`(12) Patent Application Publication (10) Pub. No.: US 2014/0067071 A1
`(43) Pub. Date:
`Mar. 6, 2014
`Weiman et al.
`
`US 2014006.7071A1
`
`(54)
`
`(71)
`
`(72)
`
`(21)
`(22)
`
`(63)
`
`EXPANDABLE FUSON DEVICE AND
`METHOD OF INSTALLATION THEREOF
`
`Applicants: Mark Weiman, Coatesville, PA (US);
`Kevin Gahman, Douglassville, PA (US);
`Jody L. Seifert, Birdsboro, PA (US);
`Andrew Iott, Villanova, PA (US)
`Inventors: Mark Weiman, Coatesville, PA (US);
`Kevin Gahman, Douglassville, PA (US);
`Jody L. Seifert, Birdsboro, PA (US);
`Andrew Iott, Villanova, PA (US)
`Appl. No.: 13/961,603
`Filed:
`Aug. 7, 2013
`
`Related U.S. Application Data
`Continuation-in-part of application No. 13/531,844,
`filed on Jun. 25, 2012, which is a continuation-in-part
`of application No. 12/875,637, filed on Sep. 3, 2010.
`
`Publication Classification
`
`(51) Int. Cl.
`A6IF 2/44
`(52) U.S. Cl.
`CPC ...................................... A61F 2/447 (2013.01)
`USPC ....................................................... 623/1716
`
`(2006.01)
`
`(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 spinal stability,
`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 moved in 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.
`
`
`
`s iii. S.
`
`Exhibit 1004
`LIFE SPINE, INC.
`IPR2022-01602
`
`000001
`
`
`
`Patent Application Publication
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`Mar. 6, 2014 Sheet 1 of 44
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`US 2014/OO67071 A1
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`Mar. 6, 2014 Sheet 3 of 44
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`Mar. 6, 2014
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`EXPANDABLE FUSION DEVICE AND
`METHOD OF INSTALLATION THEREOF
`
`CROSS-REFERENCE TO RELATED
`APPLICATION
`0001. This application is a continuation-in-part of U.S.
`patent application Ser. No. 13/531.544, entitled “Expandable
`Fusion Device and Method of Installation Thereof filed on
`Jun. 25, 2012, which is a continuation-in-part of U.S. patent
`application Ser. No. 12/875,637, entitled “Expandable
`Fusion Device and Method of Installation Thereof filed on
`Sep. 3, 2010, the entire disclosures of which are herein incor
`porated by reference in their entireties.
`
`FIELD OF THE INVENTION
`0002 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.
`
`BACKGROUND OF THE INVENTION
`0003. A common procedure for handling pain associated
`with intervertebral discs that have become degenerated due to
`Various factors such as trauma or aging is the use of interver
`tebral fusion devices for fusing one or more adjacent vertebral
`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 insertd between
`neighboring vertebrae to maintain normal disc spacing and
`restore spinal stability, thereby facilitating an intervertebral
`fusion.
`0004. There are a number of known conventional fusion
`devices and methodologies in the art for accomplishing the
`intervertebral fusion. These include screw and rod arrange
`ments, 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.
`0005. 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 make it difficult for a Surgeon to install the fusion
`device in the distracted intervertebral space.
`0006. As such, there exists a need for a fusion device
`capable of being installed inside an intervertebral disc space
`at a minimum to no distraction height and for a fusion device
`that can maintain a normal distance between adjacent verte
`bral bodies when implanted.
`
`SUMMARY OF THE INVENTION
`0007. In an exemplary embodiment, the present invention
`provides an expandable fusion device capable of being
`installed inside an intervertebral disc space to maintain nor
`mal disc spacing and restore spinal Stability, thereby facili
`
`tating an intervertebral fusion. In one embodiment, the fusion
`device includes a central ramp, a first endplate, and a second
`endplate. The central ramp may be capable of moving in a first
`direction to push the first 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
`expanded configuration.
`0008 Further areas of applicability of the present inven
`tion will become apparent from the detailed description pro
`vided hereinafter. It should be understood that the detailed
`description and specific examples, while indicating the pre
`ferred or exemplary embodiments of the invention, are
`intended for purposes of illustration only and are not intended
`to limit the scope of the invention.
`
`BRIEF DESCRIPTION OF THE DRAWINGS
`0009. The present invention will become more fully
`understood from the detailed description and the accompa
`nying drawings, wherein:
`0010 FIG. 1 is a side view of an embodiment of an
`expandable fusion device shown between adjacent vertebrae
`according to the present invention;
`0011
`FIG. 2 is a front perspective view of the expandable
`fusion device of FIG. 1 shown in an unexpanded position in
`accordance with one embodiment of the present invention;
`0012 FIG. 3 is a front perspective view of the expandable
`fusion device of FIG. 1 shown in an expanded position in
`accordance with one embodiment of the present invention;
`0013 FIG. 4 is a rear perspective view of the expandable
`fusion device of FIG. 1 shown in an unexpanded position in
`accordance with one embodiment of the present invention;
`0014 FIG. 5 is a rear perspective view of the expandable
`fusion device of FIG. 1 shown in an expanded position in
`accordance with one embodiment of the present invention;
`0015 FIG. 6 is a side view of the expandable fusion device
`of FIG. 1 shown in an unexpanded position in accordance
`with one embodiment of the present invention;
`0016 FIG. 7 is a side view of the expandable fusion device
`of FIG. 1 shown in an expanded position in accordance with
`one embodiment of the present invention;
`0017 FIG. 8 is a perspective view of the central ramp of
`the expandable fusion device of FIG. 1 in accordance with
`one embodiment of the present invention;
`0018 FIG. 9 is a perspective view of the driving ramp of
`the expandable fusion device of FIG. 1 in accordance with
`one embodiment of the present invention;
`(0019 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;
`0020 FIG. 11 a perspective view showing placement of
`the first endplate of an embodiment of an expandable fusion
`device down an endoscopic tube and into the disc space in
`accordance with one embodiment of the present invention;
`0021
`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 embodiment of the present invention;
`0022 FIG. 13 is a perspective view showing placement of
`the central ramp of the expandable fusion device down an
`endoscopic tube and into the disc space in accordance with
`one embodiment of the present invention;
`
`000046
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`US 2014/OO67071 A1
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`Mar. 6, 2014
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`0023 FIG. 14 is a perspective view showing expansion of
`the expandable fusion device in accordance with one embodi
`ment of the present invention;
`0024 FIG. 15 is a side schematic view of the expandable
`fusion device of FIG. 1 having different endplates:
`0025 FIG. 16 is a partial side schematic view of the
`expandable fusion device of FIG. 1 showing different modes
`of endplate expansion;
`0026 FIG. 17 is a side schematic view of the expandable
`fusion device of FIG. 1 with artificial endplates shown
`between adjacent vertebrae;
`0027 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 embodiment of
`the present invention;
`0028 FIG. 19 is a front perspective view of the expandable
`fusion device of FIG. 18 shown in an expanded position in
`accordance with one embodiment of the present invention;
`0029 FIG.20 is a rear perspective view of the expandable
`fusion device of FIG. 18 shown in an unexpanded position in
`accordance with one embodiment of the present invention;
`0030 FIG. 21 is a rear perspective view of the expandable
`fusion device of FIG. 18 shown in an expanded position in
`accordance with one embodiment of the present invention;
`0031
`FIG. 22 is a side view of the expandable fusion
`device of FIG. 18 shown in an unexpanded position in accor
`dance with one embodiment of the present invention;
`0032 FIG. 23 is a side view of the expandable fusion
`device of FIG. 18 shown in an expanded position in accor
`dance with one embodiment of the present invention;
`0033 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;
`0034 FIG. 25 is a perspective view of the central ramp of
`the expandable fusion device of FIG. 18 in accordance with
`one embodiment of the present invention:
`0035 FIG. 26 is a side view of the central ramp of the
`expandable fusion device of FIG. 18 in accordance with one
`embodiment of the present invention;
`0036 FIG. 27 is a top view of the central ramp of the
`expandable fusion device of FIG. 18 in accordance with one
`embodiment of the present invention;
`0037 FIG. 28 a perspective view showing placement of
`the central ramp of the expandable fusion device of FIG. 18 in
`accordance with one embodiment of the present invention;
`0038 FIG. 29 is a perspective view showing placement of
`the first endplate of the expandable fusion device of FIG. 18
`in accordance with one embodiment of the present invention;
`0039 FIG. 30 is a perspective view showing placement of
`the second endplate of the expandable fusion device of FIG.
`18 in accordance with one embodiment of the present inven
`tion;
`0040 FIG.31 is a perspective view showing placement of
`the actuation member of the expandable fusion device of FIG.
`18 in accordance with one embodiment of the present inven
`tion;
`FIG. 32 is a perspective view showing expansion of
`0041
`the expandable fusion device of FIG. 18 in accordance with
`one embodiment of the present invention:
`0042 FIG.33 is a front perspective view of an alternative
`embodiment of an expandable fusion device shown in an
`unexpanded position in accordance with one embodiment of
`the present invention;
`
`0043 FIG.34 is a front perspective view of the expandable
`fusion device of FIG. 33 shown in an expanded position in
`accordance with one embodiment of the present invention;
`0044 FIG. 35 is a rear perspective view of the expandable
`fusion device of FIG.33 shown in an unexpanded position in
`accordance with one embodiment of the present invention;
`0045 FIG. 36 is a rear perspective view of the expandable
`fusion device of FIG. 33 shown in an expanded position in
`accordance with one embodiment of the present invention;
`0046 FIG. 37 is a side cross-sectional view of the expand
`able fusion device of FIG. 33 shown in an unexpanded posi
`tion in accordance with one embodiment of the present inven
`tion;
`0047 FIG.38 is a side cross-sectional view of the expand
`able fusion device of FIG.33 shown in an expanded position
`in accordance with one embodiment of the present invention;
`0048 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;
`0049 FIG. 40 is a rear perspective view of an alternative
`embodiment of an expandable fusion device shown in an
`unexpanded position in accordance with one embodiment of
`the present invention;
`0050 FIG. 41 is a rear perspective view of the expandable
`fusion device of FIG. 40 shown in a partially expanded posi
`tion in accordance with one embodiment of the present inven
`tion;
`0051 FIG. 42 is a rear perspective view of the expandable
`fusion device of FIG. 40 shown in an expanded position in
`accordance with one embodiment of the present invention;
`0052 FIG. 43 is a side exploded view of the expandable
`fusion device of FIG. 40 in accordance with one embodiment
`of the present invention;
`0053 FIG. 44 is a side cross-sectional view of the expand
`able fusion device of FIG. 40 shown in an unexpanded posi
`tion in accordance with one embodiment of the present inven
`tion;
`0054 FIG. 45 is a perspective view of an endplate of the
`expandable fusion device of FIG. 40 in accordance with one
`embodiment of the present invention;
`0055 FIG. 46 is a perspective view of the central ramp of
`the expandable fusion device of FIG. 40 in accordance with
`one embodiment of the present invention;
`0056 FIGS. 47-49 are perspective views of the driving
`ramp of the expandable fusion device of FIG. 40 in accor
`dance with one embodiment of the present invention;
`0057 FIG.50 is a rear perspective view of an alternative
`embodiment of an expandable fusion device shown in an
`expanded position in accordance with one embodiment of the
`present invention;
`0.058
`FIG. 51 is a side cross-sectional view of the expand
`able fusion device of FIG. 50 shown in an expanded position
`in accordance with one embodiment of the present invention;
`0059 FIG. 52 is an exploded view of the expandable
`fusion device of FIG.50 in accordance with one embodiment
`of the present invention;
`0060 FIG. 53 is a top view of the expandable fusion
`device of FIG.50 shown in an unexpanded position in accor
`dance with one embodiment of the present invention;
`0061
`FIG. 54 is a read end view of the expandable fusion
`device of FIG. 50 shown in an expanded position in accor
`dance with one embodiment of the present invention;
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`0062 FIG.55 is a perspective view of an endplate of the
`expandable fusion device of FIG.50 in accordance with one
`embodiment of the present invention;
`0063 FIG. 56 is a perspective of a central ramp of the
`expandable fusion device of FIG.50 in accordance with one
`embodiment of the present invention;
`0064 FIG.57 is a perspective view of a driving ramp of the
`expandable fusion device of FIG.50 in accordance with one
`embodiment of the present invention;
`0065 FIG. 58 is an exploded view of an alternative
`embodiment of an expandable fusion device in accordance
`with one embodiment of the present invention;
`0066 FIG.59 is a rear perspective view of the expandable
`fusion device of FIG. 58 in an unexpanded position in accor
`dance with one embodiment of the present invention;
`0067 FIG. 60 is a rear perspective view of the expandable
`fusion device of FIG. 58 in an expanded position in accor
`dance with one embodiment of the present invention;
`0068 FIG. 61 is a side cross-sectional view of the expand
`able fusion device of FIG. 58 in an unexpanded position in
`accordance with one embodiment of the present invention;
`0069 FIG. 62 is a side cross-sectional view of the expand
`able fusion device of FIG. 58 in an expanded position in
`accordance with one embodiment of the present invention;
`0070 FIG. 63 is a top view of the expandable fusion
`device of FIG. 58 in an unexpanded position in accordance
`with one embodiment of the present invention;
`0071
`FIG. 64 is an exploded view of an alternative
`embodiment of an expandable fusion device in accordance
`with one embodiment of the present invention;
`0072 FIG. 65 is a side cross-sectional view of the expand
`able fusion device of FIG. 63 in an unexpanded position in
`accordance with one embodiment of the present invention;
`0073 FIG. 66 is a side cross-sectional view of the expand
`able fusion device of FIG. 64 in an expanded position in
`accordance with one embodiment of the present invention;
`0074 FIG. 67 is an exploded view of an alternative
`embodiment of an expandable fusion device in accordance
`with one embodiment of the present invention;
`0075 FIG. 68 illustrates dilator in accordance with
`embodiments of the present invention; and
`0076 FIGS. 69-73 illustrate cannula in accordance with
`embodiments of the present invention.
`0077 FIG. 74 is an exploded view of an alternative
`embodiment of an expandable fusion device with a graft
`delivery hole in accordance with embodiments of the present
`invention;
`0078 FIGS. 75A and 75B are rear views of the expandable
`fusion device of FIG. 74;
`0079 FIG. 76 is a top view of the expandable fusion
`device of FIG.74;
`0080 FIG. 77 is a side view of the expandable fusion
`device of FIG.74;
`I0081
`FIG. 78 is an exploded view of an alternative
`embodiment of an expandable fusion device having remov
`ably attachable plates in accordance with embodiments of the
`present invention;
`I0082 FIG. 79 is a side view of the expandable fusion
`device of FIG. 78;
`I0083 FIG. 80 is a perspective view of the expandable
`fusion device of FIG. 78;
`0084 FIG. 81 is a rear view of the expandable fusion
`device of FIG. 78; and
`
`0085 FIGS. 82A and 82B are rear views of alternative
`expandable fusion devices having different attachable plates
`in accordance with embodiments of the present invention.
`
`DETAILED DESCRIPTION OF THE PREFERRED
`EMBODIMENTS
`I0086. The following description of the preferred embodi
`ment(s) is merely exemplary in nature and is in no way
`intended to limit the invention, its application, or uses.
`I0087. 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 embodiment of 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
`expandable fusion device 10 can be manufactured from a
`number of materials including titanium, stainless Steel, tita
`nium alloys, non-titanium metallic alloys, polymeric materi
`als, plastics, plastic composites, PEEK, ceramic, and elastic
`materials.
`I0088. In an embodiment, the expandable fusion device 10
`can be configured and sized to be placed down an endoscopic
`tube and into the disc space between the adjacent vertebral
`bodies 2 and 3. For example, the expandable fusion device 10
`can be figured for insertion through an endoscopic tube, such
`as a cannula having a diameter equal to or less than about 15
`millimeters (“mm) and, alternatively, less than about 10 mm.
`In one particular embodiment, the expandable fusion 10 may
`be configured for insertion through a cannula having a diam
`eter of about 8.5 mm. In some embodiments, the expandable
`fusion device 10 may have a width in a range of from about 8
`mm to about 12 mm and a length in a range of from about 22
`mm to about 34 mm. In some embodiments, the expandable
`fusion device 10 may have an initial height in an unexpanded
`position of less than about 15 mm and, alternatively, less than
`about 10 mm. In one particular embodiment, the expandable
`fusion device 10 may have an initial height in an unexpanded
`position of about 8.5 mm. In some embodiments, the expand
`able fusion device 10 may be expanded to a height that is
`equal to or greater than about 150% of its initial height. In one
`embodiment, the expandable fusion device 10 may be
`expanded to a height that is equal to or greater than about
`170% of its initial height. For example, the expandable fusion
`device 10 may be expanded from an initial height of about 8
`mm to a height in the expanded position of about 14 mm.
`I0089. In an exemplary embodiment, bone graft or similar
`bone growth inducing material can be introduced around and
`within the fusion device 10 to further promote and facilitate
`the intervertebral fusion. The fusion device 10, in one
`embodiment, is preferably packed with bone graft or similar
`bone growth inducing material to promote the growth of bone
`through and around the fusion device. Such bone graft may be
`packed between the endplates of the adjacent vertebral bodies
`prior to, Subsequent to, or during implantation of the fusion
`device.
`0090. With reference to FIGS. 2-7, an embodiment of the
`fusion device 10 is shown. In an exemplary embodiment, the
`fusion device 10 includes a first endplate 14, a second end
`plate 16, a central ramp 18, and a driving ramp 260. In an
`embodiment, the expandable fusion device 10 can be config
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`ured to be placed down an endoscopic tube and into the disc
`space between the adjacent vertebral bodies 2 and 3. One or
`more components of the fusion device 10 may contain fea
`tures, such as through bores that facilitate placement down an
`endoscopic tube. In an embodiment, components of the
`fusion device 10 are placed down the endoscopic tube with
`assembly of the fusion device 10 in the disc space.
`0091 Although the following discussion relates to the
`second endplate 16, it should be understood that it also
`equally applies to the first endplate 14 as the second endplate
`16 is substantially identical to the first endplate 14 in embodi
`ments of the present invention. Turning now to FIGS. 2-7 and
`10, in an exemplary embodiment, the second endplate 16 has
`a first end 39 and a second end 41. In the illustrated embodi
`ment, the second endplate 16 further comprise an upper Sur
`face 40 connecting the first end 39 and the second end 41, and
`a lower surface 42 connecting the first end 39 and the second
`end 41. In an embodiment, the second endplate 16 further
`comprises a through opening 44, as seen on FIG. 11. The
`through opening 44, in an exemplary embodiment, is sized to
`receive bone graft or similar bone growth inducing material
`and further allow the bone graft or similar bone growth induc
`ing material to be packed in the central opening in the central
`ramp 18.
`0092. As best seen in FIGS. 7 and 10, the lower surface 42
`includes at least one extension 46 extending along at least a
`portion of the lower Surface 42, in an embodiment. In an
`exemplary embodiment, the extension 46 can extend along a
`substantial portion of the lower surface 42, including, along
`the center of the lower surface 42. In the illustrated embodi
`ment, the extension 46 includes a generally concave Surface
`47. The concave surface 47 can form a through bore with the
`corresponding concave surface 47 (not illustrated) of the first
`endplate 14, for example, when the device 10 is in an unex
`panded configuration. In another exemplary embodiment, the
`extension 46 includes at least one ramped surface 48. In
`another exemplary embodiment, there are two ramped Sur
`faces 48, 50 with the first ramped surface 48 facing the first
`end 39 and the second ramped surface facing the second end
`41. In an embodiment, the first ramped surface 48 can be
`proximate the first end 39, and the second ramped surface 50
`can be proximate the second end 41. It is contemplated that
`the slope of the ramped surfaces 48, 50 can be equal or can
`differ from each other. The effect of varying the slopes of the
`ramped surfaces 48, 50 is discussed below.
`0093. In one embodiment, the extension 46 can include
`features for securing the endplate 16 when the expandable
`fusion device 10 is in an expanded position. In an embodi
`ment, the extension 46 includes one or more protuberances 49
`extending from the lateral sides 51 of the extension. In the
`illustrated embodiment, there are two protuberances 49
`extending from each of the lateral sides 51 with each of the
`sides 53 having one of the protuberances 49 extending from a
`lower portion of either end. As will be discussed in more
`detail below, the protuberances 49 can be figured to engage
`the central ramp 18 preventing and/or restricting longitudinal
`movement of the endplate 16 when the device 10 is in an
`expanded position.
`0094. As illustrated in FIGS. 2-5, in one embodiment, the
`upper surface 40 of the second endplate 16 is flat and gener
`ally planar to allow the upper surface 40 of the endplate 16 to
`engage with the adjacent vertebral body 2. Alternatively, as
`shown in FIG. 15, the upper surface 40 can be curved con
`vexly or concavely to allow for a greater or lesser degree of
`
`engagement with the adjacent vertebral body 2. It is also
`contemplated that the upper Surface 40 can be generally pla
`nar but includes a generally straight ramped Surface or a
`curved ramped surface. The ramped surface allows for
`engagement with the adjacent vertebral body 2 in a lordotic
`fashion. While not illustrated, in an exemplary embodiment,
`the upper Surface 40 includes texturing to aid in gripping the
`adjacent vertebral bodies. Although not limited to the follow
`ing, the texturing can include teeth, ridges, friction increasing
`elements, keels, or gripping or purchasing projections.
`(0095 Referring now to FIGS. 2-8, in an exemplary
`embodiment, the central ramp 18 has a first end 20, a second
`end 22, a first side portion 24 connecting the first end 20 and
`the second end 22, and a second side portion 26 (best seen on
`FIG. 5) on the opposing side of the central ramp 12 connect
`ing the first end 20 and the second end 22. The first side
`portion 24 and the second si