Patent Description:
Implantable medical devices (IMDs), such as cardiac pacemakers and implantable cardioverter defibrillators (ICDs), provide therapeutic electrical stimulation to a heart of a patient via electrodes carried by one or more medical electrical leads and/or electrodes on a housing of the medical device. The electrical stimulation may include signals such as pacing pulses or cardioversion or defibrillation shocks. In some cases, a medical device may sense cardiac electrical signals attendant to the depolarizations of the heart and control delivery of stimulation signals to the heart based on sensed cardiac electrical signals. Upon detection of an abnormal rhythm, such as bradycardia, tachycardia or fibrillation, an appropriate electrical stimulation signal or signals may be delivered to restore or maintain a more normal rhythm of the heart.

Single chamber pacemakers sense cardiac electrical signals in a single heart chamber and deliver pacing pulses to the heart chamber in the absence of electrical activity. Dual chamber pacemakers sense cardiac electrical signals in two heart chambers, e.g., in the atrial and ventricular chambers, and may deliver cardiac pacing pulses in one or both chambers to provide appropriate timing and synchrony between the contractions of the atrial and ventricular chambers. <CIT> relates to mode switching by a ventricular leadless pacing device. <CIT> relates to a method and apparatus for diagnosis and treatment of arrhythmias.

In general, the disclosure is directed to techniques for controlling automatic switching between an atrial-synchronized ventricular pacing mode and an atrial-asynchronous ventricular pacing mode based on a cardiac signal including far-field atrial events. An IMD system operating according to the techniques disclosed herein may determine atrial cycle lengths or other atrial time intervals based on atrial events sensed from the cardiac signal. The IMD system determines whether pacing mode switching criteria are met based on an analysis of the atrial cycle length and/or other atrial time intervals and operates to deliver ventricular pacing to a patient's heart according to the selected pacing mode.

In one example, the disclosure provides an implantable medical device system including a sensing circuit configured to receive a cardiac signal comprising far-field atrial events; a therapy delivery circuit configured to deliver ventricular pacing pulses via electrodes coupled to the therapy delivery circuit; and a control circuit configured to control the therapy delivery circuit to deliver the ventricular pacing pulses in an atrial-synchronized pacing mode. During the atrial synchronized pacing mode, the control circuit determines atrial cycle lengths between far-field atrial events sensed from the cardiac signal, detects a cycle length change between two atrial cycle lengths that is greater than a cycle length change threshold, determines if pacing mode switching criteria are satisfied subsequent to detecting the cycle length change, and in response to the pacing mode switching criteria being satisfied, switches from the atrial-synchronized ventricular pacing mode to an atrial-asynchronous pacing mode for controlling the therapy delivery circuit in delivering the ventricular pacing pulses.

In another example, the disclosure provides a method, which is not claimed as such, for controlling a ventricular pacing mode by an IMD system. The method includes receiving a cardiac signal comprising far-field atrial events; controlling a therapy delivery circuit to deliver ventricular pacing pulses in an atrial-synchronized pacing mode; during the atrial synchronized pacing mode, determining atrial cycle lengths between far-field atrial events sensed from the cardiac signal; detecting a cycle length change between two atrial cycle lengths that is greater than a cycle length change threshold; determining if pacing mode switching criteria are satisfied subsequent to detecting the cycle length change; and in response to the pacing mode switching criteria being satisfied, switching from the atrial-synchronized ventricular pacing mode to an atrial-asynchronous pacing mode for controlling the therapy delivery circuit in delivering the ventricular pacing pulses.

In another example, the disclosure provides a non-transitory, computer-readable storage medium comprising a set of instructions which, when executed by a control circuit of an IMD system, cause the system to receive a cardiac signal comprising far-field atrial events; deliver ventricular pacing pulses in an atrial-synchronized pacing mode; during the atrial synchronized pacing mode, determine atrial cycle lengths between far-field atrial events sensed from the cardiac signal; detect a cycle length change between two atrial cycle lengths that is greater than a cycle length change threshold; determine if pacing mode switching criteria are satisfied subsequent to detecting the cycle length change; and in response to the pacing mode switching criteria being satisfied, switch from the atrial-synchronized ventricular pacing mode to an atrial-asynchronous pacing mode for controlling delivery of the ventricular pacing pulses.

This summary is intended to provide an overview of the subject matter described in this disclosure. It is not intended to provide an exclusive or exhaustive explanation of the apparatus and methods described in detail within the accompanying drawings and description below. Further details of one or more examples are set forth in the accompanying drawings and the description below.

In general, this disclosure describes techniques for controlling mode switching between atrial-synchronized ventricular pacing and asynchronous ventricular pacing in an implantable medical device (IMD) system. During atrial-synchronized ventricular pacing, ventricular pacing pulses are triggered when an atrial event is sensed so that ventricular pacing pulses track atrial events, e.g., by delivering ventricular pacing pulses at a programmed atrioventricular (AV) delay interval. Ventricular pacing pulses are inhibited when a ventricular intrinsic event, e.g., an R-wave, is sensed prior to a scheduled pacing pulse, e.g., during the AV delay interval. This pacing mode is sometimes referred to as a VDD or VDDR pacing mode, indicating single-chamber ventricular pacing, dual chamber sensing, and a dual response to sensed events that includes triggering and inhibiting the ventricular pacing pulses as indicated above (the R designating a rate response mode to meet patient activity and metabolic demand). During atrial-asynchronous ventricular pacing, ventricular pacing pulses do not track atrial events. Ventricular pacing pulses are delivered at a programmed V-V interval, sometimes referred to as ventricular pacing escape interval, and are inhibited if an intrinsic ventricular event is sensed during the pacing escape interval. This pacing mode may be referred to as a VDI or VDIR pacing mode, indicating single-chamber ventricular pacing, dual chamber sensing, and a response of inhibiting a scheduled pacing pulse when an intrinsic event is sensed.

<FIG> is a conceptual diagram of one IMD system in which the methods disclosed herein for controlling pacing mode switching may be implemented. In <FIG>, an intracardiac pacemaker <NUM> is shown positioned in the right ventricle. <FIG> is a diagram of pacemaker <NUM>. Pacemaker <NUM> may be a transcatheter intracardiac pacemaker adapted for implantation within the heart, e.g., within the right ventricle (RV) or within the left ventricle (LV), for sensing cardiac signals and delivering cardiac pacing pulses to the respective ventricle in which it is implanted. Pacemaker <NUM> is shown positioned along an endocardial wall of the RV, e.g., near the RV apex. The techniques disclosed herein, however, are not limited to the pacemaker location shown in the example of <FIG> and other relative locations within or along a ventricular chamber for delivering ventricular pacing pulses are possible.

Pacemaker <NUM> is capable of producing electrical stimulation pulses, e.g., pacing pulses, delivered to heart <NUM> via one or more electrodes on the outer housing of the pacemaker <NUM>. Pacemaker <NUM> is configured to sense a cardiac electrical signal in the RV using the housing-based electrodes. The cardiac electrical signal may include far-field atrial events, e.g., P-waves occurring in the right atrium (RA).

Pacemaker <NUM> may be capable of bidirectional wireless communication with an external device <NUM>. External device <NUM> is 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 pacemaker <NUM> as well as for retrieving device- and/or patient-related data from pacemaker <NUM>. External device <NUM> may be located in a clinic, hospital or other medical facility. External device <NUM> may 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, such as sensing and therapy delivery control parameters, may be programmed into pacemaker <NUM> using external device <NUM>.

External device <NUM> may include a microprocessor, memory, user display, user interface (such as a mouse, keyboard, or pointing device) and telemetry circuit for receiving, transmitting and processing signals sent to or received from pacemaker <NUM> and for enabling a clinician to view data and enter programming commands. Aspects of external device <NUM> may generally correspond to the external programming/monitoring unit disclosed in <CIT>).

External device <NUM> is configured with an external telemetry circuit for bidirectional communication with an implantable telemetry circuit (shown in <FIG>) included in pacemaker <NUM>. The external telemetry circuit establishes a wireless radio frequency (RF) communication link <NUM> with pacemaker <NUM> using a communication protocol that appropriately addresses pacemaker <NUM>. Communication link <NUM> may be established between pacemaker <NUM> and external device <NUM> using a radio frequency (RF) link in the Medical Implant Communication Service (MICS) band, Medical Data Service (MEDS) band, BLUETOOTH® or Wi-Fi or other communication bandwidth.

In <FIG>, pacemaker <NUM> is shown to include two housing-based electrodes <NUM> and <NUM> spaced apart along the housing <NUM> for sensing cardiac electrical signals and delivering pacing pulses. Electrode <NUM> is shown as a tip electrode along a distal end <NUM> of pacemaker housing <NUM>. Electrode <NUM> is shown as a ring electrode along a midportion of housing <NUM>, for example adjacent housing proximal end <NUM>. Housing distal end <NUM> is referred to as "distal" in that it is expected to be the leading end as it advanced to an implant site using a delivery tool, such as a catheter, and placed against a targeted pacing site.

Electrodes <NUM> and <NUM> form an anode and cathode pair for bipolar cardiac pacing and sensing. Electrodes <NUM> and <NUM> may be positioned on or as near as possible to respective proximal and distal ends <NUM> and <NUM> to increase the inter-electrode spacing between electrodes <NUM> and <NUM>. In alternative embodiments, pacemaker <NUM> may include two or more ring electrodes, two tip electrodes, and/or other types of electrodes exposed along pacemaker housing <NUM> for delivering electrical stimulation to heart <NUM> and sensing cardiac electrical signals that include near-field ventricular events, e.g., R-waves attendant to ventricular depolarizations, and far-field atrial events, e.g., P-waves attendant to atrial depolarizations. Electrodes <NUM> and <NUM> may 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.

Housing <NUM> is formed from a biocompatible material, such as a stainless steel or titanium alloy. In some examples, the housing <NUM> may include an insulating coating. Examples of insulating coatings include parylene, urethane, PEEK, or polyimide among others. The entirety of the housing <NUM> may be insulated, but only electrodes <NUM> and <NUM> uninsulated. In other examples, the entirety of the housing <NUM>, isolated from cathode tip electrode <NUM>, may function as an electrode instead of providing a localized electrode, such as electrode <NUM>, to serve as a return anode electrode for delivering bipolar pacing and sensing.

The housing <NUM> includes a control electronics subassembly <NUM>, which houses the electronic circuitry for sensing cardiac signals, producing pacing pulses and controlling ventricular pacing pulse delivery and other functions of pacemaker <NUM>. Housing <NUM> further includes a battery subassembly <NUM>, which provides power to the control electronics subassembly <NUM>. Battery subassembly <NUM> may include features of the batteries disclosed in commonly-assigned <CIT>) and <CIT>).

Pacemaker <NUM> may include a set of fixation tines <NUM> to secure pacemaker <NUM> to patient tissue, e.g., by interacting with the ventricular trabeculae or actively engaging endocardial tissue. Fixation tines <NUM> are configured to anchor pacemaker <NUM> to position electrode <NUM> in 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 pacemaker <NUM> in an implant position. Pacemaker <NUM> may include a set of fixation tines as disclosed in commonly-assigned, pre-grant publication <CIT>).

In some examples, pacemaker <NUM> may include a delivery tool interface <NUM>. Delivery tool interface <NUM> may be located at the proximal end <NUM> of pacemaker <NUM> and is configured to connect to a delivery device, such as a catheter, used to position pacemaker <NUM> at an implant location during an implantation procedure, for example within a heart chamber.

<FIG> is a conceptual diagram of an alternative embodiment of an intracardiac pacemaker <NUM>' which may be configured to perform automatic ventricular pacing mode switching according to the techniques disclosed herein. Pacemaker <NUM>' includes housing <NUM>, control electronics assembly <NUM>, battery assembly <NUM>, fixation member <NUM> and housing-based electrodes <NUM> and <NUM>, and may include a delivery tool interface <NUM> along the proximal end <NUM> as described above in conjunction with <FIG>. Pacemaker <NUM>' is shown to include a proximal sensing extension <NUM> extending away from housing <NUM> and carrying a pair of sensing electrodes <NUM> and <NUM>. The proximal sensing extension <NUM> may be coupled to the housing <NUM> for positioning a return sensing electrode <NUM> or <NUM> which may be paired with distal electrode <NUM> at an increased inter-electrode distance compared to housing-based electrodes <NUM> and <NUM>. The increased inter-electrode distance may facilitate sensing of far-field atrial signals such as P-waves attendant to atrial depolarization.

Alternatively, electrodes <NUM> and <NUM> may form a sensing electrode pair for sensing atrial P-waves. When distal end <NUM> is fixed along the RV apex, sensing extension <NUM> may extend toward the RA thereby positioning electrodes <NUM> and <NUM> nearer the atrial tissue for sensing far-field atrial P-waves. One electrode <NUM> may be coupled to sensing circuitry enclosed in housing <NUM> via an electrical feedthrough crossing housing <NUM>, and one electrode <NUM> may be coupled to housing <NUM> to serve as a ground electrode.

<FIG> is a diagram of one example configuration of pacemaker <NUM>. Pacemaker <NUM> includes a control circuit <NUM>, memory <NUM>, power source <NUM>, pulse generator <NUM>, sensing circuit <NUM> and telemetry circuit <NUM>. Electrodes <NUM> and <NUM> are shown coupled to pulse generator <NUM> and sensing circuit <NUM> to provide bipolar cardiac electrical signal sensing and pacing pulse delivery. It is to be understood that when pacemaker <NUM>' is provided with a sensing extension including one or more additional sensing electrodes <NUM> and <NUM> for sensing cardiac electrical signals, the additionally available electrodes <NUM> and <NUM> are also coupled to sensing circuit <NUM> and may be selected via switching circuitry or coupled to a second sensing channel of sensing circuit <NUM> for sensing far-field atrial P-waves for use in controlling automatic ventricular pacing mode switching as described herein.

Pulse generator <NUM> generates electrical stimulation pulses that are delivered to heart tissue via electrodes <NUM> and <NUM>. Pulse generator <NUM> may include one or more holding capacitors and a charging circuit to charge the capacitor(s) to a pacing pulse voltage. At controlled time intervals, the holding capacitor(s) may be discharged through an output capacitor across a pacing load, e.g., across electrodes <NUM> and <NUM>. Pacing circuitry generally disclosed in <CIT>), may be implemented in pacemaker <NUM> for charging a pacing capacitor to a predetermined pacing pulse amplitude under the control of control circuit <NUM> and delivering a pacing pulse.

Control circuit <NUM> may include a pace timing circuit that includes one or more timers or counters set according to programmed pacing escape intervals, which may be stored in memory <NUM>. A pacing escape interval may be set to a V-V interval during atrial-asynchronous ventricular pacing. An atrial-asynchronous ventricular pacing mode is a non-tracking pacing mode during which ventricular pacing pulses are delivered independent of the timing of atrial activity. The V-V interval may be started when sensing circuit <NUM> senses an R-wave or when pulse generator <NUM> delivers a ventricular pacing pulse. If sensing circuit <NUM> senses an R-wave from the cardiac electrical signal prior to the V-V interval expiring, the V-V interval is restarted and the scheduled pacing pulse is inhibited. If the V-V interval expires without the sensing circuit <NUM> sensing an R-wave, the scheduled pacing pulse is delivered by pulse generator <NUM>.

At other times, control circuit <NUM> may control pulse generator <NUM> to deliver ventricular pacing pulses in an atrial-synchronized pacing mode. An atrial-synchronized pacing mode is an atrial-tracking mode during which the timing of ventricular pacing pulses is dependent on, e.g., triggered by, sensed far-field atrial events such as P-waves from an electrical signal or atrial mechanical systole, sometimes referred to as "atrial kick" sensed from a mechanical sensor such as a motion sensor. Ventricular pacing pulses track the atrial rate. In this case, the pace timing circuit of control circuit <NUM> may set a timer or counter to an A-V interval when the sensing circuit <NUM> senses an atrial P-wave. If an R-wave is not sensed by sensing circuit <NUM> during the A-V interval, a ventricular pacing pulse is delivered by pulse generator <NUM> at the expiration of the A-V interval, synchronizing ventricular electrical activation (and ventricular mechanical systole) to the timing of the atrial activity. If an R-wave is sensed during the A-V interval, the ventricular pacing pulse may be inhibited and a new A-V interval may be restarted upon sensing the next atrial P-wave by sensing circuit <NUM>.

Sensing circuit <NUM> receives a cardiac electrical signal, e.g., across electrodes <NUM> and <NUM> or across any combination of the electrodes <NUM>, <NUM>, <NUM> and <NUM> shown in <FIG>. Sensing circuit <NUM> may include an analog filter and amplifier, an analog-to-digital converter, a digital filter, a rectifier, a sense amplifier, comparator or other event detection circuitry or components for filtering, amplifying and rectifying the cardiac electrical signal and for sensing cardiac electrical events such as far-field P-waves and near-field R-waves from the cardiac electrical signal. Sensing circuit <NUM> may generate a sensed event signal, e.g., a P-wave sensed event signal or an R-wave sensed event signal, in response to the cardiac electrical signal crossing a respective P-wave sensing threshold or R-wave sensing threshold.

In some examples, sensing circuit <NUM> may include two sensing channels, an atrial sensing channel and a ventricular sensing channel. Each channel receives a cardiac electrical signal, which may be the same signal or may be two different signals when pacemaker <NUM> is coupled to more than two electrodes, e.g., when sensing extension <NUM> is present carrying electrodes <NUM> and <NUM>. The atrial sensing channel receives a cardiac electrical signal that includes far-field atrial events, e.g., far-field atrial P-waves. Both of the ventricular and atrial sensing channels may include a pre-filter and pre-amplifier, analog-to-digital convertor, filter, rectifier and a sense amplifier, comparator or other detection circuitry configured to sense respective near-field R-waves and far-field P-waves, e.g., based on a respective R-wave sensing threshold crossing and P-wave sensing threshold crossing. A P-wave sensing window or post-atrial sensing blanking period may be applied to avoid falsely sensing R-waves or T-waves as P-waves.

For example, in response to sensing an atrial event, the sensing circuit <NUM> may set an atrial blanking period during which atrial events are not sensed by sensing circuit <NUM>. Since far-field atrial P-waves will generally have a small amplitude, sensing circuit <NUM> may be programmed to a high sensitivity for P-wave sensing. The programmed sensitivity sets the minimum P-wave sensing threshold amplitude. The P-wave sensing threshold may decay from a starting value at the expiration of the atrial blanking period to a sensing floor equal to the programmed sensitivity. Therefore, a low programmed value of the atrial sensitivity, such as <NUM> mV or <NUM> mV, corresponds to high sensitivity since very small amplitude P-waves that exceed the low sensing floor will be sensed by sensing circuit <NUM>. In order to avoid oversensing of noise or other events as P-waves, the sensing circuit <NUM> may apply a relatively long atrial blanking period, e.g., at least <NUM>, at least <NUM>, or as long as <NUM> in some cases. Far-field atrial events that do occur during the atrial blanking period are not sensed by sensing circuit <NUM>. An atrial blanking period is shown in and described in conjunction with <FIG>.

Control circuit <NUM> may use the sensed event signals received from sensing circuit <NUM> in controlling the delivery of ventricular pacing pulses, e.g., by starting and restarting pacing escape intervals in response to sensed events and inhibiting pacing pulses. As described below, control circuit <NUM> may determine PP intervals between consecutively sensed P-waves and/or other time intervals defined by sensed P-waves for use in automatically switching between atrial-synchronized and atrial-asynchronous ventricular pacing. Techniques for sensing P-waves by intracardiac pacemaker <NUM> may correspond to the methods disclosed in <CIT>).

Sensing of far-field atrial activity for use in controlling ventricular pacing is not limited to sensing atrial electrical activity. In some examples, pacemaker <NUM> may include an accelerometer <NUM> or other motion sensor producing a signal correlated to patient and cardiac motion. The accelerometer signal includes far-field atrial mechanical event signals. Control circuit <NUM> may detect an atrial mechanical event, e.g., atrial systole or correlated to the timing of atrial systole, from a signal received from accelerometer <NUM>. Atrial mechanical events may be used instead of or in combination with atrial electrical events for determining atrial event time intervals and controlling automatic switching from atrial-synchronized to atrial-asynchronous ventricular pacing based on the sensed atrial events and associated time intervals. An intracardiac pacemaker and associated techniques for detecting atrial events from a motion signal, e.g., from an accelerometer signal, are generally disclosed in <CIT>).

Control circuit <NUM> may be a microprocessor-based controller that communicates with memory <NUM>, pulse generator <NUM>, sensing circuit <NUM> and telemetry circuit <NUM>, and accelerometer <NUM> for example via a data bus. Power source <NUM> provides power to each of the other components of pacemaker <NUM> as required. Control circuit <NUM> may execute power control operations to control when various components are powered to perform various pacemaker functions and when they are powered down to conserve energy. Power source <NUM> may include one or more energy storage devices, such as one or more rechargeable or non-rechargeable batteries. Power source <NUM> provides power to pulse generator for charging pacing capacitor(s) for generating pacing pulses.

Circuitry represented by the block diagram shown in <FIG> and other IMD block diagrams presented herein may include any discrete and/or integrated electronic circuit components that implement analog and/or digital circuits capable of producing the functions attributed to pacemaker <NUM> or another IMD performing the automatic ventricular pacing mode switching as described herein. The functions attributed to pacemaker <NUM> or other IMDs presented herein may be embodied as one or more processors, hardware, firmware, software, or any combination thereof. Control circuit <NUM> may 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), state machine, or equivalent discrete or integrated logic circuitry.

Depiction of different features of pacemaker <NUM> as discrete circuits or components is intended to highlight different functional aspects and does not necessarily imply that such circuits must be realized by separate hardware or software components. Rather, functionality associated with one or more circuits may be performed by separate hardware or software components, or integrated within common or separate hardware or software components, which may include combinational or sequential logic circuits, state machines, memory devices, etc..

Memory <NUM> may include computer-readable instructions that, when executed by control circuit <NUM>, cause control circuit <NUM> to perform various functions attributed throughout this disclosure to pacemaker <NUM>. The computer-readable instructions may be encoded within memory <NUM>. Memory <NUM> may 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.

Pacemaker <NUM> may include a telemetry circuit <NUM> having a transceiver and antenna for bidirectional communication with external device <NUM>. Sensing control parameters and pacing control parameters may be received from external device <NUM> via telemetry circuit <NUM> and passed to control circuit <NUM> or stored in memory <NUM> for retrieval by control circuit <NUM> as needed.

<FIG> is a conceptual diagram of an extra-cardiovascular implantable cardioverter defibrillator (ICD) system <NUM> according to one example. As used herein, the term "extra-cardiovascular" refers to a position outside the blood vessels, heart, and pericardium surrounding the heart of a patient. Implantable electrodes carried by extra-cardiovascular leads may be positioned extra-thoracically (outside the ribcage and sternum) or intra-thoracically (beneath the ribcage or sternum) but generally not in intimate contact with myocardial tissue. The techniques disclosed herein for controlling switching between atrial-synchronized and atrial-asynchronous ventricular pacing may be implemented in an extra-cardiovascular ICD or other extra-cardiovascular IMD system configured to sense cardiac signals and deliver pacing pulses to the patient's heart <NUM> via extra-cardiovascular electrodes.

<FIG> is a front view of a patient <NUM> implanted with extra-cardiovascular ICD system <NUM> including ICD <NUM> connected to an extra-cardiovascular electrical stimulation and sensing lead <NUM>. ICD system <NUM> may be capable of providing defibrillation and/or cardioversion shocks and pacing pulses to heart <NUM>.

ICD <NUM> includes a housing <NUM> that forms a hermetic seal that protects internal components of ICD <NUM>. The housing <NUM> of CD <NUM> may be formed of a conductive material, such as titanium or titanium alloy. The housing <NUM> may function as an electrode (sometimes referred to as a can electrode). Housing <NUM> may be used as an active can electrode for use in delivering cardioversion/defibrillation (CV/DF) shocks or other high voltage pulses delivered using a high voltage therapy circuit. In other examples, housing <NUM> may be available for use in delivering unipolar, low voltage cardiac pacing pulses in conjunction with lead-based cathode electrodes and for sensing cardiac electrical signals including far-field atrial events in conjunction with lead-based electrodes. In other instances, the housing <NUM> of ICD <NUM> may include a plurality of electrodes on an outer portion of the housing. The outer portion(s) of the housing <NUM> functioning as an electrode(s) may be coated with a material, such as titanium nitride.

ICD <NUM> includes a connector assembly <NUM> (also referred to as a connector block or header) that includes electrical feedthroughs crossing housing <NUM> to provide electrical connections between conductors extending within the lead body <NUM> of lead <NUM> and electronic components included within the housing <NUM> of ICD <NUM>. As will be described in further detail herein, housing <NUM> may house one or more processors, memories, transceivers, electrical cardiac signal sensing circuitry, therapy delivery circuitry, power sources and other components for sensing cardiac electrical signals, detecting a heart rhythm, and controlling and delivering electrical stimulation pulses to treat an abnormal heart rhythm.

Lead <NUM> includes an elongated lead body <NUM> having a proximal end <NUM> that includes a lead connector (not shown) configured to be connected to ICD connector assembly <NUM> and a distal portion <NUM> that includes one or more electrodes. In the example illustrated in <FIG>, the distal portion <NUM> of lead <NUM> includes defibrillation electrodes <NUM> and <NUM> and pace/sense electrodes <NUM>, <NUM> and <NUM>. In some instances, defibrillation electrodes <NUM> and <NUM> are coupled to electrically isolated conductors, and ICD <NUM> may include switching mechanisms to allow electrodes <NUM> and <NUM> to be utilized as a single defibrillation electrode (e.g., activated concurrently to form a common cathode or anode) or as separate defibrillation electrodes, (e.g., activated individually, one as a cathode and one as an anode or activated one at a time, one as an anode or cathode and the other remaining inactive with housing <NUM> as an active electrode).

Electrodes <NUM> and <NUM> (and in some examples housing <NUM>) are referred to herein as defibrillation electrodes because they are utilized, individually or collectively, for delivering high voltage stimulation therapy (e.g., cardioversion or defibrillation shocks). Electrodes <NUM> and <NUM> may be elongated coil electrodes and generally have a relatively high surface area for delivering high voltage electrical stimulation pulses compared to low voltage pacing and sensing electrodes <NUM>, <NUM> and <NUM>. However, electrodes <NUM> and <NUM> and housing <NUM> may also be utilized to provide pacing functionality, sensing functionality or both pacing and sensing functionality in addition to or instead of high voltage stimulation therapy. In this sense, the use of the term "defibrillation electrode" herein should not be considered as limiting the electrodes <NUM> and <NUM> for use in only high voltage cardioversion/defibrillation shock therapy applications. For example, electrodes <NUM> and <NUM> may be used in a pacing electrode vector for delivering extra-cardiovascular pacing pulses, such as ventricular pacing pulses in an atrial tracking or non-tracking pacing mode, and/or in a sensing vector used to sense cardiac electrical signals including far-field atrial events for controlling ventricular pacing and for detecting ventricular tachyarrhythmias for controlling high voltage therapies.

Electrodes <NUM>, <NUM> and <NUM> are relatively smaller surface area electrodes for delivering low voltage pacing pulses and for sensing cardiac electrical signals. Electrodes <NUM>, <NUM> and <NUM> are referred to as pace/sense electrodes because they are generally configured for use in low voltage applications, e.g., used as either a cathode or anode for delivery of pacing pulses and/or sensing of cardiac electrical signals. In some instances, electrodes <NUM>, <NUM> and <NUM> may provide only pacing functionality, only sensing functionality or both.

Electrode <NUM> is shown proximal to defibrillation electrode <NUM>, and electrode <NUM> is located between defibrillation electrodes <NUM> and <NUM>. A third pace/sense electrode <NUM> may be located distal to defibrillation electrode <NUM>. Electrodes <NUM> and <NUM> are illustrated as ring electrodes, and electrode <NUM> is illustrated as a hemispherical tip electrode in the example of <FIG>. However, electrodes <NUM>, <NUM> and <NUM> may comprise any of a number of different types of electrodes, including ring electrodes, short coil electrodes, hemispherical electrodes, directional electrodes, segmented electrodes, or the like, and may be positioned at any position along the distal portion <NUM> of lead <NUM> and are not limited to the positions shown. Further, electrodes <NUM>, <NUM> and <NUM> may be of similar type, shape, size and material or may differ from each other.

Lead <NUM> extends subcutaneously or submuscularly over the ribcage <NUM> medially from the connector assembly <NUM> of ICD <NUM> toward a center of the torso of patient <NUM>, e.g., toward xiphoid process <NUM> of patient <NUM>. At a location near xiphoid process <NUM>, lead <NUM> bends or turns and extends superiorly beneath sternum <NUM>. Extra-cardiovascular lead <NUM> of system <NUM> is implanted at least partially underneath sternum <NUM> of patient <NUM>. At a location near xiphoid process <NUM>, lead <NUM> may bend or turn and extend superiorly within the anterior mediastinum in a substernal position. A lead implanted such that the distal portion <NUM> is substantially within anterior mediastinum may be referred to as a "substernal lead.

In the example illustrated in <FIG>, lead <NUM> is located substantially centered under sternum <NUM>. In other instances, however, lead <NUM> may be implanted such that it is offset laterally from the center of sternum <NUM>. Lead <NUM> may angle laterally such that distal portion <NUM> of lead <NUM> is underneath/below the ribcage <NUM> in addition to or instead of stemum <NUM>. The distal portion <NUM> of lead <NUM> may be offset laterally from sternum <NUM>, e.g., to the right or left of sternum <NUM>, angled laterally from sternum <NUM> toward the left or the right, or the like. In other examples, the distal portion <NUM> of lead <NUM> may be implanted in other extra-cardiovascular, intra-thoracic locations, including the pleural cavity or around the perimeter of and adjacent to but typically not within the pericardium <NUM> of heart <NUM>.

Electrical conductors (not illustrated) extend through one or more lumens of the elongated lead body <NUM> of lead <NUM> from the lead connector at the proximal lead end <NUM> to respective electrodes <NUM>, <NUM>, <NUM>, <NUM> and <NUM> located along the distal portion <NUM> of the lead body <NUM>. The lead body <NUM> of lead <NUM> may be formed from a non-conductive material, including silicone, polyurethane, fluoropolymers, mixtures thereof, and other appropriate materials, and shaped to form one or more lumens within which the one or more conductors extend. However, the techniques disclosed herein are not limited to such constructions or to any particular lead body design.

The respective conductors electrically couple the electrodes <NUM>, <NUM>, <NUM>, <NUM> and <NUM> to circuitry, such as a therapy delivery circuit and/or a sensing circuit as described below, of ICD <NUM> via connections in the connector assembly <NUM>, including associated electrical feedthroughs crossing housing <NUM>. The electrical conductors transmit therapy from a therapy delivery circuit within ICD <NUM> to one or more of defibrillation electrodes <NUM> and <NUM> and/or pace/sense electrodes <NUM>, <NUM> and <NUM> and transmit sensed electrical signals from one or more of defibrillation electrodes <NUM> and <NUM> and/or pace/sense electrodes <NUM>, <NUM> and <NUM> to the sensing circuit within ICD <NUM>.

ICD <NUM> may obtain electrical signals corresponding to electrical activity of heart <NUM> via a combination of sensing vectors that include combinations of electrodes <NUM>, <NUM>, and/or <NUM>. In some examples, housing <NUM> of ICD <NUM> is used in combination with one or more of electrodes <NUM>, <NUM> and/or <NUM> in a sensing electrode vector. ICD <NUM> may even obtain cardiac electrical signals using a sensing vector that includes one or both defibrillation electrodes <NUM> and/or <NUM>, e.g., between electrodes <NUM> and <NUM> or one of electrodes <NUM> or <NUM> in combination with one or more of electrodes <NUM>, <NUM>, <NUM>, and/or the housing <NUM>.

ICD <NUM> analyzes the cardiac electrical signals received from one or more of the sensing vectors to monitor for abnormal rhythms, such as bradycardia, ventricular tachycardia (VI) or ventricular fibrillation (VF). ICD <NUM> may analyze the heart rate and/or morphology of the cardiac electrical signals to monitor for tachyarrhythmia in accordance with any of a number of tachyarrhythmia detection techniques. One example technique for detecting tachyarrhythmia is described in <CIT>).

ICD <NUM> generates and delivers electrical stimulation therapy in response to detecting bradycardia or a tachyarrhythmia (e.g., VT or VF). ICD <NUM> may deliver anti-tachycardia pacing (ATP) in response to VT detection, and in some cases may deliver ATP prior to a cardioversion/defibrillation (CV/DF) shock or during high voltage capacitor charging in an attempt to avert the need for delivering a CV/DF shock. If ATP does not successfully terminate VT or when VF is detected, ICD <NUM> may deliver one or more CV/DF shocks via one or both of defibrillation electrodes <NUM> and <NUM> and/or housing <NUM>.

Ventricular pacing pulses may be delivered using an extra-cardiovascular pacing electrode vector selected from any of electrodes <NUM>, <NUM>, <NUM>, <NUM>, <NUM> and/or housing <NUM>. Ventricular pacing mode may be controlled based on far-field atrial events sensed using a sensing vector selected from electrodes <NUM>, <NUM>, <NUM>, <NUM><NUM> and/or housing <NUM>. The pacing electrode vector may be different than the sensing electrode vector. In one example, cardiac electrical signals are sensed between pace/sense electrodes <NUM> and <NUM> and/or between one of pace/sense electrodes <NUM> or <NUM> and housing <NUM>, and pacing pulses are delivered between pace/sense electrode <NUM> used as a cathode electrode and defibrillation electrode <NUM> used as a return anode electrode. In other examples, pacing pulses may be delivered between pace/sense electrode <NUM> and either (or both) defibrillation electrodes <NUM> or <NUM> or between defibrillation electrode <NUM> and defibrillation electrode <NUM>. These examples are not intended to be limiting, and it is recognized that other sensing electrode vectors and pacing electrode vectors may be selected according to individual patient need. The techniques for controlling pacing mode switching are not limited by pacing electrode vector and electrode positions. Various examples of extra-cardiovascular IMD systems and associated techniques for delivering extra-cardiovascular pacing pulses are described in <CIT>), provisionally-filed <CIT>) and provisionally-filed <CIT>).

<FIG> is illustrative in nature and should not be considered limiting of the practice of the techniques in an extra-cardiovascular ICD system as disclosed herein. In other examples, extra-cardiovascular lead <NUM> may include more or fewer electrodes than the number of electrodes shown in <FIG>, and the electrodes may be arranged along the lead <NUM> in different configurations than the particular arrangement shown in <FIG>. Various example configurations of extra-cardiovascular leads and electrodes and dimensions that may be implemented in conjunction with the extra-cardiovascular pacing techniques disclosed herein are described in <CIT>) and <CIT>). Other examples of extra-cardiovascular leads including one or more defibrillation electrodes and one or more pacing and sensing electrodes carried by curving, serpentine, undulating or zig-zagging distal portion of the lead body that may be implemented with the pacing techniques described herein are generally disclosed in <CIT>).

In other examples, the distal portion <NUM> may extend subcutaneously or submuscularly over the ribcage and/or sternum or along other subcutaneous or submuscular paths. For instance, as described with respect to <FIG>, the distal portion <NUM> of lead <NUM> may be implanted outside the thorax, over the stemum/ribcage rather than in the substernal space as shown in <FIG>. The path of extra-cardiovascular lead <NUM> may depend on the location of ICD <NUM>, the arrangement and position of electrodes carried by the lead distal portion <NUM>, and/or other factors. For example, ICD <NUM> is shown implanted subcutaneously on the left side of patient <NUM> along the ribcage <NUM>, but in other examples ICD <NUM> may be implanted between the left posterior axillary line and the left anterior axillary line of patient <NUM> or other subcutaneous or submuscular locations in patient <NUM>. For example, ICD <NUM> may be implanted in a subcutaneous pocket in the pectoral region. In this case, lead <NUM> may extend subcutaneously or submuscularly from ICD <NUM> toward the manubrium of sternum <NUM> and bend or tum and extend inferiorly from the manubrium to the desired location subcutaneously or submuscularly. In yet another example, ICD <NUM> may be placed abdominally.

As generally described above in conjunction with <FIG> and pacemaker <NUM>, an external device <NUM> may be used to establish a telemetric communication link <NUM> with ICD <NUM> to retrieve data from ICD <NUM> and to program operating parameters and algorithms in ICD <NUM> for controlling ICD functions. Data stored or acquired by ICD <NUM>, including physiological signals or associated data derived therefrom, results of device diagnostics, and histories of detected rhythm episodes and delivered therapies, may be retrieved from ICD <NUM> by external device <NUM> following an interrogation command. External device <NUM> may alternatively be embodied as a home monitor or hand held device.

<FIG> is a schematic diagram of ICD <NUM> according to one example. The electronic circuitry enclosed within housing <NUM> (shown schematically as an electrode in <FIG>) includes software, firmware and hardware that cooperatively monitor cardiac electrical signals, determine when an electrical stimulation therapy is necessary, and deliver therapies as needed according to programmed therapy delivery algorithms and control parameters. The software, firmware and hardware are configured to detect tachyarrhythmias and deliver anti-tachyarrhythmia therapy, e.g., detect ventricular tachyarrhythmias and in some cases discriminate VT and VF for determining when ATP or CV/DF shocks are required. According to the techniques disclosed herein, the software, firmware and hardware are further configured to sense far-field atrial events and control ventricular pacing mode switching based on the sensed atrial events. Ventricular pacing pulses are delivered according to the selected pacing mode.

ICD <NUM> includes a control circuit <NUM>, memory <NUM>, therapy delivery circuit <NUM>, sensing circuit <NUM>, and telemetry circuit <NUM>. A power source <NUM> provides power to the circuitry of ICD <NUM>, including each of the components <NUM>, <NUM>, <NUM>, <NUM>, and <NUM> as needed. Power source <NUM> may include one or more energy storage devices, such as one or more rechargeable or non-rechargeable batteries. The connections between power source <NUM> and each of the other components <NUM>, <NUM>, <NUM>, <NUM> and <NUM> are to be understood from the general block diagram of <FIG>, but are not shown for the sake of clarity. For example, power source <NUM> may be coupled to a low voltage (LV) charging circuit and to a high voltage (HV) charging circuit included in therapy delivery circuit <NUM> for charging low voltage and high voltage capacitors, respectively, included in therapy delivery circuit <NUM> for producing respective low voltage pacing pulses, such as bradycardia pacing, post-shock pacing or ATP pulses, or for producing high voltage pulses, such as CV/DF shock pulses. In some examples, high voltage capacitors are charged and utilized for delivering pacing pulses, e.g., for ATP, post-shock pacing or other ventricular pacing pulses, instead of low voltage capacitors. Power source <NUM> is also coupled to components of sensing circuit <NUM>, such as sense amplifiers, analog-to-digital converters, switching circuitry, etc. as needed.

The functional blocks shown in <FIG> represent functionality included in ICD <NUM> and may include any discrete and/or integrated electronic circuit components that implement analog and/or digital circuits capable of producing the functions attributed to ICD <NUM> herein. The various components may include an application 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 or combinations of components that provide the described functionality. The particular form of software, hardware and/or firmware employed to implement the functionality disclosed herein will be determined primarily by the particular system architecture employed in the ICD and by the particular detection and therapy delivery methodologies employed by the ICD. Providing software, hardware, and/or firmware to accomplish the described functionality in the context of any modern IMD system, given the disclosure herein, is within the abilities of one of skill in the art.

Memory <NUM> may include any volatile, non-volatile, magnetic, or electrical non-transitory 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 memory device. Furthermore, memory <NUM> may include non-transitory computer readable media storing instructions that, when executed by one or more processing circuits, cause control circuit <NUM> or other ICD components to perform various functions attributed to ICD <NUM> or those ICD components. The non-transitory computer-readable media storing the instructions may include any of the media listed above.

The functions attributed to ICD <NUM> herein may be embodied as one or more integrated circuits. Depiction of different features as components is intended to highlight different functional aspects and does not necessarily imply that such components must be realized by separate hardware or software components. Rather, functionality associated with one or more components may be performed by separate hardware, firmware or software components, or integrated within common hardware, firmware or software components.

Control circuit <NUM> communicates, e.g., via a data bus, with therapy delivery circuit <NUM> and sensing circuit <NUM> for sensing cardiac electrical activity, detecting cardiac rhythms, and controlling delivery of cardiac electrical stimulation therapies in response to sensed cardiac signals. Therapy delivery circuit <NUM> and sensing circuit <NUM> are electrically coupled to electrodes <NUM>, <NUM>, <NUM>, <NUM> and <NUM> and the housing <NUM>, which may function as a common or ground electrode or as an active can electrode for delivering CV/DF shock pulses or cardiac pacing pulses.

Sensing circuit <NUM> may be selectively coupled to electrodes <NUM>, <NUM>, <NUM> and/or housing <NUM> in order to monitor electrical activity of the patient's heart. Sensing circuit <NUM> may additionally be selectively coupled to defibrillation electrodes <NUM> and/or <NUM> for use in a sensing electrode vector. Sensing circuit <NUM> may include multiple sensing channels for receiving cardiac electrical signals from two or more sensing electrode vectors selected from the available electrodes <NUM>, <NUM>, <NUM>, <NUM>, <NUM> and housing <NUM>. For example, sensing circuit <NUM> may include a ventricular sensing channel configured to sense ventricular R-waves from a received cardiac electrical signal and an atrial sensing channel configured to sense far-field atrial P-waves from the same or a difference cardiac electrical signal. Sensing circuit <NUM> may include switching circuitry for selecting which of electrodes <NUM>, <NUM>, <NUM>, <NUM>, <NUM> and housing <NUM> are coupled to the one or more sensing channels. Switching circuitry may include a switch array, switch matrix, multiplexer, or any other type of switching device suitable to selectively couple components of sensing circuit <NUM> to selected electrodes.

Cardiac event detection circuitry within sensing circuit <NUM> may include one or more sense amplifiers, filters, rectifiers, threshold detectors, comparators, analog-to-digital converters (ADCs), or other analog or digital components configured to filter and amplify a cardiac electrical signal received from a selected sensing electrode vector and sense cardiac events, e.g., P-waves and R-waves. A cardiac event sensing threshold may be automatically adjusted by sensing circuit <NUM> under the control of control circuit <NUM>, based on timing intervals and sensing threshold values determined by control circuit <NUM>, stored in memory <NUM>, and/or controlled by hardware of control circuit <NUM> and/or sensing circuit <NUM>.

Upon detecting a cardiac event based on a sensing threshold crossing, sensing circuit <NUM> may produce a sensed event signal, such as a P-wave sensed event signal or an R-wave sensed event signal, which is passed to control circuit <NUM>. Sensing circuit <NUM> may be configured to sense far-field atrial P-waves from a cardiac signal using a high sensitivity and relatively long atrial blanking period as described above in conjunction with <FIG>. The sensed event signals produced by sensing circuit <NUM> are used by control circuit <NUM> to control the timing of pacing pulses delivered by therapy delivery circuit <NUM>. As described below in conjunction with <FIG> and <FIG>, control circuit <NUM> may determine atrial cycle lengths, e.g., PP intervals, as the time intervals between consecutively sensed P-waves. Other atrial time intervals may be determined between the expiration of the atrial blanking period and the next atrial sensed event. These atrial cycle lengths and atrial time intervals may be used for determining when ventricular pacing pulses are delivered synchronized to atrial events and when ventricular pacing pulses are delivered in a non-tracking, atrial-asynchronous pacing mode.

R-wave sensed event signals generated by sensing circuit <NUM> may cause control circuit <NUM> to withhold a scheduled ventricular pacing pulse and/or start a V-V pacing escape interval. R-wave sensed event signals may also be used by control circuit <NUM> for determining RR intervals (RRIs) for detecting tachyarrhythmia and determining a need for therapy. An RRI is the time interval between consecutively sensed R-waves and may be determined between consecutive R-wave sensed event signals received from sensing circuit <NUM>. For example, control circuit <NUM> may include a timing circuit for determining RRIs between consecutive R-wave sensed event signals received from sensing circuit <NUM> and PP intervals between consecutive P-wave sensed event signals. R-wave and P-wave sensed event signals are also used for controlling various timers and/or counters used to control the timing of therapy delivery by therapy delivery circuit <NUM>. The timing circuit may additionally set time windows such as morphology template windows, morphology analysis windows, P-wave sensing windows, blanking periods, R-wave sensing windows, pacing escape intervals including A-V and V-V intervals or perform other timing related functions of ICD <NUM> including synchronizing cardioversion shocks or other therapies delivered by therapy delivery circuit <NUM> with sensed cardiac events.

Therapy delivery circuit <NUM> includes charging circuitry, one or more charge storage devices, such as one or more high voltage capacitors and/or low voltage capacitors, and switching circuitry that controls when the capacitor(s) are discharged across a selected pacing electrode vector or CV/DF shock vector. Charging of capacitors to a programmed pulse amplitude and discharging of the capacitors for a programmed pulse width may be performed by therapy delivery circuit <NUM> according to control signals received from control circuit <NUM>. Control circuit <NUM> may include various timers or counters that control when ATP or other cardiac pacing pulses are delivered For example, the timing circuit of control circuit <NUM> may include programmable digital counters set by a microprocessor of the control circuit <NUM> for controlling the basic time intervals associated with ventricular pacing modes or ATP sequences delivered by ICD <NUM>. The microprocessor of control circuit <NUM> may also set the amplitude, pulse width, polarity or other characteristics of the cardiac pacing pulses, which may be based on programmed values stored in memory <NUM>.

During pacing, escape interval counters within control circuit <NUM> are reset upon sensing of R-waves as indicated by signals from sensing circuit <NUM>. In accordance with the selected mode of pacing, pacing pulses are generated by a pulse output circuit of therapy delivery circuit <NUM> when an escape interval counter expires. The pace output circuit is coupled to the desired pacing electrodes via a switch matrix for discharging one or more capacitors across the pacing load. The escape interval counters are reset upon generation of pacing pulses, and thereby control the basic timing of cardiac pacing functions. The durations of the escape intervals are determined by control circuit <NUM> via a data/address bus. The value of the count present in the escape interval counters when reset by sensed R-waves can be used to measure RRIs for detecting the occurrence of a tachyarrhythmia.

Memory <NUM> may include read-only memory (ROM) in which stored programs controlling the operation of the control circuit <NUM> reside. Memory <NUM>. may further include random access memory (RAM) or other memory devices configured as a number of recirculating buffers capable of holding a series of measured PP intervals, RR intervals, counts or other data for analysis by control circuit <NUM> for controlling therapy delivery.

Control parameters utilized by control circuit <NUM> for detecting cardiac rhythms and controlling therapy delivery may be programmed into memory <NUM> via telemetry circuit <NUM>. Telemetry circuit <NUM> includes a transceiver and antenna for communicating with external device <NUM> (shown in <FIG>) using RF communication as described above. Under the control of control circuit <NUM>, telemetry circuit <NUM> may receive downlink telemetry from and send uplink telemetry to external device <NUM>. In some cases, telemetry circuit <NUM> may be used to transmit and receive communication signals to/from another medical device implanted in patient <NUM>.

<FIG> is a conceptual diagram of another example of an IMD system <NUM>' which may be configured to deliver ventricular pacing to a patient's heart <NUM>. IMD system <NUM>' includes extra-cardiovascular ICD <NUM> coupled to extra-cardiovascular lead <NUM> and intracardiac pacemaker <NUM>. The distal portion <NUM> of lead <NUM> is shown extending outside the thoracic cavity, substantially parallel to sternum <NUM> in <FIG>, but may alternatively be positioned in any of the substernal or supra-sternal configurations described above in conjunction with <FIG>.

IMD system <NUM>' is configured as a triggered pacing system in which ICD <NUM> senses cardiac electrical signals for determining the timing of ventricular pacing pulses and transmits a trigger signal to intracardiac pacemaker <NUM> for triggering pacemaker <NUM> to deliver the appropriately timed ventricular pacing pulse.

In this example, a trigger signal emitting device <NUM> is carried by a separate lead <NUM> coupled to ICD <NUM> and positioned extrathoracically, e.g., along an intercostal space, to direct a trigger signal toward pacemaker <NUM> through the intercostal space and intervening muscle, blood, myocardial tissue, etc. Trigger signal emitting device <NUM> is capable of receiving an electrical control signal from ICD <NUM> conducted along lead <NUM>. Upon receipt of the control signal, emitting device <NUM> emits a trigger signal to cause pacemaker <NUM> to deliver a ventricular pacing pulse.

A dedicated lead <NUM> carrying emitting device <NUM> may be provided to position emitting device <NUM> at an optimal location for transmitting a trigger signal to pacemaker <NUM>. An optimal location is a location of emitting device <NUM> relative to pacemaker <NUM> that allows a trigger signal to reach pacemaker <NUM> with adequate signal intensity and signal-to-noise ratio that it is reliably detected by pacemaker <NUM>. Depending on the type of trigger signal being transmitted, a trigger signal path between emitting device <NUM> and pacemaker <NUM> may include tissues that attenuate the trigger signal through absorption, scattering or reflection of the signal. The location of emitting device <NUM> is selected such that signal losses along the path do not reduce the intensity of the trigger signal below a threshold level that is detectable by pacemaker <NUM>.

In some examples, emitting device <NUM> may have its own battery, which may be rechargeable, such that the power required by ICD <NUM> for sensing and therapy delivery functions and the power required for trigger signal emission is distributed across two devices and two (or more) batteries or other power sources. Emitting device <NUM> may alternatively be embodied as a leadless device capable of receiving a wireless control signal from ICD <NUM> to cause trigger signal emission. For example, emitting device <NUM> may include an RF receiver for receiving a wireless RF control signal from ICD <NUM> transmitted by the ICD telemetry circuit <NUM>.

Emitting device <NUM> carried by a dedicated lead <NUM>, or a leadless emitting device, may be positioned at an optimal location for transmitting a trigger signal to pacemaker <NUM> without limitations associated with optimal positioning of electrodes <NUM>, <NUM>, <NUM> and <NUM>, and <NUM> for sensing cardiac electrical signals and delivering or electrical stimulation therapies. A leadless emitting device may be implanted at a desired site without requiring lead tunneling. The emitting device <NUM> may act as a relay device for transmitting a pacing timing control signal from ICD <NUM> to pacemaker <NUM> by converting the pacing timing control signal to a trigger signal that is transmitted to and detected by pacemaker <NUM>. In other examples, the trigger signal emitting device may be incorporated within ICD housing <NUM>, connector assembly <NUM>, or along lead <NUM>. Various examples of a triggered pacing system in which the presently disclosed techniques for controlling automatic switching of a ventricular pacing mode may be implemented are generally described in <CIT>), <CIT>), and <CIT>).

<FIG> is a schematic diagram of ICD <NUM> and trigger signal emitting device <NUM>. Control circuit <NUM> passes a timing control signal <NUM> to emitting device <NUM> in response to a pacing escape interval expiring, which may be an A-V interval set in response to a far-field P-wave sensed by sensing circuit <NUM> during atrial-synchronized ventricular pacing or a V-V interval set in response to an R-wave sensed by sensing circuit <NUM> or a delivered ventricular pacing pulse during atrial-asynchronous ventricular pacing. As indicated above, emitting device <NUM> may be electrically coupled to ICD <NUM> via a dedicated lead <NUM> or alternatively carried by lead <NUM>, in which case control signal <NUM> may be conducted to emitting device <NUM> via an electrical conductor extending through lead <NUM> or lead <NUM>. In other examples, emitting device <NUM> may be incorporated in housing <NUM> or connector assembly <NUM> in which case control signal <NUM> is passed to emitting device <NUM> via an electrical conductor coupling emitting device <NUM> to control circuit <NUM>. In still other examples, emitting device <NUM> may be a wireless device including a receiver and antenna for receiving a control signal <NUM> as a wireless signal transmitted from control circuit <NUM> via telemetry circuit <NUM>. In some examples, when emitting device <NUM> is a wireless device, control signal <NUM> may be transmitted from ICD <NUM> to emitting device <NUM> using tissue conductance communication (TCC). Communication between two implanted medical devices using tissue conductance is generally disclosed in <CIT>). The control signal <NUM> may be referred to as a pacing control timing signal because it causes pacemaker <NUM> to deliver a pacing pulse to a heart chamber. The control signal <NUM> is relayed to pacemaker <NUM> via emitting device <NUM>.

Trigger signal emitting device <NUM> includes a drive signal circuit <NUM> that receives the control signal <NUM>. Drive signal circuit <NUM> passes an electrical signal to transducer <NUM> to enable transducer <NUM> to emit the trigger signal. Transducer <NUM> may be an optical transducer producing an optical trigger signal or an acoustical transducer producing an acoustical trigger signal.

Transducer <NUM> may be embodied as one or more transducers configured to emit sound or light, for example, upon receiving a drive signal from circuit <NUM>. Transducer <NUM> may include any combination of one or more of a ceramic piezoelectric crystal, a polymer piezoelectric crystal,. capacitive micromachined ultrasonic transducer (CMUT), piezoelectric micromachined ultrasonic transducer (PMUT), or other ultrasonic transducer, a light emitting diode (LED), a vertical cavity surface emitting laser (VCSEL) or other light source having a high quantum efficiency at a selected light wavelength. Transducer <NUM> may include multiple transducers arranged in an array and/or configured to emit signals in multiple directions from emitting device <NUM> to promote reception of the trigger signal by pacemaker <NUM> despite shifting, rotation or other changes of the relative orientations of emitting device <NUM> and pacemaker <NUM> with respect to each other. The multiple transducers may be selectable by drive circuit <NUM> such that a single one or combination of transducers is selected that produces the best signal-to-noise ratio at a receiving transducer of pacemaker <NUM>.

The transducer <NUM> is configured to emit a trigger signal at an amplitude and frequency that is detectable by a receiving transducer of pacemaker <NUM>, after attenuation by body tissues along the pathway between the transducer <NUM> and the pacemaker <NUM>. In one example, transducer <NUM> is configured to emit sounds in the range of approximately <NUM> to over <NUM>. An optical trigger signal may be emitted with a wavelength greater than approximately <NUM>. An RF signal can be radiated from an antenna at frequencies between <NUM> and <NUM>. The frequency of the trigger signal is selected in part based on the types and thicknesses of body tissues encountered along the signal pathway.

In some examples, emitting device <NUM> may include electrodes for transmitting the trigger signal as a tissue conductance communication signal or a tissue conductance communication signal may be transmitted using electrodes carried by lead <NUM>. In still other examples, the drive signal circuit <NUM> is coupled to an antenna for transmitting the trigger signal as an RF signal to pacemaker <NUM>. When the trigger signal is transmitted as an RF trigger signal, emitting device <NUM> may be optional and control circuit <NUM> may pass control signal <NUM> directly to telemetry circuit <NUM> for transmitting the trigger signal.

In this example, control circuit <NUM> is configured to monitor far-field P-waves and R-waves for controlling the timing of control signal <NUM> according to a selected ventricular pacing mode. As described below in conjunction with <FIG> and <FIG>, control circuit <NUM> may determine PP intervals based on P-wave sensed events signals received from sensing circuit <NUM> Control circuit <NUM> compares the PP intervals to mode-switching criteria and switches between an atrial-synchronized ventricular pacing mode and an atrial-asynchronous pacing mode based on the PP intervals. Control signal <NUM> causes emitting device <NUM> to transmit a trigger signal to pacemaker <NUM> to control ventricular pacing by pacemaker <NUM> according to the selected pacing mode.

<FIG> is a functional block diagram of another example configuration of pacemaker <NUM> including a receiver <NUM> for receiving a trigger signal from emitting device <NUM>. Pacemaker <NUM> includes control circuit <NUM>, memory <NUM>, power source <NUM> and pulse generator <NUM> as described above in conjunction with <FIG>. Pacemaker <NUM> may also include sensing circuit <NUM>, accelerometer <NUM> and telemetry circuit <NUM> as described above. Pacemaker <NUM> may be configured to generate pulsing pulses using power supplied by power source <NUM> in response to receiving a trigger signal by receiver <NUM>, transmitted by emitting device <NUM>.

In other examples, an on-board power source <NUM> is optional. When an on-board power source II0 is not included in pacemaker <NUM> for supplying power to pulse generator <NUM> required for delivering pacing pulses, receiver <NUM> may act as a power-harvesting device. Power may be harvested from a trigger signal received from emitting device <NUM> and used for producing the pacing pulse delivered by pulse generator <NUM>. Examples of power-harvesting techniques in an IMD system in which the techniques disclosed herein may be implemented are generally disclosed in <CIT>).

Pacemaker <NUM> may rely only on receiving trigger signals by receiver <NUM> for controlling timing of pacing pulses such that sensing circuit <NUM> and accelerometer <NUM> are optional. In other examples, sensing circuit <NUM> and/or accelerometer <NUM> may be included for monitoring a cardiac electrical signal and/or a motion signal, respectively, for use in controlling ventricular pacing delivered by IMD system <NUM>'.

As described above, pulse generator <NUM> generates electrical stimulation pulses that are delivered to heart tissue via electrodes <NUM> and <NUM>. Control circuit <NUM> controls pulse generator <NUM> to deliver a stimulation pulse in response to receiving a trigger detect (TD) signal <NUM> from receiver <NUM>. Pulse generator <NUM> may include one or more holding capacitors and a charging circuit to charge the capacitor(s) to a pacing pulse voltage. The pacing holding capacitor may be charged to the pacing pulse voltage while control circuit <NUM> waits for a trigger detect signal <NUM> from receiver <NUM>. Upon detecting the trigger signal, the holding capacitor is coupled to pacing electrodes <NUM>, <NUM> to discharge the holding capacitor voltage, typically through an output capacitor, and thereby deliver the pacing pulse. Alternatively, detection of the trigger signal initiates holding capacitor charging and when a predetermined pacing pulse voltage is reached, the pulse is delivered.

In other embodiments, pulse generator <NUM> may be configured to be enabled to deliver a stimulation pulse directly by an input signal received from receiver <NUM>. For example, a switch responsive to a trigger detect signal <NUM> produced by receiver <NUM> may enable pulse generator <NUM> to deliver a stimulation pulse to a targeted tissue via electrodes <NUM> and <NUM>. Pulse generator <NUM> may include a switch that connects power source <NUM> to pacing electrodes <NUM> and <NUM> to deliver the pacing pulse. The switch is opened by trigger detect signal <NUM> or by a control signal from control circuit <NUM>, and power source <NUM> delivers energy to pulse generator <NUM> for generating a pacing pulse.

Receiver <NUM> may receive trigger signals through a coupling member <NUM>. Coupling member <NUM> may be an acoustical or optical coupling member that improves transmission, e.g., by reducing signal losses, of the trigger signal from the surrounding tissue to receiver <NUM>. Receiver <NUM> may include one or more receiving transducers, which may be mounted directly along an inner surface of coupling member <NUM>, e.g., for receiving sound waves or light. The trigger signal causes a receiving transducer to produce a voltage signal which may be passed to a comparator included in receiver <NUM> (or control circuit <NUM>) for comparison to a trigger signal detection threshold. If the voltage signal produced by the receiving transducer is greater than the detection threshold, a trigger detect signal <NUM> is passed to control circuit <NUM> (or directly to pulse generator <NUM>), to cause pacing pulse delivery. Receiver <NUM> may be "tuned" to detect an acoustical or optical trigger signal of a predetermined signal frequency or bandwidth.

Control circuit <NUM> may control pulse generator <NUM> to deliver a pacing pulse according to programmed therapy delivery control parameters such as pulse amplitude, pulse width, etc., which may be stored in memory <NUM>. In some examples, pulse generator <NUM> is enabled to deliver a pacing pulse immediately upon receiving a trigger detect signal <NUM>, either directly from receiver <NUM> or via control circuit <NUM>. Alternatively, the pacing pulse may be delivered after a predetermined time delay.

When sensing circuit <NUM> is included in pacemaker <NUM>, sensing circuit <NUM> may generate R-wave sensed event signals that are provided to pacemaker control circuit <NUM>. Control circuit <NUM> may start a pacing timing interval upon receiving a trigger detect signal <NUM> from receiver <NUM>. If an R-wave sense event signal is received by control circuit <NUM> from sensing circuit <NUM> prior to the pacing timing interval expiring, the scheduled pacing pulse is inhibited. No pacing pulse is delivered by pulse generator <NUM>. If the pacing timing interval expires prior to receiving an R-wave sense event signal from sensing circuit <NUM>, control circuit <NUM> enables pulse generator <NUM> to deliver the scheduled pacing pulse at the expiration of the pacing timing interval. An A-V or V-V interval set by ICD control circuit <NUM> to control the timing of timing control signal <NUM> and transmission of a trigger signal by emitting device <NUM> may take into account any inherent system delays and built-in timing delays so that a pacing pulse is ultimately delivered at a desired A-V or V-V interval.

The IMD systems shown in <FIG>, <FIG>, and <FIG> are examples of systems that may utilize the techniques disclosed herein for automatically switching from atrial-synchronized to atrial-asynchronous ventricular pacing modes and back again. The examples shown and described herein are intended to be illustrative, not limiting. For example, another IMD system that may utilize the ventricular pacing mode switching techniques includes a subcutaneous sensing device that is configured to sense P-waves and emit trigger signals to an intracardiac pacemaker for controlling ventricular pacing but does not include cardioversion/defibrillation capabilities, e.g., as generally disclosed in <CIT>).

<FIG> and <FIG> show a flow chart <NUM> of a method that may be performed by an IMD system for automatically switching between an atrial-synchronized ventricular pacing mode and an atrial-asynchronous ventricular pacing mode. Said method as such is not part of the claimed invention. The method of FIG. <NUM> is performed by control circuitry of an IMD system, e.g., by control circuit <NUM> of pacemaker <NUM> (<FIG>) or by control circuit <NUM> of ICD <NUM> in system <NUM> (<FIG>) or system <NUM>' (<FIG>). The IMD system may normally function in an atrial-synchronized ventricular pacing mode at block <NUM>, e.g., a VDD(R) mode, in which both atrial events and ventricular events are sensed, and ventricular pacing pulses are triggered by atrial sensed events and delivered at a programmed A-V delay following the atrial sensed events and inhibited when an intrinsic ventricular event is sensed, e.g., when an R-wave is sensed prior to expiration of the A-V delay.

At block <NUM>, the sensing circuit, e.g., sensing circuit <NUM> of pacemaker <NUM> or sensing circuit <NUM> of ICD <NUM>, senses far-field atrial events, e.g., P-waves. Intra-cardiac, far-field P-wave sensing by pacemaker <NUM> or extra-cardiac, far-field P-wave sensing by ICD <NUM> from a cardiac electrical signal may be performed as described above or other techniques described by the documents cited herein. Far-field P-wave sensing is further described below in conjunction with <FIG>. Far-field atrial events may additionally or alternatively be sensed from a motion signal from accelerometer <NUM> positioned in the ventricle.

In pacemaker <NUM> and IMD system <NUM> or <NUM>', P-waves are sensed from a far-field signal, e.g., a signal received by electrodes <NUM> and <NUM> positioned in the RV (<FIG>) or a signal received by extra-cardiovascular electrodes carried by lead <NUM> (<FIG>) as opposed to being sensed from a near-field atrial signal received using electrodes positioned in or on an atrial chamber. As used herein, the term "far-field signal" is in reference to a cardiac electrical signal including P-waves or a cardiac motion signal including atrial motion signals that is acquired by electrodes or a motion sensor such as accelerometer <NUM>, respectively, that are not positioned within or on an atrial chamber. When P-waves are sensed from a near-field signal, e.g., from electrodes positioned within the atrial chamber in a dual chamber pacemaker coupled to transvenous endocardial electrodes, confirmation of the atrial rate is relatively straight forward based on P-waves sensed from the near-field atrial signal. When the atrial rate determined from the near-field signal exceeds an upper tracking limit, the ventricular pacing mode may be switched from an atrial-tracking to a non-tracking pacing mode.

Since far-field atrial signals, e.g., P-waves, tend to be much smaller in amplitude than ventricular signals, e.g., R-waves, atrial sensing from a far-field signal can be challenging, particularly if the atrial P-waves become small during an atrial tachyarrhythmia such as atrial fibrillation or atrial flutter. Some P-waves may be missed such that the atrial rate may appear normal when determined based on PP intervals. In addition to having smaller amplitude, when the atrial rate is fast, atrial P-waves may occur during an atrial blanking period that is applied by sensing circuit <NUM> or sensing circuit <NUM> following an atrial sensed event. The resulting sensed atrial rate determined based on sensed P-waves outside an atrial blanking period may be slower than the actual atrial rate, e.g., half the actual rate if every other P-wave occurs during an atrial blanking period. As a result, the ventricular pacing mode may continue tracking atrial events during a fast atrial rate or atrial tachyarrhythmia, which may result in an irregular ventricular pacing rate or an unacceptably fast ventricular pacing rate.

Accordingly, rather than determining an atrial rate based on P-P intervals for controlling ventricular pacing mode switching, the control circuit (<NUM> or <NUM>) controlling the timing of ventricular pacing pulse delivery in pacemaker <NUM> or IMD system <NUM> or <NUM>' may monitor atrial event signals for detecting an absence of atrial sensed events and/or for detecting a sudden change in atrial cycle length. At block <NUM>, the control circuit determines if atrial events have not been sensed during a predetermined number of M ventricular cycles. For example, the control circuit may include a timer or counter to count the number of R-waves sensed with no intervening atrial events sensed as P-waves by the sensing circuit or sensed by the pacemaker control circuit <NUM> from a signal from accelerometer <NUM>. If no atrial events are sensed for M ventricular cycles, e.g., for five to ten or other programmable number of ventricular cycles, the control circuit may switch immediately to a non-tracking (atrial asynchronous) ventricular pacing mode at block <NUM>.

In some examples, however, if an absence of atrial events for M ventricular cycles is detected at block <NUM>, the control circuit may analyze the M ventricular cycles for evidence of sinus tachycardia. At block <NUM>, the M cycles are compared to sinus tachycardia criteria. For instance, a maximum ventricular cycle length threshold and or cycle length regularity criteria may be applied to the M cycles. In one example, if all M ventricular cycle lengths determined between consecutively sensed R-waves are less than a maximum ventricular cycle length, e.g., less than or equal to <NUM>, and are determined to be regular based on applied regularity criteria, then sinus tachycardia is detected at block <NUM>. One example of regularity criteria that may be applied at block <NUM> may include determining the mean cycle length of the M ventricular cycle lengths and comparing the mean cycle length to each of the M cycle lengths. If the differences between the mean and each individual cycle length is less than a regularity threshold (for example less than <NUM> to <NUM>), the M ventricular cycle lengths are determined to be regular. This regularity is evidence of a sinus rhythm during which P-wave sensing may have been lost. Other metrics of regularity that may be determined and compared to a respective threshold may include cycle length range, standard deviation, mode sum, etc..

If ventricular cycle length, regularity, and or other criteria for detecting sinus tachycardia are met by the M ventricular cycle lengths at block <NUM>, sinus tachycardia is detected at block <NUM> and in this case, the control circuit remains in the atrial-synchronized ventricular pacing mode ("yes" branch of block <NUM>) and waits until P-wave sensing rettims. Since evidence of a sinus rhythm is present, with regularly sensed R-waves, switching to a non-tracking pacing mode is not performed. Pacing the ventricle at an unacceptably fast rate is not occurring since the P-waves are not being sensed and intrinsic R-waves are being sensed. In such cases, the control circuit waits until P-waves are sensed and delivers ventricular pacing in the atrial-synchronized pacing mode unless the sensed atrial cycle length meets mode-switching criteria as described below.

If sinus tachycardia is not detected at block <NUM> based on the comparison(s) made at block <NUM>, the M ventricular cycle-lengths are irregular and/or long indicating a need to switch to an atrial-asynchronous (non-tracking) ventricular pacing mode. The absence of atrial events may indicate an atrial arrhythmia and to avoid an irregular ventricular rate, a pacing mode switch is warranted. The control circuit switches to the non-tracking pacing mode at block <NUM>.

If atrial events are being sensed ("no" branch of block <NUM>), the control circuit determines atrial cycle lengths at block <NUM>. The atrial cycle lengths may be determined as P-P intervals between consecutive P-waves sensed by the sensing circuit <NUM> of pacemaker <NUM> or the sensing circuit <NUM> of ICD <NUM>. In other examples, the atrial cycle lengths may be determined as time intervals between atrial events detected from a motion sensor, e.g., accelerometer <NUM>, by pacemaker control circuit <NUM>. The respective control circuit <NUM> or <NUM> compares one consecutive cycle length to the next consecutive cycle length at block <NUM>. If the difference between two consecutive cycle lengths is greater than a cycle length change threshold, as determined at decision block <NUM>, the control circuit <NUM> or <NUM> determines the next N atrial cycle lengths at block <NUM>. The change in atrial cycle length is detected independent of the actual atrial rate. As such the sensed atrial rate may be any rate at the time the atrial cycle length change is detected, including rates that are faster or slower than an atrial tachyarrhythmia.

If the next N atrial cycle lengths are shorter than a cycle length threshold, as determined at decision block <NUM>, the control circuit <NUM> or <NUM> switches from an atrial-tracking (synchronized) ventricular pacing mode to a non-tracking (atrial asynchronous) ventricular pacing mode at block <NUM>. The cycle length threshold may be based on an atrial blanking period set by the control circuit or by the sensing circuit of pacemaker <NUM> or ICD <NUM>. In one example, the atrial blanking period is at least <NUM>. In another example, the atrial blanking period is at least <NUM>. These examples are illustrative and longer or shorter atrial blanking periods may be used. The pacemaker control circuit <NUM> or ICD control circuit <NUM> may set the cycle length threshold to a predetermined time interval greater than the atrial blanking period. The predetermined time interval may be at least <NUM> in some examples.

If a change in cycle length greater than the change threshold is not detected ("no" branch of block <NUM>) or N cycle lengths after a threshold cycle length change are not less than the cycle length threshold ("no" branch of block <NUM>), the control circuit remains in the atrial synchronized pacing mode and continues to monitor atrial sensed events by returning to block <NUM>. The control circuit <NUM> or <NUM> monitors atrial sensed events for detecting a pacing mode switch condition, e.g., absence of atrial sensed events for M ventricular cycles or a threshold cycle length change followed by N atrial cycle lengths less than the cycle length threshold.

If the pacing mode is switched to a non-tracking pacing mode at block <NUM>, the process continues to <FIG> (flow chart <NUM> continued) as indicated by connector B. Asynchronous ventricular pacing is delivered at block <NUM> according to the non-tracking pacing mode. When the method of flow chart <NUM> is implemented in intracardiac pacemaker <NUM> implanted in a ventricular chamber, pacemaker control circuit <NUM> controls the pulse generator <NUM> to deliver asynchronous ventricular pacing at block <NUM>, e.g., via the housing-based cathode electrode <NUM> and return anode electrode162. When the method <NUM> is implemented in ICD <NUM> of an extra-cardiovascular ICD system <NUM>, ICD control circuit <NUM> controls therapy delivery circuit <NUM> to deliver asynchronous ventricular pacing at block <NUM> via a selected extra-cardiovascular pacing electrode vector including at least one electrode carried by extra-cardiovascular lead <NUM>, e.g., using pace/sense electrode <NUM> as a cathode electrode and defibrillation electrode <NUM> as a return anode though numerous other pacing electrode vectors may be selected. The asynchronous ventricular pacing is delivered by the respective pulse generator <NUM> or therapy delivery circuit <NUM> to a programmed pacing rate, e.g., <NUM> to <NUM> pulses per minute to provide bradycardia pacing support. In some examples, the ventricular pacing rate may be a rate-responsive rate set according to a sensor-indicated rate based on a patient activity metric determined from accelerometer <NUM>. Upon switching to the non-tracking ventricular pacing mode, the pacing rate may be gradually adjusted to a targeted ventricular pacing rate to avoid a sudden ventricular rate change. A method for adjusting a ventricular pacing rate is generally disclosed in <CIT>).

When the method of flow chart <NUM> is implemented in a triggered pacing system, e.g., system <NUM>' of <FIG>, the ICD control circuit <NUM> passes a timing control signal <NUM> to emitting device <NUM> at the desired ventricular pacing rate. In this way, emitting device <NUM> transmits a trigger signal to pacemaker <NUM> at the desired ventricular pacing rate to control intracardiac pacemaker <NUM> to deliver ventricular pacing at the atrial asynchronous ventricular pacing rate.

During ventricular pacing, atrial events are still sensed at block <NUM> for monitoring a return of atrial events that meet criteria for switching back to atrial synchronized ventricular pacing. As such, the non-tracking ventricular pacing mode may be a VDI(R) pacing mode in which both atrial and ventricular events are sensed and ventricular pacing pulses are inhibited when an intrinsic R-wave is sensed during a V-V pacing escape interval. Sensed atrial events may be analyzed by pacemaker control circuit <NUM> or ICD control circuit <NUM> by determining atrial event time intervals. Atrial time intervals may be determined and analyzed on a beat-by-beat basis or periodically during the asynchronous ventricular pacing mode, e.g., after every <NUM> to <NUM> ventricular pacing pulses or another predetermined number of pacing pulses.

Atrial time intervals may be determined at block <NUM> relative to an atrial blanking period applied to pacemaker sensing circuit <NUM> or ICD sensing circuit <NUM> after an atrial sensed event. A relatively high sensitivity is used for sensing low amplitude P-waves from a far-field cardiac electrical signal. In order to avoid noise, ventricular events or other artifact being falsely sensed as P-waves, a relatively long post-atrial sensing blanking period may be applied. The atrial blanking period may be up to <NUM> or even up to <NUM>. During blanking, atrial events are not sensed. As such, atrial events occurring during the blanking period when the atrial rate is high may go un-sensed such that atrial rate alone may not be reliable for controlling ventricular pacing mode switching. In some examples, therefore, rather than determining P-P intervals (or atrial event intervals from a motion sensor), atrial time intervals are determined as the time interval from the expiration of the atrial blanking period to the sensed atrial event.

At block <NUM>, pacemaker control circuit <NUM> or ICD control circuit <NUM> determines time intervals from the end of the atrial blanking period to the next sensed atrial event for X atrial sensed events. The X atrial sensed events may be consecutive atrial events. If a predetermined number of atrial events are sensed more than a threshold time interval after the atrial blanking period expires, "yes" branch of block <NUM>, the pacemaker control circuit <NUM> or ICD control circuit <NUM> switches back to the atrial synchronized ventricular pacing mode at block <NUM>. The process returns to block <NUM> as indicated by connector A.

The predetermined number of atrial events sensed more than the threshold time interval after blanking period expiration may be X consecutive atrial events or X out of Y consecutive atrial events. For example, at least five to ten consecutive atrial events may be required to be sensed more than <NUM> after the expiration of the atrial blanking period. In another example, at least five non-consecutive atrial events out of eight consecutive atrial events may be required to be at least <NUM> after the expiration of the atrial blanking period. When a threshold number of atrial events are regularly sensed after a threshold interval after the atrial blanking period expires, the atrial rhythm is expected to have returned to a normal rhythm and atrial tracking of the ventricular pacing pulses may be resumed. The process returns to block <NUM> (<FIG>) as indicated by connector A to deliver ventricular pacing pulses in the atrial synchronized ventricular pacing mode.

<FIG> is a timing diagram <NUM> of atrial events, e.g., P-waves, sensed by pacemaker sensing circuit <NUM> or ICD sensing circuit <NUM>. Atrial events sensed by pacemaker sensing circuit <NUM> or ICD sensing circuit <NUM> are denoted by "AS. " Each AS event <NUM> is followed by an atrial blanking period <NUM>, during which no atrial event sensing occurs. Atrial events that occur during a blanking period <NUM>, such as event <NUM>, are labeled "non-sensed" or "NS. " Initially the pacemaker <NUM>, ICD <NUM>, or triggered pacing system <NUM>' is operating in an atrial-synchronized ventricular pacing mode during which ventricular pacing pulses (VP) <NUM> are delivered upon expiration of an A-V interval <NUM>. Each A-V interval <NUM> is started in response to an AS event.

When the atrial rate increases, for example at the onset of an atrial tachyarrhythmia, some atrial events occur during the atrial blanking period <NUM> and are non-sensed events (NS) <NUM>. When the atrial events are sensed from a far-field signal, a high sensitivity may be used with a relatively long atrial blanking period <NUM> to prevent atrial oversensing. As a result, determination of the atrial rate based on P-P intervals, e.g., intervals <NUM>, <NUM> and <NUM>, between two consecutive AS events, may not be reliable for controlling pacing mode switching because some atrial events may occur during the relatively long blanking period <NUM>.

As described in conjunction with <FIG>, pacemaker control circuit <NUM> or ICD control circuit <NUM> may determine atrial event cycle lengths, e.g., as P-P intervals between consecutive AS events. At time <NUM>, control circuit <NUM> or <NUM> detects a cycle length change between two consecutive atrial cycle lengths <NUM> and <NUM> that is greater than a cycle length change threshold. Atrial cycle length <NUM> is shorter than the immediately preceding atrial cycle length <NUM> by more than the cycle length change threshold. In other examples, an atrial cycle length change between non-consecutive atrial cycle lengths may be compared to a change threshold. In response to detecting the change in cycle length that is greater than the change threshold (the change being a decrease in cycle length), the control circuit <NUM> or <NUM> determines if the next N atrial cycle lengths are all less than a cycle length threshold <NUM>.

In the example of <FIG>, the atrial cycle length <NUM> is the fifth consecutive cycle length less than the cycle length threshold <NUM> after a change in consecutive cycle lengths that is greater than the change threshold detected at time <NUM>. In this example, this combination of a cycle length change exceeding the change threshold followed by <NUM> cycle lengths less than the cycle length threshold <NUM> meets pacing mode switching criteria. The pacemaker control circuit <NUM> or ICD control circuit <NUM> switches the pacing mode of operation from the atrial-synchronized pacing mode to the non-tracking, atrial-asynchronous pacing mode at time <NUM>.

Thereafter, ventricular pacing pulses are delivered at a non-tracking ventricular pacing rate controlled by setting a V-V interval <NUM>. When the V-V interval expires, a pacing pulse (VP) is delivered. If an intrinsic R-wave is sensed during the V-V interval <NUM>, the pacing pulse is inhibited. The ventricular pacing pulses are asynchronous with the sense atrial events (AS).

During this non-tracking, atrial-asynchronous pacing mode, the pacemaker control circuit <NUM> or the ICD control circuit <NUM> monitors atrial sensed events to determine when criteria for switching back to the atrial-synchronized pacing mode are satisfied. Since some atrial events, such as NS event <NUM> may occur during the relatively long atrial blanking period applied to the far-field atrial signal, determination of the atrial rate based on AS events may not be reliable for detecting when the atrial rate falls below an upper tracking rate or is slower than an atrial tachyarrhythmia rate. Instead, pacemaker control circuit <NUM> or ICD control circuit <NUM> determines atrial time interval <NUM> between the time of expiration <NUM> of an atrial blanking period and the next AS event. During the fast atrial rate prior to mode switching at time <NUM>, the time intervals from the expiration of each blanking period to the next respective AS event are observed to be very short. As the atrial rate slows, the atrial time interval <NUM> from the blanking period expiration <NUM> to the immediately subsequent AS event increases and will eventually remain greater than a predetermined interval threshold <NUM> during a normal, stable atrial rate.

Pacemaker control circuit <NUM> or ICD control circuit <NUM> may determine and monitor this atrial time interval following each atrial blanking period <NUM> until a predetermined number of AS events occur at least a threshold interval <NUM> after the blanking period expiration <NUM>. For example, AS event <NUM> occurs at an atrial time interval <NUM> that is the fifth consecutive atrial time interval (starting with atrial time interval <NUM>) that is greater than the interval threshold <NUM>. In response to detecting five atrial time intervals greater than the interval threshold <NUM>, the control circuit <NUM> or <NUM> switches back to atrial-synchronized ventricular pacing at time <NUM>. The next pacing pulse is scheduled and delivered at an A-V interval <NUM> following AS event <NUM>.

It is recognized that in some cases switching between atrial-synchronized and atrial-asynchronous ventricular pacing may not occur on a single pacing cycle; one additional pacing cycle may occur according to the current pacing mode before switching to the new pacing mode after detecting that mode switching criteria are met. Furthermore, the pacing rate may be adjusted gradually toward a target V-V interval or target A-V interval to avoid abrupt changes in pacing rate.

As can be seen in <FIG>, rather than relying on determining an atrial rate or detecting an atrial tachyarrhythmia for controlling pacing mode switching, initially a threshold change in atrial cycle length is required before switching from an atrial-synchronized pacing mode to a non-tracking mode. For example, if atrial events are initially being sensed at approximately <NUM> to <NUM> cycle lengths, a sudden change in cycle length greater than <NUM>, e.g., a drop to sensed atrial cycle lengths of <NUM> to <NUM>, may be evidence of a fast atrial rate that is above a desired tracking rate, even though the atrial cycle lengths determined between sensed atrial events may still be greater than an atrial tachyarrhythmia cycle length or upper tracking rate, e.g., greater than <NUM>. This may occur when a long atrial blanking period, which may be adaptable to the current cycle length such as an atrial blanking period of <NUM> to <NUM> percent of the current cycle length, is applied to prevent oversensing of T-waves or other ventricular activity by the atrial sensing channel. Atrial events that occur at atrial cycle lengths shorter than the blanking period will not be sensed during the long blanking period. The sudden change in cycle length that is greater than the change threshold may indicate that a rate change has occurred and some atrial events may be under-sensed during the atrial blanking period. The sensed atrial cycle lengths following the threshold change in atrial cycle length may remain greater than an upper atrial tracking rate or an atrial tachyarrhythmia rate that might normally be used for controlling mode switching in a dual chamber pacemaker when atrial events are sensed from a near field signal.

As the atrial rate slows again or returns to a sinus rhythm, some atrial events may still occur during the atrial blanking period, e.g., NS event <NUM>, but as the rate slows even more, the atrial events will occur at intervals longer than the blanking period and will eventually occur at time intervals after the expiration of the blanking period that are consistently greater than an interval threshold <NUM>. Even if some atrial events occur during the atrial blanking period, switching to the atrial-synchronized pacing mode results in ventricular pacing at a pacing rate interval that tracks only the atrial events sensed outside of the atrial blanking period by a predetermined time interval, e.g., <NUM> outside a <NUM> atrial blanking period in the example above, which may be considered a safe ventricular pacing rate interval. At this point, switching back to an atrial-synchronized pacing mode may be performed without having to rely on determining actual atrial cycle lengths or an actual atrial rate.

Claim 1:
An implantable medical device comprising:
a sensing circuit (<NUM>) configured to receive a cardiac signal comprising far-field atrial events;
a therapy delivery circuit (<NUM>) configured to deliver ventricular pacing pulses via electrodes coupled to the therapy delivery circuit; and
a control circuit (<NUM>) configured to:
control the therapy delivery circuit to deliver the ventricular pacing pulses in an atrial-synchronized pacing mode;
during the atrial synchronized pacing mode, determine atrial cycle lengths between the far-field atrial events sensed from the cardiac signal;
determine a difference between two atrial cycle lengths of the atrial cycle lengths;
determine, based on the difference being greater than a cycle length change threshold, a cycle length change between the two atrial cycle lengths;
after determining the cycle length change, determine if first pacing mode switching criteria is satisfied; and
in response to determining that the first pacing mode switching criteria is satisfied, switch from the atrial-synchronized ventricular pacing mode to an atrial-asynchronous pacing mode for controlling the therapy delivery circuit in delivering the ventricular pacing pulses.