WO2009025597A1 - Dérivation médicale avec un revêtement de protection - Google Patents

Dérivation médicale avec un revêtement de protection Download PDF

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Publication number
WO2009025597A1
WO2009025597A1 PCT/SE2007/050567 SE2007050567W WO2009025597A1 WO 2009025597 A1 WO2009025597 A1 WO 2009025597A1 SE 2007050567 W SE2007050567 W SE 2007050567W WO 2009025597 A1 WO2009025597 A1 WO 2009025597A1
Authority
WO
WIPO (PCT)
Prior art keywords
lead
cover
helix
opening
fixation means
Prior art date
Application number
PCT/SE2007/050567
Other languages
English (en)
Original Assignee
St. Jude Medical Ab
ÖRNBERG, Andreas
Barlov, Armin
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 St. Jude Medical Ab, ÖRNBERG, Andreas, Barlov, Armin filed Critical St. Jude Medical Ab
Priority to PCT/SE2007/050567 priority Critical patent/WO2009025597A1/fr
Publication of WO2009025597A1 publication Critical patent/WO2009025597A1/fr

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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

Definitions

  • the present invention relates to methods for manufacturing active fixation electrodes for electrical medical leads, in particular helix electrodes intended to be screwed into body tissue.
  • Implantable medical electrical stimulation and/or sensing leads are well known in the fields of tissue and organ stimulation and monitoring. Such fields include cardiac pacing. Leads may be attached to an organ by an active fixation means which is designed to penetrate the surface of the organ that is to be stimulated or sensed.
  • a common active fixation means employs a helix which has a sharpened tip and is mounted at the end of the electrode lead.
  • Such an active fixation means can be called a fixation helix, a helical screw, a screw-in anchoring means or a corkscrew- type anchoring means.
  • the helix is electrically connected to one or more conductors in the electrode lead in order to permit stimulation and/or sensing of the tissue which it is attached to.
  • These conductors can be electrically connected to one or more exposed surfaces of the helix which then can be used as stimulating and/or sensing electrodes.
  • a fixation helix therefore may contain one or a plurality of conductors.
  • the outer surface of the helix, including the exposed surfaces used as electrodes, is partly covered with a biocompatible coating to minimise interference with the tissue to which it is to be attached.
  • the biocompatible coating on a helix may be electrically conducting in which case it is arranged in a predetermined pattern with continuous gaps on the insulating material around the exposed electrode surfaces in order to prevent the different electrodes from being in electrical contact with each other.
  • the sizes of the surface areas of the exposed electrodes are set at levels which are compatible with the organ they are attached to.
  • the fixation helix typically has an outside helix diameter which is slightly less than that of the lead body and extends in axial alignment with the lead body. During positioning of the lead in the patient the helix is retracted into the lead body in order to prevent its sharp tip damaging the patient.
  • US4311153 shows an example of a screw-in lead tip having a membrane which covers the distal end of the lead during positioning and which the helix can penetrate when the surgeon rotates the helix.
  • a problem which may occur when attaching helices is that the pressure applied by the surgeon to hold the lead in place which the helix is being rotated may cause the annular end of the lead to punch a hole in the tissue - the so-called "cookie cutter effect". This problem becomes more acute as the diameter of leads decrease and the area of the end of the lead decreases thereby increasing the contact force per unit contact area.
  • the present invention relates to electrical medical leads comprising helix electrodes intended to be screwed into body tissue in which the risk of damage to tissue caused by the end of the lead punching holes in the tissue is reduced. This is achieved by providing the end of the lead with a cover which has a shape which reduces the contact force per unit contact area at the end of the lead during attachment of the helix
  • a first embodiment of a method in accordance with the present invention comprises a convex lead end cover with a curved opening which is concentric with the lead body and helix , said opening being arranged at a radial distance which corresponds to the radius of the helix and subtending through an arc which is less than 180°.
  • Fig. Ia shows schematically a section through a first embodiment of an electrical medical lead provided with an active fixation means and a cover in accordance with the present invention with the active fixation means retracted;
  • Fig Ib) shows and end-on view of the lead of figure 1;
  • FIGs. 2a) and 2b) shows schematically views corresponding to those of figures Ia)-Ib) with the active fixation means in the insertion position:
  • Figs. 3a) and 3b) shows schematically views corresponding to those of figures Ia)-Ib) with the active fixation means extended.
  • Figs. Ia) and Ib) show schematically an example of an electrical medical lead 1 in accordance with the present invention.
  • Lead 1 comprises an elongated hollow lead body 3 which encloses active fixation means, for example helix 5.
  • Helix 5 may be made of conducting material or non-conducting material.
  • the distal end of lead 1 is covered by a hemispherical convex cover 7 which has an asymmetrically positioned opening 9.
  • the edge of opening 9 which is nearest the centre of the cover is positioned at a distance Ro from the centre of the cover 7 which distance Ro is substantially the same as the radius Rh of the part of the coils at the distal end of helix 5 which is nearest the centre of the cover so that opening 9 extends radially over a portion of the cover 7 which is aligned with the coils of material forming helix 5.
  • opening 9 has a diameter Do which is substantially the same as, or slightly smaller (for example up to 20% smaller) than, the diameter Dh of the material of which the coils of helix 5 is made, in order than when a portion of helix 5 of diameter Dh passes through opening 9 the surface of helix 5 is in sealing engagement with, and substantially forms a fluid tight seal with, the wall 11 of opening 9.
  • Opening 9 is inclined so it forms curved, sloping grooves 13', 13" in the inner and outer surfaces 15, 17 of cover 7.
  • the radius of curvature of the grooves 13', 13" substantially match that of helix 5 and the slope of grooves 13', 13" substantially matches the pitch of the helix 5.
  • helix 5 is retracted away from the distal end of cover 7 as might occur during assembly, storage or pre-insertion testing of lead 1.
  • Figures 2a) and 2b) show the lead of figures Ia) and Ib) where helix 5 has been advanced by being rotated so the tip 19 of helix 5 has entered opening 9 and then moved along groove 13', 13" so that the tip 19 is flush with the end 17 of groove 13" which is furthest away from opening 9.
  • the surface 21 of tip 19 which faces in the longitudinal direction of helix 5 is shaped so that it in this position forms a smooth surface together with the outer surface 17 of cover 7.
  • the helix is moved to this position before the lead is inserted into a patient.
  • Figures 3a) and 3b) show the lead of the previous figure where helix 5 has been further advanced so that one revolution of it is outside cover 7.
  • a second embodiment of a lead in accordance with the present invention has a convex cover which has a radius of curvature in the longitudinal direction of the lead which is greater than the radius of the lead. This forms a cover which is flatter than the cover of the first embodiment.
  • All embodiments of a convex cover in accordance with the present invention may be covered with an electrically conducting coating and attached to a conductor extending the length of the lead in order to enable it to be used for stimulation and/or sensing.
  • an electrically conducting coating Preferably any coatings used, electrically conducting or not, are biocompatible.

Landscapes

  • Health & Medical Sciences (AREA)
  • Cardiology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (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 porte sur une dérivation médicale comprenant une électrode en hélice destinée à être vissée dans le tissu corporel, l'extrémité distale de la dérivation étant recouverte d'un revêtement de protection convexe, doté d'une ouverture pour diriger l'électrode en hélice à partir de sa position rétractée.
PCT/SE2007/050567 2007-08-22 2007-08-22 Dérivation médicale avec un revêtement de protection WO2009025597A1 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
PCT/SE2007/050567 WO2009025597A1 (fr) 2007-08-22 2007-08-22 Dérivation médicale avec un revêtement de protection

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
PCT/SE2007/050567 WO2009025597A1 (fr) 2007-08-22 2007-08-22 Dérivation médicale avec un revêtement de protection

Publications (1)

Publication Number Publication Date
WO2009025597A1 true WO2009025597A1 (fr) 2009-02-26

Family

ID=40378377

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/SE2007/050567 WO2009025597A1 (fr) 2007-08-22 2007-08-22 Dérivation médicale avec un revêtement de protection

Country Status (1)

Country Link
WO (1) WO2009025597A1 (fr)

Citations (11)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4106512A (en) * 1976-12-16 1978-08-15 Medtronic, Inc. Transvenously implantable lead
US4819661A (en) * 1987-10-26 1989-04-11 Cardiac Pacemakers, Inc. Positive fixation cardiac electrode with drug elution capabilities
US4827940A (en) * 1987-04-13 1989-05-09 Cardiac Pacemakers, Inc. Soluble covering for cardiac pacing electrode
US5261417A (en) * 1990-12-14 1993-11-16 Peter Osypka Cardiac pacemaker lead with protected fixed tissue securing means
US5658326A (en) * 1995-09-12 1997-08-19 Pacesetter Ab Protective body for an implantable electrical conductor and an electrical conductor equipped with such an end protector
US5728140A (en) * 1996-06-17 1998-03-17 Cardiac Pacemakers, Inc. Method for evoking capture of left ventricle using transeptal pacing lead
WO2000009204A1 (fr) * 1998-08-12 2000-02-24 Cardiac Pacemakers, Inc. Joint d'etancheite extensible pouvant equiper un instrument medical et systeme
US6212434B1 (en) * 1998-07-22 2001-04-03 Cardiac Pacemakers, Inc. Single pass lead system
US6360129B1 (en) * 1999-12-13 2002-03-19 Cardiac Pacemakers, Inc. Mannitol/hydrogel cap for tissue-insertable connections
US6501990B1 (en) * 1999-12-23 2002-12-31 Cardiac Pacemakers, Inc. Extendable and retractable lead having a snap-fit terminal connector
US6501994B1 (en) * 1997-12-24 2002-12-31 Cardiac Pacemakers, Inc. High impedance electrode tip

Patent Citations (12)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4106512A (en) * 1976-12-16 1978-08-15 Medtronic, Inc. Transvenously implantable lead
US4827940A (en) * 1987-04-13 1989-05-09 Cardiac Pacemakers, Inc. Soluble covering for cardiac pacing electrode
US4819661A (en) * 1987-10-26 1989-04-11 Cardiac Pacemakers, Inc. Positive fixation cardiac electrode with drug elution capabilities
US5261417A (en) * 1990-12-14 1993-11-16 Peter Osypka Cardiac pacemaker lead with protected fixed tissue securing means
US5658326A (en) * 1995-09-12 1997-08-19 Pacesetter Ab Protective body for an implantable electrical conductor and an electrical conductor equipped with such an end protector
US5728140A (en) * 1996-06-17 1998-03-17 Cardiac Pacemakers, Inc. Method for evoking capture of left ventricle using transeptal pacing lead
US6501994B1 (en) * 1997-12-24 2002-12-31 Cardiac Pacemakers, Inc. High impedance electrode tip
US20040133259A1 (en) * 1997-12-24 2004-07-08 Cardiac Pacemakers, Inc. High impedance electrode tip
US6212434B1 (en) * 1998-07-22 2001-04-03 Cardiac Pacemakers, Inc. Single pass lead system
WO2000009204A1 (fr) * 1998-08-12 2000-02-24 Cardiac Pacemakers, Inc. Joint d'etancheite extensible pouvant equiper un instrument medical et systeme
US6360129B1 (en) * 1999-12-13 2002-03-19 Cardiac Pacemakers, Inc. Mannitol/hydrogel cap for tissue-insertable connections
US6501990B1 (en) * 1999-12-23 2002-12-31 Cardiac Pacemakers, Inc. Extendable and retractable lead having a snap-fit terminal connector

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