US3902501A - Endocardial electrode - Google Patents

Endocardial electrode Download PDF

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Publication number
US3902501A
US3902501A US372269A US37226973A US3902501A US 3902501 A US3902501 A US 3902501A US 372269 A US372269 A US 372269A US 37226973 A US37226973 A US 37226973A US 3902501 A US3902501 A US 3902501A
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United States
Prior art keywords
tine
tip
catheter
lead
electrode
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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.)
Expired - Lifetime
Application number
US372269A
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English (en)
Inventor
Paul Citron
Eugene A Dickhudt
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Medtronic Inc
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Medtronic Inc
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First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=34312054&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=US3902501(A) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Medtronic Inc filed Critical Medtronic Inc
Priority to US372269A priority Critical patent/US3902501A/en
Priority to AU77566/75A priority patent/AU490702B2/en
Priority to GB3444/75A priority patent/GB1491942A/en
Priority to NLAANVRAGE7501094,A priority patent/NL172617C/xx
Priority to FR7506366A priority patent/FR2302107A1/fr
Application granted granted Critical
Publication of US3902501A publication Critical patent/US3902501A/en
Anticipated expiration legal-status Critical
Expired - Lifetime legal-status Critical Current

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    • 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

Definitions

  • ABSTRACT A medical electrode uniquely adapted for use as an endocardial electrode.
  • An electrical conductor is encased in a material which is generally inert to body fluids and terminates at an exposed electrically conductive tip.
  • a plurality of pliant tines extend from the electrode adjacent the tip and form an acute angle with the electrode body. Provision is made for holding the tines against the electrode body during insertion while allowing their release when the tip is in position. The released tines cooperate with the heart tissue, particularly the trabeculae found in the ventricles and the right atrial appendage, to maintain the electrode tip in position.
  • the atrial trabeculae and shape of the catheter being relied upon to maintain it in location until the heart tissue itself enveloped and fixed the tip.
  • the metal parts of the catheter may be radiopaque to facilitate placement by viewing through fluoroscopy.
  • a sensing atrial endocardial electrode is described in Portsmann et. al., P Wave Synchronous Pacing Using Anchored Atrial Electrode Implanted Without Thoractomy", The American Journal of Cardiology, Volume 30, July 1 l, 1972, pages 74-76.
  • a .I-shaped applicator catheter was used to direct the electrode tip into the right atrial appendage.
  • the electrode however, had two fine wire hooks positioned at its tip each ending in a relieving loop. The hooks were held back by the applicator catheter to spring out and anchor the electrode in the trabeculae of the right atrial appendage whenthe electrode tip left the end of the applicator catheter.
  • the applicator catheter was radiopaque so that it could be viewed as it was inserted into the right atrial appendage. It is imperative with the double hook tip that the electrode be properly placed before the hooks are released. The placement was checked not only through fluoroscopy but also by extending the tip slightly beyond the end of the applicator catheter to take a threshold measurement. The tip had-to be extended sufficiently to take an accurate measurementwhile still I retaining the hooks within the applicator catheter. Be-
  • the present invention provides an electrode uniquely adapted for use as an atrial endocardial electrode.
  • the electrode may be positioned in the right atrial appendage through the use of a .I-shaped catheter known to the prior art.
  • a J-shaped stylet may be employed which is held in a straightened position by thewalls of the vein used to approach the heart, the stylet assuming its J-shape upon entry into the right atrium.
  • a plurality of pliant non-conductive tines are provided at the tip of the electrode to cooperate with the heart tissue, particularly the trabeculae found in the right atrial appendage, to maintain the electrode tip in electrical contact with the heart tissue while allowing a removal of the electrode should that prove necessary.
  • the electrode is discussed inthe context of the right atrial appendage, it is suitable for use in any portion of the heart having the requisite cooperating tissue and may be employed as either a sensing or pacing electrode.
  • FIG. I shows a preferred embodiment of the present invention.
  • FIG. 2 shows a cross section of the preferred embodiment of FIG. Itaken along the line 22 in FIG. 1.
  • FIG. 3 shows a cross section of another preferred embodiment taken-along the line 2-2 in FIG. 1.
  • FIG. 4 illustrates apparatus which may be used with the preferred embodiment of FIG. I.
  • FIG. 5 shows acomponentof another preferred embodiment of the present invention.
  • FIG. 6 shows'a preferred embodiment of the present invention whichutilizes the component of FIG. 5, the tines being in a restrained position.
  • FIG. 7 shows the embodiment. of FIG. 6 with the tines unrestrained.
  • FIG. '8 shows another preferred embodiment of the present invention.
  • FIG. 9 shows still another preferred embodiment of the present invention.
  • FIG. 10 shows a further preferred embodiment of the present invention.
  • FIG. 11 shows a portion of the preferred embodiment of FIG.- 10.
  • FIG. 12 shows a portion of the preferred embodiment of FIG. 10.
  • FIG. 13 shows anadditional preferred embodiment of the present invention.
  • the electrically conductive tip 11 may be of any material suitable for the environment; platinum-iridium, for example.
  • the tines 12 are ofa pliant material which is generally inert to body fluids; silicone rubber or polyurethane, for example.
  • the tines 12 may be attached to the body member 10 in any convenient manner.
  • the tines may extend from, and be unitary with, a disc 13 which disc is held in position between the body member 10 and tip 11.
  • the member 13 may be in the form of a ring which lies over either the body member 10 or tip 11 and is adhered thereto in any convenient manner.
  • the tines 12 may take any angle with the body member 10, their purpose being to cooperate with the body tissue, particularly the trabeculae of the right atrial appendage, to maintain the tip 11 in electrical contact with the body tissue. It can be seen that an acute angle formed by the tines l2 and the body member 10 will have the greatest tendency to push against and become involved with the cooperating trabeculae and maintain the tip 11 in electrical contact. It has been found, that an angle of approximately 45 maintains the necessary electrical contact is a very efficient manner. Further, any number of tines may be used; three having proven to be adequate in most situations.
  • FIG. 2 wherein there is shown a cross section of a preferred embodiment of the body member 10 of FIG. 1 taken along the line 22.
  • an elongated electrical conductor 15 runs substantially the length of the body member 10 and makes electrical contact with the tip 11.
  • the conductor 15 is encased within a catheter 16 of a material which is generally inert to body fluids.
  • the catheter conductor combination be made as flexible as possible.
  • a stylet lumen 19 is provided, the stylet being within the lumen 19 during insertion of the electrode and being withdrawn after placement is accomplished.
  • the stylet which is placed into the lumen 19 has a J configuration similar to that of the prior art applicator catheters.
  • the stylet is maintained in a straightened configuration by the walls of the vessel through which insertion is accomplished.
  • the stylet assumes its J configuration thereby allowing an easy insertion into the appendage.
  • the electrical conductor can be of any known type, one preferred form being a multistrand wire of platinum, for example, commonly referred to as tinsel wire.
  • FIG. 3 A second preferred form for the body member 10 is illustrated in FIG. 3.
  • the electrical conductor is a coiled member 17 which again runs substantially the length of the body member 10.
  • the coil 17 is encased in a catheter 16 substantially identical to that shown in FIG. 2.
  • the central portion of the coil 17 is left at least partially void to forma lumen 18 for the insertion of a stylet, the stylet serving essentially the same function in this embodiment as in the embodiment of FIG. 2.
  • the lumens l9 and 18 may be lined with Teflon or any other appropriate material to facilitate the insertion and removal of the stylet.
  • an electrode body portion 10 this time at the end farthest from the tip 11.
  • the body portion 10 commonly has an enlarged segment 20 from which extends the connecting pin 21.
  • the catheter must be made suffieiently large to slide back over the enlarged portion 20 or, alternatively, some other system for removal of the catheter must be provided.
  • the applicator catheter is shown at 22 of a size not sufficiently large to be withdrawn over the enlarged portion 20.
  • a cutting tool 23 is shown adjacent the enlarged portion 20 and extending forward of the enlarged portion with a wedge 24 and a knife blade 25.
  • the cutting tool 23 may be separate from the electrode body 10 or may be attached thereto in any convenient manner.
  • the wedge portion 24 slips under the edge of the applicator catheter 22 and, as the applicator catheter 22 is drawn toward the cutting tool 23, the wedge will direct the catheter 22 into contact with the knife blade which will then cut and separate it thus allowing the removal of the applicator catheter over the enlarged portion 20.
  • the electrode shown in the embodiment of FIG. 1 may be successfully inserted into the right atrial appendage through a transvenous approach using the stylet technique of either FIGS. 2 or 3 or the .I-shaped applicator catheter technique.
  • the tines 12 are not exposed during insertion.
  • the tines are non-restrained or extended during the entire operation.
  • the electrode may be successfully positioned in this condition, it is found that the blood flow tends to draw the electrode tip into the ventrical. For this reason, some means of restraining the tines during insertion is desirable.
  • the catheter body 10 has a portion 30 which is inflatable from an end 32.
  • the inflation is accomplished through a lumen similar to the stylet lumen 19 and 18 of FIGS. 2 and 3 respectively. Indeed, the inflation can be accomplished through the stylet lumens 19 and 18, the lumens being made sufficiently large to accomodate the stylet while allowing a passage for air to inflate the balloon.
  • the ballooning feature of the electrode body 10 may be accomplished in any known manner.
  • FIG. 6 there is shown an electrode having a body 10 and a tip 11 as described with reference to the embodiment of FIG. 1.
  • the body 10 is composed of a balloon catheter as illustrated in FIG.
  • a hold down shroud 31 is positioned near the tip 11 and is adapted to receive at least the ends of the tines 12 to restrain them in a position wherein they overlie the inflatable portion 30 of the electrode body 10. With the tines in this restrained position, a stylet may be inserted into a lumen such as that illustrated in FIGS. 2 or 3 and the electrode inserted through a transvenous approach without any interference from the extended tines. When the electrode tip is believed to be in an acceptable position as viewed by fluoroscopy, a test measurement can be made.
  • the balloon 30 can be inflated from the end of the electrode still outside the body causing the tines to withdraw from the shroud 31 and extend into their normal unrestrained position as illustrated in FIG. 7. With the tines freed from the shroud 31 the inflating pressure can be released and the balloon 30 will deflate to a normal configuration.
  • the shroud 31 may take any shape which can accept at least the end portions of the tines 12. A ring which is attached to the body by spaced tethers is an example of an obvious modification of the shroud 31.
  • FIG. 8 An alternative shroud to the shroud 31 of FIG. 7 is illustrated at 35 in FIG. 8.
  • This shroud 35 again is adapted to accept at least the end portion of the tines 12 to restrain them in a position wherein they overlie the body of the electrode 10.
  • a line 36 is attached to the shroud 35 at 37, and when the tip is properly positioned, a force on the line 36 will cause the shroud 35 to withdraw thus freeing the tines 12 to assume their extended unrestrained position.
  • FIG. 9 wherein a stylet 40 is shown having a coiled portion 41 which coiled portion is wrapped around the tines causing them to lie flat against the body member 10. Again, when the tip 11 is properly positioned, the stylet will be withdrawn thereby freeing the tines for interaction with the trabeculae of the right atrial appendage, for example.
  • an electrode body 10 composed of a connecting portion 50, a central portion 51 and an end portion 52 which lies between the tip 11 and the shroud 53.
  • the cross section of the central portion 51 may be as illustrated in FIG. 3. That is, the electrical conductor is a coiled member 17 having a void lumen forming central portion 18, the conductor extending from the tip 11 back to the connecting portion 50.
  • the connecting portion 50 is similar to that illustrated in FIG. 4 with the connecting pin 54 making an electrical contact with the electrical conductor 17 and having a lumen coincident with the lumen 18 of the conductor 17.
  • the electrical conductor is a coiled member it can be stretched or elongated by applying a pressure against the tip 11 with the stylet 55. Since the electrical conductor is typically uniform throughout its length, the location at which the elec trode body will give or elongate can be controlled to the durometer or diameter of the electrode body, or both. For reasons to be explained more fully below, it is desired that the portion 52 of the electrode body 10 give before the central portion 51 or the connecting portion 50. Therefore, the portion 52 is illustrated as having a smaller diameter than either the central portion 51 or the connecting portion 50. Alternatively, the material comprising the portion 52 may have a lower durometer than either of the other portions of the electrode body 10 or it may have a lower durometer and diameter, as desired.
  • FIG. 11 illustrates the embodiment of FIG. 10 with the tines 12 having at least their ends restrained by the shroud 53 in a manner substantially identical to that illustrated in FIG. 6.
  • the electrode With the tines in their restrained position, the electrode can be inserted and positioned and, when a proper positioning is obtained as described above, the stylet is forced against the tip 11 causing the portion 52 to stretch as illustrated in FIG. 12 thereby releasing the tines 12 from the shroud 53. With the tines released, the stylet is removed thereby allowing the portion 52 to assume its normal shape as illustrated in phantom at FIG. 12.
  • the shroud 53 of FIGS. 10-12 may take the form of a ring connected to the electrode body by means of a plurality of tethers.
  • a ring shroud is illustrated at in FIG. 13.
  • the shroud 60 has a ring or a doughnut configuration and is held in place by means of tethers 61 which perform essentially as the spokes of a wheel, the tethers 61 being positioned so as not to interfere with the restraining and release of the tines 12.
  • the present invention provides a new medical electrode uniquely adapted for use as an endocardial electrode.
  • the electrode provides means for cooperating with the heart tissue, particularly the trabeculae of the ventricles and right atrial appendage, to provide an artificial fixation until such time as a natural fixation has occurred.
  • the tines are of a pliant material which is sufficiently rigid to accomplish their purpose without having the snapping action and sharp points attendant in the prior art devices.
  • the present invention provides a system for positioning the electrode and making any necessary test measurements prior to its being finally posi tioned, the position of the tip with regard to the inserting devices being much less critical in the present invention than in the prior art devices because the tines may be selectively released independently of the insertion device.
  • an endocardial lead of the type having an electrical conductor encased in a material which is generally inert to body fluids, the conductor terminating at an exposed electrically conductive electrode tip, the improvement which comprises:
  • nonconducting tine means extending from said encasing material and away from said tip from a location adjacent said tip for cooperating with heart tissue, to hold the tip in position, said tine means forming a generally acute angle with said encasing material and being entirely of a pliant material having sufficient rigidity to maintain said angle when said tine means are unrestrained, but sufficiently pliant to prevent penetration of said heart tissue, said pliant material being generally inert to body fluids.
  • said restraining means comprises shroud means for accepting at least the end portion of said tine means.
  • said restraining means further comprise means cooperating with said shroud means for effecting the release of said tine means at a point spaced from said shroud means.
  • inflatable means underlying said tine means when said tine means are in said restrained position; and means spaced from said inflatable means for selectively inflating said inflatable means.
  • An endocardial lead which comprises:
  • nonconducting tine means extending from said catheter means and away from said tip from a point adjacent said tip means for cooperation with heart tissue, to hold the tip in position, said tine means forming a generally acute angle with said catheter means and being entirely of a pliant material having sufficient rigidity to maintain said angle when said tine means are unrestrained, but sufficiently pliant to prevent penetration of said heart tissue, said pliant material being generally inert to body fluids.
  • the lead of claim 7 further comprising means for releasable restraining said tines in a position wherein they overlie said catheter means.
  • said restraining means comprises shroud means for accepting at least the end portion of said tine means.
  • said restraining means further comprises means cooperating with said shroud means for effecting the release of said tine means at a point spaced from said shroud means.
  • said catheter means comprises a balloon catheter, the balloon underlying the tines when the tines are in the restrained position.
  • said elongated electrically conductive means comprises a coiled electrical conductor having a void central portion, said lumen coinciding with said void central portion.
  • nonconducting tine means including a plurality of tines each extending from said catheter and away from said tip from a point adjacent said tip and forming an acute angle with said catheter for cooperating with heart tissue to hold the tip in position, said tine means being entirely of a pliant material having sufficient rigidity to maintain said angle when said tine means are unrestrained, but sufficiently pliant to prevent penetration of said heart tissue; means for releasably restraining said tine means in a position wherein said tine means overlie said catheter; and I means underlying said tine means when said tine means are in said restrained position and inflatable from a point spaced from said restraining means for releasing said tine means from said restraining means upon inflation.
  • said pliant tine means material comprises a material which is relatively inert to body fluids, at least a portion of said material being radiopaque.
  • radiopaque material portion is a material treated with a material selected from the group consisting of carbon, barium sulfate or Tantalum.

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  • 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)
US372269A 1973-06-21 1973-06-21 Endocardial electrode Expired - Lifetime US3902501A (en)

Priority Applications (5)

Application Number Priority Date Filing Date Title
US372269A US3902501A (en) 1973-06-21 1973-06-21 Endocardial electrode
AU77566/75A AU490702B2 (en) 1973-06-21 1975-01-23 Endocardial electrode
GB3444/75A GB1491942A (en) 1973-06-21 1975-01-27 Electromedical lead assembly
NLAANVRAGE7501094,A NL172617C (nl) 1973-06-21 1975-01-30 Hartelektrode.
FR7506366A FR2302107A1 (fr) 1973-06-21 1975-02-28 Electrode intracardiaque

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US372269A US3902501A (en) 1973-06-21 1973-06-21 Endocardial electrode

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US3902501A true US3902501A (en) 1975-09-02

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US372269A Expired - Lifetime US3902501A (en) 1973-06-21 1973-06-21 Endocardial electrode

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FR (1) FR2302107A1 (enExample)
GB (1) GB1491942A (enExample)
NL (1) NL172617C (enExample)

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GB1491942A (en) 1977-11-16
FR2302107B1 (enExample) 1979-04-27
NL7501094A (nl) 1976-08-03
NL172617C (nl) 1983-10-03
FR2302107A1 (fr) 1976-09-24

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