(12) INTERNATIONAL APPLICATION PUBLISHED UNDER THE PATENT COOPERATION TREATY(PCT)
`
`(19) World Intellectual Property Organization
`International Bureau
`
` DMAT
`
`(43) International Publication Date
`10 May 2001 (10.05.2001)
`
`PCT
`
`(10) International Publication Number
`WO 01/32259 Al
`
`(51) International Patent Classification’:
`
`AGIN 1/05
`
`LASKE,Timothy, G.; 5820 Evergreen Lane, Shoreview,
`MN 55126 (US).
`
`(21) International Application Number:
`
`PCT/US00/27833
`
`(22) International Filing Date: 10 October 2000 (10.10.2000)
`
`(25) Filing Language:
`
`(26) Publication Language:
`
`English
`
`English
`
`(30) Priority Data:
`09/430,890
`
`1 November 1999 (01.11.1999)
`
`US
`
`(71) Applicant: MEDTRONIC,INC. [US/US]; 7000 Central
`Avenue NE, Minneapolis, MN 55432 (US).
`
`(74) Agents: WOLDE-MICHAEL, Girma etal.; Medtronic,
`Inc., 7000 Central Avenue NE, Minneapolis, MN 55432
`(Us).
`
`(81) Designated States (national): CA, JP.
`
`(84) Designated States (regional): European patent (AT, BE,
`CH, CY, DE, DK, ES, FI, FR, GB, GR, IE, IT, LU, MC,
`NL, PT, SE).
`
`Published:
`With international search report.
`
`(72) Inventors: HUEPENBECKER, Georges, M.; 3450
`Montmorency, Vadnais Heights, MN 55110 (US).
`
`For two-letter codes and other abbreviations, refer to the "Guid-
`ance Notes on Codes andAbbreviations" appearingat the begin-
`ning ofeach regular issue ofthe PCT Gazette.
`
`(54) Title: HIGH STRENGTH MEDICAL ELECTRICAL LEAD
`
`AAAA
`
`
`
`KROESPOLSONBTaaAAaaaARePKORRIOSIISSESISOSOBESEERS é
`
`
`
`SSQoph
`
`62
`
`NN
`a
`
`IS,
`
`odeeeohhAN gt
`=
`46
`SSS)
`<
`a
`Ww
`AN
`“A
`
`58
`
`< (57) Abstract: Animplantableelectricalleadhavingatleasttwo mutuallyinsulatedelectricalcomponents(30, 38)thatareseparated
`
`by a portion of the lead’s body fabricated of a pliant, extensible biocompatible insulated material. An extensible conductor (44)
`extends from the proximal end ofthe lead body toafirst one of the electrical components, and a second, inextensible conductor
`(42) extends from the proximal end of the lead body to a second oneofthe electrical components. An inextensible reinforcement
`member (50)is coupled to the inextensible conductorand extendsdistally from the secondelectrical componentto the first electrical
`componentand is coupled mechanically to the first electrical component.
`
`Nevro Corp.
`Ex. 1012
`U.S. Patent No. 7,891,085
`
`Nevro Corp.
`Ex. 1012
`U.S. Patent No. 7,891,085
`
`

`

`WO 01/32259
`
`PCT/US00/27833
`
`1
`
`HIGH STRENGTH MEDICAL ELECTRICAL LEAD
`
`Background of the Invention
`
`The present invention relates to implantable medical leads generally and more
`
`particularly to multi-conductor implantable leads employing coiled conductors that extend
`
`to a distal portion ofthe lead.
`
`In the context of implantable pacing and cardioversion leaves, it is desirable that the
`
`lead be provided with a tensile memberthat extends along the entire length ofthelead.
`
`Such a tensile memberis desirable in that it prevents disassembly of the lead in response to
`
`traction forces applied to the proximal end ofthelead, in conjunction with removal of the
`
`lead after implant. One approachto providing such a longitudinal reinforcementis set forth
`
`in U.S. Patent No. 5,231,996 issued to Bardyet al, which suggests adding a nonconductive
`
`tensile reinforcing member from the connector assembly at the proximal end ofthe lead to
`
`an electrode located at the distal end of the lead. An alternative approachto providing a
`
`tensile member extending the length of the lead is set forth in U.S. Patent Application
`
`SN08/938,269 by Bischoff et al., filed on September 27, 1997, which disclosesa structure
`
`in which the tip and ring electrode are mountedtoa rigid plastic head and the conductor
`
`extending from the proximalend ofthe leadto the ring electrode is mechanically
`
`interconnected with the rigid plastic head. The disadvantage with the approachsetforth in
`
`the Bardyetal patentis that it requires an additional tensile member extending the entire
`
`20
`
`length of the lead, which in turn generally increases in the required diameterofthe lead
`
`body over the majority of its length. Although the approach setforth in the above-cited
`
`Bischoff et al. application avoids the problem ofan increased lead diameter, it requires a
`
`rigid memberinterconnecting the ring electrode and thetip electrode in order to provide
`
`tensile reinforcement all the way to thedistal electrode.
`
`In the context of tined leads or
`
`25
`
`other leads in which a coiled conductoris used to connectto the tip electrode and in which
`
`the portion of the lead body intermediate the tip electrode and electrodes located proximal
`
`theretois typically fabricated outofa flexible elastomer, the approach of the Bischoff etal.
`
`applicationis not readily applicable.
`
`

`

`WO 01/32259
`
`PCT/US00/27833
`
`Summary of the Invention
`
`Thepresent inventionis directed toward a provision of a pacing or cardioversion
`
`lead of the type havingadistal or tip electrode and one or moreelectrodes located proximal
`
`to the tip electrode, separated therefrom bya flexible lead body segment, and having a
`
`coiled conductor extending from the proximal endofthe lead to the tip electrode,
`
`permitting passageofa stylet.
`
`In such leads, the coiled conductor does not prevent
`
`stretching and breaking of the flexible lead body segment betweenthetip electrode and the
`
`electrode located most closely proximal thereto and hasthe potential for causing serious
`
`problems during attempted extractions of the lead, in that the coiled conductoris capable of
`
`significant longitudinal extension. The present invention provides a mechanism for
`
`providing a reinforcement extending the entire length ofthe lead body, in such a lead,
`
`without the disadvantage of an over-all increase in lead body diameter.
`
`The present invention accomplishes the objects discussed above by meansofa
`
`reinforcement member which is mechanically coupled to and extendsdistally from an
`
`15
`
`inextensible conductor coupled to an electrode or sensor located proximal to the tip
`
`electrode, and which in turn is mechanically coupled tothetip electrode located at the
`
`distal end of the lead. The reinforcement member mechanically couples but does not
`
`electrically couple the inextensible conductor andthe tip electrode. Because the
`
`reinforcementextends from the distal termination of a lead conductor, it can occupythe
`
`20
`
`portion of the lead body that the lead conductor occupies in portionsof the lead body
`
`proximal thereto, avoiding the necessity for an increased lead body diameter along the
`
`entire length of the lead. The reinforcement memberis preferably non-conductive but may
`
`be conductive if insulated from the inextensible conductor to whichit is coupled and/or
`
`from thedistal or tip electrode. Limiting the reinforcement memberto a distal portion of
`
`25
`
`the lead also simplifies construction of the lead, in that it requires no additional
`
`interconnections to be made between the reinforcement memberand the connector
`
`assembly at the proximal end of the lead. The reinforcement memberis preferably coupled
`
`to the largest and/or strongest ofthe inextensible conductors within the lead body.
`
`

`

`WO 01/32259
`
`PCT/US00/27833
`
`Brief Description of the Drawings
`
`Figure | is a plan view of a lead according to the present invention.
`
`Figure 2 is a cross section throughthe lead body in the portion ofthe lead proximal
`
`to the coiled defibrillation electrode 60.
`
`Figure3 illustrates a cross section of the lead taken in the vicinity of the distal end
`
`of defibrillation electrode 30
`
`Figure4illustrates a cross-section through the lead in the vicinity oftip electrode
`
`38.
`
`Detailed Description of the Embodiment
`
`10
`
`Figure | is a plan view of a lead according to the present invention. The lead is
`
`provided with an elongated insulative lead body 10, which terminatesat its proximal
`
`extremity in a molded bifurcation member 12, from which two connector assemblies 14 and
`
`16 extend. Connector assembly 14 carries a single connector pin 18 and associatedsealing
`
`rings 20 for sealing the connector assembly in the bore of an implantable cardiac
`
`15
`
`pacemaker/cardioverter/defibrillator. Connector assembly 16 carries a connector ring 22
`
`and a connector pin 24 and associated sealing rings 26 and 28for sealing the connector
`
`assembly. Thedistal portion of the lead body carries an elongated coiled defibrillation
`
`electrode 30, coupled to connector pin 18 internally by meansof an elongated, inextensible
`
`stranded conductor. Located distal to defibrillation electrode 30 is a ring electrode 32, in
`
`20
`
`turn coupled to connectorring 22 by a second, elongated, inextensible stranded conductor.
`
`At the distal end of the lead is a tip electrode 38 which is connected to connectorpin 24 by
`
`an elongated, extensible, coiled conductor, configured so that a stylet may pass through
`
`connector pin 24 to the distal end of the lead at or adjacent electrode 38. Electrode 38 is
`
`provided with an internal electrode shank, around whichinsulative tine sleeve 36 is
`
`25
`
`mounted. Thelead is optionally provided with tines 40 toassist in acute fixation of the
`
`electrode 38 in the right ventricular apex. Separating tip electrode 38 and ring electrode 32
`
`is a tip-ring spacer 34, whichis, fabricated of a pliant elastomeric material such
`
`polyurethaneorsilicone rubbertubing.
`
`Figure 2 is a cross section through the lead bodyin the portion of the lead proximal
`
`30
`
`to the coiled defibrillation electrode 30.
`
`In this view it can be seen that the lead body 10 is
`
`

`

`WO 01/32259
`
`PCT/US00/27833
`
`4
`
`provided with three internal lumenscarrying two inextensible, stranded conductors 42 and
`
`44 which may correspondto the conductors disclosed in U.S. Patent No. 5,246,014 issued
`
`to Williams et al or U.S. Patent No. 5,584,873 issued to Shoberg etal, both of which are
`
`incorporated herein by reference in their entireties. Conductor 42 extends from connector
`
`pin 22 (Figure 1) to ring electrode 32, and conductor 44 extends from connectorpin 18 to
`defibrillation electrode 30. In the embodimentillustrated, conductor 34 hasa greater
`
`diameter, as a result of its need for higher current carrying capabilities in conjunction with
`
`delivery of cardioversion and defibrillation pulse energies to electrode 30. Conductor 34
`
`correspondingly hasa higher tensile strength and is the conductor to which the
`
`nonconductor reinforcement memberis coupledasillustrated in Figure 3 below.
`
`Figure 3 illustrates a cross section of the lead taken in the vicinity of the distal end
`
`of defibrillation electrode 30.
`
`In this view, the interconnection of stranded conductor 44
`
`and defibrillation electrode 30 isillustrated. These two elementsofthe lead are
`
`interconnected by meansofa cross-groove crimp sleeve generally as described in U.S.
`
`15
`
`Patent No. 5,676,694,issued to Boser et al. and incorporatedherein by referencein its
`
`20
`
`entirety. Like the cross-groovecrimpsleeve in the Boseret al. patent, cross-groove crimp
`sleeve 48 is provided with an elongated tubular section in which thedistal termination of
`
`conductor 44 is located, and in whichit is maintained by meansofcrimps 54. The crimp
`sleeve 48 is provided with a laterally extending projection, which carries a groove 49in
`whichthe distal end ofdefibrillation electrode 30 is located and welded in order to provide
`a mechanical andelectrical interconnection with conductor 44. Unlike the cross-groove
`crimp sleeve ofthe Boseret al. patent, the cylindrical portion of the crimp sleeve 48
`
`extends distally to the laterally extending shoulder, providing a lumenin whichtensile
`
`member 50 maybeinserted and in which tensile member 50 is maintained by means of
`
`25
`
`crimps 52.
`
`Tensile member 50 may take the form of a monofilament or stranded cord
`
`fabricated of a high tensile strength, nonconductive plastic or fiber, for example, ultra-high
`
`molecular weight polyethylene or polyester. Tensile member 50 mayalso be adhesively
`
`coupled to the interior of cross-groove crimpsleeve 48, if desired. Tensile member 50
`
`30
`
`extends to and is mechanically connected totip electrode 38 (Figure 1) asillustrated in
`
`

`

`WO01/32259
`
`PCT/US00/27833
`
`5
`
`moredetail in Figure 4 discussed below. Alternatively, tensile member 50 may be
`conductive, althoughthis will require an insulated connection with either conductor 44 or
`
`tip electrode 38. If the reinforcementis conductive, it may simply be an extension of
`
`conductor 44. By meansof the interconnection between conductor 44 and tensile member
`
`50, traction forces applied to the proximal end of the lead are communicated totip
`electrode 38, located at the distal end of the lead, preventing stretching and/or tearing of
`the lead intermediate the defibrillation electrode 30 andthetip electrode 38.
`
`An outer insulative sleeve 56 coversthe distal end of defibrillation coil electrode 30
`
`and extendsdistally to abut the exposed portionofring electrode 32 (Figure 1). Lead body
`
`10
`
`10 extendsdistally from defibrillation electrode 30 to ring electrode 32, where the lead
`
`body structure transitions from the multi-lumenstructureillustrated in Figure 2 to a single
`lumentube,asillustrated in Figure 4, discussed below as is commoninpresent
`
`commercially marketed multi-conductorleads. Distal to the ring electrode 32,
`
`reinforcement member 50 and coiled conductor 46 extend within this single lumen tube,
`
`15
`
`which makesupthetip-ring spacer 34.
`
`Figure4 illustrates a cross-section throughtheleadin the vicinity oftip electrode
`
`38.
`
`In this view,it can be seen that tip-ring spacer 34 takes the form of a tube of
`
`biocompatible plastic such as polyurethaneorsilicone rubber, and surroundsthe
`
`20
`
`In this view it can be seen that ring
`reinforcement member50 andthe coiled conductor 46.
`electrode 36 is provided with a proximally extending inner shank portion 58 comprising an
`
`internal lumenin which the distal end of coiled connector 46 is maintained by crimping core
`60 and associated circumferential crimps, which compress the shank 58 of the electrode
`
`around conductor 46. The crimpsare notvisible in this cross section, but are conventional.
`
`Reinforcement member 50 extends along a longitudinal groove 51 machinedintothe side of
`
`25
`
`the shank of electrode 38. Thedistal end of reinforcement member51 is provided with a
`
`circumferential ferrule or crimp sleeve 62 which maintainsthe distal end of reinforcement
`
`51 in a cross bore 64, extending through electrode 38. An internal shoulder 66 engagesthe
`
`crimpsleeveor ferrule 62, maintaining the distal end of reinforcement member 50 coupled
`
`to electrode 38, Alternative mechanisms for maintaining the distal end of reinforcement
`
`30
`
`member 50 engaged with electrode 38 mayinclude simply tying a knot in the distal end of
`
`

`

`WO01/32259
`
`PCT/US00/27833
`
`6
`
`the reinforcement member, adhesives, crimps, swages and all other conventional mechanical
`interconnection mechanisms knownto the art. Tine sleeve 36 carrying tines 40 covers the
`electrode shank 58 andis adhesively coupled to the distal end ofthe tip ring spacer 34.
`In the above-illustrated embodiment, the tensile reinforcement member extends
`
`from a conductorassociated with a cardioversion ordefibrillation electrode.
`
`In the context
`
`of the disclosed embodiment,this is desirable because the conductor associated with the
`
`defibrillation or cardioversion electrodeis the largest, highest tensile strength inextensible
`conductoravailable in the lead body. However, the present invention may also of course be
`practiced by extending aninextensible conductorcoupled to a ring electrode, sensor or
`other electrical componentlocated proximalto the distal, tip electrode.
`
`It should also be noted that while the electrodeasillustrated in Figure 4 is a
`
`conventionalsolid metal pacing electrode, any known form ofelectrode may be substituted
`therefor.
`In addition,it is envisioned that some embodiments ofthe invention, rather than
`an electrode being the distal electrical componentofthe lead, a sensor might be substituted.
`As such, the embodimentdisclosed above should be considered exemplary, rather than
`limiting, with regard to the claimsthatfollow.
`
`

`

`WO 01/32259
`
`PCT/US00/27833
`
`WE CLAIM:
`
`1.
`
`An implantableelectrical lead comprising:
`
`an elongated lead body having a proximalend andadistal end;
`
`first and secondelectrical componentslocated along said lead body,a first of said
`
`electrical components located distal to and spaced from a secondofsaidelectrical
`
`components,said first and second electrical components separated by a portion of said lead
`
`body whichin turn is fabricated of a pliant, extensible biocompatible insulated material:
`
`an extensible conductor extending from the proximalendofsaid lead body to said
`
`first electrical component;
`
`10
`
`a second,inextensible conductor extending from the proximal end of said lead body
`
`to said second electrical component; and
`
`an inextensible reinforcement membercoupled to said second electrical conductor
`
`and extendingdistally from said secondelectrical componentto said first electrical
`
`component, said reinforcement member mechanically coupledtosaid first electrical
`
`15
`
`component,said first electrical componentinsulated from said second electrical component.
`
`2.
`
`A lead according to claim | whereinsaidfirst electrical component comprises an
`
`electrode.
`
`20
`
`3.
`
`A lead according to claim 2 whereinsaid first and second electrical components
`
`comprise electrodes.
`
`4.
`
`A lead according to claim | wherein said extensible conductor comprises a coiled
`
`conductor.
`
`25
`
`5:
`
`A lead according to claim | wherein said inextensible conductor comprises a
`
`stranded conductor.
`
`6.
`
`A lead according to claim 1 wherein said reinforcement memberis fabricated of a
`
`30
`
`nonconductive material.
`
`

`

`WO01/32259
`
`PCT/US00/27833
`
`hs
`
`A lead according to claim 1, comprising multiple inextensible conductors, wherein
`
`said reinforcement memberis coupled to the inextensible conductor ofhighest tensile
`
`strength.
`
`8.
`
`A lead according to claim 1 wherein said lead body comprises first and second
`
`longitudinal lumens, said inextensible conductor extending within a first of said lumens and
`
`wherein said reinforcement memberextendsdistally from said inextensible conductor,
`
`within said first lumen.
`
`

`

`PCT/US00/27833
`
`WO 01/32259
`
`SUBSTITUTE SHEET (RULE 26)
`
`

`

`WO 01/32259
`
`PCT/US00/27833
`
`Bh 2
`
`INNNINWNANANVANNANANssseatee
`
`RUSeeeeranaaaeCOOVese
`
`
` aaaae
`pS SOITBZ?
`
`46
`
`SSS
`
`FIG. 4
`
`SUBSTITUTE SHEET (RULE 26)
`
`

`

`ional Application No
`
`PCT/US 00/27833
`
`A, CLASSIFICATION
`A6INo SUBJECT MATTER
`IPC 7
`05
`
`According to International Patent Classification (IPC) or to both nationalclassification and IPC
`B. FIELDS SEARCHED
`
`Minimum documentation searched (classification system tollowed byclassification symbols)
`
`Documentation searched other than minimum documentation to the extent that such documents are included in the fields searched
`
`Electronic data base consulted during the international search (name of dala base and, where practical, search terms used)
`
`EPO-Internal, WPI Data
`
`C. DOCUMENTS CONSIDERED TO BE RELEVANT
`
`
`
`Category °|Cilation of document, with indication, where appropnate,of the relevant passages Relevantto claim No.
`
`US 5 676 694 A (MEREGOTTE PEDRO A
`14 October 1997 (1997-10-14)
`cited in the application
`column 6,
`line 10 -column 8,
`figures
`
`line 12;
`
`ET AL)
`
`INTERNATIONAL SEARCH REPORT Inte
`
`26 January 2001
`Name and mailing address of the ISA
`European Patent Office, P.6. 5618 Patentlaan 2
`a — 2280 HV Rijswijk
`1.
`(431-70) 340-2040, Tx. 31 657
`I,
`Foncoi 70) 300-2006
`Form PCT/SA/210 (second sheet} (July 1992)
`
`US 5 231 996 A (THORNTON ARNOLD W
`3 August 1993 (1993-08-03)
`cited in the application
`column 6,
`line 35 -column 10,
`figures
`
`line 6;
`
`ET AL)
`
`WO 98 47560 A (MEDTRONIC INC)
`29 October 1998 (1998-10-29)
`page 4,
`line 10 -page 7,
`line 27; figures
`
`fe
`
`[x] Further documents are listed in the continuation of box C. x]Patent family members are listed in annex,
`
`° Special categories of cited documents :
`;
`;
`later Scie aes alienie aerators erg ate
`ee
`ae
`ie
`date and not
`the application but
`or priority
`in conflict with
`i
`‘nic
`;
`A* documentdefining the general state of the art whichis not
`cited to understandthe principle or theory underlying the
`cinpidered 10 be of particular wikevanos
`invention
`*E* earlier documentbut published on or after the international
`*X" documentofparticular relevance: the claimed invention
`tiling date
`cannot be considered novel or cannot be considered to
`aL a wet maynow rece parity a.
`involve an inventive step when the documentis taken alone
`which
`is ciled
`to establish the publication
`dale of another
`*Y" documentof particular relevance: the claimed invention
`cilation or other special reason (as specified)
`cannot be considered to involve an inventive step when the
`‘O" documentreferring to an oral disclosure, use, exhibition or
`documentis combined with one or more other such docu-
`other means
`ments, such combination being obvious to a person skilled
`*P* documentpublished prior to the internationalfiling date but
`in the art.
`later than the priority dale claimed
`*&* document member of the same palent family
`
`*T"
`
`Date of the actual completion of the international search
`
`Date of mailing of the international search report
`
`see
`
`02/02/2001
`Authorized officer
`
`7
`Rakotondrajaona, C
`
`page 1 of:2
`
`

`

`INTERNATIONAL SEARCH REPORT
`
`Inte
`
`onal Application No
`
`PCT/US 00/27833
`
`C.(Continuation) DOCUMENTS CONSIDERED TO BE RELEVANT
`
`
`Category °|Citation of document. with indication,where appropnate, of the relevant passages Relevant to claim No
`
`
`
`US 5 584 873 A (SHOBERG BRET R_
`17 December 1996 (1996-12-17)
`cited in the application
`column 2,
`line 35 -column 4,
`figures
`
` Form PCT/ISA/210 (continuation of sacond sheet) (July 1992)
`
`
`
`ET AL)
`
`1-6,8
`
`line 28;
`
`page 2 of 2
`
`

`

`information on patent family members
`
`
`ional Application No
`
`PCT/US 00/27833
`
`Patent document
`cited in search report
`
`Publication
`date
`
`Patent family
`member(s)
`
`Publication
`date
`
`US 5676694
`
`US 5231996
`
`A
`
`A
`
`14-10-1997
`
`NONE
`
`03-08-1993
`
`AU
`AU
`CA
`DE
`DE
`EP
`JP
`JP
`WO
`
`US
`AU
`EP
`EP
`US
`US
`
`649911 B
`3223493 A
`2104861 A
`69200527 D
`69200527 T
`0577787 A
`2601761 B
`6505665 T
`9314811 A
`
`5954759 A
`6564998 A
`1023915 A
`0980281 A
`6018683 A
`6061598 A
`
`21-09-1999
`13-11-1998
`02-08-2000
`23-02-2000
`25-01-2000
`09-05-2000
`
`02-06-1994
`01-09-1993
`29-07-1993
`17-11-1994
`16-02-1995
`12-01-1994
`16-04-1997
`30-06-1994
`05-08-1993
`
`INTERNATIONAL SEARCH REPORT Inte
`
`WO 9847560
`
`A
`
`29-10-1998
`
`US 5584873.
`
`A
`
`22-10-1998
`697915 B
`AU
`29-11-1996
`5178496 A
`AU
`14-11-1996
`2219419 A
`CA
`08-09-1999
`0939657 A
`EP
`
`JP=11504543 T 27-04-1999
`WO
`9635475 A
`14-11-1996
`
`17-12-1996
`
`Form PCT/SA/210 (patent family annex) (July 1992)
`
`