`(12) Patent Application Publication (10) Pub. No.: US 2012/0185049 A1
`(43) Pub. Date:
`Jul.19, 2012
`VARELA
`
`US 2012O185049A1
`
`(54)
`
`EXPANDABLE INTERVERTEBRALIMPLANT
`AND ASSOCATED SURGICAL METHOD
`
`(75)
`
`Inventor:
`
`(73)
`
`Assignee:
`
`(21)
`
`Appl. No.:
`
`ARMANDO VARELA, Boca
`Raton, FL (US)
`INNOVA SPINAL
`TECHNOLOGIES, LLC,
`Plantation, FL (US)
`13/432,270
`
`(22)
`
`Filed:
`
`Mar. 28, 2012
`
`(63)
`
`(60)
`
`Related U.S. Application Data
`Continuation-in-part of application No. 12/974.511,
`filed on Dec. 21, 2010.
`Provisional application No. 61/293,997, filed on Jan.
`11, 2010, provisional application No. 61/296,932,
`filed on Jan. 21, 2010.
`
`Publication Classification
`
`(51) Int. Cl.
`(2006.01)
`A6IF 2/44
`(52) U.S. Cl. ..................................................... 623/1716
`
`ABSTRACT
`(57)
`The present invention provides an expandable intervertebral
`implant, including: a Superior member configured to engage a
`superior intervertebral body; an inferior member configured
`to engage an inferior intervertebral body; and an expansion
`mechanism disposed between the Superior member and the
`inferior member configured to selectively adjust a separation
`of the superior member from the inferior member; wherein
`the expansion mechanism includes a proximal wedge struc
`ture and a distal wedge structure that are relatively translated
`between the superior member and the inferior member,
`wherein the proximal wedge structure and the distal wedge
`structure are each coupled to the Superior member and the
`inferior member by a plurality of aligned and/or staggered
`(i.e. nested) track structures and rail structures.
`
`10
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`16
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`14
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`Exhibit 1030
`LIFE SPINE, INC.
`IPR2022-01602
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`000001
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`Patent Application Publication
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`FIG. 2
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`FIG. 9a
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`10
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`FIG 11
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`10
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`\TVs ver S.
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`FIG. 13
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`000019
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`000020
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`FIG. 18b.
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`000026
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`FIG 21b.
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`FIG. 22b
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`Patent Application Publication
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`FIG. 24b
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`US 2012/0185049 A1
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`FIG. 25
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`000031
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`Patent Application Publication
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`FIG. 27a
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`as/
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`FIG.27b.
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`000033
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`FIG. 28b.
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`FIG. 30b
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`US 2012/0185049 Al
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`152
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`FIG. 31a
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`FIG. 31b
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`FIG. 33b
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`S.N
`s Sists -
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`110
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`FIG. 36b
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`US 2012/0185049 A1
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`FIG. 38a
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`US 2012/0185049 A1
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`FIG. 39
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`2O2
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`Jul. 19, 2012
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`EXPANDABLE INTERVERTEBRAL MPLANT
`AND ASSOCATED SURGICAL METHOD
`
`no such alternative devices or systems are currently available,
`at least not any that are adequate.
`
`CROSS-REFERENCE TO RELATED
`APPLICATION(S)
`0001. The present patent application/patent is a continua
`tion-in-part (CIP) of co-pending U.S. patent application Ser.
`No. 12/974,511, filed on Dec. 21, 2010, and entitled
`EXPANDABLE INTERVERTEBRAL IMPLANT AND
`ASSOCIATED SURGICAL METHOD, which claims the
`benefit of priority of U.S. Provisional Patent Application No.
`61/293,997, filed on Jan. 11, 2010, and entitled “EXPAND
`ABLE INTERVERTEBRAL BODY STABILIZATION
`DEVICES AND ASSOCIATED SURGICAL METHODS
`and U.S. Provisional Patent Application No. 61/296,932, filed
`on Jan. 21, 2010, and entitled “EXPANDABLE INTERVER
`TEBRAL BODY STABILIZATION DEVICES AND ASSO
`CIATED SURGICAL METHODS, the contents of all of
`which are incorporated in full by reference herein.
`
`FIELD OF THE INVENTION
`
`0002 The present invention relates generally to mini
`mally-invasive, Surgically-implantable spinal devices and
`systems. More specifically, the present invention relates to an
`expandable intervertebral implant that is Surgically implanted
`to, in-situ, distract, realign, and/or stabilize or fuse a portion
`of the spine of a patient in the treatment of injury, disease,
`and/or degenerative condition. Exemplary indications
`include, but are not limited to, spinal Stenosis, degenerative
`disc disease with a loss of disc height, disc herniation,
`spondylolisthesis, retrollisthesis, and disogenic back pain.
`This expandable intervertebral implant may be surgically
`implanted via an open or, more preferably, a minimally-inva
`sive Surgical procedure. Advantageously, the expandable
`intervertebral implant has both a very small undeployed ver
`tical cross-section and a very Small undeployed horizontal
`footprint due to the use of superior and inferior members that
`nest against one another in a novel manner.
`
`BACKGROUND OF THE INVENTION
`
`0003. In various cases, it is desirable to restore the ana
`tomic relationship between various vertebral elements,
`thereby re-establishing spinal stability, by means other than
`conventional monolithic and/or multi-piece interbody spac
`ers. Typically, these devices require sizable working chan
`nels, Soft tissue disruption, nerve root retraction, and signifi
`cant bone resection, thereby increasing the resulting stress on
`other vertebral elements. Further, morbidities associated with
`these more-invasive procedures include, but are not limited
`to, greater blood loss, longer recovery, and increased risk of
`Surgical site infection.
`0004. In such cases, the use of an alternative intervertebral
`implant, especially one compatible with minimally-invasive
`Surgical techniques, is desirable. An intervertebral implant
`that expands in-situ would allow implantation without the
`iatrogenic insult that is commonly associated with the
`implantation of conventional monolithic and/or multi-piece
`interbody spacers in a minimally-invasive manner. However,
`
`BRIEF SUMMARY OF THE INVENTION
`0005. In various exemplary embodiments, the present
`invention provides an expandable intervertebral implant that
`is selectively disposed in the intervertebral space and
`deployed, thereby in-situ distracting, realigning, and/or sta
`bilizing or fusing a portion of the spine of a patient in the
`treatment of injury, disease, and/or degenerative condition.
`The expandable intervertebral implant includes a superior
`member and an inferior member, each of which has apartially
`or Substantially wedge or prismatic shape and a partially or
`substantially convex or other-shaped surface that is suitable
`for engaging the Substantially concave surfaces of the asso
`ciated bony superior and inferior intervertebral endplates.
`Optionally, the superior member and the inferior member are
`each thinner at the leading edge of the expandable interver
`tebral implant than they are at the trailing edge of the expand
`able intervertebral implant, such that insertion into the inter
`Vertebral space may be aided, although this is not a
`requirement and the expandable intervertebral implant may
`have a uniform thickness, when undeployed, from the leading
`edge to the trailing edge. For similar reasons, the leading edge
`of the both the superior member and the inferior member may
`have a knifed or rounded shape. Once disposed in the inter
`vertebral space, the expandable intervertebral implant is actu
`ated and deployed, with the superior member and the inferior
`member moving apart from one another, seating against the
`associated intervertebral endplates, and distracting, realign
`ing, and/or stabilizing them to a desired degree. In order to
`ensure that the expandable intervertebral implant is held
`securely in the intervertebral space, the external surface of
`each of the superior member and the inferior member is
`provided with a plurality of ridges or other friction structures,
`providing purchase with the associated intervertebral end
`plates.
`0006 When undeployed, the superior member and the
`inferior member are configured such that they nest against
`one another, thereby providing the undeployed expandable
`intervertebral implant with the smallest possible form factor
`for insertion through the skin and musculature of the patient
`and into the intervertebral space. In the exemplary embodi
`ment provided, this is accomplished via the use of cut-away
`sections associated with the superior member and the inferior
`member, not unlike a tongue-in-groove joint assembly. The
`combined total height of the superior member and the inferior
`member when nested together in the undeployed State is less
`than the sum of the heights of the superior member and the
`inferior member individually. This is accomplished via a
`plurality of nesting ramp structures and/or other angled Sur
`faces associated with the superior member and/or the inferior
`member that selectively cause distraction/separation of the
`superior member and the inferior member via interaction with
`a translating wedge structure. These various ramp structures
`are offset (i.e. staggered) in Such a manner that the form factor
`of the expandable intervertebral implant is minimized when
`undeployed.
`0007. In one exemplary embodiment, the present inven
`tion provides an expandable intervertebral implant, includ
`ing: a Superior member configured to engage a Superior inter
`Vertebral body; an inferior member configured to engage an
`inferior intervertebral body; and an expansion mechanism
`disposed between the Superior member and the inferior mem
`
`000051
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`Jul. 19, 2012
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`ber configured to selectively adjust a separation of the Supe
`rior member and the inferior member. The expansion mecha
`nism includes a wedge structure that is translated between the
`superior member and the inferior member. The expansion
`mechanism also includes a screw that is coupled to the wedge
`structure and causes the wedge structure to translate when
`rotated. One or more of the Superior member and the inferior
`member include a ramp structure on their opposed faces.
`Interaction of the wedge structure and the ramp structure of
`the one or more of the superior member and the inferior
`member as the wedge structure is translated causes adjust
`ment of the separation of the superior member and the inferior
`member. The superior member is coupled to the inferior
`member through the wedge structure and the ramp structure
`of the one or more of the superior member and the inferior
`member. Optionally, the superior member is coupled to the
`inferior member via a track (i.e. channel) and rail system. The
`expansion mechanism disposed between the Superior mem
`ber and the inferior member may also be configured to selec
`tively translate the Superior member with respect to the infe
`rior member.
`0008. In another exemplary embodiment, the present
`invention provides an expandable intervertebral implant,
`including: a Superior member configured to engage a Superior
`intervertebral body; an inferior member configured to engage
`an inferior intervertebral body; and an expansion mechanism
`disposed between the superior member and the inferior mem
`ber configured to selectively adjust a separation of the Supe
`rior member and the inferior member, wherein the expansion
`mechanism includes a wedge structure that is translated
`between the superior member and the inferior member. The
`expansion mechanism also includes a screw that is coupled to
`the wedge structure and causes the wedge structure to trans
`late when rotated. One or more of the superior member and
`the inferior member include a ramp structure on their opposed
`faces. Interaction of the wedge structure and the ramp struc
`ture of the one or more of the superior member and the
`inferior member as the wedge structure is translated causes
`adjustment of the separation of the Superior member and the
`inferior member. The superior member is coupled to the infe
`rior member through the wedge structure and the ramp struc
`ture of the one or more of the superior member and the
`inferior member. Optionally, the superior member is coupled
`to the inferior member via a track and rail system. The expan
`sion mechanism disposed between the Superior member and
`the inferior member may also be configured to selectively
`translate the superior member with respect to the inferior
`member.
`0009. In a further exemplary embodiment, the present
`invention provides a spinal Surgical method, including: pro
`viding an expandable intervertebral implant, including: a
`Superior member configured to engage a Superior interverte
`bral body; an inferior member configured to engage an infe
`rior intervertebral body; and an expansion mechanism dis
`posed between the superior member and the inferior member
`configured to selectively adjust a separation of the Superior
`member and the inferior member, disposing the expandable
`intervertebral implant between the superior intervertebral
`body and the inferior intervertebral body; and selectively
`adjusting the separation of the Superior member and the infe
`rior member, thereby selectively adjusting a distraction of the
`superior intervertebral body from the inferior intervertebral
`body. The expansion mechanism includes a wedge structure
`that is translated between the superior member and the infe
`
`rior member. The expansion mechanism also includes a screw
`that is coupled to the wedge structure and causes the wedge
`structure to translate when rotated. One or more of the supe
`rior member and the inferior member include a ramp structure
`on their opposed faces. Interaction of the wedge structure and
`the ramp structure of the one or more of the superior member
`and the inferior member as the wedge structure is translated
`causes adjustment of the separation of the Superior member
`and the inferior member. The superior member is coupled to
`the inferior member through the wedge structure and the
`ramp structure of the one or more of the superior member and
`the inferior member. Optionally, the Superior member is
`coupled to the inferior member via a track and rail system.
`The expansion mechanism disposed between the Superior
`member and the inferior member may also be configured to
`selectively translate the superior member with respect to the
`inferior member.
`0010. In a still further exemplary embodiment, the present
`invention provides an expandable intervertebral implant,
`including: a Superior member configured to engage a Superior
`intervertebral body; an inferior member configured to engage
`an inferior intervertebral body; and an expansion mechanism
`disposed between the Superior member and the inferior mem
`ber configured to selectively adjust a separation of the Supe
`rior member from the inferior member; wherein the expan
`sion mechanism includes a proximal wedge structure and a
`distal wedge structure that are relatively translated between
`the superior member and the inferior member, wherein the
`proximal wedge structure and the distal wedge structure are
`each coupled to the superior member and the inferior member
`by a plurality of track structures and rail structures. One or
`more track structures and rail structures associated with a top
`surface of the distal wedge structure are offset horizontally
`with respect to one or more track structures and rail structures
`associated with a bottom surface of the distal wedge structure.
`One or more track structures and rail structures associated
`with a top Surface of the proximal wedge structure are aligned
`horizontally with respect to one or more track structures and
`rail structures associated with a bottom surface of the proxi
`mal wedge structure. The expansion mechanism also includes
`an actuation bolt that passes through the proximal wedge
`structure and is coupled to the distal wedge structure and
`causes the wedge structures to relatively translate when
`rotated. The superior member and the inferior member each
`include a plurality of ramp structures on their opposed faces.
`The Superior member includes a ramp structure that engages
`the proximal wedge structure and a ramp structure that
`engages the distal wedge structure. The inferior member
`includes a ramp structure that engages the proximal wedge
`structure and a ramp structure that engages the distal wedge
`structure. The expandable intervertebral implant also
`includes a plurality of elongate arm structures protruding
`from the superior member and the inferior member and
`engaging a corresponding recess of the other component.
`0011. In a still further exemplary embodiment, the present
`invention provides a Surgical method including providing an
`expandable intervertebral implant, including: a Superior
`member configured to engage a Superior intervertebral body;
`an inferior member configured to engage an inferior interver
`tebral body; and an expansion mechanism disposed between
`the superior member and the inferior member configured to
`selectively adjust a separation of the Superior member from
`the inferior member, wherein the expansion mechanism
`includes a proximal wedge structure and a distal wedge struc
`
`000052
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`Jul. 19, 2012
`
`ture that are relatively translated between the superior mem
`ber and the inferior member, wherein the proximal wedge
`structure and the distal wedge structure are each coupled to
`the superior member and the inferior member by a plurality of
`track structures and rail structures. One or more track struc
`tures and rail structures associated with a top surface of the
`distal wedge structure are offset (i.e. staggered) horizontally
`with respect to one or more track structures and rail structures
`associated with a bottom surface of the distal wedge structure.
`One or more track structures and rail structures associated
`with a top surface of the proximal wedge structure are aligned
`horizontally with respect to one or more track structures and
`rail structures associated with a bottom surface of the proxi
`mal wedge structure. Alternatively, one or more track struc
`tures and rail structures associated with a top surface of the
`proximal wedge structure are offset (i.e. staggered) horizon
`tally with respect to one or more track structures and rail
`structures associated with a bottom Surface of the proximal
`wedge structure. The expansion mechanism also includes an
`actuation bolt that passes through the proximal wedge struc
`ture and is coupled to the distal wedge structure and causes
`the wedge structures to relatively translate when rotated. The
`superior member and the inferior member each include a
`plurality of ramp structures on their opposed faces. The Supe
`rior member includes a ramp structure that engages the proxi
`mal wedge structure and a ramp structure that engages the
`distal wedge structure. The inferior member includes a ramp
`structure that engages the proximal wedge structure and a
`ramp structure that engages the distal wedge structure. The
`expandable intervertebral implant also includes a plurality of
`elongate arm structures protruding from the Superior member
`and the inferior member and engaging a corresponding recess
`of the other component.
`
`BRIEF DESCRIPTION OF THE DRAWINGS
`0012. The expandable intervertebral implant of the
`present invention is illustrated and described herein with ref
`erence to the various drawings, in which like reference num
`bers are used to denote like device components, as appropri
`ate, and in which:
`0013 FIG. 1 is a perspective view of one exemplary
`embodiment of the expandable intervertebral implant of the
`present invention;
`0014 FIG. 2 is another perspective view of one exemplary
`embodiment of the expandable intervertebral implant of the
`present invention;
`0015 FIG. 3 is a further perspective view of one exem
`plary embodiment of the expandable intervertebral implant of
`the present invention;
`0016 FIG. 4 is a still further perspective view of one
`exemplary embodiment of the expandable intervertebral
`implant of the present invention;
`0017 FIG. 5 is a planar end view of one exemplary
`embodiment of the expandable intervertebral implant of the
`present invention;
`0018 FIG. 6 is a still further perspective view of one
`exemplary embodiment of the expandable intervertebral
`implant of the present invention;
`0019 FIG. 7 is another planar end view of one exemplary
`embodiment of the expandable intervertebral implant of the
`present invention;
`0020 FIG. 8 is a still further perspective view of one
`exemplary embodiment of the expandable intervertebral
`implant of the present invention;
`
`FIG. 9a is a partial perspective view of one exem
`0021
`plary embodiment of the expandable intervertebral implant of
`the present invention;
`0022 FIG.9b is another partial perspective view of one
`exemplary embodiment of the expandable intervertebral
`implant of the present invention;
`0023 FIG. 10a is an exploded perspective view of one
`exemplary embodiment of the expandable intervertebral
`implant of the present invention;
`0024 FIG. 10b is a partial exploded perspective view of
`one exemplary embodiment of the expandable intervertebral
`implant of the present invention;
`0025 FIG. 10c is another partial exploded perspective
`view of one exemplary embodiment of the expandable inter
`vertebral implant of the present invention;
`0026 FIG. 10d is another exploded perspective view of
`one exemplary embodiment of the expandable intervertebral
`implant of the present invention;
`0027 FIG. 10e is a further partial exploded perspective
`view of one exemplary embodiment of the expandable inter
`vertebral implant of the present invention;
`0028 FIG. 11 is a planar side view of one exemplary
`embodiment of the expandable intervertebral implant of the
`present invention;
`0029 FIG. 12 is another planar side view of one exem
`plary embodiment of the expandable intervertebral implant of
`the present invention;
`0030 FIG. 13 is a further planar side view of one exem
`plary embodiment of the expandable intervertebral implant of
`the present invention;
`0031 FIG. 14 is a still further perspective view of one
`exemplary embodiment of the expandable intervertebral
`implant of the present invention, along with a partial perspec
`tive view of one exemplary embodiment of the implantation
`tool of the present invention;
`0032 FIG. 15 is a still further perspective view of one
`exemplary embodiment of the expandable intervertebral
`implant of the present invention, along with another partial
`perspective view of one exemplary embodiment of the
`implantation tool of the present invention;
`0033 FIG. 16 is a still further perspective view of one
`exemplary embodiment of the expandable intervertebral
`implant of the present invention, along with a perspective
`view of one exemplary embodiment of the implantation tool
`of the present invention;
`0034 FIG. 17 is a still further perspective view of one
`exemplary embodiment of the expandable intervertebral
`implant of the present invention, along with another perspec
`tive view of one exemplary embodiment of the implantation
`tool of the present invention;
`0035 FIGS.18a and 18b are perspective views of an alter
`native exemplary embodiment of the expandable interverte
`bral implant of the present invention in an unexpanded con
`figuration;
`0036 FIGS. 19a and 19b are perspective views of an alter
`native exemplary embodiment of the expandable interverte
`bral implant of the present invention in a partially or wholly
`expanded configuration;
`0037 FIG.20 is a top/bottom planar view of an alternative
`exemplary embodiment of the expandable intervertebral
`implant of the present invention;
`0038 FIGS. 21a and 21b are side planar views of an alter
`native exemplary embodiment of the expandable interverte
`
`000053
`
`
`
`US 2012/0185049 A1
`
`Jul. 19, 2012
`
`bral implant of the present invention in both unexpanded and
`partially or wholly expanded configurations;
`0039 FIGS. 22a and 22b are partial planar views of an
`alternative exemplary embodiment of the expandable inter
`vertebral implant of the present invention in both unexpanded
`and partially or wholly expanded configurations;
`0040 FIGS. 23a and 23b are perspective views of the
`Superior and inferior members of an alternative exemplary
`embodiment of the expandable intervertebral implant of the
`present invention;
`0041
`FIGS. 24a and 24b are additional perspective views
`of the superior and inferior members of an alternative exem
`plary embodiment of the expandable intervertebral implant of
`the present invention;
`0042 FIG. 25 is an additional perspective view of the
`Superior and inferior members of an alternative exemplary
`embodiment of the expandable intervertebral implant of the
`present invention;
`0043 FIG. 26 is a partial perspective view of the Superior
`and inferior members of an alternative exemplary embodi
`ment of the expandable intervertebral implant of the present
`invention in an assembled configuration (see also FIGS. 22a
`and 22b for partial planar views of the same);
`0044 FIGS. 27a and 27b are end planar views of the
`Superior member and the distal wedge structure of an alter
`native exemplary embodiment of the expandable interverte
`bral implant of the present invention, respectively;
`004.5 FIGS. 28a and 28b are perspective views of the
`Superior and inferior members of an alternative exemplary
`embodiment of the expandable intervertebral implant of the
`present inventioninanassembled configuration, both without
`and with the associated proximal and distal wedge structures
`in place, respectively;
`0046 FIGS. 29a and 29b are perspective views of the
`distal wedge structure of an alternative exemplary embodi
`ment of the expandable intervertebral implant of the present
`invention;
`0047 FIGS.30a and 30b are side planar views of an alter
`native exemplary embodiment of the expandable interverte
`bral implant of the present invention in both unexpanded and
`partially or wholly expanded configurations;
`0048 FIGS. 31a and 31b are end planar views of the
`proximal wedge structure of an alternative exemplary
`embodiment of the expandable intervertebral implant of the
`present invention;
`0049 FIGS. 32a and 32b are perspective views of the
`proximal wedge structure of an alternative exemplary
`embodiment of the expandable intervertebral implant of the
`present invention;
`0050 FIGS. 33a and 33b are perspective views of the
`actuation bolt of an alternative exemplary embodiment of the
`expandable intervertebral implant of the present invention;
`0051 FIG.34 is a perspective view of the proximal wedge
`structure, the distal wedge structure, and the actuation bolt of
`an alternative exemplary embodiment of the expandable
`intervertebral implant of the present invention in an
`assembled configuration;
`0052 FIG.35 is a perspective view of the implant inserter
`tool used to insert an alternative exemplary embodiment of
`the expandable intervertebral implant of the present inven
`tion;
`0053 FIGS. 36a and 36b are perspective views of an end
`portion of the implant inserter tool used to insert an alterna
`tive exemplary embodiment of the expandable intervertebral
`
`implant of the present invention, both disengaged from and
`engaged with the expandable intervertebral implant, respec
`tively;
`0054 FIGS. 37a and 37b are perspective views of another
`end portion of the implant inserter tool used to insert an
`alternative exemplary embodiment of the expandable inter
`vertebral implant of the present invention, both in unlocked
`and locked configurations, respectively;
`0055 FIGS. 38a and 38b are partial perspective views of
`another end portion of the implant inserter tool used to insert
`an alternative exemplary embodiment of the expandable
`intervertebral implant of the present invention, both in
`unlocked and locked configurations, respectively;
`0056 FIG. 39 is a perspective view of another end portion
`of the implant inserter tool used to insert an alternative exem
`plary embodiment of the expandable intervertebral implant of
`the present invention, highlighting the engagement of the
`associated handle assembly;
`0057 FIG. 40 is a perspective view of the implant inserter
`tool used to insert an alternative exemplary embodiment of
`th