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WO2025108643A1 - Dispositif médical implantable pour réaliser une stimulation cardiaque - Google Patents

Dispositif médical implantable pour réaliser une stimulation cardiaque Download PDF

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Publication number
WO2025108643A1
WO2025108643A1 PCT/EP2024/079682 EP2024079682W WO2025108643A1 WO 2025108643 A1 WO2025108643 A1 WO 2025108643A1 EP 2024079682 W EP2024079682 W EP 2024079682W WO 2025108643 A1 WO2025108643 A1 WO 2025108643A1
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WIPO (PCT)
Prior art keywords
signal
electrical
electrode
stimulation
implantable medical
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PCT/EP2024/079682
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English (en)
Inventor
Thomas Dörr
Frank Becker
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Biotronik SE and Co KG
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Biotronik SE and Co KG
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Publication of WO2025108643A1 publication Critical patent/WO2025108643A1/fr
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/18—Applying electric currents by contact electrodes
    • A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/362—Heart stimulators
    • A61N1/37—Monitoring; Protecting
    • A61N1/371—Capture, i.e. successful stimulation
    • A61N1/3712—Auto-capture, i.e. automatic adjustment of the stimulation threshold
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/24—Detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof
    • A61B5/316—Modalities, i.e. specific diagnostic methods
    • A61B5/318—Heart-related electrical modalities, e.g. electrocardiography [ECG]
    • A61B5/346—Analysis of electrocardiograms
    • A61B5/349—Detecting specific parameters of the electrocardiograph cycle
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/48—Other medical applications
    • A61B5/4836—Diagnosis combined with treatment in closed-loop systems or methods
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/02—Details
    • A61N1/04—Electrodes
    • A61N1/05—Electrodes for implantation or insertion into the body, e.g. heart electrode
    • A61N1/056—Transvascular endocardial electrode systems

Definitions

  • Implantable medical device for performing a cardiac stimulation
  • the present invention relates to an implantable medical device for performing a cardiac stimulation according to the preamble of claim 1 and to a method for operating an implantable medical device for performing a cardiac stimulation.
  • An implantable medical device of this kind comprises a generator device comprising processing circuitry for processing electrical signals, an electrode lead connected to the generator device and extending from the generator device, and an electrode pole arrangement comprising at least three electrode poles.
  • the electrode lead comprises a lead body forming a distal end to be arranged on cardiac tissue within a patient’s heart.
  • the processing circuitry is configured to generate an electrical stimulation signal and to provide the electrical stimulation signal to said electrode pole arrangement for stimulating cardiac activity.
  • an injection of stimulation signals generally is possible at the surface of intra-cardiac tissue, an electrode being in contact with intra-cardiac tissue in order to allow an injection of stimulation energy into the tissue.
  • LBBAP left bundle branch area pacing
  • an electrode pole arranged on an electrode lead shall engage with intra-cardiac tissue in the range of the septum of the heart in the vicinity of the left bundle branch.
  • a stimulation signal is generated at an energy that allows for a reliable stimulation by coupling to the conductive structure of the left bundle branch and by hence stimulating the left ventricle.
  • a so-called capture threshold test is performed in which the signal energy of the stimulation signal is adaptively changed to determine such minimum signal energy which still allows for a reliable capture, i.e., a coupling of energy to the conductive structure to allow for an effective stimulation.
  • the signal energy of the stimulation signal is progressively reduced from a maximum starting energy until no capture is observed any longer.
  • the value of the signal energy at which no capture is observed any more is determined to correspond to a capture threshold.
  • WO 2008/058265 A2 discloses a cardiac stimulation system and method which allow to deliver a left ventricle stimulator from a right ventricle lead system in the right ventricle chamber, into a right side of the septum at a first location, and transmuscularly from the first location to a second location along the left side of the septum.
  • the left ventricle stimulator is fixed at the second location for transmuscular stimulation of the left ventricular conduction system.
  • a biventricular stimulation system further includes a right ventricle stimulator also delivered by the right ventricle lead system to the first location along the right side of the septum for right ventricular stimulation.
  • US 2009/0276000 Al discloses a method for delivering physiological pacing by selecting an electrode implant site for sensing cardiac signals, which is in proximity to the hearts intrinsic conduction system. An arrangement of multiple electrodes herein is arranged on a tip of a lead.
  • an implantable medical device for performing a cardiac stimulation comprises a generator device comprising a processing circuitry for processing electrical signals, an electrode lead connected to the generator device and extending from the generator device, the electrode lead comprising a lead body forming a distal end to be arranged on cardiac tissue within a patient’ s heart, in particular in the septum of a patient’ s heart, and an electrode pole arrangement comprising at least three electrode poles, wherein the processing circuitry is configured to generate an electrical stimulation signal and to provide the electrical stimulation signal to said electrode pole arrangement for stimulating cardiac activity.
  • the processing circuitry is configured to measure at least two electrical response signals indicative of a stimulated cardiac activity in response to said electrical stimulation signal using at least two different pairs of electrode poles out of said at least three electrode poles and to derive information indicative of a stimulation effectiveness of said electrical stimulation signal based on said at least two electrical response signals.
  • the implantable medical device comprises a generator device and an electrode lead connected to the generator device.
  • the electrode lead extends from the generator device and comprises a lead body forming a distal end to be arranged on cardiac tissue within a patient's heart, in particular in the septum of a patient’s heart.
  • An electrode pole arrangement comprising electrode poles arranged on the electrode lead and/or on the generator device and/or on another electrode lead connected to the generator device, is used to output electrical stimulation signals such that by means of the electrode pole arrangement an electrical stimulation of a desired cardiac region, in particular the septum of a patient’s heart, may be achieved.
  • the processing circuitry generates, during operation, electrical stimulation signals and provides the electrical stimulation signals to the electrode pole arrangement for stimulating cardiac activity.
  • a cardiac stimulation in particular a cardiac pacing
  • the implantable medical device for example functioning as a CRT device, in particular a CRT-P or CRT-D device (CRT: cardiac resynchronization therapy).
  • the implantable medical device may function as an IPG or ICD device (IPG: implantable pulse generator; ICD: implantable cardioverter defibrillator).
  • an effective cardiac stimulation of a desired kind Prior to operation, in an initial calibration phase, or repeatedly during operation it may be desired to evaluate whether an effective cardiac stimulation of a desired kind is obtained in response to an electrical stimulation signal. It herein is desired to be able to evaluate a cardiac stimulation in order to distinguish between different types of stimulations, for example no capture (corresponding to a situation in which no identifiable stimulation is observed in response to the output of an electrical stimulation signal), a selective left bundle branch area pacing (selective LBBAP, corresponding to a stimulation of only the left bundle branch resulting in a stimulated left ventricular activity), a non-selective left bundle branch area pacing (non-selective LBBAP, resulting in a stimulation of the left bundle branch and the right bundle branch and/or the septum), or a right bundle branch area pacing (RBBAP, corresponding to a stimulation of the right bundle branch and/or or the septum alone, without a stimulation of the left bundle branch).
  • no capture corresponding to a situation in which no
  • LBBAP left bundle branch area pacing
  • the processing circuitry is configured to measure at least two electrical response signals indicative of a stimulated cardiac activity in response to an electrical stimulation signal using at least two different pairs of electrode poles out of said at least three electrode poles.
  • the different pairs of electrode poles due to a spatial separation of the electrode poles of the electrode arrangement, span different signal reception vectors and hence couple in a spatially differentiated manner to tissue in an implanted state of the implantable medical device. By recording different electrical response signals using the different pairs of electrode poles, hence, information is obtained about a spatially differentiated response to the electrical stimulation signal.
  • the different pairs of electrode poles span different signal reception vectors and hence are indicative of an electrical signal response in different areas, by assessing the different electrical response signals it may be evaluated in which areas or in which conductive structures the electrical stimulation signal causes an electrical stimulation and in which areas or in which conductive structures the electrical stimulation signal does not cause an electrical stimulation.
  • information indicative of a stimulation effectiveness i.e., information whether a particular desired stimulation is effectively achieved, based on at least two electrical response signals measured in response to an electrical stimulation signal
  • an electrical stimulation signal yields a stimulation of a desired kind, namely of a particular spatial region or conductive structure, such as the left bundle branch.
  • the different electrical response signals are measured by different pairs of electrode poles spanning different signal reception vectors, hence allowing for a spatially differentiated measurement of response signals and hence a spatially differentiated assessment of an electrical stimulation in certain regions or certain conductive structures.
  • a first of the at least three electrode poles is arranged on the distal end of the lead body and is configured to be inserted into cardiac tissue.
  • the first electrode pole is arranged on the distal end of the lead body and is configured to be inserted into cardiac tissue to operatively engage with a conductive structure of the left bundle branch in intra-cardiac tissue.
  • the first electrode pole may for example have the shape of a helical screw which may be inserted into intra-cardiac tissue by screwing the helical screw into tissue.
  • the first electrode pole may have the shape of a pike or a tine protruding from the distal end of the lead body and being configured for insertion into intracardiac tissue.
  • a second of the at least three electrode poles is arranged on the lead body at a location proximal to the first of the at least three electrode poles.
  • the second electrode pole may for example have the shape of a ring electrode extending circumferentially about the lead body.
  • a third of the at least three electrode poles may for example be arranged on the generator device, formed for example by the housing or a housing section of the generator device.
  • Electrode poles in the electrode pole arrangement may be present and may be arranged on the lead body of the electrode lead or on the housing of the generator device or on another lead connected to the generator device.
  • a first pair of electrode poles is formed by the first of the at least three electrode poles and the third of the at least three electrode poles.
  • a second pair of electrode poles is formed by the second of the at least three electrode poles and the third of the at least three electrode poles.
  • the processing circuitry herein is configured to measure a first electrically response signal using the first pair and a second electrical response signal using the second pair.
  • the first pair of electrode poles spans a signal reception vector in between the first electrode pole at the distal end of the electrode lead and the third electrode pole arranged on the housing of the generator device.
  • the first electrode pole preferably is configured for insertion into cardiac tissue such that it reaches towards the left bundle branch and hence establishes a coupling to the left bundle branch, by means of the signal reception vector spanned by the first pair of electrode poles in particular a response signal indicative of an electrical stimulation of the left bundle branch may be obtained.
  • the second pair of electrode poles spans a signal reception vector in between the second electrode pole at a proximal location on the electrode lead and the third electrode pole arranged on the housing of the generator device.
  • the second electrode pole formed for example by a ring electrode proximally with respect to the first electrode pole, may for example rest, in an implanted state of the implantable medical device, in proximity to the right bundle branch such that by means of the second pair of electrode poles in particular a response signal indicative of an electrical stimulation of the right bundle branch may be obtained.
  • a third pair of electrode poles may be formed by the first of the at least three electrode poles and the second of the at least three electrode poles.
  • the processing circuitry thus is configured to measure a third electrical response signal using the third pair.
  • the third pair of electrode poles spans a signal reception vector in between the first electrode pole and the second electrode pole, that is between the first electrode pole at the distal end of the electrode lead and the second electrode pole arranged proximally with respect to the first electrode pole, such that the third signal reception vector may for example span across conductive structures of the left bundle branch and right bundle branch.
  • the different response signals may be put into relation with one another.
  • signal levels of the different response signals may be compared in order to assess a stimulated activity in response to the outputting of the electrical stimulation signal. If for example one response signal yields a rather large signal level, whereas another response signal yields a comparatively low signal level, this may indicate that a conductive structure associated with the one response signal, but not a conductive structure associated with the other response signal has been stimulated by the electrical stimulation signal.
  • the processing circuitry is configured to measure the at least two electrical response signals using different pairs of electrode poles at a defined timing distance with respect to the electrical stimulation signal.
  • the timing distance may for example correspond to the length of a blanking window in a measurement channel following the outputting of the electrical stimulation signal.
  • the measurements may take place in a defined time window, wherein all response signals are recorded in the same time window in order to allow for a comparison of the different response signals measured using the different pairs of electrode poles of the electrode pole arrangement.
  • a signal processing of the at least two electrical response signals may be applied to determine one or multiple characteristic metrics for at least one of the at least two electrical response signals.
  • a maximum or minimum amplitude value may be determined for one or all of the at least two electrical response signals.
  • a temporal location of a zero-crossing or a maximum or minimum amplitude value may be determined.
  • an area under a curve of the respective electrical response signal may be determined.
  • a signal width of a defined portion of the respective electrical response signal may be determined, for example a temporal width in between zero-crossings of the respective electrical response signal.
  • a derivative value of the respective electrical response signal may be determined, for example a maximum or minimum derivative value of the respective electrical response signal to assess a steepness of the curve.
  • Other characteristic metrics of a respective electrical response signal may be determined and assessed, for example relating to the positions of zero-crossings, threshold-crossings, maximum or minimum values, area values under certain portions of the curve, first, second or third derivative values or the like.
  • the processing circuitry is configured to compare at least one of the at least two electrical response signals to a reference curve and to derive the information indicative of a stimulation effectiveness of the electrical stimulation signal based on the comparison.
  • the reference curve may for example be predefined and stored within the processing circuitry, namely within an electronic memory of the processing circuitry.
  • the reference curve may correspond to an electrical response signal as obtained for one or multiple prior stimulation signals, for example an average of multiple prior electrical response signals.
  • certain characteristic measures may be determined indicative of a difference between an electrical response signal and the reference curve. For example, a difference in maximum or minimum values, a difference in temporal locations of zero-crossings or maximum or minimum values, and/or a difference area in between the electrical response signal and the reference curve may be determined.
  • the processing circuitry is configured to compare the at least two electrical response signals to each other and to derive said information indicative of a stimulation effectiveness of said electrical stimulation signal based on the comparison. For example, certain characteristic metrics of the different response signals may be compared to each other, for example relating to a maximum or minimum amplitude value, a derivative value, temporal locations of zero-crossings or a maximum or minimum amplitude value, an area metrics or the like.
  • certain parameters preferably a set of predefined parameters, the response signals may be put into relation with one another, such that it may be assessed whether one response signal indicates an effective stimulation in a certain region or a certain conductive structure in comparison to another response signal.
  • the processing circuitry is configured, for deriving said information indicative of a stimulation effectiveness of said electrical stimulation signal, to evaluate based on at least one of the at least two electrical response signals whether a left ventricular activity is identifiable in response to the electrical stimulation signal.
  • the left ventricular activity may result from a left bundle branch area pacing, that is the coupling of the electrical stimulation signal to the left bundle branch.
  • the left ventricular activity may result from a left ventricular stimulation using a left ventricular electrode lead extending into the left ventricle.
  • the processing circuitry is configured to measure, repeatedly, at least two electrical response signals in response to the outputting of an electrical stimulation signal in a capture threshold test.
  • stimulation energy shall be determined which reliably results in a desired capture and hence a desired stimulated cardiac activity.
  • stimulation signals may for example be repeatedly generated and output, wherein the energy of the stimulation signals may for example be progressively reduced starting from a maximum starting energy, until a capture loss is identified.
  • the signal energy at which (for the first time) a capture loss is observed corresponds to the capture threshold above which it is assumed that a reliable capture may be obtained, such that, during subsequent operation, the signal energy of the stimulation signal may be set to a value above the threshold.
  • the processing circuitry is configured, for conducting a capture threshold test, to repeatedly measure at least two electrical response signals indicative of a stimulated cardiac activity in response to an electrical stimulation signal using at least two different pairs of electrode poles out of said at least three electrode poles and to derive information indicative of a stimulation effectiveness of said electrical stimulation signal based on said at least two electrical response signals.
  • a capture threshold test hence, repeated measurements of response signals are carried out, wherein for each electrical stimulation signal at least two electrical response signals are recorded and assessed.
  • a capture at the left bundle branch is obtained. Only if this is the case the capture is assumed to be effective, such that within the threshold test a signal energy is determined such that a desired capture is reliably obtained.
  • the capture threshold test it hence is not only distinguished between an effective stimulation (resulting in any stimulated activity whatsoever) and a non-effective stimulation, but it may be distinguished between a desired capture corresponding to an effective stimulation of a desired conductive structure, e.g. the left bundle branch, and a capture which does not include a stimulation of the desired conductive structure, e.g. the left bundle branch.
  • the capture threshold test may be automatically conducted by the implantable medical device prior to operation, e.g. in an initial calibration phase upon initial implantation, and/or repeatedly during operation, for example once or multiple times per day.
  • the energy of the electrical stimulation signal may be set such that during subsequent operation a reliable stimulation is obtained.
  • the processing circuitry is configured to adapt a signal strength of a current electrical stimulation signal with respect to a prior electrical stimulation signal during the capture threshold test based on information indicative of a stimulation effectiveness of the prior electrical stimulation signal. By repeating such measurements, for example starting from a maximum starting energy and by progressively reducing the signal energy until a non-effective stimulation of a desired structure is detected, a capture threshold is determined and the signal energy for subsequent operation may be set to a value above the threshold.
  • the capture threshold test it may be observed whether for a current stimulation signal a capture of a desired type is obtained. If this is the case, the signal energy is further reduced, until no effective stimulation of a desired, particular cardiac structure is observed, upon which the threshold is identified and the signal energy for subsequent operation may be set to a value above the threshold.
  • the assessment of a stimulation effectiveness may also be employed during regular operation, outside of a capture threshold test. For example, based on measuring at least two electrical response signals using different pairs of electrode poles in response to an electrical stimulation signal, it may be assessed whether during operation a desired stimulation in response to an electrical stimulation signal is obtained during a cardiac cycle, for example a left bundle branch stimulation. If, according to the at least two electrical response signals, it is determined that the desired structure (for example the left bundle branch) is not effectively stimulated, a backup pulse of a higher stimulation energy may be output.
  • the signal energy of a stimulation pulse may be adaptively changed and hence automatically adapted during operation.
  • the electrical stimulation signal may have the shape of an electrical stimulation pulse.
  • Such pulse may have one or multiple pulse phases of positive and/or negative amplitudes.
  • the different pairs of electrode poles may also be used for outputting electrical stimulation signals for causing a stimulation action, for example to cause a spatially differentiated stimulation of cardiac structures, for example to cause a left bundle branch pacing as well as a stimulation of the cardiac septum and hence a right ventricular stimulation.
  • the processing circuitry may be configured to switch between different pairs of electrode poles for outputting electrical stimulation signals, such that in case of a capture loss it may be switched automatically from one stimulation polarity to another.
  • the processing circuitry may be configured to generate and output electrical stimulation signals using different stimulation vectors spanned by different pairs of electrode poles.
  • at least two electrical response signals may be measured and may be assessed in order to evaluate an obtained capture.
  • that stimulation vector may be used during operation which results in the optimum capture, e.g. that stimulation vector resulting in the narrowest QRS complex indicative of a most effective capture.
  • the implantable medical device may be a one-chamber IPG device.
  • the implantable medical device may be a two-chamber IPG device.
  • the implantable medical device may be a one-chamber ICD device.
  • the implantable medical device may be a two-chamber ICD device.
  • the implantable medical device may be a CRT device (CRT-P or CRT-D).
  • a method for operating an implantable medical device for performing a cardiac stimulation comprises: processing electrical signals using a processing circuitry of a generator device of the implantable medical device, wherein an electrode lead is connected to the generator device and extends from the generator device, the electrode lead comprising a lead body forming a distal end to be arranged on cardiac tissue within a patient’s heart; generating, using the processing circuitry, an electrical stimulation signal and providing the electrical stimulation signal to an electrode pole arrangement for stimulating cardiac activity, the electrode pole arrangement comprising at least three electrode poles; measuring, using the processing circuitry, at least two electrical response signals indicative of a stimulated cardiac activity in response to said electrical stimulation signal using at least two different pairs of electrode poles out of said at least three electrode poles; and deriving information indicative of a stimulation effectiveness of said electrical stimulation signal based on said at least two electrical response signals.
  • Fig. 1 shows a schematic view of an implantable medical device having a generator device and electrode leads
  • Fig. 2 shows a schematic drawing of a distal end of an electrode lead in an implanted state
  • Fig. 3 shows a schematic drawing of signal vectors spanned by different pairs of electrode poles of an electrode pole arrangement of the implantable medical device
  • Fig. 4A shows the electrode pole arrangement of Fig. 3 spanning different signal vectors, illustrating a stimulation of the conductive structures of a right bundle branch and a left bundle branch;
  • Fig. 4B shows curves of response signals as measured using the different signal vectors in the stimulation scenario of Fig. 4A;
  • Fig. 5A shows the electrode pole arrangement of Fig. 3 spanning different signal vectors, illustrating a stimulation of the conductive structure of only the right bundle branch;
  • Fig. 5B shows curves of response signals as measured using the different signal vectors in the stimulation scenario of Fig. 5 A;
  • Fig. 6A shows the electrode pole arrangement of Fig. 3 spanning different signal vectors, illustrating a stimulation of the conductive structure of only the left bundle branch;
  • Fig. 6B shows curves of response signals as measured using the different signal reception vectors in the stimulation scenario of Fig. 6A;
  • Fig. 7 shows an example of an electrical response signal as measured using a certain pair of electrode poles, indicating characteristic metrics that may be derived from the electrical response signal for deriving information indicative of a stimulation effectiveness.
  • Fig. 1 shows, in a schematic drawing, the human heart H comprising the right atrium RA, the right ventricle RV, the left atrium LA and the left ventricle LV.
  • An implantable medical device 1 is implanted in a patient, the implantable medical device 1 comprising a generator 12 connected to leads 10, 11 extending from the generator 12 through the superior vena V into the patient's heart H.
  • leads 10, 11 electrical signals for providing a pacing action in the heart H shall be injected into intra-cardiac tissue potentially at different locations within the heart, and sense signals may be received.
  • an electrode lead 10 is implanted into the heart H such that it extends into the right ventricle RV of the heart H and, at a distal end 101 of a lead body 100, is arranged on intra-cardiac tissue at the septum M in between the right ventricle RV and the left ventricle LV of the heart H.
  • An electrode lead 11 in turn is implanted such that it reaches into the right atrium RA.
  • An implantable medical device 1 as concerned herein may generally be a cardiac stimulation device such as a cardiac pacemaker device.
  • a stimulation device of this kind comprises a generator 12, as shown in Fig. 1, which may be subcutaneously implanted in a patient at a location remote from the heart H, one or multiple leads 10, 11 extending from the generator 12 into the heart H for emitting stimulation signals in the heart H or for obtaining sense signals at one or multiple locations from the heart H.
  • the leads 10, 11 each form a generally longitudinal, tubular body 100, which reaches into the heart H and is anchored at a location of interest within the heart H.
  • the implantable medical device 1 as described herein in particular shall serve to provide a so-called left bundle branch area pacing, in short LBBAP.
  • the electrode lead 10 is implanted such that the lead body 100, with the distal end 101, is placed on tissue on the septum M such that it engages with tissue and reaches into tissue in order to couple to the left bundle branch LBB which, as part of the conductive structure of the patient’s heart H, is coupled via the so-called His bundle HIS to the atrioventricular node AVN and runs in parallel to the right bundle branch RBB.
  • the left bundle branch LBB extends within myocardial tissue around the vertex of the left ventricle LV and conducts excitation signals for exciting tissue in the region of the left ventricle LV.
  • the electrode lead 10 comprises an electrode pole 102 which is arranged on and protrudes from the distal end 101 of the lead body 100.
  • the electrode pole 102 is formed by a helical spiral and is shaped such that it may be screwed into tissue in order to electrically couple to tissue and provide for a mechanical anchoring of the electrode lead 10 on tissue.
  • the electrode lead 10 comprises another electrode pole 103 which is formed by a ring electrode arranged proximally with respect to the electrode pole 102 on the lead body 100 of the electrode lead 10.
  • the electrode pole 102 formed by the helical spiral is engaged with tissue and reaches into tissue such that it electrically couples to the conductive structure within the myocardial tissue of the septum M, in particular the left bundle branch LBB, in order to enable a stimulation of the conductive structure by coupling stimulation signals to the conductive structure.
  • the electrode pole 103 may electrically contact tissue in that it fully or at least partially rests within tissue and hence electrically couples to tissue.
  • the electrode lead 10 is inserted, from the region of the right ventricle RV, into tissue such that the electrode pole 102 at the distal end 101 reaches a sufficient insertion depth within the tissue in order to couple to a desired conductive structure.
  • the electrode pole 103 shall establish a desired coupling to tissue.
  • electrical stimulation signals shall be output to couple into tissue in particular in the region of the left bundle branch LBB, as shown in Fig. 2, such that a spatially differentiated stimulation of the conductive structure of the left bundle branch LBB is obtained, causing a stimulated left ventricular activity, for example in the context of a cardiac resynchronization therapy (CRT).
  • CRT cardiac resynchronization therapy
  • electrical stimulation signals in particular electrical stimulation pulses having one or multiple phases, exhibiting a signal energy which is sufficient to cause a reliable stimulation of a desired structure, in particular the left bundle branch LBB for a left bundle branch area pacing (LBBAP), while avoiding an excessive load of the electrical energy resources of the implantable medical device 1.
  • LBBAP left bundle branch area pacing
  • typically a capture threshold test is carried out at the initial startup of the implantable medical device 1 and repeatedly during operation, for example once or multiple times per day, in order to assess and set a signal strength for an electrical stimulation signal to cause a reliable stimulation of a desired structure.
  • electrical stimulation signals are generated and output starting at a maximum start energy, wherein the signal energy is progressively reduced until a capture loss is detected.
  • the signal energy at the capture loss is identified as a capture threshold.
  • the signal energy for the electrical stimulation signal during subsequent operation is then set to a value above the threshold in order to obtain a reliable capture of a desired structure.
  • a spatially dedicated stimulation of a certain conductive structure namely the left bundle branch LBB
  • a ventricular contraction is substantially prolonged and starts with a moderate mechanic contraction gradient caused by the contraction of the right ventricle, wherein only with a substantial time delay a contraction of also the left ventricle is observed.
  • the left bundle branch LBB is stimulated synchronously with the right bundle branch RBB, generally the ventricular contraction is significantly shortened and will exhibit a steeper mechanical contraction gradient, such that it is desirous to synchronously stimulate the left bundle branch LBB in case of e.g. a left bundle branch block to achieve synchronicity of the ventricular contractions.
  • the different electrode poles 102, 103 of the electrode lead 10 together with an electrode pole 121 formed by the housing of the generator device 12 span different signal vectors A, B, C, which may be used both for stimulation and for signal reception.
  • the electrode pole 102 formed by the helical screw on the distal end 101 of the electrode lead 10 together with the electrode pole 121 of the generator device 12 forms a signal vector B.
  • the electrode pole 103 arranged proximally with respect to the first electrode pole 102 on the electrode lead 10 forms a signal vector A together with the electrode pole 121 of the generator device 12.
  • the electrode pole 102 and the electrode pole 103 together form a signal reception vector C.
  • the electrode pole 102 formed by the helical screw on the distal end 101 of the electrode lead 10 shall couple to the conductive structure of the left bundle branch LBB and hence shall be placed in close proximity to the left bundle branch LBB.
  • the signal vector B hence, a stimulation predominantly at the left bundle branch LBB and, in turn, a signal reception predominantly at the left bundle branch LBB may be achieved.
  • the electrode pole 103 in comparison, is placed close to the conductive structure of the right bundle branch RBB, such that the signal vector A may be used predominantly for a signal stimulation and/or signal reception at the right bundle branch RBB.
  • the signal vector C between the electrode poles 102, 103 on the electrode lead 10 spans across the conductive structures of the right bundle branch RBB and the left bundle branch LBB, such that by means of the signal vector C a (non-selective) stimulation at both the left bundle branch LBB and the right bundle branch RBB may be obtained, and signals indicative of a difference in electrical potential and hence a difference in stimulation at the left bundle branch LBB and the right bundle branch RBB may be received.
  • stimulation signals may be output using a particular signal vector A, B, C or using multiple signal vectors A, B, C in combination, for example by using one (or both) of the electrode poles 102, 103 as a cathode and the electrode pole 121 of the generator device 12 as an anode.
  • response signals may be measured using different pairs of electrode poles 102, 13, 1021 spanning different signal vectors A, B, C, such that response signals are obtained carrying spatially differentiated information relating to a stimulation of certain regions and structures.
  • a stimulation signal in the shape of a stimulation pulse using for example the pair of electrode poles 102, 103 spanning the signal vector C
  • the conductive structures of both the left bundle branch LBB and the right bundle branch RBB may be stimulated, as illustrated by the stars in Fig. 4A.
  • response signals SA, SB, SC as illustrated in Fig. 4B are obtained.
  • the response signals SA, SB associated with the signal vectors A, B indicate a substantial signal level, whereas the response signal SC is of substantially smaller magnitude, as the difference between the stimulation responses in the conductive structures of the left bundle branch LBB and the right bundle branch RBB is comparatively small.
  • the response signal SA associated with the signal vector A may exhibit a substantial signal level, whereas the response signal SB associated with the signal vector B does not, as apparent from Fig. 5B.
  • the response signal SC associated with the signal vector C exhibits a comparatively large signal level, due to the difference in electrical potential of the stimulation responses of the left bundle branch LBB and the right bundle branch RBB.
  • the stimulation signal causes a stimulation only of the conductive structure of the left bundle branch LBB, as indicated by the stars in Fig. 6A
  • the response signal SB associated with the signal vector B is strong, as apparent from Fig. 6B, whereas the response signal SA associated with the signal vector A is comparatively small.
  • the response signal SC of the signal vector C is comparatively large, due to the difference in the stimulation responses of the left bundle branch LBB and the right bundle branch RBB.
  • a stimulation signal yields a capture, that is an effective stimulation, extending to a particular conductive structure, such as the left bundle branch LBB, or not.
  • each response signal SA, SB, SC - in Fig. 7 referred to simply as response signal S - is measured at a defined time distance TW with respect to a prior stimulation signal P, the timing distance TW for example corresponding to a blanking window in a measurement channel following the output of the stimulation signal P during a cardiac cycle.
  • the response signal S herein is measured over a defined time period TM using a particular pair of electrode poles 102, 103, 121.
  • characteristic metrics values may be determined, for example maximum and minimum amplitude values Ml, M2, temporal locations XI, X2, X3 relating to zero-crossings, threshold-crossings or maximum or minimum amplitude values, time durations Tl, T2 of certain signal portions, for example relating to a positive signal portion and a negative signal portion, or area values Al, A2 indicative of the area under certain portions of the signal curve.
  • the metrics value may in particular be useful to evaluate a signal level (signal energy) of an overall response signal or certain portions of a response signal.
  • the different response signals SA, SB, SC may be compared according to the characteristic metrics, such that for example an effective signal level of one response signal in comparison to another response signal may be assessed.
  • the assessment of a capture may in particular be useful in a capture threshold test in which, during the initial startup of the implantable medical device 1 or repeatedly during operation, a capture threshold is determined indicative of a signal energy below which a capture loss is to be expected.
  • electrical stimulation signals may be repeatedly generated, starting from a maximum signal energy and progressively reducing the signal energy of the electrical stimulation signal.
  • electrical response signals SA, SB, SC are measured using different pairs of electrode poles 102, 103, 121, such that for each electrical stimulation signal it is assessed whether a desired stimulation is effectively achieved, in particular a stimulation of the left bundle branch LBB.
  • a stimulation signal yields a selective left bundle branch area pacing (LBBAP, i.e., a stimulation of only the left bundle branch LBB), a non-selective LBBAP (i.e., a stimulation of both the left bundle branch LBB and the right bundle branch RBB and/or the septum), a right bundle branch area pacing (RBBAP, i.e., a stimulation of only the right bundle branch RBB and/or the septum), or a no capture.
  • LBBAP selective left bundle branch area pacing
  • RBBAP right bundle branch area pacing
  • the capture threshold test it hence may be assessed whether a particular stimulation is achieved, and the capture threshold may be set accordingly.
  • the signal level of the stimulation pulse is then set to a value above the capture threshold, such that an effective, reliable stimulation during operation can be expected.
  • An electrode pole arrangement of an implantable medical device may comprise three or more electrode poles arranged on one or more electrode leads and on the housing of the generator device.
  • An implantable medical device may be configured for providing for a left bundle branch area pacing, but may, alternatively or in addition, implement different pacing functions.
  • P Stimulation signal (pacing signal)

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Abstract

Un dispositif médical implantable (1) pour effectuer une stimulation cardiaque comprend un dispositif générateur (12) comportant un circuit de traitement (120) destiné à traiter des signaux électriques, un fil d'électrode (10, 11) connecté au dispositif générateur (12) et s'étendant à partir du dispositif générateur (12), le fil d'électrode (10) comprenant un corps de fil (100) formant une extrémité distale (101) à disposer sur un tissu cardiaque à l'intérieur du cœur (H) d'un patient, et un agencement de pôle d'électrode comprenant au moins trois pôles d'électrode (102, 103, 121). Le circuit de traitement (120) est conçu pour générer un signal de stimulation électrique (P) et pour fournir le signal de stimulation électrique (P) audit agencement de pôle d'électrode pour stimuler l'activité cardiaque. Le circuit de traitement (120) est en outre configuré pour mesurer au moins deux signaux de réponse électrique (S, SA, SB, SC) indiquant une activité cardiaque stimulée en réponse audit signal de stimulation électrique (P) à l'aide d'au moins deux paires différentes de pôles d'électrode parmi lesdits au moins trois pôles d'électrode (102, 103, 121) et pour dériver des informations indiquant une efficacité de stimulation dudit signal de stimulation électrique (P) sur la base desdits au moins deux signaux de réponse électrique (S, SA, SB, SC).
PCT/EP2024/079682 2023-11-22 2024-10-21 Dispositif médical implantable pour réaliser une stimulation cardiaque Pending WO2025108643A1 (fr)

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Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2008058265A2 (fr) 2006-11-08 2008-05-15 Emerge Medsystems Llc Dérivations de stimulation cardiaque transmusculaire pour le ventricule gauche et systèmes et procédés apparentés
US20090276000A1 (en) 2002-09-30 2009-11-05 Medtronic, Inc. Pacing method
US20150321005A1 (en) * 2014-08-19 2015-11-12 Biotronik Se & Co. Kg Heart stimulator for implantation in a heart ventricle
US20160354605A1 (en) * 2007-08-07 2016-12-08 Cardiac Pacemakers, Inc. Method and apparatus to perform electrode combination selection
US20210361953A1 (en) * 2020-05-19 2021-11-25 Biotronik Se & Co. Kg Implantable medical device for stimulating a human or animal heart employing an evaluation of signals between a his electrode and a further electrode

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20090276000A1 (en) 2002-09-30 2009-11-05 Medtronic, Inc. Pacing method
WO2008058265A2 (fr) 2006-11-08 2008-05-15 Emerge Medsystems Llc Dérivations de stimulation cardiaque transmusculaire pour le ventricule gauche et systèmes et procédés apparentés
US20160354605A1 (en) * 2007-08-07 2016-12-08 Cardiac Pacemakers, Inc. Method and apparatus to perform electrode combination selection
US20150321005A1 (en) * 2014-08-19 2015-11-12 Biotronik Se & Co. Kg Heart stimulator for implantation in a heart ventricle
US20210361953A1 (en) * 2020-05-19 2021-11-25 Biotronik Se & Co. Kg Implantable medical device for stimulating a human or animal heart employing an evaluation of signals between a his electrode and a further electrode

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