U.S. UTILITY PATENT APPLICATION
`
`PATENT NUMBER
`6117167
`
`6117167
`
`] DISK (CRF) E] FICHE
`
`(Attached In pocket on right Inside flap)
`
`NK
`
`:
`
`Aq
`
`CC= AMC
`
`CVm4
`
`SECTOR
`
`CLASS
`
`/SUSCL
`
`I.
`
`r'"
`
`- 2001
`
`ot UKLII
`
`ISSUING CLASSIFICATION
`CROSS REFERENCE(S)
`SUBCLASS (ONE SUBCLASS PER BLOCK)
`
`CL4SS
`
`_
`
`__
`
`ORIGINAL
`SUBCLASS
`
`CLASS
`
`INTERNATIONAL CLASSIFICATION
`
`--
`
`-2
`
`/0
`
`-
`
`4,-
`
`/-~
`
`-
`
`-
`
`-
`
`TERMINAIL
`El DISCILAIMER
`
`HContinued on lssu'S&0,1nslde File Jacket
`lJ~
`§
`~~~~Fra OraWwingsf( _shts)setA
`DRAWINGS
`Figs. Drwg.
`
`Sheets Drwg.
`
`Print Fig.
`
`CLAIMS ALLOWED
`Prflt Claim fO.G.
`TtalClaimrj
`
`(date)
`
`___________________
`
`09rTitnt Examiner)
`
`NOTICE OF ALLOWANCE MAILED
`
`(Date)
`
`Ll a) The'term of this patent
`sul;,sequent to ______
`has been disclaimed.
`l b) The term of this patent shaii
`not extend beyond the expiration dateMCALJ.NLO
`of U.S Patent. No. _
`
`____
`
`.PRIMARY
`
`EXAMIINER
`
`SUEFEE
`Date Paid
`Amount Due
`
`-__months of
`c ) The terminal
`this patent have been disclaimed.
`
`(Legal Instruments Examiner)
`
`(TDate)
`
`ISSUE BATCH NUbEh
`
`WARNING:
`The Information disciosed heroin may be restricted. Unauthorized disclosure may be prohibited by the United States Code Title 35, Sections 122, 181 and 368.
`Possession outside the U.S. Patent & Trademark Office is restricted to authorized employees and contractors only.
`Form PT0-436A
`(Rev. 10/97)
`
`(LABEL AREA)
`
`Issue FOG 14n$e
`
`(FACE)
`
`W.L. Gore & Associates, Inc.
`Exhibit 1008-1
`
`

`

`6,117,167
`
`BIFURCATED ENDOLUMINAL PROSTHESIS
`
`Transaction History
`
`Date
`
`Transaction Description
`
`2/9/1998 Workflow - Drawings Finished
`
`2/9/1998 Workflow - Drawings Matched with File at Contractor
`
`2/9/1998 Workflow - Drawings Received at Contractor
`
`2/9/1998 Preliminary Amendment
`
`2/19/1998
`
`Initial Exam Team nn
`
`4/15/1998
`
`IFW Scan & PACR Auto Security Review
`
`4/27/1998 Application Dispatched from OIPE
`
`5/26/1998
`
`Information Disclosure Statement (IDS) Filed
`
`5/26/1998
`
`Information Disclosure Statement (IDS) Filed
`
`5/27/1998 Case Docketed to Examiner in GAU
`
`8/31/1998 Preexamination Location Change
`
`2/8/1999 Case Docketed to Examiner in GAU
`
`2/10/1999 Preliminary Amendment
`
`5/6/1999 Non-Final Rejection
`
`5/10/1999 Mail Non-Final Rejection
`
`12/15/1999 Response after Non-Final Action
`
`12/29/1999 Date Forwarded to Examiner
`
`3/13/2000 Mail Notice of Allowance
`
`3/13/2000 Notice of Allowance Data Verification Completed
`
`6/14/2000
`
`Issue Fee Payment Verified
`
`6/14/2000 Workflow - Incoming Correspondence - Finish
`
`6/14/2000 Amendment after Notice of Allowance (Rule 312)
`
`6/14/2000 Workflow - Incoming Correspondence - Begin
`
`7/24/2000 Mail Acknowledgement of Priority Papers
`
`7/24/2000 Priority Paper Acknowledgement
`
`7/24/2000 Mail Response to 312 Amendment (PTO-271)
`
`7/24/2000 Response to Amendment under Rule 312
`
`7/24/2000 Date Forwarded to Examiner
`
`7/26/2000 Workflow - Complete WF Records for Drawings
`
`7/30/2000 Application Is Considered Ready for Issue
`
`8/28/2000
`
`Issue Notification Mailed
`
`9/12/2000 Recordation of Patent Grant Mailed
`
`10/19/2001 Mail Miscellaneous Communication to Applicant
`
`10/19/2001 Miscellaneous Communication to Applicant - No Action Count
`
`11/29/2001 Post Issue Communication - Certificate of Correction
`
`W.L. Gore & Associates, Inc.
`Exhibit 1008-2
`
`

`

`12/5/2001 Post Issue Communication - Certificate of Correction
`
`
`W.L. Gore & Associates, Inc.
`Exhibit 1008-3
`
`

`

`jc525 U.S.
`
`09/020749
`
`PTO0
`
`'02/09/98
`
`I?A:
`
`WION
`
`CONTENTS
`Date received4
`(Ir.cI. C. of M.)
`or
`
`t
`
`7/
`
`INITIALS
`
`Date received
`(incl. C. of M.)
`or
`Date Mailed
`
`1. Application
`
`-
`
`papers%'4
`
`3.
`
`4.4
`
`5.ij
`s/LS. 3fALeAIwA(AMu
`
`IZO' 44.
`45.
`46.
`47.
`48.
`
`4LUO'9 2
`S649.
`
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`
`4!
`
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`
`17.
`18.
`19.
`20.
`21.
`22.
`23.
`24.
`26'
`26.
`
`27.
`289.
`
`30.
`31.
`32.
`33..
`34.
`35.
`36.
`37.
`38.
`39.
`40.
`41..
`
`______ _____
`
`__________
`
`____ ___
`
`___
`
`______ _____
`
`______ _____
`
`_________
`
`______ _____
`
`______ _____
`
`_____ _____
`
`______ _____
`
`______ _____
`
`______ _____
`
`______ _____
`
`______ _____
`
`____ ___
`
`___
`
`____ ___
`
`___
`
`______ _____
`
`______ _____
`
`______ _____
`
`______ _____
`
`so.
`
`52.
`53.
`54.
`55.
`56..
`57..
`58..
`59..
`
`60..
`
`61..
`
`62..
`
`63..
`64..
`65..
`
`66..
`67.,
`68..
`69..
`
`70..
`
`71.
`
`72..
`
`73.
`
`74..
`
`75..
`
`76..
`
`77.,
`
`78.,
`
`79..
`
`80..
`
`81.
`
`82.,
`(FRONT.)
`
`W.L. Gore & Associates, Inc.
`Exhibit 1008-4
`
`

`

`SEARCH NOTES
`(INCLUDING SEARCH STRATEGY)
`
`Date
`
`Exmr.
`
`N
`
`//
`
`INTERFERENCE_SEARCHED
`
`(RIGHT OUTSIDE)
`
`W.L. Gore & Associates, Inc.
`Exhibit 1008-5
`
`

`

`ISST (E SLIP STAPLF A-F. A (
`
`'aciditional cross references)
`
`POSITION
`
`INITIALS
`
`O.I.P.E. CLASSIFIER If
`
`FEE DETERMINATION
`
`FORMALITY REVIEW
`
`_
`
`ID NO.
`
`DATE
`
`__________________
`
`ix~~ i
`
`/
`
`/
`
`INDEX OF CLAIMS
`N ...................... Non-elected
`.
`................. Rejected
`Interference
`I ........................
`.... Allowed
`.............
`A...................... Appeal
`(Through numeral) Canceled
`0 ...................... Objected
`..................
`Restricted
`
`Claim'
`
`Date
`
`Cl im
`
`Date
`
`Claim
`
`_
`
`Date
`
`W0 IN
`V /14
`%A
`
`19
`I K IK
`
`io KAif TI#q
`MI hIr W
`
`U.0
`
`I
`1 ---
`I I
`
`W9
`
`114
`S115
`11 .6
`117
`
`120
`
`" 123
`
`SI128
`
`_
`
`IX131
`132
`13
`
`137
`138 ___
`
`139 _
`1V,40
`141
`142
`
`1 46S 144
`5,145
`~147_
`
`I
`I
`-1
`
`4 J 68611
`
`6 0
`,66 W
`
`66
`
`Iiv/._
`
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`T
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`
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`7YTV_
`
`83
`q4 IV M.
`
`LJ 47
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`
`90
`
`92
`93
`94
`95
`96
`97.
`98
`P9
`loc
`
`3#
`
`3"
`3t
`
`B4
`
`4 41 1
`
`A
`
`if more than 150 claims or 10 actions
`staple additional sheet here
`
`(LEFT INSIDE)
`
`W.L. Gore & Associates, Inc.
`Exhibit 1008-6
`
`

`

`United States Patent [1
`Goicoechea et al.
`
`[75]
`
`[54) ENDOLUMINAL PROSTHESIS AND SYSTEM
`FOR JOWNING
`Inventors: George Goicoechea, Ereeport,
`Bahamas; John Hudson, Glenfield,
`United Kingdom; Claude Mialhe,
`Draguignan, France; Andrew 11.
`Cragg, Edina, Minn.; Michael DI.
`Dake, Stanford, Calif.
`[73) Assignee: Boston Scientific Technology, Inc.,
`Maple Grove, Minn.
`
`[21] Appl. No.: 09/020,749
`Feb. 9, 1998
`[22] Filed:
`Related US. Application Data
`
`[63) Continuation of application No. 08/461.513. Jun. 5, 1995,
`Pat. No. 5,716.365. and a division of application No. 08/3 17,
`763, Oct. 4, 1994, Pat. No. 5.609.627, which is a continu-
`ation-in-part of application No. 08/312.881, Sep. 27, 1994.
`Foreign Application Priority Data
`[30]
`European Pat. Off........... 94400284
`[EP]
`Feb. 9, 1994
`European Pat. Off........... 94401306
`Jun. 10, 1994
`[EP]
`. . . . . . . . . . . . . . . . . . . . . . . A61F 2/00
`Int. Cl.7 .................
`(51]
`623/1.16
`[52) U.S. Cl ............................................
`623/1, 11, 12,
`[58] Field of Search .........................
`623/1- 16
`
`623/11
`
`References Cited
`U.S. PATENT DOCUMENTS
`Ersek.............................
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`Alfidi et al..
`3/1975
`Sauvage.
`4/ 1975
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`Clabbumn.
`7/1980
`Sakcura, Jr.
`Mano et al. .
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`Simon.
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`(List continued on next page.)
`
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`4,306,318
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`4,503,569
`4.512,338
`
`US0O61 17167A
`[m1 Patent Number:
`[45] Date of Patent:
`
`6,117,167
`Sep. 12,200
`
`FOREIGN PATENT DOCUMENTS
`6/1985 European Pat. Off..
`0145166BI
`4/1991 European Pat. Off..
`04239 16AI
`1/1992 European Pat. Off..
`0 464 755 Al
`4/1992 European Pat. Off..
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`(List continued on next page.)
`OTHER PUBLICATIONS
`Dotter et al,, "Transluminal Expandable Nitinol Coil Stent
`Grafting: Preliminary Report", Technical Developments and
`Instrumentation, Radiology, vol. 147, pp. 259-260 (Apr.
`1983).
`Schetky, "Shape Memory Alloys", pp. 74-82.
`K. Otsuka et al., "Shape-Memory Alloys-Pseudoelasticity",
`Metals Forum, vol. 4, No. 3, pp. 142-152 (1981).
`Cragg et al., "Nonsurgical Placement of Arterial Endopros-
`theses; A New Technique Using Nitinol Wire", Radiology,
`vol. 147, No, 1, pp. 261-263 (Apr. 1983).
`Cragg et at., "Percutaneous Arterial Grafting", Radiology,
`vol. 150, No. 1, pp. 45-49 (1984).
`T. W. Duerig et al, "An Engineer's Perspective Pseudoelas-
`ticity", pp. 369-393.
`Cragg et al., "Stends/Nascular Stents", Interventional Radi-
`ology, pp. 686-692 (1990.
`Primary Examiner-Michael J. Milano
`Attorney, Agent, or Firm-Ratner & Prestia
`ABSTRACT
`[57)
`A stent joining means is provided for joining a first endolu-
`to define a
`minal. stent to a second endolurninal stent
`continuous lumen through the first and second endoluminal
`stents. The stent joining means includes two transversely
`spaced female portions on the first endoluminal stent. The
`stent joining means also includes a male engaging portion of
`the second endoluminal stent. The male engaging portion is
`configured to be entered into one of the female portions in
`a radially compressed state and thereafter expanded in the
`female portion such that an outer surface of the male
`engaging portion and an inner surface of the female portion
`are interengaged to resist longitudinal movement to prevent
`separation of the first and second endolum-inal stents in
`service.
`
`82 Claims, 23 Drawing Sheets
`
`W.L. Gore & Associates, Inc.
`Exhibit 1008-7
`
`

`

`6,117,167
`Page 2
`
`U.S. PATENT DOCUMENTS
`11/1985 Maass et al.,
`12/1985 Hamimerslag.
`1/1986 Kornberg.
`3/1986 Kreamer.
`4/1986 Gianturco
`10/1986 Kornberg.
`3/19 87 WiWor.
`4/1987 Wallsten .
`5/1987 Jervis.
`5/1987 Gamz ct al..
`7/1987 Witkcor.
`3/1988 Hughes .
`3/1988 Bergentz et at.
`3/1988 Wallsten et al..
`3/1988 Pahniaz.
`4/1988 Palmaz .
`8/1988 Rosenbluth .
`9/1988 Fischell et at.
`9/1988 Cragg.,
`10/1988 Palmaz .
`1/1989 Gianturco.
`4/1989 Leveen et al.t
`5/1989 Wolffetal..
`8/1989 Hillstead .
`11/1989 Lindemann et al..
`12/1989 Wilder .
`12/1989 Collins, Jr. .
`4/1990 Hillstead.
`5/1990 Strecker.
`11/1990 Wiktor .
`11/1990 Sugita etal .
`2/1991 MacGregor .
`5/1991 H-illstead .
`5/199 1 Pinchuk.,
`7/1991 Gianturco,
`8/1991 Haradla et al..
`8/1991 Gianturco .
`9/1991 Arpesani .
`10/199 1 Webster, Jr. .
`11/1991 Porter ...........................
`Jervis.
`11/1991
`1/1992 Kreanier .
`1/1992 Behl ,
`2/1992 Cragg .
`4/1992 Lazarus.
`4/1992 Wolff,.
`6/1992 Lee.
`7/1992 Wikctor.
`8/1992 Hillstead.
`9/1992 Kwan-Gett,
`11/1992 Tower,
`2/1993 Timmermans.
`3/1993 Hull,.
`4/1993 Harada et al..
`5/1993 Trout.
`8/1993 Dumon
`
`4,553,545
`4,560,374
`4,562,596
`4,577,631
`4,580,568
`4,617,932
`4,649,922
`4,655,771
`4,665,906
`4,665,918
`4,681,110
`4,728,328
`4,729,766
`4,732,152
`4,733,665
`4,739,762
`4,762,128
`4,768,507
`4,772,264
`4,776,337
`4,800,882
`4,820,298
`4,830,003
`4,856,516
`4,878,906
`4,886,062
`4,886,065
`4,913,141
`4,922,905
`4,969,458
`4,969,890
`4,994,071
`5,019,085
`5,019,090
`5,035,706
`5,037,427
`5,041,126
`5,047,050
`5,057,092
`5,064,435
`5,067,957
`5,078,726
`5,078,736
`5,085,635
`5,104,399
`5,104,404
`5,123,917
`5,133,732
`5,135,536
`5,151,105
`5,161,547
`5,183,085
`5,192,297
`5,201,901
`5,207,695
`5.236,446
`
`606/198
`
`5,275,622
`1/1994 Lazarus.
`5,282,824
`2/1994 Gianturco.
`5,290,305
`3/1994
`Inone.
`5,292,331
`3/1994 Boneau
`4/1994 Spaulding
`5,304,200
`5,314,472
`5/1994 Fontaine .
`7/1994 Song ............................
`5,330,500
`6061198
`5,342.387
`8/1994 Summers .......................
`606/198
`10/1994 Schnepp-Pesch.................. 623/12
`5,354,309
`11/1994 Barone et al.................... 606t195
`5,360.443
`5,366,504
`11/1994 Anderson et al,.
`12/1994 Fontaine.
`5,370,683
`1/1995 Scott et at.
`5,383,928
`2/1995 Chuter.
`5,387,235
`2/1995 Tower .
`5,389,106
`3/1995 Lazarus.
`5,397,345
`5,405,377
`4/1995 Cragg,
`511995 Pinchuk.
`5,415,664
`5,429, 144
`7/1995 Wilk .
`8/1995 Schwartz .
`5,443,496
`5,443,498
`8/1995 Fontaine.
`5,456,713
`10/1995 Chuter .
`11/1995 Ryan et al..
`5,464,449
`5,507,767
`4/1996 Maeda .
`4/1996 Gianturco.
`5,507,771
`10/1996 Vorwerk ...........................
`5,562,724
`623/1
`5,562,727
`10/1996 Turk et al ........................
`623/12
`10/1996 Lazarus et al ...................
`5,562,728
`606/194
`11/1996 Palmaz et al.................... 606/io8
`5,571,170
`5,575,817
`11/1996 Martin ......................................... 623/1
`9/1997 Polanskcyj-Stockert ............... 623/1
`5,662,675
`10/1997 McDonald ........................ 623/1
`5,676,697
`FOREIGN PATENT DOCUMENTS
`10/1992
`European Pat. Off..
`0508473 A2
`5/1993
`0 540 290 A2
`European Pat. Off..-
`055 1179A]
`7/1993
`European Pat. Off. .
`8/1993
`European Pat. Off. .
`0556850A1
`European Pat. Off. .
`1/1994
`0579523AI
`0 536 164 B I
`European Pat. Off. .
`3/1994
`0 481 365 B I
`European Pat. Off. .
`6/ 1994
`0 621 015 Al
`European Pat. Off. .
`10/1994
`European Pat. Off. .
`10/ 1994
`0 621 016 Al
`0 622 088 Al
`European Pat. Off..
`11/1994
`European Pat. Off. .
`4/ 1995
`0 646 365 Al
`0 656 197 A2
`6/ 1995
`European Pat. Off,.
`0 657 147 A2
`6/ 1995
`European Pat. Off..
`0 662 307 Al
`7/1995
`European Pat. Off. .
`4/1991
`France .
`2678508
`1/1993
`France,.
`2678508AI
`3 918 736 Al
`12/ 1990
`Germany .
`8/1994
`Germany ,
`4303 181lAI
`4/1983
`United Kingdom.
`2106190A
`W089/08433
`9/1989
`WIPO.
`W09 1/07928
`6/1991
`WIPO.
`WIPO............................. 623/1
`1/1992
`92/00043
`W093/13825
`7/1993
`WIPO.
`WIPO.
`W094/17754
`8/1994
`W095/01761
`1/1995
`WwPO.
`
`W.L. Gore & Associates, Inc.
`Exhibit 1008-8
`
`

`

`U.S. PatentSe.1,20She1of261717
`Sep.12,2000
`
`Sheet I of 23
`
`691179167
`
`FIG. IA
`
`14{
`
`W.L. Gore & Associates, Inc.
`Exhibit 1008-9
`
`

`

`U.S. Patent
`
`Sep. 12,2000
`
`Sheet 2 of 23
`
`6,117,167-
`
`25~
`
`FIG. 2A
`
`FIG. 2B
`20a
`
`20b
`
`%.-
`
`W.L. Gore & Associates, Inc.
`Exhibit 1008-10
`
`

`

`U.S. Patent
`
`Sep. 12,2000
`
`Sheet 3 of 23
`
`6,117,167
`
`FIG. 3
`
`FIG. 4A
`
`W.L. Gore & Associates, Inc.
`Exhibit 1008-11
`
`

`

`U.S. PatentSe.1,00
`
`Sep.12,2000
`
`Set4o'261717
`Sheet 4 of 23
`
`691179167
`
`LL.
`
`Lu
`
`v
`
`ILL
`
`Qi
`
`LLw
`
`u L
`
`L
`
`W.L. Gore & Associates, Inc.
`Exhibit 1008-12
`
`

`

`U.S. Patent
`
`Sep. 12, 2000
`
`Sheet 5 of 23
`
`6,117,167
`
`W.L. Gore & Associates, Inc.
`Exhibit 1008-13
`
`

`

`U.S. Patent
`
`Sep. 12, 2000
`
`Sheet 6 of 23
`
`6,1179167
`
`K
`
`W.L. Gore & Associates, Inc.
`Exhibit 1008-14
`
`

`

`U.S. Patent
`
`Sep. 12,2000
`
`Sheet 7 of 23
`
`6,117,167
`
`/
`
`V
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`-4
`-4
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`

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`U.S. Patent
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`Sep. 12,2000
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`Sheet 8 of 23
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`6,117,167
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`U.S. Patent
`
`Sep. 12,2000
`
`Sheet 9 of 23
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`6,117,167
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`W.L. Gore & Associates, Inc.
`Exhibit 1008-17
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`

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`U.S. Patent
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`Sep. 12,2000
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`Sheet 10 of 23
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`Exhibit 1008-18
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`

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`U.S. Patent
`
`Sep. 12,2000
`
`Sheet 11 of 23
`
`69117J167
`
`W.L. Gore & Associates, Inc.
`Exhibit 1008-19
`
`

`

`U.S. Patent
`
`Sep. 12, 2000
`
`Sheet 12 of 23
`
`6,117,167
`
`W.L. Gore & Associates, Inc.
`Exhibit 1008-20
`
`

`

`U.S. Patent
`
`Sep. 12,2000
`
`Sheet 13 of 23
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`6,117,167
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`W.L. Gore & Associates, Inc.
`Exhibit 1008-21
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`

`

`U.S. Patent
`
`Sep. 12,2000
`
`Sheet 14 of 23
`
`6,117,167
`
`cii
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`W.L. Gore & Associates, Inc.
`Exhibit 1008-22
`
`

`

`U.S. Patent
`
`Sep. 12,2000
`
`Sheet 15 of 23
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`6,117,167
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`Exhibit 1008-23
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`

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`U.S. Patent
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`Sep. 12,2000
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`Sheet 16 of 23
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`Exhibit 1008-24
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`U.S. Patent
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`Sep. 12,2000
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`Sheet 17 of 23
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`6,117,167
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`W.L. Gore & Associates, Inc.
`Exhibit 1008-25
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`

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`U.S. Patent
`
`Sep. 12, 290
`
`Sheet 18 of 23
`
`6,117,167
`
`W.L. Gore & Associates, Inc.
`Exhibit 1008-26
`
`

`

`U.S. Patent
`
`Sep. 12,2000
`
`Sheet 19 of 23
`
`6,117,167
`
`W.L. Gore & Associates, Inc.
`Exhibit 1008-27
`
`

`

`U.S. Patent
`
`Sep. 12, 2000
`
`Sheet 20 of 23
`
`6,117,167
`
`W.L. Gore & Associates, Inc.
`Exhibit 1008-28
`
`

`

`U.S. Patent
`
`Sep. 12,200
`
`Sheet 22 of 23
`
`6,117,167
`
`W.L. Gore & Associates, Inc.
`Exhibit 1008-29
`
`

`

`U.S. Patent
`
`Sep. 12, 2000
`
`Sheet 23 of 23
`
`69117,167
`
`CD
`H-
`
`W.L. Gore & Associates, Inc.
`Exhibit 1008-30
`
`

`

`6,117,167
`
`1
`ENDOLUMINAL PROSTHESIS AND SYSTEM
`FOR JOINING
`This is a Continuation of U.S. patent application Ser. No.
`08/461,5 13, filed Jun. 5, 1995 (status: allowed), which is a 5
`Divisional of U.S. patent application 3cr. No. 08/317,763,
`filed Oct. 4, 1994 (status: issued), which in turn is a
`Continuation-In-Part of U.S. patent application 8cr. No.
`08/312,881, filed Sep. 27, 1994 (status: pending).
`This is a continuation-in-part application of the applica- 10
`dion of common assignment herewith of inventors George
`Goicoechea, Claude Mialhe, John Hudson and Andrew
`Cragg, entitled BIFURCATED ENDOLUMINAL
`PROSTHESIS, filed on Sep. 27, 1994, for which application
`a serial number had not yet been assigned as of the date of 15
`filing this continuation-in-part appiication.
`BACKGROUND OF THE INVENTION
`The present invention relates to a bifurcated endoluminal
`prosthesis for use in a bifurcated blood vessel such, for 2
`example, as the infrarenal portion of a mammalian aortic 2
`artery where it bifurcates to the common iliac arteries. The
`present invention also embraces a stent connecting means
`for connecting a stent (e.g. a stent which forns part of an
`endoluminal prosthesis) to another stent, as well as appara- 2
`tus and method for introducing prostheses to the vasculature 2
`and methods of treating angeological diseases.
`A stunt is used to provide a prosthetic intraluminal wall
`e.g. in the case of a stenosis to provide an unobstructed
`conduit for blood in the area of the stenosis. An endoluminal 3
`prosthesis comprises a stent which carries a prosthetic graft 3
`layer of fabric and is used e.g. to treat an aneurysm by
`removing the pressure on a weakened part of an artery so as
`to reduce the risk of embolism, or of the natural artery wall
`bursting. Typically, a stent or endolun-dnal prosthesis is 3
`implanted in a blood vessel at the site of a stenosis or
`aneurysm by so-called "minimally invasive techniques" in
`which the stent is compressed radially inwards and is
`delivered by a catheter to the site where it is required
`through the patient's skin or by a "cut down" technique in 40
`which the blood vessel concerned is exposed by minor
`surgical means. When the stunt is positioned at the correct
`location, the catheter is withdrawn and the stent is caused or
`allowed to re-expand to a predetermined diameter in the
`vessel.
`U.S. Pat. No. 4,886,062 discloses a vascular stunt which
`comprises a length of sinuous or "zig-zag"s wire formed into
`a helix; the helix defines a generally cylindrical wall which,
`in use, constitutes a prosthetic intraluninal wall. The sinu-
`ous configuration of the wire permits radial expansion and 50
`compression of the stent; U.S. Pat. No. 4,886,062 discloses
`that the stent can be delivered percutaneously and expanded
`in situ using a balloon catheter.
`U.S. Pat. No. 4,733,665 discloses an expandable intralu-
`minal graft which is constituted by a tubular member formed 55
`from a plurality of intersecting elongate members which
`permit radial expansion and compression of the stent.
`EP-A-0556850 discloses an intraluminal stent which is
`constituted by a sinuous wire formed into a helix; juxtaposed
`apices of the wire are secured to one another so that each 6o
`hoop of the helix is supported by its neighboring hoops to
`increase the overall strength of the stent and to minimize the
`risk of plaque herniation; in some embodiments the stent of
`EP-A-0556850 further comprises a tubular graft member to
`form an endoluminal prosthesis.
`The prior art stents and prostheses mentioned above are
`generally satisfactory for the
`treatment of aneurysms,
`
`65
`
`stenoses and other angeological diseases at sites in continu-
`ous unbifurcated portions of arteries or veins.
`However,
`the prior art stents and prostheses are not
`wholly satisfactory for use where the site of desired appli-
`cation of the stent or prosthesis is juxtaposed or extends
`across a bifurcation in an artery or vein such, for example,
`as the bifurcation in the mammalian aortic artery into the
`common iliac arteries. For example,
`in the case of an
`abdominal aortic aneurysm ("AAA") in the infrarenal por-
`tion of the aorta which extends into one of the common iliac
`arteries, the use of one of the prior art prosthesis referred to
`above across the bifurcation into the one iliac artery will
`result in obstruction of the proximal end of the other
`common iliac artery; by-pass surgery is therefore required to
`connect the one iliac artery in juxtaposition with the distal
`end of the prosthesis to the other blocked iliac artery. It will
`be appreciated by a person skilled in the art that it is
`desirable to avoid surgery wherever possible; the require-
`ment for by-pass surgery associated with the use of the prior
`art prosthesis in juxtaposition with a bifurcation in an artery
`therefore constitutes a significant disadvantage.
`SUMMARY OF THE INVENTION
`Throughout this specification, the term "proximal" shall
`mean "nearest to the heart," and the term "distal" shall mean
`"furthest from the beant."
`According to one aspect of the present invention there is
`provided a stent connecting means for connecting two
`intralumninal stunts one to the other to define a continuous
`lumen through the two stents, the stunt connecting means
`including a first stent including a male engaging portion
`which can be compressed radially inwardly, and a second
`stent including a female cooperating portion. The male
`engaging portion may be entered into the female cooperating
`portion in a radially compressed state and thereafter caused
`or allowed to expand in the female cooperating portion; the
`arrangement being such that in service the interengagemnent
`of the male engaging portion and the female cooperating
`portion serves to resist longitudinal separation of the two
`stunts one from the other.
`Typically, the first stent may include a proximal male
`engaging portion; the second stunt may include a distal
`female cooperation portion. The male engaging portion may
`be flared radially outwardly towards its extremity, and the
`female cooperating portion may be tapered radially inwardly
`the male
`towards its extremity. In some embodiments,
`engaging portion may comprise a frustoconical wall which
`flares outwardly towards its longitudinal extremity; the
`female engaging portion may comprise a frustoconical wall
`which tapers radially inwardly towards
`its longitudinal
`extremity.
`Alternatively, said male engaging and female cooperating
`portions may be substantially untapered;, they may be sub-
`stantially cylindrical.
`The male engaging portion of the first stent may be
`resiliently compressible in a radially inwards direction such
`that in the radially compressed state it is capable of self-
`reexpansion to engage in the female cooperating portion.
`Typically, each of' said first and second stents may be
`resiliently compressible.
`In use therefore the second stent may be delivered in a
`radially compressed state by using a catheter; when the
`second stent is located at the site of use, the catheter may be
`withdrawn thereby allowing the second stent to re-expand to
`engage the endoluminal surface of the blood vessel.
`The first stent may then be delivered percutaneously or by
`a "cut down" technique to a site distal of the second stent
`
`45
`
`W.L. Gore & Associates, Inc.
`Exhibit 1008-31
`
`

`

`6,117,167
`
`3
`such that the male engaging portion of the first stent in the
`radially compressed state is entered into the expanded
`female cooperating portion of the second stent: the catheter
`may then be withdrawn allowing the first stent to re-expand
`such that the male engaging portion engages in the female
`cooperating portion of the second stent,
`In some embodiments of the present invention the second
`stent may have two transversely spaced distal female coop-
`erating portions; the second stent may therefore constitute a
`bifurcated stent for use in juxtaposition with a bifurcation in
`a blood vessel.
`Each of the two transversely spaced distal female coop-
`erating portions may be adapted for connection to a first
`male stent which, in use, extends across the bifurcation into
`a respective one of the branched blood vessels.
`In a particular aspect of the present invention there is
`provided a bifurcated intraluninal stent for use in juxtapo-
`sition with an angeological bifurcation;
`the bifurcated
`intraluminal stent comprising a proximal portion adapted to
`be positioned in service in a blood vessel in juxtaposition
`with a bifurcation, a first distal. stent portion adapted to
`extend across the bifurcation into one of the branched blood
`vessels and a second distal stent portion adapted to allow
`blood to flow from the proximal portion into the other
`branched vessel. The first dista stent portion may be formed
`integrally with the proximal portion.
`In some embodiments the second distal stent portion may
`comprise a female cooperating portion which is adapted to
`engage a male engaging portion of a another stent adapted
`to extend in the other branched blood vessel such that, in
`use, the bifurcated stent can be connected in situ to the other
`stent. The bifurcated intraluminal stent may therefore con-
`stitute a second stent in accordance with the present inven-
`tion comprising a distal female cooperating portion disposed
`intermediate the proximal and distal extremities of the stent;
`the other stent may constitute a first stent in accordance with
`the present invention.
`Typically, the proximal end of said second stent may be
`flared radially outwardly towards its extremity to engage the
`endolunminal surface of the artery thereby to resist longitu-
`dinal movement of the second stent in service.
`Each of the first and second stents may comprise a sinuous
`wire formed into a tubular configuration. The sinuous and
`tubular configurations may be imparted to the wire by
`winding it on a mandrel. Typically, each stent may be made
`from a shape memory nitinol (nickel-titanium) wire which
`may be wound on to the mandrel to form the stent in a
`tubular configuration of slightly greater diameter than the
`diameter of the blood vessel in which the stent is intended
`to be used. The stent may be annealed at an elevated
`temperature and then allowed to cool in air so that the nitinol
`wire "remembers" the configuration in which it was wound
`on the mnandrel.
`Said nitinol wire may be type "M" nitinol wire which is
`martensitic at temperatures below about 130 C. and is
`austenitic at temperatures above about 25* C.; it will be
`appreciated therefore that the type "M" wire will be auste-
`nitic at body temperature of 370 C. Typically, the annealing
`may be conducted at about 5001 C. or more for at least about
`60 minutes; after cooling the wire may be immersed in cold
`water to facilitate removal of the wire from the mandrel with
`the wire in its maleable martensitic form. Typically, the cold
`water may have temperature of less than about 1O1 C.; the
`wire may be immersed for about 5 minutes or more. An
`advantage of using nitinol wire to form the stent in accor-
`dance with the present invention is that the nitinol wire is
`
`"super elastic" in its austenitic state; the radial outward force
`exerted by the stent on the wall of the blood vessel in use is
`therefore substantially constant irrespective of the diameter
`of the vessel and the expanded stent.
`5 In some embodiments the wire may have a helical con-
`figuration as disclosed in EP-A-0556850. Alternatively, the
`wire may be of an entirely novel configuration, namely one
`in which the wire forms a plurality of hoops such that the
`plane of the circumference of each hoop is substantially
`10 perpendicular to the longitudinal axis of the stent. Each hoop
`may comprise a substantially complete
`turn of the wire
`having a sinuous configuration; optionally, as each hoop is
`completed, the point of winding the wire may be displaced
`longitudinally with respect to the winding axis to fo 'rm the
`next hoop. When the next hoop is complete, the point of
`15 winding is moved further longitudinally with respect to the
`winding axis to the form the next succeeding hoop and so on.
`It will appreciated that an advantage of this novel arange-
`ment is that the planes of the hoops are not skewed with
`respect to the longitudinal axis of the stent; the longitudinal
`20 ends of the stent are "square"~ to said longitudinal axis, so
`that when the stent is caused or allowed to expand in situ
`there is substantially no twisting of the stent as it shortens in
`length. It will be appreciated that this represents a siguificant
`advantage, as in areas of stenosis or aneurysm it is desirable
`25 to minimize the movement of the stent within the blood
`vessel so as to reduce the potential trauma to the patient. A
`stunt of this configuration may be used, apart from the
`bifurcated embodiment otherwise
`taught herein, in any
`application which in stents generally have heretofor been
`30 used.
`Typically, the stents of this invention whether of the
`helical or perpendicular variety, also comprise a securing
`means for securing an apex of the sinuous wire in one hoop
`to a juxtaposed apex of a neighboring hoop so that each hoop
`3is supported by its neighbors. The securing means may
`comprise a loop element of a suture material, for example,
`to tie the juxtaposed apices together; the loop element may
`also comprise a loop formed of a thermoplastics material
`such, for example, as polypropylene. Alternatively,
`the
`securing means may be a bead formed of a thermoplastic
`40 material around juxtaposed apices. Also alternatively, the
`securing means may be a loop, ring, or staple formed of wire
`such as nitinol.
`The male engaging portion and female cooperating
`portion, of the first and second interengaging stents of this
`invention, may be formed separately from the remainder of
`the respective non-engaging portions of these stents and then
`the engaging and non-engaging portions secured to one
`another by securing means.
`In one embodiment of the present invention, the proximal
`50 and distal stunt portions of the bifurcated stent in accordance
`with the present invention may be formed separately; the
`distal end of the proximal stent portion may be secured to the
`wider proximal end of a first intermediate frustoconical stunt
`portion; the narrower distal end of the first intermediate
`55 frustoconical stent portion may be secured to the proximal
`end of the distal stent portion. The female cooperating
`portion of the bifurcated stent may be constituted by a
`second frustoconical stunt portion which is secured to the
`distal end of the proximal stent portion in juxtaposition with
`the first frustoconical portion.
`Alternatively the first and second frustoconical portions
`may be omitted; the proximal and distal stunt portions may
`be secured directly one to the other.
`The female cooperating portion may be constituted by a
`65 generally cylindrical stent portion secured to said proximal
`stent portion in transversely spaced relation to the distal
`portion.
`
`60
`
`45
`
`W.L. Gore & Associates, Inc.
`Exhibit 1008-32
`
`

`

`6,117,167
`
`25
`
`5
`Each of the first and second stents of the bifurcated form
`of the present invention may carry a tubular graft layer
`formed from a biocompatible fabric in juxtaposition with the
`stent; the combined stent and graft layer constituting an
`endoluminal prosthesis. 'Typically the graft layer may be 5
`it will be appreciated
`disposed externally of the stent;
`however that in some embodiments the graft layer may be
`disposed internally of the stent. In some embodiments the
`graft layer may be secured to the stent by loop elements
`such, for example, as loops of polypropylene. The biocom- l0
`patible fabric may be a polyester fabric or a polytetrafluo-
`roethylene fabric; typically said fabric may be woven or a
`warp knitted polyester fabric. In some embodiments the
`woven or a warp knitted fabric may be formed in a seamn-free
`bifurcated configuration as a sleeve for a bifurcated stent. 15
`In some embodiments the male engaging portion of the
`first stent and the female cooperating portion of the second
`stent may be left uncovered. Alternatively, the fabric graft
`layer may extend to the proximal extremity on the external
`surface of the male engaging portion, and may be folded 20
`over the distal extremity of the female engaging portion to
`form an inner sleeve; in use the external fabric of the male
`engaging portion may butt against the folded over portion of
`the fabric internally of the female cooperating portion to
`form a substantially blood right seal.
`The present invention in one aspect therefore includes a
`bifurcated endoluninal prosthesis comprising a bifurcated
`stent in accordance with the invention and a tubular graft
`layer.
`The first stent having the male engaging portion may also 30
`have a tubular graft layer. If r