WO2008115383A2 - Methods and apparatus for fabricating leads with conductors and related flexible lead configurations - Google Patents

Methods and apparatus for fabricating leads with conductors and related flexible lead configurations Download PDF

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Publication number
WO2008115383A2
WO2008115383A2 PCT/US2008/003266 US2008003266W WO2008115383A2 WO 2008115383 A2 WO2008115383 A2 WO 2008115383A2 US 2008003266 W US2008003266 W US 2008003266W WO 2008115383 A2 WO2008115383 A2 WO 2008115383A2
Authority
WO
WIPO (PCT)
Prior art keywords
lead
conductor
coil
layer
reverse
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.)
Ceased
Application number
PCT/US2008/003266
Other languages
English (en)
French (fr)
Other versions
WO2008115383A3 (en
Inventor
Paul A. Bottomley
Parag V. Karmarkar
Justin M. Allen
William A. Edelstein
Peter Piferi
Brian Gore
J. Michael Shifflette
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.)
SURGI-VISION Inc
Boston Scientific Neuromodulation Corp
Original Assignee
SURGI-VISION Inc
Boston Scientific Neuromodulation Corp
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 SURGI-VISION Inc, Boston Scientific Neuromodulation Corp filed Critical SURGI-VISION Inc
Priority to JP2009554530A priority Critical patent/JP5568315B2/ja
Priority to EP08726739.9A priority patent/EP2134413B1/en
Priority to ES08726739.9T priority patent/ES2605170T3/es
Priority to AU2008227102A priority patent/AU2008227102C1/en
Priority to KR1020097021816A priority patent/KR101413677B1/ko
Priority to CA2679498A priority patent/CA2679498C/en
Publication of WO2008115383A2 publication Critical patent/WO2008115383A2/en
Publication of WO2008115383A3 publication Critical patent/WO2008115383A3/en
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/02—Details
    • A61N1/04—Electrodes
    • A61N1/05—Electrodes for implantation or insertion into the body, e.g. heart electrode
    • 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
    • A61N1/0404—Electrodes for external use
    • A61N1/0472—Structure-related aspects
    • A61N1/0488—Details about the lead
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/16—Screening or neutralising undesirable influences from or using, atmospheric or terrestrial radiation or fields
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C33/00—Moulds or cores; Details thereof or accessories therefor
    • B29C33/12—Moulds or cores; Details thereof or accessories therefor with incorporated means for positioning inserts, e.g. labels
    • B29C33/123—Moulds or cores; Details thereof or accessories therefor with incorporated means for positioning inserts, e.g. labels for centering the inserts
    • B29C33/126—Moulds or cores; Details thereof or accessories therefor with incorporated means for positioning inserts, e.g. labels for centering the inserts using centering means forming part of the insert
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N3/00—Investigating strength properties of solid materials by application of mechanical stress
    • G01N3/32—Investigating strength properties of solid materials by application of mechanical stress by applying repeated or pulsating forces
    • H—ELECTRICITY
    • H01—ELECTRIC ELEMENTS
    • H01B—CABLES; CONDUCTORS; INSULATORS; SELECTION OF MATERIALS FOR THEIR CONDUCTIVE, INSULATING OR DIELECTRIC PROPERTIES
    • H01B7/00—Insulated conductors or cables characterised by their form
    • H01B7/04—Flexible cables, conductors, or cords, e.g. trailing cables
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/02—Details
    • A61N1/08—Arrangements or circuits for monitoring, protecting, controlling or indicating
    • A61N1/086—Magnetic resonance imaging [MRI] compatible leads
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29L—INDEXING SCHEME ASSOCIATED WITH SUBCLASS B29C, RELATING TO PARTICULAR ARTICLES
    • B29L2031/00—Other particular articles
    • B29L2031/753—Medical equipment; Accessories therefor
    • 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
    • Y10T29/4902—Electromagnet, transformer or inductor
    • Y10T29/49071—Electromagnet, transformer or inductor by winding or coiling

Definitions

  • the first forward coiled section resides on a first layer
  • the reverse coiled layer resides on a second layer over the first layer
  • the second forward coiled section resides on a third layer over the second layer to define a three-layer stacked conductor coil configuration.
  • the first coiled forward section and the reverse coiled section have substantially the same pitch and the second forward coiled section has a smaller (closer) pitch than that of the first and reverse coiled sections.
  • the at least one conductor is a plurality of conductors, each having at least one segment with a multi-layer stacked coil configuration of at least one set of the first and second forward coiled sections and the reverse coiled section.
  • Some embodiments are directed at methods of fabricating a lead which may be particularly suitable as a medical lead. The methods include: (a) winding at least one conductor about a mandrel in a forward lengthwise direction to form a forward coil; then (b) winding the at least one conductor over the mandrel in a reverse lengthwise direction to form a reverse coil.
  • inventions are directed to an electrical lead subassembly that includes at least one conductor comprising at least one spiral line of flexible material over an outer surface thereof.
  • Figure 3 is a schematic illustration of three different conductor configurations according to embodiments of the present invention.
  • Figure 9 is a schematic illustration of a lead with multiple closely spaced conductors, the conductors having reverse and forward segments according to embodiments of the invention.
  • FIG. 3OA is a schematic illustration of a DBS system with at least one lead, IPG and electrodes according to some embodiments of the present invention (the DBS system includes two leads and two IPGs).
  • Figure 40 is a schematic illustration of a lead with multiple conductors having multiple respective current suppression modules spaced apart along the length of the lead according to some embodiments of the invention.
  • Figure 44 is a schematic illustration of another lead configuration with multiple conductors where each conductor includes current suppression modules spaced apart along its length according to embodiments of the present invention.
  • This lead configuration may be particularly suitable as an active fixation tachyarrhythmia lead.
  • Figure 55A is a side view of a portion of a lead that may be suitable to be a passive fixation pacemaker lead according to embodiments of the present invention.
  • the term "lead” refers to an elongate assembly that includes one or more conductors.
  • the lead typically connects two spaced apart components, such as, for example, a power source and/or input at one end portion and an electrode and/or sensor at another position, such as at a distal end portion or electrodes at both end portions.
  • the lead is typically flexible.
  • the lead can be substantially tubular with a cylindrical shape, although other shapes may be used.
  • the lead can have a solid or hollow body and may optionally include one or more lumens.
  • a lead can be a relatively long implantable lead having a physical length of greater than about 10 cm (up to, for example, 1 m or even longer).
  • backward refers to a lengthwise or longitudinal direction that is substantially opposite a forward lengthwise or longitudinal direction.
  • sections refers to discrete sub-portions of a conductor or lead.
  • MR compatible means that the material is selected so as to be non-ferromagnetic and to not cause MR operational incompatibility, and may also be selected so as not to cause undue artifacts in MR images.
  • RF safe means that the device, lead or probe is configured to operate within accepted heat- related safety limits when exposed to normal RF signals associated with target (RF) frequencies such as those frequencies associated with conventional MRI systems or scanners.
  • the leads can be used in several situations where individuals who have external or implanted conductors and devices may be exposed to EM fields that could induce currents in them and thereby present a safety concern or equipment malfunction, such as, for example, but not limited to, RADAR, radio, wireless (cellular) telephone or communications and TV transmission and reception installations/facilities/equipment (fixed or mobile), RF devices, as well as MRI.
  • RADAR radio, wireless (cellular) telephone or communications and TV transmission and reception installations/facilities/equipment (fixed or mobile), RF devices, as well as MRI.
  • the FS and BS portions 9, 10 of proposed current suppression modules 8 have RF electrical impedances comprised of the total resistance of the section, and a reactive component comprised primarily of the inductance of coil portions.
  • coil can include discrete circuit inductors (which are typically micro-wound coils; non-magnetic and MRI-compatible for MRI applications) in addition to those coils formed by the conducting leads.
  • Figure 14E illustrates that the FS 9 can include a coiled segment 9c and a linear segment 91, analogous to Figure 6E.
  • the coiled segment 9c can reside proximate the BS 10c.
  • the BS coil 10c and the FS coil 9c can be substantially cowound but with each coil in opposing directions or coiled over or about one another or proximate each other to electrically couple, potentially produce current cancellation at the end of the BS and may generate increased impedance, such as, for example at least about 100 Ohms, and typically about 300 Ohms or more.
  • the coil diameter, conductor size and/or type, and length of coil may be the same in the 9c and 10c sections, or one or more of these parameters may be different.
  • the conductor 3 can be a single continuous conductor along substantially its entire length, and is typically the same conductor at least along a length of a respective CSM 8.
  • Figure 14F illustrates that the conductor 3 can include a continuous closely spaced section of conductor that turns on itself several times in a lengthwise direction, analogous to the axial/lengthwise turns or loops introduced in embodiments Figurel4C and 14C.
  • This configuration is similar to that in Figure 14A, except that the coil axis is rotated 90 degrees, whereupon multiple BSs 10 are created by the coil windings.
  • Figures 14G-14I illustrate yet other conductor CSM 8 configurations with a plurality of adjacent longitudinally extending back and forth lengths (which may be straight, taper or may be curvilinear) forming a series of stacked reverse and forward segments 10, 9, respectively.
  • Figures 14L and 14M illustrate that the lead 20 can have at least one conductor 3 at least one CSM 8 that extends between an electrode 4 and a power source, such as an IPG.
  • Figure 14M illustrates that the distal end of the conductor 3 can be coiled as it connects to the electrode 4 to further reduce heating proximate the electrode.
  • Figure 14L illustrates that more than one conductor 3 may be used to connect a single electrode 4 for redundancy and/or lower power or energy transmission or the like.
  • Figure 16 illustrates impedance versus frequency for an entire lead with eleven axially spaced consecutive CSMs, when immersed in a physiological saline solution.
  • the lead is a 4 electrode system with FS having a length of about 9 cm and the CBS having a length of about 4.3 cm and an inner diameter of about 0.046 inches.
  • the use of multiple CSMs may alter the impedance dispersion in accordance with the cumulative impedance and wavelength effects associated with the longer lead length.
  • the impedance data shows very low resistance ( ⁇ 1 ohm) at DC frequencies and around 60-300 Ohm impedance at RF frequencies, although a peak of around 1600 Ohm is evident at ⁇ 20 MHz.
  • the conductors 3 can have broadband low pass filtering, while affording a higher impedance narrowband filtering effect at specific frequencies.
  • the leads 20 can be configured with multiple FSs 9 and BSs 10, to generate maxima at multiple frequencies (or frequency bands) by adjusting the configuration, e.g., length/diameter/number of revolutions of different ones of the FSs 9 and/or BSs 10.
  • the conductors 3 with CSMs 8 can have an impedance that varies and exhibits local maxima at a frequency band and/or over a target frequency range.
  • the CSMs 8 can exhibit an impedance of at least about 100 Ohms over its respective length at a target radio frequency of interest.
  • the FS and BS sections 9, 10, respectively, can be configured such that at least one local impedance maxima substantially coincides with at least one frequency (or frequency band) of interest (e.g., 64 MHz for 1.5T, 128 MHz for 3T, etc.) within that range.
  • conductors 3 and/or current suppression modules 8 may incorporate one or more of the above configurations described above and/or other features, such as, for example, but not limited to, one or more of the following:
  • a lead incorporating multiple CSMs 8 (as illustrated in Figure 23) was prototyped and tested with two 0.007" diameter 35N LT -DFT conductors (e.g., wires/filars) with silver core (19 filar cable, 0.005" conductor OD and 0.001" wall ETFE insulation), with the conductors (e.g., wires/filars) cowound parallel to each other and coiled in three layers.
  • the first layer (coiled forward section) has an inner diameter of 0.023”
  • the second layer (coiled back section) is coiled over the first
  • the third final layer (coiled forward section) is over the first and the second layers.
  • This CSM had an impedance of over 200 ohms at 64 MHz and length of 4.7 cm.
  • Table 1 The winding details are listed in Table 1 below.
  • Figure 22B illustrates a single conductor 3 configuration of a double stack 8m with both the inner coil FS 9c and the BS coil 10c being inside the second layer 8o with coil FS 9c.
  • Figure 22C illustrates two conductors 3i, 3 2 coiled to form a two-conductor 8-2 double stack CSM 8m with the inner layer 8i having both a FS and BS 9c, 10c, respectively, and the outer layer 8o having a FS 9c.
  • the sleeve 190 typically has a continuous closed outer wall, but may be discontinuous and/or have open pores or apertures.
  • the sleeve 190 is biocompatible can comprise any suitable material, typically a polymer such as PTFE or Nylon (such as Vestamid® L2140), and can have any suitable size, such as, but not limited to, an outer diameter of between about 0.01 inches to about 0.1 inches, typically between about .01 to about .05 inches, more typically about 0.024 inches, a wall thickness of between about 0.001 inches to about 0.02 inches, and can include a through lumen inner diameter of between about 0.001 inches to about 0.025 inches, typically between about 0.010 to about 0.02 inches, such as about 0.014 inches.
  • Figures 28A and 28B are schematic cross-sectional views of a conductor 3 in the plane of its long axis with a multi-layer coiled CSM configuration 8m.
  • Figure 28A corresponds to the first layer of a two-layer configuration such as that shown in Figure 22 A.
  • Figure 28B corresponds to the three separate layers of a three-layer configuration such as shown in Figure 21A.
  • FIG. 3OD schematically illustrates that the lead system 20 interconnects two electronic devices 50i, 5O 2 residing either inside or external to a human or animal body.
  • the devices can be non-medical devices, such as communication devices.
  • the devices can be medical devices.
  • at least one end portion of the at least one conductor 3 connects an electrocardiographic electrode 50 1 and at least another end is connected to an electrocardiographic monitoring device 5O 2 .
  • at least one end portion of the at least one conductor 3 is connected to an electroencephalograph ⁇ graphic electrode 5Oi and at least another end is connected to an electroencephalographic monitoring device 5O 2 .
  • Figure 3OF illustrates that the tool 5O 2 can be an adjustable trajectory frameless head mount 510 that can be used to adjust the trajectory of the implantable lead to place and implant DBS leads using MR guidance while the patient remains in the magnet bore 500b.
  • Figure 3OG is an example of one surgical tool, a frameless head mount 510, with cables or leads 20 configured with at least one CSM 8 according to embodiments of the present invention.
  • the RF/MRI safe leads 20 can include one or more conductors 3 of the lead arranged in multiple CSMs 8 where each CSM has a length of between about 1.5 cm to about 6 cm, and each CSM 8 is arranged such that it has impedance exceeding about 100 ohms at target MRI frequencies (for example, 128 and 64 MHz).
  • conducting leads of the tachyarrhythmia, bradyarrhythmia, ICD (implantable cardio- defibrillator) and/or pacing lead system may be formed with CSMs 8 or with CSMs and shield elements to suppress induced RF currents and improve the safety of such devices during MRI, as exemplified in Figures 33-44 and Figures 55A-58B.
  • Figure 33 illustrates a lead 20 with a passive fixation bradyarrhythmia lead design with two conductors 3i, 3 2 , each conductor is wound in CSMs 8 and arranged along the length of the lead one conductor 3i, alternating the other 3 2 .
  • the winding operations can be carried out to from two of the coils substantially on one layer and the other in another layer to form a two-layer stacked coil configuration (block 215).
  • the first coil can be wound in a clockwise direction, the second in a counterclockwise direction, and the third in the counterclockwise direction (or the windings can be reversed, with the first coil in the CCW direction and the second and third in the CW direction) (block 216).
  • Winding of the third coil on the upper or top layer can continue forward to form the first (lower) forward layer of the next adjacent coils.
  • an end portion of the first coil can be held in position while the reverse rotational turning is initiated for the second coil.
  • Distal section of the most distal CSM exhibits typical three layer construction.
  • 1.1.20 Feed the DFT cable through the top left two guiding tubes (with the left spool wire through the left tube and the right spool wire through the right tube); through the upper felt tension clamp; through the guide/tension rollers; through the lower felt tension clamp; and through the coil winder guide.
  • the electrodes can be attached to the MCSM in the following order: - Proximal-Distal (IPG) electrode

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  • General Physics & Mathematics (AREA)
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PCT/US2008/003266 2007-03-19 2008-03-13 Methods and apparatus for fabricating leads with conductors and related flexible lead configurations Ceased WO2008115383A2 (en)

Priority Applications (6)

Application Number Priority Date Filing Date Title
JP2009554530A JP5568315B2 (ja) 2007-03-19 2008-03-13 Ｒｆ／ｍｒｉ適合リード線
EP08726739.9A EP2134413B1 (en) 2007-03-19 2008-03-13 Methods and apparatus for fabricating leads with conductors and related flexible lead configurations
ES08726739.9T ES2605170T3 (es) 2007-03-19 2008-03-13 Procedimientos y aparato de fabricación de cables con conductores y configuraciones de cable flexible relacionadas
AU2008227102A AU2008227102C1 (en) 2007-03-19 2008-03-13 Methods and apparatus for fabricating leads with conductors and related flexible lead configurations
KR1020097021816A KR101413677B1 (ko) 2007-03-19 2008-03-13 전도체를 갖는 리드 제조 방법 및 장치와 관련 가요성 리드 구성
CA2679498A CA2679498C (en) 2007-03-19 2008-03-13 Methods and apparatus for fabricating leads with conductors and related flexible lead configurations

Applications Claiming Priority (6)

Application Number Priority Date Filing Date Title
US89561907P 2007-03-19 2007-03-19
US60/895,619 2007-03-19
US91283507P 2007-04-19 2007-04-19
US60/912,835 2007-04-19
US95573007P 2007-08-14 2007-08-14
US60/955,730 2007-08-14

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WO2008115383A2 true WO2008115383A2 (en) 2008-09-25
WO2008115383A3 WO2008115383A3 (en) 2008-12-31

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US (2) US9248270B2 (enExample)
EP (2) EP2134413B1 (enExample)
JP (1) JP5568315B2 (enExample)
KR (1) KR101413677B1 (enExample)
AU (1) AU2008227102C1 (enExample)
CA (1) CA2679498C (enExample)
ES (2) ES2615402T3 (enExample)
WO (1) WO2008115383A2 (enExample)

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JP2012522564A (ja) * 2009-04-02 2012-09-27 コーニンクレッカ フィリップス エレクトロニクス エヌ ヴィ 多重共鳴磁気共鳴システムで用いられる装置及びケーブル
JP2012531254A (ja) * 2009-06-26 2012-12-10 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 改善されたトルク伝達性能を備えｍｒｉによる加熱を低減した単線コイルからなるコンダクタアセンブリを含む医療器具リード
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US8364279B2 (en) 2008-09-25 2013-01-29 Boston Scientific Neuromodulation Corporation Electrical stimulation leads having RF compatibility and methods of use and manufacture
US8406897B2 (en) 2009-08-19 2013-03-26 Boston Scientific Neuromodulation Corporation Systems and methods for disposing one or more layers of material between lead conductor segments of electrical stimulation systems
JP2013516223A (ja) * 2009-12-31 2013-05-13 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 多層導体を備えるｍｒｉの条件付きで安全なリード
JP2013520238A (ja) * 2010-02-19 2013-06-06 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 Ｍｒｉ誘導電流の低減のために構成された導体を含むリード線及び移植式医療用デバイス
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US10092367B2 (en) 2014-03-18 2018-10-09 Monteris Medical Corporation Image-guided therapy of a tissue
US10327830B2 (en) 2015-04-01 2019-06-25 Monteris Medical Corporation Cryotherapy, thermal therapy, temperature modulation therapy, and probe apparatus therefor
US10675113B2 (en) 2014-03-18 2020-06-09 Monteris Medical Corporation Automated therapy of a three-dimensional tissue region
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