• 专利附录
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    • 专利摘要:
    An energy recuperator converts the external stresses applied to the implant to the rhythm of the heartbeats into electrical energy. This recuperator includes an inertial assembly. A transducer provides an oscillating electrical signal (S) that is rectified and regulated to provide power to the implant and / or recharge a battery. The instantaneous variations of this electrical signal (S) between two heartbeats are analyzed within successive time windows (F1, F2, F3), to deduce a physiological parameter and / or a physical activity parameter of the patient carrier. of the implant, in particular according to an amplitude peak (PSE) of the first oscillation of the electrical signal (S), and the level of this signal after the rebound phase (Ø1) of the oscillation of the signal.
    公开号:FR3068253A1
    申请号:FR1755938
    申请日:2017-06-28
    公开日:2019-01-04
    发明作者:Jean-Luc Bonnet；Guillaume FERIN
    申请人:Cairdac SAS；
    IPC主号:
    专利说明:

    The invention relates to active implantable medical devices (AIMD), in particular cardiac implants responsible for monitoring the activity of the myocardium and delivering stimulation, resynchronization or defibrillation pulses in the event of a rhythm disturbance detected by the device.
    The invention relates more precisely to those of these devices which incorporate a self-supply system comprising a mechanical energy recuperator associated with an integrated buffer battery. The recuperator, also called harvester or scavenger, collects the mechanical energy resulting from the various movements undergone by the body of the implanted device. These movements can originate from a certain number of phenomena occurring at the rhythm of the cardiac beats, in particular the periodic tremors of the wall on which the implant is anchored, the vibrations of the cardiac tissues linked inter alia to the closings and openings of the cardiac valves, or variations in the flow of blood in the surrounding environment, which stress the implant and cause it to oscillate at the rate of variations in flow. The mechanical energy collected by the recuperator is converted into electrical energy (voltage or current) by means of an appropriate mechanical-electrical transducer, for supplying the various circuits and sensors of the device and recharging the buffer battery.
    This energy recovery technique is particularly well suited to supplying autonomous implanted capsules devoid of any physical connection to a remote device. These capsules are therefore called leadless capsules, to distinguish them from the electrodes or sensors arranged at the distal end of a probe (lead) traversed over its entire length by one or more conductors connected to a generator connected to the opposite end , proximal.
    In the case of cardiac application, these may be epicardial leadless capsules, attached to the outer wall of the heart, or endocavitary capsules, attached to the inner wall of a ventricular or atrial cavity, or alternatively capsules attached to a wall of a vessel near the myocardium. The invention is however not limited to a particular type of capsule, and it is applicable equally to any type of leadless capsule, whatever its functional destination.
    The attachment of the capsule to the implantation site is ensured by a protruding anchoring system extending the body of the capsule and intended to penetrate into the cardiac tissue, in particular by means of a screw. The capsule also includes various electronic circuits, sensors, etc. as well as wireless communication transmitter / receiver means for exchanging data remotely, all of which is integrated into a body of very small dimensions which can be installed in sites that are difficult to access or that leave little space, such as the apex of the ventricle, the inner wall of the atrium, etc.
    US 2009/0171408 A1 (Solem) describes various examples of such leadless intracardiac capsules.
    In all cases, the processing of signals within the capsule and their remote transmission requires significant energy compared to the energy resources that this capsule can store in a very small available volume. However, given its autonomous nature, the capsule can only call on its own resources, hence the need for an integrated self-supply system including an energy recuperator associated with a small integrated buffer battery. .
    There are several types of energy recuperators, based on different physical principles: automatic watch movement type system, mobile magnet system, bellows system or the like recovering variations in blood pressure, etc. The invention relates more precisely to leadless capsules (or similar implantable devices), the energy recuperator of which uses an inertial assembly subjected to the external stresses described above, with such an inertial assembly. This inertial assembly can in particular use - but not be limited to - a transducer coupled to a pendulum mechanism comprising in the capsule a mobile mass, called seismic mass or inertial mass. This inertial mass is driven according to the movements of the capsule, which is permanently subjected to the various external stresses described above. After each of these stresses, the inertial mass, which is coupled to an elastically deformable element, oscillates at a natural frequency of free oscillation.
    Other types of inertial assemblies for energy recovery also exhibit this oscillation phenomenon. In any event, the invention is not limited to a particular type of inertial assembly, and covers not only assemblies with an electromechanical transducer than those with a piezoelectric, electromagnetic, electrostatic or tribological transducer, all suitable for delivering a signal. electric oscillating under the effect of an external mechanical stress, and which will be designated by the generic term of translator.
    The frequency of oscillation of the inertial assembly, typically of the order of a few tens of hertz, is notably higher than the frequency of external cyclic stresses which corresponds to the frequency of heartbeat (a few hertz at most). Thus, at each cardiac contraction, the seismic mass (or other functionally analogous mechanical organ) will be stressed with a greater or lesser amplitude, then the inertial system will oscillate several times with decreasing amplitudes (rebounds characteristic of a damped periodic oscillation), and finally will stabilize until the next heartbeat, where the cycle of stress / oscillations will reproduce in a comparable manner.
    The mechanical energy of the oscillation of the inertial assembly is, for example, converted into electrical energy by a mechanoelectric transducer producing an oscillating electrical signal. This signal is delivered to a power supply management circuit of the implant, which rectifies and regulates the electrical signal to deliver a stabilized DC voltage or current as an output to supply the various electronic circuits and sensors. the implant, as well as the recharge of the buffer battery.
    Advantageously, but in a nonlimiting manner, the mechanoelectric transducer can be a piezoelectric component subjected to a cyclic and alternately bending manner so as to generate within the material that constitutes it, electric charges which are recovered at the surface of the component to be used by the self-feeding system of the capsule.
    The piezoelectric component can for example be a piezoelectric plate embedded at one of its ends and coupled to the inertial mass at its other end, which is free. We can refer in particular to
    EP 2 857 064 A1 (Sorin CRM) which describes such an energy recovery arrangement particularly suitable for supplying a leadless capsule.
    It has been proposed, in addition to the recovery of electrical energy, to use the electrical signal delivered by the transducer to obtain information on the clinical state of the patient's heart.
    Thus, the aforementioned US 2009/0171408 A1 (Solem) proposes to derive energy information from the electrical conversion signal making it possible to evaluate parameters such as the heart rate, or the amplitude or the acceleration of the cardiac beats. The analysis is based on the observation that the electrical energy delivered by the generator, that is to say the amount of electricity produced over a given period, is an indicator of the kinetic energy of the heart, reflecting the acceleration and the movements of the site where the device is located. In other words and in a simplified way, the stronger the electrical signal, the more this reveals a good condition of the myocardium.
    Similarly, US 2015/0224325 A1 (Imran) describes the possibility of using the electrical signal from the energy recovery device also as a sensor signal enabling clinical monitoring of the patient. In particular, it is possible to detect the appearance of fibrillation or similar episode by a sudden drop in the average voltage level of the electrical signal delivered by the energy recuperator. An alert can then be transmitted to a monitoring or surveillance device, worn or not, carried by the patient, which continuously monitors the supply signal delivered by the recuperator.
    However, in either case, relatively summary and / or slowly evolving clinical information, deduced from the average amplitude of the electrical signal evaluated over several successive cardiac cycles.
    The object of the invention is to propose a technique for analyzing the electrical supply signal delivered by the energy recuperator of an autonomous implanted device, which allows:
    - to obtain clinical information much more specific than that which was possible to obtain with known prior techniques;
    - in particular, to obtain such clinical information both of a physiological nature (relating to the intrinsic behavior of the myocardium) and of a physical nature (giving an indication of the level of activity of the patient at a given instant); and
    - obtain all this information in real time, immediately after each cardiac cycle.
    It is known to obtain such information with an implanted device, in particular a device of the leadless capsule type, but it is therefore necessary for the capsule to integrate one or more specific sensors, such as an accelerometer (sensor G) for the evaluation of the level. activity and / or an endocardial acceleration sensor (EA sensor) for the evaluation of parameters such as myocardial contractility, as for example described by EP 3,025,758 A1 (Sorin CRM).
    The basic idea of the invention consists in analyzing the very short-term variations of the electrical signal delivered by the energy recuperator, between two heart beats.
    This analysis is performed in real time on the signal reflecting the oscillations of the inertial assembly (typically, the oscillations of the inertial mass in the case of a pendulum assembly) at its oscillation frequency just after the cardiac contraction, therefore corresponding to damped oscillations or rebounds described above.
    Unlike known techniques, it is not a question of analyzing the evolution of the average level of the electrical signal from one cardiac cycle to the next, or over several successive cardiac cycles, therefore to analyze much slower variations.
    As will be seen, the analysis technique according to the invention makes it possible to obtain a number of important clinical information, both physical and physiological in nature, such as the instantaneous activity level of the patient, the degree of contractility myocardium, possibly distinguishing isovolumic contraction and ventricular ejection, etc.
    Advantageously, this information is obtained from the single electrical signal produced by the energy recuperator, without it being necessary to provide the implant with one or more specific sensors, since the inertial assembly (typically, the (pendulum inertial mass / mechano-electric transducer) plays a dual role of energy recuperator and physiological and / or physical activity sensor.
    To this end, the invention provides an autonomous cardiac implant of leadless capsule type comprising, in itself known from US 2015/0224325 A1 mentioned above: an implant body provided with means for anchoring to a cardiac wall , the implant body housing an electronic assembly; and an energy recovery module with an energy storage member for supplying the electronic assembly.
    The energy recovery module is capable of converting external stresses applied to the body of the implant into electrical energy under the effect of movements of a wall to which the implant is anchored and / or variations in flow rate. blood in the environment surrounding the implant to the rhythm of heartbeat and / or vibrations of heart tissue.
    The energy recovery module comprises: an inertial assembly subjected to said external stresses; a translator able to convert the mechanical energy produced by the oscillations of the inertial assembly into an oscillating electrical signal; and a power management circuit, capable of rectifying and regulating said oscillating electrical signal, for outputting a stabilized DC voltage or current for supplying said electronic assembly and / or recharging said energy storage member.
    Characteristically of the invention, such an implant also comprises:
    a sequencing module comprising a circuit for detecting successive ventricular or atrial cardiac events, and a windowing circuit, capable of defining at least one predetermined time window between two consecutive cardiac events; and
    an analysis module receiving as input the electrical signal delivered by the translator and capable of analyzing the instantaneous variations of said electrical signal oscillating inside said at least one time window thus defined, and deducing therefrom a current value of at least at least one physiological parameter and / or at least one physical activity parameter of the patient carrying the implant.
    According to various advantageous subsidiary characteristics:
    - The inertial assembly comprises a pendulum assembly with an elastically deformable element according to at least one degree of freedom, coupled to an inertial mass. In such a case, the energy recovery module advantageously comprises at least one piezoelectric blade coupled at one of its ends to the inertial mass, said piezoelectric blade forming both said elastically deformable element and said translator;
    the windowing circuit is capable of defining a first time window for searching for a first peak of the oscillating electrical signal;
    the windowing circuit is capable of defining a second time window corresponding to a phase in free oscillation damped by the inertial assembly;
    the windowing circuit is able to search for an amplitude peak of the first oscillation of the electrical signal, and to define the second time window as a function of the instant of said amplitude peak;
    the analysis module is capable of determining a quantity linked to at least part of the duration of an alternation of the first oscillation of the electrical signal; and deduce at least one physiological parameter from the patient as a function of said quantity. Said quantity is advantageously one of: the amplitude of a first signal peak of the first half-wave of the oscillating electrical signal; the derivative of the amplitude of the oscillating electrical signal at the start of the first half-wave; or the integral of the amplitude of the electrical signal oscillating over all or part of the duration of the first half-wave;
    the analysis module is capable of: discriminating a first oscillation and a second consecutive oscillation of the electrical signal occurring in the first sub-window; determining two quantities linked to at least part of the duration of a respective alternation of said first and second oscillations; and deduce i) two distinct physiological parameters of the patient as a function of these two respective quantities or ii) a physiological parameter of the patient as a function of a combination of these two respective quantities;
    the windowing circuit is capable of defining a third time window, posterior to the second time window, corresponding to a substantially non-oscillating phase of the inertial system in damped free oscillation;
    the analysis module is capable of: determining a quantity linked to the variations of the electrical signal during the third time window; and deducing at least one parameter of physical activity from the patient as a function of said quantity;
    - Said quantity is the energy of the rectified and integrated electrical signal for the duration of the second sub-window.
    We will now describe an example of implementation of the present invention, with reference to the accompanying drawings where the same references designate from one figure to another identical or functionally similar elements.
    Figure 1 illustrates a leadless capsule type medical device in its environment, with various examples of implantation sites in, on or near the heart of a patient.
    Figure 2 is a general side view of a leadless capsule comprising an energy recovery unit with pendulum assembly.
    Figure 3 shows, in isolation, the pendulum assembly of the leadless capsule of Figure 2, with a piezoelectric blade coupled to an inertial mass.
    Figure 4 is a timing diagram of the oscillations of the electrical signal delivered by the energy recovery module of the leadless capsule during successive cardiac cycles, with the corresponding electrogram trace opposite.
    Figure 5 presents, in the form of a block diagram, the main internal components of the electronic assembly of the leadless capsule.
    Figure 6 is a timing diagram of the oscillations of the electrical signal, illustrating in particular the characteristics of the first oscillation to be analyzed in order to derive one or more physiological parameters specific to the patient carrying the leadless capsule.
    Figure 7 is a timing diagram of the oscillations of the electrical signal, illustrating the possibility of discriminating the two phases of isovolumic contraction and ventricular ejection of the same cardiac cycle, to allow a specific analysis of the cardiac contractility on these two phases.
    Figures 8a to 8c are timing diagrams of the oscillations of the electrical signal, illustrating the manner of analyzing this signal after the rebound phase so as to derive therefrom a parameter of instant physical activity of the patient carrying the leadless capsule.
    FIG. 9 is a flowchart detailing, according to an illustrative example of implementation of the invention, the sequence of operations and tests carried out on the electrical signal delivered by the energy recovery module, as a function of the cardiac events detected , for obtaining data making it possible to determine physiological parameters and physical activity.
    We will now describe an embodiment of the device of the invention.
    With regard to its software aspects, the invention can be implemented by appropriate programming of the software for controlling a known pacemaker device, for example a pacemaker of the endocavitary leadless capsule type.
    These devices include a programmable microprocessor coupled to circuits for receiving, shaping and processing electrical signals collected by implanted electrodes, and delivering stimulation pulses to these electrodes. The adaptation of these devices to carry out the invention is within the reach of those skilled in the art, and it will not be described in detail. In particular, the software stored in memory and executed can be adapted and used to implement the functions of the invention which will be described below
    The method of the invention is in fact implemented by mainly software means, by means of appropriate algorithms executed by a microcontroller or a digital signal processor. For the sake of clarity, the various treatments applied will be broken down and schematized by a number of separate modules or functional blocks and / or interconnected circuits, but this representation is however only illustrative, these functions or circuits comprising common elements and corresponding in practice to a plurality of functions globally executed by the same software.
    In FIG. 1, various possibilities of implantation site of a leadless type device have been represented, inside the myocardium (endocavitary implant) or on an external region of this same myocardium (epicardial implant), or else on or in a vessel close to the heart. In a preferred advantageous example, the leadless capsule 10 is implanted at the apex of the right ventricle. As a variant, the capsule can also be implanted in the right ventricle on the interventricular septum, or else on a wall of the right atrial cavity, as illustrated in 10 'and 10 respectively. Another configuration consists, as in 10', in implanting the leadless capsule on an outer wall of the myocardium.
    In all cases, the leadless capsule is fixed to the heart wall by means of a protruding anchor screw intended to penetrate into the heart tissue by screwing to the implantation site. Other anchoring systems can be used, and do not in any way modify the implementation of the present invention.
    Figure 2 is a general side view of such a leadless capsule, comprising an energy recovery unit with pendulum assembly.
    The leadless capsule 10 is in this example produced in the external form of a cylindrical tubular implant body 12 enclosing an assembly 14 including the various electronic and supply circuits of the capsule. The typical dimensions of such a capsule are a diameter of about 6 mm for a length of about 25 mm.
    At its distal end 16, the capsule carries a helical screw 18 for anchoring the capsule against a wall of a cardiac cavity, as illustrated above with respect to FIG. 1. A detection / stimulation electrode 20, in contact with the cardiac tissue at the implantation site, ensures the collection of cardiac depolarization potentials and / or the application of stimulation pulses. In certain embodiments, the function of the electrode 20 is ensured by the anchoring screw 18, which is then an active screw, electrically conductive and connected to the detection / stimulation circuits of the capsule. The electrode 20 in contact with the tissue is generally a cathode, and it is associated with an anode whose function is ensured by a second remote electrode, most often an annular electrode such as at 21.
    The opposite proximal end 22 of the leadless capsule 10 has a rounded atraumatic shape, and is provided with suitable gripping means for connection to a guide catheter or other implantation accessory usable at the time of placement or explantation of the capsule.
    The leadless capsule 10 is provided with an energy recovery module intended to supply the electronic assembly 14 and / or to recharge an integrated battery or an energy storage capacitor.
    Such an energy recovery module comprises an inertial assembly which, inside the capsule, oscillates according to the various external stresses to which the leadless capsule is subjected. These stresses can in particular result from: movements of the wall to which the capsule is anchored, which are transmitted to the implant body 12 by the anchor screw 18; and / or variations in the start of blood flow in the environment surrounding the implant, which produces oscillations of the implant body at the rate of the heartbeat; and / or various vibrations transmitted by heart tissue.
    FIG. 3 illustrates an example of an inertial assembly for an energy recovery module, an assembly which here consists of a piezoelectric plate 24 embedded at one of its ends 26 and the opposite end of which is free, is coupled to an inertial mass 28. The piezoelectric plate 24 is a flexible plate which, in the example illustrated, is elastically deformable according to at least one degree of freedom in longitudinal bending.
    From the mechanical point of view, this assembly constitutes a pendulum assembly of the mass-spring type (the spring being constituted by the flexible piezoelectric blade) which, due to the inertia of the mass 28, oscillates as soon as the elastic blade 24 is moved away from its stable resting position. In fact, this assembly can be assimilated, in terms of its mechanical behavior, to a structure of the recessed-free beam type, which has a natural frequency of free oscillation, which is here the frequency on which the mass system oscillates. spring.
    The piezoelectric blade 24 also provides a mechanical-electrical transducer function making it possible to convert the mechanical stress applied to it when it is bent into electrical charges, charges recovered by electrodes formed on the surface of the blade. The blade is preferably a bimorph type blade, that is to say capable of generating energy on both sides when it is subjected to deformation. These transduction properties are typical of a piezoelectric material such as PZT ceramics or single crystals of the PMNPT type, barium titanate or lithium niobate.
    Of course, the invention is not limited to this particular pendulum assembly configuration given as an example, and other types of inertial assemblies can be used for energy recovery, such as those mentioned in the introduction, from when they have at least one natural frequency of free oscillation.
    Likewise, the inertial assembly can be a deformable assembly according to several degrees of freedom, with as many corresponding vibrational modes and natural frequencies of oscillation, and electrical signals respectively output.
    Figure 4 is a timing diagram of the oscillations of the electrical signal S delivered by the energy recovery module of the leadless capsule during successive cardiac cycles, with the corresponding electrogram trace opposite.
    The EGM electrogram signal, which is the electrical signal of the cardiac depolarization wave, is for example detected by the electrode 20 in contact with the myocardium. In the example illustrated in Figure 4, the electrogram is that of a sinus rhythm, with a P wave corresponding to the atrial electrical activity, a QRS complex corresponding to the ventricular electrical activity and a T wave corresponding to the ventricular repolarization. . Signal filtering and processing means, included in the circuits of the assembly 14, make it possible to easily derive from the EGM a time marker R indicating the time of ventricular depolarization. If the depolarization results from an electrical stimulation delivered by the leadless capsule, the corresponding marker V corresponds to the instant of delivery of the pulse. It is also possible to obtain, in the same way, markers of the atrial electrical activity P (spontaneous) or A (stimulated).
    In the following, we will mainly refer to an R marker (spontaneous ventricular depolarization), but it will be necessary to assimilate to this case that of a V marker (stimulated ventricular depolarization) or a P / A marker (spontaneous atrial depolarization) or stimulated).
    This method of detecting cardiac events (ventricular events or atrial events) from an EGM signal collected by an electrode system is however not limiting, and there are other detection techniques, in particular detection techniques. mechanical (non-electrical) such as those obtained by analysis of the signal delivered by an accelerometer integrated into the implant, this accelerometer delivering a signal representative of endocardiac acceleration (EA). EP 3 025 758 A1 describes such a technique, where the leadless capsule comprises an EA sensor, the signal of which is analyzed to detect capture or absence of capture (presence or absence of a contraction of the ventricle) following application. of a stimulation pulse. However, in such a known technique, these signals are no longer linked to the electrical activity of the myocardium, but to its mechanical activity.
    FIG. 4 also illustrates, with reference to the electrogram EGM, the variations of the electrical signal S delivered by the energy recovery unit, that is to say the variable signal produced by the mechanical-electrical transducer constituted by the piezoelectric plate 24, in the example shown.
    This signal is a recurrent signal, repeating at the rate of successive heartbeats, and at each occurrence it has two successive characteristic phases, 01 and 02.
    The first phase 01 consists of a series of damped sinusoidal oscillations, with a first amplitude peak followed by a series of bounces of decreasing amplitudes. The first oscillation of this phase 01 occurs after an EMD delay called electromechanical delay corresponding to the physiological delay between i) the arrival of the depolarization wave (spontaneous or stimulated) at the level of the tissues of the ventricle, and ii) the mechanical contraction of the myocardium produced by this depolarization wave.
    The first phase 01 of damped oscillations is followed by a second, consecutive phase, 02 substantially without rebounds, which continues until a new contraction of the myocardium producing similar variations of the signal S.
    The order of magnitude of the frequency of recurrence of cardiac cycles is typically 1 to 2 Hz (60 to 120 bpm (beats per minute)). The natural frequency of the pendulum assembly, for its part, is determined by the geometry of the piezoelectric plate 24 (mainly its length and its thickness), by the elasticity of the material which composes it, and by the mass of the inertial mass. 28. These various parameters are chosen so as to give the natural frequency of free oscillation a value much higher than the frequency of the cardiac rhythm, for example a frequency of the order of 20 Hz, this figure not of course being in no way limiting. It is a question that, practically in all circumstances, the pendulum assembly produces between two heartbeats a plurality of rebounds followed by a phase without rebounds before the next heartbeat.
    Figure 5 is a block diagram of the electronic assembly 14 integrated into the leadless capsule 10, presented in the form of functional blocks. This circuit 14 is advantageously implemented in the form of an ASIC or a combination of ASICs.
    The block 30 designates 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. The block 30 comprises filters and analog processing means and / or digital signal received. The signal thus processed is applied to the input of a computer 32 associated with a memory 34. The computer 32 operates on the basis of the collected signals a detection of successive ventricular or atrial cardiac events, so as to generate (among other things) a series successive R / V (and / or P / A) markers to the rhythm of the heartbeat.
    The electronic assembly 14 also includes a stimulation circuit 36 operating under the control of the computer 32 for, as necessary, delivering to the electrode system 20 and 21 pulses of stimulation of the myocardium and generating corresponding markers V or A
    An energy recovery circuit 38 is also provided, consisting of the pendulum assembly formed by the piezoelectric plate 24 and the inertial mass 28 described above with reference to FIGS. 2 and 3.
    This energy recovery circuit 38 produces a variable electrical signal S as an output, the variations of which are illustrated in various situations, notably in FIG. 4 and FIGS. 6 to 8.
    The signal S is, first of all, delivered to a power management circuit 40, which rectifies and regulates the signal S so as to produce at output a stabilized DC voltage or current used to supply the assembly electronics 14 and recharging a buffer battery 42 or a similar device such as an energy storage capacitor.
    This same signal S is, secondly, applied to a circuit 44 for analysis of the instantaneous variations of the signal in order to deliver at the output, in a characteristic manner and in the manner which will be described below, at least one physiological parameter of the carrier patient of the implant and / or at least one physical activity parameter of this same patient (or, at the very least, state data making it possible to derive these parameters). These parameters could in particular be used by the computer 32 to monitor the patient's condition in the short term, medium term or long term and to modulate, as necessary, the application of the stimulation pulses by the circuit 36.
    The analysis circuit 44 operates under the control of a sequencing circuit 46 which defines the time position of one or more analysis windows on the basis of the determined cardiac electrical events (R / V and / or P / A) by the computer 32, these windows limiting the various processing operations carried out by the circuit 44 with a view to extracting from the raw signal S the significant information sought.
    Advantageously, as illustrated in FIG. 4, there are provided three windows designated F1, F2 and F3, successively triggered by the sequencing circuit 46.
    The first window F1 is a window for scanning the signal S, triggered on detection of a spontaneous or stimulated cardiac event (ventricular event in the example illustrated).
    The function of this window F1 is to start monitoring and analyzing the variations of the electrical signal S, so as to detect there the occurrence of the first maximum of the free oscillation of the pendulum assembly (piezoelectric plate 24 and inertial mass 28). This first maximum is the PSE electrical signal peak in Figure 4.
    The detail of the search for the PSE peak, as well as the steps which follow it, will be given below with reference to Figure 9.
    Other criteria for triggering the window F1 for scanning the signal can be envisaged, as a variant or in addition to a simple detection of the PSE peak of the electrical signal, in particular:
    - on detection of the cardiac event, the application of a fixed or configurable delay before triggering of the window F1, in particular to take account of the elapse of the electromechanical delay EMD: a variation of the signal which would be detected in this interval would correspond indeed an artifact, to ignore in the search for the oscillation peak; or
    - the application of a similar delay, but variable cycle-to-cycle depending on the heart rate, for example a delay calculated as being a percentage of the preceding RR (or VV, RV or VR) interval.
    Obtaining a physiological parameter from the patient
    FIG. 6 illustrates, more precisely, various possible ways of deriving information representative of a physiological parameter of the patient once the peak of electrical signal PSE has been detected, in particular from:
    - the maximum amplitude Apse of the electrical signal S (that is to say the amplitude level of the PSE peak);
    - a derivation of the amplitude of the electrical signal S at the start of the first half-wave (that of the PSE peak), as illustrated in Figure 4 by the slope Dpse of the signal S;
    - integration of the amplitude of the electrical signal S over all or part of the duration of the first half-wave, for example, as illustrated in FIG. 4, on the part Ipse of the first half-wave which is between the instant of the beginning of the alternation and the moment of the PSE peak.
    Each of these data, or a combination of these data, makes it possible to derive a physiological parameter of the patient, representative in particular of the contractility of the myocardium.
    In addition, the time elapsed between the instant of detection of the cardiac event and the instant of the start of the first oscillation of the signal, which is a duration corresponding to the electromechanical delay EMD, can also provide relevant information on the contractility of the myocardium.
    The physiological parameter (s) thus determined can be memorized in a memory of the device for diagnostic purposes, according to analysis techniques in themselves known and which are not part of the invention, in particular techniques:
    - analysis of short-term variations, cycle-to-cycle, of the parameter (s) ^), making it possible in particular to detect a situation of onset of infarction;
    - analysis of medium-term variations, of the order of a few days, of the parameter (s), making it possible in particular to diagnose pathologies with slow progression such as ischemia or cardiac decompensation;
    - analysis of long-term variations, of the order of a few weeks or a few months, of the parameter (s), making it possible to assess pathologies with very slow evolution, in particular in the context of prevention or monitoring of heart failure.
    FIG. 7 illustrates another possibility offered by the technique of the invention, which makes it possible to discriminate in certain configurations the successive main components of myocardial contraction, namely
    i) isovolumic contraction and ii) immediately consecutive ventricular ejection.
    This discrimination is made by analyzing the first two peaks of the electrical signal S: if this signal, as illustrated in FIG. 7, is detected, a first minor peak PSE1 immediately followed by a second major peak PSE2, of higher amplitude, then this means that the first PSE1 peak is that produced by the isovolumic contraction and the second PSE2 peak is that produced by the ventricular ejection (it will be noted that these two peaks, which are distinguishable in the example of Figure 7, are on the other hand with the same PSE peak on the examples of timing diagrams in Figures 4 and 6).
    Once the instants of occurrence and the amplitudes of each of the peaks PSE1 and PSE2 have been determined, the device can derive from this information one or more physiological and / or physical activity parameters of the patient, notably from:
    - the peak amplitude of the first peak PSE1 (value linked in particular to the level of activity of the patient);
    - the instant of appearance of the first peak PSE1;
    - the time interval separating the two peaks PSE1 and PSE2.
    The combined analysis of information representative respectively of the isovolumic contraction and of the ventricular ejection is a technique in itself known, for example from EP 2 495 013A1 and EP 2 684 515 A1, where this information is obtained from an endocardial acceleration signal (EA), which is a signal of mechanical origin delivered by an accelerometric sensor placed for example at the end of an endocavitary probe implanted at the bottom of the ventricle.
    In all cases and generally, as a variant or in addition to the use for diagnostic purposes of the physiological parameter (s) obtained by the technique of the invention, this (s) ) parameter (s) can be used to control the rate of cardiac stimulation.
    Indeed, the cardiac contractility increasing with the effort, this physiological parameter can be used to control the rhythm of delivery of the stimulation pulses, in the case where the patient is not in sinus rhythm but is stimulated by the implanted device.
    Obtaining a physical activity parameter from the patient
    We will now describe the function of the following two windows F2 and F3.
    The detection of the PSE peak triggers a second window F2 (Figure 4), which is a window for erasing the rebound phase.
    The function of this window F2 is to analyze the variations of the signal S so as to limit phase 01 of successive rebounds (damped oscillations) of the pendulum assembly, to determine an instant when it can be considered that this phase 01 of bounces is over.
    The end of the rebound phase can be defined according to several possible criteria, possibly combinable with each other, such as:
    - duration, fixed or configurable, counted from the detection of the first PSE peak of the signal S;
    - variable duration depending on the heart rate, for example a duration of 50% of the previous RR interval, or an average of the previous RR intervals;
    amplitude of the signal S becoming, on at least one complete oscillation, less than a given threshold, which can be a fixed or configurable threshold or else a variable threshold corresponding to a given percentage (for example 5%) of the amplitude of the peak PSE;
    - variability of signal S becoming lower than a given threshold: in fact, due to the damping of the sinusoid this variability decreases as successive oscillations.
    The determination of the end of the rebound phase (end of phase 01) has the effect of triggering a third window F3, which is a window for detecting patient activity.
    This window F3 extends over a period (phase 02) between the end of the damped sinusoid and the start of the next cardiac contraction. Insofar as the pendulum assembly has completed its free oscillation phase following the cardiac contraction (phase 01), the variations of the signal which can be detected in all or part of this window F3 do not come from the cardiac contraction, but from stresses external to the myocardium. Concretely, these requests result essentially from the patient's movements, that is to say from his own level of physical activity: walking, climbing stairs, exercise, various movements of the bust, etc., which induce irregular movements of the inertial mass, therefore deformations of the piezoelectric plate and consequently the production of electric charges and of a corresponding voltage or current at the output of the energy recovery unit.
    The evaluation of this level of activity can in particular be obtained by rectification and integration of the signal S over all or part of the duration of the window F3.
    Figures 8a to 8c illustrate examples of variation of the electrical signal S in various situations of patient activity.
    Figure 8a is an example of a signal collected when the patient is at rest. The rebound phase and followed by a phase, indicated in dashed lines and corresponding to window F3, during which the variations of the signal S are very slight, even imperceptible, until the next cardiac cycle occurs.
    On the other hand, in the case of Figure 8b, the patient's activity increases, with a much greater level of signal variation over the duration of window F3.
    The patient activity parameter is advantageously evaluated by rectification and integration of the signal S during the duration of the window F3, that is to say by summation of the absolute values of the signal samples successively collected during this period.
    Figure 8c illustrates an example where the level of activity is even higher, typically corresponding to a situation of intense exercise such as running, climbing stairs, etc. It may even happen that in this case the average level of the signal S in the window F3 of activity detection of the patient is higher than the average level of the signal outside this window, in particular in periods corresponding to the window F1 for scanning the signal in search of the first peak of the free oscillation of the pendulum assembly) and in the window F2 for erasing the rebound phase described with reference to Figure 4.
    In such a case, the window F3 can no longer be defined by the techniques described above (detection of the first PSE peak then application of a window F2 for erasing the rebound phase), since the variations of the electrical signal do not exhibit the more the appearance they had before, as in the case of Figures 8a and 8b where it was possible to easily discriminate the PSE peak characterizing the start of the free oscillation of the pendulum assembly. The window F3 can no longer be determined by analysis of the signal during the current cycle, it can be determined for example from the value that this window had in the previous cycle (s), while maintaining the same time position by report the cardiac event, and by keeping the same window duration or by adjusting this duration by a predetermined factor (for example 10 ms or 10%) to take into account the fact that an increase in activity s is most likely accompanied by an acceleration of the heart rate, which must be taken into account when defining the window.
    As a variant, the duration of window F3 can be determined from the current heart rate, for example in the form of a percentage of the current RR interval, possibly averaged over the previous few cycles, this window being offset by a duration predetermined with respect to the ventricular contraction detection marker (marker which is given by the analysis of the EGM signal, independent of the mechanical disturbances produced by the intense activity of the patient).
    FIG. 9 is a flowchart 100 detailing, according to an illustrative example of implementation of the invention, the sequence of operations and tests carried out on the electrical signal S delivered by the energy recovery module as a function of cardiac events detected, with a view to obtaining data which will make it possible to determine one or more physiological and / or physical activity parameters.
    Block 102 corresponds to a preliminary step of resetting to zero the various memories and timers which will be used subsequently. A parameter W is also set to zero, this parameter indicating the analysis phase in which the algorithm finds itself during its various successive iterations, and can take the following values:
    W = 0: initial value, undetermined phase,
    W = 1: phase of scanning the electrical signal in search of the first peak (PSE peak in Figure 4), corresponding to the window F1 in Figure 4 and during which the signal S produces significant information for obtaining a physiological parameter,
    W = 2: phase of erasure of the rebound phase, corresponding to window F2 of FIG. 4, during which the signal does not produce significant information for obtaining a physical or physiological parameter,
    W = 3: phase subsequent to the rebound phase, corresponding to window F3 in Figure 4 and during which the signal S produces significant information for obtaining a physical activity parameter.
    The algorithm is iterated regularly on each reception of a sequencing pulse corresponding to an interrupt delivered by the microprocessor (block 104).
    If a cardiac event (typically an R or V marker) is detected, or the nature of the window is not yet determined (W = 0), test 106 directs the algorithm to a set of steps 108 and following management of cardiac events.
    At block 108, a new heart tag is established, and the sample memory for signal S is reset.
    If this is the first iteration (i.e. if W = 0, test 110), then the window indicator W is set to 1 and a time counter is started (block 112) so to trigger the scanning of the electrical signal in search of the signal peak (PSE peak).
    At each sample received from signal S (test 114), the sample is stored and the measured times are updated (block 116). If we are still in the search for the signal peak (W = 1, test 118), as long as the peak is not reached, that is to say as long as the level of the signal S increases, then the algorithm is iterated (test 120, return to step 104). Otherwise, the time of occurrence and the level of the PSE peak are memorized (block 122) and, the search phase of the peak having ended, the indicator W is positioned at W = 2. This iteration of the flowchart is completed with return to step 104.
    During the rebound phase (W = 2, test 124), the successive signal samples are analyzed to determine whether this rebound phase has ended, according to the various criteria which have been explained above (signal level below a given threshold, elapse of a maximum time, etc.). If we are still in the rebound phase (test 126) the algorithm is iterated (return to block 104). Otherwise, the indicator W is positioned at W = 3 (block 128).
    At each iteration, the algorithm will collect a new sample and accumulate it with the previous ones (block 130) to allow, as explained above, the rectification and integration of the signal over the entire duration of the activity detection window ( W = 3).
    These iterations will continue until a new cardiac event is detected (test 106).
    This new cardiac event, detected by test 132, will trigger (block 134) various operations for closing the cycle analysis, in particular the memorization of the accumulation of the samples obtained previously in block 130, and will trigger the counting of time to determine 5 the instant of occurrence of the upcoming peak of the electrical signal (this operation of block 134 being the same as that which had been carried out on initialization in block 112). The window indicator is then positioned at W = 1 (block 136) to indicate that we are again in a window for scanning the signal.
    The algorithm then returns to step 114 waiting for a new sample of the signal S, which will be treated in the same manner as described above.
    权利要求:
    Claims (12)
    [1" id="c-fr-0001]
    1. An autonomous cardiac implant (10) of leadless capsule type, comprising an implant body (12) provided with means (18) for anchoring to a heart wall, the implant body housing an electronic assembly (14) and an energy recovery module with an energy storage member (42) for supplying the electronic assembly, the energy recovery module being capable of converting external stresses applied to the body of the body into electrical energy. implant under the effect of movements of a wall to which the implant is anchored and / or variations in the flow of blood flow in the environment surrounding the implant to the rhythm of heartbeats and / or vibrations of cardiac tissues, in which the energy recovery module comprises:
    - an inertial assembly (24, 28) subjected to said external stresses;
    - a translator (24) able to convert the mechanical energy produced by the oscillations of the inertial assembly into an oscillating electrical signal (S); and
    - a power management circuit (40), capable of rectifying and regulating said oscillating electrical signal (S), for outputting a stabilized DC voltage or current for supplying said electronic assembly (14) and / or the recharging of said energy storage member (42), characterized in that it further comprises:
    - a sequencing module (46), comprising:
    a circuit for detecting successive ventricular or atrial cardiac events; and a windowing circuit, capable of defining at least one predetermined time window (F1, F2, F3) between two consecutive cardiac events; and
    - an analysis module (44) receiving the electrical signal (S) delivered by the translator as input and capable of:
    analyze the instantaneous variations of said oscillating electrical signal (S) inside said at least one time window (F1, F2, F3) thus defined, and deduce therefrom a current value of at least one physiological parameter and / or at least one parameter of physical activity of the patient carrying the implant.
    [2" id="c-fr-0002]
    2. The implant of claim 1, wherein the inertial assembly comprises a pendulum assembly with an elastically deformable element (24) according to at least one degree of freedom, coupled to an inertial mass (28).
    [3" id="c-fr-0003]
    3. The implant of claim 2, wherein the energy recovery module comprises at least one piezoelectric blade (24) coupled at one of its ends to the inertial mass (28), said piezoelectric blade forming at the times said elastically deformable element and said translator.
    [4" id="c-fr-0004]
    4. The implant of claim 1, wherein the windowing circuit is able to define a first time window (F1) for searching for a first peak of the oscillating electrical signal (S).
    [5" id="c-fr-0005]
    5. The implant of claim 1, in which the windowing circuit is capable of defining a second time window (F2) corresponding to a phase in free oscillation damped by the inertial assembly.
    [6" id="c-fr-0006]
    6. The implant of claim 5, in which the windowing circuit is able to search for an amplitude peak (PSE) of the first oscillation of the electrical signal (S), and to define the second time window (F2) in function of the instant of said amplitude peak (PSE).
    [7" id="c-fr-0007]
    7. The implant of claim 4, wherein the analysis module is capable of determining a quantity linked to at least part of the duration of an alternation of the first oscillation of the electrical signal (S); and deduce at least one physiological parameter from the patient as a function of said quantity.
    [8" id="c-fr-0008]
    8. The implant of claim 7, wherein said quantity is one of: the amplitude (Apse) of a first signal peak (PSE) of the first half-wave of the oscillating electrical signal (S); the derivative (Dpse) of the amplitude of the oscillating electrical signal (S) at the start of the first half-wave; or the integral (Ipse) of the amplitude of the oscillating electrical signal (S) over all or part of the duration of the first half-wave.
    [9" id="c-fr-0009]
    9. The implant of claim 4, in which the analysis module is able to: discriminate a first oscillation (PSE1) and a second oscillation (PSE2) consecutive from the electrical signal occurring in the first sub-window; determining two quantities linked to at least part of the duration of a respective alternation of said first and second oscillations (PSE1, PSE2); and deduce i) two distinct physiological parameters of the patient as a function of these two respective quantities or ii) a physiological parameter of the patient as a function of a combination of these two respective quantities.
    [10" id="c-fr-0010]
    10. The implant of claim 5, wherein the windowing circuit is capable of defining a third time window (F3), posterior to the second time window (F2), corresponding to a substantially non-oscillating phase of the inertial system in oscillation. free amortized.
    [11" id="c-fr-0011]
    11. The implant of claim 10, wherein the analysis module is capable of: determining a quantity linked to the variations of the electrical signal during the third time window (F3); and deduce at least one parameter of physical activity of the patient as a function of said quantity.
    [12" id="c-fr-0012]
    12. The implant of claim 11, wherein said quantity is the energy of the rectified and integrated electrical signal for the duration of the second sub-window.
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    同族专利:
    公开号 | 公开日
    US20200391038A1|2020-12-17|
    EP3592420A1|2020-01-15|
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    WO2019001829A1|2019-01-03|
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    EP3025758A1|2014-11-28|2016-06-01|Sorin CRM SAS|Active implantable medical device, in particular a leadless capsule, with cycle-to-cycle capture detection by analysing an endocardial acceleration signal|
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    EP2857064B1|2013-10-01|2015-10-14|Sorin CRM SAS|Autonomous intracorporeal capsule with energy recovery by piezoelectric transducer|US11190113B2|2019-02-07|2021-11-30|Cairdac|Leadless autonomous cardiac capsule with rotatably-mounted piezoelectric energy harvester|
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    法律状态:
    2019-01-04| PLSC| Search report ready|Effective date: 20190104 |
    2020-06-09| PLFP| Fee payment|Year of fee payment: 4 |
    2021-03-12| CA| Change of address|Effective date: 20210202 |
    2021-06-10| PLFP| Fee payment|Year of fee payment: 5 |
    优先权:
    申请号 | 申请日 | 专利标题
    FR1755938|2017-06-28|
    FR1755938A|FR3068253B1|2017-06-28|2017-06-28|LEADLESS CAPSULE TYPE AUTONOMOUS HEART IMPLANT, INCLUDING AN ENERGY RECOVERY DELIVERING PHYSIOLOGICAL INFORMATION OR PATIENT ACTIVITY|FR1755938A| FR3068253B1|2017-06-28|2017-06-28|LEADLESS CAPSULE TYPE AUTONOMOUS HEART IMPLANT, INCLUDING AN ENERGY RECOVERY DELIVERING PHYSIOLOGICAL INFORMATION OR PATIENT ACTIVITY|
    PCT/EP2018/062485| WO2019001829A1|2017-06-28|2018-05-15|Leadless capsule type autonomous cardiac implant comprising an energy recovery providing information on the physiology or activity of the patient|
    EP18726098.9A| EP3592420A1|2017-06-28|2018-05-15|Leadless capsule type autonomous cardiac implant comprising an energy recovery providing information on the physiology or activity of the patient|
    US16/344,973| US11045657B2|2017-06-28|2018-05-15|Leadless-capsule autonomous cardiac implant comprising an energy harvester providing physiological or activity information about the patient|
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