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EP4626543A1 - Système et méthode d'implantation d'électrode de dérivation pour la mise en oeuvre d'une stimulation de la zone de branche gauche - Google Patents

Système et méthode d'implantation d'électrode de dérivation pour la mise en oeuvre d'une stimulation de la zone de branche gauche

Info

Publication number
EP4626543A1
EP4626543A1 EP23809241.5A EP23809241A EP4626543A1 EP 4626543 A1 EP4626543 A1 EP 4626543A1 EP 23809241 A EP23809241 A EP 23809241A EP 4626543 A1 EP4626543 A1 EP 4626543A1
Authority
EP
European Patent Office
Prior art keywords
electrode
electrical
electrode pole
lead
during implantation
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
EP23809241.5A
Other languages
German (de)
English (en)
Inventor
Frank Becker
Thomas Dörr
Volker Lang
Björn Henrik Diem
Dominic WIST
Daniel Krüger
Carsten Hennig
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Biotronik SE and Co KG
Original Assignee
Biotronik SE and Co KG
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Biotronik SE and Co KG filed Critical Biotronik SE and Co KG
Publication of EP4626543A1 publication Critical patent/EP4626543A1/fr
Pending legal-status Critical Current

Links

Classifications

    • 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
    • A61N1/057—Anchoring means; Means for fixing the head inside the heart
    • A61N1/0573—Anchoring means; Means for fixing the head inside the heart chacterised by means penetrating the heart tissue, e.g. helix needle or hook
    • 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
    • A61N1/372—Arrangements in connection with the implantation of stimulators
    • A61N1/37211—Means for communicating with stimulators
    • A61N1/37252—Details of algorithms or data aspects of communication system, e.g. handshaking, transmitting specific data or segmenting data
    • A61N1/37258—Alerting the patient
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/02—Details
    • A61N1/08—Arrangements or circuits for monitoring, protecting, controlling or indicating
    • A61N2001/083—Monitoring integrity of contacts, e.g. by impedance measurement

Definitions

  • a system of this kind comprises a generator device, wherein the generator device comprises processing circuitry for processing electrical signals. Furthermore, the system comprises an electrode lead connected to the generator device, the electrode lead comprising a lead body forming a distal end to be arranged, during implantation of the electrode lead, on cardiac tissue within a patient’s heart.
  • the electrode lead further comprises an electrode pole arrangement comprising at least a first electrode pole and a second electrode pole, wherein the first electrode pole and the second electrode pole form a first pair of electrode poles.
  • the first electrode pole is arranged on the distal end of the lead body and is configured to be inserted into cardiac tissue during implantation.
  • the second electrode pole is arranged on the lead body at a location proximal to the first electrode pole.
  • 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
  • the electrode when inserting an electrode arranged on a lead from the right ventricle into the septum in order to reach towards the left bundle branch, the electrode must be inserted into the tissue to reach a substantial depth to come to lie in the vicinity of the left bundle branch. This comes with the inherent risk that the electrode may pierce through the septum and may reach into the left ventricle.
  • 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 simulation 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.
  • This object is achieved by means of an implantable medical stimulation device comprising the features of claim 1.
  • the processing circuitry is configured to perform the measurements of the first electrical signal via the first pair of electrodes by
  • the system is configured to derive, from said first electrical signal, the first electrical impedance value based on said at least one electrical excitation signal and from said at least one electrical response signal.
  • the processing circuitry is configured to repeatedly generate the at least one electrical excitation signal and receive said at least one electrical response signal during the process of inserting the first electrode pole into cardiac tissue during implantation of the electrode lead.
  • an electrode lead is implanted for example in the right ventricle in the region of the septum such that the distal end of the lead body of the electrode lead is placed on the septum in between the right ventricle and the left ventricle.
  • an electrode pole of an electrode pole arrangement is placed, which serves to couple with tissue at the septum in order to provide for an electrical excitation during a pacing action.
  • the generator device comprises a housing forming a third electrode pole of said electrode pole arrangement.
  • the first electrode pole and the third electrode pole form a second pair of electrode poles.
  • the processing circuitry is configured, during implantation, to perform measurements of a second electrical signal via said second pair of electrode poles.
  • the system is configured to derive, from said second electrical signal, a second electrical impedance value, and wherein the system is configured to monitor said second electrical impedance value during implantation of the electrode lead. Accordingly, the processing circuitry is configured to perform the measurements of the second electrical signal via the second pair of electrodes by
  • the system is configured to derive, from said second electrical signal, the second electrical impedance value based on said at least one second electrical excitation signal and from said at least one second electrical response signal.
  • the second electrode pole and the third electrode pole form a third pair of electrode poles.
  • the processing circuitry is configured, during implantation, to perform measurements of a third electrical signal via said third pair of electrode poles.
  • the system is configured to derive, from said second electrical signal, a third electrical impedance value, and wherein the system is configured to monitor said third electrical impedance value during implantation of the electrode lead. Accordingly, the processing circuitry is configured to perform the measurements of the third electrical signal via the third pair of electrodes by
  • the system is configured to derive, from said third electrical signal, the third electrical impedance value based on said at least one third electrical excitation signal and from said at least one third electrical response signal.
  • first electrode pole comprises a helical shape arranged on the distal end of the lead body and is configured to be screwed into cardiac tissue during implantation.
  • first electrode pole comprises a needle shape or tapered shape arranged on the distal end of the lead body and is configured to be pierced into cardiac tissue during implantation.
  • the distal end of the lead body can have any shape which is suitable for facilitated insertion into cardiac tissue.
  • the electrode pole of the electrode pole arrangement is to be placed within tissue such that it couples to the conductive structure within the septum of the heart, specifically the left bundle branch extending from the so- called atrioventricular node along the septum and within myocardial tissue around the vertex of the left ventricle.
  • tissue such that it couples to the conductive structure within the septum of the heart, specifically the left bundle branch extending from the so- called atrioventricular node along the septum and within myocardial tissue around the vertex of the left ventricle.
  • the electrode pole arrangement is formed (at least) by the first electrode pole on the distal end of the lead body and the second electrode pole arranged proximally with respect to the first electrode pole on the lead body, wherein further electrode poles may be present on the electrode lead, on another, additional lead or on the housing of the generator device.
  • An electrical excitation signal generated by the processing circuitry for outputting by the electrode pole arrangement may for example be a current signal produced by a defined current source, in which case the electrical response signal is a voltage signal.
  • an electrical impedance may be computed, wherein the impedance calculation is repeated throughout the implantation process such that an impedance curve is obtained which varies in dependence on the progress of the implantation, in particular the actual position of the distal end of the electrode lead on and within tissue. From the impedance curve, hence, information about the implantation may be derive, in particular, information with respect to the insertion depth of the distal end of the lead body in cardiac tissue.
  • an electrical excitation signal generated by the processing circuitry for outputting by the electrode pole arrangement is a voltage signal produced by a defined voltage source, in which case the electrical response signal is a current signal.
  • an impedance value may be computed, wherein the impedance calculation is repeated throughout implantation such that an impedance curve is obtained, which may be processed for monitoring the implantation procedure.
  • the at least one electrical excitation signal is a current signal and the at least one electrical response signal is a voltage signal.
  • the at least one electrical excitation signal is a voltage signal and the at least one electrical response signal is a current signal.
  • the impedance value may be monitored during the action of screwing the helically shaped first electrode pole into tissue in order to insert the distal end of the lead body into tissue.
  • the distal end of the lead the body is advanced into the tissue, such that the distal end engages with tissue and enters into the tissue until also the second electrode pole comes into electrical contact with tissue.
  • the impedance value changes because blood generally has a different electrical conductivity than cardiac tissue, such that the impedance changes in the progress of the first electrode pole entering into tissue and the second electrode pole coming into contact with tissue.
  • the first electrode pole For screwing the helically shaped first electrode pole into tissue, the first electrode pole may be rotated with respect to the lead body or the lead body with the helically shaped first electrode pole arranged thereon may be rotated as a whole, such that the first electrode pole due to its helical shape is screwed into tissue. Due to the screwing action the distal end of the lead body enters into tissue and the second electrode pole arranged on the lead body may come into contact and couple with tissue.
  • the generator device is an external device.
  • the generator device is an implantable device, wherein the electrode lead is connected to the implantable device via an adapter.
  • the first electrode pole and the second electrode pole form a first pair of electrode poles.
  • the processing circuitry herein is configured to repeatedly generate, during implantation, a first electrical excitation signal for outputting by the first pair of electrode poles and to receive, using the first pair of electrode poles, a first electrical response signal in response to the first electrical excitation signal.
  • the system is configured to derive, from the first electrical excitation signal and from the first electrical response signal, a first electrical impedance value and to monitor the first electrical impedance value during implantation of the electrode lead.
  • a first electrical excitation signal hence is output using the first pair of electrode poles formed between the helically shaped first electrode pole on the distal end of the lead body and the second electrode pole arranged proximally with respect to the first electrode pole on the lead body. From the electrical excitation signal and from an electrical response signal received in response to the electrical excitation signal, hence, an electrical impedance value indicative of the impedance in between the first electrode pole and the second electrode pole is determined, wherein the impedance value is monitored during implantation, and based on the impedance value information with respect to the progress of the implantation procedure may be derived.
  • Fig. 1 shows a schematic view of an implantable medical stimulation 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. 4D shows an embodiment of the implantable medical device during implantation, whereby the electrode leads are coupled to the implantable medical device via an adapter;
  • Fig. 5 shows impedance curves as measured during implantation
  • Fig. 6 shows biphasic excitation pulses as output for performing impedance measurements.
  • 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 stimulation device 1 as concerned herein may generally be a cardiac stimulation device such as a cardiac pacemaker device.
  • a stimulation device of this kind may comprise 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 stimulation device 1 as described herein in particular shall serve to provide a so-called left bundle branch area pacing, in short LBBAP.
  • 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 a first 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 a second electrode pole 103 which is formed by a ring electrode arranged proximally with respect to the first electrode pole 102 on the lead body 100 of the electrode lead 10.
  • impedance values are measured, for example in between the first electrode pole 102 and the second electrode pole 103 (ZBI P ), between the first electrode pole 102 and a third electrode pole 121 formed by the housing of the generator device 12 (Zu P u) and between the second electrode pole 103 and the third electrode pole 121 (ZRingu).
  • the impedance measurements are carried out in a connected state of the electrode lead 10 in that the processing circuitry 120 of the generator device 12 generates electrical excitation signals which are output using a respective pair of electrode poles 102, 103, 121.
  • electrical response signals are received, such that by correlating the electrical excitation signals and the electrical response signals impedance values for the different pairs of electrode poles 102, 13, 121 may be computed and monitored.
  • a first pair of electrode poles is formed by the first electrode pole 102 and the second electrode pole 103 (ZBI P ).
  • a second pair of electrode poles is formed by the first electrode pole 102 and the third electrode pole 121 (ZTI P U).
  • a third pair of electrode poles is formed by the second electrode pole 103 and the third electrode pole 121 (ZRingu).
  • the electrical excitation signals as generated by the processing circuitry 120 to be output by a respective pair of electrode poles 102, 103, 121 are current signals which are generated by a controlled current source.
  • the electrical response signals are voltage signals.
  • impedance curves for the different impedance values ZBI P , ZTI P U, ZRingu overtime during implantation are shown, the solid line indicating the impedance curve for the impedance ZBI P in between the first electrode pole 102 and the second electrode pole 103, the dashed line indicating the impedance curve for the impedance ZTI P U in between the first electrode pole 102 and the third electrode pole 121 formed by the housing of the generator device 12, and the dash-dotted line indicating the impedance curve for the impedance Zi ⁇ mgu in between the second electrode pole 103 and the third electrode pole 121.
  • the second electrode pole 103 comes into contact with tissue, upon which the impedance in between the first electrode pole 102 and the second electrode pole 103 experiences an impedance rise AZBI P 2, and similarly the impedance in between the second electrode pole 103 and the third electrode pole 121 experiences an impedance rise AZRingui, due to the changing electrical conditions in the vicinity of the electrode pole 103.
  • an alert message may be produced and output to a user, hence informing the user of a particular progress step during implantation.
  • implantation may be facilitated in that messages with respect to the progress of implantation may be displayed to a user.
  • the implantation process may be automatically controlled in accordance with a control parameter derived from the impedance curves.
  • the processing circuitry 120 generates excitation signals to be output by a respective pair of electrode poles 102, 103, 121, and receives corresponding response signals.
  • the processing for deriving impedance values ZBI P , ZTI P U, ZRingu herein in one embodiment may be carried out by the processing circuitry 120 within the generator device 12.
  • the processing circuitry 120 may communicate information relating to the electrical excitation signals and the received response signals to an external device 2 resting outside of the patient, as is shown in Fig. 3, such that the external device 2 is enabled to process the signals and to compute impedance values for monitoring during the implantation procedure.
  • one pulse Pl, P2, P3 is generated and output after the other, and for each excitation pulse Pl, P2, P3 a corresponding response signal is received and processed.
  • the different impedance values hence are computed repeatedly during implantation, such that the implantation procedure may be continuously monitored.
  • An implantable medical stimulation device may be configured for providing for a left bundle branch area pacing, but may, alternatively or in addition, implement different pacing functions.

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  • Health & Medical Sciences (AREA)
  • Cardiology (AREA)
  • Animal Behavior & Ethology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Radiology & Medical Imaging (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Biomedical Technology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (AREA)
  • Electrotherapy Devices (AREA)

Abstract

L'invention concerne un système d'implantation d'une électrode (10) permettant de procéder à une stimulation de la zone de la branche gauche, comprenant un dispositif générateur (12) doté de circuits de traitement (120) pour traiter les signaux électriques, une électrode de dérivation (10, 11) et un agencement de pôles d'électrodes comprenant au moins un premier pôle d'électrode (102) et un second pôle d'électrode (103). Le premier pôle d'électrode (102) est disposé sur une extrémité distale (101) d'un corps de dérivation (100) et est configuré pour être inséré dans un tissu cardiaque pendant l'implantation. Le circuit de traitement (120) est configuré, pendant l'implantation, pour effectuer des mesures d'un premier signal électrique par l'intermédiaire dudit agencement de pôle d'électrode. Le système est configuré pour dériver, à partir dudit premier signal électrique, une première valeur d'impédance électrique. De plus, le système est configuré pour surveiller ladite première valeur d'impédance électrique pendant l'implantation de l'électrode de dérivation.
EP23809241.5A 2022-12-01 2023-11-21 Système et méthode d'implantation d'électrode de dérivation pour la mise en oeuvre d'une stimulation de la zone de branche gauche Pending EP4626543A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
EP22210870 2022-12-01
PCT/EP2023/082484 WO2024115189A1 (fr) 2022-12-01 2023-11-21 Système et méthode d'implantation d'électrode de dérivation pour la mise en œuvre d'une stimulation de la zone de branche gauche

Publications (1)

Publication Number Publication Date
EP4626543A1 true EP4626543A1 (fr) 2025-10-08

Family

ID=84370845

Family Applications (1)

Application Number Title Priority Date Filing Date
EP23809241.5A Pending EP4626543A1 (fr) 2022-12-01 2023-11-21 Système et méthode d'implantation d'électrode de dérivation pour la mise en oeuvre d'une stimulation de la zone de branche gauche

Country Status (2)

Country Link
EP (1) EP4626543A1 (fr)
WO (1) WO2024115189A1 (fr)

Family Cites Families (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20030199938A1 (en) * 2002-04-22 2003-10-23 Karel Smits Precise cardiac lead placement based on impedance measurements
US7082335B2 (en) 2002-09-30 2006-07-25 Medtronic, Inc. Multipolar pacing method and apparatus
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
US10874850B2 (en) * 2018-09-28 2020-12-29 Medtronic, Inc. Impedance-based verification for delivery of implantable medical devices
US11911166B2 (en) * 2019-07-20 2024-02-27 Medtronic, Inc. Method and apparatus for implantation of a pacing electrode
US11045653B1 (en) * 2021-02-11 2021-06-29 Eagle Point Medical LLC Multi-electrode leads, adapters, and methods for left bundle branch pacing with depth control

Also Published As

Publication number Publication date
WO2024115189A1 (fr) 2024-06-06

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