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
  • A61N1/0587—Epicardial electrode systems; Endocardial electrodes piercing the pericardium
• • 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
  • A61N1/0587—Epicardial electrode systems; Endocardial electrodes piercing the pericardium
  • A61N1/059—Anchoring means
• • 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
  • A61N1/0587—Epicardial electrode systems; Endocardial electrodes piercing the pericardium
  • A61N1/0592—Introducing the lead through the pericardium with a needle
• • 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
  • A61N1/38—Applying electric currents by contact electrodes alternating or intermittent currents for producing shock effects
  • A61N1/39—Heart defibrillators
  • A61N1/3956—Implantable devices for applying electric shocks to the heart, e.g. for cardioversion
• • 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
  • A61N1/38—Applying electric currents by contact electrodes alternating or intermittent currents for producing shock effects
  • A61N1/39—Heart defibrillators
  • A61N1/3956—Implantable devices for applying electric shocks to the heart, e.g. for cardioversion
  • A61N1/3962—Implantable devices for applying electric shocks to the heart, e.g. for cardioversion in combination with another heart therapy
  • A61N1/39622—Pacing therapy

Definitions

• the invention relates to an electromedical electrode arrangement with at least one implantable cardioversion electrode for delivering electrical pulses and cardioversion pulses to a target tissue, in particular to myocardial tissue.
• Such electromedical electrode arrangements are temporarily implanted in patients, for example after heart surgery, and used to support cardiac activity.
• the implantable cardioversion electrode it is possible to deliver cardioversion pulses to the patient's heart if necessary in order to eliminate conduction disorders. Compared to pacing or pacemaker pulses, which are delivered to set or support a specific heart rhythm, such cardioversion pulses are stronger.
• cardioversion pulses must not be delivered via electrodes intended exclusively for the delivery of pacemaker pulses.
• cardioversion impulses are often perceived by patients as painful. This is particularly true when the cardioversion pulses are delivered via external electrodes. But cardioversion pulses delivered via implantable cardioversion electrodes can also be perceived as unpleasant, if not painful, for patients. Another difficulty in delivering cardioversion pulses via implantable cardioversion electrodes is to sufficiently stimulate the target tissue for successful cardioversion.
• the effectiveness of the cardioversion impulses can be influenced by contact the cardioversion electrode to the target tissue have an important influence.
• the object of the invention is to provide an electrode arrangement of the type mentioned at the outset with improved usage properties.
• an electromedical electrode arrangement with at least one implantable cardioversion electrode for delivering cardioversion pulses to a target tissue, in particular to cardiac muscle tissue is proposed, which has the means and features of the independent claim directed to such an electrode arrangement.
• the cardioversion electrode of the electromedical electrode arrangement consists of a flexible, electrically conductive surface structure which is flat in the undeformed position of use and which is set up for flat contact with a target tissue.
• Such a flat structure can be applied particularly reliably to the target tissue of the heart to be treated.
• the flat structure can be placed in the body of the patient to be treated, for example on an outside of the heart, for example on the outside of an atrium of the heart to be treated.
• the flat structure can establish a comparatively large area of contact with the target tissue to be treated and can be reliably applied to the generally curved surfaces of the target tissue to be treated. In this way, sufficient contact can be established between the cardioversion electrode of the electrode arrangement and the tissue to be treated for gentle and safe cardioversion. On the one hand, this promotes the effectiveness of the cardioversion treatment and On the other hand, the large-area system allows cardioversion pulses to be delivered over a comparatively large area.
• the fabric can promote cardioversion with cardioversion pulses of lower intensity. Cardioversion pulses of lower intensity are generally perceived as less painful and often cause fewer side effects. In the best case scenario, pain during cardioversion treatment can be reduced or even completely avoided.
• the electrode arrangement according to the invention thus promotes effective and at the same time gentle cardioversion by means of an implanted cardioversion electrode.
• the electrode arrangement according to the invention is characterized by its simplified handling and application on the patient. The electrode arrangement can be easily applied and allows the use of an electromedical pulse generator, namely a pacer and/or cardioverter, at the patient's bed.
• the cardioversion electrode of the electrode arrangement consists of a flexible sheet structure
• the flat structure can stretch and deform, for example by pulling on the proximal end of the electrode arrangement, in such a way that during explantation an expansion of the flat structure oriented transversely to an explantation direction is reduced. This favors atraumatic explantation of the cardioversion electrode.
• the flat structure has an electrical resistance of less than 150 ohms, preferably less than 70 ohms. This can promote the delivery of sufficiently strong cardioversion impulses and protect the target tissue to be treated from injury protect .
• the fabric can have a longitudinal axis, in particular a longitudinal central axis, which runs in one plane when the fabric is undeformed.
• the flat structure is therefore flat in the undeformed starting position, but due to its flexibility it is deformable in such a way that it can be applied flatly to a target tissue to be treated.
• the flat structure can consist of a longitudinal structure, for example an electrical conductor, with changing bending directions and/or be sinusoidal.
• the longitudinal structure can be an electrical conductor, for example a stranded wire.
• the conductor can be bent, for example bent in a sinusoidal shape, in order to shape the sheet structure of the cardioversion electrode.
• the conductor is preferably not insulated, so that cardioversion pulses can be delivered via the conductor forming the flat structure.
• the fabric can be designed sinusoidally and/or consist of a longitudinal structure, for example a conductor that is bent with alternating bending directions, the fabric can be not only flexible, but also elastic. The elasticity of the fabric can promote the reliable contact of the fabric with a target tissue.
• the flat structure is formed from exactly one electrical conductor.
• the fabric it is also possible for the fabric to be formed from several electrical conductors for delivering cardioversion pulses.
• the exactly one or at least one conductor from which the fabric can be formed can have an electrical resistance that is less than 150 ohms, preferably less than 70 ohms. In this way, a flat structure with an electrical resistance that is less than 150 ohms, preferably less than 70 ohms, can be formed from the conductor.
• the conductor can have a longitudinal axis, in particular a longitudinal central axis, which, when the flat structure is undeformed, runs in a plane, for example in a central plane, of the flat structure and/or with a changing bending direction.
• a flat structure with a shape that can be described as a zigzag shape can be provided from the electrical conductor.
• the electrical conductor can be bent into the flat structure with alternating bending directions.
• the changing bending direction of the electrical conductor can give the fabric its flexibility and/or elasticity.
• the conductor can be bent in a sinusoidal shape to form a sinusoidal surface structure.
• the electrical conductor can have a diameter D of, for example, 0.1-0.5 mm. In one embodiment, the conductor can have a diameter D of 0.1-0.3 mm, for example a diameter D of 0.2 mm.
• the electrical conductor can have at least two adjacent and/or interconnected conductor sections which together form an angle a between 10° and 170°.
• the conductor can have at least two adjacent conductor sections, which together form an angle a between 30 ° and 90 ° or an angle a between 30 ° and 60 ° or an angle a of 35 ° on tension.
• Two adjacent conductor sections of the conductor can be connected to one another by a bending radius of, for example, 0.3 mm to 2 mm.
• the flat structure When not in a tensioned state, the flat structure can have a measurable length LI in the direction of its longitudinal axis of between 10 and 50 mm, in particular between 25 and 40 mm.
• the flat structure When not in a tensioned state, the flat structure can have an extension L2 of 5-30 mm, which can be measured transversely to its longitudinal axis, and/or can be formed from at least one conductor whose length is 40-140 mm.
• the fabric can have a stripped wire as at least one electrical conductor for delivering cardioversion impulses.
• the flat structure in particular the electrical conductor, can consist, for example, of stainless steel, of platinum, of a platinum alloy, of gold, of a gold alloy, of magnesium, of a magnesium alloy, of molybdenum or even of a molybdenum alloy.
• the use of stainless steel is particularly preferred because this material has been tested on patients for decades, has been found to be harmless to humans and, due to its resilience, flexibility and elasticity, is particularly suitable for the application for producing the previously explained fabric.
• the electrode arrangement has two fixing means between which the flat structure is arranged.
• the fixing means of the electrode arrangement are for fastening and/or tensioning of the fabric on a target tissue, in particular on the outside of the heart.
• the flat structure can be brought into flat contact as a cardioversion electrode on an outside of a target tissue to be treated and held there.
• the fabric is not only flexible but also elastic, the fabric can be stretched in its position of use on a target tissue to be treated using the two fixing means. Due to the elasticity, the fabric can then automatically attach itself to the target tissue and keep it in place against the retaining force of the two fixing means, thus ensuring reliable contact with the target tissue to be stimulated.
• the two fixing means thus promote the reliable contact of the flat structure of the electrode arrangement, which serves as a cardioversion electrode, with a beating heart.
• the flat contact of the fabric under tension can prevent the fabric or even parts of the fabric from detaching. This promotes reliable and gentle cardioversion treatment using the electrode arrangement.
• the flat structure has a distance of between 10 and 70 mm from at least one of the two fixing means or both fixing means.
• the fabric can be stretched onto a target tissue and/or adapted to an atrium size of a heart to be treated, in particular by means of the previously mentioned fixing means.
• the flat structure can cover an area, for example, between 30 mm 2 and 1600 mm 2 .
• the area covered by the flat structure can be calculated from the product of the longitudinal extension and transverse extension of the stretched flat structure.
• a distal fixing means of the electrode arrangement for fastening and/or clamping the fabric can be arranged distally of the fabric.
• the flat structure can be arranged at a distal end of the electrode arrangement or between a distal end of the electrode arrangement and the flat structure.
• the electrode arrangement can have at its distal end at least one positioning means, for example a heart needle, for positioning a fixation means, in particular the aforementioned fixation means, in the target tissue.
• a fixation means in particular the aforementioned fixation means
• the fixing means can be positioned there to anchor the target tissue. After successful positioning, the positioning means can be separated and removed.
• the electrode arrangement can have a connection line via which the flat structure can be connected to a stimulation transmitter.
• the electrode arrangement can have a connection means which is arranged or formed at the proximal end of the connection line.
• the connecting line can be connected to the fabric at a point that lies on a longitudinal axis, in particular on a longitudinal central axis of the fabric.
• the connecting cable can be used as a traction device, with the help of which the flat structure functioning as a cardioversion electrode is pulled out of its implanted position position of use can be explanted. If the
• Connecting line is connected to the fabric at a point which lies on a longitudinal central axis of the fabric, the fabric can be deformed by the pull during explantation in such a way that a cross-sectional reduction of the fabric is oriented transversely to the direction of pull and is preferably uniform. This can promote atraumatic explantation of the fabric.
• the electrode arrangement it is provided that it has at least one lateral electrode for delivering pacing pulses, which can also be referred to as pacemaker pulses.
• pacing pulses can also be delivered to the heart to be treated using the lateral electrode.
• the electrode arrangement can then take on a dual function and deliver not only cardioversion pulses, but also pacing pulses to the heart.
• the at least one lateral electrode of the electrode arrangement can be assigned at least one fixing means for fastening the lateral electrode to or in a target tissue. In this way, it is possible to reliably anchor the lateral electrode in the target tissue for the time during which the electrode arrangement is to be used to support a patient's cardiac function.
• the fixing means which is assigned to the lateral electrode, is one of at least two fixing means for fastening and/or clamping the flat structure.
• the fixing agent assigned to the lateral electrode has a dual function.
• the fixing agent is used to anchor the lateral electrode in the target tissue; on the other hand, it also serves to reliably hold the flat structure serving as a cardioversion electrode in its position of use.
• the at least one lateral electrode and the at least one cardioversion electrode can be arranged at a freely selectable angle relative to one another.
• the lateral electrode and the cardioversion electrode together form an angle between 1° and 170°.
• the previously mentioned connecting cable, the lateral electrode and the cardioversion electrode can together form a Y shape in the implanted position of use.
• the electrode arrangement in particular the at least one cardioversion electrode and/or the at least one lateral electrode, can be explantable by pulling on a proximal end of the electrode arrangement, in particular on a proximal end of the previously mentioned connection line.
• the conductor from which the fabric can consist can be a be the electrical conductor of the connecting cable.
• the flat structure can therefore consist of an electrical conductor, in particular a stranded wire, of the connecting cable.
• FIG. 1 shows a side view of a first embodiment of an electrode arrangement with an implantable cardioversion electrode, which consists of a flexible, electrically conductive fabric that is flat in the undeformed initial position and is set up for flat contact with a target tissue,
• Figure 2 a variant of the electrode arrangement shown in Figure 1, with a lateral electrode present in addition to the cardioversion electrode, via which pacing pulses can be delivered to a target tissue, and
• FIG 3 an enlarged detailed view of the fabric of the electrode arrangements shown in Figures 1 and 2.
• Each electrode arrangement 1 shown is set up to deliver electrical pulses to a target tissue, namely heart muscle tissue.
• Each electrode arrangement 1 shown has an implantable cardioversion electrode 2 for delivering cardioversion pulses.
• the cardioversion electrodes 2 each consist of a flexible, electrically conductive surface structure 3, which is flat in the undeformed starting position and which is set up for flat contact with a target tissue.
• the fabric 3 is elastic and has an electrical resistance of less than 150 ohms, preferably less than 70 ohms.
• the flat structure 3 has a longitudinal axis 4, namely a longitudinal central axis, which runs in one plane when the flat structure 3 is undeformed.
• the flat structure 3 is formed from a longitudinal structure, namely from an electrical conductor 5 with alternating bending directions and is therefore zigzag-shaped. In the exemplary embodiments of flat structures 3 shown in the figures, these consist of exactly one electrical conductor 5, which is set up to deliver cardioversion pulses.
• the conductor 5 has an electrical resistance that is less than 150 ohms, preferably less than 70 ohms. In this way, a flat structure 3 can be provided with the conductor 5, which has an electrical resistance of less than 150 ohms, preferably less than 70 ohms, which is favorable for cardioversion.
• a longitudinal axis of the conductor 5 is arranged in a plane, in particular in a central plane, of the flat structure 3 and runs through this central plane with alternating bending directions.
• the conductor 5 has a diameter D of 0.1-0.5 mm.
• the diameter of the conductor 5 can be, for example, 0.1-0.3 mm or even 2 mm.
• the Conductor 5 has adjacent conductor sections 6 which are connected to one another and together span an angle a between 10° and 170°.
• the angle a is approximately. 35°.
• the adjacent conductor sections 6 are connected to one another via a bending radius R.
• the bending radius R can be between 0.3 mm and 2 mm, for example.
• the flat structure 3 When not in a tensioned state, the flat structure 3 can, for example, have a length LI measurable in the direction of its longitudinal axis 4 of between 10 and 50 mm. When not in a tensioned state, the flat structure has an expansion L2 of, for example, 5-30 mm, which can be measured transversely to its longitudinal axis 4.
• the electrical conductor 5 from which the fabric 3 is made can have a length of, for example, 40-140 mm.
• Figure 3 also indicates a linear extension L3, which the fabric 3 can have in a stretched, stretched state.
• the linear expansion L3 is greater than the linear expansion LI and can be a multiple of the linear expansion LI of the fabric 3 in the non-stretched state, for example one and a half times, two times, two and a half times or even three times.
• the flat structure 3 has a stripped wire as an electrical conductor 5 for delivering cardioversion pulses.
• the flat structure 3, namely its electrical conductor 5, consists of stainless steel.
• the electrode arrangement 1 has two fixing means 7, 8, between which the flat structure 3 is arranged.
• the fixing means 7, 8 serve to tension the fabric 3 on the outside of the heart and to fasten it in a tensioned manner.
• the flat structure 3 is at a distance of between 10 and 70 mm from at least one of the two fixing means 7, 8.
• the flat structure 3 is also arranged between two fixing means 7 and 8 of the electrode arrangement 1 which are comparable in terms of their function. These fixing means 7 and 8 also serve to fasten and/or tension the fabric 3 on a target tissue, for example on the outside of the heart.
• the flat structure 3 can be stretched by the two fixing means 7 and 8 and can be adapted to the atrial size of a heart to be treated by stretching and stretching the flat structure 3.
• the flat structure 3 can cover an area between 30 mm 2 and 1600 mm 2 . This area can correspond to the product of the previously mentioned dimensions L2 and L3 of the stretched and stretched fabric 3.
• the distal fixing means 8 of the two fixing means 7 and 8 of the electrode arrangement 1 is arranged distally of the flat structure 3, for example between a distal end 9 of the electrode arrangement 1 and the flat structure 3.
• the electrode arrangement 1 has at its distal end 9 an anchoring means 10 in the form of a heart needle. With the help of the anchoring means 10, the electrode arrangement 1 can be anchored in the target tissue.
• the positioning means 10 serves to bring the distal fixation means 8 into its position of use in the target tissue. After that it can Positioning means 10 are separated and removed.
• the electrode arrangement 1 also has a further needle 12, with which the electrode arrangement 1, namely its connecting lead 13, can be pierced through the body wall of a patient and guided outwards.
• the flat structure 3 can be connected to a stimulation transmitter via the connecting line 13.
• the connecting line 13 is connected to the fabric 3 at a point 14, which lies on the longitudinal central axis 4 of the fabric 3.
• Point 14 can also be referred to as the connection point.
• the conductor 5 can be an electrical conductor, in particular a stranded wire, of the connecting cable 13.
• the flat structure 3 can therefore consist of an electrical conductor, in particular a stranded wire, the connecting cable 13.
• the previously mentioned point 14 then defines the transition between the connection line 13 and the flat structure 3.
• each of the electrode arrangements 1 shown has a connection means 16 with which the respective connection line 13 can be connected to a stimulation transmitter.
• the connection means 16 can be, for example, a connection plug.
• the electrode arrangement 1 shown in Figure 2 has, in addition to the cardioversion electrode 2, an implantable lateral electrode 15.
• the lateral electrode 15 is used to deliver pacing pulses to the target tissue. The delivery of pacing pulses can take place in conjunction with the cardioversion electrode 2.
• Electrode arrangement 1 is assigned the fixing means 7 of the two fixing means 7 and 8.
• the fixing agent 7 is therefore also used to fasten the lateral electrode 15 in a target tissue.
• the fixing means 7 assigned to the lateral electrode 15 is therefore one of the two fixing means 7 and 8, which serves to fasten and/or clamp the flat structure 3.
• This fixation means 7 can be introduced into the target tissue using an anchoring means 10 which is arranged distally from the lateral electrode 15.
• This positioning means 10 is also designed as a heart needle.
• Figure 2 indicates that the lateral electrode 15 and the at least one cardioversion electrode 2, namely the flat structure 3, can be arranged at a freely selectable angle relative to one another, for example at an angle between 1° and 170°.
• the arrangement of the lateral electrode 15 and the cardioversion electrode 2 in an angular range of 1° to 170° and preferably at an angle to one another that is less than 90° can promote the gentle and preferably atraumatic explanation of the electrode arrangement.
• the lateral electrode 15, the cardioversion electrode 2 and the connecting line 13 then form a Y-shape.
• the electrode arrangement 1, namely the cardioversion electrode 2 and the lateral electrode 15, can be explanted by pulling on the proximal end 11 of the electrode arrangement 1, namely by pulling on the proximal end 11 of the connecting line 13 of the electrode arrangement 1.
• the electrode arrangement 1 shown in FIG. 1 can also be explanted in the same way by pulling on the connecting line 13.
• Electromedical electrode arrangement 1 which has at least one implantable cardioversion electrode 2, which is made of a flexible, undeformed

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

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• 2022
  • 2022-04-21 DE DE102022109680.7A patent/DE102022109680A1/de active Pending
• 2023
  • 2023-04-12 JP JP2024560687A patent/JP2025513244A/ja active Pending
  • 2023-04-12 CA CA3255731A patent/CA3255731A1/en active Pending
  • 2023-04-12 EP EP23717571.6A patent/EP4395878B1/de active Active
  • 2023-04-12 WO PCT/EP2023/059541 patent/WO2023202925A1/de not_active Ceased

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