LEADLESS CARDIAC PACEMAKER DEVICE CONFIGURED TO PROVIDE INTRA-CARDIAC PACING

Abstract

A leadless pacemaker device configured to provide for an intra-cardiac pacing includes a processing circuitry configured to generate ventricular pacing signals for stimulating ventricular activity at a ventricular pacing rate and a sensor configuration configured to receive a sense signal over a multiplicity of heart cycles. The processing circuitry is configured to derive, from signal portions of the sense signal relating to the multiplicity of heart cycles, a combined signal portion and to analyze the combined signal portion for obtaining information relating to an atrial event. The processing circuitry is configured to sum a predefined number of signal portions relating to different heart cycles to obtain the combined signal portion. The leadless pacemaker device allows, in particular, for a reliable detection of signals relating to an atrial activity and the use of such signals for controlling a ventricular pacing rate for a ventricular pacing.

Claims

1. A leadless pacemaker device configured to provide for an intra-cardiac pacing, the leadless pacemaker device comprising: a processing circuitry configured to generate ventricular pacing signals for stimulating ventricular activity at a ventricular pacing rate; and a sensor configuration configured to receive a sense signal over a multiplicity of heart cycles; said processing circuitry configured to derive, from signal portions of said sense signal relating to the multiplicity of heart cycles, a combined signal portion and to analyze said combined signal portion for obtaining information relating to an atrial event; and said processing circuitry configured to sum a predefined number of signal portions relating to different heart cycles to obtain said combined signal portion.

2. The leadless pacemaker device according to claim 1, wherein said processing circuitry is configured to identify an atrial event based on a monitoring as to whether said combined signal portion crosses a threshold.

3. The leadless pacemaker device according to claim 1, wherein said processing circuitry is configured to determine said combined signal portion anew for each heart cycle.

4. The leadless pacemaker device according to claim 1, wherein said processing circuitry is configured to obtain, based on said sense signal, a signal portion relating to a heart cycle based on a time window within the heart cycle.

5. The leadless pacemaker device according to claim 4, wherein said processing circuitry is configured to adaptively set said time window for a heart cycle based on a prior ventricular event.

6. The leadless pacemaker device according to claim 4, wherein a start of said time window is defined based on a predefined delay time following a prior ventricular event.

7. The leadless pacemaker device according to claim 6, wherein at least one of said predefined delay time or a length of said time window is set based on an actual heart rate.

8. The leadless pacemaker device according to claim 1, wherein said sensor configuration includes at least two electrodes for receiving an electrical sense signal indicative of an atrial activity.

9. The leadless pacemaker device according to claim 8, which further comprises: a housing having a tip and a far end; said at least two electrodes including one electrode disposed in a vicinity of said tip and another electrode disposed in a vicinity of said far end; and said electrical sense signal being received by using said electrode in the vicinity of said tip and said electrode in the vicinity of said far end.

10. The leadless pacemaker device according to claim 1, wherein said sensor configuration includes at least one of a motion sensor, a pressure sensor or a sound sensor.

11. A method for operating a leadless pacemaker device configured to provide for an intra-cardiac pacing, the method comprising the following steps: generating, using a processing circuitry of the leadless pacemaker device, ventricular pacing signals for stimulating ventricular activity at a ventricular pacing rate; receiving, using a sensor configuration of the leadless pacemaker device, a sense signal over a multiplicity of heart cycles; deriving, using the processing circuitry, a combined signal portion from signal portions of the sense signal relating to the multiplicity of heart cycles; analyzing, using the processing circuitry, the combined signal portion for obtaining information relating to an atrial event; and obtaining, using the processing circuitry, the combined signal portion by summing a predefined number of signal portions relating to different heart cycles.

Description

BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWING

[0043] FIG. 1 is a diagrammatic, cross-sectional view of the human heart;

[0044] FIG. 2 is an elevational view of a leadless pacemaker device;

[0045] FIG. 3 is an elevational view of a leadless pacemaker device, indicating signal vectors between different electrodes of the leadless pacemaker device;

[0046] FIG. 4 is a graphical representation of an intra-cardiac electrogram (IEGM);

[0047] FIG. 5 is a graphical representation of a processed signal portion to derive an atrial event;

[0048] FIG. 6 is a graphical representation of a portion of the processed signal to determine characteristic values from that signal for the determination of an atrial event;

[0049] FIG. 7 includes graphs relating to signal portions including signal contributions due to atrial activity in multiple heart cycles;

[0050] FIG. 8 is a graphical representation of a combined signal portion derived from the different signal portions of FIG. 7; and

[0051] FIG. 9 is a graphical representation of a sense signal relating to multiple heart cycles and a placement of time windows to derive signal portions from the sense signal relating to multiple heart cycles.

DETAILED DESCRIPTION OF THE INVENTION

[0052] Subsequently, embodiments of the invention shall be described in detail with reference to the drawings. In the drawings, like reference numerals designate like structural elements.

[0053] It is to be noted that the embodiments are not limiting for the invention, but merely represent illustrative examples.

[0054] In the present disclosure it is proposed to provide a leadless pacemaker device providing for an intra-cardiac pacing, in particular a ventricular pacing.

[0055] Referring now to the figures of the drawings in detail and first, particularly, to FIG. 1 thereof, there is seen a diagrammatic view of the human heart including the right atrium RA, the right ventricle RV, the left atrium LA and the left ventricle LV, the so-called sinoatrial node SAN being located in the wall of the right atrium RA, and the sinoatrial node SAN being formed by a group of cells having the ability to spontaneously produce an electrical impulse that travels through the heart's electrical conduction system, thus causing the heart to contract in order to pump blood through the heart. The atrioventricular node AVN serves to coordinate electrical conduction in between the atria and the ventricles and is located at the lower back section of the intra-atrial septum near the opening of the coronary sinus. The so-called HIS bundle H extends from the atrioventricular node AVN. The HIS bundle H includes heart muscle cells specialized for electrical conduction and forming part of the electrical conduction system for transmitting electrical impulses from the atrioventricular node AVN via the so-called right bundle branch RBB around the right ventricle RV and via the left bundle branch LBB around the left ventricle LV.

[0056] In the case of a block at the atrioventricular node AVN, the intrinsic electrical conduction system of the heart H may be disrupted, causing a potentially insufficient intrinsic stimulation of ventricular activity, i.e., insufficient or irregular contractions of the right and/or left ventricle RV, LV. In such a case, a pacing of ventricular activity by a pacemaker device may be indicated, such pacemaker device stimulating ventricular activity by injecting stimulation energy into intra-cardiac tissue, specifically myocardium M.

[0057] Within the instant text, it is proposed to use a leadless cardiac pacemaker device 1, as diagrammatically indicated in FIG. 1, for providing for a ventricular pacing action.

[0058] Whereas common leadless pacemaker devices are constructed to sense a ventricular activity by receiving electrical signals from the ventricle RV, LV they are placed in, it may be desirable to provide for a pacing action which achieves atrioventricular (AV) synchrony by providing a pacing in the ventricle in synchrony with an intrinsic atrial activity. For such pacing mode, also denoted as atrial tracking, it is required to sense atrial activity and identify atrial events relating to atrial contractions in order to base a ventricular pacing on such atrial events.

[0059] Referring now to FIGS. 2 and 3, in one embodiment a leadless pacemaker device 1 configured to provide for an intra-cardiac pacing, in particular employing an atrial tracking, includes a housing 10 enclosing electrical and electronic components for operating the leadless pacemaker device 1. In particular, enclosed within the housing 10 is a processing circuitry 15, including for example also a communication interface for communicating with an external device, such as a programmer wand. In addition, electrical and electronic components such as an energy storage in the form of a battery are confined in the housing 10. The housing 10 provides for an encapsulation of components received therein, the housing 10 having the shape of, e.g., a cylindrical capsule having a length of for example a few centimeters.

[0060] The leadless pacemaker device 1 is to be implanted on intra-cardiac tissue M. For this purpose, the leadless pacemaker device 1 includes, in the region of the tip 100, a fixation device 14 for example in the form of nitinol wires to engage with intra-cardiac tissue M for fixedly holding the leadless pacemaker device 1 on the tissue in an implanted state.

[0061] The leadless pacemaker device 1 does not include leads, but receives signals relating to a cardiac activity, in the illustrated embodiment, by different sensors located on or in the housing.

[0062] In particular, the leadless pacemaker device 1 in the illustrated embodiment includes an electrode configuration disposed on the housing 10 for receiving electrical signals and also for emitting stimulation signals. In the embodiment of FIGS. 2 and 3, the leadless pacemaker device 1 includes different electrodes 11, 12, 13 making up the electrode configuration and serving to emit pacing signals towards intra-cardiac tissue M for providing a pacing and to sense electrical signals indicative of a cardiac activity, in particular indicative of atrial and ventricular contractions.

[0063] A first electrode 11 herein is denoted as a pacing electrode. The first electrode 11 is placed at the tip 100 of the housing 10 and is configured to engage with cardiac tissue M.

[0064] A second electrode 12 serves as a counter-electrode for the first electrode 11, a signal vector P arising between the first electrode 11 and the second electrode 12 providing for a pacing vector for emitting pacing signals towards the intra-cardiac tissue M.

[0065] In addition, the second electrode 12 may serve as a sensing electrode for sensing signals, in particular relating to ventricular contractions, a signal vector V arising between the second electrode 12 and the first electrode 11, the signal vector V being denoted as a near-field vector.

[0066] The second electrode 12 is placed at a distance from the first electrode 11 and for example has the shape of a ring extending circumferentially about the housing 10. The second electrode 12 is for example placed at a distance of about 1 cm from the tip 100 of the housing 10 at which the first electrode 11 is placed.

[0067] The leadless pacemaker device 1, in the embodiment of FIGS. 2 and 3, in addition includes a third electrode 13 placed at a far end 101 of the housing 10, the third electrode 13 serving as a sensing electrode to sense signals indicative of cardiac activity in the far-field. In particular, a signal vector A arises between the third electrode 13 and the first electrode 11, the signal vector A being suited to pick up differential signals indicative for example of atrial contractions and being denoted as a far-field vector.

[0068] The electrodes 11, 12, 13 are in operative connection with the processing circuitry 15, the processing circuitry 15 being configured to cause the first electrode 11 and the second electrode 12 to emit a pacing signal for providing a stimulation at the ventricle. The processing circuitry 15 furthermore is configured to process signals received via the electrodes 11, 12, 13 to provide for a sensing of cardiac activity, in particular atrial and ventricular contractions.

[0069] The electrodes 11, 12, 13 make up a sensor configuration for sensing electrical signals. In particular, the pair of electrodes 11, 13 defining the far-field vector A may allow for a detection of atrial events in an electrical signal received as a differential signal between the electrodes 11, 13.

[0070] The leadless pacemaker device 1 in the embodiment of FIGS. 2 and 3in addition or alternatively to sense electrodes as described beforeincludes further sensors 16, 17, 18, one sensor 16 for example being a motion sensor, in particular an accelerometer, another sensor 17 being a pressure sensor and yet another sensor 18 being a sound sensor. Through the use of such sensors 16, 17, 18 different sense signals may be received in order to allow for an identification of atrial events, hence improving the detection reliability of atrial events and increasing the stability of an atrial tracking.

[0071] Any of such sensor configurations 11, 13, 16, 17, 18 may generally be used to obtain a sense signal in order to obtain and derive information relating to an atrial activity occurring in the atrium.

[0072] Generally, in order to provide for a pacing in the ventricle using an atrial tracking, a sensing of atrial activity is required to provide for detected atrial sense markers in order to time a pacing in the ventricle in atrioventricular (AV) synchrony.

[0073] Referring now to FIG. 4, for example by the electrode configuration 11, 12, 13, in particular by the pair of electrodes and 11, 13 defining the far field vector A, a sense signal (e.g. an intra-cardiac electrogram IEGM) may be obtained and processed to derive atrial events As and ventricular events Vs, the atrial events As relating to a so-called P wave in the electrogram signal and the ventricular events Vs being derived from a so-called QRS wave form in the signal.

[0074] Generally, ventricular events Vs arise at a ventricular interval TV, and atrial events As arise at an atrial interval TA, wherein the ventricular interval TV and the atrial interval TA (approximately) match in the case that the ventricular rate is in synchrony with the atrial rate. A ventricular event Vs herein appears at a delaythe so-called atrioventricular delay AVfollowing a prior atrial event As, due to the fact that within the intrinsic conduction mechanism of the heart the atrium is caused to contract earlier than the ventricle.

[0075] As visible from FIG. 4, the amplitude of a QRS waveform associated with a ventricular event Vs is much larger than the amplitude of a P wave associated with an atrial event As. Hence, the detection of an atrial event As generally requires a processing of the signal, involving for example a filtering, in particular a bandpass filtering, a rectification and/or a windowing in order to determine, for example by monitoring a threshold crossing, whether an atrial event As occurs.

[0076] In one embodiment, as illustrated in FIG. 5, a windowed search strategy may be employed by using a search window W in which it is searched for an atrial event As. In particular, within a sense signal, for example an electrical sense signal, a search window W of a predefined width and predefined temporal position with respect to a prior ventricular event Vs may be used, the search window W being centered for example around a calculated ventricular-atrial delay VA as illustrated in FIG. 4.

[0077] The ventricular-atrial delay VA represents a time following a prior ventricular event Vs at which a next atrial event As is predicted to occur, the ventricular-atrial delay VA being computed for example from an average atrial interval TA and an average atrioventricular delay AV at which a ventricular pacing or sense event Vs has occurred after a prior atrial event As. According to the ventricular-atrial delay VA the temporal position of the window W is determined in such a way that signal portions not relating to atrial activity, in particular a QRS waveform, are excluded from a signal processing, in such a way that stronger amplitudes of signals relating to a heart activity other than an atrial activity are suppressed and do not interfere with a processing of atrial signals.

[0078] A signal sensed in this way may be generally processed as illustrated in FIG. 6. In particular, from sense signal characteristic values characterizing an atrial event As may be derived, in particular a positive peak amplitude PP, a negative peak amplitude PN, a positive average value AP relating to an average of signal portions above a baseline B, and a negative average value AN relating to negative signal portions below the baseline B. In addition, for example a pulse width PW relating to the full-width-at-half-maximum of a peak in the signal may be determined. Alternatively, or in addition a frequency analysis may be performed in order to determine an energy content of the signal in certain frequency bands.

[0079] To determine an atrial event, for example a threshold crossing of a threshold D may be monitored. Herein, for example a positive threshold and/or a negative threshold may be applied, wherein it may be found for an atrial event if either one or both of the thresholds are crossed by the signal. The thresholds herein may be adaptive and may be determined for example in dependence of other characteristic values, such as the negative peak amplitude PN or the positive peak amplitude PP.

[0080] As theelectrical or mechanicalsignals relating to atrial activity inherently are small when received by the leadless pacemaker device 1 placed in the ventricle, a differentiation of signal contributions relating to atrial activity from other signal contributions, may be difficult. Referring now to FIG. 7 illustrating signal portions S within a time window W within eight consecutive heart cycles #1-#8, in each particular heart cycle a signal contribution relating to atrial activity AA may hardly rise above noise contributions N, such that an easy differentiation from signals relating to atrial activity AA from a noise contribution N is not possible by applying for example a simple threshold technique.

[0081] As signal contributions relating to atrial activity AA can generally be assumed to be aligned at least for a reasonable number of consecutive heart cycles (at least if conditions, for example due to physical activity, for a patient do not drastically change), it herein is proposed to combine signal portions S relating to multiple heart cycles #1-#8 to differentiate signal contributions relating to atrial activity AA from other signal contributions, in particular noise.

[0082] In order to provide for the combining, the signal portions S for a predefined number of heart cycles, i.e. for the actual heart cycle and a multiplicity of previous heart cycles, may be summed to obtain a combined signal portion S.sub.comb as illustrated in FIG. 8. Within the combined signal portion S.sub.comb, a signal contribution relating to atrial activity AA is pronounced with respect to noise contributions N, since the signal contributions relating to atrial activity AA in the individual signal portions S relating to the heart cycles #1-#8 constructively add, whereas noise can be assumed to effectively cancel out.

[0083] The predefined number of heart cycles may be any number between for example 2 and 30, for example 8.

[0084] Since signal contributions relating to atrial activity AA are pronounced in the combined signal portion S.sub.comb, the combined signal portion S.sub.comb may be analyzed for detecting an atrial event As, for example by applying a simple threshold technique, for example by comparing the combined signal portion S.sub.comb to a predefined threshold D as illustrated in FIG. 8. Alternatively, or in addition, any other characteristic value as indicated in FIG. 6 may be determined in order to identify an atrial event As in the combined signal portion S.sub.comb.

[0085] For the analysis, herein, a filtering and/or a rectification of the combined signal portion may be applied prior to the identification of the atrial event As.

[0086] Since the combined signal portion S.sub.comb does not (solely) relate to the actual heart cycle, an identified atrial event As in the combined signal portion S.sub.comb does not immediately indicate an atrial event As in the actual heart cycle. Rather, atrial activity in the actual heart cycle only contributes to the combined signal portion S.sub.comb. Nevertheless, the atrial event As determined in this way from the combined signal portion S.sub.comb may be used for an atrial tracking, since the identification of the atrial event As substantially relates to an averaging of the timing of atrial events As over a multiplicity of heart cycles and hence may be assumed to provide for a reliable indication of an atrial event As in a particular, actual heart cycle and an actual atrial rate.

[0087] The search window W, as illustrated in FIGS. 5 and 7, is determined based on a prior ventricular event Vs in such a way that the search window W is substantially centered about an expected time of an atrial event as following a prior ventricular event Vs. The search window W herein may be adaptively changed in its position with respect to a prior ventricular event Vs and also in its time length, as this is illustrated in FIG. 9.

[0088] In particular, for each heart cycle, the timing and length of the window W1-W3 may be individually determined and set, in such a way that the window W1-W3 is suitably placed within the heart cycle in order to cover a time range in which an atrial event As may occur.

[0089] In the example of FIG. 9, each window W1-W3 is set in relation to a prior ventricular event Vs. In particular each window W1-W3 starts at a predefined delay time T1-T3 with respect to a prior ventricular event Vs. Hence, at a particular ventricular event Vs (which may be a pacing event or an intrinsic sense event) a timer corresponding to the delay time T1-T3 and effectively covering in particular a repolarization phase of the ventricle following a prior ventricular event Vs is started. At the end of the delay time T1-T3 the window W1-W3 is started, and within the window W1-W3 signal portions are obtained relating to atrial activity within the particular heart cycle.

[0090] If the heart rate changes, the delay time T1-T3 may be proportionally adapted according to a change in the heart rate. For example, if the heart rate initially is at 60 bpm (relating to a heart interval of 1000 ms), the delay time T1-T3 may be set to 800 ms, and the window length of the window W1-W3 may be set to 200 ms. If the heart rate for example doubles to 120 bpm (relating to a heart interval of 500 ms), the delay time T1-T3 and the window length of the window W1-W3 may be proportionally adapted to 400 ms respectively 100 ms.

[0091] For combining signal portions relating to different heart cycles, for example a scaling of signal portions relating to the different windows W1-W3 may be applied in such a way that sample portions having a corresponding number of samples may suitably be summed.

[0092] It will be apparent to those skilled in the art that numerous modifications and variations of the described examples and embodiments are possible in light of the above teaching. The disclosed examples and embodiments are presented for purposes of illustration only. Other alternate embodiments may include some or all of the features disclosed herein. Therefore, it is the intent to cover all such modifications and alternate embodiments as may come within the true scope of this invention.

[0093] The following is a summary list of reference numerals and the corresponding structure used in the above description of the invention: [0094] 1 Leadless pacemaker device [0095] 10 Housing [0096] 100 Tip [0097] 101 Far end [0098] 11 First electrode (pacing electrode) [0099] 12 Second electrode (pacing ring) [0100] 13 Third electrode [0101] 14 Fixation device [0102] 15 Processing circuitry [0103] 16 Motion sensor [0104] 17 Pressure sensor [0105] 18 Sound sensor [0106] A Atrial vector [0107] AA Atrial activity [0108] AN Negative average [0109] AP Positive average [0110] As Atrial event [0111] AV Atrial-ventricular delay [0112] AVN Atrioventricular node [0113] B Baseline [0114] D Threshold value [0115] H HIS bundle [0116] LA Left atrium [0117] LBB Left bundle branch [0118] LV Left ventricle [0119] M Intra-cardiac tissue (myocardium) [0120] N Noise contribution [0121] P Pacing vector [0122] PN Negative peak value [0123] PP Positive peak value [0124] PW Peak width [0125] RA Right atrium [0126] RBB Right bundle branch [0127] RV Right ventricle [0128] S Signal portion [0129] S.sub.comb Combined signal portion [0130] t Time [0131] T1-T3 Delay time [0132] TA Atrial interval [0133] TV Ventricular interval [0134] T.sub.blank Blanking window [0135] SAN Sinoatrial node [0136] Ventricular vector [0137] VA Ventricular-atrial delay [0138] Vs Ventricular event [0139] W, W1-W3 Search window