Autonomous cardiac implant of the “leadless capsule” type, with detection of atrial activity by analysis of the charging electric signal delivered by an energy harvesting module
10821291 · 2020-11-03
Assignee
Inventors
Cpc classification
A61N1/3956
HUMAN NECESSITIES
A61N1/36507
HUMAN NECESSITIES
A61N1/025
HUMAN NECESSITIES
A61N1/3684
HUMAN NECESSITIES
A61N1/3756
HUMAN NECESSITIES
A61B5/686
HUMAN NECESSITIES
A61N1/3785
HUMAN NECESSITIES
International classification
A61B5/00
HUMAN NECESSITIES
A61N1/365
HUMAN NECESSITIES
A61N1/368
HUMAN NECESSITIES
Abstract
An energy harvester converts into electrical energy the external stresses applied to the implant at the heartbeat rhythm. This harvester includes an inertial unit and a transducer delivering an oscillating electrical signal that is rectified and regulated for powering the implant and charging an energy storage component. The instantaneous variations of this electrical signal are analyzed in a detection window following or preceding a ventricular contraction, to obtain atrial activity information representative of the atrium contribution to the electric signal, in particular information about the presence/absence of a spontaneous atrial contraction, and/or parameters making it possible to determine an atrioventricular delay to be applied if the ventricle has to be stimulated.
Claims
1. An autonomous cardiac implant of a leadless capsule type, comprising an implant body provided with means for anchoring to a cardiac wall, the implant body accommodating an electronic unit and an energy harvesting module with an energy storage component for powering the electronic unit, the energy harvesting module being adapted to convert into electrical energy external stresses applied to the implant body under an effect of movements of the cardiac wall to which the implant is anchored and/or of blood flow variations in the environment surrounding the implant at a heartbeat rhythm and/or of cardiac tissue vibrations, wherein an energy harvesting module comprises: an inertial unit subjected to said external stresses; a transducer adapted to convert mechanical energy produced by oscillations of the inertial unit into an oscillating electrical signal; and a power management circuit, adapted to rectify and regulate said oscillating electrical signal, to deliver as an output a stabilized direct voltage or current, for powering said electronic unit and/or charging said energy storage component, and wherein the implant further comprises atrial detection means, adapted to analyze, between successive beats, the oscillating electrical signal to derive therefrom atrial activity information proving in heartbeats the presence of an atrial event and/or to characterize an instant of occurrence thereof.
2. The implant of claim 1, wherein the atrial activity information is information about the presence/absence of an atrial contraction.
3. The implant of claim 1, further comprising: ventricular detection means, adapted to deliver a ventricular time marker defining an instant of occurrence of a ventricular event of a cardiac beat, and means for defining a detection window, preceding or following the ventricular time marker, and wherein the atrial detection means are means adapted to analyze variations of the oscillating electrical signal by searching for an atrial activity component within the detection window.
4. The implant of claim 3, wherein the ventricular detection means are means adapted to derive the ventricular time marker by analyzing the variations of the oscillating electrical signal delivered by the transducer.
5. The implant of claim 1, further comprising: ventricular detection means, adapted to detect an occurrence, or the absence of occurrence, of a spontaneous ventricular event in a heartbeat; ventricular stimulation means, adapted to apply a ventricular stimulation in the absence of the spontaneous ventricular event detected by the ventricular detection means; and sequencing means, adapted to define an instant of application of the stimulation after a predetermined atrioventricular delay following an atrial event detected by the atrial detection means.
6. The implant of claim 5, wherein the ventricular detection means are means adapted to detect the occurrence, or the absence of occurrence, of the spontaneous ventricular event by analyzing the variations of the oscillating electrical signal delivered by the transducer.
7. The implant of claim 1, further comprising: means for measuring a duration of the interval separating two prior consecutive spontaneous atrial and ventricular events; means for comparing said measured duration of the interval with a limit value; and means for conditionally activating sequencing means, for a later atrial and ventricular events, when said duration exceeds a limit value.
8. The implant of claim 5, wherein the sequencing means comprise: means adapted to define an instant of application of the ventricular stimulation after a predetermined escape interval has elapsed after a prior spontaneous or stimulated ventricular event; and means adapted to, after each of the later atrial events detected by the atrial detection means, apply a ventricular stimulation at an end of a predetermined atrioventricular delay without later ventricular event detected by the ventricular detection means.
9. The implant of claim 8, wherein said predetermined escape interval is one among: an interval corresponding to a basis stimulation frequency; or an interval of increased duration with respect to a basis stimulation frequency.
10. The implant of claim 5, wherein the sequencing means further comprise means adapted to temporarily activate the atrial detection means after each later spontaneous or stimulated ventricular event detected by the ventricular detection means.
11. The implant of claim 10, wherein the sequencing means further comprise means adapted to activate the atrial detection means only after a predetermined blanking interval has elapsed after the detection of the later ventricular event.
12. The implant of claim 5, wherein the atrial detection means further comprise means adapted, after each later spontaneous or stimulated ventricular event, to: upon detection of an atrial event, evaluate a contribution to the heartbeat of this atrial event; and decide that the atrial event is present if said evaluated contribution fulfils a predetermined criterion.
13. The implant of claim 12, wherein the atrial detection means further comprise means adapted, beforehand, to: evaluate the contribution to the heartbeat of an atrial event in a window preceding an instant of ventricular stimulation, by a retrospective analysis of the variations of the oscillating electrical signal in said window; and determine said predetermined criterion based on said so-evaluated contribution.
14. The implant of claim 13, wherein said criterion can be one among: a threshold level reached in absolute value by the oscillating electrical signal; and/or an energy of the oscillating electrical signal over a given time interval.
15. The implant of claim 12, wherein the atrial detection means further comprise means adapted, beforehand, to: evaluate the contribution to the heartbeat of an atrial event in a window preceding the instant of ventricular stimulation, by a prospective analysis of the variations of the oscillating electrical signal in said window, said window being triggered subsequently to the previous ventricular event; and determine said predetermined criterion based on said so-evaluated contribution.
16. The implant of claim 5, further comprising: means adapted, in case of the presence of the atrial event detected by the atrial detection means and of a consecutive spontaneous or stimulated ventricular event, to calculate a mechanical atrioventricular delay counted between the respective instants of occurrence of the atrial and ventricular events; and means adapted to adjust said atrioventricular stimulation delay so as to match the value of the mechanical atrioventricular delay with a predetermined atrioventricular delay.
Description
BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWINGS
(1) The accompanying drawings, which are incorporated in and constitute part of this specification, illustrate embodiments of the invention and together with the description, serve to explain the principles of the invention. The embodiments illustrated herein are presently preferred, it being understood, however, that the invention is not limited to the precise arrangements and instrumentalities shown, wherein:
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DETAILED DESCRIPTION OF THE INVENTION
(15) An exemplary embodiment of the device of the invention will now be described.
(16) As regards its software aspects, the invention may be implemented by a suitable programming of the control software of a known cardiac stimulator device, for example a stimulator of the endocavitary leadless capsule type.
(17) These devices include a programmable microprocessor or microcontroller coupled to circuits for receiving, shaping and processing electrical signals collected by electrodes arranged on the capsule, at least one of which is in contact with the myocardium, and delivering stimulation pulses to these electrodes. The adaptation of these devices to make the invention is within the reach of the one skilled in the art, and won't be described in detail. In particular, the software programs stored in memory and executed may be adapted or used to implement the functions of the invention that will be described hereinafter.
(18) The method of the invention is indeed mainly implemented by software means, using suitable algorithms executed by a microcontroller or a digital signal processor. For the sake of clarity of the presentation, the various processings applied will be decomposed and schematized by a certain number of distinct functional modules or blocks and/or of interconnected circuits, but this representation has nevertheless only an illustrative character, these functions or circuits including common elements, corresponding in practice to a plurality of functions wholly executed by a single software.
(19) In
(20) In any case, the leadless capsule is attached to the cardiac wall using a protruding anchoring system intended to enter the cardiac tissue for the holding on the implantation site. Other anchoring systems may be used and modify in no way the implementation of the present invention.
(21)
(22) The leadless capsule 10 is in this example made in the external form of a cylindrical tubular implant body 12 enclosing a unit 14 including the various electronic and power supply circuits of the capsule. The typical dimensions of such a capsule are a diameter of the order of about 6 mm over a length of about 25 mm.
(23) At its distal end 16, the capsule carries a helical screw 18 for the anchoring of the capsule against a wall of a cardiac cavity, as illustrated hereinabove as regards
(24) The opposite proximal end 22 of the leadless capsule 10 has an atraumatic rounded shape and is provided with suitable gripping means for the connection to a guiding catheter or other implantation accessory usable at the time of positioning or explanting the capsule.
(25) The leadless capsule 10 is provided with an energy harvesting module intended to power the electronic unit 14 and to charge an integrated energy storage component.
(26) Such an energy harvesting module includes an inertial unit that, inside the capsule, oscillates according to the various external stresses to which the leadless capsule is subjected. These stresses may result in particular from: movements of the wall to which the capsule is anchored, which are transmitted to the implant body 12 by the anchoring screw 18; and/or blood flow variations in the environment surrounding the implant, which produce oscillations of the implant body at the heartbeat rhythm; and/or various vibrations transmitted by the cardiac tissues.
(27)
(28) From the mechanical point of view, this unit constitutes a pendular system of the mass-spring type (the spring being made up from the flexible piezoelectric beam) that, due to the inertia of the mass 28, oscillates as soon as the elastic beam 24 is spaced apart from its stable rest position. De facto, this unit may be likened, as regards its mechanical behavior, to a structure of the fitted-free beam type, which has a natural frequency of free oscillation, which is herein the frequency at which the mass-spring system oscillates.
(29) The piezoelectric beam 24 further provides a function of mechanical-electrical transducer for converting into electrical charges the mechanical stress that is applied thereto when it is flexed, the charges being collected by electrodes formed at the surface of the beam. The beam is preferably a beam of the bimorphous type, i.e. capable of generating energy on its two faces when subjected to a deformation. These transduction properties are typical of a piezoelectric material such as the PZT ceramics or the monocrystals of the PMN-PT, barium titanate or lithium niobate type.
(30) Of course, the invention is not limited to this particular configuration of pendular unit given as an example, and other types of inertial units may be used for the energy harvesting, such as those mentioned in introduction, from the moment that they have at least one natural frequency of free oscillation.
(31) Likewise, the inertial unit may be a unit deformable according to several degrees of freedom, with then as much corresponding vibratory modes and natural frequencies of oscillation, and of electrical signals respectively delivered at the output.
(32)
(33) Block 30 denotes a circuit for detecting the cardiac depolarization wave, connected to the electrode 20 in contact with the cardiac tissue and to the opposite electrode 21. Block 30 includes filters and means for analog and/or digital processing of the signal collected. The so-processed signal is applied to the input of a calculator 32 associated with a memory 34.
(34) The electronic unit 14 also includes a stimulation circuit 36 operating under the control of the calculator 32 for, as and whenever necessary, delivering myocardium stimulation pulses to the system of electrodes 20 and 21.
(35) An energy harvesting circuit 38 is moreover provided, made up by the pendular unit formed by the piezoelectric beam 24 and the inertial mass 28 described hereinabove with reference to
(36) This energy harvesting circuit 38 produces as an output a variable electrical signal S such as that of
(37) Firstly, the signal S is delivered to a power management circuit 40, which rectifies and regulates the signal S so as to produce as an output a stabilized direct voltage or current used for powering the electronic unit 14 and charging the energy storage component 42, which itself powers the electronic unit 14.
(38) Secondly, this same signal S is applied to a circuit 44 for analyzing instantaneous variations of the signal in order to deliver as an output, characteristically of the invention and as will be described hereinafter, an indicator of detection (presence/absence) of an atrial contraction, as well as, as the case may be, parameters for controlling an atrioventricular delay.
(39) The data will make it possible, as will be described hereinafter, to control, as and whenever necessary, the application of the ventricular stimulation pulses by the circuit 36.
(40) The analysis circuit 44 operates under the control of a sequencing circuit 46 that defines the time position of one or several analysis windows determined by the calculator 32, the windows delimiting the various processings operated by the circuit 44 in order to extract from the raw signal S the desired significant information.
(41) The circuit 44 advantageously includes a pre-processing unit, composed of analog and/or digital circuits, with a digitization system and a typically analog, digital or morphological filtering, which makes it possible to discriminate, as a function of the frequency bands, the slow waves, of atrial origin, from the faster ones, of ventricular origin.
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(43) This signal is a recurrent signal, repeated at the rhythm of the successive heartbeats, with, at each occurrence, a series of damped sinusoidal oscillations, including a first amplitude peak PSE followed with a series of bounces R1, R2, R3 . . . of decreasing amplitudes. This oscillation phase is followed with a second, consecutive phase, substantially without bounce, which continues until a new contraction of the myocardium that will produce similar variations of the signal S.
(44) The order of magnitude of the recurrence rate of the cardiac cycles is typically of 1 to 2 Hz (60 to 120 bpm (beats per minute)). The natural frequency of the pendular unit is determined by the geometry of the piezoelectric beam 24 (mainly its length and thickness), by the elasticity of the material that composes it, and by the mass of the inertial mass 28. These different parameters may be advantageously chosen so as to give the natural frequency of free oscillation a value that is far higher than that of the cardiac rhythm, for example a rate of the order of 20 Hz, this value being of course not limitative. Almost in all circumstances, the pendular unit will then produce between two heartbeats a plurality of bounces followed with a phase with no bounces before the following heartbeat.
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(46) However, concretely, the energy harvesting by the power management circuit 40 deteriorates the signal S, which is clipped as a function of a threshold value of this circuit 40.
(47) The typical signal becomes as that illustrated in
(48) This clipping of S does not change the principle of the present invention and, for the sake of clarity of the presentation, the ideal case of
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(50) In
(51) As can be seen, the atrial contribution produces a signal CA1, CA2 . . . whose amplitude is lower, and whose frequency is lower, than those of the ventricular contribution CV1, CV2 . . . .
(52) In
(53) In the case, illustrated in
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(55) This desynchronization produces from one cycle to the other very important variations of the AV delays. Hence, in the illustrated example, due to the AVB, the second ventricular contraction CV2 is delayed with respect to the atrial contraction CA2 of the same cycle (it will be noted that the AV delays are herein mechanical-mechanical delays and not electrical-electrical nor mechanical-electrical delays).
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(57) Indeed, such an AVB is characterized by the fact that a part (AVB2) or the totality (AVB3) of the atrial waves, stimulated or spontaneous, are no longer conducted, i.e. they are no longer followed with ventricular depolarizations/contractions. In such a case, the contraction of the ventricle must necessarily be triggered by a stimulation produced by the device.
(58) In the case of a single-chamber stimulator in VVI mode, this stimulation is triggered at the end of an escape interval EI, which is a time interval, counted after a ventricular detection or stimulation (related to a spontaneous or stimulated contraction by an electrical pulse applied by the device), at the end of which a stimulation is delivered to the ventricle in the absence of detection of a spontaneous event of the latter.
(59) Within the framework of the present invention, which aims at reproducing a VDD mode, the ventricular detection is made in a conventional manner, using the circuit 30 (
(60) In the example illustrated in
(61) The matter is then to detect the presence or the absence of an atrial contraction and, in presence of an atrial contraction, to determine the instant of occurrence of the latter, in order to: reveal a potential situation of atrial fibrillation, typically corresponding to an absence of atrial detection characteristic of a sinus rhythm. In this case, there is no need to try to synchronize the ventricular rhythm to the atrial rhythm, because the latter is totally disordered due to the atrium fibrillation; or in the opposite hypothesis, i.e. in case of present and confirmed sinus rhythm (normal atrial activity, sinoatrial rhythm), determine the instants of occurrence of the successive atrial contractions, so as to resynchronize if necessary the ventricular stimulation to the sinus rhythm.
(62) Advantageously, to allow a better detection of the atrial contraction, the current escape interval EI is temporarily modified by giving it an increased value EI, for example increased to 2000 ms instead of 1000 ms.
(63) During this increased escape interval EI, the electrical signal S delivered by the energy harvester is analyzed in the following manner.
(64) Firstly, it is advisable to exclude from the detection the detected atrial contractions that, due to a desynchronization produced by an AVB, would not be relevant to stimulate the ventricle with a regular rhythm.
(65) Hence, in the example of
(66) For that purpose, a detection window W0 is defined retrospectively, after the end of the increased escape interval EI (i.e. after the ventricular stimulation V). The atrial contribution is searched for and analyzed inside this detection window W0, which, in the illustrated example, makes it possible to determine the presence of an atrial contraction CA4.
(67) As a variant, the detection window W0, instead of being counted retrospectively after the end of the escape interval EI, may be counted prospectively, i.e. positively from the beginning of the escape interval (i.e. from the ventricular contraction CV2 in the illustrated example).
(68) The criterion making it possible to detect the presence or the absence of an atrial contraction is for example: a threshold level reached in absolute value by the oscillating electric signal S, or the energy of this signal S (by integration of the latter over a given interval), or a combination of the preceding criteria.
(69) The atrial detection may also include additional criteria, in particular for detecting a possible arrhythmia over several successive cycles, the atrial contraction being proved only in the absence of arrhythmia.
(70) Once the atrial contraction detected (the contraction CA4 in the illustrated example), its variation parameters (such as maximum amplitude in absolute value, maximum amplitude excursion, root mean square value, energy, etc.) are analyzed and converted into an indicator that will be used for the later detections, for example an amplitude threshold level Th in absolute value.
(71) For the following detection, the device opens a first window W1 for blanking the signal bounces, followed with a window W2 for atrial detection, these successive windows W1 and W2 being triggered from the instant V of the detected ventricular event (CV3 in the illustrated example).
(72) If, in the time period of the detection window W2, the electric signal S delivered by the energy harvester fulfils the previously determined indicator (i.e., in the illustrated example, exceeds the threshold Th), then the device considers that a spontaneous atrial event As is present.
(73) The device then begins to count an atrioventricular stimulation delay AVDstim from the instant of the spontaneous atrial contraction As that has been detected.
(74) This phase is more precisely illustrated in
(75) A new series of blanking W1 and detection W2 windows is then triggered, to detect the presence or the absence of a later atrial contraction (present contraction CA3 in the example illustrated in
(76)
(77) In such a case, the just-described mechanism of the invention makes it possible to restore the synchronism between the atrial and ventricular contractions.
(78) As illustrated in the first cycle in
(79) If, at the following heartbeat, the device applies the mechanism described hereinabove in relation with
(80) The spontaneous atrial contraction As detected in the window W2 triggers an atrioventricular delay AVDstim producing, at the end of this delay, a ventricular stimulation Vp that allows restoring a physiological, short PR interval.
(81)
(82) The device firstly determines (test 102) whether such a detection is effectively possible, for example in the case where a prior detection has been tried but has failed; in this latter case, a waiting delay is applied before any new detection.
(83) If the detection is possible, then the escape interval EI is increased, for example to a value EI=2000 ms (block 104).
(84) The device then waits until the end of the detection window W0 (test 106) to begin recording, and/or analyzing on the fly, the variations of the signal S (block 108).
(85) This action is continued up to the end of the escape interval EI (test 110), after what the device determines (test 112) whether or not the variations of the signal S, in terms of time and/or amplitude variations, correspond to an effective atrial activity. If the computing power allows it, more complex tests are possible, in particular with shape analysis of the signal S, using self-learning neuronal circuits, and/or using an artificial intelligence system.
(86) If the result of the test 112 is negative, the process returns to the beginning of the sequence of steps, at test 102. In the opposite case, i.e. in the presence of a proven atrial event, the atrial contraction indicator is then calculated (block 114), typically as an amplitude threshold value Th in absolute value as in the example illustrated and described in
(87)
(88) The matter is to analyze the delays between atrial and ventricular events only on the basis of components corresponding to the mechanical activity of the contractions of these cavities, so as to eliminate the effect of the electromechanical delay EMD (cf.
(89) The atrioventricular stimulation delay AVDstim is initially parameterized to a predetermined initial value (Block 202). Upon detection (Block 204) of an atrial contraction (at the instant As in
(90) If a spontaneous ventricular contraction is detected, the real atrioventricular delay (mechanical atrioventricular delay) AVDm=AsVs is then measured (Bloc 208). This real, mechanical, atrioventricular delay AVDm is compared with a predetermined target value AVDp (tests 210, 212, with application of hysteresis limits hyst1 and hyst2).
(91) If the measured mechanical atrioventricular delay AVDm is higher than the predetermined target value AVDp, then the memorized atrioventricular delay is reduced (Block 214). If the measured mechanical atrioventricular delay AVDm is lower than the predetermined target value AVDp, then the memorized atrioventricular delay is increased (Block 216). The so-memorized atrioventricular delay becomes the next stimulation AV delay AVDstim that will be applied after detection of an atrial activity As.
(92) Hence, if during later cycles it is necessary to apply a stimulation (stimulated ventricular event Vp), then this stimulation will be performed with an optimized AV stimulation delay AVDstim, because corresponding to an actually measured delay in case of spontaneous event, and with no bias introduced due to the electromechanical delay EMD. Having thus described the invention of the present application in detail and by reference to embodiments thereof, it will be apparent that modifications and variations are possible without departing from the scope of the invention defined in the appended claims as follows.