throbber
(12) INTERNATIONAL APPLICATION PUBLISHED UNDER THE PATENT COOPERATION TREATY (PCT)
`
`(19) World Intellectual Property Organization
`International Bureau
`
`(43) International Publication Date
`10 May 2001 (10.05.2001)
`
` |||ll|||l|l|l||||l|l||llll|||||||l||||||||l|[||||lllllllllllllllllllllllll
`
`PCT
`
`(10) International Publication Number
`WO 01/32259 Al
`
`(51) International Patent Classification":
`
`A61N 1t05
`
`LASKE. Timothy. G.; 5820 Evergreen Lane. Shoreview.
`MN 55126 (US).
`
`(ll) International Application Number:
`
`PC'UUSODJZ’FSBS
`
`(22) International Filing Date: 10 October 2000 (10.10.2000)
`
`(25) Filing Language:
`
`(26) Publication Language:
`
`English
`
`English
`
`(30) Priority Data:
`09l430,890
`
`1 November 1999 (01.1 1.1999)
`
`US
`
`(71) Applicant: MEDTRONIC. INC. [USfUS]; 7000 Central
`Avenue NE, Minneapolis. MN 55432 (US).
`
`(74) Agents: WOLDE-MJCHAEL Girma et al.: MedlmniC.
`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 Mo-letter codes and other abbreviations. refer to the "Guid—
`ance Notes on Codes ondAbbreviotiom" appearing at the begin-
`ning ofeoch regular issue ofthe PCT Gazette.
`
`(54) Title: HIGH STRENGTH MEDICAL ELECTRICAL LEAD
`
`
`
`
`
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`
`32259A1
`
`~...__ (57) Abstract: An implantable electrical lead having at least two mutually insulated electrical components (30. 38) that are separated
`by a portion of the leads body fabricated of a pliant. extensible biocompatible insulated material. An extensible conductor (44)
`01
`extends from the proximal end of the lead body to a first one of the electrical components. and a second. inextensible conductor
`0 (42) extends from the proximal end of the lead body to a second one of the electrical components. An inextensible reinforcement
`member (50) is coupled to the inextensible conductor and extends distally from the second electrical component to the first electrical
`component and is coupled mechanically to the first electrical component.
`
`Nevro Corp.
`Ex. 1012
`
`US. Patent No. 7,891,085
`
`Nevro Corp.
`Ex. 1012
`U.S. Patent No. 7,891,085
`
`

`

`W0 01f32259
`
`PCTfUSGfll27833
`
`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 of the lead.
`
`In the context of implantable pacing and cardioversion leaves, it is desirable that the
`
`lead be provided with a tensile member that extends along the entire length of the lead.
`
`Such a tensile member is desirable in that it prevents disassembly of the lead in response to
`
`traction forces applied to the proximal end of the lead, in conjunction with removal of the
`
`lead after implant. One approach to providing such a longitudinal reinforcement is set forth
`
`in US. Patent No. 5,231,996 issued to Bardy et al, which suggests adding a nonconductive
`
`tensile reinforcing member from the connector assembly at the proximal end of the lead to
`
`an electrode located at the distal end of the lead. An alternative approach to providing a
`
`tensile member extending the length of the lead is set forth in US. Patent Application
`
`SNOS!938,269 by Bischoff et al., filed on September 27, 1997, which discloses a structure
`
`in which the tip and ring electrode are mounted to a rigid plastic head and the conductor
`
`extending from the proximal end of the lead to the ring electrode is mechanically
`
`interconnected with the rigid plastic head. The disadvantage with the approach set forth in
`
`the Bardy et al patent is that it requires an additional tensile member extending the entire
`
`length ofthe lead, which in turn generally increases in the required diameter ofthe lead
`
`body over the majority of its length. Although the approach set forth in the above-cited
`
`Bischofi‘ et al. application avoids the problem of an increased lead diameter, it requires a
`
`rigid member interconnecting the ring electrode and the tip electrode in order to provide
`
`tensile reinforcement all the way to the distal electrode. 1n the context of tined leads or
`
`other leads in which a coiled conductor is used to connect to the tip electrode and in which
`
`the portion of the lead body intermediate the tip electrode and electrodes located proximal
`
`thereto is typically fabricated out of a flexible elastomer, the approach of the Bischoff et al.
`
`application is not readily applicable.
`
`10
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`

`

`W0 0132259
`
`PCTIUSflBl'27833
`
`Summgy of the Invention
`
`The present invention is directed toward a provision of a pacing or cardioversion
`
`lead of the type having a distal or tip electrode and one or more electrodes located proximal
`
`to the tip electrode, separated therefrom by a flexible lead body segment, and having a
`
`coiled conductor extending from the proximal end of the lead to the tip electrode,
`
`permitting passage of a stylet.
`
`In such leads, the coiled conductor does not prevent
`
`stretching and breaking of the flexible lead body segment between the tip electrode and the
`
`electrode located most closely proximal thereto and has the potential for causing serious
`
`problems during attempted extractions of the lead, in that the coiled conductor is capable of
`
`significant longitudinal extension. The present invention provides a mechanism for
`
`prOviding a reinforcement extending the entire length of the 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 means of a
`
`reinforcement member which is mechanically coupled to and extends distally fi‘orn an
`
`inextensible conductor coupled to an electrode or sensor located proximal to the tip
`
`electrode, and which in turn is mechanically coupled to the tip electrode located at the
`
`distal end of the lead. The reinforcement member mechanically couples but does not
`
`electrically couple the inextensible conductor and the tip electrode. Because the
`
`reinforcement extends from the distal termination of a lead conductor, it can occupy the
`
`portion of the lead body that the lead conductor occupies in portions ofthc lcad body
`
`proximal thereto, avoiding the necessity for an increased lead body diameter along the
`
`entire length of the lead. The reinforcement member is preferably non-conductive but may
`
`be conductive if insulated from the inextensible conductor to which it is coupled andfor
`
`from the distal or tip electrode. Limiting the reinforcement member to a distal portion of
`
`the lead also simplifies construction of the lead, in that it requires no additional
`
`interconnections to be made between the reinforcement member and the connector
`
`assembly at the prOximal end of the lead. The reinforcement member is preferably coupled
`
`to the largest audior strongest of the inextcnsible conductors within the lead body.
`
`10
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`

`

`W0 01.132259
`
`PCTIUSBOJ‘27833
`
`Brief Description of the Drawings
`
`Figure 1 is a plan View of a lead according to the present invention.
`
`Figure 2 is a cross section through the lead body in the portion of the lead proximal
`
`to the coiled defibrillation electrode 60.
`
`Figure 3 illustrates a cross section of the lead taken in the vicinity of the distal end
`
`of defibrillation electrode 30
`
`Figure 4 illustrates a cross-section through the lead in the vicinity of tip electrode
`
`38.
`
`Detailed Description of the Embodiment
`
`Figure 1 is a plan view of a lead according to the present invention. The lead is
`
`provided with an elongated insulative lead body 10, which terminates at 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 associated sealing
`
`rings 20 for sealing the connector assembly in the bore of an implantable cardiac
`
`pacemakericardioverterfdefibrillator. Connector assembly 16 carries a connector ring 22
`
`and a connector pin 24 and associated sealing rings 26 and 28 for sealing the connector
`
`assembly. The distal portion of the lead body carries an elongated coiled defibrillation
`
`electrode 30, coupled to connector pin 18 internally by means of an elongated, inextensible
`
`stranded conductor. Located distal to defibrillation electrode 30 is a ring electrode 32, in
`
`turn coupled to connector ring 22 by a second, elongated, inextensible stranded conductor.
`
`At the distal end of the lead is a tip electrode 38 which is connected to connector pin 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 which insulative tine sleeve 36 is
`
`mounted. The lead is optionally provided with tines 40 to assist 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, which is, fabricated of a pliant elastomeric material such
`
`polyurethane or silicone rubber tubing.
`
`Figure 2 is a cross section through the lead body in the portion of the lead proximal
`
`to the coiled defibrillation electrode 30.
`
`In this view it can be seen that the lead body 10 is
`
`10
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`30
`
`

`

`W0 0182259
`
`PCTJ'US00127833
`
`4
`
`provided with three internal lumens carrying two inextensible, stranded conductors 42 and
`
`44 which may correSpond to the conductors disclosed in US. Patent No. 5,246,014 issued
`
`to Williams et al or US. Patent No. 5,584,873 issued to Shoberg et a1, 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 connector pin 18 to
`
`defibrillation electrode 30. In the embodiment illustrated, conductor 34 has a 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 has a higher tensile strength and is the conductor to which the
`
`nonconductor reinforcement member is coupled as illustrated in Figure 3 below.
`
`Figure 3 illustrates a cross section of the lead taken in the vicinity of the distal end
`
`of deflbrillation electrode 30.
`
`In this view, the interconnection of stranded conductor 44
`
`and defibrillation electrode 30 is illustrated. These two elements of the lead are
`
`interconnected by means of a cross-groove crimp sleeve generally as described in US.
`
`Patent No. 5,676,694, issued to Boser et al. and incorporated herein by reference in its
`
`entirety. Like the cross-groove crimp sleeve in the Boser et al. patent, cross-groove crimp
`
`sleeve 48 is provided with an elongated tubular section in which the distal termination of
`
`conductor 44 is located, and in which it is maintained by means of crimps 54. The crimp
`
`sleeve 48 is provided with a laterally extending projection, which carries a groove 49 in
`
`which the distal end of defibrillation electrode 30 is located and welded in order to provide
`
`a mechanical and electrical interconnection with conductor 44. Unlike the cross-groove
`
`crimp sleeve of the Boser et al. patent, the cylindrical portion of the crimp sleeve 48
`
`extends distally to the laterally extending shoulder, providing a lumen in which tensile
`
`member 50 may be inserted and in which tensile member 50 is maintained by means of
`
`10
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`20
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`25
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`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 may also be adhesively
`
`coupled to the interior of cross-groove crimp sleeve 48, if desired. Tensile member 50
`
`30
`
`extends to and is mechanically connected to tip electrode 38 (Figure 1) as illustrated in
`
`

`

`W0 0182259
`
`PCTfUSflOIZ7833
`
`5
`
`more detail in Figure 4 discussed below. Alternatively, tensile member 50 may be
`
`conductive, although this will require an insulated connection with either conductor 44 or
`
`tip electrode 38. If the reinforcement is conductive, it may simply be an extension of
`
`conductor 44. By means of the interconnection between conductor 44 and tensile member
`
`50, traction forces applied to the proximal end of the lead are communicated to tip
`
`electrode 38, located at the distal end of the lead, preventing stretching and“or tearing of
`
`the lead intermediate the defibrillation electrode 30 and the tip electrode 38.
`
`An outer insulative sleeve 56 covers the distal end of defibrillation coil electrode 30
`
`and extends distally to abut the exposed portion of ring electrode 32 (Figure 1). Lead body
`
`10 extends distally from defibrillation electrode 30 to ring electrode 32, where the lead
`
`body structure transitions from the multi-lumen structure illustrated in Figure 2 to a single
`
`lumen tube, as illustrated in Figure 4, discussed below as is common in present
`
`commercially marketed multi-conductor leads. Distal to the ring electrode 32,
`
`reinforcement member 50 and coiled conductor 46 extend within this single lumen tube,
`
`which makes up the tip—ring spacer 34.
`
`Figure 4 illustrates a cross-section through the lead in the vicinity of tip electrode
`
`38,
`
`In this view, it can be seen that tip-ring spacer 34 takes the form ofa tube of
`
`biocompatible plastic such as polyurethane or silicone rubber, and surrounds the
`
`reinforcement member 50 and the coiled conductor 46.
`
`In this view it can be seen that ring
`
`electrode 36 is provided with a proximally extending inner shank portion 58 comprising an
`
`internal lumen in 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 crimps are not visible in this cross section, but are conventional.
`
`Reinforcement member 50 extends along a longitudinal groove 51 machined into the side of
`
`the shank of electrode 38. The distal end of reinforcement member 51 is provided with a
`
`circumferential ferrule or crimp sleeve 62 which maintains the distal end of reinforcement
`
`51 in a cross bore 64, extending through electrode 38, An internal shoulder 66 engages the
`
`crimp sleeve or ferrule 62, maintaining the distal end of reinforcement member 50 coupled
`
`to electrode 38. Alternative mechanisms for maintaining the distal end of reinforcement
`
`member 50 engaged with electrode 38 may include simply tying a knot in the distal end of
`
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`
`30
`
`

`

`W0 0182259
`
`PCTIUSIJIJIZ'ISSS
`
`6
`
`the reinforcement member, adhesives, crimps, swages and all other conventional mechanical
`
`interconnection mechanisms known to the art. Tine sleeve 36 carrying tines 40 covers the
`
`electrode shank 58 and is adhesively coupled to the distal end of the tip ring spacer 34.
`
`In the above-illustrated embodiment, the tensile reinforcement member extends
`
`from a conductor associated with a cardioversion or defibrillaticn electrode. 1n the context
`
`of the disclosed embodiment, this is desirable because the conductor associated with the
`
`defibrillation or cardioversion electrode is the largest, highest tensile strength inextensible
`
`conductor available in the lead body. However, the present invention may also of course be
`
`practiced by extending an inextensible conductor coupled to a ring electrode, sensor or
`
`other electrical component located proximal to the distal, tip electrode,
`
`It should afso be noted that while the electrode as illustrated in Figure 4 is a
`
`conventional solid metal pacing electrode, any known form of electrode may be substituted
`
`therefor.
`
`In addition, it is envisioned that some embodiments of the invention, rather than
`
`an electrode being the distal electrical component of the lead, a sensor might be substituted.
`
`As such, the embodiment disclosed above should be considered exemplary, rather than
`
`limiting, with regard to the claims that follow.
`
`10
`
`15
`
`

`

`W0 0132259
`
`PCTI'USOOJZTSSS
`
`WE CLAIM:
`
`1.
`
`An implantable electrical lead comprising:
`
`an elongated lead body having a proximal end and a distal end;
`
`first and second electrical components located along said lead body, a first of said
`
`electrical components located distal to and spaced from a second of said electrical
`
`components, said first and second electrical components separated by a portion of said lead
`
`body which in turn is fabricated of a pliant, extensible biocompatible insulated material;
`
`an extensible conductor extending from the proximal end of said lead body to said
`
`first electrical component;
`
`a second, inextensible conductor extending from the proximal end of said lead body
`
`to said second electrical component; and
`
`an inextensible reinforcement member coupled to said second electrical conductor
`
`and extending distally from said second electrical component to said first electrical
`
`component, said reinforcement member mechanically coupled to said first electrical
`
`component, said first electrical component insulated from said second electrical component.
`
`2.
`
`A lead according to claim l wherein said first electrical component comprises an
`
`electrode.
`
`3.
`
`A lead according to claim 2 wherein said first and second electrical components
`
`comprise electrodes.
`
`4.
`
`A lead according to claim 1 wherein said extensible conductor comprises a coiled
`
`conductor.
`
`5.
`
`A lead according to claim 1 wherein said inextensible conductor comprises a
`
`stranded conductor.
`
`10
`
`15
`
`20
`
`25
`
`6.
`
`A lead according to claim 1 wherein said reinforcement member is fabricated of a
`
`30
`
`nonconductive material.
`
`

`

`W0 0152259
`
`PCTIU800127333
`
`7.
`
`A lead according to claim 1, comprising multiple inextensible conductors, wherein
`
`said reinforcement member is coupled to the inextensible conductor of highest 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 member extends distally from said inextensible conductor,
`
`within said first lumen.
`
`10
`
`

`

`WO 01132259
`
`PCTmsoomsss
`
`1 / 2
`
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`SUBSTITUTE SHEET (RULE 26)
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`SUBSTITUTE SHEET (RULE 2B)
`
`

`

`INTERNATIONAL SEARCH REPORT
`
`Into
`
`ional Application No
`
`PCT/US 00/27833
`
`CLASSIFICJUIUN F SUBJECT MATTER0
`it.
`
`IPC ?
`A61N1 05
`
`According to internationai Patent Cteesiticalrcn (IPC) Otto both national ciassiticalion and IPC.‘
`B. FIELDS SEARCHED
`
`Minimum documentation searched tdassrfication system toliowed by classification symootst
`IPC 7
`A61N
`
`Documentation searched olher than minimum documentation lo the extent tnal such documents are included In Ihe fields searched
`
`L-lectronlc data base consulted during Ihe International search {name at data base and, where pratfiical. search terms used:
`
`EPO—Internai. HPI Data
`
`C. DOCUMENTS CONSIDERED TO BE RELEVANT
`
`Calegory °
`
`Cilalion ol documenl, with indtcallon. where appropnale, 01' lhe relevant passages
`
`Fleievant to claim No.
`
`US 5 676 694 A (MEREGOTTE PEDRO A
`14 October 199? (1997—10~14)
`cited in the application
`coiumn 6,
`tine 10 —coiumn 8,
`figures
`
`iine 12;
`
`ET AL)
`
`
`
`US 5 231 996 A (THORNTON ARNOLD u
`3 August 1993 (1993-08—03)
`cited in the appiication
`column 6,
`line 35 —coiumn 10,
`figures
`
`iine 6;
`
`ET AL)
`
`NO 98 47560 A (MEDTRONIC INC)
`29 October 1998 (1998—10—29)
`page 4,
`iine 10 -page 7,
`iine 2?; figures
`
`_/.-
`
`m Further dowments are listed in the conlinuation at box C.
`° Speciai categories of oiled downwards:
`
`'A' document aetining the general state of the art which is nol
`consider” to m m particutar relevance
`13' earliet document but published on or afler the international
`filing date
`'L' dowment which may throw doubts on priority cle'u'nts} or
`which is cited Io establish the publication dale ot another
`Guam" 0' ”In” Spam“! “339°" ‘35 Spam“)
`'0‘ document retemng to an oral disclomre. use. exhibition or
`other means
`'P' document published prior to the international tiling date but
`Later than the priorily dale claimed
`
`II] Patent familyr rnerttbers are listed in annex.
`..
`_
`.
`‘1" laterdocurnenl published after the intemetionel tiling date
`
`°' ”my date and "m 1” mm“ “”1" "'9 app'm‘im ”"1
`invention
`died to understand the principle or theory undertying the
`'X' WITH“ ot ”Hum relevance the claimed invention
`cannot be considered novel or cannot be considered to
`'
`involve an inventive step when the document is taiten alone
`'Y' document of particular relevance the claimed invention
`cannot be considered to involve an inventive step when the
`document is combined with one or rmre other such docu—
`ments‘ such combination being obvious to a person skilled
`"1 "‘9 3"-
`‘8? document member of the some patent [army
`
`Date or the actual completion oi the mien-rational search
`
`Date or mailing of the Intemationai search report
`
`26 January 2001
`Name and mailing address of the ISA
`European Patent Office. PB. 5818 Palenllaan 2
`I,
`31—?0 340—20401 T . 31 651
`i.
`1w. — 2280 HV Rijswijk
`Pg};m_fl$3w_ana *
`Form esteem-210 {second sheet} {Jutyl 1992}
`
`am"
`
`02/02/2001
`Authon'zed officer
`
`'
`RakotondraJaona, C
`
`page 1 of-2
`
`

`

`INTERNATIONAL SEARCH REPORT
`
`lnte
`anal applicaflon No
`
`PCT/US 00/27833
`
`
`
`C.(Continuationl DOCUMENTS CONSIDERED TO BE RELEVANT
`Cllalion 0| document. wilh indication. where appropnale 0| 1he rerevanl passages
`
`Relevant to claim No.
`
`
`
`
`
`
`
`
`
`
`A
`
`US 5 584 8?3 A (SHOBERG BRET R
`1? December 1996 (1996--12- 1?")
`cited in the app11cation
`column 2,
`Iine 35 —c01umn 4, 11ne 28;
`figures
`
`ET AL)
`
`
`
`
`
`
`
`
`
`Form PCTFISAI'210 [umunual-on of 99mm! sheet} [July 1992}
`
`page 2 of 2
`
`

`

`iflViiEIUV!\11()DhAI,SEHAIUCTIIIEINDICT
`
`Inlurmation on patent famliy membets
`
`
`Int:
`
`jonal Appilcation No
`
`PCT/US 00/27833
`
`Patent document
`cited in seamh report
`
`Publication
`date
`
`Patent familyr
`memberis)
`
`Publication
`date
`
`US 5676694
`
`US 5231996
`
`A
`
`A
`
`14-10-1997
`
`NONE
`
`03-08F1993
`
`AU
`AU
`CA
`DE
`DE
`EP
`JP
`JP
`NO
`
`US
`AU
`EP
`EP
`US
`US
`
`AU
`AU
`CA
`E?
`JP
`H0
`
`649911 B
`3223493 A
`2104861 A
`6920052? D
`6920052? T
`0577787 A
`2601761 B
`6505665 T
`9314811 A
`
`5954759 A
`6564998 A
`1023915 A
`0980281 A
`6018683 A
`6061598 A
`
`697915 B
`5178496 A
`2219419 A
`0939657 A
`11504543 T
`96354?5 A
`
`02-06-1994
`01-09-1993
`29*07-1993
`17-11*1994
`16-02-1995
`12-01-1994
`16-04-199?
`30—06—1994
`05~08-1993
`
`21-09-1999
`13-11—1998
`02-08—2000
`23-02-2000
`25-01-2000
`09-05-2000
`
`22-10-1998
`29-11-1996
`14-11—1996
`08-09-1999
`27-04-1999
`14-11-1996
`
`
`
`NO 9847560
`
`A
`
`29—10-1998
`
`US 5584823
`
`A
`
`17-12-1996
`
`Fan-n PCYASN'ZN [paw-II Imihl ml} {July 1992:
`
`

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