`Predick et al .
`
`( 10 ) Patent No .: US 11,337,825 B2
`( 45 ) Date of Patent :
`May 24 , 2022
`
`US011337825B2
`
`( 54 ) STEERABLE IMPLANT ASSEMBLY
`( 71 ) Applicant : LIFE SPINE , INC . , Huntley , IL ( US )
`( 72 ) Inventors : Daniel P. Predick , West Lafayette , IN
`( US ) ; Madeline Wolters , Carol Stream ,
`IL ( US ) ; Michael S. Butler , St.
`Charles , IL ( US )
`( 73 ) Assignee : Life Spine , Inc. , Huntley , IL ( US )
`Subject to any disclaimer , the term of this
`( * ) Notice :
`patent is extended or adjusted under 35
`U.S.C. 154 ( b ) by 0 days .
`( 21 ) Appl . No .: 16 / 875,465
`May 15 , 2020
`( 22 ) Filed :
`( 65 )
`Prior Publication Data
`Nov. 18 , 2021
`US 2021/0353428 A1
`
`( 2006.01 )
`( 2006.01 )
`
`( 51 ) Int . CI .
`A61F 2/44
`A61F 2/30
`( 52 ) U.S. CI .
`A61F 2/4425 ( 2013.01 ) ; A61F 2002/3055
`CPC
`( 2013.01 ) ; A61F 2002/30578 ( 2013.01 ) ; A61F
`2002/443 ( 2013.01 )
`( 58 ) Field of Classification Search
`CPC . A61F 2/4425 , A61F 2002/443 ; A61F 2/4455
`See application file for complete search history .
`References Cited
`U.S. PATENT DOCUMENTS
`11/1974 Fischer
`3,846,846 A
`6,443,990 B1
`9/2002 Aebi et al .
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`8/2012 Hansell et al .
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`9/2013 Marino et al .
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`8/2015 Petersheim
`12/2015 Weiman
`12/2015 Weiman et al .
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`1/2017 Weiman
`( Continued )
`FOREIGN PATENT DOCUMENTS
`
`GB
`WO
`
`0 284 462 A
`WO - 2014 / 134590 A1
`
`2/1928
`9/2014
`
`OTHER PUBLICATIONS
`International Search Report and Written Opinion in PCT / US2021 /
`031596 dated Sep. 28 , 2021 ( 12 pages ) .
`Primary Examiner — Matthew J Lawson
`( 74 ) Attorney , Agent , or Firm - Foley & Lardner LLP
`( 57 )
`ABSTRACT
`A steerable expandable implant including a base member , an
`adjustable member coupled to the base member , the adjust
`able member movable between a collapsed position and an
`expanded position , a pivot member rotatably received by the
`base member and configured to receive a tool such that the
`tool and the pivot member are rotatable relative to the base
`member between a first position and a second position ,
`wherein the pivot member is translationally fixed relative to
`the base member , and a first control member received by the
`a
`base member , wherein manipulation of the first control
`member causes the adjustable member to move between the
`collapsed position and the expanded position .
`16 Claims , 20 Drawing Sheets
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`520
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`522
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`543
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`540
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`543
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`-522
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`620
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`502
`602
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`644
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`652
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`604
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`504
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`Globus Medical, Inc. Exhibit 2008, Page 1 of 33
`Life Spine, Inc. v. Globus Medical, Inc.
`IPR2022-01602
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`US 11,337,825 B2
`Page 2
`
`A61F 2/4465
`A61F 2/4425
`
`( 56 )
`
`References Cited
`U.S. PATENT DOCUMENTS
`4/2017 Taylor et al .
`9/2017 Weiman
`10/2017 Weiman et al .
`5/2018 Weiman
`6/2018 Weiman et al .
`9/2018 Taylor et al .
`11/2019 Foley et al .
`9/2020 Weiman et al .
`12/2020 Weiman
`12/2020 Weiman et al .
`6/2008 Gately et al .
`7/2011 Gately
`8/2011 Yedlicka et al .
`1/2012 Spann
`2/2012 Spann
`2/2016 Weiman et al .
`12/2017 Weiman
`2/2018 Weiman et al .
`8/2018 Foley
`11/2018 Weiman et al .
`1/2021 . Weiman
`
`9,622,879 B2
`9,770,343 B2
`9,782,265 B2
`9,968,462 B2
`10,004,607 B2
`10,064,742 B2
`10,470,894 B2
`10,765,528 B2
`10,874,522 B2
`10,874,523 B2
`2008/0140085 Al
`2011/0166654 A1
`2011/0196494 A1
`2012/0010717 Al
`2012/0035730 A1
`2016/0051377 A1
`2017/0348116 A1
`2018/0049885 Al
`2018/0243107 A1 *
`2018/0325693 A1
`2021/0015627 A1 *
`* cited by examiner
`
`Globus Medical, Inc. Exhibit 2008, Page 2 of 33
`Life Spine, Inc. v. Globus Medical, Inc.
`IPR2022-01602
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`U.S. Patent
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`May 24 , 2022
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`Sheet 1 of 20
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`US 11,337,825 B2
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`100
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`120
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`140
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`120
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`200
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`202
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`130
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`FIG . 1
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`100
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`200
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`-202 102
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`a
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`104
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`FIG . 2
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`Globus Medical, Inc. Exhibit 2008, Page 3 of 33
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`IPR2022-01602
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`U.S. Patent
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`May 24 , 2022
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`Sheet 2 of 20
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`US 11,337,825 B2
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`100
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`120
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`140
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`120
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`122
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`Globus Medical, Inc. Exhibit 2008, Page 4 of 33
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`IPR2022-01602
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`U.S. Patent
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`May 24 , 2022
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`Sheet 3 of 20
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`US 11,337,825 B2
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`122
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`0
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`120
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`140
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`148
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`122
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`100
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`200
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`120
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`200
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`- 140
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`148
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`Globus Medical, Inc. Exhibit 2008, Page 5 of 33
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`May 24 , 2022
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`Sheet 4 of 20
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`US 11,337,825 B2
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`120
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`170
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`172
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`132
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`163
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`202
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`210
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`FIG . 7
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`Globus Medical, Inc. Exhibit 2008, Page 6 of 33
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`IPR2022-01602
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`U.S. Patent
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`May 24 , 2022
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`Sheet 5 of 20
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`US 11,337,825 B2
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`300
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`302
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`400 402
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`a
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`1
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`1
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`304
`
`FIG . 8
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`320
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`340
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`Globus Medical, Inc. Exhibit 2008, Page 7 of 33
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`IPR2022-01602
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`U.S. Patent
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`May 24 , 2022
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`Sheet 6 of 20
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`US 11,337,825 B2
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`300
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`302
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`1 1
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`3
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`400
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`330
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`304
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`FIG . 9
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`402
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`320
`
`340
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`Globus Medical, Inc. Exhibit 2008, Page 8 of 33
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`IPR2022-01602
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`U.S. Patent
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`May 24 , 2022
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`Sheet 7 of 20
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`US 11,337,825 B2
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`-330
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`402
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`400
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`340
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`FIG . 10
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`300
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`372
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`370
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`Globus Medical, Inc. Exhibit 2008, Page 9 of 33
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`IPR2022-01602
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`U.S. Patent
`300
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`May 24 , 2022
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`Sheet 8 of 20
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`US 11,337,825 B2
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`310
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`340
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`300
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`FIG . 11
`
`310
`
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`
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`
`Globus Medical, Inc. Exhibit 2008, Page 10 of 33
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`IPR2022-01602
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`U.S. Patent
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`May 24 , 2022
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`Sheet 9 of 20
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`US 11,337,825 B2
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`370 322 372
`
`320
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`300
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`324 VTT 326
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`334
`336
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`330
`332
`
`FIG . 13
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`Globus Medical, Inc. Exhibit 2008, Page 11 of 33
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`IPR2022-01602
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`U.S. Patent
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`May 24 , 2022
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`Sheet 10 of 20
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`US 11,337,825 B2
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`500
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`520
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`522
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`543
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`540
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`
`Globus Medical, Inc. Exhibit 2008, Page 12 of 33
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`IPR2022-01602
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`U.S. Patent
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`May 24 , 2022
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`Sheet 11 of 20
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`US 11,337,825 B2
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`500
`
`644
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`646
`
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`610
`
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`
`FIG . 16
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`FIG . 17
`
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`
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`
`Globus Medical, Inc. Exhibit 2008, Page 13 of 33
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`IPR2022-01602
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`U.S. Patent
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`May 24 , 2022
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`Sheet 12 of 20
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`US 11,337,825 B2
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`500
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`520
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`534
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`572
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`570
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`644
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`
`FIG . 19
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`Globus Medical, Inc. Exhibit 2008, Page 14 of 33
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`May 24 , 2022
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`Sheet 13 of 20
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`US 11,337,825 B2
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`526
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`U.S. Patent
`500
`
`524
`520
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`FIG . 21
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`
`Globus Medical, Inc. Exhibit 2008, Page 15 of 33
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`U.S. Patent
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`May 24 , 2022
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`Sheet 14 of 20
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`US 11,337,825 B2
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`516
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`620
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`Globus Medical, Inc. Exhibit 2008, Page 16 of 33
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`IPR2022-01602
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`U.S. Patent
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`May 24 , 2022
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`Sheet 15 of 20
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`US 11,337,825 B2
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`880
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`823
`822
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`Globus Medical, Inc. Exhibit 2008, Page 17 of 33
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`U.S. Patent
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`May 24 , 2022
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`Sheet 16 of 20
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`US 11,337,825 B2
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`-823
`825
`827
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`FIG . 27
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`706
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`704
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`Globus Medical, Inc. Exhibit 2008, Page 18 of 33
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`U.S. Patent
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`May 24 , 2022
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`Sheet 17 of 20
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`US 11,337,825 B2
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`500
`
`500
`
`700
`
`-724
`
`722
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`720
`
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`
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`
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`
`Globus Medical, Inc. Exhibit 2008, Page 19 of 33
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`U.S. Patent
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`May 24 , 2022
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`Sheet 18 of 20
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`US 11,337,825 B2
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`500
`
`700
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`610
`
`-722
`
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`
`FIG . 30
`
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`
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`
`FIG . 31
`
`-722
`
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`
`700
`
`Globus Medical, Inc. Exhibit 2008, Page 20 of 33
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`U.S. Patent
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`May 24 , 2022
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`Sheet 19 of 20
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`US 11,337,825 B2
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`-500
`
`-722
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`720
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`700
`
`700
`
`FIG . 32
`
`708
`
`FIG . 33
`
`500
`
`520
`
`540
`
`Globus Medical, Inc. Exhibit 2008, Page 21 of 33
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`U.S. Patent
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`May 24 , 2022
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`Sheet 20 of 20
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`US 11,337,825 B2
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`500
`520
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`701
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`700
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`540
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`732
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`730
`
`734
`
`FIG . 34
`
`1401 -
`
`1400
`Couple a tool to a pivot member of an implant
`1410
`
`Insert the implant in a first position
`a
`
`1420
`Operate the tool to pivot the pivot member
`1430
`Manipulate the implant via the tool to a location
`a
`1440
`Operate a first control member of the implant to
`expand an adjustable member of the implant
`from a collapsed position to an expanded position
`
`FIG . 35
`
`Globus Medical, Inc. Exhibit 2008, Page 22 of 33
`Life Spine, Inc. v. Globus Medical, Inc.
`IPR2022-01602
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`a
`
`a
`
`a
`
`1
`STEERABLE IMPLANT ASSEMBLY
`
`US 11,337,825 B2
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`2
`Another embodiment relates to a steerable expandable
`implant including a base member , one or more adjustable
`members coupled to the base member , the adjustable mem
`BACKGROUND
`ber movable between a collapsed position and an expanded
`The present disclosure relates to expandable implants and 5 position , a first control member translationally coupled and
`pivotally fixed relative to the base member , and a second
`devices , including spinal interbody and intravertebral body
`devices , and vertebral interbody and intravertebral devices
`control member slidably coupled to the first control member
`that are expandable after spinal placement thereof .
`and the adjustable member , wherein an axis of the second
`Fusion cages , as well as other types of implants , bodies
`control member is offset relative to an axis of the first control
`and / or devices , are frequently utilized in spinal surgery 10 member , wherein manipulation of the first control member
`inside a vertebra ( intravertebral ) and / or between vertebrae of
`causes at least one of the adjustable member to move
`a patient ( interbody ) , or adjacent other bone bodies . With
`between the collapsed position and the expanded position .
`interbody devices , one or more such spinal bodies are placed
`In some embodiments , the steerable expandable implant
`between vertebrae to provide support and promote fusion
`further comprises an adjustment member threadingly
`between adjacent vertebrae where such is necessary due to 15 coupled to the first control member , wherein rotation of the
`disease , injury , general deterioration or congenital problems .
`adjustment member causes movement of the first control
`With intravertebral devices , one or more spinal bodies are
`member . In some embodiments , the steerable expandable
`placed within a vertebra . Spinal devices , such as fusion
`implant further comprises a pivot member pivotally received
`cages and / or the like , are inserted into a spinal space either
`by the base member and configured to receive tool such
`anteriorly , posteriorly , laterally or posteriolaterally .
`20 that the tool and the pivot member are pivotable relative to
`the base member . In some embodiments , the base member
`further includes an alignment portion configured to receive
`SUMMARY
`an alignment member of the tool to align the tool to the base
`One embodiment relates to a steerable expandable
`member . In some embodiments , a top surface of a first
`implant including a base member , an adjustable member 25 adjustable member and one of a bottom surface of the base
`coupled to the base member , the adjustable member mov-
`member or a bottom surface of a second adjustable member
`able between a collapsed position and an expanded position ,
`define a height of the steerable expandable implant . In some
`a pivot member rotatably received by the base member and
`embodiments , the first control member includes a first guide
`configured to receive a tool such that the tool and the pivot
`extending into the base member and configured to limit a
`member are rotatable relative to the base member between 30 range of motion of the first control member , and wherein the
`a first position and a second position , wherein the pivot
`second control member includes a second guide extending
`member is translationally fixed relative to the base member ,
`into the base member and configured to limit a range of
`and a first control member received by the base member ,
`motion of the second control member . In some embodi
`wherein manipulation of the first control member causes the
`ments , the second control member includes a control portion
`adjustable member to move between the collapsed position 35 configured to slidably align the second control member with
`and the expanded position .
`the base member .
`In some embodiments , the steerable expandable implant
`Another embodiment relates to a method of positioning a
`further includes a second control member coupled to the first
`spinal implant including coupling a tool to an implant ,
`control member , wherein the pivot member includes a bore
`manipulating the tool to move the implant to a desired
`extending therethrough and defining a first axis , wherein a 40 location , rotating the tool relative to a base member of the
`second axis of the second control member is aligned with the
`implant , coupling a control member of the tool to a first
`first axis of the pivot member when the pivot member is in
`control member of the implant , and operating the control
`the first position . In some embodiments , the first axis of the
`member of the tool to change a height of the implant .
`pivot member at the second position is at an angle to the
`In some embodiments , rotating the tool relative to the
`second axis of the second control member when the pivot 45 base member includes rotating the tool until the control
`member is in the second position . In some embodiments , the
`member of the tool is axially aligned with the first control
`base member further includes an alignment portion config-
`member . In some embodiments , operating the control mem
`ured to receive an alignment member of the tool to position
`ber includes rotating the control member of the tool to cause
`the tool relative to the base member in the first and second
`translation of the first control member . In some embodi
`positions , and wherein the base member includes an align- 50 ments , translation of the first control member causes trans
`ment protrusion configured to slidably engage an alignment
`lation of a second control member slidably coupled to an
`track of the second control member and align the second
`adjustable member of the implant . In some embodiments ,
`control member to the base member . In some embodiments ,
`the second control member includes at least one control
`an axis of the tool is parallel to an axis of the steerable
`portion slideably coupled to the adjustable member and
`expandable implant when the pivot member is in the first 55 configured to cause the adjustable member to move relative
`position . In some embodiments , a top surface of a first
`to the base member responsive to translation of the second
`adjustable and a bottom surface of the base member define
`control member .
`a height of the steerable expandable implant and are con
`figured to engage adjacent portions of bone . In some
`embodiments , translation of the first control member 60
`changes a height of the steerable expandable implant . In
`some embodiments , a top surface of a first adjustable
`member and a bottom surface of a second adjustable mem-
`ber define a height of the steerable expandable implant and
`are configured to engage adjacent portions of bone , and 65
`wherein translation of the first control member changes a
`height of the steerable expandable implant .
`
`BRIEF DESCRIPTION
`The foregoing and other features of the present invention
`will become more apparent to one skilled in the art upon also
`reading the following description of embodiments with
`reference to the accompanying drawings .
`FIG . 1 is a perspective view of a steerable expandable
`implant in a first configuration , according to one embodi
`ment .
`
`Globus Medical, Inc. Exhibit 2008, Page 23 of 33
`Life Spine, Inc. v. Globus Medical, Inc.
`IPR2022-01602
`
`
`
`US 11,337,825 B2
`
`a
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`5
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`10
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`15
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`3
`4
`FIG . 28 is a perspective view of the tool of FIG . 27
`FIG . 2 is a top view of the steerable expandable implant
`aligning to an implant in a first configuration , according to
`of FIG . 1 , according to one embodiment .
`one embodiment .
`FIG . 3 is a perspective view of the steerable expandable
`FIG . 29 is a perspective view of the tool of FIG . 27
`implant of FIG . 1 in a second configuration , according to one
`a
`coupled to an implant in a first configuration , according to
`embodiment .
`one embodiment .
`FIG . 4 is a top view of the steerable expandable implant
`FIG . 30 is a perspective view of the tool of FIG . 27
`of FIG . 1 in the second configuration , according to one
`manipulating an implant , according to one embodiment .
`embodiment .
`FIG . 31 is a perspective view of the tool of FIG . 27
`FIG . 5 is a perspective view of the steerable expandable
`coupled to an implant in a second configuration , according
`implant of FIG . 1 in an expanded position , according to one
`to one embodiment .
`embodiment .
`FIG . 32 is a perspective view of the tool of FIG . 27
`FIG . 6 is another perspective view of the steerable
`aligning to an implant in a second configuration , according
`expandable implant of FIG . 1 in an expanded configuration ,
`according to one embodiment .
`to one embodiment .
`FIG . 33 is a perspective view of the tool of FIG . 27
`FIG . 7 is an exploded view of the steerable expandable
`coupled to an implant in a collapsed position , according to
`implant of FIG . 1 , according to one embodiment .
`one embodiment .
`FIG . 8 is a perspective view of a steerable expandable
`FIG . 34 is a perspective view of the tool of FIG . 27
`implant in a first configuration , according to another
`20 coupled to an implant in an expanded position , according to
`embodiment .
`one embodiment .
`FIG . 9 is a perspective view of the steerable expandable
`FIG . 35 is a flow chart of a process for positioning an
`implant of FIG . 8 in a second configuration , according to one
`implant , according to one embodiment .
`embodiment .
`Corresponding reference characters indicate correspond
`FIG . 10 is a perspective view of the steerable expandable
`implant of FIG . 8 in an expanded position , according to one 25 ing parts throughout the several views . Although the draw
`ings represent embodiments of the disclosure , the drawings
`embodiment .
`are not necessarily to scale and certain features may be
`FIG . 11 is an internal view of a control shaft in a first
`a
`exaggerated in order to better illustrate and explain the
`position usable with the implants disclosed herein , accord-
`ing to one embodiment .
`principles of the present disclosure . The exemplifications set
`FIG . 12 is an internal view of a control shaft in a second 30 out herein illustrate several embodiments , but the exempli
`position usable with the implants disclosed herein , accord-
`fications are not to be construed as limiting the scope of the
`ing to one embodiment .
`disclosure in any manner .
`FIG . 13 is an exploded view of the steerable expandable
`implant of FIG . 8 , according to one embodiment .
`DETAILED DESCRIPTION
`FIG . 14 is a perspective view of a steerable expandable 35
`implant , according to another embodiment .
`The present disclosure relates to steerable and expandable
`FIG . 15 is a bottom view of the steerable expandable
`and / or dynamic implants , including , but not limited to ,
`interbody ( between adjacent vertebrae ) , intravertebral - body
`implant of FIG . 15 , according to one embodiment .
`FIG . 16 is a right view of the steerable expandable
`( inside the vertebrae ) and / or spinal stabilization devices that
`implant of FIG . 15 , according to one embodiment .
`40 may or may not be used as interbody fusion cages or devices ,
`FIG . 17 is a left perspective view of the steerable expand-
`interbody / intravertebral bodies / body stabilization devices
`able implant of FIG . 15 , according to one embodiment .
`and / or the like ( e.g. , spinal device ( s ) ) for providing support ,
`FIG . 18 is a left perspective view of the steerable expand-
`stabilization and / or promoting bone growth between or
`able implant of FIG . 15 in an expanded position , according
`inside vertebrae or other portions of bone that have been
`45 destabilized or otherwise due to injury , illness and / or the
`to one embodiment .
`FIG . 19 is a right perspective view of the steerable
`like . Particularly , the present disclosure provides various
`expandable implant of FIG . 15 in the expanded position ,
`versions of dynamic ( steerable and expandable / retractable )
`interbody / intravertebral body devices that are usable in a
`according to one embodiment .
`FIG . 20 is a front view of the steerable expandable
`spinal column or other areas of a human .
`implant of FIG . 15 in the expanded position , according to 50
`Spinal interbody and intravertebral devices may be diffi
`cult to position . That is , a compact orientation , conducive to
`one embodiment .
`FIG . 21 is an exploded view of the steerable expandable
`insertion , may be inconvenient to maneuver into a final
`implant of FIG . 15 , according to one embodiment .
`position . Such spinal interbody and intravertebral devices
`FIG . 22 is a perspective view of a control shaft in a first
`lack the ability to change an orientation once inserted . This
`position usable with the implants disclosed herein , accord- 55 poses various problems with their use and / or implantation .
`Particularly , statically oriented spinal devices require com
`ing to one embodiment .
`FIG . 23 is a perspective view of a control shaft in a second
`plex positioning instruments or techniques to properly posi
`position usable with the implant disclosed herein , according
`tion the device and bridge the gap between adjacent verte
`brae . These instruments and techniques do not lend
`to one embodiment .
`FIG . 24 is a cutaway view of a steerable expandable 60 themselves to microsurgery , arthroscopic surgery or the like .
`implant , according to another embodiment .
`Expandable interbody devices allow the device to be
`FIG . 25 is an exploded view of the steerable expandable
`initially smaller than traditional non - expandable ( static )
`interbody devices such that expandable interbody devices
`implant of FIG . 24 , according to one embodiment .
`FIG . 26 is another exploded view of the steerable expand-
`may be more easily inserted or implanted into the vertebral
`able implant of FIG . 24 , according to one embodiment .
`65 space . Moreover , expandable devices allow the surgeon to
`FIG . 27 is a perspective view of a tool for positioning an
`set the amount of expansion necessary for the particular
`patient rather than the static device dictating the spacing .
`implant , according to one embodiment .
`
`a
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`a
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`a
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`Globus Medical, Inc. Exhibit 2008, Page 24 of 33
`Life Spine, Inc. v. Globus Medical, Inc.
`IPR2022-01602
`
`
`
`US 11,337,825 B2
`
`a
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`a
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`5
`6
`126 include pin slots 125 and 127. Pin slots 125 and 127 may
`Various embodiments disclosed herein are directed to
`receive a pin inserted into apertures 143 to limit expansion
`steerable expandable implants that are implantable between
`and / or contraction of adjustable member 120. For example ,
`adjacent bodies of bone . For example , the implant may be
`pin slots 125 and 127 may facilitate expansion of adjustable
`implanted or inserted into a human spine adjacent upper and
`lower vertebrae of the spine . According to various exem- 5 member 120 such that adjustable member 120 cannot
`plary embodiments , the components of the implants dis-
`decouple from base member 140. Base member 140 and
`closed herein may be made of any suitable material ( s ) ,
`adjustable member 120 are shown to include surface pat
`including a variety of metals , plastics , composites , or other
`terns 122 and 148 respectively . Surface patterns 122 and 148
`suitable bio - compatible materials . In some embodiments ,
`are configured to promote bonding to an adjacent surface
`one or more components of the implants disclosed herein 10 ( e.g. , a portion of bone ) and prevent slippage of implant 100 .
`may be made of the same material , while in other embodi-
`In some embodiments , surface patterns 122 and 148 are
`ments , different materials may be used for different compo-
`patterned ridges .
`nents of the various implants .
`Implant 100 includes control member 200 coupled to an
`Referring now to FIG . 1-7 , steerable expandable implant
`end of base member 140 and usable to manipulate implant
`100 is shown , according to an exemplary embodiment . 15 100 into a location on the patient . Control member 200 may
`a
`Implant 100 is usable , for example , between and / or within
`rotate about the end of base member 140 between a first
`vertebral bodies of the spine , and may share many of the
`position 102 ( shown in FIG . 2 ) and a second position 104
`features of the other inter / intra - body implants discussed
`( shown in FIG . 4 ) . First position 102 may reduce the
`elsewhere herein . It should be understood that implant 100
`cross - sectional footprint of implant 100 for implantation ,
`may , in some embodiments , be usable in other portions of 20 allowing for smaller opening incisions and less invasive
`the body in addition to the spine , and all such applications
`surgery techniques . Second position 104 may facilitate posi
`are to be understood to be within the scope of the present
`tioning implant 100 to align with the intended implantation
`location , thereby allowing for less reorientation of implant
`disclosure .
`Implant 100 may be inserted into a patient while in a first
`100 and a more straightforward implantation . Control mem
`orientation . Once inserted , an appropriate tool may be used 25 ber 200 may include manipulation connector 202 to connect
`to engage a portion of the implant 100 to reorient the implant
`a tool for manipulation of implant 100 during implantation .
`100 into a second orientation . Implant 100 may be posi-
`In some embodiments , manipulation connector 202 is a male
`tioned within a desired space ( e.g. , between adjacent por-
`screw thread to receive a female mating thread . Implant 100
`tions of bone ) while in a first , collapsed position . An
`may include first control shaft 130 received by base member
`appropriate tool may be used to engage a portion of implant 30 140. First control shaft 130 may be used to expand implant
`100 to manipulate implant 100 into a desired position . Once
`100. For example , a user may use a tool to manipulate ( e.g. ,
`in a desired position , the same or a subsequent tool may be
`rotate , etc. ) first control shaft 130 thereby causing expansion
`utilized to engage a portion of implant 100 to expand
`of implant 100. In various embodi ats , an axis of first
`implant 100 to a desired degree of expansion . It should be
`control shaft 130 aligns with an axis of control member 200
`understood that based on a particular application , implant 35 in the second position 104. Control member 200 may
`100 may be utilized in a fully collapsed position , a fully
`include an opening to facilitate access to first control shaft
`expanded position , or any intermediate position therebe-
`130 while control member 200 is in the second position 104 .
`tween . Once implant 100 is properly positioned and
`Referring now specifically to FIG . 7 , first control shaft
`expanded to a desired height , bone graft material may be
`130 may include or be coupled to connector 132 to receive
`delivered by way of an access aperture and placed into a 40 a tool or other manipulation accessory . In some embodi
`central cavity of implant 100. The various apertures in and
`ments , connector 132 is a screw drive ( e.g. , Philips , Hex ,
`through implant 100 may facilitate the growth of bone
`Slot , etc. ) . In various embodiments , implant 100 includes a
`material in and around implant 100 to further stabilize
`second control shaft 110 positioned between base member
`implant 100 .
`140 and adjustable member 120. Second control shaft 110
`Referring again to FIGS . 1-7 , according to an exemplary 45 may facilitate adjustment of the adjustable member 120 by
`embodiment , implant 100 includes base member 140 and
`transferring a force from a user to the adjustable member
`adjustable member 120 adjustably coupled to the base
`120. In some embodiments , a user operates a different
`member 140. In various embodiments , base member 140
`member ( e.g. , first control shaft 130 ) which transfers the
`includes alignment channels 144 and 146 to receive align-
`operational force to second control shaft 110. First control
`ment portions 124 and 126. Alignment channels 144 and 146 50 shaft 130 may include engagement portion 134 configured to
`and alignment portions 124 and 126 may align adjustable
`couple to contact 118 of second control shaft 110 and
`member 120 to base member 140. For example , the align-
`facilitate force transfer thereto . In some embodiments ,
`ment features ( e.g. , alignment channels 144 and 146 and / or
`engagement portion 134 is a geared portion to engage a
`alignment portions 124 and 126 ) may facilitate alignment of
`corresponding geared portion of second control shaft 110. In
`adjustable member 120 to base member 140 during expan- 55 various embodiments , second control shaft 110 and first
`sion of implant 100. The alignment features may couple to
`control shaft 130 have different axes of rotation ( i.e. , are at
`one another and allow for vertical ( e.g. , up and down ,
`an angle to one another ) . For example , first control shaft 130
`expansive and contractive , etc. ) movement of base member
`may have a first axis that is conducive to manipulation by a
`140 and adjustable member 120. In some embodiments , the
`user during implantation , while second control shaft 110
`alignment features have a relatively close fit to facilitate 60 may have a second axis that facilitates adjustment of adjust
`alignment between adjustable member 120 and base mem-
`able member 120. In some embodiments , second control
`ber 140 , while in other embodiments , the alignment features
`shaft 110 includes one or more threaded portions 114 and
`have a relatively loose fit to facilitate a desired angular offset
`116. In some embodiments , implant 100 includes adjustment
`a
`between adjustable member 120 and base member 140. In
`members 160 and 162 that may couple to second control
`some embodiments , alignment channels 144 and 146 and 65 shaft 110. Adjustment members 160 and 162 are shown to
`alignment portions 124 and 126 form a tongue and groove
`include threaded portions 161 and 163 respectively .
`joint . In various embodiments , alignment portions 124 and
`Threaded portions 161 and 163 may correspond to the
`
`a
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`a
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`Globus Medical, Inc. Exhibit 2008, Page 25 of 33
`Life Spine, Inc. v. Globus Medical, Inc.
`IPR2022-01602
`
`
`
`US 11,337,825 B2
`
`a
`
`7
`8
`the amount of manual manipulation a