`Case 1:21-cv-01445-CFC Document 1-1 Filed 10/13/21 Page 1 of 412 PagelD #: 25
`
`EXHIBIT
`EXHIBIT
`A
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`
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`Case 1:21-cv-01445-CFC Document 1-1 Filed 10/13/21 Page 2 of 412 PageID #: 26
`eS SSTTTTATTAATTA
`
`US008845731B2
`
`US 8,845,731 B2
`(10) Patent No.:
`a2) United States Patent
`Weiman
`(45) Date of Patent:
`Sep. 30, 2014
`
`
`(54) EXPANDABLE FUSION DEVICE AND
`METHOD OF INSTALLATION THEREOF
`:
`.
`Inventor: Mark Weiman, Coatesville, PA (US)
`(75)
`(73) Assignee: as) Medical, Inc., Audubon, PA
`
`(*) Notice:
`
`Subject to any disclaimer, the term ofthis
`patent is extended or adjusted under 35
`U.S.C. 154(b) by 118 days.
`
`(21) Appl. No.: 12/875,637
`tad.
`Filed:
`
`(22)
`(65)
`
`(S51)
`
`(2006.01)
`(2006.01)
`(2006.01)
`(2006.01)
`
`Sep. 3, 2010
`Prior Publication Data
`US 2012/0059470 Al
`Mar. 8, 2012
`Int. Cl.
`AOLF 2/44
`A6LF 2/28
`AGLF 2/30
`AOLF 2/46
`(52) U.S. Cl.
`CPC oo. AG6ILF 2/447 (2013.01); A6LF 2002/2817
`(2013.01); A6LF 2002/30828 (2013.01); AOIF
`2002/4475 (2013.01); AGLF 2002/30415
`(2013.01); AGLF 2310/00023 (2013.01); A6IF
`2002/30405 (2013.01); A61F 2002/30411
`(2013.01); A6LF 2002/30517 (2013.01); AOIF
`2002/30904 (2013.01); A6IF 2/4465 (2013.01):
`AGIF 2002/30556 (2013.01); AGLF 2310/00011
`(2013.01); A61F 2310/0017 (2013.01); AGIF
`2002/30484 (2013.01); AGIF 2002/30843
`(2013.01); AOLF 2/4611 (2013.01); ASIF
`2002/30579 (2013.01); A61F 2002/30601
`(2013.01); A6LF 2002/30523 (2013.01); AOIF
`2002/2835 (2013.01); AGIF 2/442 (2013.01);
`AGIF 2002/30266 (2013.01); ALF 2002/30482
`(2013.01); A6LF 2310/00179 (2013.01); AOIF
`2002/30522 (2013.01); A61F 2002/30841
`(2013.01); A61F 2002/3056 (2013.01); AGIF
`2002/30387 (2013.01); A61F 2002/30471
`(2013.01)
`
`USPC cecceecceeccssteeseteteteeseenseneees 623/17.15; 623/17.11
`(58) Field of Classification Search
`USPC weeeeeesecteeeees 623/17.11-17.16; 606/246—249
`See applicationfile for complete search history.
`References Cited
`
`(56)
`
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`WO
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`FOREIGN PATENT DOCUMENTS
`2006045094 A2
`10/2005
`2006113080 A2
`10/2006
`2008044057 Al
`10/2007
`
`Primary Examiner — Jan Christopher Merene
`
`(57)
`
`ABSTRACT
`
`The present invention provides an expandable fusion device
`capable of being installed inside an intervertebral disc space
`to maintain normal disc spacing and restore spinalstability,
`thereby facilitating an intervertebral fusion. In one embodi-
`ment, the fusion device includes a central ramp, a first end-
`plate, and a second endplate, the central ramp capable of
`being movedin a first direction to move the first and second
`endplates outwardly and into an expanded configuration. The
`fusion device is capable of being deployed down an endo-
`scopic tube.
`
`15 Claims, 29 Drawing Sheets
`
`
`2 ER
`
`.
`
`
`316
`306
`Se
`
`
`
`ra A a
`
`Nou
`
`N10
`
`
`
`Case 1:21-cv-01445-CFC Document 1-1 Filed 10/13/21 Page 3 of 412 PageID #: 27
`Page 3 of 412 PagelD #: 27
`Case 1:21-cv-01445-CFC Document 1-1 Filed 10/13/21
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`US 8,845,731 B2
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`Page 2
`
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`Case 1:21-cv-01445-CFC Document 1-1 Filed 10/13/21 Page 4 of 412 PageID #: 28
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`Sep. 30, 2014
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`U.S. Patent
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`Case 1:21-cv-01445-CFC Document 1-1 Filed 10/13/21 Page 14 of 412 PageID #: 38
`Case 1:21-cv-01445-CFC Document 1-1 Filed 10/13/21 Page 14 of 412 PagelD #: 38
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`U.S. Patent
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`Sep. 30, 2014
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`Sheet 11 of 29
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`Case 1:21-cv-01445-CFC Document 1-1 Filed 10/13/21 Page 15 of 412 PageID #: 39
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`U.S. Patent
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`Sep. 30, 2014
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`Case 1:21-cv-01445-CFC Document 1-1 Filed 10/13/21 Page 16 of 412 PageID #: 40
`Case 1:21-cv-01445-CFC Document 1-1 Filed 10/13/21 Page 16 of 412 PagelD #: 40
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`U.S. Patent
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`Sep. 30, 2014
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`Sheet 13 of 29
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`Case 1:21-cv-01445-CFC Document 1-1 Filed 10/13/21 Page 17 of 412 PageID #: 41
`Case 1:21-cv-01445-CFC Document 1-1 Filed 10/13/21 Page 17 of 412 PagelD #: 41
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`U.S. Patent
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`Sep. 30, 2014
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`Case 1:21-cv-01445-CFC Document 1-1 Filed 10/13/21 Page 18 of 412 PageID #: 42
`Case 1:21-cv-01445-CFC Document 1-1 Filed 10/13/21 Page 18 of 412 PagelD #: 42
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`U.S. Patent
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`Sep. 30, 2014
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`U.S. Patent
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`Sep. 30, 2014
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`U.S. Patent
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`Sep. 30, 2014
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`Case 1:21-cv-01445-CFC Document 1-1 Filed 10/13/21 Page 21 of 412 PageID #: 45
`Case 1:21-cv-01445-CFC Document 1-1 Filed 10/13/21 Page 21 of 412 PagelD #: 45
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`U.S. Patent
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`Sep. 30, 2014
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`Sheet 18 of 29
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`US 8,845,731 B2
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`Case 1:21-cv-01445-CFC Document 1-1 Filed 10/13/21 Page 22 of 412 PageID #: 46
`Case 1:21-cv-01445-CFC Document 1-1 Filed 10/13/21 Page 22 of 412 PagelD #: 46
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`U.S. Patent
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`Sep. 30, 2014
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`Sheet 19 of 29
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`US 8,845,731 B2
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`Case 1:21-cv-01445-CFC Document 1-1 Filed 10/13/21 Page 23 of 412 PageID #: 47
`Case 1:21-cv-01445-CFC Document 1-1 Filed 10/13/21 Page 23 of 412 PagelD #: 47
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`U.S. Patent
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`Sep. 30, 2014
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`Sheet 20 of 29
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`US 8,845,731 B2
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`Case 1:21-cv-01445-CFC Document 1-1 Filed 10/13/21 Page 24 of 412 PageID #: 48
`Case 1:21-cv-01445-CFC Document 1-1 Filed 10/13/21 Page 24 of 412 PagelD #: 48
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`U.S. Patent
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`Sep. 30, 2014
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`Sheet 21 of 29
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`Case 1:21-cv-01445-CFC Document 1-1 Filed 10/13/21 Page 25 of 412 PageID #: 49
`Case 1:21-cv-01445-CFC Document 1-1 Filed 10/13/21 Page 25 of 412 PagelD #: 49
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`U.S. Patent
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`Sep. 30, 2014
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`Sheet 22 of 29
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`US 8,845,731 B2
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`Case 1:21-cv-01445-CFC Document 1-1 Filed 10/13/21 Page 26 of 412 PageID #: 50
`Case 1:21-cv-01445-CFC Document 1-1 Filed 10/13/21 Page 26 of 412 PagelD #: 50
`
`U.S. Patent
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`Sep. 30, 2014
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`Sheet 23 of 29
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`US 8,845,731 B2
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`Case 1:21-cv-01445-CFC Document 1-1 Filed 10/13/21 Page 27 of 412 PageID #: 51
`Case 1:21-cv-01445-CFC Document 1-1 Filed 10/13/21 Page 27 of 412 PagelD #: 51
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`U.S. Patent
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`Sep. 30, 2014
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`Sheet 24 of 29
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`Case 1:21-cv-01445-CFC Document 1-1 Filed 10/13/21 Page 28 of 412 PageID #: 52
`Case 1:21-cv-01445-CFC Document 1-1 Filed 10/13/21 Page 28 of 412 PagelD #: 52
`
`U.S. Patent
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`Sep. 30, 2014
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`Sheet 25 of 29
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`US 8,845,731 B2
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`Case 1:21-cv-01445-CFC Document 1-1 Filed 10/13/21 Page 29 of 412 PageID #: 53
`Case 1:21-cv-01445-CFC Document 1-1 Filed 10/13/21 Page 29 of 412 PagelD #: 53
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`U.S. Patent
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`Sep. 30, 2014
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`Sheet 26 of 29
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`Case 1:21-cv-01445-CFC Document 1-1 Filed 10/13/21 Page 30 of 412 PageID #: 54
`Case 1:21-cv-01445-CFC Document 1-1 Filed 10/13/21 Page 30 of 412 PagelD #: 54
`
`U.S. Patent
`
`Sep. 30, 2014
`
`US 8,845,731 B2
`
`Sheet 27 of 29
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`Case 1:21-cv-01445-CFC Document 1-1 Filed 10/13/21 Page 31 of 412 PageID #: 55
`Case 1:21-cv-01445-CFC Document 1-1 Filed 10/13/21 Page 31 of 412 PagelD #: 55
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`U.S. Patent
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`Sep. 30, 2014
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`Sheet 28 of 29
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`US 8,845,731 B2
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`Case 1:21-cv-01445-CFC Document 1-1 Filed 10/13/21 Page 32 of 412 PageID #: 56
`Case 1:21-cv-01445-CFC Document 1-1 Filed 10/13/21 Page 32 of 412 PagelD #: 56
`
`U.S. Patent
`
`Sep. 30, 2014
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`Sheet 29 of 29
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`US 8,845,731 B2
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`Case 1:21-cv-01445-CFC Document 1-1 Filed 10/13/21 Page 33 of 412 PageID #: 57
`Case 1:21-cv-01445-CFC Document 1-1 Filed 10/13/21 Page 33 of 412 PagelD #: 57
`
`US 8,845,731 B2
`
`1
`EXPANDABLE FUSION DEVICE AND
`METHOD OF INSTALLATION THEREOF
`
`FIELD OF THE INVENTION
`
`The present invention relates to the apparatus and method
`for promoting an intervertebral fusion, and more particularly
`relates to an expandable fusion device capable of being
`inserted between adjacent vertebrae to facilitate the fusion
`process.
`
`10
`
`BACKGROUND OF THE INVENTION
`
`A common procedure for handling pain associated with
`intervertebral discs that have become degenerated due to
`various factors such as traumaor aging is the use of interver-
`tebral fusion devices for fusing one or more adjacentvertebral
`bodies. Generally, to fuse the adjacent vertebral bodies, the
`intervertebral disc is first partially or fully removed. An inter-
`vertebral fusion device is then typically inserted between
`neighboring vertebrae to maintain normal disc spacing and
`restore spinal stability, thereby facilitating an intervertebral
`fusion.
`There are a number of known conventional fusion devices
`
`and methodologies in the art for accomplishing the interver-
`tebral fusion. These include screw and rod arrangements,
`solid bone implants, and fusion devices which include a cage
`or other implant mechanism which,typically, is packed with
`bone and/or bone growth inducing substances. These devices
`are implanted between adjacent vertebral bodies in order to
`fuse the vertebral bodies together, alleviating the associated
`pain.
`However, there are drawbacks associated with the known
`conventional
`fusion devices
`and methodologies. For
`example, present methods for installing a conventional fusion
`device often require that the adjacent vertebral bodies be
`distracted to restore a diseased disc space to its normal or
`healthy height prior to implantation of the fusion device. In
`order to maintain this height once the fusion device is
`inserted, the fusion device is usually dimensioned larger in
`height than the initial distraction height. This difference in
`height can makeit difficult for a surgeonto install the fusion
`device in the distracted intervertebral space.
`Assuch,there exists a need for a fusion device capable of
`being installed inside an intervertebral disc space at a mini-
`mum to no distraction height and for a fusion device that can
`maintain a normaldistance between adjacentvertebral bodies
`when implanted.
`
`SUMMARYOF THE INVENTION
`
`20
`
`30
`
`35
`
`40
`
`45
`
`50
`
`In an exemplary embodiment, the present invention pro-
`vides an expandable fusion device capable of being installed
`inside an intervertebral disc space to maintain normal disc
`spacing and restore spinal stability, thereby facilitating an
`intervertebral fusion. In one embodiment, the fusion device
`includes a central ramp, a first endplate, and a second end-
`plate. The central ramp may be capable of moving ina first
`direction to pushthefirst and second endplates outwardly and
`into an unexpanded configuration. The expandable fusion
`device may be capable of being placed into the disc space
`down an endoscopic tube and then expanded into an
`expandedconfiguration.
`Further areas of applicability of the present invention will
`become apparentfrom the detailed description provided here-
`inafter. It should be understoodthat the detailed description
`and specific examples, while indicating the preferred or
`
`2
`exemplary embodiments of the invention, are intended for
`purposesofillustration only andare not intendedto limit the
`scope ofthe invention.
`
`BRIEF DESCRIPTION OF THE DRAWINGS
`
`The present invention will become morefully understood
`from the detailed description and the accompanying draw-
`ings, wherein:
`FIG. 1 is a side view of an embodiment of an expandable
`fusion device shown between adjacent vertebrae according to
`the present invention;
`FIG. 2 is a front perspective view of the expandable fusion
`device of FIG. 1 shown in an unexpandedposition in accor-
`dance with one embodimentofthe present invention;
`FIG.3 is a front perspective view of the expandable fusion
`device of FIG. 1 shownin an expandedposition in accordance
`with one embodimentof the present invention;
`FIG.4 is a rear perspective view of the expandable fusion
`device of FIG. 1 shown in an unexpandedposition in accor-
`dance with one embodimentofthe present invention;
`FIG.5 is a rear perspective view of the expandable fusion
`device of FIG. 1 shownin an expandedposition in accordance
`with one embodimentof the present invention;
`FIG.6 is a side view of the expandable fusion device of
`FIG. 1 shown in an unexpandedposition in accordance with
`one embodimentof the present invention;
`FIG. 7 is a side view of the expandable fusion device of
`FIG. 1 shownin an expandedposition in accordance with one
`embodimentof the present invention;
`FIG. 8 is a perspective view of the central ramp of the
`expandable fusion device of FIG. 1 in accordance with one
`embodimentof the present invention;
`FIG. 9 is a perspective view of the driving ramp of the
`expandable fusion device of FIG. 1 in accordance with one
`embodimentof the present invention;
`FIG. 10 is a perspective of an endplate of the expandable
`fusion device of FIG. 1 in accordance with one embodiment
`of the present invention;
`FIG. 11 a perspective view showing placementofthe first
`endplate of an embodiment of an expandable fusion device
`down an endoscopic tube and into the disc space in accor-
`dance with one embodimentofthe present invention;
`FIG. 12 is a perspective view showing placement of the
`second endplate of the expandable fusion device down an
`endoscopic tube and into the disc space in accordance with
`one embodimentof the present invention;
`FIG. 13 is a perspective view showing placement of the
`central ramp of the expandable fusion device down an endo-
`scopic tube and into the disc space in accordance with one
`embodimentof the present invention;
`FIG. 14 is a perspective view showing expansion of the
`expandable fusion device in accordance with one embodi-
`mentof the present invention;
`FIG. 15 is a side schematic view of the expandable fusion
`device of FIG. 1 having different endplates;
`FIG.16 is a partial side schematic view of the expandable
`fusion device of FIG. 1 showing different modes of endplate
`expansion;
`FIG. 17 is a side schematic view of the expandable fusion
`device of FIG. 1 with artificial endplates shown between
`adjacent vertebrae;
`FIG. 18 is a front perspective view of an alternative
`embodiment of an expandable fusion device shown in an
`unexpanded position in accordance with one embodimentof
`the present invention;
`
`
`
`Case 1:21-cv-01445-CFC Document 1-1 Filed 10/13/21 Page 34 of 412 PageID #: 58
`Case 1:21-cv-01445-CFC Document 1-1 Filed 10/13/21 Page 34 of 412 PagelD #: 58
`
`US 8,845,731 B2
`
`3
`FIG. 19 isa front perspective view ofthe expandable fusion
`device of FIG. 18 shown in an expanded position in accor-
`dance with one embodimentofthe present invention;
`FIG. 20 is a rear perspective view of the expandable fusion
`device of FIG. 18 shownin an unexpandedposition in accor-
`dance with one embodimentofthe present invention;
`FIG.21 is a rear perspective view of the expandable fusion
`device of FIG. 18 shown in an expanded position in accor-
`dance with one embodimentofthe present invention;
`FIG. 22 is a side view of the expandable fusion device of
`FIG. 18 shownin an unexpandedposition in accordance with
`one embodimentofthe present invention;
`FIG.23 is a side view of the expandable fusion device of
`FIG. 18 shownin an expandedposition in accordance with
`one embodimentofthe present invention;
`FIG.24 is a perspective of an endplate of the expandable
`fusion device of FIG. 18 in accordance with one embodiment
`
`of the present invention;
`FIG. 25 is a perspective view of the central ramp of the
`expandable fusion device of FIG. 18 in accordance with one
`embodimentof the present invention;
`FIG.26 is a side view ofthe central ramp ofthe expandable
`fusion device of FIG. 18 in accordance with one embodiment
`
`of the present invention;
`FIG. 27is a top view of the central ramp of the expandable
`fusion device of FIG. 18 in accordance with one embodiment
`
`of the present invention;
`FIG.28 a perspective view showing placementofthe cen-
`tral ramp of the expandable fusion device of FIG. 18 in
`accordance with one embodimentofthe present invention;
`FIG.29 is a perspective view showing placementofthefirst
`endplate of the expandable fusion device of FIG. 18 in accor-
`dance with one embodimentofthe present invention;
`FIG. 30 is a perspective view showing placement of the
`second endplate ofthe expandable fusion device ofFIG. 18 in
`accordance with one embodimentofthe present invention;
`FIG. 31 is a perspective view showing placement of the
`actuation memberofthe expandable fusion device of FIG. 18
`in accordance with one embodimentofthe present invention;
`FIG. 32 is a perspective view showing expansion of the
`expandable fusion device of FIG. 18 in accordance with one
`embodimentof the present invention;
`FIG. 33 is a front perspective view of an alternative
`embodiment of an expandable fusion device shown in an
`unexpandedposition in accordance with one embodimentof
`the present invention;
`FIG. 341s a front perspective view ofthe expandable fusion
`device of FIG. 33 shown in an expanded position in accor-
`dance with one embodimentofthe present invention;
`FIG. 35 is a rear perspective view of the expandable fusion
`device of FIG. 33 shown in an unexpandedposition in accor-
`dance with one embodimentofthe present invention;
`FIG.36 is a rear perspective view of the expandable fusion
`device of FIG. 33 shown in an expanded position in accor-
`dance with one embodimentofthe present invention;
`FIG. 37 is a side cross-sectional view of the expandable
`fusion device of FIG. 33 shownin an unexpandedposition in
`accordance with one embodimentofthe present invention;
`FIG. 38 is a side cross-sectional view of the expandable
`fusion device of FIG. 33 shown in an expandedposition in
`accordance with one embodimentofthe present invention;
`FIG.39 is a perspective of an endplate of the expandable
`fusion device of FIG. 33 in accordance with one embodiment
`
`of the present invention;
`
`10
`
`20
`
`25
`
`35
`
`40
`
`45
`
`55
`
`4
`FIG.40 is a rear perspective view of an alternative embodi-
`ment ofan expandable fusion device shown in an unexpanded
`position in accordance with one embodimentof the present
`invention;
`FIG.41 is a rear perspective view ofthe expandable fusion
`device of FIG. 40 shownin a partially expandedposition in
`accordance with one embodimentofthe present invention;
`FIG.42is a rear perspective view ofthe expandable fusion
`device of FIG. 40 shown in an expanded position in accor-
`dance with one embodimentofthe present invention;
`FIG.43 is a side exploded view of the expandable fusion
`device of FIG. 40 in accordance with one embodimentof the
`
`present invention;
`FIG. 44 is a side cross-sectional view of the expandable
`fusion device of FIG. 40 shownin an unexpandedposition in
`accordance with one embodimentofthe present invention;
`FIG.45is a perspective view of an endplate of the expand-
`able fusion device of FIG. 40 in accordance with one embodi-
`mentof the present invention;
`FIG. 46 is a perspective view of the central ramp of the
`expandable fusion device of FIG. 40 in accordance with one
`embodimentof the present invention;
`FIGS. 47-49 are perspective views of the driving ramp of
`the expandable fusion device of FIG. 40 in accordance with
`one embodimentof the present invention;
`FIG. 50 is arear perspective view of an alternative embodi-
`ment of an expandable fusion device shown in an expanded
`position in accordance with one embodimentof the present
`invention;
`FIG. 51 is a side cross-sectional view of the expandable
`fusion device of FIG. 50 shown in an expandedposition in
`accordance with one embodimentofthe present invention;
`FIG. 52 is an exploded view of the expandable fusion
`device of FIG. 50 in accordance with one embodimentof the
`
`present invention;
`FIG. 53 is a top view of the expandable fusion device of
`FIG. 50 shownin an unexpandedposition in accordance with
`one embodimentof the present invention;
`FIG.54is a read end view of the expandable fusion device
`of FIG. 50 shownin an expandedposition in accordance with
`one embodimentof the present invention;
`FIG. 55is a perspective view of an endplate of the expand-
`able fusion device of FIG. 50 in accordance with one embodi-
`
`mentof the present invention;
`FIG. 56 is a perspective of a central ramp ofthe expandable
`fusion device of FIG. 50 in accordance with one embodiment
`ofthe present invention; and
`FIG. 57 is a perspective view of a driving ramp of the
`expandable fusion device of FIG. 50 in accordance with one
`embodimentof the present invention.
`
`DETAILED DESCRIPTION OF THE PREFERRED
`EMBODIMENTS
`
`The following description of the preferred embodiment(s)
`is merely exemplary in nature and is in no way intended to
`limit the invention,its application, or uses.
`A spinal fusion is typically employed to eliminate pain
`caused by the motion of degenerated disk material. Upon
`successful fusion, a fusion device becomes permanently fixed
`within the intervertebral disc space. Looking at FIG. 1, an
`exemplary embodimentof an expandable fusion device 10 is
`shown between adjacent vertebral bodies 2 and 3. The fusion
`device 10 engages the endplates 4 and 5 of the adjacent
`vertebral bodies 2 and 3 and, in the installed position, main-
`tains normal intervertebral disc spacing and restores spinal
`stability, thereby facilitating an intervertebral fusion. The
`
`
`
`Case 1:21-cv-01445-CFC Document 1-1 Filed 10/13/21 Page 35 of 412 PageID #: 59
`Case 1:21-cv-01445-CFC Document 1-1 Filed 10/13/21 Page 35 of 412 PagelD #: 59
`
`US 8,845,731 B2
`
`5
`expandable fusion device 10 can be manufactured from a
`numberof materials including titanium,stainless steel, tita-
`nium alloys, non-titanium metallic alloys, polymeric materi-
`als, plastics, plastic composites, PEEK, ceramic, and elastic
`materials. Inan embodiment, the expandable fusion device 10
`can be configured to be placed down an endoscopic tube and
`into the disc space between the adjacent vertebral bodies 2
`and 3.
`In an exemplary embodiment, bone graft or simil