Leadless Cardiac Pacemaker Device Configured to Provide Intra-Cardiac Pacing

Abstract

A leadless pacemaker device configured to provide for an intra-cardiac pacing comprises a housing; an electrode arrangement arranged on the housing and configured to receive electrical signals; and a processing circuitry enclosed in the housing and operatively connected to the electrode arrangement, wherein the processing circuitry comprises a first processing channel having a first gain for processing a first processing signal derived from electrical signals received via the electrode arrangement and a second processing channel having a second gain for processing a second processing signal derived from electrical signals received via the electrode arrangement, the second gain being higher than the first gain.

Claims

1. A leadless pacemaker device configured to provide for an intra-cardiac pacing, the leadless pacemaker device comprising: a housing; an electrode arrangement arranged on the housing and configured to receive electrical signals; and a processing circuitry enclosed in the housing and operatively connected to the electrode arrangement, wherein the processing circuitry comprises a first processing channel having a first gain for processing a first processing signal derived from electrical signals received via the electrode arrangement and a second processing channel having a second gain for processing a second processing signal derived from electrical signals received via the electrode arrangement, the second gain being higher than the first gain.

2. The leadless pacemaker device according to claim 1, wherein the housing comprises a tip, the electrode arrangement comprising a first electrode placed on the tip for engaging with intra-cardiac tissue.

3. The leadless pacemaker device according to claim 2, wherein the electrode arrangement comprises a second electrode formed by an electrode ring circumferentially extending about the housing and being placed at a distance from said tip.

4. The leadless pacemaker device according to claim 3, wherein the processing circuitry is configured to process, as said first and/or second processing signal, a first and/or second signal sensed between the first electrode and the second electrode.

5. The leadless pacemaker device according to claim 2, wherein the housing comprises a far end opposite the tip the electrode arrangement comprising a third electrode arranged in the vicinity of the far end.

6. The leadless pacemaker device according to claim 5, wherein the processing circuitry is configured to process, as said first and/or second processing signal, a first and/or second signal sensed between the first electrode and the third electrode.

7. The leadless pacemaker device according to claim 1, wherein the processing circuitry is configured to process the first processing signal to detect a ventricular activity and the second processing signal to detect an atrial activity.

8. The leadless pacemaker device according to claim 1, wherein the second processing channel comprises a processing stage for differentiating one wave portion from another wave portion in the second processing signal.

9. The leadless pacemaker device to claim 8, wherein the processing stage configured to apply, to the second processing signal, at least one of a bandpass filtering, a blanking window (T.sub.blank) for excluding a portion of the second processing signal from further processing, a moving average filtering, a finite difference filtering, and a rectification.

10. The leadless pacemaker device according to claim 8, wherein the first processing channel comprises a first detection stage for detecting at least one near-field event in the first processing signal, wherein the processing stage of the second processing channel is configured to determine at least one limit of a blanking window (T.sub.blank) for excluding a portion of the second processing signal from further processing based on at least one near-field event detected by said first detection stage.

11. The leadless pacemaker device according to claim 10, wherein the second processing channel comprises an amplification stage for amplifying the second processing signal, wherein the amplification stage is switched off during said blanking window.

12. The leadless pacemaker device according to claim 1, wherein the second processing channel comprises a second detection stage for detecting at least one far-field event in the second processing signal.

13. The leadless pacemaker device according to claim 12, wherein the second detection stage is configured to detect said at least one far-field event by at least one of comparing the second processing signal to a threshold, and evaluating at least one morphological feature of the second processing signal, wherein the evaluating of at least one morphological feature includes at least one of determining an amplitude value from the second processing signal, determining a duration of a wave portion of the second processing signal, determining a number of threshold crossings or zero crossings in the second processing signal, and determining a location of a wave portion in a detection window.

14. The leadless pacemaker device according to claim 12, wherein the processing circuitry is configured to trigger a pacing signal based on at least one detected far-field event.

15. Method for operating a leadless pacemaker device for providing intra-cardiac pacing, comprising: receiving electrical signals, using an electrode arrangement arranged on a housing of the leadless pacemaker device; and processing, using a processing circuitry enclosed in the housing and operatively connected to the electrode arrangement, a first processing signal and a second processing signal derived from electrical signals received via the electrode arrangement, wherein the processing circuitry comprises a first processing channel having a first gain for processing said first processing signal and a second processing channel having a second gain for processing said second processing signal, the second gain being higher than the first gain.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0038] The various features and advantages of the present invention may be more readily understood with reference to the following detailed description and the embodiments shown in the drawings. Herein,

[0039] FIG. 1 shows a schematic view of the human heart;

[0040] FIG. 2 shows a schematic view of a leadless pacemaker device;

[0041] FIG. 3 shows a schematic view of a leadless pacemaker device, indicating signal vectors between different electrodes of the leadless pacemaker device;

[0042] FIG. 4 shows a schematic view of a processing circuitry of an embodiment of a leadless pacemaker device;

[0043] FIG. 5A shows a first processing signal in the shape of an intra-cardiac electrogram (IEGM) received by a first processing channel of the processing circuitry;

[0044] FIG. 5B shows a second processing signal, in a raw state prior to processing by a second processing channel;

[0045] FIG. 5C shows the second processing signal, after processing by means of a processing stage of the second processing channel; and

[0046] FIG. 5D shows the timing of detected ventricular and atrial events in the first processing signal and the second processing signal.

DETAILED DESCRIPTION

[0047] Subsequently, embodiments of the present invention shall be described in detail with reference to the drawings. In the drawings, like reference numerals designate like structural elements.

[0048] It is to be noted that the embodiments are not limiting for the present invention, but merely represent illustrative examples.

[0049] In the instant invention, it is proposed to provide a leadless pacemaker device providing for an intra-cardiac pacing, in particular a ventricular pacing, specifically a so-called VDD pacing.

[0050] s FIG. 1 shows, in a schematic drawing, the human heart comprising 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, 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. From the atrioventricular node AVN the so-called HIS bundle H is extending, the HIS bundle H being comprised of 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.

[0051] In 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 means of a pacemaker device may be indicated, such pacemaker device stimulating ventricular activity by injecting stimulation energy into intra-cardiac tissue, specifically myocardium M.

[0052] Within the instant text, it is proposed to use a leadless cardiac pacemaker device 1, as schematically indicated in FIG. 1, for providing for a ventricular pacing action.

[0053] Whereas common leadless pacemaker devices are designed 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 VDD pacing mode, 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.

[0054] 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 in a VDD pacing mode, comprises 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, comprising, 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 shape of a battery are confined in the housing 10. The housing 10 encloses components received therein, the housing 10 having the shape of, e.g., a cylindrical shaft having a length of, for example, a few centimeters.

[0055] The leadless pacemaker device 1 is to be implanted immediately on intra-cardiac tissue M. For this, the leadless pacemaker device 1 comprises, in the region of the tip 100, a fixation device 14, for example, in the shape 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.

[0056] The leadless pacemaker device 1 does not comprise leads, but receives signals relating to a cardiac activity by means of an electrode arrangement arranged on the housing 10 and also emits stimulation signals by means of such electrode arrangement. In the embodiment of FIGS. 2 and 3, the leadless pacemaker device 1 comprises different electrodes 11, 12, 13 making up the electrode arrangement 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.

[0057] A first electrode 11 herein is denoted as pacing electrode. The first electrode 11 is placed at a tip 100 of the housing 10 and is configured to engage with cardiac tissue M.

[0058] 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 P for emitting pacing signals towards the intra-cardiac tissue M.

[0059] In addition, the second electrode 12 serves 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 near-field vector.

[0060] 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.

[0061] The leadless pacemaker device 1, in the embodiment of FIGS. 2 and 3, in addition comprises a third electrode 13 placed at a far end 101 of the housing 10, the third electrode 13 serving as a sensing electrode for sensing 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 picking up signals being indicative, for example, of atrial contractions and being denoted as far-field vector.

[0062] 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.

[0063] In order to provide for a pacing in the ventricle in which the leadless pacemaker device 1 is placed, in particular to enable a pacing in the VDD mode, a sensing of atrial activity is required to provide for detected atrial sense markers in order to time a pacing in the ventricle to obtain atrioventricular (AV) synchrony. For this, a far-field signal from, in particular, the right atrium RA (see FIG. 1) shall be sensed in order to allow for a synchronous pacing in the right ventricle RV by means of the leadless pacemaker device 1 being implanted on intra-cardiac tissue M in the right ventricle RV.

[0064] s Referring now to FIG. 4, the processing circuitry 15 comprises, in one embodiment, two processing channels 16, 17 for processing different processing signals relating to ventricular activity and atrial activity. Herein, typically, an intra-cardiac electrogram (IEGM) contains a signal portions relating to ventricular activity (in particular a QRS wave) and atrial activity (in particular a P wave), signal portions relating to atrial activity however resulting from a far-field signal source and hence being far less pronounced and having a far smaller amplitude then signal portions relating to a ventricular activity in the near-field, i.e., arising in close proximity to the implanted leadless pacemaker device 1. For this reason, the two processing channels 16, 17 are associated with different gains G1, G2, a first processing channel 16 serving to process a first processing signal to identify ventricular events at a rather low gain G1 and a second processing channel 17 being configured to process a second processing signal to identify atrial events at a significantly higher gain G2.

[0065] In particular, the first processing channel 16 is connected to the electrode arrangement comprised of the electrodes 11, 12, 13, the first processing channel 16 being configured, in particular, to sense and process a signal received via the electrodes 11, 12 (near-field vector V in FIGS. 2 and 3). The first processing channel 16 comprises a first amplification stage 161 having a gain G1 and, following the amplification stage 161, a detection stage 162 which is configured to identify ventricular sense markers Vs from the first processing signal processed within the first processing channel 16.

[0066] This is illustrated in FIG. 5A. The first processing signal processed within the first processing channel 16 resembles an intra-cardiac electrogram (IEGM) picked up in the ventricle in which the leadless pacemaker device 1 is implanted, the signal including portions relating to ventricular activity as well as atrial activity, signal portions relating to a ventricular activity however being far pronounced with respect to other signal portions (QRS waves as visible from FIG. 5A). For example, by means of comparing the signal to a suitable threshold or by applying a morphological analysis, the occurrence of ventricular events, in particular the start of a QRS wave, may be discerned, the second processing channel 16 outputting ventricular sense markers Vs indicative of such ventricular events.

[0067] The second processing channel 17 is likewise connected to the electrode arrangement comprised of electrodes 11, 12, 13, wherein the second processing channel 17 may, in particular, be configured to process a signal sensed via the far-field vector A, that is in between the electrodes 11, 13 placed at the tip 100 and the far end 101 of the housing 10 as illustrated in FIGS. 2 and 3. The second processing channel 17 comprises a second amplification stage 171 having a second gain G2, the second amplification stage 171 being followed by a processing stage 172 and a second detection stage 173.

[0068] The processing stage 172 serves to pre-process the second processing signal after amplification. The detection stage 173 in turn serves to evaluate and analyze the processed signal in order to identify atrial events within the second processing signal, the second processing channel 17 then outputting atrial sense markers As indicative of atrial events detected in the processed signal.

[0069] In order to identify and analyze atrial events, the gain G2 of the second processing channel 17 could be (significantly) higher than the gain G1 of the first processing channel 16. As visible from FIG. 5B illustrating the second processing signal in a raw state prior to processing by means of the processing stage 172, this allows to analyze signal portions relating to atrial events, but makes it necessary to discern such signal portions relating to atrial events from other signal portions, in particular, signal portions relating to ventricular events in the near-field and hence being far stronger than signal portions originating from atrial events in the far-field.

[0070] Within the processing stage 172, for example, a bandpass filtering, a partial blanking, a smoothing by means of a moving average filtering and a rectification may take place. A first or second order difference may be applied to remove a non-zero baseline while enhancing P wave detections.

[0071] FIG. 5C illustrates the signal after processing by means of the processing stage 172 in the second processing channel 17. In particular, within the processing a blanking window T.sub.blank may be applied serving to mute the signal in such time intervals which—likely—do not relate to an atrial activity. The position of the blanking window T.sub.blank herein is determined, in the embodiment of FIG. 4, according to an identification of prior ventricular events by means of the first processing channel 16.

[0072] In particular, by means of the detection of ventricular events in the first processing channel 16 a timing in between atrial events and ventricular events may be determined. According to such timing, a start point and an end point of the blanking window T.sub.blank may be set, hence excluding signal portions from the processing which do not relate to atrial activity. Strong ventricular signals in this way may be suppressed such that signal portions relating to a ventricular activity may not interfere with a detection of atrial events.

[0073] During the blanking window T.sub.blank, the second processing channel 17 may be turned off. In particular, the amplification stage 171 of the second processing channel 17 may be switched of in order to save power.

[0074] Generally, a detection for atrial events takes place outside of the blanking window T.sub.blank. Herein, a detection window for detecting atrial events may start at the end of a prior blanking window T.sub.blank. Alternatively, a detection window may have a delay with respect to the end of a prior blanking window T.sub.blank, such that a signal processing within the second processing channel 17 starts at the end of a prior blanking window T.sub.blank, a detection for atrial events however starting only after a certain delay.

[0075] For detecting atrial events within the second processing signal processed in the second processing channel 17 in order to output atrial sense markers As illustrated in FIG. 5D, different measures may be taken.

[0076] In order to allow for a fast detection of atrial events, the signal may, for example, be rectified within the processing stage 172, the detection stage 173 being configured to monitor whether the processed signal exceeds a (positive) threshold. Alternatively, no rectification may be applied in the processing stage 172, the detection stage 173 monitoring for a crossing of a positive threshold or a negative threshold (or both).

[0077] Such thresholds herein may be continuously adapted according to a detected P wave amplitude. In particular, the thresholds for a following cycle for a subsequent atrial event detection may be set according to a predefined percentage of the amplitude of a detected P wave in a prior cycle.

[0078] By monitoring a threshold crossing, a fast detection of atrial events is possible, however at the expense of a potentially reduced reliability. Therefore, in one embodiment, a further analysis of, for example, morphological features of the signals, in particular a detected P wave, may be applied in order to confirm an atrial event or, in the negative, to reject a false detection of an atrial event. For such morphological analysis, for example, the amplitude of a detected P wave, the duration of a detected P wave, a number of threshold crossings or zero crossings in a detected P wave, and/or a location of a detected P wave in the detection window may be evaluated. In case it is concluded from the morphological analysis that a true atrial event is present, the atrial event identified by the initial threshold crossing monitoring is confirmed. Otherwise, the atrial event is rejected as false.

[0079] As the morphological analysis requires an evaluation of the signal within a certain time interval, confirmation or rejection by means of the morphological analysis may come at a delay with respect to the identification according to a threshold crossing. It herein is possible to output an atrial sense marker. As already at the initial identification by means of a threshold crossing in order to then, after the morphological analysis, cancel the atrial sense markers in case of a false detection. Alternatively, an atrial sense marker As may only be output after a confirmation by means of the morphological analysis, at the expense of an increased delay in between a true occurrence of a P wave and the output of the atrial sense marker As.

[0080] Using atrial sense markers As output by the second processing channel 17, a ventricular synchronous pacing may be achieved. For this, it can be detected whether, following a detected atrial sense marker As, an intrinsic ventricular sense marker Vs occurs (output by the first processing channel 16) within a predefined time delay window after the atrial sense marker As, in which case no stimulation is required. If no ventricular sense marker Vs is detected, a stimulation pulse may be emitted, causing a synchronous pacing at the ventricle.

[0081] Conversely, also an asynchronous pacing can be performed.

[0082] Utilizing a far-field electrical signal received by means of a leadless pacemaker device can offer a superior detection of far-field events, in particular atrial events in case the leadless pacemaker device is implanted into the ventricle. A tracking of far-field events by using and evaluating electrical signals may allow for an increased consistency and reliability, in particular with respect to external factors such as posture and patient activity.

[0083] 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 teachings of the disclosure. 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, which is to be given the full breadth thereof. Additionally, the disclosure of a range of values is a disclosure of every numerical value within that range, including the end points.

LIST OF REFERENCE NUMERALS

[0084] 1 Leadless pacemaker device [0085] 10 Housing [0086] 100 Tip [0087] 101 Far end [0088] 11 First electrode (pacing electrode) [0089] 12 Second electrode (pacing ring) [0090] 13 Third electrode [0091] 14 Fixation device [0092] 15 Processing circuitry [0093] 16 Processing channel [0094] 160 Electrode arrangement [0095] 161 Amplification stage [0096] 162 Detection stage [0097] 17 Processing channel [0098] 170 Electrode arrangement [0099] 171 Amplification stage [0100] 172 Processing stage [0101] 173 Detection stage [0102] A Atrial vector [0103] As Atrial event [0104] AVN Atrioventricular node [0105] G1, G2 Gain [0106] H HIS bundle [0107] LA Left atrium [0108] LBB Left bundle branch [0109] LV Left ventricle [0110] M Intra-cardiac tissue (myocardium) [0111] P Pacing vector [0112] RA Right atrium [0113] RBB Right bundle branch [0114] RV Right ventricle [0115] SAN Sinoatrial node [0116] T.sub.blank Blanking window [0117] V Ventricular vector [0118] Vs Ventricular event