162. Pulse generator202may include charging circuit230, switching circuit232and an output circuit234Charging circuit230may include a holding capacitor that may be charged to a pacing pulse amplitude by a multiple of the battery voltage signal of power source214under the control of a voltage regulator. The pacing pulse amplitude may be set based on a control signal from control circuit206. Switching circuit232may control when the holding capacitor of charging circuit230is coupled to the output circuit234for delivering the pacing pulse. For example, switching circuit232may include a switch that is activated by a timing signal received from pace timing circuit242upon expiration of an AV pacing interval (or lower rate pacing interval) and kept closed for a programmed pacing pulse duration to enable discharging of the holding capacitor of charging circuit230. The holding capacitor, previously charged to the pacing pulse voltage amplitude, is discharged across electrodes162and164through the output capacitor of output circuit234for the programmed pacing pulse duration. Examples of pacing circuitry generally disclosed in U.S. Pat. No. 5,507,782 (Kieval, et al.) and in commonly assigned U.S. Pat. No. 8,532,785 (Crutchfield, et al.), both of which patents are incorporated herein by reference in their entirety, may be implemented in pacemaker14for charging a pacing capacitor to a predetermined pacing pulse amplitude under the control of control circuit206and delivering a pacing pulse.

Memory210may include computer-readable instructions that, when executed by control circuit206, cause control circuit206to perform various functions attributed throughout this disclosure to pacemaker14. The computer-readable instructions may be encoded within memory210. Memory210may include any non-transitory, computer-readable storage media including any volatile, non-volatile, magnetic, optical, or electrical media, such as a random access memory (RAM), read-only memory (ROM), non-volatile RAM (NVRAM), electrically-erasable programmable ROM (EEPROM), flash memory, or other digital media with the sole exception being a transitory propagating signal. Memory210may store timing intervals and other data used by control circuit206to control the delivery of pacing pulses by pulse generator202, e.g., by detecting an atrial systolic event by atrial event detector circuit240from the motion sensor signal and setting a pacing escape interval timer included in pace timing circuit242, according to the techniques disclosed herein.

Power source214provides power to each of the other circuits and components of pacemaker14as required. Control circuit206may execute power control operations to control when various circuits or components are powered to perform various pacemaker functions. Power source214may include one or more energy storage devices, such as one or more rechargeable or non-rechargeable batteries. The connections between power source214and other pacemaker circuits and components are not shown inFIG.3for the sake of clarity.

Telemetry circuit208includes a transceiver209and antenna211for transferring and receiving data via a radio frequency (RF) communication link. Telemetry circuit208may be capable of bi-directional communication with external device20(FIG.1) as described above. Motion sensor signals and cardiac electrical signals, and/or data derived therefrom may be transmitted by telemetry circuit208to external device20. Programmable control parameters and algorithms for performing atrial event detection and ventricular pacing control may be received by telemetry circuit208and stored in memory210for access by control circuit206.

FIG.4is an example of a motion sensor signal250that may be acquired by motion sensor212over a cardiac cycle. Vertical dashed lines252and262denote the timing of two consecutive ventricular events (an intrinsic ventricular depolarization or a ventricular pace), marking the respective beginning and end of the ventricular cycle251. The motion signal includes an A1 event254, an A2 event256, an A3 event258and an A4 event260. The A1 event254is an acceleration signal (in this example when motion sensor250is implemented as an accelerometer) that occurs during ventricular contraction and marks the approximate onset of ventricular mechanical systole. The A1 event is also referred to herein as a “ventricular contraction event.” The A2 event265is an acceleration signal that occurs during ventricular relaxation and marks the approximate offset or end of ventricular mechanical systole. The A2 event is also referred to herein as the “ventricular relaxation event.” The A3 event258is an acceleration signal that occurs during passive ventricular filling and marks ventricular mechanical diastole. The A3 event is also referred to herein as the “ventricular passive filling event.” Since the A2 event occurs with the end of ventricular systole, it is an indicator of the onset of ventricular diastole. The A3 event occurs during ventricular diastole. As such, the A2 and A3 events may be collectively referred to as ventricular mechanical diastolic events because they are both indicators of the ventricular diastolic period.

The A4 event260is an acceleration signal that occurs during atrial contraction and active ventricular filling and marks atrial mechanical systole. The A4 event260is also referred to herein as the “atrial systolic event” or merely the “atrial event,” and is the atrial systolic event that is detected from motion sensor signal250by atrial event detector circuit240for controlling pace timing circuit242to trigger ventricular pacing pulse delivery by starting an AV pacing interval in response to detecting the A4 event260. As described below, control circuit206may be configured to detect one or more of the A1, A2, and A3 events from motion sensor signal250, for at least some ventricular cardiac cycles, for use in positively detecting the A4 event260and setting atrial event detection control parameters. The A1, A2 and/or A3 events may be detected and characterized to avoid false detection of A4 events and promote reliable A4 event detection for proper timing of atrial-synchronized ventricular pacing pulses.

FIG.5is a flow chart300of one method performed by pacemaker14for detecting the A4 event and controlling ventricular pacing. At block302, control circuit206identifies a ventricular event. The ventricular event may be an R-wave sensed event signal received from sensing circuit204or a ventricular pacing pulse delivered by pulse generator202. Since the ventricular A1, A2 and A3 events may have different characteristics during an intrinsic ventricular rhythm than during a ventricular paced rhythm, the methods described herein for determining amplitudes, time intervals or other characteristics of the A1, A2 and A3 events for use in setting A4 detection control parameters or confirming A4 event detection may be determined for both an intrinsic ventricular rhythm and a ventricular paced rhythm.

For example, as described in conjunction with the flow charts and timing diagrams presented herein, various time intervals, sensing windows, atrial refractory period, and atrial event detection threshold amplitude may be set based on characterizations of one or more of the A1, A2 and A3 events. One set of A4 detection control parameters and characteristics of the A1, A2 and A3 events may be determined and stored for use during episodes of ventricular sensing (ventricular intrinsic rhythm), and another set of A4 detection control parameters and characteristics of the A1, A2 and A3 events may be determined and stored for used during episodes of ventricular pacing.

During ventricular sensing, control circuit206may be configured to discriminate a normal sinus R-wave from a premature ventricular contraction (PVC) so that ventricular events identified at block302for use in starting a search for the A1 through A4 events from the motion sensor signal do not include PVCs. When a ventricular event, sensed or paced, is identified at block302that is not a PVC, pace timing circuit242may set an escape interval timer to a lower rate (LR) pacing interval. If the lower rate pacing interval expires (as described below in conjunction with block315), a ventricular pacing pulse may be delivered, asynchronous to atrial activity, in order to maintain some minimum, base ventricular rate.

At block304, atrial event detector240detects the A1 through A3 motion signals. Briefly, atrial event detector240may compare the motion sensor signal to one or more predetermined detection threshold amplitudes during one or more time windows set in response to identifying the ventricular event at bock302for detecting the A1 through A3 events. In some examples, the A4 event may also be detected at block304to increase confidence in the positive identification of each of the four motion sensor signals A1 through A4 in a given cardiac cycle. In this example, the A1 through A3 events, and optionally A4, may be detected on a beat-by-beat basis.

After the A1 through A3 events are detected, the A1-A3 time interval is determined at block304as the time interval from the A1 event detection to the A3 event detection. The A1-A3 time interval may be used to update an A1-A3 interval trend at block308. For example, a running average A1-A3 time interval may be updated at block308using the most recent N A1-A3 time interval measurements, e.g., the most recent three to twelve A1-A3 time intervals.

The A1-A3 time interval is used to set a post-ventricular atrial refractory period at block310. This atrial refractory period is also referred to herein as an “A4 refractory period” because A4 event detection is inhibited during the atrial refractory period. When a ventricular event is identified at block302, atrial event detector240may start the atrial refractory period at block310. The atrial refractory period may be set to a percentage longer than or a fixed interval longer than the A1-A3 time interval. For example, the atrial refractory period may be set to be 50 to 150 ms longer than the A1-A3 time interval, though shorter or longer fixed intervals may be added to the A1-A3 time interval for setting the atrial refractory period. The fixed time interval used to set the atrial refractory period may vary depending on heart rate in some examples.

During the atrial refractory period, any motion sensor events that are detected, or cross a detection threshold amplitude, are ignored for the purposes of triggering a ventricular pacing pulse and starting an AV pacing interval. Ventricular mechanical events A1 through A3 may be detected during the atrial refractory period, as indicated at block304, to determine the A1-A3 time interval and update the A1-A3 interval trend (blocks306and308), either periodically or on a beat-by-beat basis.

At block312, atrial event detector circuit240monitors the motion sensor signal to detect the A4 event after the expiration of the atrial refractory period. If the A4 event is not detected before the lower pacing rate interval expires (block315), a ventricular pacing pulse is delivered at block316to ensure a minimum ventricular rate, e.g., 40 to 60 beats per minute. Furthermore, it is to be understood that if an intrinsic R-wave is sensed before an A4 event is detected, the process ofFIG.5may return to block302where the sensed R-wave is identified as a ventricular electrical event and control circuit206restarts the process of detecting the A4 event on the next ventricular cycle.

If the A4 event is detected before the lower pacing rate interval expires, control circuit206sets the AV pacing interval at block314in response to detecting the A4 event. If an intrinsic R-wave is not sensed from the cardiac electrical signal by sensing circuit204during the AV pacing interval, “no” branch of block316, a ventricular pacing pulse is delivered by pulse generator202at block318upon expiration of the AV pacing interval. The ventricular pacing pulse, if delivered, and otherwise the sensed R-wave, is identified as the next ventricular event at block302and the process repeats.

In this way, the A1 through A3 events may be detected from the motion sensor signal on a beat-by-beat (or less frequent) basis for updating the A1-A3 time interval trend used to set the atrial refractory period to provide a high likelihood of positively detecting the A4 event and properly timing a ventricular pacing pulse in synchrony with the atrial event. Other motion sensor signal events A1 through A3 are unlikely to be falsely detected as the A4 event by applying the atrial refractory period set based on the A1-A3 timing.

In some examples, rather than determining an A1-A3 time interval, a time interval to the A2 event may be determined so that the atrial refractory period is set based on the A1-A2 time interval to extend through at least the A2 event and expire before the A3 event. In this example, an A4 detection threshold amplitude may be set higher than an expected A3 event amplitude to allow detection of the A4 event earlier in the ventricular cycle, for example as the atrial rate is increasing. In other cases, the time interval from the identified ventricular electrical event to the A1, A2 or A3 event may be determined and used in setting the atrial refractory period.

In some examples, the process of blocks304through308is performed periodically rather than on a beat-by-beat basis. For example detection of A1-A3 events during the atrial refractory period may occur on every third cardiac cycle, every eighth cardiac cycle, once a minute, or other predetermined schedule for updating the A1-A3 time interval (or other ventricular event time interval as discussed above) used for setting the atrial refractory period at block310. In some cases, the heart rate, paced or intrinsic, may be monitored and the A1-A3 events may be detected for updating the A1-A3 interval trend when the heart rate changes by more than a predetermined amount. For example, ventricular event intervals between consecutive ventricular events may be determined upon identifying ventricular events at block302. The ventricular event intervals may be RR intervals between consecutively sensed intrinsic R-waves or VV intervals between consecutively delivered ventricular pacing pulses and may include RV intervals between a sensed intrinsic R-wave and a consecutively delivered pacing pulse and VR intervals between a delivered pacing pulse and a consecutively sensed R-wave. Both the intrinsic heart rate and the paced rate may change, e.g., when pacemaker14is a rate responsive pacemaker. If the ventricular event interval changes or a trend in the ventricular event interval changes by more than a predetermined amount, the control circuit may perform blocks304through308to update the A1-A3 interval trend used for setting the atrial refractory period.

In other examples, if the A4 event is not detected at block312after the atrial refractory period and before the next ventricular event (intrinsic or paced) is identified at block302, the control circuit206may perform the process of blocks304through306for a predetermined number of consecutive or non-consecutive cardiac cycles to update the A1-A3 interval trend used to set the atrial refractory period to restore A4 detection.

FIG.6is an example of a motion sensor signals400and410acquired over two different cardiac cycles. A ventricular pacing pulse is delivered at time 0.0 seconds for both cardiac cycles. The top sensor signal400is received over one cardiac cycle and the bottom sensor signal401is received over a different cardiac cycle. The two signals400and410are aligned in time at 0.0 seconds, the time of the ventricular pacing pulse delivery.

The A1 events402and412of the respective motion sensor signals400and410, which occur during ventricular contraction, are observed to be well-aligned in time following the ventricular pacing pulse at time 0.0 seconds. Similarly, the A2 events404and414(occurring during ventricular relaxation) and the A3 events406and416(occurring during passive ventricular filling) are well-aligned in time. Since the A1, A2 and A3 events are ventricular events, occurring during ventricular contraction, ventricular relaxation, and passive ventricular filling, respectively, these events are expected to occur at relatively consistent intervals following a ventricular electrical event, the ventricular pacing pulse in this example, and relative to each other. The time relationship of the A1, A2 and A3 events may be different following a ventricular pacing pulse compared to following a sensed intrinsic R-wave, however, during a stable paced or intrinsic ventricular rhythm, the relative timing of A1, A2 and A3 events to each other and the immediately preceding ventricular electrical event is expected to be consistent.

The A4 events408and418of the first and second motion sensor signals400and410respectively are not aligned in time. The A4 event occurs during atrial systole and as such the time interval of the A4 event following the immediately preceding ventricular electrical event (sensed R-wave or ventricular pacing pulse) and the preceding A1 through A3 events may vary between cardiac cycles.

The consistency of the timing of the A1 through A3 events relative to each other and the immediately preceding ventricular electrical event may be used for determining the atrial refractory period and increasing confidence in reliably detecting A4 events408and418. In some examples, an A1 sensing window420may be set based on an expected Vpace-A1 time interval. The Vpace-A1 time interval430may be measured when the motion sensor signal400or410crosses an A1 sensing threshold amplitude440. The A1 sensing window420may be adjusted on the next cardiac cycle based on the Vpace-A1 time interval430determined on the current cardiac cycle or a running average Vpace-A1 time interval.

An A2 sensing window422may be set based on an expected Vpace-A2 time interval (not explicitly shown but understood to be the total time from 0.0 seconds to an A2 event detection) or an A1-A2 time interval432(time from A1 detection to time of A2 detection). The A2 event404or414may be detected at the time of the first positive-going crossing of an A2 sensing threshold amplitude442by the motion sensor signal400or410during the A2 sensing window422. The A2 sensing window422may be adjusted on the next cardiac cycle based on the Vpace-A2 time interval or A1-A2 time interval432determined on the current cardiac cycle.

Similarly, an A3 sensing window424may be set based on an expected Vpace-A3 time interval (not explicitly labeled but understood to be sum of time intervals430and434), A1-A3 time interval434, or A2-A3 time interval (not explicitly labeled but understood to be the time interval from the sensed A2 event404or414to the sensed A3 event406or416). The A3 event406or416may be detected during the A3 sensing window424when the motion sensor signal400or410, respectively, crosses an A3 sensing threshold amplitude444. The A3 sensing window424may be adjusted on the next cardiac cycle based on the Vpace-A3 time interval, A1-A3 time interval434, or the A2-A3 time interval determined during the current cardiac cycle.

Each of the sensing windows420,422and424may be set based on a history of time intervals determined from a ventricular pacing pulse or sensed intrinsic R-wave to the respective A1 event402or412, A2 event404or414and A3 event406or416or based on a history of time intervals between the detected A1, A2 and A3 events or any combination thereof. For example, the A2 sensing window422may be set to start based on time intervals measured between a ventricular pacing pulse or sensed R-wave and the detected A1 event. The end of the A2 sensing window422may be set to start based on an A1-A2 time interval432or based on an A1-A3 time interval434. It is recognized that numerous methods may be conceived for setting the A1, A2 and A3 sensing windows420,422and424, respectively, based on the consistency of the expected time intervals between any combinations of the ventricular electrical event (paced or sensed) and subsequent A1, A2 and A3 events. Furthermore, it is contemplated that these sensing windows420,422and424may be set according to different control parameters, such as different fixed time intervals added to or subtracted from measured event time intervals depending on whether the ventricular electrical event is a paced or sensed event and/or depending on heart rate. The event time intervals that may be measured and used for setting the onset, offset and duration of the sensing windows420,422and424may include any of the Vpace-A1, Vpace-A2, Vpace-A3, Rsense-A1, Rsense-A2, Rsense-A3, A1-A2, A1-A3, and/or A2-A3 time intervals determined during a paced and/or intrinsic rhythm.

The sensing threshold amplitudes440,442and444may be set uniquely during each of the respective sensing windows420,422and424, respectively, or set to a fixed value for all sensing windows. The sensing threshold amplitudes440,442, and444may be fixed or decaying thresholds and may be automatically adjusted thresholds set to starting threshold values based on the peak motion sensor signal amplitude detected during each respective window420,422and424. The motion sensor signals400and410are shown as raw signals, but the motion sensor signal may be filtered, amplified and rectified by circuitry included in motion sensor212to provide control circuit206with a rectified signal that is used to detect the A1 through A4 events.

A post-ventricular, atrial refractory period436may be set based on the A1-A3 time interval434or based on the Vpace-A3 time interval (sum of Vpace-A1 interval430and A1-A3 time interval434). In some examples, the atrial refractory period436ends upon the expiration of the A3 sensing window424. In other examples, the atrial refractory period436ends after the expiration of the A3 sensing window424. The A4 event408or418may be detected in response to the first positive-going crossing of an A4 sensing threshold amplitude446by the rectified motion sensor signal.

In some examples, the A4 detection is confirmed when the A1, A2 and A3 events have each been detected during the atrial refractory period436. If any one of the A1, A2 or A3 events was not detected during the atrial refractory period436, the A4 event detection based on a crossing of threshold446may not be confirmed and not used for starting an AV pacing interval. In other examples, at least one of the A1, A2 or A3 events may be required to be detected during a respective sensing window420,422, or424on a beat-by-beat basis for confirming an A4 detection after the atrial refractory period436.

The A1, A2 and/or A3 events sensed during the respective A1 sensing window420, A2 sensing window422and A3 sensing window424may be used for updating the atrial refractory period436as described in conjunction withFIG.5on a beat-by-beat or less frequent basis without requiring positive detection of each of A1, A2, and/or A3 for confirming an A4 detection on each beat. Setting the atrial refractory period based on detection and relative timing of the A1 through A3 events enables the atrial refractory period to be set based on the consistent timing of the ventricular motion sensor signal events so that A4 events may be detected with high reliability even when the timing of the A4 event relative to the A1-A3 events and the preceding ventricular electrical event is variable.

FIG.7is an averaged motion sensor signal500that may be determined by control circuit206by averaging the motion sensor signal obtained over multiple cardiac cycles, e.g., signals400and410ofFIG.6. The averaged motion sensor signal500may represent the average of 3 to 20 or other predetermined number of cardiac cycles. The raw motion sensor signal or a filtered, amplified and/or rectified motion sensor signal may be buffered beginning from a ventricular electrical event, pacing pulse or sensed R-wave, at time 0.0 seconds until the next ventricular electrical event. The buffered motion sensor signal obtained over one cardiac cycle may be averaged with the buffered motion sensor signals obtained over a predetermined number of other cardiac cycles to produce averaged motion sensor signal500.

A ventricular electrical signal510is shown aligned in time with averaged motion sensor signal500. Ventricular electrical signal510may be passed from sensing circuit204to control module206and includes an R-wave512, which may be an evoked or intrinsic R-wave, and a T-wave514. R-wave512is followed by the ventricular contraction A1 event502. The ventricular relaxation A2 event504occurs during T-wave514. The passive ventricular filling A3 event506occurs after T-wave514.

Since the A1, A2 and A3 events are ventricular mechanical events, they occur at consistent time intervals relative to each other and relative to ventricular electrical events (R-wave512and T-wave514). As a result, the signal-to-noise ratio of the A1 signal502, A2 signal504and A3 signal506is improved in the averaged motion sensor signal500compared to the single-cycle motion sensor signals400and410ofFIG.6. The averaged A1 event502, A2 event504and A3 event506have an improved signal-to-noise ratio compared to the A1, A2 and A3 events observed in the motion sensor signal400or410of a single cardiac cycle as shown inFIG.6, making A1, A2, and A3 event detection from the averaged motion signal500more reliable.

A single event detection threshold amplitude540may be defined such that the first positive-going crossing of the threshold540by the averaged, rectified motion sensor signal500within the A1 sensing window520, A2 sensing window522and A3 sensing window524is detected as the respective A1 event502, A2 event504, and A3 event506. Alternatively, unique detection threshold amplitudes may be defined for each sensing window520,522and524for detecting the respective A1, A2 and A3 events. The sensing windows520,522and524may be initially set according to expected A1, A2 and A3 event timing following the ventricular pacing pulse or R-wave512and may be adjusted according to the actual detection time of each respective A1 event502, A2 event504, and A3 event506. The sensing windows520,522and524may be set based on ventricular pacing rate or atrial event rate, e.g., based on A4-A4 event intervals. The sensing windows520,522and524may also be set differently following a ventricular pacing pulse than following an intrinsic R-wave sensed event since the timing of the A1, A2 and A3 events and T-wave514may be altered during ventricular pacing compared to during an intrinsic ventricular rhythm.

The atrial systolic A4 event timing, which is independent of the ventricular electrical event timing, may be more variable from one cardiac cycle to the next with respect to the ventricular electrical and mechanical events, e.g., as shown by the relative timing of the A4 events408and418of signals400and410(FIG.6). As a result, the A4 signal is largely attenuated in the averaged motion signal500inFIG.7. The improved signal-to-noise ratio of the A1 through A3 events and attenuation of the A4 event in the averaged motion signal500enables control circuit206to reliably detect the signal averaged A1 event502, A2 event504and A3 event506for determining one or more ventricular event time intervals for use in setting A1, A2 and A3 detection windows420,422, and424, respectively, setting detection threshold amplitudes for detecting the A1, A2, A3 and/or A4 events, and/or setting atrial refractory period436used on a beat-by-beat basis for A4 event detection as shown inFIG.6.

For example, a ventricular R-wave or pacing pulse to A1 time interval530, an A1-A3 time interval534, A1-A2 time interval536, a ventricular R-wave or pacing pulse to A3 time interval516, and/or a T-wave to A3 time interval518may be determined by control circuit206from the averaged motion signal500and the cardiac electrical signal510. The atrial refractory period436is started upon delivering a ventricular pacing pulse or sensing an intrinsic R-wave. The atrial refractory period436may be set to expire after a predetermined time interval, e.g., 30 to 100 ms, after the A3 time interval516. For instance, if time interval516is 700 ms, the atrial refractory period436may be set to expire 750 ms after the ventricular pacing pulse or sensed R-wave that started the atrial refractory period. Instead of using a time interval ending with the A3 event detection, a time interval ending with the A2 event detection may be determined and used in controlling the duration of the atrial refractory period436. As described above, the A2 event, which occurs during T-wave514, is an indicator of the end of ventricular mechanical systole and the onset of ventricular mechanical diastole. The A3 event occurs during ventricular mechanical diastole, during the passive ventricular filling phase. As such the timing of the A2 event504or the timing of the A3 event506relative to another ventricular electrical event (ventricular pacing pulse, R-wave512, or T-wave514) may be used for controlling the duration and expiration time of atrial refractory period436. In other words, the timing of a ventricular mechanical diastolic event, A2 event504or A3 event506, may be determined and used to set the atrial refractory period436that is applied on a beat-by-beat basis for detecting A4 events.

The T-wave514may be sensed by sensing circuit206on a beat-by-beat basis by control circuit206or by sensing circuit204from cardiac electrical signal510. The T-wave514may be sensed at a maximum peak amplitude of a rectified cardiac electrical signal or a maximum absolute peak amplitude in a non-rectified cardiac signal received by control circuit206from sensing circuit204. Alternatively, T-wave514may be sensed by sensing circuit204in response to the cardiac electrical signal crossing a T-wave sensing threshold amplitude after the ventricular pacing pulse or R-wave sensed event signal. In some cases, a T-wave sensing window may be applied after the R-wave sensed event signal or a delivered pacing pulse to facilitate T-wave sensing.

The T-wave514may be sensed during the atrial refractory period436. Control circuit206may terminate the atrial refractory period436at a predetermined time interval after sensing T-wave514. For instance if the T-wave to A3 time interval518is determined to be 150 ms from the averaged motion signal500, control circuit206may terminate the atrial refractory period436at 180 ms after sensing the T-wave to promote reliable sensing of the A4 event.

Atrial event detector circuit240may be a processor-based circuit that determines the averaged motion sensor signal500over multiple cardiac cycles, detects A1, A2 and A3 events502,504, and506from the averaged motion sensor signal500, and sets the atrial refractory period436based on the timing of at least one ventricular mechanical diastolic event, e.g., the A3 event506, detected from the average motion sensor signal500. In other examples, the A2 event is used as a ventricular diastolic mechanical event for marking the approximate timing of the onset of ventricular diastole. The A4 event, e.g., event408or418(FIG.6) may be detected on a beat-by-beat basis from the non-averaged motion sensor signal after the atrial refractory period436expires.

FIG.8is a flow chart600of a method performed by pacemaker14for detecting atrial events and controlling atrial-synchronized ventricular pacing according to another example. At block602, a ventricular electrical event is identified, which may be a sensed intrinsic R-wave or delivered ventricular pacing pulse. A lower rate pacing interval may be set at block602upon identifying the ventricular electrical event, as described in conjunction withFIG.5, in order to maintain a minimum, base ventricular rate in the absence of A4 event detections.

At block604, the motion sensor signal is buffered over the cardiac cycle, e.g., until the next ventricular electrical event is identified. At block606, the buffered motion signal is averaged with buffered motion sensor signals acquired over a predetermined number of cardiac cycles to obtain an averaged motion signal with improved A1, A2 and A3 signal-to-noise ratio and attenuated A4 signal compared to the non-averaged motion sensor signal.

At block608the A1-A3 time interval or a ventricular electrical event to A3 time interval is determined from the averaged motion sensor signal by detecting the signal averaged A1, A2 and A3 events as described above in conjunction withFIG.7. The A3 time interval is used to set the atrial refractory period at block610by atrial event detector circuit240. As described above, the atrial refractory period may be set a predetermined percentage or fixed time interval longer than the A1-A3 time interval or a ventricular electrical event to A3 time interval or set to expire upon expiration of an A3 sensing window that is defined based on relative timing of the A1, A2, and A3 events. In other examples, an A2 time interval is determined at block608for use in setting the A4 refractory period. The A2 and A3 events are ventricular mechanical diastolic event markers that may be used for controlling the timing of the expiration of the A4 refractory period to occur near the start or during the ventricular passive filling phase, before the active ventricular filling phase associated with atrial systole.

The atrial refractory period is started at block610upon identifying a ventricular electrical event (pacing pulse or R-wave sensed event) at block602. In some examples, signal averaging and determination of the A3 time interval (or A2 time interval) for setting the atrial refractory period may occur on a beat-by-beat basis using an averaged motion signal. In other examples, the A3 time interval is determined periodically or in response to a change in the atrial rate, e.g., determined from A4-A4 intervals, or a change between a sensed and paced ventricular rhythm. The most recently updated A3 time interval (or A2 time interval) determined from the averaged motion sensor signal may be used to set the atrial refractory period at block610. The expiration of the atrial refractory period may be set on the fly during an already started atrial refractory period based on the A3 time interval determined during the current ventricular cycle. In other examples, the A3 time interval determined on a preceding ventricular cycle is used to set the atrial refractory period for the current ventricular cycle so that the atrial refractory period ends during or after an expected time of the A3 event, or in some cases prior to an expected A3 event but after an expected A2 event.

In other examples, the duration of the atrial refractory period may be controlled on a beat-by-beat basis by starting the atrial refractory period upon the identified ventricular event, sensing the T-wave during the atrial refractory period, and terminating the atrial refractory period a predetermined time interval after the sensed T-wave, where the predetermined time interval is based on the T-wave to A3 time interval518determined from the averaged motion signal500(FIG.7).

If an A4 event is detected from the non-averaged motion sensor signal at block612, after the atrial refractory period expires, an AV pacing interval is set at block614. The A4 event may be detected based on an A4 detection threshold amplitude crossing by the raw motion sensor signal or by the rectified signal. The pace timing circuit242sets an AV pacing interval at block614in response to the detected A4 signal. If an intrinsic R-wave is not sensed before expiration of the AV pacing interval, as determined at block616, the scheduled ventricular pacing pulse is delivered at block620. In some cases, the A4 event may not be detected before a lower rate pacing interval expires at block615. An atrial-asynchronous ventricular pacing pulse may be delivered at block620if the lower rate pacing interval expires before an A4 event is detected to maintain a programmed minimum ventricular base rate, causing the process to return to block602where the ventricular pacing pulse is identified as the next ventricular electrical event.

FIG.9is a timing diagram700of sensed motion sensor signal events during ventricular pacing at two different AV pacing intervals. Timing markers701indicate the time that atrial event detector circuit240detects the A1, A2, A3 and A4 events from the motion sensor signal. The atrial rate is a stable intrinsic rate in this example such that the A4 events occur at regular A4-A4 intervals720. The ventricular pacing pulses702and704are delivered at a first AV pacing interval (AV1)708following detected A4 events. The Vpace-A3 time interval730and the A3-A4 time interval740are consistent following pacing pulses702and704.

The third ventricular pacing pulse706is delivered at a shortened AV pacing interval (AV2)710. The ventricular cycle length724is shortened compared to the preceding ventricular cycle length722due to the earlier Vpace706at the shortened AV pacing interval710. When the AV pacing interval is adjusted, the Vpace-A3 time interval730stays consistent between ventricular cycles722,724and726since the A1, A2 and A3 events are ventricular mechanical events occurring as consequence of the electrical activation of the ventricle. The A4-A4 interval720remains unaffected by the change in AV pacing interval. As a result, the A3-A4 interval744is lengthened since the A3 event follows the earlier Vpace706at the shortened AV pacing interval710.

This change in the A3-A4 time interval744, or in the time between any of the ventricular events including the Vpace, A1, A2 and A3 events and the subsequent A4 event, caused by adjusting the AV pacing interval (during a stable atrial heart rate) may be determined by control circuit206. If a change in the A3-A4 time interval744occurs as a result of changing the AV pacing interval, this change is evidence that the A4 event is a true A4 event. Adjustment of the AV pacing interval to check for a corresponding change in the A3-A4 time interval may be performed by control module206for verifying the detection of A4 events and avoiding false detections of A3 events as A4 events. During atrial-synchronized ventricular pacing, the AV pacing interval may be periodically adjusted to determine if the time interval between the Vpace or any of the A1, A2, or A3 events to the A4 event changes. If so, the event detected as the A4 event is confirmed. Determining that no change in the time interval from the Vpace to any of the A1, A2 and A3 events when the AV pacing interval is changed may be used to confirm the respective A1, A2 or A3 event or at least confirm that a detected motion sensor event is not an A4 event if the event is detected at a consistent time interval from the Vpace despite changes in the AV pacing interval.

FIG.10is a flow chart800of a method for updating the atrial refractory period by pacemaker14. At block801, an A4 event is detected using an initial atrial refractory period and A4 detection threshold amplitude. A ventricular pacing pulse is delivered at an AV pacing interval following the detected A4 event at block802. Upon delivering the ventricular pacing pulse, the atrial refractory period is started at block803, and an A1 detection window is set at block804. The A1 detection window may be set according to an expected Vpace-A1 time interval, e.g., beginning 50 to 100 ms after the ventricular pacing pulse and ending 300 to 400 ms after the ventricular pacing pulse. The A1 event is detected during the A1 detection window at block806in response to a threshold amplitude crossing during the A1 detection window.

An A2 detection window is set at block808. The A2 detection window may be set to start a predetermined interval after the ventricular pacing pulse, after the A1 detection, after the expiration of the A1 detection window, or at the expiration of the A1 detection window. The A2 detection window may begin 300 ms to 400 ms after the ventricular pacing pulse and end 500 to 600 ms after the ventricular pacing pulse. An A2 event is detected at block810in response to a threshold amplitude crossing of the motion sensor signal during the A2 detection window.

The A3 detection window is set at block814and may be based on the timing of the ventricular pacing pulse, a sensed T-wave, the A1 detection, the A2 detection or the expiration of the A2 detection window in various examples. The A3 detection window may begin 500 to 600 ms after the ventricular pacing pulse and end at 700 to 800 ms after the ventricular pacing pulse.

The examples of the starting and ending times of the A1, A2 and A3 detection windows given above are illustrative in nature and not intended to be limiting. The given examples may be applicable to a heart rate up to approximately 60 beats per minute. As heart rate increases, the Vpace-A3 interval is expected to decrease. As such, the A1, A2, and A3 detection windows may start and/or end earlier in time relative to the immediately preceding ventricular pacing pulse when the intrinsic atrial rate is faster, resulting in a faster ventricular pacing rate that is tracking the atrial A4 events.

At block815, the next A4 event is detected after the atrial refractory period expires. The A4 event is detected in response to a threshold amplitude crossing of the motion sensor signal outside the atrial refractory period. The atrial refractory period may extend through at least a portion of the A3 detection window and may extend later than the A3 detection window. As described above, a single threshold amplitude may be used for detecting all A1 through A4 events or a unique threshold amplitude may be defined for detecting the A4 event outside the refractory period.

At block816, detected event time intervals are determined. In one example, at least a Vpace-A3 time interval is determined for comparison to a Vpace-A3 time interval determined after adjusting the AV pacing interval as described below. In other examples, at least a T-wave to A3 time interval is determined. In still other examples, multiple time intervals may be determined between a ventricular electrical event and a ventricular mechanical event and/or between two ventricular mechanical events, e.g., between the ventricular pacing pulse or a sensed T-wave and one or more of the A1, A2 and A3 events and/or between one or more pairs of the A1, A2 and A3 events. Additionally, at least one time interval defined by the A4 event detection time is determined at block816. For example, the A1-A4, A2-A4, A3-A4, Vpace-A4 and or T-wave-A4 time interval may be determined. These time intervals are stored in memory210for use in confirming the detected A4 event as described below.

The next ventricular pacing pulse is delivered at block818at an adjusted AV pacing interval. The AV pacing interval may be shortened by a predetermined interval compared to the AV pacing interval used at block802. At block820the A1 through A4 events are detected and the event intervals determined at block816are re-determined at block822for the current ventricular cycle. The ventricular event intervals, e.g., any of the Vpace-A1, Vpace-A2, Vpace-A3, T-wave-A3, A1-A2, A1-A3, and/or A2-A3 event intervals, are re-determined to verify consistency in ventricular event interval(s) previously determined at block816and the ventricular event interval(s) determined at block822. At block824, comparisons are made between ventricular event intervals determined at block816and re-determined at block822after adjusting the AV pacing interval to verify that the ventricular event intervals are consistent despite the change in AV pacing interval. Verification of the ventricular event interval consistency provides confidence that none of the events detected as A1, A2 or A3 events are actually an atrial event. If a change in timing of any of the A1, A2 or A3 events is detected at block824, the A1, A2 and/or A3 detection windows may be adjusted at block832. In some examples, the detection threshold amplitude(s) used for detecting the A1, A2 and/or A3 events may also be adjusted.

At block826, a time interval from any one of the ventricular events (Vpace, T-wave, A1, A2, or A3) to the A4 event is verified as being changed from an analogous time interval determined from the ventricular event to the atrial A4 event at block816. The A4-A4 interval may also be determined at block826and compared to one or more preceding A4-A4 intervals or a running average A4-A4 interval to verify that the atrial rate is stable and unchanged. If the AV pacing interval is shortened, a time interval between a ventricular event, mechanical or electrical, and the A4 atrial event is expected to be lengthened by a corresponding amount if the atrial rate is unchanged. If the timing of the A4 event relative to a preceding ventricular event is not changed after adjusting the AV pacing interval, the detected A4 event may not be a true atrial event. A change in the A4 event timing may be detected if the A4 event time interval determined at block822is more than a threshold difference from the A4 event time interval determined at block816.

For example, the A3 event may be falsely detected as the A4 event. The control circuit206may adjust the A1, A2, A3 detection windows and/or atrial refractory period at block832and repeat the process beginning at block801. In some examples, the detection threshold amplitude used for detecting one or more of the A1 through A4 events may be adjusted at block832in addition to or instead of adjusting a detection window and/or atrial refractory period. Adjustments made at block832may be based on the event time interval determined at block816. Alternatively, the methods described above in conjunction withFIG.7of obtaining an averaged motion signal500for detecting the A1, A2 and A3 events may be performed to reset the A1, A2 and A3 detection windows based on event time intervals determined from the averaged motion signal when the A4 event signal is attenuated.

If the ventricular event time intervals are verified as being unchanged at block824and a ventricular event to A4 time interval is verified as being increased at block826, the A4 event detection is verified at block828. The atrial refractory period may be updated at block830based on the Vpace-A3 time interval (or other A2 or A3 event time interval) and/or based on the ventricular event to A4 event time interval that was determined when the first, target AV pacing interval was used. The updated atrial refractory period is started upon the next ventricular pacing pulse or sensed R-wave. The A1, A2 and A3 event detection windows may also be updated at block830based on the timing of the detected A1, A2 and A3 events.

It is recognized that in some examples all three of the A1, A2 and A3 events may not be detected within a respective detection window during a given cardiac cycle. Detection of all three A1, A2 and A3 events sequentially during an atrial refractory period may provide greater confidence in an A4 event detection made outside the atrial refractory period on a given cardiac cycle. In some cases, however, detection of all three events is not necessary for confirming the A4 detection and updating detection windows and the atrial refractory period. For example, only an A3 detection window may be set for detecting the A3 event and determining a Vpace-A3 time interval. In other examples, all three detection windows may be set, and as long as at least one or more of the A1, A2 and A3 events is detected, a consistent ventricular event interval may be determined for use in confirming A4 detection and updating detection windows and the atrial refractory period.

The method ofFIG.10may be performed on a periodic basis or in response to an atrial rate change (determined based on A4-A4 intervals) to enable adjustments to the A1, A2 and/or A3 detection windows and/or atrial refractory period to be made to promote reliable A4 event detection on an ongoing basis. Shifts in the timing of the A1 through A4 events with changes in heart rate or other factors may be accounted for by adjusting the detection windows and/or atrial refractory period before losing detection of any of the A1 through A4 events. In this way, reliable ongoing detection of the A4 atrial systolic events by ventricular pacemaker14enables appropriately timed, atrial-synchronized ventricular pacing pulses to be delivered.

Thus, various examples of an intracardiac pacemaker configured to deliver atrial-synchronized ventricular pacing have been described according to illustrative embodiments. In other examples, various methods described herein may include steps performed in a different order or combination than the illustrative examples shown and described herein. Furthermore, other circuitry may be conceived by one of ordinary skill in the art for implementing the techniques disclosed herein; the particular examples described herein are illustrative in nature and not intended to be limiting. It is appreciated that various modifications to the referenced examples may be made without departing from the scope of the disclosure and the following claims.