EP0027465A1 - Cable d'electrode flexible a longue duree - Google Patents

Cable d'electrode flexible a longue duree

Info

Publication number
EP0027465A1
EP0027465A1 EP80901031A EP80901031A EP0027465A1 EP 0027465 A1 EP0027465 A1 EP 0027465A1 EP 80901031 A EP80901031 A EP 80901031A EP 80901031 A EP80901031 A EP 80901031A EP 0027465 A1 EP0027465 A1 EP 0027465A1
Authority
EP
European Patent Office
Prior art keywords
electrode
wire
inch
lead wire
diameter
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Withdrawn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
EP80901031A
Other languages
German (de)
English (en)
Other versions
EP0027465A4 (fr
Inventor
James H. Donachy
G.Frank O. Tyers
Howard C. Hughes
Robert R. Brownlee
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.)
Individual
Original Assignee
Individual
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 Individual filed Critical Individual
Publication of EP0027465A1 publication Critical patent/EP0027465A1/fr
Publication of EP0027465A4 publication Critical patent/EP0027465A4/fr
Withdrawn legal-status Critical Current

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
    • A61N1/056Transvascular endocardial electrode systems

Definitions

  • the present invention relates to the electrical stimulation art and more particularly to a long-life flexible electrode lead for connecting a cardiac pacer to the heart of a patient.
  • Improved pacemaker power sources have increased the demand for a pacemaker electrode lead that will last for the life of the patient and the implanted pacer, and yet will not increase the energy drained from the im ⁇ planted power source.
  • a pacemaker electrode lead in normal use is flexed approximately 37,000,000 times a year if the pacer and/or the heart are firing at a rate of 70 beats per minute. In a 10-year period this comes to over 360,000,000 flexes.
  • Presently-available leads cannot reliably withstand this stress, so that there exists a critical need for an electrode lead with a re ⁇ liable lifetime to compare with that of the newer long life power sources.
  • Conventional pacemaker electrode leads are formed of coiled, insulated wires having tip and terminal elec- trodes connected at their opposite ends.
  • the wire itself has a diameter of 0.010 inch and the external coil diam ⁇ eter ranges from 0.037 to 0.039 inch.
  • thin guide wires are passed axially through these coils, but due to their small diameter provide the implanting physician with minimal torque control of the electrode tip and no remote flex control.
  • the insu ⁇ lation is in the form of silicone rubber tubing into which the wire coil is inserted during manufacture, and which encapsulates, but usually is not anchored or bonded to, the wire.
  • the neces ⁇ sary metal connectors and electrode tips are crimped onto the exposed ends of the insulated wire, and silicone rubber ends are molded in place.
  • the diameter of the layer of insulation is considerably larger than that of the wire, so that the variability of the coil diameter is considerably limited.
  • the flex-stress resistance of pacer elec- trode leads can be considerably improved with the use of larger wire coil diameters, and an improved insulation and method of construction has been found to permit in ⁇ creasing of the wire coil diameter, while in most cases, decreasing the overall diameter of the lead.
  • the inven- tion facilitates improved torque and flex control of the electrode tip and the construction of multipolar con ⁇ centric leads.
  • the present invention involves a pacemaker elec ⁇ trode lead having a larger internal wire coil diameter and improved insulation and other construction qualities which permit a smaller outside lead diameter as compared to conventional leads of the same type and which provides significant long-life reliability.
  • the electrode lead of the present invention while conveniently employing a conventional 0.010 inch diameter lead wire, uses an enlarged coil diameter for the helix in the range of from 0.040 to about 0.100 inch, and pref ⁇ erably about 0.065 inch, which markedly reduces the stress on the wire as compared with that imposed on the smaller coil diameter standard lead.
  • the tips and connectors are joined to the lead wire with a special solder,-welding, or plating, technique be ⁇ fore the insulation is .applied.
  • the wire is then primed to accept the bonding of a polymer coating for the insu- lation.
  • the coating is in the form of segmented poly- urethane which is a much higher strength material than the previously-used silicone rubber and yet has consid ⁇ erable elasticity which adds to the improved mechanical function of the electrode lead.
  • This insulation material has a 700% elongation factor and a high modulus charac ⁇ teristic which allows a very thin layer to be used in coating the wire, while still achieving improved strength
  • the thin ⁇ ner layer of insulation results in a final electrode lead no larger, and usually smaller,, than those currently available, but differing substantially in that it may be made up of a large conductor with a • small layer of insu ⁇ lation, in contrast with previous leads having a relatively tenuous conductor encased in a very large layer of insu ⁇ lation. Also, the coating process offers better control of electrode lead flexibility by permitting variations in thickness along the length.
  • a method of manufacturing the lead has been de ⁇ veloped involving dipping which is easily applicable to mass production of the lead and therefore should make the cost comparable with or even less than currently- available mechanically and functionally inferior elec ⁇ trode leads.
  • the electrodes can be con- " . veniently manufactured in volume using one or more con ⁇ trolled dipping machines. These machines in their pres ⁇ ently commercially-obtainable form can be readily modi- fied to dip four to six leads at a time, and two of these machines may be disposed at a time under a conventional laminar flow hood.
  • a single operator can suitably con ⁇ trol at least four dipping machines at a time which will permit the simultaneous production of at least 16 elec- trodes per worker.
  • the resulting electrode lead of the present inven ⁇ tion permits easy implantation of the electrode into the
  • the segmented polyurethane- coated electrode lead may also be made much smaller (e.g. 0.050 inch O.D.) than current silicone-coated electrodes to accommodate it to special applications such as in elderly patients with very tiny friable veins or in - youger children.
  • Such an external diameter is signifi- cantly smaller than any heretofore achieved with a re ⁇ liable permanent electrode, and facilitates percutaneous insertion.
  • This invention also permits the development of multipolar concentric leads, no larger than current stan- dard unipolar leads, with the further advantage that a single slot in the pacemaker connector block may be used for connecting multiple electrically active members, thus avoiding the bulky configuration of existing bipolar con ⁇ nectors.
  • Fig. 1 is a diagrammatic view in section of a long- life electrode lead constructed in accordance with the present invention.
  • Fig. 2a is a plan view of an electrode lead of the type shown in Fig. 1 in combination with an electrode steering device in accordance with the present invention.
  • Fig. 2b is a side view of the lead and steering device of Fig. 2a.
  • Fig. 3 is a diagrammatic view in section of a concentric bipolar type electrode lead connected to a pacer connector block in accordance with the present in ⁇ vention.
  • Fig. 4a is a perspective view of a pacemaker hav ⁇ ing a connector block with a single port and two elec ⁇ trode-connecting set screws arranged linearly therealong for use with the bipolar electrode lead shown in Fig. 3.
  • Fig. 4b is a perspective view of a prior art pacer having a connector block with a double port arrangement and two electrode-connecting set screws arranged thereon in the manner of the prior art.
  • a long-life pacer electrode lead in accordance with the present invention is shown in section in Fig .1.
  • the electrode lead member 1 is constructed with an elec ⁇ trode tip 2 at one end for contacting the heart of a patient and with a terminal electrode 4 at the other end which is connected to the pacer.
  • a coiled or helical lead wire 3 is connected between the electrodes 2 and 4 with its opposite coiled ends accommodated in appropriate cavities formed within cylindrical portions or extensions 2a and 4a on the electrodes.
  • the coiled ends of the lead wire 3 are conductively connected to the portions 2a and 4a by a low-temperature silver solder or other suitable means 7.
  • the lead wire 3 and the portions 2a and 4a are covered with an insulating material 5, and the terminal end may also be provided with a flex stress resisting, tapered shield member 6 for connecting the lead member 1 to the connector on the pacemaker.
  • An axial channel or lumen 8 is formed within the electrode lead and permits the insertion of a steering mechanism or other guiding tool as will be more fully explained in connection with Figures 2a-b.
  • the lead wire itself may be of the conventional type used with cardiac pacers such as manufactured by the Elgiloy Co. of Elgin, Illinois, having a diameter of 0.010 inch. Smaller wire diameters have been tested
  • Multifilar helical coils may be used rather than monofilar, and MP35N or pl ' atinum-iridium may be used instead of Elgiloy.
  • the outside diameter of the coil or helix is made larger such as at least 0.040 inch and preferably much larger, for example, 0.065 or 0.100 inch. The larger diameter reduces the stress on the wire during flexure as compared with that imposed on a lead with a smaller diameter.
  • the insulation 5 is of a polymer which will bond to the wire, preferably segmented polyurethane.
  • Seg ⁇ mented polyurethane has been tested intravascularly in left heart bypass pumps in both patients and animals and found suitable in this environment, as reported in the medical literature and has proven successful in unpub ⁇ lished animal electrode tests.
  • This preferred material is much tougher than the conventionally used silicone rubber while having an elasticity which adds to the mechanical function of the electrode member already im ⁇ proved by the larger outside diameter wire coil.
  • Seg ⁇ mented polyurethane also has a memory so that by heat setting, specific memory effects can be induced into the electrode lead structure for regulating its shape and stiffness. This feature is of value, for example, in right atrial applications where a hook- or J-shaped
  • _OMPI configuration would be preferable.
  • atrial applica ⁇ tions an increased degree of rigidity may be required in the distal " portion of the electrode member so that it may be pulled back into the atrial appendage with a less- end chance of displacement from the atrium.
  • These re ⁇ quirements cannot be met with conventional silicone rubber insulated leads without a significant increase in their diameter, and even with large diameters, the stiffness control is less with silicone tube leads.
  • a commercially-obtainable segmented polyurethane that may be used is BIOMER, produced by Ethicon Corporation, but other polyurethane-based materials such as AVCOTHANE or biocompatible polymers may also be found suitable.
  • a suitable process for manufacturing an electrode lead member in accordance with the present invention involves the following steps.
  • the lead wire 3 which has been coiled to the desired enlarged diameter is thoroughly cleaned and its coiled ends conductively con ⁇ nected to the tip portion 2a and terminal portion 4a using low temperature silver solder.
  • Suitable welding techniques, heliarcing,electroplating, or the like may also be used in making this connection or even a mechan ⁇ ical crimp as in current art can be used, although this last technique is- not preferred.
  • the tip and terminal electrode connections to the coil 3 may be made inside the coil, rather than outside as shown, or optimally, the tip portion 2a may be disposed inside to permit reduction of the tip diameter, while the terminal or hub portion may be attached outside the coil, to maximize the size of the steerable guide wire that can be inserted in the channel 8. In any event, a secure permanent attach- ment of the lead wire and the electrodes is performed be ⁇ fore application of the insulation.
  • the lead wire and the portions 2a and 4a are again cleaned with propyl al ⁇ cohol and treated with a primer such as 607 Chemlock primer after which a 15 to 20 minute drying time is al ⁇ lowed.
  • the lead wire 3 and the end portions 2a and 4a are then mounted on a mandrel, which extends axially therethrough, and dipped in the polymer, that is seg ⁇ mented polyurethane,-whose viscosity will be controlled in accordance with the diameter of the wire being dipped. After dipping, the polymer is cured for from 45 minutes to 1 hour at 150° F. The same dipping procedure is then repeated until the proper wall thickness is obtained.
  • a single wall thickness of 0.005 to 0.007 inch, or 0.014 inch total additional diameter, will be suffi- • cient, but the ' electrode member can be coated to any thickness desired, depending upon the application planned for the finished electrode member. Normally the viscosity of the polymer will be such that 0.002 inch is applied with each dipping.
  • the electrode member When the desired insulation thickness is achieved, the electrode member may be cured for about 25 hours and
  • a special anchor or tip such as a flange or tine, can be molded on the op ⁇ posite end of the lead for fixing it to the heart of a patient.
  • the finished electrode lead can then be cleaned and inspected and will be ready for use.
  • the stiffness of the lead can be controlled by the spacing of the wire coils and the thickness of the polymer coat ing, a tightly wound helical coil being stiffer than one that has each coil spaced at a specific dimension.
  • the stiffness can be varied along the full length of the member or in any specified area, for example, towards the * tip end to provide increased flexibility and reduce the risk of perforation.
  • the manufacturing operation lends itself to mass production as the dipping may be conveniently carried out in a controlled dipping machine.
  • currently-available machines of this type can be readily modified by the skilled artisan to dip four to six leads at a time under a normal laminar flow hood, which in turn can hold two machines.
  • one operator can productively control at least four machines at a time, one person should be able to polymer coat at least 16 electrode leads at one time.
  • the stimulating electrode tip 2 may be in the form of a ball tip, spher ⁇ ical, bullet shaped, cylindrical or other similar con- figuration and of Elgiloy, platinum, platinum-iridium or other biocompatible material;
  • the end terminal 4 may be of Elgiloy, 316L stainless steel, vitalium, or other corrosion-resistant material; and
  • the flex-stress resist ⁇ ing tapered connector and shield 6 may be of silicone rubber, segmented polyurethane, AVCOTHANE or other bio ⁇ compatible material.
  • the thickness of the segmented polyurethane coat ⁇ ing can be tapered toward the tip of a transvenous or transthoracic version of the electrode member to provide maximum tip flexibility and decrease cardiac tissue trauma and the risk of perforation.
  • the coat ⁇ ing can be gradually thickened toward the terminal con ⁇ nector end to maximize fracture resistance.
  • transvenous lead If a transvenous lead is too flexible, it will not stay in position, but will provide maximal fracture resistance. If the coil diameter is made much larger than 0.065 inch, it has limitations with respect to peripheral vein size, even though much larger bipolar transvenous leads are presently available. Transthoracic leads on the other hand, may have diameters up to a centimeter (0.394 inch), although a somewhat smaller diameter would be optimal. Consequently, coil diameters in the range from 0.040 inch to about 0.100 inch are regarded as optimal with 0.065 inch particularly preferred.
  • wire diam-- eters of greater than 0.010 inch would be applicable with a helix of greater than 0.065 inch and suitable in appli ⁇ cations where greater stiffness was considered advanta ⁇ geous as in atrial J-shaped electrodes.
  • wire diam-- eters of greater than 0.010 inch would be applicable with a helix of greater than 0.065 inch and suitable in appli ⁇ cations where greater stiffness was considered advanta ⁇ geous as in atrial J-shaped electrodes.
  • heavier wire sizes and larger helical coils can be adapted to the present electrode lead design to reduce its resistance and to further increase its mechanical reliability and stability.
  • a larger channel 8 is available within the wire coil 3 than previously obtainable.
  • the larger channel allows the insertion of a much larger guide wire or a steerable flex-torque control mechanism through the lead to the tip or distal end, thus permitting the application of better torque and angle changes to the electrode tip when manipulating and implanting the electrode apparatus.
  • Am improved steering mechanism 20 for this purpose is shown in Figs. 2a-b.
  • the mechanism 20 has a handle composed of three rings 21a, 21b and 21c for re- spectively receiving the index, thumb and middle fingers of an operator who, in the present case, would be the physician implanting the electrode lead in the heart of a patient.
  • the " rings 21a and 21c are mounted on the op ⁇ posite ends of a crosspiece 22 which is slidable along a rod-like member 23 having ring 21b on one end.
  • the other end of the rod-like member 23 is connected to or integral with a body portion 24 having a longitudinal bore 24a therein.
  • a guide wire member 25 of the flex type is connected to crosspiece 22, by block 22' and set screw 22", and extends through bore 24a into the channel 8 in the electrode lead 1.
  • This three-ring handle and controlled flex guide wire arrangement is essentially kn ⁇ wn,in the art, particularly for use in selective vascu ⁇ lar radiology and bronchial brushing techniques and may be of the type " manufactured by €ook Inc., Bloomington, Ind., as Deflecting Handle, Cat. No. TDH100.
  • body portion 24 is modi ⁇ fied for use with the improved electrode lead. More par ⁇ ticularly, the body portion 24 is adapted at the forward end of the bore 24a to receive the hub or terminal end of an electrode lead, and a bore 27 is provided, which
  • the 10 communicates with the bore 24 and receives a set screw 26.
  • the set screw 26 may be used to engage and fix the end of the lead in the bore 24a so that the lead 1 will fol ⁇ low rotational motion of the handle.
  • the flex guide wire 25 is in ⁇ serted into the channel or lumen 8 in the lead and may . be extended as far as the electrode tip end.
  • the oppo ⁇ site or hub end of the electrode lead is inserted in the handle bore 24a, and the set screw 26 is tightened there-
  • the set screw 26 is released, and the guide wire 25 is removed from the interior of the lead by withdrawing the hub or terminal end of the lead from the three ring handle body. The terminal end of the lead may then be inserted into the receptacle or port in the connector block of a pace ⁇ maker.
  • An additional advantage of the improved manufac ⁇ turing technique and construction is the enhancement of the ability to construct redundant electrodes as required for EMI protection sheaths, bipolar pacing, and/or when separate electrodes are used for pacing and sensing, and/or unipolar pacing and bipolar sensing as disclosed in U.S. Pat. No. 3,977,411.
  • the embodiment of the inven ⁇ tion shown in Fig. 3 represents one multipolar electrode
  • OMPI WIPO arrangement which may be used for such redundant or bi ⁇ polar applications where two or more conductive elements are essential or considered advantageous.
  • a small insulation-coated helical coil 3' having a diameter, for example of 0.037 inch may be fitted in ⁇ side a larger insulation-coated helical coil 3" of a diam ⁇ eter of 0.065 inch to provide a two-conductor element or bipolar coil in the form of a single electrode lead mem ⁇ ber 1*.
  • the inner and outer coils 3' and 3" may be coated separately with the segmented polyurethane, or other suit ⁇ able polymer material.
  • a larger contact area, ring elec ⁇ trode 2 n , at the tip or distal end of the lead is connected to outer coil 3" and may be used to sense cardiac activity, while the smaller contact area, tip electrode 2', con- nected to inner coil 3* applies stimulating pulses to the heart.
  • the two coils 3' and 3", at the opposite hub or proximal end of the lead 1' are respectively connected to a terminal electrode 40 and a ring electrode 41 which are embedded in the insulating material 5' with their outer surfaces exposed.
  • the connector block 50 on the pacemaker for re ⁇ closing the hub end of " the electrode lead is provided with respective block and screw connectors 41a and 40a which conductively contact the exposed surfaces of the ring and terminal electrodes 41 and 40.
  • the lead elec ⁇ trodes are held in place in the connector block 50 by the respective set screws 41b and 40b.
  • the ring electrode 41a usually being of positive polarity
  • the terminal electrode 40a is of negative polarity.
  • the remaining structural features of the tip and hub of 5 the lead 1* may be essentially the same as those shown in connection with the unipolar lead 1 in Fig. 1, such as the inclusion of a flexion shield at the hub end.
  • OMPI construction while permitting greater variability of coil size also lends itself to adaptation to simplified, small ⁇ er bipolar electrode leads, the- use of smaller diameter electrodes and the unprecedented application of 360° torque control and over 90° flex control to the electrode tip by means of an improved steering device.
  • the larger coil diameter also facilitates the incorporation of a re ⁇ motely (hub) operated lead tip myocardial grasping mech ⁇ anism to fully take advantage of permanent electrode po ⁇ sitioning in any of the unprecedented variety of locations enabled by the flex torque control mechanism.
  • the leads can be used in a wide variety of applications as well as with pacemakers and other organ stimulators.

Abstract

Un cable flexible d'electrode (1) pour l'utilisation avec des stimulateurs cardiaques et autres et un procede de preparation du cable, dans lesquels une resistance amelioree a la flexion est obtenue par l'utilisation d'un enroulement de fil conducteur (31) de diametre plus grand avec un diametre se situant dans la gamme de 0,040 a environ 0,100 pouce, de preference d'environ 0,065 pouce, l'extremite (2) et la borne (4) des electrodes etant connectees solidement avant l'application de l'isolement (5) et dans lequel l'isolement est en polyurethane segmente qui est soude au fil et aux electrodes ameliorant la duree et permettant une reduction dans le diametre hors-tout du cable. La reduction en diametre du cable permet aussi la construction de cables concentriques multipolaires (1') pas plus encombrants que les cables standard unipolaires couramment disponibles avec l'avantage supplementaire qu'un bloc de connection (50) de stimulateur avec une seule ouverture peut etre utilise pour relier des pieces multiples actives electriquement. De plus, le plus grand diametre du cable resulte en un canal ou lumiere (8) plus grand de facon marquee a l'interieur de l'enroulement conductif (0,045 pouce ou plus) permettant l'insertion d'un mecanisme de guidage ameliore (20) qui permet un controle jusqu'alors inegale du couple et de la flexion de l'extremite de l'electrode. Finalement, la technique de revetement peut etre utilisee avec des enroulements de diametre standard externe d'environ 0,039 pouce pour aboutir a des conducteurs avec des diametres externes totaux tres petits (par exemple 0,050 pouce) convenant a des utilisations pediatriques et autres necessitant l'acces au travers de tres petites veines ou au travers d'une aiguille intravasculaire ou de protection guide.
EP19800901031 1979-04-24 1980-11-04 Cable d'electrode flexible a longue duree. Withdrawn EP0027465A4 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US3273179A 1979-04-24 1979-04-24
US32731 1998-02-27

Publications (2)

Publication Number Publication Date
EP0027465A1 true EP0027465A1 (fr) 1981-04-29
EP0027465A4 EP0027465A4 (fr) 1981-08-31

Family

ID=21866514

Family Applications (1)

Application Number Title Priority Date Filing Date
EP19800901031 Withdrawn EP0027465A4 (fr) 1979-04-24 1980-11-04 Cable d'electrode flexible a longue duree.

Country Status (2)

Country Link
EP (1) EP0027465A4 (fr)
WO (1) WO1980002231A1 (fr)

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EP0027465A4 (fr) 1981-08-31
WO1980002231A1 (fr) 1980-10-30

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