US20140343654A1 - Implantable medical electrical lead conductors and construction methods - Google Patents
Implantable medical electrical lead conductors and construction methods Download PDFInfo
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- US20140343654A1 US20140343654A1 US14/453,885 US201414453885A US2014343654A1 US 20140343654 A1 US20140343654 A1 US 20140343654A1 US 201414453885 A US201414453885 A US 201414453885A US 2014343654 A1 US2014343654 A1 US 2014343654A1
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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
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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
- A61N1/0563—Transvascular endocardial electrode systems specially adapted for defibrillation or cardioversion
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- H—ELECTRICITY
- H01—ELECTRIC ELEMENTS
- H01R—ELECTRICALLY-CONDUCTIVE CONNECTIONS; STRUCTURAL ASSOCIATIONS OF A PLURALITY OF MUTUALLY-INSULATED ELECTRICAL CONNECTING ELEMENTS; COUPLING DEVICES; CURRENT COLLECTORS
- H01R43/00—Apparatus or processes specially adapted for manufacturing, assembling, maintaining, or repairing of line connectors or current collectors or for joining electric conductors
- H01R43/02—Apparatus or processes specially adapted for manufacturing, assembling, maintaining, or repairing of line connectors or current collectors or for joining electric conductors for soldered or welded connections
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- H—ELECTRICITY
- H01—ELECTRIC ELEMENTS
- H01R—ELECTRICALLY-CONDUCTIVE CONNECTIONS; STRUCTURAL ASSOCIATIONS OF A PLURALITY OF MUTUALLY-INSULATED ELECTRICAL CONNECTING ELEMENTS; COUPLING DEVICES; CURRENT COLLECTORS
- H01R43/00—Apparatus or processes specially adapted for manufacturing, assembling, maintaining, or repairing of line connectors or current collectors or for joining electric conductors
- H01R43/04—Apparatus or processes specially adapted for manufacturing, assembling, maintaining, or repairing of line connectors or current collectors or for joining electric conductors for forming connections by deformation, e.g. crimping tool
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- Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
- Y10T—TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
- Y10T29/00—Metal working
- Y10T29/49—Method of mechanical manufacture
- Y10T29/49002—Electrical device making
- Y10T29/49117—Conductor or circuit manufacturing
- Y10T29/49174—Assembling terminal to elongated conductor
-
- Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
- Y10T—TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
- Y10T29/00—Metal working
- Y10T29/49—Method of mechanical manufacture
- Y10T29/49002—Electrical device making
- Y10T29/49117—Conductor or circuit manufacturing
- Y10T29/49204—Contact or terminal manufacturing
Definitions
- the present invention pertains to implantable medical electrical leads, and, more particularly to conductors and construction methods thereof.
- Implantable medical systems that are designed to deliver electrical stimulation, for example, to cardiac muscle or the spinal cord, and/or to monitor bodily electrical activity, typically include a relatively compact implantable device to which one or more elongate implantable electrical leads are coupled, for example, like the exemplary system 10 schematically shown in FIG. 1A .
- FIG. 1A illustrates system 10 including an implantable defibrillator device 500 and a defibrillation lead 100 , which is connected to device 500 and extends transvenously therefrom, into a heart of a patient, such that a defibrillation electrode 11 and a pace-sense electrode 13 of lead 100 are located in the right ventricle RV of the heart.
- a power source and circuitry of device 500 are contained in a hermetically sealed housing 55 of device 500 , which housing 55 , being formed from a conductive metal such as titanium, may function as an electrode, in concert with electrode 11 , to deliver high voltage pulses for defibrillation therapy in response to a cardiac arrhythmia, for example, sensed by electrodes 13 , 11 .
- FIG. 1A further illustrates device 500 including a connector module 51 that has a port 501 into which a connector terminal 15 of lead 100 is inserted for electrical coupling with the circuitry contained in housing 55 , for example, via electrical contacts, which are mounted within port 501 and coupled to the circuitry via hermetically sealed feedthroughs. Suitable constructions for such a connector module and lead connector are known to those skilled in the art.
- an outer insulation sheath 12 of lead 100 contains a first elongate conductor that couples electrode 11 to a first connector terminal contact 151 , and a second elongate conductor that couples electrode 13 to a connector terminal contact pin 153 .
- each of electrodes 11 , 13 are joined to the corresponding conductor via a crimp and/or weld joint that may include a separate coupling component.
- a coiled conductor include an integral electrode length that extends distally out from outer insulation sheath 12 to form electrode 11 . Improvements on such a construction are desired, for example, to enhance lead performance in a system such as system 10 .
- a continuous conductor wire of an implantable medical electrical lead which has been formed in a coil, includes a first, electrode length and a second, insulated length, wherein the insulated length of the wire has a radial cross-section defined by a round profile, while the electrode length of the wire has a radial cross-section defined by a flattened profile, a long axis edge of which defines an outer diameter surface of the electrode length.
- the radial cross-section profile of the electrode length of wire is flattened after the wire has been coiled, preferably by rotary swaging.
- the outer diameter surface of the first, electrode length by virtue of the flattened profile, has a larger area that faces outward than if the radial cross-section of this same length of wire were left with a round profile.
- a distal end of the coil, in proximity to the electrode length of wire, is formed into a ring-like structure, for example, by welding multiple turns of the distal end of the coil together.
- a length of the coil corresponding to the first, electrode length of the conductor wire may be between approximately 4 cm and 8 cm, for example, to function as a defibrillation electrode, however, alternate embodiments of the present invention may be directed toward shorter electrode lengths more suitable for sensing only.
- the electrode length includes a shunt portion located in proximity to the insulated length, wherein the shunt portion is overlaid with a relatively thin layer of dielectric material.
- FIG. 1A is a schematic depicting an exemplary implantable medical system
- FIG. 1B is a plan view of an implantable medical electrical lead, which may be included in the system of FIG. 1A , and which may be constructed according to some embodiments of the present invention
- FIG. 2 is a cross-section view, with an enlarged detail view, of a continuous conductor wire coil, according to some embodiments;
- FIG. 3 is a front elevation view of a working portion of an exemplary rotary swaging machine, which may be employed according to some methods of the present invention, along with schematic depicting wire cross-section profiles;
- FIG. 4 is an enlarged view, with a cut-away cross-section, of a distal portion of the lead shown in FIG. 1B , according to some embodiments;
- FIG. 5 is a cross-section view of the continuous conductor wire coil including a welded distal end, according to some embodiments.
- FIG. 6 is a plan view, with a cut-away cross-section, of a distal portion of a pace-sense lead, according to some embodiments.
- FIG. 2 is a cross-section view of a continuous conductor wire coil 20 , according to some embodiments, which may be incorporated in lead 100 of FIG. 1B .
- embodiments of the present invention include other configurations of leads constructed to locate electrode length E at alternative sites, for example, in the superior vena cava SVC (for defibrillation therapy), or in a coronary vein CV (for pacing therapy).
- FIG. 2 illustrates coil 20 as a multi-filar coil formed from a plurality of continuous conductor wires 201 , 202 , 203 , 204 , 205 , 206 .
- coil 20 may be a single-filar coil, for example, including only conductor wire 201 wound in a tighter pitch than illustrated in FIG. 2 , or a coil having any other suitable number of filars.
- the designation of conductor wire 201 - 206 refers to one or more conductor wires.
- FIG. 2 illustrates continuous conductor wire 201 - 206 including a first, electrode length E, and a second, insulated length B, wherein a radial cross-section of insulated length B of conductor wire 201 - 206 has a round profile 32 ( FIG.
- a radial cross-section of electrode length E of conductor wire 201 - 206 has a flattened profile 31 , which will be described in greater detail below, in conjunction with FIG. 3 .
- the radial cross-section profile of electrode length E of wire 201 - 206 is flattened after wire 201 - 206 is wound into coil 20 .
- Conductor wire 201 - 206 may be formed from any suitable conductive material, such as MP35N alloy, a platinum-iridium alloy (Pt/Ir), tantalum (Ta), a Ta alloy, titanium (Ti), a Ti alloy, or any suitable combination thereof, for example, a Pt/Ir-cladded Ta, or Ta or MP35N having a layer of Pt, titanium-nitride (TiN), or any other suitable coating formed thereover, for example, by sputtering, electro-deposition, ion implantation, or any other suitable coating method.
- Additional suitable materials for conductor wires 201 - 206 include cored-composites such as silver-cored MP35N or Ta alloy.
- electrode length E of conductor wire 201 - 206 forms electrode 11 , for example, having a length of between approximately 4 cm and 8 cm to function as a defibrillation electrode, while insulated length B of conductor wire 201 - 206 extends within outer insulation sheath 12 , for example, formed from a medical grade silicone rubber or polyurethane. It should be noted that electrode length E may be shorter to function as a pace-sense electrode in alternate embodiments of leads, for example, a lead 600 described below, in conjunction with FIG. 6 . The enlarged detail in FIG.
- jacket 219 is removed from wire 201 - 206 , along electrode length E, prior to forming the flattened radial cross-section thereof, for example, by laser ablation, or grit blasting, or any other suitable method.
- conductor wire 201 - 206 at a proximal end 27 of coil 20 , is preferably coupled to connector terminal contact 151 , and another elongate conductor, for example, an insulated conductor 43 shown in FIG. 4 , couples electrode 13 to connector terminal contact pin 153 .
- distal end 28 of coil 20 may be terminated with a ring 42 of insulative or conductive material attached thereto, or with a weld, for example, a laser tack weld, or a more substantial laser weld, for example, extending 360 degrees, that welds multiple turns of distal end 28 of coil together to form a ring-like structure, for example, as illustrated in FIG. 5 .
- FIG. 5 is a cross-section view of continuous conductor wire coil 20 including a welded distal end 28 forming a ring 52 , according to some embodiments.
- Ring 52 may be of any suitable length according to the number of filars/turns of coil 20 that are welded together, and, according to the illustrated embodiment, ring 52 may include one or more features, such as slots 512 , formed therein, for example, by laser or EDM machining methods known in the art. The one or more features may facilitate the termination of coil 20 , for example, by interlocking with mating features of other components of lead 100 / 600 .
- FIG. 4 further illustrates a backfill 412 , for example, of silicone medical adhesive, that extends between coil 20 and insulated conductor 43 , for example to stabilize wire 201 - 206 along electrode length E and to provide strain relief for coil 20 in proximity to a distal end terminal end of insulation sheath 12 .
- wire 201 - 206 may be embedded in an outer surface of insulation material that surrounds conductor 43 , at least along length E, according to methods known to those skilled in the art.
- FIG. 3 is a front elevation view of a working portion of an exemplary rotary swaging machine 30 , which may be employed according to some methods of the present invention, along with schematic depicting radial cross-section profiles 31 , 32 of conductor wire 201 - 206 .
- FIG. 3 shows conductor wire 201 - 206 , which has been wound in a coil, positioned around a mandrel 33 , and mounted within machine 30 .
- FIG. 3 illustrates machine 30 including four dies 37 mounted on a spindle 5 which rotates, per arrow C, so that each die 37 moves, per arrow D, in response to a cam surface 36 of a corresponding hammer H coming into contact with guide rollers 34 , and then moves, per arrow 0 , in response to a centrifugal force created by the spindle rotation, when the corresponding cam surface 36 moves out of contact with rollers 34 .
- only a portion of a length of the coil is positioned within inner peripheral surfaces of dies 37 , so that the rest of conductor wire 201 - 206 that extends along a remainder of the length of the coil is not impacted by dies 37 .
- cold working methods known in the art, for example, performed on a lathe, may be employed to plastically deform the radial cross-section of wire 201 - 206 , for example, from round profile 32 to flattened profile 31 .
- the cold working method employed to plastically deform the radial cross-section of wire 201 - 206 into flattened profile 31 , along electrode length E may simultaneously remove the optional insulation jacket 219 from around wire 201 - 206 .
- FIG. 3 shows flattened profile 31 having a short axis S, a long axis L, and a long axis edge Le, wherein, with reference to FIG. 4 , long axis edge Le defines an outer diameter surface 290 of electrode length E.
- round profile 32 of wire 201 - 206 has a diameter of approximately 0.005 inch, whereas long axis edge Le of flattened profile 31 extends approximately 0.007 inch, and short axis S approximately 0.003 inch.
- outer diameter surface 290 along electrode length E has a consistently larger area that faces outward from lead 100 , than if the radial cross-section of this same length of wire 201 - 206 had been left with the round profile 32 .
- the larger area of outer diameter surface 290 is useful for increasing defibrillation shock energy delivered by electrode 11 , particularly when a smaller diameter of coil 20 is employed to reduce a profile of lead 100 .
- outer diameter surface 290 is made approximately isodiametric with an outer diameter of insulation sheath 12 by slightly enlarging an inner diameter of coil 20 along first electrode length E of wire 201 - 206 , for example, with mandrel 33 ( FIG. 3 ) just prior to swaging.
- coil 20 may be wound such that a distal length thereof, which corresponds to electrode length E of wire 201 - 206 , has a larger diameter than a proximal length thereof, which corresponds to insulated length B.
- elongate insulated conductor 43 i.e.
- a cabled bundle of MP35N conductor wires contained within a fluoropolymer jacket and/or a silicone or polyurethane sheath extends within an inner diameter of coil 20 to electrically couple electrode 13 to connector terminal contact pin 153 ( FIG. 1B ); and an insulator member 46 mechanically joins the assembly of electrode 13 and insulated conductor 43 to coil 20 , by any suitable interlocking and/or bonded junction known to those skilled in the art.
- ring 42 may have features formed therein (i.e. via EDM or laser machining) to interlock/mate together components, such as coil 20 and insulator member 46 .
- a diameter of distal end 28 of coil 20 may subsequently be reduced, for example, by swaging distal end 28 a second time, around a smaller diameter mandrel than that previously employed, in order fit distal end 28 within ring 42 for a lower profile junction therewith, according to some embodiments.
- coil 20 may be originally wound with two pitches, wherein a pitch over the distal length, corresponding to electrode length E of wire 201 - 206 , is longer than that over the proximal length, corresponding to insulated length B.
- the longer original pitch of the distal length may be necessary, in some instances, to provide extra longitudinal space between turns of wire 201 - 206 to accommodate the subsequently flattened profile 31 .
- a insulated length B of conductor wire 201 - 206 includes a transition length T at a distal end thereof, in proximity to electrode length E, according to some embodiments, wherein wire 201 - 206 along transition length T has a profile that is flattened somewhat from round profile 32 , but not to the degree of flattened profile 31 .
- This ‘intermediate’ flattened profile, along transition length T, is also preferably formed after conductor wire 201 - 206 is wound into coil 20 by a suitable cold working method, for example, rotary swaging.
- conductor wire 201 - 206 in which conductor wire 201 - 206 is formed from Ta, Pt, TiN, or other suitable coatings may be applied via sputtering, electro-deposition, ion implantation, or other suitable methods, to form all or a portion of outer diameter surface 290 of electrode length E of wire 201 - 206 ; or a Pt-Ir cladding may surround a Ta core to form outer diameter surface 290 .
- Ta conductor wire 201 - 206 includes a native oxide coating, such as tantalum pentoxide (Ta 2 O 5 ), or a TiN coating extending over a portion of outer diameter surface 290 of electrode length E, for example, at distal end 28 of coil 20 .
- any of the Pt, Ta 2 O 5 , and TiN coatings are preferably formed after flattening the cross-section of wire 201 - 206 along electrode length E.
- the pentoxide coating may be formed by anodizing and annealing the portion of electrode length E of conductor wire 201 - 206 , for example, by methods known in the art.
- the Pt or TiN coating may be formed according to processes known in the art. Any of the Pt, Ta 2 O 5 and TiN coatings may shift electrical shock energy somewhat proximally during the leading, high amplitude phase (i.e.
- ring 42 may be a conductive extension of electrode length E of wire 201 - 206 to form part of electrode 11 , in which case, ring 42 may be formed from Ta having one of the above-described coatings.
- FIG. 6 is a plan view, with a cut-away cross-section, of a distal portion of pace-sense lead 600 , according to some alternate embodiments.
- lead 600 may be implanted in coronary vein CV (designated with a dashed line), or in either chamber of the right side of the heart.
- FIG. 6 illustrates electrode length E of coiled conductor wire 201 - 206 , which has the radial cross-section with flattened profile 31 , including an exposed sense portion 61 at distal end 28 , and an optional shunt portion 61 -S, which extends proximally from sense portion 61 .
- FIG. 1B illustrates electrode length E of coiled conductor wire 201 - 206 , which has the radial cross-section with flattened profile 31 , including an exposed sense portion 61 at distal end 28 , and an optional shunt portion 61 -S, which extends proximally from sense portion 61 .
- FIG. 6 further illustrates shunt portion 61 -S located in proximity to insulated length B and having an outer surface overlaid with a relatively thin layer of dielectric material 602 , for example, polyurethane or polyimide.
- dielectric material 602 for example, polyurethane or polyimide.
- the cross-section profile of wire 201 - 206 is preferably flattened to form electrode length E, prior to overlaying the outer surface of optional shunt portion 61 -S with material 602 .
- Optional shunt portion 61 -S can be useful reduce heating of exposed sense portion 61 of electrode length E during magnetic resonance imaging procedures.
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Abstract
A coiled continuous conductor wire of an implantable medical electrical lead includes a first, electrode length and a second, insulated length, wherein the insulated length of the wire has a radial cross-section defined by a round profile, while the electrode length of the wire has a radial cross-section defined by a flattened profile, a long axis edge of which defines an outer diameter surface of the electrode length. The radial cross-section profile, along the electrode length of wire, is preferably flattened after an entire length of the wire has been coiled.
Description
- This application is a continuation of U.S. patent application Ser. No. 13/664,959, filed Oct. 31, 2012 entitled “IMPLANTABLE MEDICAL ELECTRICAL LEAD CONDUCTORS AND CONSTRUCTION METHODS”, herein incorporated by reference in its entirety.
- The present invention pertains to implantable medical electrical leads, and, more particularly to conductors and construction methods thereof.
- Implantable medical systems that are designed to deliver electrical stimulation, for example, to cardiac muscle or the spinal cord, and/or to monitor bodily electrical activity, typically include a relatively compact implantable device to which one or more elongate implantable electrical leads are coupled, for example, like the
exemplary system 10 schematically shown inFIG. 1A .FIG. 1A illustratessystem 10 including animplantable defibrillator device 500 and adefibrillation lead 100, which is connected todevice 500 and extends transvenously therefrom, into a heart of a patient, such that adefibrillation electrode 11 and a pace-sense electrode 13 oflead 100 are located in the right ventricle RV of the heart. Those skilled in the art appreciate that a power source and circuitry ofdevice 500 are contained in a hermetically sealedhousing 55 ofdevice 500, which housing 55, being formed from a conductive metal such as titanium, may function as an electrode, in concert withelectrode 11, to deliver high voltage pulses for defibrillation therapy in response to a cardiac arrhythmia, for example, sensed byelectrodes -
FIG. 1A further illustratesdevice 500 including aconnector module 51 that has aport 501 into which aconnector terminal 15 oflead 100 is inserted for electrical coupling with the circuitry contained inhousing 55, for example, via electrical contacts, which are mounted withinport 501 and coupled to the circuitry via hermetically sealed feedthroughs. Suitable constructions for such a connector module and lead connector are known to those skilled in the art. With reference toFIG. 1B , anouter insulation sheath 12 oflead 100 contains a first elongate conductor that coupleselectrode 11 to a first connectorterminal contact 151, and a second elongate conductor that coupleselectrode 13 to a connectorterminal contact pin 153. Typically each ofelectrodes outer insulation sheath 12 to formelectrode 11. Improvements on such a construction are desired, for example, to enhance lead performance in a system such assystem 10. - According to embodiments of the present invention, a continuous conductor wire of an implantable medical electrical lead, which has been formed in a coil, includes a first, electrode length and a second, insulated length, wherein the insulated length of the wire has a radial cross-section defined by a round profile, while the electrode length of the wire has a radial cross-section defined by a flattened profile, a long axis edge of which defines an outer diameter surface of the electrode length. According to some methods of the present invention, the radial cross-section profile of the electrode length of wire is flattened after the wire has been coiled, preferably by rotary swaging. The outer diameter surface of the first, electrode length, by virtue of the flattened profile, has a larger area that faces outward than if the radial cross-section of this same length of wire were left with a round profile.
- In some embodiments, a distal end of the coil, in proximity to the electrode length of wire, is formed into a ring-like structure, for example, by welding multiple turns of the distal end of the coil together. A length of the coil corresponding to the first, electrode length of the conductor wire may be between approximately 4 cm and 8 cm, for example, to function as a defibrillation electrode, however, alternate embodiments of the present invention may be directed toward shorter electrode lengths more suitable for sensing only. According to some embodiments, in which the electrode length is appropriate for sensing only, the electrode length includes a shunt portion located in proximity to the insulated length, wherein the shunt portion is overlaid with a relatively thin layer of dielectric material.
- The following drawings are illustrative of particular embodiments of the present invention and therefore do not limit the scope of the invention. The drawings are not to scale (unless so stated) and are intended for use in conjunction with the explanations in the following detailed description. Embodiments will hereinafter be described in conjunction with the appended drawings wherein like numerals/letters denote like elements, and:
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FIG. 1A is a schematic depicting an exemplary implantable medical system; -
FIG. 1B is a plan view of an implantable medical electrical lead, which may be included in the system ofFIG. 1A , and which may be constructed according to some embodiments of the present invention; -
FIG. 2 is a cross-section view, with an enlarged detail view, of a continuous conductor wire coil, according to some embodiments; -
FIG. 3 is a front elevation view of a working portion of an exemplary rotary swaging machine, which may be employed according to some methods of the present invention, along with schematic depicting wire cross-section profiles; -
FIG. 4 is an enlarged view, with a cut-away cross-section, of a distal portion of the lead shown inFIG. 1B , according to some embodiments; -
FIG. 5 is a cross-section view of the continuous conductor wire coil including a welded distal end, according to some embodiments; and -
FIG. 6 is a plan view, with a cut-away cross-section, of a distal portion of a pace-sense lead, according to some embodiments. - The following detailed description is exemplary in nature and is not intended to limit the scope, applicability, or configuration of the invention in any way. Rather, the following description provides practical examples, and those skilled in the art will recognize that some of the examples may have suitable alternatives. Examples of constructions, materials, dimensions and fabrication processes are provided for select elements and all other elements employ that which is known by those skilled in the art.
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FIG. 2 is a cross-section view of a continuousconductor wire coil 20, according to some embodiments, which may be incorporated inlead 100 ofFIG. 1B . With reference back toFIG. 1A , it should be noted that embodiments of the present invention include other configurations of leads constructed to locate electrode length E at alternative sites, for example, in the superior vena cava SVC (for defibrillation therapy), or in a coronary vein CV (for pacing therapy).FIG. 2 illustratescoil 20 as a multi-filar coil formed from a plurality ofcontinuous conductor wires coil 20; yet, according to alternate embodiments,coil 20 may be a single-filar coil, for example, including onlyconductor wire 201 wound in a tighter pitch than illustrated inFIG. 2 , or a coil having any other suitable number of filars. Thus, the designation of conductor wire 201-206, as used herein, refers to one or more conductor wires.FIG. 2 illustrates continuous conductor wire 201-206 including a first, electrode length E, and a second, insulated length B, wherein a radial cross-section of insulated length B of conductor wire 201-206 has a round profile 32 (FIG. 3 ), while a radial cross-section of electrode length E of conductor wire 201-206 has aflattened profile 31, which will be described in greater detail below, in conjunction withFIG. 3 . According to preferred methods, the radial cross-section profile of electrode length E of wire 201-206 is flattened after wire 201-206 is wound intocoil 20. Conductor wire 201-206 may be formed from any suitable conductive material, such as MP35N alloy, a platinum-iridium alloy (Pt/Ir), tantalum (Ta), a Ta alloy, titanium (Ti), a Ti alloy, or any suitable combination thereof, for example, a Pt/Ir-cladded Ta, or Ta or MP35N having a layer of Pt, titanium-nitride (TiN), or any other suitable coating formed thereover, for example, by sputtering, electro-deposition, ion implantation, or any other suitable coating method. Additional suitable materials for conductor wires 201-206 include cored-composites such as silver-cored MP35N or Ta alloy. - With reference to
FIGS. 1B and 4 , electrode length E of conductor wire 201-206forms electrode 11, for example, having a length of between approximately 4 cm and 8 cm to function as a defibrillation electrode, while insulated length B of conductor wire 201-206 extends withinouter insulation sheath 12, for example, formed from a medical grade silicone rubber or polyurethane. It should be noted that electrode length E may be shorter to function as a pace-sense electrode in alternate embodiments of leads, for example, alead 600 described below, in conjunction withFIG. 6 . The enlarged detail inFIG. 2 shows a radial cross-section ofwire 206 along insulated length B, according to some embodiments, wherein an optional jacket of one or more layers ofinsulation 219, for example, a fluoropolymer and/or a polyimide, encases insulated length B of each conductor wire 201-206. According to some preferred methods,jacket 219 is removed from wire 201-206, along electrode length E, prior to forming the flattened radial cross-section thereof, for example, by laser ablation, or grit blasting, or any other suitable method. With further reference toFIGS. 1B and 2 , conductor wire 201-206, at aproximal end 27 ofcoil 20, is preferably coupled to connectorterminal contact 151, and another elongate conductor, for example, aninsulated conductor 43 shown inFIG. 4 ,couples electrode 13 to connectorterminal contact pin 153. - With further reference to
FIGS. 2 and 4 ,distal end 28 ofcoil 20 may be terminated with aring 42 of insulative or conductive material attached thereto, or with a weld, for example, a laser tack weld, or a more substantial laser weld, for example, extending 360 degrees, that welds multiple turns ofdistal end 28 of coil together to form a ring-like structure, for example, as illustrated inFIG. 5 .FIG. 5 is a cross-section view of continuousconductor wire coil 20 including a weldeddistal end 28 forming aring 52, according to some embodiments.Ring 52 may be of any suitable length according to the number of filars/turns ofcoil 20 that are welded together, and, according to the illustrated embodiment,ring 52 may include one or more features, such asslots 512, formed therein, for example, by laser or EDM machining methods known in the art. The one or more features may facilitate the termination ofcoil 20, for example, by interlocking with mating features of other components oflead 100/600. -
FIG. 4 further illustrates abackfill 412, for example, of silicone medical adhesive, that extends betweencoil 20 andinsulated conductor 43, for example to stabilize wire 201-206 along electrode length E and to provide strain relief forcoil 20 in proximity to a distal end terminal end ofinsulation sheath 12. According to some alternate embodiments, rather than includingbackfill 412, wire 201-206 may be embedded in an outer surface of insulation material that surroundsconductor 43, at least along length E, according to methods known to those skilled in the art. -
FIG. 3 is a front elevation view of a working portion of an exemplaryrotary swaging machine 30, which may be employed according to some methods of the present invention, along with schematic depicting radial cross-section profiles 31, 32 of conductor wire 201-206.FIG. 3 shows conductor wire 201-206, which has been wound in a coil, positioned around amandrel 33, and mounted withinmachine 30.FIG. 3 illustratesmachine 30 including four dies 37 mounted on a spindle 5 which rotates, per arrow C, so that each die 37 moves, per arrow D, in response to acam surface 36 of a corresponding hammer H coming into contact withguide rollers 34, and then moves, per arrow 0, in response to a centrifugal force created by the spindle rotation, when the correspondingcam surface 36 moves out of contact withrollers 34. It should be noted that only a portion of a length of the coil is positioned within inner peripheral surfaces of dies 37, so that the rest of conductor wire 201-206 that extends along a remainder of the length of the coil is not impacted by dies 37. With reference to the schematic ofFIG. 3 , as spindle 5 rotates, the ‘hammering’ of dies 37 plastically deforms, in a radial direction (corresponding to arrows D and O), a radial cross-section of wire 201-206 from an originalround profile 32 to flattenedprofile 31, along a length of the coil that corresponds to a length of each die (into the page), to create first, electrode length E of wire 201-206. It should be noted that rotary swaging is known in the art and may be accomplished with alternative configurations of rotary swaging machines. Alternately, other cold working methods known in the art, for example, performed on a lathe, may be employed to plastically deform the radial cross-section of wire 201-206, for example, fromround profile 32 to flattenedprofile 31. Furthermore, with reference back toFIG. 2 , it is contemplated that the cold working method employed to plastically deform the radial cross-section of wire 201-206 into flattenedprofile 31, along electrode length E, may simultaneously remove theoptional insulation jacket 219 from around wire 201-206. - The schematic of
FIG. 3 shows flattenedprofile 31 having a short axis S, a long axis L, and a long axis edge Le, wherein, with reference toFIG. 4 , long axis edge Le defines anouter diameter surface 290 of electrode length E. According to an exemplary embodiment,round profile 32 of wire 201-206 has a diameter of approximately 0.005 inch, whereas long axis edge Le of flattenedprofile 31 extends approximately 0.007 inch, and short axis S approximately 0.003 inch. Thus, by virtue of flattenedprofile 31, whencoil 20 is employed inlead 100,outer diameter surface 290 along electrode length E has a consistently larger area that faces outward fromlead 100, than if the radial cross-section of this same length of wire 201-206 had been left with theround profile 32. The larger area ofouter diameter surface 290 is useful for increasing defibrillation shock energy delivered byelectrode 11, particularly when a smaller diameter ofcoil 20 is employed to reduce a profile oflead 100. - According to some preferred embodiments,
outer diameter surface 290 is made approximately isodiametric with an outer diameter ofinsulation sheath 12 by slightly enlarging an inner diameter ofcoil 20 along first electrode length E of wire 201-206, for example, with mandrel 33 (FIG. 3 ) just prior to swaging. Alternately,coil 20 may be wound such that a distal length thereof, which corresponds to electrode length E of wire 201-206, has a larger diameter than a proximal length thereof, which corresponds to insulated length B. According to the illustrated embodiment ofFIG. 4 , elongate insulated conductor 43 (i.e. a cabled bundle of MP35N conductor wires contained within a fluoropolymer jacket and/or a silicone or polyurethane sheath) extends within an inner diameter ofcoil 20 to electrically couple electrode 13 to connector terminal contact pin 153 (FIG. 1B ); and aninsulator member 46 mechanically joins the assembly ofelectrode 13 andinsulated conductor 43 tocoil 20, by any suitable interlocking and/or bonded junction known to those skilled in the art. According to embodiments in which ring 42 is a separate component coupled to distal end ofcoil 28,ring 42 may have features formed therein (i.e. via EDM or laser machining) to interlock/mate together components, such ascoil 20 andinsulator member 46. Furthermore, whether or not the diameter ofcoil 20 is enlarged along electrode length E, prior to flattening, a diameter ofdistal end 28 ofcoil 20 may subsequently be reduced, for example, by swaging distal end 28 a second time, around a smaller diameter mandrel than that previously employed, in order fitdistal end 28 withinring 42 for a lower profile junction therewith, according to some embodiments. - With reference back to
FIG. 2 , it should be noted that, according to some methods,coil 20 may be originally wound with two pitches, wherein a pitch over the distal length, corresponding to electrode length E of wire 201-206, is longer than that over the proximal length, corresponding to insulated length B. The longer original pitch of the distal length may be necessary, in some instances, to provide extra longitudinal space between turns of wire 201-206 to accommodate the subsequently flattenedprofile 31. With further reference back toFIG. 2 , a insulated length B of conductor wire 201-206 includes a transition length T at a distal end thereof, in proximity to electrode length E, according to some embodiments, wherein wire 201-206 along transition length T has a profile that is flattened somewhat fromround profile 32, but not to the degree of flattenedprofile 31. This ‘intermediate’ flattened profile, along transition length T, is also preferably formed after conductor wire 201-206 is wound intocoil 20 by a suitable cold working method, for example, rotary swaging. - According to some embodiments, in which conductor wire 201-206 is formed from Ta, Pt, TiN, or other suitable coatings may be applied via sputtering, electro-deposition, ion implantation, or other suitable methods, to form all or a portion of
outer diameter surface 290 of electrode length E of wire 201-206; or a Pt-Ir cladding may surround a Ta core to formouter diameter surface 290. Alternately, Ta conductor wire 201-206 includes a native oxide coating, such as tantalum pentoxide (Ta2O5), or a TiN coating extending over a portion ofouter diameter surface 290 of electrode length E, for example, atdistal end 28 ofcoil 20. Any of the Pt, Ta2O5, and TiN coatings are preferably formed after flattening the cross-section of wire 201-206 along electrode length E. The pentoxide coating may be formed by anodizing and annealing the portion of electrode length E of conductor wire 201-206, for example, by methods known in the art. Likewise the Pt or TiN coating may be formed according to processes known in the art. Any of the Pt, Ta2O5 and TiN coatings may shift electrical shock energy somewhat proximally during the leading, high amplitude phase (i.e. 600-700 volts) of each biphasic high voltage pulse (delivered throughelectrode 11, for defibrillation therapy) by attenuating current density atdistal end 28. The attenuation of current density atdistal end 28 may prevent undesirable current shunting to electrode 13 that could damage cardiac tissue and/or degrade sensing viaelectrode 13. According to some alternate embodiments, in which conductor wire 201-206 is formed from Pt/Ir or Pt/Ir cladded Ta,ring 42 may be a conductive extension of electrode length E of wire 201-206 to form part ofelectrode 11, in which case,ring 42 may be formed from Ta having one of the above-described coatings. -
FIG. 6 is a plan view, with a cut-away cross-section, of a distal portion of pace-sense lead 600, according to some alternate embodiments. With reference back toFIG. 1B , it should be noted thatlead 600 may be implanted in coronary vein CV (designated with a dashed line), or in either chamber of the right side of the heart.FIG. 6 illustrates electrode length E of coiled conductor wire 201-206, which has the radial cross-section with flattenedprofile 31, including an exposedsense portion 61 atdistal end 28, and an optional shunt portion 61-S, which extends proximally fromsense portion 61.FIG. 6 further illustrates shunt portion 61-S located in proximity to insulated length B and having an outer surface overlaid with a relatively thin layer ofdielectric material 602, for example, polyurethane or polyimide. The cross-section profile of wire 201-206 is preferably flattened to form electrode length E, prior to overlaying the outer surface of optional shunt portion 61-S withmaterial 602. Optional shunt portion 61-S can be useful reduce heating of exposedsense portion 61 of electrode length E during magnetic resonance imaging procedures. - In the foregoing detailed description, the invention has been described with reference to specific embodiments. However, it may be appreciated that various modifications and changes can be made without departing from the scope of the invention as set forth in the appended claims.
Claims (15)
1. An implantable medical electrical lead comprising a continuous conductor wire wound in a coil, the conductor wire comprising an insulated length, extending distally from a connector terminal of the lead, and an electrode length, extending distally from the insulated length, and wherein the improvement comprises: the insulated length of the wire having a radial cross-section defined by a round profile, while the electrode length of the wire having a radial cross-section defined by a flattened profile, the flattened profile having a long axis and a short axis, and an outer diameter surface of the electrode length being defined by a long axis edge of the flattened profile.
2. The lead of claim 1 , wherein the conductor wire is formed of Ta, and the electrode length of the wire includes a native pentoxide coating extending over a portion of the outer diameter surface thereof.
3. The lead of claim 1 , wherein the electrode length of the conductor wire includes a coating extending over all or a portion of the outer diameter surface thereof, the coating being one of: a TiN coating and a Pt coating.
4. The lead of claim 1 , wherein the conductor wire is formed of Pt/IR cladded Ta.
5. The lead of claim 1 , wherein the coil includes a distal end located in proximity to the electrode length of the conductor wire; and further comprising a conductive ring coupled to the distal end.
6. The lead of claim 1 , wherein the coil includes a distal end located in proximity to the electrode portion of the conductor wire; the distal end of the coil comprising a weld.
7. The lead of claim 6 , wherein the weld forms a ring structure, and the ring structure includes a slot extending therethrough.
8. The lead of claim 1 , comprising a plurality of the continuous conductor wires, such that the coil is a multi-filar coil.
9. The lead of claim 1 , further comprising an elongate insulated conductor extending within an inner diameter of the coil, and an electrode tip coupled to the insulated conductor and located distal to the electrode length of the conductor wire.
10. A method for constructing an implantable medical electrical lead, the method comprising:
flattening a radial cross-section profile of at least one conductor wire along a first length of an overall length of the wire to form an electrode length, the overall length of the at least one wire having been wound in a coil, and the coil extending from a proximal end thereof to a distal end thereof;
insulating a second length of the overall length of the at least one conductor wire; and
coupling a connector terminal contact to the proximal end of the coil;
wherein the first length of the at least one conductor wire extends proximally from the distal end of the coil; and
and the second length of the at least one conductor wire extends distally from the coupled connector terminal and toward the first length of the conductor wire.
11. The method of claim 10 , further comprising forming a coating on all or a portion of an outer surface of the first length of the conductor wire, after flattening the radial cross-section profile thereof, the coating comprising one of: a Pt coating, a native pentoxide coating, and a TiN coating.
12. The method of claim 10 , further comprising coupling a conductive ring to the distal end of the coil.
13. The method of claim 10 , further comprising welding the distal end of the coil.
14. The method of claim 13 , wherein the welding forms a ring-like structure; and further comprising forming a slot in the ring-like structure.
15. The method of claim 10 , wherein the at least one conductor wire comprises a plurality of conductor wires such that the coil is a multi-filar coil.
Priority Applications (1)
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US14/453,885 US20140343654A1 (en) | 2012-10-31 | 2014-08-07 | Implantable medical electrical lead conductors and construction methods |
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
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US13/664,959 US8831749B2 (en) | 2012-10-31 | 2012-10-31 | Implantable medical electrical lead conductors and construction methods |
US14/453,885 US20140343654A1 (en) | 2012-10-31 | 2014-08-07 | Implantable medical electrical lead conductors and construction methods |
Related Parent Applications (1)
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US13/664,959 Continuation US8831749B2 (en) | 2012-10-31 | 2012-10-31 | Implantable medical electrical lead conductors and construction methods |
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US13/664,959 Active US8831749B2 (en) | 2012-10-31 | 2012-10-31 | Implantable medical electrical lead conductors and construction methods |
US14/453,885 Abandoned US20140343654A1 (en) | 2012-10-31 | 2014-08-07 | Implantable medical electrical lead conductors and construction methods |
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US13/664,959 Active US8831749B2 (en) | 2012-10-31 | 2012-10-31 | Implantable medical electrical lead conductors and construction methods |
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EP (1) | EP2914333A1 (en) |
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CN108233141A (en) * | 2016-12-13 | 2018-06-29 | 本田技研工业株式会社 | The joint method of electric conductor |
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EP3589350A4 (en) * | 2017-03-02 | 2020-12-09 | Medtronic, Inc. | Medical device, method for preparation thereof, and use thereof |
EP3589670A4 (en) | 2017-03-02 | 2020-11-25 | Chinese Academy of Sciences, Ningbo Institute of Material Technology & Engineering | Elastomer, method for preparation thereof, and use thereof |
DE102017216424A1 (en) * | 2017-09-15 | 2019-03-21 | AdjuCor GmbH | Supply system for a medical implant |
WO2019097495A1 (en) * | 2017-11-20 | 2019-05-23 | Cochlear Limited | Electrode array manufacture |
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US5849031A (en) | 1997-12-16 | 1998-12-15 | Medtronic, Inc. | Method and apparatus for termination of tachyarrhythmias |
US6544275B1 (en) | 2000-08-11 | 2003-04-08 | Scimed Life Systems, Inc. | Vaso-occlusive coils with selectively flattened areas |
US6501992B1 (en) | 2000-10-17 | 2002-12-31 | Medtronic, Inc. | Radiopaque marking of lead electrode zone in a continuous conductor construction |
JP2002216864A (en) | 2001-01-19 | 2002-08-02 | Yazaki Corp | Connection structure and connection method of electric cable |
US8136241B2 (en) | 2003-11-12 | 2012-03-20 | Biosense Webster, Inc. | Method for making a low ohmic pressure-contact electrical connection between the ring electrode under surface and the lead wire |
CN101001663A (en) * | 2004-08-05 | 2007-07-18 | 导管治疗有限公司 | A process of manufacturing an electrical lead |
US8364281B2 (en) * | 2008-11-07 | 2013-01-29 | W. L. Gore & Associates, Inc. | Implantable lead |
US8442650B2 (en) | 2008-11-29 | 2013-05-14 | Medtronic, Inc. | Medical electrical lead with backfilled electrode sub-assembly |
US20100133003A1 (en) | 2008-11-29 | 2010-06-03 | Medtronic, Inc. | Implantable medical electrical leads including coil electrodes |
US8538553B2 (en) | 2009-10-06 | 2013-09-17 | Pacesetter, Inc. | MRI compatible implantable lead |
US8442646B2 (en) | 2010-05-17 | 2013-05-14 | Medtronic, Inc. | Forming conductive couplings in medical electrical leads |
JP5604597B2 (en) | 2010-11-18 | 2014-10-08 | カーディアック ペースメイカーズ, インコーポレイテッド | Medical device lead wire and medical device having the lead wire |
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2012
- 2012-10-31 US US13/664,959 patent/US8831749B2/en active Active
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2013
- 2013-10-15 EP EP13788805.3A patent/EP2914333A1/en not_active Withdrawn
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- 2013-10-15 WO PCT/US2013/065095 patent/WO2014070449A1/en active Application Filing
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2014
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US5746616A (en) * | 1993-09-24 | 1998-05-05 | Pacesetter, Inc. | Defibrillation electrode connection |
Cited By (1)
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CN108233141A (en) * | 2016-12-13 | 2018-06-29 | 本田技研工业株式会社 | The joint method of electric conductor |
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EP2914333A1 (en) | 2015-09-09 |
CN104870051A (en) | 2015-08-26 |
US8831749B2 (en) | 2014-09-09 |
CN104870051B (en) | 2017-03-08 |
US20140121742A1 (en) | 2014-05-01 |
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