EP4626543A1 - System and method for implanting an electrode lead for performing a left bundle branch area pacing - Google Patents

System and method for implanting an electrode lead for performing a left bundle branch area pacing

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)
French (fr)
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/en
Pending legal-status Critical Current

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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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Abstract

A system for implanting an electrode lead (10) for performing a left bundle branch area pacing comprises a generator device (12) comprising processing circuitry (120) for processing electrical signals, an electrode lead (10, 11), and an electrode pole arrangement comprising at least a first electrode pole (102) and a second electrode pole (103). The first electrode pole (102) is arranged on a distal end (101) of a lead body (100) and is configured to be inserted into cardiac tissue during implantation. The processing circuitry (120) is configured, during implantation, to perform measurements of a first electrical signal via said electrode pole arrangement. The system is configured to derive, from said first electrical signal, a first electrical impedance value. Moreover, the system is configured to monitor said first electrical impedance value during implantation of the electrode lead.

Description

SYSTEM AND METHOD FOR IMPLANTING AN ELECTRODE LEAD FOR
PERFORMING A LEFT BUNDLE BRANCH AREA PACING
The present invention relates to a system for implanting an electrode lead for performing a left bundle branch area pacing according to the preamble of claim 1 and to a method for operating a system for implanting an electrode lead for performing a left bundle branch area pacing.
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.
With common electrode arrangements of leads of implantable medical stimulation devices, 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. With new approaches for example for providing a stimulation in case of a so-called left bundle block, it may be desired to provide for an excitation in a localized fashion in the region of the so-called left bundle branch, also denoted as left bundle branch area pacing (LBBAP), which requires to engage with intra-cardiac tissue in the range of the septum of the heart and to place an electrode in the vicinity of the left bundle branch, such that stimulation energy may be specifically injected into the conductive structure of the left bundle branch.
As this requires a piercing of the septum, there is a general desire to closely monitor the implantation procedure for implanting an electrode lead on cardiac tissue, such that a desired coupling to the conductive structure of the patient’s heart may be established, while at the same time avoiding for example a penetration of the septum by a piercing structure.
In particular, 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.
It is an object of the instant invention to provide a system for implanting an electrode lead for performing a left bundle branch area pacing and a method for operating a system for implanting an electrode lead for performing a left bundle branch area pacing which allow for an easy, controllable and reliable implantation of the electrode lead on cardiac tissue. This object is achieved by means of an implantable medical stimulation device comprising the features of claim 1.
According to the present invention, a system for implanting an electrode lead for performing a left bundle branch area pacing is proposed. The system 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. The processing circuitry is configured, during implantation, to perform measurements of a first electrical signal via said electrode pole arrangement. The system is furthermore configured to derive, from said first electrical signal, a first electrical impedance value, and to monitor said first electrical impedance value during implantation of the electrode lead.
According to an embodiment of the present invention, the processing circuitry is configured to perform the measurements of the first electrical signal via the first pair of electrodes by
- repeatedly generate at least one electrical excitation signal,
- provide said at least one electrical excitation signal to the first pair of electrodes for outputting by said first pair of electrodes,
- repeatedly receive, using said first pair of electrodes, at least one electrical response signal in response to said at least one electrical excitation signal.
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. Moreover, according to an embodiment, 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.
The generator device, the electrode lead and the electrode pole arrangement placed thereon together form an implantable medical stimulation device which, in an implanted state, is operative to carry out a pacing action, in particular a left bundle branch area pacing (LBBAP).
By means of the system, implantation of an electrode lead on cardiac tissue, in particular in the region of the septum of the heart in between the right ventricle and the left ventricle, may be facilitated.
In the context of providing for a left bundle branch area pacing (LBBAP), 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. On the distal end of the lead body, herein, 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.
Furthermore, according to an embodiment of the present invention, the generator device comprises a housing forming a third electrode pole of said electrode pole arrangement. In that embodiment, 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
- repeatedly generate at least one second electrical excitation signal, - provide said at least one second electrical excitation signal to the second pair of electrodes for outputting by said second pair of electrodes,
- repeatedly receive, using said second pair of electrodes, at least one second electrical response signal in response to said at least one second electrical excitation signal.
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.
Preferably, according to an embodiment of the present invention, 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
- repeatedly generate at least one third electrical excitation signal,
- provide said at least one third electrical excitation signal to the third pair of electrodes for outputting by said third pair of electrodes,
- repeatedly receive, using said third pair of electrodes, at least one third electrical response signal in response to said at least one third electrical excitation signal.
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.
Moreover, according to an embodiment of the present invention, the processing circuitry is configured to process said at least one of the first, second or third electrical response signal in correlation to said at least one first, second or third electrical excitation signal to derive at least one of the said first, second or third electrical impedance value during implantation of the electrode lead. Accordingly, during implantation the electrode pole arranged on the distal end of the lead body is inserted into tissue, such that the electrode pole engages with tissue and electrically couples with tissue and, in addition, provides for a mechanical anchoring of the distal end on tissue.
Preferably, according to an embodiment of the present invention, 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. Alternatively or additionally, the 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. In general, the distal end of the lead body can have any shape which is suitable for facilitated insertion into cardiac tissue.
For providing for a left bundle branch area pacing, 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. When implanting the helically shaped electrode pole within tissue, it herein must be observed that the electrode pole reaches into a sufficient depth within the septum in order to couple to a desired conductive structure, while at the same time not penetrating through the septum in order to avoid the electrode pole to reach into the left ventricle.
In addition, during implantation it is desirous that also the second electrode pole, arranged proximally with respect to the first electrode pole, comes into contact with tissue, such that during operation of the implantable medical stimulation device after implantation an excitation of desired structures may be achieved.
In order to facilitate implantation, it is proposed to monitor an electrical impedance which, during implantation, is derived from measured information obtained with the electrode pole arrangement of the implantable medical stimulation device. 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.
For deriving impedance information and for monitoring an electrical impedance value, the processing circuitry is configured to generate electrical excitation signals which are output by means of the electrode pole arrangement. In reaction to outputting the electrical excitation signals, response signals are received, which are processed by the processing circuitry of the generator device or by a different entity of the system, for example an external device which is in communicative connection with the generator device. By correlating the electrical excitation signals and the electrical response signals received in response to the electrical excitation signals, impedance information is derived and is monitored, wherein according to the impedance information about the progress of the implantation of the distal end of the lead body on cardiac tissue may be obtained.
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. From the excitation signal and from the associated response signal, hence, 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.
In another embodiment, 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. Again, from the electrical excitation signal and from the associated electrical response 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.
According to an embodiment of the present invention, the at least one electrical excitation signal is a current signal and the at least one electrical response signal is a voltage signal. Alternatively, the at least one electrical excitation signal is a voltage signal and the at least one electrical response signal is a current signal.
In particular, 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. During the screwing of the helically shaped first electrode pole 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. Dependent on the progress of implantation, 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.
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.
According to an embodiment of the inventive system, the generator device is an external device. Alternatively, the generator device is an implantable device, wherein the electrode lead is connected to the implantable device via an adapter.
In one embodiment, the first electrode pole and the second electrode pole form a first pair of electrode poles. The processing circuitry herein, in one embodiment, 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. Herein, 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.
The electrode pole arrangement may comprise one or multiple further electrode poles. For example, a third electrode pole may be formed by a housing of the generator device, such that electrical excitation signals may be generated and output by involving the electrode pole formed by the housing of the generator device.
For example, a second pair of electrode poles may be formed by the first electrode pole and the third electrode pole. Herein, the processing circuitry may be configured, during implantation, to repeatedly generate a second electrical excitation signal for outputting by the second pair of electrode poles and to receive, using the second pair of electrode poles, a second electrical response signal in response to the second electrical excitation signal. The system is configured to derive, from the second electrical excitation signal and from the second electrical response signal, a second electrical impedance value and to monitor the second electrical impedance value during implantation of the electrode lead.
Alternatively or in addition, a third pair of electrode poles may be formed by the second electrode pole and the third electrode pole. Herein, the processing circuitry is configured, during implantation, to repeatedly generate a third electrical excitation signal for outputting by the third pair of electrode poles and to receive, using the third pair of electrode poles, a third electrical response signal in response to the third electrical excitation signal. The system is configured to derive, from the third electrical excitation signal and from the third electrical response signal, a third electrical impedance value and to monitor the third electrical impedance value during implantation of the electrode lead.
Hence, multiple different impedance values may be derived and may be monitored during implantation. One impedance value may be indicative of the impedance in between the first electrode pole having a helical shape and being arranged 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. Another impedance value may be indicative of the impedance between the first electrode pole and the third electrode pole formed by the housing of the generator device. Yet another impedance value may be indicative of the impedance in between the second electrode pole proximal to the distal end of the lead body and the third electrode pole formed by the housing of the generator device. The different impedance values may be processed each by itself or in a combined fashion in order to derive information with respect to the progress of the implantation such that it may for example be identified once the first electrode pole has fully engaged with tissue, once the second electrode pole comes into contact with tissue, once the second electrode pole fully rests within tissue and, potentially, once the first electrode pole has penetrated through the septum and should be moved backwards.
In one embodiment, electrical excitation signals as generated by the processing circuitry to be output by the electrode pole arrangement are biphasic electrical pulse signals. Such biphasic electrical pulse signals may be formed by a first pulse section having a positive amplitude and a consecutive, second pulse section having a negative amplitude, or vice versa.
In one embodiment, the processing circuitry is configured to generate multiple electrical excitation signals to be output using different pairs of electrode poles of the electrode pole arrangement by employing a time multiplexing. In particular, electrical excitation signals, for example pulse signals, may be output in an alternating, staggered fashion such that a first electrical excitation signal to be output by a first pair of electrode poles of the electrode pole arrangement is followed by a second electrical excitation signal to be output by a second pair of electrode poles, which again is followed by a third electrical excitation signal to be output by a third pair of electrode poles, upon which again a first electrical excitation signal is produced and output. In this way electrical excitation signals are continuously generated and output in a multiplexed fashion, such that impedance values may be continuously monitored throughout an implantation procedure in the course of which the distal end of the lead body of the electrode lead is inserted into cardiac tissue.
In one embodiment, the processing circuitry of the generator device is configured to process the at least one electrical response signal in correlation to the at least one electrical excitation signal to derive the electrical impedance value during implantation of the electrode lead. The processing hence is carried out by the processing circuitry of the generator device in order to derive the impedance value according to which the implantation procedure may be monitored.
In another embodiment, the system comprises an external device, for example an external programming device, which is in wireless communication connection with the generator device of the implantable medical stimulation device and is not implanted in the patient. The processing circuitry of the generator device is configured to transmit information relating to the at least one electrical excitation signal and the at least one electrical response signal to the external device, such that the external device is enabled to derive the electrical impedance value during implantation of the electrode lead. In this embodiment, the processing circuitry forwards information relating to the excitation signal and the response signal to the external device, which carries out the processing for deriving information about the impedance value in order to monitor the progress of the implantation procedure.
Moreover, according to an embodiment, the system comprises an external device in wireless communicative connection with said generator device. The processing circuitry of the generator device is configured to transmit information relating to said at least one of the first, the second or the third electrical excitation signal and said at least one of the first, the second or the third electrical response signal to said external device. The external device is configured to derive at least one of said first, second and/or third electrical impedance value during implantation of the electrode lead. Information about the impedance value as repeatedly computed during the implantation procedure may be output to a physician, using for example an external device, for example using a screen for displaying graphical information.
In one embodiment, the system is configured to identify, according to a variation in the electrical impedance value during implantation of the electrode lead, information relating to the insertion depth of the distal end of the lead body into cardiac tissue. For example, in an impedance curve step-like variations may occur when the first electrode pole has fully engaged with tissue, when the second electrode pole first comes into contact with tissue and when the second electrode pole is fully buried within tissue. According to such variations, it may be derived how far the lead body is engaged with tissue, such that information about the insertion depth may be obtained.
Based on information relating to the insertion depth, for example an alert message may be produced, such that a physician, during implantation, is notified e.g. of a completion of the implantation or of an incomplete or potentially erroneous implantation.
In another aspect, a method is proposed for operating a system for implanting an electrode lead for performing a left bundle branch area pacing. The method comprises the steps of:
- implanting a generator device comprising processing circuitry for processing electrical signals,
- implanting an electrode lead connected to the generator device and extending from the generator device. The electrode lead comprises a lead body forming a distal end which is to be arranged, during implantation of the electrode lead, on cardiac tissue within a patient’s heart; and
- inserting a first electrode pole of an electrode pole arrangement into cardiac tissue during implantation, the electrode pole arrangement comprising at least the first electrode pole and a second electrode pole, wherein the first electrode pole is arranged on the distal end of the lead body and the second electrode pole is arranged on the lead body at a location proximal to the first electrode pole; - performing, during implantation, measurements of a first electrical signal via said electrode pole arrangement,
- deriving, from said first electrical signal, a first electrical impedance value, wherein said first electrical impedance value is monitored during implantation of the electrode lead.
Moreover, a method for operating a system for implanting an electrode lead for performing a left bundle branch area pacing comprises: implanting a generator device comprising processing circuitry for processing electrical signals; implanting 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, during implantation of the electrode lead, on cardiac tissue within a patient’s heart; screwing a first electrode pole of an electrode pole arrangement into cardiac tissue during implantation, the electrode pole arrangement comprising at least the first electrode pole and a second electrode pole, wherein the first electrode pole comprises a helical shape arranged on the distal end of the lead body and the second electrode pole is arranged on the lead body at a location proximal to the first electrode pole; during implantation repeatedly generating, using the processing circuitry, at least one electrical excitation signal and providing said at least one electrical excitation signal to said electrode pole arrangement for outputting by said electrode pole arrangement; during implantation repeatedly receiving, by the processing circuitry using said electrode pole arrangement, at least one electrical response signal in response to said at least one electrical excitation signal; deriving, from said at least one electrical excitation signal and from said at least one electrical response signal, an electrical impedance value and monitoring said electrical impedance value during implantation of the electrode lead.
The advantages and advantageous embodiments described above for the system equally apply also to the method, such that it shall be referred to the above in this respect.
The idea of the invention shall subsequently be described in more detail with reference to the embodiments shown in the figures. Herein: 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. 3 shows the implantable medical stimulation device during implantation, in the course of which the progress of implantation is monitored by impedance measurements;
Fig. 4A-4C show views of the distal end of the electrode lead in the progress of implantation;
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; and
Fig. 6 shows biphasic excitation pulses as output for performing impedance measurements.
Subsequently, embodiments of the invention shall be described in detail with reference to the drawings. In the drawings, like reference numerals designate like structural elements.
It is to be noted that the embodiments are not limiting for the invention, but merely represent illustrative examples.
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 stimulation device 1 is implanted in a patient, the implantable medical stimulation 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. By means of the 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.
In the embodiment of Fig. 1, 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.
Referring now to Fig. 2, 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. For this, 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.
In the shown embodiment, 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.
In addition, 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.
In an implanted state, as shown in Fig. 2, 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 an excitation of the conductive structure by injecting stimulation signals into the conductive structure. At the same time, the second electrode pole 103 may electrically contact tissue in that it fully or at least partially rests within tissue and hence electrically couples to tissue.
During implantation, 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, where it however must be made sure that the electrode poles 102 does not penetrate through the septum M and does not reach into the left ventricle LV. In addition, also the second electrode pole 103 shall establish a desired coupling to tissue.
To facilitate implantation, it herein is proposed to monitor, during the process of advancing the distal end 101 of the lead body 100 of the electrode lead 10 into tissue, one or multiple impedance values which are recorded during the implantation procedure. According to the impedance values, the progress of implantation may be identified and observed, such that according to the monitoring the implantation may be controlled and stopped if a desired implantation depth is reached.
Referring now to Fig. 3, during implantation impedance values are measured, for example in between the first electrode pole 102 and the second electrode pole 103 (ZBIP), between the first electrode pole 102 and a third electrode pole 121 formed by the housing of the generator device 12 (ZuPu) 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. In response to such electrical excitation signals, 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.
In particular, a first pair of electrode poles is formed by the first electrode pole 102 and the second electrode pole 103 (ZBIP). A second pair of electrode poles is formed by the first electrode pole 102 and the third electrode pole 121 (ZTIPU). A third pair of electrode poles is formed by the second electrode pole 103 and the third electrode pole 121 (ZRingu). Making use of the different pairs of electrode poles 102, 103, 121, excitation signals are output, and correspondingly response signals are received, such that by correlating the excitation signals and the response signals respective impedance values may be computed and monitored.
In one embodiment, 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. In this case, the electrical response signals are voltage signals.
In another embodiment, 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 voltage signals which are generated by a controlled voltage source. In this case, the electrical response signals are current signals.
By repeatedly computing and monitoring the respective impedance values ZBIP, ZUPU, ZRingu, the progress of implantation, in particular the progress of inserting the distal end 101 of the lead body 100 of the electrode lead 10 into tissue, may be monitored. Referring now to Fig. 4A to Fig. 4C, during implantation the electrode lead 10 is guided into the right ventricle RV of the patient’s heart H and, with its distal end 101, is placed on the septum M in between the right ventricle RV and left ventricle LV, as this is shown in Fig. 4A. By screwing the helical electrode pole 102 into tissue, the distal end 101 of the lead body 100 is inserted into the tissue, as shown in Fig. 4B, in an implantation direction I until, as shown in Fig. 4C, also the second electrode pole 103 comes into contact with tissue and is buried within tissue. When the electrode pole 102 has reached a desired insertion depth and the electrode pole 103 is buried within tissue, implantation is completed.
Generally, blood, as present in the chambers of the heart H, has a different electrical conductivity in comparison to myocardial tissue. Hence, impedance values ZBIP, ZTIPU, ZRingu as observed during implantation will vary dependent on the position of the first electrode pole 102 and the second electrode pole 103 with respect to tissue.
Referring now to Fig. 4D, which has the same reference numbers and features as depicted in Fig. 3, except for adapter 200. The adapter 200 is used in case during implantation, an implantable medical device is used as generator for the impedance measurements. In particular, the adapter 200 allows for screwing in the electrode(s) and at the same time, performing impedance measurements in the implantable device. According to an alternative embodiment of the inventive system, the generator device is an external device. In that case, no adapter would be required.
Referring now to Fig. 5, impedance curves for the different impedance values ZBIP, ZTIPU, ZRingu overtime during implantation are shown, the solid line indicating the impedance curve for the impedance ZBIP in between the first electrode pole 102 and the second electrode pole 103, the dashed line indicating the impedance curve for the impedance ZTIPU 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.
As visible from Fig. 5, the impedance curves for example exhibit step-like variations in certain regions Al, A2, A3. In particular, region Al corresponds, during the process of implantation, to a time range in which the first electrode pole 102 comes into contact with tissue and is electrically inserted into tissue, upon which the impedance in between the first electrode pole 102 and the second electrode pole 103 experiences an impedance rise AZBIPI, and similarly the impedance in between the first electrode pole 102 and the third electrode pole 121 experiences an impedance rise AZTIPUI, due to the changing electrical conditions in the vicinity of the electrode pole 102.
In the time range of region A2, further along in the process of implantation, 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 AZBIP2, 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.
In the time range of region A3, the second electrode pole 103 now fully is buried within tissue, such that it no longer is exposed to blood in the right ventricle RV. In this time range, the impedance in between the first electrode pole 102 and the second electrode pole 103 experiences an impedance rise AZBIP3, and similarly the impedance in between the second electrode pole 103 and the third electrode pole 121 experiences an impedance rise AZRingin.
According to the impedance curves as shown in Fig. 5, the impedance values ZBIP, ZTIPU, ZRingu may be monitored over time during implantation, and according to variations in the impedance curves conclusions with respect to the process of implantation may be drawn.
Herein, as visible from Fig. 5, it may suffice to monitor the bipolar impedance curve of the impedance ZBIP in between the electrode poles 102, 103 in the vicinity of the distal end 101 of the lead body 100 of the electrode lead 10. Beneficially, however, further impedance curves indicative of the impedances ZTIPU, Zi<mgu are additionally taken into account and may be processed by themselves or may be used by correlating them to the impedance curve of impedance ZBIP. For example, a step-like change in one or multiple impedance curves may be identified, for example by comparing an impedance value or a change in an impedance value to a predefined threshold or the like. If a change is observed which indicates that an electrode pole 102, 103 on the distal end 101 of the lead body 100 has come into contact with tissue or now is fully buried within tissue, e.g. an alert message may be produced and output to a user, hence informing the user of a particular progress step during implantation.
Hence, by monitoring impedance curves, implantation may be facilitated in that messages with respect to the progress of implantation may be displayed to a user. Alternatively or in addition, 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 ZBIP, ZTIPU, ZRingu herein in one embodiment may be carried out by the processing circuitry 120 within the generator device 12. In another embodiment, 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.
Referring now to Fig. 6, the processing circuitry 120 may for example produce, as electrical excitation signals, biphasic pulses Pl, P2, P3 to be output by the respective pair of electrode poles 102, 103, 121. The pulses Pl, P2, P3 herein are time multiplexed in that a first pulse Pl is generated to be output by the first pair of electrode poles 102, 103, subsequently a second pulse P2 is generated to be output by the second pair of electrode poles 102, 121, and subsequently a third pulse P3 is generated to be output by the third pair of electrode poles 103, 121, upon which the sequence starts again. Hence, 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.
The idea underlying the invention is not limited to the embodiments described above, but may be implemented in an entirely different fashion.
An electrode pole arrangement of an implantable medical stimulation device may comprise two or more electrode poles, e.g. three electrode poles or more than three electrode poles. Hence, during implantation a different number of impedance values may be monitored, wherein it in principle may suffice to monitor only a single impedance value to derive information with respect to the progress of the implantation procedure.
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.
List of Reference Numerals
1 Implantable medical stimulation device
10 Lead
100 Lead body
101 Distal end
102 Electrode pole
103 Electrode pole
11 Lead
12 Generator
120 Processing circuitry
121 Housing
2 External device
200 Adapter
Al -A3 Region
AVN Atrioventricular node
H Heart
HIS HIS bundle branch
I Implantation direction
LA Left atrium
LBB Left bundle branch
LV Left ventricle
M Intra-cardiac tissue (myocardium)
P1-P3 Pulse
RA Right atrium
RBB Right bundle branch
RV Right ventricle
V Superior vena

Claims

Claims
1. A system for implanting an electrode lead (10) for performing a left bundle branch area pacing, the system comprising: a generator device (12) comprising processing circuitry (120) for processing electrical signals, an electrode lead (10, 11) connected to the generator device (12) , the electrode lead (10) comprising a lead body (100) forming a distal end (101) to be arranged, during implantation of the electrode lead (10), on cardiac tissue within a patient’s heart (H), and an electrode pole arrangement comprising at least a first electrode pole (102) and a second electrode pole (103), wherein the first electrode pole (102) and the second electrode pole (103) form a first pair of electrode poles, wherein the first electrode pole (102) is arranged on the distal end (101) of the lead body (100) and is configured to be inserted into cardiac tissue during implantation, wherein the second electrode pole (103) is arranged on the lead body (100) at a location proximal to the first electrode pole (102), characterized in that the processing circuitry (120) is configured, during implantation, to perform measurements of a first electrical signal via said electrode pole arrangement, wherein the system is configured to derive, from said first electrical signal, a first electrical impedance value, and wherein the system is configured to monitor said first electrical impedance value during implantation of the electrode lead (10).
2. The system according to claim 1, characterized in that the processing circuitry (120) is configured to perform the measurements of the first electrical signal via the first pair of electrodes by repeatedly generate at least one electrical excitation signal and provide said at least one electrical excitation signal to the first pair of electrodes for outputting by said first pair of electrodes, and repeatedly receive, using said first pair of electrodes, at least one electrical response signal in response to said at least one electrical excitation signal, and wherein 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 system according to claim 1 or 2, characterized in that the at least one electrical excitation signal is a current signal and the at least one electrical response signal is a voltage signal, or the at least one electrical excitation signal is a voltage signal and the at least one electrical response signal is a current signal. The system according to one of the preceding claims, characterized in that the processing circuitry (120) is configured to repeatedly generate said at least one electrical excitation signal and receive said at least one electrical response signal during the process of inserting the first electrode pole (102) into cardiac tissue during implantation of the electrode lead (10). The system according to one of the preceding claims, characterized in that, the generator device (12) comprises a housing forming a third electrode pole (121) of said electrode pole arrangement, wherein the first electrode pole (102) and the third electrode pole (121) form a second pair of electrode poles, wherein the processing circuitry (120) is configured, during implantation, to perform measurements of a second electrical signal via said second pair of electrode poles, wherein 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 (10). The system according to claim 5, characterized in that the second electrode pole (102 103) and the third electrode pole (121) form a third pair of electrode poles, wherein the processing circuitry (120) is configured, during implantation, to perform measurements of a third electrical signal via said third pair of electrode poles, wherein 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 (10). The system according to one of the preceding claims, characterized in that the first electrode pole (102) comprises a helical shape arranged on the distal end (101) of the lead body (100) and is configured to be screwed into cardiac tissue during implantation. The system according to one of the preceding claims, characterized in that the at least one electrical excitation signal is a biphasic electrical pulse (Pl, P2, P3). The system according to one of the preceding claims, characterized in that the processing circuitry (120) is configured to generate multiple electrical excitation signals to be output using different pairs of electrode poles of the electrode pole arrangement by employing a time multiplexing. The system according to one of the claims 2 to 9, characterized in that the processing circuitry (120) is configured to process said at least one electrical response signal in correlation to said at least one electrical excitation signal to derive said electrical impedance value during implantation of the electrode lead (10). The system according to one of the claims 2 to 10, characterized in that the system comprises an external device (2) in wireless communicative connection with said generator device (12), wherein the processing circuitry (120) of the generator device (12) is configured to transmit information relating to said at least one electrical excitation signal and said at least one electrical response signal to said external device (2), wherein the external device (2) is configured to derive said first, second and/or third electrical impedance value during implantation of the electrode lead (10). The system according to one of the preceding claims, characterized in that the system is configured to identify, according to a variation in said first, second and/or third electrical impedance value during implantation of the electrode lead (10), information relating to the insertion depth of the distal end (101) of the lead body (10) into cardiac tissue. The system according to claim 12, characterized in that the system is configured to output an alert message based on said information relating to the insertion depth. The system according to one of the preceding claims, characterized in that the generator device is an external device, or the generator device is an implantable device, wherein the electrode lead (10,11) is connected to the implantable device via an adapter. A method for operating a system for implanting an electrode lead (10) for performing a left bundle branch area pacing, the method comprising: implanting a generator device (12) comprising processing circuitry (120) for processing electrical signals, implanting an electrode lead (10, 11) connected to the generator device (12) and extending from the generator device (12), the electrode lead (10) comprising a lead body (100) forming a distal end (101) to be arranged, during implantation of the electrode lead (10), on cardiac tissue within a patient’s heart (H), and inserting a first electrode pole (102) of an electrode pole arrangement into cardiac tissue during implantation, the electrode pole arrangement comprising at least the first electrode pole (102) and a second electrode pole (103), wherein the first electrode pole (102) is arranged on the distal end (101) of the lead body (100) and the second electrode pole (103) is arranged on the lead body (100) at a location proximal to the first electrode pole (102), characterized by performing, during implantation, measurements of a first electrical signal via said electrode pole arrangement, deriving, from said first electrical signal, a first electrical impedance value, wherein said first electrical impedance value is monitored during implantation of the electrode lead (10).
EP23809241.5A 2022-12-01 2023-11-21 System and method for implanting an electrode lead for performing a left bundle branch area pacing Pending EP4626543A1 (en)

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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 (en) 2006-11-08 2008-05-15 Emerge Medsystems Llc Transmuscular left ventricular cardiac stimulation leads and related systems and methods
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
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