EP1112101A1 - Catheter telescopique a navigation magnetique et procede de navigation magnetique d'un catheter telescopique - Google Patents

Catheter telescopique a navigation magnetique et procede de navigation magnetique d'un catheter telescopique

Info

Publication number
EP1112101A1
EP1112101A1 EP99945558A EP99945558A EP1112101A1 EP 1112101 A1 EP1112101 A1 EP 1112101A1 EP 99945558 A EP99945558 A EP 99945558A EP 99945558 A EP99945558 A EP 99945558A EP 1112101 A1 EP1112101 A1 EP 1112101A1
Authority
EP
European Patent Office
Prior art keywords
extension member
distal end
sleeve
electrode
sheath
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Withdrawn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
EP99945558A
Other languages
German (de)
English (en)
Inventor
Andrew F. Hall
Walter M. Blume
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.)
Stereotaxis Inc
Original Assignee
Stereotaxis 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 Stereotaxis Inc filed Critical Stereotaxis Inc
Publication of EP1112101A1 publication Critical patent/EP1112101A1/fr
Withdrawn legal-status Critical Current

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/0105—Steering means as part of the catheter or advancing means; Markers for positioning
    • A61M25/0127—Magnetic means; Magnetic markers

Definitions

  • This invention relates to a magnetically navigable telescoping catheter and a method of magnetically navigating a telescoping catheter within open body spaces.
  • the present invention relates to a magnetically navigable telescoping catheter, and to a method of navigating such catheter in the body.
  • the magnetically navigable telescoping catheter of the present invention comprises a sleeve having a proximal end and a distal end.
  • An extension member having a proximal end and a distal end is slidably mounted in the sleeve so that the distal end portion of the extension member telescopes from the distal end of the sleeve.
  • the distal end portion of the extension member is relatively more flexible than the distal end of the sleeve.
  • At least one magnet is positioned on the distal end portion of the extension member to allow the distal end of the extension member to be oriented by the application of an externally applied magnetic field.
  • the position of the distal tip of the catheter can be controlled by the controlled application of a magnetic field to orient the distal end of the extension member, and telescoping the extension member into and out of the sleeve.
  • At least one electrode is positioned on the distal end of the extension member.
  • a sheath is also provided, and the sleeve is slidably mounted in the sheath so that the distal end of the sleeve can telescope relative to the distal end of the sheath.
  • the user can also telescope the sleeve relative to the sheath to control the position of the distal end of the extension member. This gives the user a first adjustable length whose direction is controlled by the direction of the magnetic field, and a second adjustable length substantially unaffected by the direction of the magnetic field.
  • the catheter can be provided with one or more electrodes for cardiac mapping, pacing, or ablation.
  • the catheter can be used in some other procedure such as the delivery of therapeutic agents.
  • the distal end of the extension member is navigated to the site in the body.
  • a magnetic field is applied to orient the distal end portion of the extension member, and the distal end is navigated to a precise location by the relative telescoping of the extension member relative to the sleeve, and in the preferred embodiment also by the relative telescoping of the sleeve relative to the sheath.
  • an electrode on the end of the distal end of the extension member can be navigated to contact specific parts of the body, for example the chambers of the heart, to bring an electrode into contact with the tissue for mapping, pacing, or ablation.
  • the telescoping motion and magnetic guidability of the electrode catheter of the present invention allows superior control of the distal end of the catheter, without regard to the path of the catheter.
  • the improved navigation is both faster, reducing procedure times, and more accurate, allowing the procedures to be successfully completed.
  • the catheter is of relatively simple and reliable construction.
  • Fig. 1 is a top plan view of a catheter constructed according to the principles of this invention
  • Fig. 2 is an enlarged longitudinal cross-sectional view of the extension member; taken along the plane of line 2-2 in Fig. 1 ;
  • Fig. 3 is an enlarged longitudinal cross-sectional view of the extension member, showing the flex point on the extension member between the magnets and the electrodes;
  • Fig. 4 is an enlarged longitudinal cross-sectional view of the extension member, showing the flex point on the extension member between magnets and the distal end of the sleeve;
  • Fig. 5 is a distal end elevation view of an alternate construction of the catheter, showing an alternate arrangement of the electrodes;
  • Fig. 6 is a top plan view of an alternate construction of the electrode catheter in which the sheath is curved;
  • Fig. 7 is a top plan view of an alternate construction of the electrode catheter without a sleeve
  • Fig. 8 is longitudinal cross-sectional view of an alternate construction of the extension member
  • Fig. 9 is a longitudinal cross-sectional view of an alternative construction of a telescoping catheter
  • Fig. 10 is a longitudinal cross-sectional view of an alternate construction of the extension member adapted for use with a stylette;
  • Fig. 11 is a longitudinal cross-sectional view of an alternate construction of the extension member adapted for use with a stylette;
  • Fig. 12 is a longitudinal cross-sectional view of a stylette adapte'd for use with the extension members shown in Figs. 10 or 11;
  • Fig. 13 is a longitudinal cross-sectional view of a stylette adapted for use with the extension members shown in Fig. 11.
  • Corresponding reference numerals indicate corresponding parts throughout the several views of the drawings.
  • catheter 20 is an electrode catheter having one or more electrodes thereon, but this invention is not so limited and the catheter can be used for other purposes, for example the delivery of diagnostic or therapeutic agents.
  • Fig. 9 shows such a catheter 20' with a central passage 21 for the delivery of diagnostic or therapeutic agents.
  • the electrode catheter 20 of the preferred embodiment comprises a sheath 22 having a proximal end 24 and a distal end 26.
  • the sheath 22 is preferably about 120 cm long.
  • the sheath 22 is preferably made from conventional sheath material, with an outside diameter of about 9 French.
  • the sheath 22" may be pre- curved, for example to facilitate a transseptal approach to the left atrium.
  • a sleeve 30 having a proximal end 32 and a distal end 34 is slidably mounted in the sheath 22 so that the distal end portion of the sleeve telescopes from the distal end 26 of the sheath.
  • the sleeve 30 is preferably about 125 cm long.
  • the sleeve 30 is preferably made from a conventional sheath material, with an outside diameter of about 8 French. (In an alternate construction of the electrode catheter 20'" as shown in Fig. 7, there is no sleeve 30.)
  • An extension member 38 having a proximal end 40 and a distal end 42 is slidably mounted in the sleeve 30 so that the distal end portion of the extension member telescopes from the distal end 34 of the sleeve.
  • the extension member 38 is preferably a tube, made from a conventional catheter material, with an external diameter of about 7 French.
  • the extension member is preferably about ' 130 cm long.
  • the distal end portion of the extension member 38 is generally relatively more flexible than the distal end portion of the sleeve 30. In one alternate construction the entire extension member 38 is flexible.
  • the portion of the extension member containing the magnets (as discussed below) is relatively rigid, while the portion of the extension member just proximal to the magnets is flexible to allow the extension member to flex.
  • At least one electrode is positioned on the distal end of the extension member 38.
  • a first electrode 46 on the distal end of the extension member 38 having a generally hemispherical shape. This rounded shape facilitates navigation, and prevents damage to the surfaces that the distal end of the extension member contacts.
  • a lead wire 48 extends from the electrode 46, through the extension member 38, to the proximal end 40 of the extension member.
  • a second electrode 50 in the form of an annular band, extends circumferentially around the distal end portion of the extension member 38.
  • a lead wire 52 extends from the electrode 50, through the extension member 38, to the proximal end 40 of the extension member.
  • the lead wires 48 and 52 can be connected to a measuring device to measure electrical potential between the electrodes. Alternatively, the lead wires 48 and 52 can be used to force a current through the tissue for electrical pacing of the heart.
  • Lead wire 48 can also be connected to a source of RF energy to provide such energy to electrode 46 to ablate tissue in contact with the electrode. Additional electrodes, or electrodes in other configurations and arrangements can be provided.
  • the distal end 42 of the extension member 38 can be provided with two electrodes 60 and 62, separated and electrically insulated from each other by a generally diametrically extending partition 64.
  • At least one magnet is positioned on the distal end portion of the extension member 38 to allow the distal end 42 of the extension member to be oriented by the application of an externally applied magnetic field.
  • the externally applied magnetic field may be applied, for example with a magnetic surgery system like that disclosed in co-pending U.S. patent application Serial No. 08-920,446, filed August 29, 1997, entitled Method and Apparatus for Magnetically Controlling Motion- Direction of a Mechanically Pushed Catheter.
  • Each of the magnets 54 preferably has an annular shape with a central passage through which The lead wires 48 and 52 may pass. As shown in Fig.
  • the magnets 54' are solid with a smaller diameter, allowing wires 48 and 52 to pass between the magnets and the wall of the extension member 38'.
  • the magnets 54 are preferably closely spaced to each other, and may even be touching so that they are held together by mutual magnetic attraction. This configuration maximizes the volume of magnetic material while keeping the extension member 38 flexible.
  • the magnets 54 are spaced proximally from the electrodes 46 and 50 on the distal end of the extension member to form a flex point 56 in the extension member between the magnets and the electrodes.
  • the extension member 38 preferably can telescope out of the sleeve 30 beyond the most proximal of the magnets 54 to form a flex point 58 in the extension member between the magnets and the distal end of the sleeve.
  • the electrodes 46 and 50 and magnets 54 are typically radio-opaque so that the distal end portion of the extension member is visible in real time fluoroscope images.
  • the distal end 34 of the sleeve 30 is preferably provided with a radio-opaque band 66, and the distal end 26 of the sheath 22 is provided with a radio-opaque band 68, so that the distal ends of the sleeve and the shaft are also visible under fluoroscopy. This helps the user navigate the distal end 42 of the extension member into the desired position.
  • the procedure can be viewed in one or more two- dimensional images, or conventional image processing can be used to render a three dimensional view of the device which could then be placed within a three- dimensional image set (e.g., from MRI) of the body portion.
  • the radio-opaque electrodes 46 and 50, magnets 54, and bands 66 and 68 also facilitate automating navigation of the distal end, by providing feedback of the position of the distal ends of the sleeves.
  • the distal end of the device 20 is navigated to the site in the body where the procedures, such as an atrial mapping, pacing, and ablation, are to occur.
  • the device 20 extends into a heart chamber, for example into the right atrium from the inferior vena cava, into the left atrium from the right atrium via a transseptal puncture, or into the right ventricle via the tricuspid valve or into the left ventricle via the aortic valve.
  • a magnetic field is applied to provide an orienting force to the extension member 38.
  • the magnetic field causes the magnets 54 to align in the selected direction.
  • the electrode on the distal end of the extension member 38 is then manipulated to the desired location by selectively telescoping the sleeve 30 relative to the sheath 22, and the extension member relative to the sleeve.
  • the manipulation could be an iterative process, whereby the navigation system constantly tweaks the direction of the magnetic field, based on the location of the tip of the extension member and the desired target location. It would also be possible to automate the process, allowing the surgeon to input either a desired direction or location, and using a computer to control the magnetic field and the telescoping of the sleeve and the extension member.
  • the distal end portion of the extension member 38 is urged against the wall W of the chamber to cause the end to flex at flex point 56 proximal of the electrodes 46 and 50 but distal of the magnets 54.
  • the electrode 46 on the distal end of the extension member 38 can be precisely navigated along the wall of the atrium, where RF energy can be applied to ablate the underlying tissue.
  • the precise navigational control permitted by the electrode catheter allows both focal lesions and the creation of lines of continuous lesions to be formed in the chamber, blocking the path of stray electrical signals that cause the arrhythmia.
  • Such continuous lines of lesions were extremely difficult, if not impossible to form, particularly in the left atrium, with prior mechanically steerable catheters.
  • An alternate construction of the extension member 38 is indicated generally as
  • Extension member 138 having a proximal end and a distal end 142 is slidably mounted in a sleeve (not shown) so that the distal end portion of the extension member telescopes from the distal end of the sleeve.
  • the extension member 138 is preferably a tube made from a conventional catheter material with an external diameter of about 7 French.
  • the extension member is preferably about 130 cm long, the tube preferably comprises sections of different stiffness to facilitate navigation of the catheter.
  • the distal section 138a is made from a very flexible vinyl or polyethylene or polyurethane
  • the proximal section 138b is made from a relatively stiffer material such as nylon.
  • first electrode 146 on the distal end of the extension member 138, having a generally hemispherical. This rounded shape facilitates navigation, and prevents damage to the surfaces that the distal end of the extension member contacts.
  • a lead wire extends from the electrode 146, through the extension member 138, to the proximal end of the extension member.
  • a second electrode 150 in the form of an annular band, extends circumferentially around the distal end portion of the extension member 138.
  • a lead wire extends from the electrode 150, through the extension member 138, to the proximal end of the extension member.
  • the lead wires can be connected to a measuring device to measure electrical potential between the electrodes.
  • the lead wires can be used to force a current through the tissue for electrical pacing of the heart.
  • the lead wires can also be connected to a source of RF energy to provide such energy to the electrodes to ablate tissue in contact with the electrodes. Additional electrodes, or electrodes in other configurations and arrangements can be provided.
  • a localization device 153 is preferably incorporated into the extension member 138 so that the location of the extension member, and preferably both the location and orientation of the extension member, can be determined.
  • the localization is a magnet device, such as a triaxial coil receiver for AC electromagnetic fields, but the localization could be done with some other device, such as ultrasound devices.
  • a plurality of magnets 154 are positioned on the distal end portion of the extension member 138 to allow the distal end 142 of the extension member to be oriented by the application of an externally applied magnetic field.
  • the tube forming the extension member 138 is open proximal to the magnets to receive at the distal end of the stylette 156 to stiffen, shape, or guide the distal end of the extension member.
  • the stylette 156 is inserted into the proximal end of extension member 138 and advanced to the distal end where the stylette in the lumen of the tube forming the extension member selectively stiffens the extension member and/or shapes the extension member to facilitate navigation.
  • the distal end of the stylette can be preformed for a particular navigation and inserted into the extension member 138 to shape the extension member for the navigation.
  • the stylette can also be used to push the extension member.
  • the stylette can be selectively inserted and removed to selectively temporarily stiffen and temporarily soften the distal end of the extension member to facilitate navigation.
  • An alternate construction of the extension member 138 is indicated generally as 138' in Fig. 11.
  • Extension member 138' is similar in construction to extension member 138, and corresponding parts are identified with corresponding reference numerals. However, rather than cylindrical magnets 154, extension member 138' has annular magnets 154', whose central opening are aligned to form a passage 158 for the stylette 156.
  • the stylette 156 can be inserted through the proximal end of extension member 138' and into the passage 158 to selectively stiffen and/or shape the distal portion of the extension member 138. As shown in Fig. 12, the distal end portion of the stylette can be bent, and as shown in Fig. 13 it can be inserted into the extension member 138' to shape the distal end of the extension member.
  • the passage 158 also allow the stylette 156 to apply a pushing force closer to the distal end of the extension member.
  • the movement of the sheath, the extension member, and even the stylette can be automated and operated by motor instead of manually, if desired.

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Biophysics (AREA)
  • Pulmonology (AREA)
  • Engineering & Computer Science (AREA)
  • Anesthesiology (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Hematology (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Measurement And Recording Of Electrical Phenomena And Electrical Characteristics Of The Living Body (AREA)
  • Surgical Instruments (AREA)

Abstract

L'invention concerne un cathéter (20) à navigation magnétique comprenant une gaine (30) et un élément (38) d'extension, la gaine et l'élément d'extension étant dotés chacun d'une extrémité proximale et d'une extrémité distale de sorte que l'extrémité distale (42) de l'élément (38) d'extension soit télescopique à partir de l'extrémité distale (66) de la gaine (30). L'extrémité distale (42) de l'élément (38) d'extension est relativement plus souple que l'extrémité distale (66) de la gaine (30). Une ou plusieurs électrodes peuvent se trouver sur l'extrémité distale de l'élément (38) d'extension. Au moins un aimant, et de préférence plusieurs aimants, se trouvent également sur l'extrémité distale de l'élément d'extension pour permettre l'orientation de l'extrémité distale (42) de l'élément (38) d'extension par application d'un champ magnétique à partir de l'extérieur.
EP99945558A 1998-09-11 1999-09-10 Catheter telescopique a navigation magnetique et procede de navigation magnetique d'un catheter telescopique Withdrawn EP1112101A1 (fr)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US15161598A 1998-09-11 1998-09-11
US151615 1998-09-11
PCT/US1999/020496 WO2000015286A1 (fr) 1998-09-11 1999-09-10 Catheter telescopique a navigation magnetique et procede de navigation magnetique d'un catheter telescopique

Publications (1)

Publication Number Publication Date
EP1112101A1 true EP1112101A1 (fr) 2001-07-04

Family

ID=22539528

Family Applications (1)

Application Number Title Priority Date Filing Date
EP99945558A Withdrawn EP1112101A1 (fr) 1998-09-11 1999-09-10 Catheter telescopique a navigation magnetique et procede de navigation magnetique d'un catheter telescopique

Country Status (3)

Country Link
EP (1) EP1112101A1 (fr)
AU (1) AU5813899A (fr)
WO (1) WO2000015286A1 (fr)

Families Citing this family (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US7972323B1 (en) 1998-10-02 2011-07-05 Boston Scientific Scimed, Inc. Steerable device for introducing diagnostic and therapeutic apparatus into the body
US6544215B1 (en) 1998-10-02 2003-04-08 Scimed Life Systems, Inc. Steerable device for introducing diagnostic and therapeutic apparatus into the body
EP1174076A3 (fr) 2000-07-18 2002-10-16 BIOTRONIK Mess- und Therapiegeräte GmbH & Co Ingenieurbüro Berlin Appareil permettant d'effectuer automatiquement une action diagnostique et/ou thérapeutique dans les cavités corporelles
US7525309B2 (en) 2005-12-30 2009-04-28 Depuy Products, Inc. Magnetic sensor array
US8862200B2 (en) 2005-12-30 2014-10-14 DePuy Synthes Products, LLC Method for determining a position of a magnetic source
US8068648B2 (en) 2006-12-21 2011-11-29 Depuy Products, Inc. Method and system for registering a bone of a patient with a computer assisted orthopaedic surgery system

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SE336642B (fr) * 1969-10-28 1971-07-12 Astra Meditec Ab
US4809731A (en) 1985-01-17 1989-03-07 Frank A. Walton Liquid injection apparatus having an external adjustor
US5327905A (en) 1992-02-14 1994-07-12 Boaz Avitall Biplanar deflectable catheter for arrhythmogenic tissue ablation
US5354297A (en) 1992-02-14 1994-10-11 Boaz Avitall Biplanar deflectable catheter for arrhythmogenic tissue ablation
US5318525A (en) 1992-04-10 1994-06-07 Medtronic Cardiorhythm Steerable electrode catheter
JP2688115B2 (ja) 1993-04-28 1997-12-08 コーディス ウェブスター，インコーポレイティド プレカーブ型の先端を有する電気生理学的カテーテル
US5429131A (en) 1994-02-25 1995-07-04 The Regents Of The University Of California Magnetized electrode tip catheter
US5800428A (en) * 1996-05-16 1998-09-01 Angeion Corporation Linear catheter ablation system
US6015414A (en) 1997-08-29 2000-01-18 Stereotaxis, Inc. Method and apparatus for magnetically controlling motion direction of a mechanically pushed catheter

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Title
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Also Published As

Publication number Publication date
WO2000015286A1 (fr) 2000-03-23
AU5813899A (en) 2000-04-03

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