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EP2809388A1 - Fixation d'électrodes myocardiques implantables - Google Patents

Fixation d'électrodes myocardiques implantables

Info

Publication number
EP2809388A1
EP2809388A1 EP13707534.7A EP13707534A EP2809388A1 EP 2809388 A1 EP2809388 A1 EP 2809388A1 EP 13707534 A EP13707534 A EP 13707534A EP 2809388 A1 EP2809388 A1 EP 2809388A1
Authority
EP
European Patent Office
Prior art keywords
fixing
distal
electrode
fixation
proximal
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.)
Withdrawn
Application number
EP13707534.7A
Other languages
German (de)
English (en)
Inventor
Peter Osypka
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.)
Individual
Original Assignee
Individual
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 Individual filed Critical Individual
Publication of EP2809388A1 publication Critical patent/EP2809388A1/fr
Withdrawn legal-status Critical Current

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/02—Details
    • A61N1/04—Electrodes
    • A61N1/05—Electrodes for implantation or insertion into the body, e.g. heart electrode
    • A61N1/0587—Epicardial electrode systems; Endocardial electrodes piercing the pericardium
    • A61N1/0595—Temporary leads
    • 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

Definitions

  • the invention relates to the fixation of implantable myocardial temporary electrodes, which enable monitoring and / or stimulation of the heart in humans and / or defibrillation in atrial fibrillation after cardiac surgery in conjunction with a pacemaker or defibrillator connectable outside the body and at any time easily after use are removable by train.
  • Temporary myocardial electrodes allow external stimulation of the heart following cardiac surgery. Such electrodes have been known for many years and are routinely used to stimulate the atria and ventricles after any open heart surgery. The fixation on the heart must be done in such a way that on the one hand the electrodes are stably fixed during the time in the intensive care unit, on the other hand they have to be easily pulled out through a small opening in the abdominal wall of the patient to the outside.
  • the fixation of the poles of temporary myocardial electrodes is done so far by anchor, eyelet, helix, V-shape or simple Zig-Zag- form of the pole.
  • anchor, eyelet, helix, V-shape or simple Zig-Zag- form of the pole For the temporary fixation of the electrodes in the myocardium, the various methods commonly used today are shown in FIG.
  • the fixation with the plastic anchor is very popular, (see Fig. 1, 2nd illustration from the left)
  • the disadvantage here is the indeterminate surface of the electrode.
  • the anchor is cut out of the insulation of the strand into three strips. The remainder of the remaining strand forms the cathode Pol. Since this pole face is very small, every small physical movement causes a threshold change.
  • an electrode pole in the tissue may shift distally or proximally due to the beating heart or manipulation during cardiac surgery. This can lead to a stimulation failure. It is therefore an object to provide a fixation of heart wires according to the type described above, which allows a good anchoring of the heart wires and a stable temporary stimulation of the heart.
  • Displacement (dislocation) is secured, wherein the electrode pole (2) is secured either with at least one distal and at least one proximal fixing element or wherein the electrode pole is secured by two distal fixing elements.
  • the fixation device described above is suitable for use in a surgical procedure to temporarily fix an electrode pole (2) in the myoakardial tissue (3).
  • the distal and proximal fixation elements may be identical or different.
  • fixing elements are different, for example, a fixing element in
  • Zig-Zag shape can be combined with an anchor or a knot.
  • Fig. 5-9 show exemplary combination options.
  • the electrode poles are made of biocompatible conductive materials such as nitinol, a stainless steel strand that may be coated with a noble metal (gold or platinum) or conductive plastic materials. Also MRI (magnetic resonance imaging) suitable electrodes can be used.
  • the shape of the electrode poles (2) is arbitrary. Common are poles of straight wire, poles in zig-zag form, as a loop, as a hook, as a helix, as a metal sleeve. Fig. 1 shows conventional forms.
  • the myocardial electrode can be unipolar or multipolar.
  • Suitable counterelectrode are all known indifferent electrodes, such as sleeves, filaments, nets, braids of metal.
  • the counter electrode has the shape of a coil and is placed outside the heart.
  • Fig. 1b Possible arrangement of a known temporary electrode on the heart.
  • Fig. 2 Temporary myocardial electrode with a zig-zag pole and a zig-zag
  • Fig. 3 Temporary myocardial electrode with a zig-zag pole and two separate zig-zag fixations.
  • Fig. 4 Temporary myocardial electrode with a straight wire as a pole and with two separate anchor fixings.
  • Fig. 5 Temporary myocardial electrode with a metal sleeve as a pole and with a distal anchor fixation and a proximal Zig-Zag fixation.
  • Fig. 6 Temporary myocardial electrode with a coil as a pole and with a distal anchor fixation and a proximal node as fixation
  • Fig. 7 Temporary myocardial electrode with a metal sleeve as a pole and with a distal Zig-Zag fixation and a proximal node as fixation.
  • Fig. 8 Temporary myocardial electrode with a straight wire as a pole and with a distal combination of two fixation elements in zig-zag form and in anchor form.
  • Fig. 9 Temporary myocardial electrode with a straight wire as a pole and a distal combination of two fixation elements Zig-Zag + anchor and a proximal Zig-Zag fixation.
  • FIG. 1a shows an overview of common temporary electrodes for the stimulation of the heart after a heart operation in the form of poles made of metal or plastic, which are also sometimes used simultaneously as a fixation on the heart.
  • Fig. 1b shows how an electrode is placed on the heart. With the help of the breast needle (10), the electrode is usually led through the chest wall to the outside and connected there to an external pacemaker.
  • Electrode poles come.
  • shifts in the electrode pole may occur both distally and proximally.
  • Fig. 2 shows a known temporary electrode with a Zig-Zag pole (2) and a distal Zig Zag fixation (4d).
  • the Zig-Zag-shaped electrode pole (2) is drawn through the myocardium until it partially protrudes from the myocardial tissue.
  • the non-isolated zig-zag part forms the actual myocardial tissue (3)
  • the isolated zig-zag part (4d) is used for fixation. After fixation, the needle of the heart (1) is cut off.
  • FIG. 3 shows by way of example a temporary myocardial electrode according to the invention with two separate isolated Zig-Zag fixations, distal (4d) and proximal (4p).
  • the fixations prevent the electrode pole (2) from moving distally or proximally, thus ensuring reliable stimulation.
  • the non-isolated Zig-Zag electrode part forms the actual electrodes Pol (2) in the myocardial tissue (3).
  • FIG. 4 shows, by way of example, a temporary myocardial electrode with two separate armature fixations distal (5d) and proximal (5p) and a straight electrode pole (2) lying in the myocardium (3). Again, prevent the two isolated molded armature (5d and 5p) an unwanted displacement of the Elektrodenpols (2).
  • Anchoring is achieved by splicing the anchors. With the heart needle, the electrode pole is pulled through the myocardium until the distal anchor can be seen. Pulling back splices off the distal anchor.
  • FIG. 5 shows by way of example a temporary myocardial electrode with a distal anchor fixation (5d) and a proximal Zig-Zag fixation (4p) and one in the myocardium (3).
  • lying electrode pole (2) which is designed as a metal sleeve.
  • anchor (5d) and the Zig-Zag fixation (4p) prevent unwanted displacement of the electrode pole (2).
  • the fixation elements are insulated.
  • FIG. 6 shows by way of example a temporary myocardial electrode with a distal anchor fixation (5d) and a proximal node (6p) as fixation and an electrode pole (2) located in the myocardium (3), which is designed as a metal coil.
  • anchor (5d) and node (6p) prevent unintentional displacement of the electrode pole (2).
  • Fig. 7 shows by way of example a temporary myocardial electrode with a distal fixation in Zig-Zag form (4d) and a proximal node (6p). Again, the Zig-Zag fixation (4d) and the node (6p) prevent unwanted displacement of the Elektrodenpols (2).
  • FIG 8 shows a combination of two distal fixation elements, an anchor fixation (5d) and a zig-zag (4d) fixation at the distal end of the electrode pole (2).
  • an anchor fixation (5d)
  • a zig-zag (4d) fixation at the distal end of the electrode pole (2).
  • the anchor is cut out of the insulation of the stainless steel braid pole into three strips.
  • the anchor must remain connected to the proximal part of the insulation via an isolation strip that runs parallel to the pole to hold the anchor.
  • the heart wires are pulled out of the heart and thorax. It is essential that the anchor is removed with and not the electrode strand alone from the anchor fixing slips and is removed, while the anchor itself remains at the heart.
  • Fixation prevents the electrode strand from slipping out of the anchor fixation. Thus, it is even possible to dispense with the insulation strip. This also has the advantage that the surface of the existing of the stainless steel strand Elektrodenpols is greater and thus a secure contact between pole and heart muscle tissue is guaranteed.
  • Fig. 9 shows a combination of three fixing elements.
  • the temporary myocardial electrode pole (2) is secured distally by a combination of two fixation elements (anchor (5d) -Zig-Zag (4d)).
  • Proximal is a fixing element in zig-zag form (4p). Again, Zig-Zag (4p) and Anker-Zig-Zag (4d-5d) prevent unintended displacement of the electrode pole (2).
  • Combinations as shown in Fig. 1, may exist.
  • Fig. 10 shows the field strength distribution (100) of an electrode assembly assembly with the indifferent electrode (10a, 10b) positioned outside of the heart.
  • the indifferent electrode is formed in part (10a) as a metallic bare helix (30).
  • the helix may also be embedded in a protective tube made of plastic, preferably made of silicone (40), which has openings (50) to the outside, so that between the unipolar electrode (cathode) (2) and the indifferent electrode through the openings of an electric Electricity can flow.
  • the indifferent electrode is positioned so that a direct
  • Electrode contact with the heart is avoided.

Landscapes

  • 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)

Abstract

L'invention concerne un dispositif de fixation pour des électrodes myocardiques implantables qui ont au moins un pôle (2) d'électrode, les électrodes permettant une surveillance et/ou une stimulation du coeur chez l'homme en relation avec un stimulateur cardiaque pouvant être raccordé à l'extérieur du corps et les électrodes pouvant être facilement enlevées par une traction à tout moment après une utilisation réussie. Le dispositif de fixation est caractérisé en ce que le pôle (2) d'électrode est assuré contre un déplacement involontaire (dislocation) par une combinaison d'au moins deux éléments de fixation, le pôle (2) d'électrode étant bloqué par au moins un élément de fixation distal et au moins un élément de fixation proximal ou le pôle d'électrode étant bloqué par deux éléments de fixation distaux.
EP13707534.7A 2012-02-04 2013-01-14 Fixation d'électrodes myocardiques implantables Withdrawn EP2809388A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
DE201220001217 DE202012001217U1 (de) 2012-02-04 2012-02-04 Fixierung von implantierbaren myokardialen Elektroden
PCT/DE2013/000015 WO2013113303A1 (fr) 2012-02-04 2013-01-14 Fixation d'électrodes myocardiques implantables

Publications (1)

Publication Number Publication Date
EP2809388A1 true EP2809388A1 (fr) 2014-12-10

Family

ID=45936125

Family Applications (1)

Application Number Title Priority Date Filing Date
EP13707534.7A Withdrawn EP2809388A1 (fr) 2012-02-04 2013-01-14 Fixation d'électrodes myocardiques implantables

Country Status (3)

Country Link
EP (1) EP2809388A1 (fr)
DE (2) DE202012001217U1 (fr)
WO (1) WO2013113303A1 (fr)

Families Citing this family (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN113907761B (zh) * 2021-10-09 2024-05-07 中国人民解放军军事科学院军事医学研究院 用于刺激与记录的双极植入式肌电电极组件及其应用方法
DE102022109680A1 (de) 2022-04-21 2023-10-26 Osypka Ag Elektromedizinische Elektrodenanordnung

Family Cites Families (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE3412950A1 (de) * 1984-04-06 1985-10-17 Peter Dr.-Ing. 7889 Grenzach-Wyhlen Osypka Chirurgische elektrode
US5241957A (en) * 1991-11-18 1993-09-07 Medtronic, Inc. Bipolar temporary pacing lead and connector and permanent bipolar nerve wire
US6434431B1 (en) * 2000-01-20 2002-08-13 Medtronic, Inc. Intramuscular medical electrical lead with fixation member
US7499757B2 (en) * 2003-10-24 2009-03-03 Cardiac Pacemakers, Inc. Absorbable myocardial lead fixation system
US8406901B2 (en) * 2006-04-27 2013-03-26 Medtronic, Inc. Sutureless implantable medical device fixation
US8123668B2 (en) * 2006-09-28 2012-02-28 Bioventrix (A Chf Technologies' Company) Signal transmitting and lesion excluding heart implants for pacing defibrillating and/or sensing of heart beat

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
See references of WO2013113303A1 *

Also Published As

Publication number Publication date
DE202012001217U1 (de) 2012-03-14
DE112013000843A5 (de) 2014-10-16
WO2013113303A1 (fr) 2013-08-08

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