WO2010038178A1 - Electrode pour dispositif médical implantable - Google Patents

Electrode pour dispositif médical implantable Download PDF

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Publication number
WO2010038178A1
WO2010038178A1 PCT/IB2009/054199 IB2009054199W WO2010038178A1 WO 2010038178 A1 WO2010038178 A1 WO 2010038178A1 IB 2009054199 W IB2009054199 W IB 2009054199W WO 2010038178 A1 WO2010038178 A1 WO 2010038178A1
Authority
WO
WIPO (PCT)
Prior art keywords
electrode
shielding
layers
medical device
implantable medical
Prior art date
Application number
PCT/IB2009/054199
Other languages
English (en)
Inventor
Pieter G. Blanken
Dirk W. Harberts
Michel M. J. Decre
Hubert C. F. Martens
Original Assignee
Koninklijke Philips Electronics N.V.
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 Koninklijke Philips Electronics N.V. filed Critical Koninklijke Philips Electronics N.V.
Publication of WO2010038178A1 publication Critical patent/WO2010038178A1/fr

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61NELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00Electrotherapy; Circuits therefor
    • A61N1/02Details
    • A61N1/04Electrodes
    • A61N1/05Electrodes for implantation or insertion into the body, e.g. heart electrode
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61NELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00Electrotherapy; Circuits therefor
    • A61N1/02Details
    • A61N1/08Arrangements or circuits for monitoring, protecting, controlling or indicating
    • A61N1/086Magnetic resonance imaging [MRI] compatible leads

Definitions

  • This invention relates to an electrode for an implantable medical device comprising at least one electrically conducting electrode wire surrounded by a shield for shielding the electrode wire against electromagnetic radiation. This invention further relates to implantable medical device comprising such an electrode and to a method for producing such an electrode.
  • Such an electrode is, e.g., known from US patent number 5,217,010.
  • the US patent describes a pacemaker or ECG monitor for implantation in a patient.
  • the device comprises an electronic circuit in a metal shielding case.
  • a lead runs from the electronic circuitry through the patient's body tissue.
  • the lead is a relatively robust wire which is designed to withstand continuous movements of body tissue.
  • the electromagnetic radiation caused by an MRI system may impede the proper functioning of the pacemaker or ECG monitoring device.
  • the electrode will function as an antenna for the electromagnetic radiation and a resulting voltage over the electrode may harm the device electronics of the pacemaker or ECG monitor.
  • the device electronics are shielded by a metal case and the lead is also surrounded by a shield.
  • the case shield may contain multiple alternating metal and insulating layers.
  • a more flexible electrode In some situations, it may be desirable to use a more flexible electrode. For example, in implantable deep brain stimulation devices it is important to use a flexible electrode to prevent damage of the electrode in the body.
  • this object is achieved by providing an electrode according to the opening paragraph, wherein the shield comprises multiple shielding layers with electrically conductive material alternated with dielectric layers.
  • the thin layers provide the flexibility which is important for, e.g., electrodes of implantable deep brain stimulation devices.
  • the shield is enabled to provide sufficient shielding of the electrode against the electromagnetic radiation of, e.g. an MRI scanner or a cellular phone.
  • the shielding case in the above mentioned US patent also uses a multi-layered shield. It is however not obvious for a skilled person to apply that multi- layered shield to the electrode.
  • the shield of the case in the US patent is multi-layered in order to prevent the case from heating caused by currents produced by the electromagnetic field of the MRI system. Such induced currents increase linearly with the flux which is a product of magnetic field and surface area. The heat generation depends on the square of the currents.
  • an implantable medical device comprising at least one electrode as described above and device electronics coupled to the electrode wire.
  • the implantable medical device may, e.g., be a pacemaker, a defibrillator, a urinary implant, a neurostimulation device, a spinal cord stimulator or a muscle stimulator.
  • the device electronics is surrounded by a shielding case for shielding the device electronics against electromagnetic radiation, the shielding case being electrically coupled to at least one of the shielding layers of the shield surrounding the electrode wire.
  • One of the advantages of using an electrode according to the invention is that its flexibility allows for producing implantable medical devices with attached thereto one or more electrodes of a standard length. Such medical devices and their electrodes can be implanted into the human body and any excess of electrode length may thereafter be rolled up or folded up and hidden under the skin or within the medical device, e.g. in a special compartment which is provided for that purpose.
  • a method for producing an electrode for an implantable medical device comprising using thin film deposition and/or photolithography for applying multiple shielding layers with electrically conductive material alternated with dielectric layers, thereafter applying at least one electrically conducting electrode wire, and thereafter applying multiple shielding layers with electrically conductive material alternated with dielectric layers.
  • Thin film deposition and photolithography allow manufacturing of an electrode with accurately positioned and very thin layers of shielding material, dielectric layers and electrode wire. As a result a very flexible electrode is provided with optimal shielding properties.
  • Figure 1 shows a cross section of an embodiment of an electrode according to the invention
  • Figure 2 schematically shows an implantable medical device with a shielded electrode
  • FIG. 3 schematically shows an implantable medical device with three separately shielded electrodes
  • FIG. 4 schematically shows an implantable medical device with three jointly shielded electrodes
  • Figure 5 schematically shows a further embodiment of an implantable medical device with three electrodes
  • Figure 6 schematically shows an implantable medical device with a twisted electrodes pair
  • Figure 7 shows a flow diagram of the method according to the invention.
  • FIG. 1 shows a cross section of an embodiment of an electrode 10 according to the invention.
  • the electrode comprises four electrode wires 11 of an electrically conducting material, such as platinum, iridium, gold or silicon.
  • the electrode wires 11 are surrounded by multiple layers of shielding material 12 and dielectric material 13.
  • the shielding layers 12 may, e.g., comprise platinum, iridium, gold, silicon or titanium.
  • the dielectric layers 13 comprise, e.g., polyurethane, polyimide, silicon oxide or silicon nitride.
  • each electrode wire 11 is surrounded by a separate shielding layer 12.
  • a common shielding layer 14 surrounds two electrodes 11. Different shielding layers 12, 14 are separated by dielectric layers 13.
  • the shielding 12, 14 shield the electrode wire 11 against electromagnetic radiation from, e.g., an MRI scanner or mobile communication devices, thereby preventing that the electrode wire will operate as a large antenna.
  • a single wire may be surrounded by multiple shielding layers that only enclose that single wire. Then the second shielding layer is not a common shielding layers surrounding two electrodes.
  • FIG. 2 schematically shows an implantable medical device with a shielded electrode 20.
  • the medical device may, e.g., be a pacemaker, an ECG monitor, a defibrillator, a neurostimulating device or a urinary implant.
  • the shield 22 is displayed as a simple cylinder. However, according to the invention, the shield 22 does comprise multiple shielding layers alternated with dielectric layers.
  • the tip of the electrode wire 21 is not shielded, because it should be able to make contact with the body tissue in which the medical device is implanted.
  • One end of the electrode wire 21 is coupled to the device electronics 27.
  • the device electronics 27 are powered by a small battery 26.
  • the battery 26 and the device electronics 27 are shielded against electromagnetic radiation from, e.g.
  • the device electronics 27 and the battery 26 are comprised in a shielding case 24.
  • the shielding case 24 may be made of a single conductive plate which is thick enough to provide sufficient shielding.
  • a layered shielding case 24 may be used in order to avoid excessive heating of the shielding case 24. Coupling of the shielding case 24 to the shield 22 of the electrode wire 21 may be provided for avoiding potential differences between different parts of the implantable medical device.
  • the shielding case 24 also comprises layered shielding, different shielding layers of the electrode shield 22 may be coupled to specific layers in the shielding case 24.
  • Figure 3 schematically shows an implantable medical device with three separately shielded electrodes.
  • Each electrode wire 31 is surrounded by its own multi-layered shielding 32.
  • the shields 32 are all coupled to a shielding 34 of the device electronics.
  • Figure 4 schematically shows an implantable medical device with three jointly shielded electrodes. All three electrode wires 41 are jointly surrounded by a common multi- layered shielding 42. Preferably the shield 42 is coupled to a shielding 44 of the device electronics.
  • Figure 5 schematically shows a further embodiment of an implantable medical device with three electrodes.
  • One electrode wire 51 is surrounded by its own multi-layered shielding 52.
  • Two other electrode wires 57 are jointly surrounded by a common multi-layered shielding 56.
  • the shields 52, 56 are both coupled to a shielding 54 of the device electronics.
  • FIG 6 schematically shows an implantable medical device with a twisted pair of electrodes 67.
  • One electrode wire 61 is surrounded by its own multi-layered shielding 62.
  • Two other electrode wires 67 are joined as a twisted pair and are jointly surrounded by a common multi-layered shielding 66.
  • the shields 62, 66 are both coupled to a shielding 64 of the device electronics.
  • Figure 7 shows a flow diagram of the method according to the invention. The method comprises three steps 71, 72, 73.
  • a first step 71 multiple shielding layers with electrically conductive material are provided which shielding layers are alternated with dielectric layers. For forming these layers, thin film deposition and photolithography may be used.
  • this first step 71 multiple shielding layers and dielectric layers are stacked.
  • this first step 71 begins and ends with applying a dielectric layer for avoiding contact between shielding layers and the electrode wire or between shielding layers and the body tissue in which the device is implanted.
  • a second step 72 at least one electrically conducting electrode wire is put upon the available shielding layers and dielectric layers.
  • a third step 73 the first step 71 of applying shielding layers and dielectric layers is repeated.
  • the shielding layers applied in the third step 73 are coupled to the shielding layers applied in the first step in order to ensure that the at least one electrode wire is shielded against electromagnetic radiations from all sides.
  • the resulting electrode may then be applied to a unit with device electronics for completing the implantable medical device.

Landscapes

  • Health & Medical Sciences (AREA)
  • Cardiology (AREA)
  • Heart & Thoracic Surgery (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

La présente invention concerne une électrode (10, 20) pour un dispositif médical implantable. Ladite électrode comprend au moins un fil électrode électroconducteur (11, 21, 31, 41, 51, 61, 67) entouré d'une protection (32, 42, 52, 56, 62, 66) destinée à protéger le fil électrode (11, 21, 31, 41, 51, 57, 61, 67) du rayonnement électromagnétique. Ladite protection (32, 42, 52, 56, 62, 66) comprend de multiples couches de protection (12, 14), un matériau électroconducteur étant présent en alternance avec des couches diélectriques (13). En outre, la présente invention concerne un dispositif médical implantable (200, 300, 400, 500, 600) comprenant une telle électrode (10, 20). Par ailleurs, l'invention porte sur un procédé de production de ladite électrode (10, 20).
PCT/IB2009/054199 2008-10-02 2009-09-25 Electrode pour dispositif médical implantable WO2010038178A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
EP08165724.9 2008-10-02
EP08165724 2008-10-02

Publications (1)

Publication Number Publication Date
WO2010038178A1 true WO2010038178A1 (fr) 2010-04-08

Family

ID=41395816

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/IB2009/054199 WO2010038178A1 (fr) 2008-10-02 2009-09-25 Electrode pour dispositif médical implantable

Country Status (1)

Country Link
WO (1) WO2010038178A1 (fr)

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20130261423A1 (en) * 2010-10-29 2013-10-03 Mika Herrala Method and a device for measuring muscle signals
WO2019173572A1 (fr) * 2018-03-09 2019-09-12 The Board Of Trustees Of The Leland Stanford Junior University Maillage neuronal souple à faible invasivité implanté par fixation temporaire à un microfil à profil bas

Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4442315A (en) * 1980-11-17 1984-04-10 Fukuda Denshi Kabushiki Kaisha X-Ray transmissive electrode-shielded wire assembly and manufacture thereof
GB2185403A (en) * 1985-12-10 1987-07-22 Cherne Ind Flexible and disposable electrode assembly
US20030144719A1 (en) * 2002-01-29 2003-07-31 Zeijlemaker Volkert A. Method and apparatus for shielding wire for MRI resistant electrode systems
WO2005102447A1 (fr) * 2004-03-30 2005-11-03 Medtronic, Inc. Derivation implantable sure pour l'irm
WO2007047966A2 (fr) * 2005-10-21 2007-04-26 Surgi-Vision, Inc. Systemes de derivation a impedance elevee compatibles avec des systemes irm et procedes associes
US20070106332A1 (en) * 2005-11-04 2007-05-10 Stephen Denker MRI Compatible Implanted Electronic Medical Device
US20080195187A1 (en) * 2007-02-14 2008-08-14 Bernard Li Discontinuous conductive filler polymer-matrix composites for electromagnetic shielding

Patent Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4442315A (en) * 1980-11-17 1984-04-10 Fukuda Denshi Kabushiki Kaisha X-Ray transmissive electrode-shielded wire assembly and manufacture thereof
GB2185403A (en) * 1985-12-10 1987-07-22 Cherne Ind Flexible and disposable electrode assembly
US20030144719A1 (en) * 2002-01-29 2003-07-31 Zeijlemaker Volkert A. Method and apparatus for shielding wire for MRI resistant electrode systems
WO2005102447A1 (fr) * 2004-03-30 2005-11-03 Medtronic, Inc. Derivation implantable sure pour l'irm
WO2007047966A2 (fr) * 2005-10-21 2007-04-26 Surgi-Vision, Inc. Systemes de derivation a impedance elevee compatibles avec des systemes irm et procedes associes
US20070106332A1 (en) * 2005-11-04 2007-05-10 Stephen Denker MRI Compatible Implanted Electronic Medical Device
US20080195187A1 (en) * 2007-02-14 2008-08-14 Bernard Li Discontinuous conductive filler polymer-matrix composites for electromagnetic shielding

Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20130261423A1 (en) * 2010-10-29 2013-10-03 Mika Herrala Method and a device for measuring muscle signals
US10357170B2 (en) * 2010-10-29 2019-07-23 Fibrux Oy Method and a device for measuring muscle signals
WO2019173572A1 (fr) * 2018-03-09 2019-09-12 The Board Of Trustees Of The Leland Stanford Junior University Maillage neuronal souple à faible invasivité implanté par fixation temporaire à un microfil à profil bas

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