WO2003092798A2 - Appareil et procede de montage d'un fil electrique - Google Patents

Appareil et procede de montage d'un fil electrique Download PDF

Info

Publication number
WO2003092798A2
WO2003092798A2 PCT/US2003/010034 US0310034W WO03092798A2 WO 2003092798 A2 WO2003092798 A2 WO 2003092798A2 US 0310034 W US0310034 W US 0310034W WO 03092798 A2 WO03092798 A2 WO 03092798A2
Authority
WO
WIPO (PCT)
Prior art keywords
vessel
electrode
pace
electrical lead
fixation
Prior art date
Application number
PCT/US2003/010034
Other languages
English (en)
Other versions
WO2003092798A3 (fr
Inventor
Roger Dahl
Duane Zytkovicz
Original Assignee
Medtronic, Inc.
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 Medtronic, Inc. filed Critical Medtronic, Inc.
Publication of WO2003092798A2 publication Critical patent/WO2003092798A2/fr
Publication of WO2003092798A3 publication Critical patent/WO2003092798A3/fr

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/02—Details
    • A61N1/04—Electrodes
    • A61N1/05—Electrodes for implantation or insertion into the body, e.g. heart electrode
    • A61N1/056—Transvascular endocardial electrode systems
    • 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
    • A61N2001/0585—Coronary sinus electrodes

Definitions

  • This invention generally relates to an implantable medical device and, in particular, to a method and apparatus for anchoring vasculature leads using radio frequency energy.
  • implantable medical devices Since the introduction of the first implantable pacemakers in the 1960s, there have been considerable advancements in both the fields of electronics and medicine, such that there is presently a wide assortment of commercially available body-implantable electronic medical devices.
  • the class of implantable medical devices now includes therapeutic and diagnostic devices, such as pacemakers, cardioverters, defibrillators, neural stimulators, and drug administering devices, among others.
  • Today's state-of-the-art implantable medical devices are vastly more sophisticated and complex than their early counterparts, and are capable of performing significantly more complex tasks. The therapeutic benefits of such devices have been well proven.
  • an electrical lead in one aspect of the present invention, includes a coil disposed at a distal end of the electrical lead, the coil having an undulated shape in its free state and a fixation electrode disposed on and electrically coupled with the coil.
  • the electrical lead further includes a pace/sense electrode disposed on the coil distally from the fixation electrode and electrically isolated from the coil and a conductor extending to the pace/sense electrode and disposed external to the coil.
  • a method for implanting an electrical lead includes positioning the electrical lead within a vessel; partially withdrawing a stylet, inserted within a lumen of the electrical lead, to allow a portion of the electrical lead to become undulated such that a fixation electrode of the electricalilead is in contact with the vessel; and emitting an electrical energy from the fixation electrode to the vessel to anchor the electrical lead to the vessel.
  • Figure 1 is a stylized diagram of an implantable medical device according to the present invention.
  • Figure 2 is a stylized top view of an electrical lead according to the present invention.
  • Figure 4 is a stylized cross-sectional view of the electrical lead of Figure 2 taken along the IV-IV line in Figure 2;
  • Figure 5 is a stylized cross-sectional view of the electrical lead of Figure 2 taken along the V-V line in Figure 2;
  • the coil 204 is made of wound nickel-cobalt-chromium superalloy wire, such as MP35N, insulated with, for example, a modified polyvinyl acetal polymer (e.g., Formvar ® or the like), a polyimide polymer (e.g., Pyre ML ® or the like), or a fluoropolymer (e.g., Teflon ® , polytetrafluoroethylene, or the like).
  • a modified polyvinyl acetal polymer e.g., Formvar ® or the like
  • a polyimide polymer e.g., Pyre ML ® or the like
  • a fluoropolymer e.g., Teflon ® , polytetrafluoroethylene, or the like.
  • the present invention is not so limited but rather encompasses the coil 204 being made of any desired material or materials. A portion of the insulation of the coil 204 adjacent to the lumen 402 is
  • an insulating layer 502 electrically insulates the inner surface of the fixation electrode 204 and an insulating layer 504 electrically insulates the outer surface of the fixation electrode 204, except for an electrical connection with the coil 204 and an active surface 506 that protrudes through the insulating layer 504. Fixation energy is transmitted to surrounding tissue through the active surface 506.
  • the pace/sense electrode 212 has a construction corresponding to that of the fixation electrode 204, except that no electrical coimection is made between the pace/sense electrode 212 and the coil 204.
  • Figures 6-8 illustrate the implantation of the lead 200 within a vessel 602.
  • Figure 6 depicts the lead 200 configured such that it may be inserted into the vessel 602.
  • Figure 7 illustrates the lead 200 at a midpoint during its implantation within the vessel 602.
  • Figure 8 shows the lead 200 as it is finally implanted in the vessel 602.
  • a stylet 604 is inserted into the lumen 402 (shown in Figures 4 and 5) and advanced to straighten the lead 200, as shown in Figure 6.
  • a catheter (not shown) may be inserted into the vessel 602 to provide a pathway for guiding the lead 200 during implantation.
  • the lead 200 is fed into the vessel 602, either within the catheter or omitting the use of the catheter, to a desired position for the pace/sense electrode 212.
  • the stylet 604 is then retracted from the lumen 402 a predetermined distance, as illustrated in Figure 7, to allow a portion of the coil 204 to return to its undulated shape, thus urging the pace/sense electrode 212 against the vessel 602.
  • the stylet 604 has a marking 702 indicating the proper distance to retract the stylet 604.
  • the stylet 604 may be used to rotate the lead 200 so that the pace/sense electrode 212 is in intimate contact with a desired portion of the vessel 602, such as the myocardial side of the vessel 602.
  • the pacing threshold generally is lower when the distance to viable tissue is shorter, such as when the pace/sense electrode 212 is facing the myocardium.
  • the pacing impedance may generally be lower when the pace/sense electrode 212 is facing the myocardium as opposed to the pericardium, since the impedance is influenced by the conductivity of the material proximate the surface of the pace/sense electrode 212.
  • the impedance of fat is about 1000 ohm-cm
  • the impedance of muscle is about 450 ohm-cm
  • the impedance of blood is about 150 ohm-cm.
  • the integrity of the contact between the pace/sense electrode 212 and the vessel 602 may be determined by evaluating the impedance level.
  • the width and/or amplitude of the QRS complex may be used as an indicator of the position of the pace/sense electrode 212. As the active surface 506 move further away from the myocardium, the signal amplitude of the QRS complex generally decreases and the pulse width of the QRS complex generally increases.
  • the stylet 604 is withdrawn from the lumen 402 a predetermined distance, as illustrated in Figure 8, to allow the remaining portion of the coil 204 to return to its undulated shape, thus urging the fixation electrode 206 against the vessel 602.
  • the stylet 604 has a marking 802 indicating the proper distance to retract the stylet 604. Techniques described previously to determine proper positioning of the pace/sense electrode 212 may also be applied to determining proper positioning of the fixation electrode 206. In one embodiment, the position of the pace/sense electrode 212 is rechecked after verifying proper positioning of the fixation electrode 206.
  • a pulse generator 804 such as an ablation pulse generator or the like, is connected to the stylet 604 and to the patient via a skin patch 806, as illustrated in Figure 8.
  • a fixating pulse is then delivered to the fixation electrode 206.
  • RF fixation of a lead is disclosed in U.S. Patent No. 5,383,922 to Zipes et al., incorporated herein by reference in its entirety. Similar to the disclosure in Zipes et al., the energy required to fix electrode 206 will vary from design to design. However, fixation can generally be accomplished using a prior art RF electrosurgical power source within the range of power levels recommended for use in electrocoagulation.
  • RF sensors equipped with impedance meter may be used to control the duration of application of the RF signal with a change of impedance in a given range known to indicate that fixation has occurred.
  • Initial or temporary fixation may be accomplished with an RF signal terminated prior to the occurrence of the impedance change with permanent fixation being accomplished by extending the signal period with the change in impedance occurs.
  • stylet 604 is removed from lumen 402.

Landscapes

  • Health & Medical Sciences (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (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 fil électrique dont l'extrémité distale comporte une bobine de forme ondulée lorsqu'elle est en état de repos, ainsi qu'une électrode de fixation disposée sur la bobine à laquelle elle est électriquement couplée. Par ailleurs, ce fil électrique comprend une électrode de pas/détection qui est électriquement isolée de la bobine tout en étant disposée sur celle-ci de manière distale par rapport à l'électrode de fixation, ainsi qu'un conducteur disposé à l'extérieur de la bobine, qui s'étend vers l'électrode de pas/détection. Par ailleurs, l'invention concerne un procédé de montage d'un fil électrique qui consiste à : placer le fil électrique dans un récipient, placer une électrode de fixation du fil électrique en contact avec le récipient, et enfin, induire l'émission d'une énergie électrique de l'électrode de fixation vers le récipient pour assujettir le fil électrique au récipient.
PCT/US2003/010034 2002-04-30 2003-04-02 Appareil et procede de montage d'un fil electrique WO2003092798A2 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US10/136,801 2002-04-30
US10/136,801 US20030203704A1 (en) 2002-04-30 2002-04-30 Apparatus and method for implanting an electrical lead

Publications (2)

Publication Number Publication Date
WO2003092798A2 true WO2003092798A2 (fr) 2003-11-13
WO2003092798A3 WO2003092798A3 (fr) 2004-03-25

Family

ID=29249664

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US2003/010034 WO2003092798A2 (fr) 2002-04-30 2003-04-02 Appareil et procede de montage d'un fil electrique

Country Status (2)

Country Link
US (1) US20030203704A1 (fr)
WO (1) WO2003092798A2 (fr)

Families Citing this family (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20050080472A1 (en) * 2003-10-10 2005-04-14 Atkinson Robert Emmett Lead stabilization devices and methods

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0606688A2 (fr) * 1993-01-11 1994-07-20 Incontrol, Inc. Dispositif et méthode de fixation d'un conducteur cardiaque intraveineux
US5925073A (en) * 1998-02-23 1999-07-20 Cardiac Pacemakers, Inc. Intravenous cardiac lead with wave shaped fixation segment
EP0951920A2 (fr) * 1998-04-22 1999-10-27 BIOTRONIK Mess- und Therapiegeräte GmbH & Co Ingenieurbüro Berlin Electrode destinée à être fixée à la paroi d'un vaisseau

Family Cites Families (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5179952A (en) * 1990-08-13 1993-01-19 Arzco Medical Electronics Inc. Electrocardial stimulator probe
US5383922A (en) * 1993-03-15 1995-01-24 Medtronic, Inc. RF lead fixation and implantable lead
US5836990A (en) * 1997-09-19 1998-11-17 Medtronic, Inc. Method and apparatus for determining electrode/tissue contact
US6445952B1 (en) * 2000-05-18 2002-09-03 Medtronic, Inc. Apparatus and method for detecting micro-dislodgment of a pacing lead

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0606688A2 (fr) * 1993-01-11 1994-07-20 Incontrol, Inc. Dispositif et méthode de fixation d'un conducteur cardiaque intraveineux
US5925073A (en) * 1998-02-23 1999-07-20 Cardiac Pacemakers, Inc. Intravenous cardiac lead with wave shaped fixation segment
EP0951920A2 (fr) * 1998-04-22 1999-10-27 BIOTRONIK Mess- und Therapiegeräte GmbH & Co Ingenieurbüro Berlin Electrode destinée à être fixée à la paroi d'un vaisseau

Also Published As

Publication number Publication date
US20030203704A1 (en) 2003-10-30
WO2003092798A3 (fr) 2004-03-25

Similar Documents

Publication Publication Date Title
US6141594A (en) Single pass lead and system with active and passive fixation elements
US5383922A (en) RF lead fixation and implantable lead
US7386351B2 (en) Method and apparatus for placing a coronary sinus/cardiac vein pacing and defibriliation lead with adjustable electrode spacing
US8630719B2 (en) Implantable medical lead with biased electrode
US7890188B2 (en) Implantable lead for septal placement of electrode with fixation mechanism in the pulmonary artery
EP2526997B1 (fr) Systeme de stimulation du faisceau de His
US7555351B2 (en) Pulmonary artery lead for atrial therapy and atrial pacing and sensing
US7392094B2 (en) Implantable lead for septal placement of pacing electrodes
US20040260374A1 (en) Implantable lead with fixation mechanism in the pulmonary artery
US8781604B2 (en) Method of implanting stimulation lead with biased curved section through the interatrial septum
US20040122498A1 (en) Pulmonary artery lead for atrial therapy
US6577904B1 (en) Ultrasound echogenic cardiac lead
EP3866912B1 (fr) Fils pour le faisceau de his avec électrode extensible et caractéristiques de repositionnement
WO2003030988A2 (fr) Systeme d'electrodes pour l'apport d'une stimulation electrique au faisceau de his
US11911623B2 (en) Implantable medical electrode assemblies, devices, systems, kits, and methods
US20030203704A1 (en) Apparatus and method for implanting an electrical lead

Legal Events

Date Code Title Description
AK Designated states

Kind code of ref document: A2

Designated state(s): CA JP

AL Designated countries for regional patents

Kind code of ref document: A2

Designated state(s): AT BE BG CH CY CZ DE DK EE ES FI FR GB GR HU IE IT LU MC NL PT RO SE SI SK TR

121 Ep: the epo has been informed by wipo that ep was designated in this application
122 Ep: pct application non-entry in european phase
NENP Non-entry into the national phase

Ref country code: JP

WWW Wipo information: withdrawn in national office

Country of ref document: JP