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`US008361156B2
`
`c12) United States Patent
`Curran et al.
`
`(IO) Patent No.:
`(45) Date of Patent:
`
`US 8,361,156 B2
`Jan.29,2013
`
`(54) SYSTEMS AND METHODS FOR SPINAL
`FUSION
`
`(75)
`
`Inventors: Matthew Curran, Carlsbad, CA (US);
`Mark Peterson, Medford, CA (US)
`
`(73) Assignee: NuVasive, Inc., San Diego, CA (US)
`
`( *) Notice:
`
`Subject to any disclaimer, the term ofthis
`patent is extended or adjusted under 35
`U.S.C. 154(b) by 0 days.
`
`(21) Appl. No.: 13/441,092
`
`(22) Filed:
`
`Apr. 6, 2012
`
`(65)
`
`Prior Publication Data
`
`US 2012/0209388 Al
`
`Aug. 16, 2012
`
`Related U.S. Application Data
`
`(63) Continuation of application No. 13/440,062, filed on
`Apr. 5, 2012, now Pat. No. 8,246,686, which is a
`continuation of application No. 13/079,645, filed on
`Apr. 4, 2011, now Pat. No. 8,187,334, which is a
`continuation of application No. 11/093,409, filed on
`Mar. 29, 2005, now Pat. No. 7,918,891.
`
`(60) Provisional application No. 60/557,536, filed on Mar.
`29, 2004.
`
`(51)
`
`Int. Cl.
`A61F 2144
`(2006.01)
`(52) U.S. Cl. .................................................... 623/17.16
`( 58) Field of Classification Search . ... . 623/17 .11-17 .19
`See application file for complete search history.
`
`(56)
`
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`Primary Examiner - Ellen C Hammond
`Assistant Examiner - Stuart S Bray
`(74) Attorney, Agent, or Firm - Fish & Richardson P.C.
`
`ABSTRACT
`(57)
`A system and method for spinal fusion comprising a spinal
`fusion implant of non-bone construction releasably coupled
`to an insertion instrument dimensioned to introduce the spinal
`fusion implant into any of a variety of spinal target sites.
`
`27 Claims, 20 Drawing Sheets
`
`4
`
`.j
`
`< ••
`... ····'
`
`"'.·
`
`}l
`//
`
`/
`
`4
`
`'<
`
`ALPHATEC HOLDINGS, INC., ALPHATEC SPINE INC.
`IPR2019-00362, Ex. 1001, p. 1 of 30
`
`

`

`US 8,361,156 B2
`Page 2
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`ALPHATEC HOLDINGS, INC., ALPHATEC SPINE INC.
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`
`ALPHATEC HOLDINGS, INC., ALPHATEC SPINE INC.
`IPR2019-00362, Ex. 1001, p. 3 of 30
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`

`

`U.S. Patent
`
`Jan.29,2013
`
`Sheet 1of20
`
`US 8,361,156 B2
`
`:FIG. 1
`
`ALPHATEC HOLDINGS, INC., ALPHATEC SPINE INC.
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`

`

`U.S. Patent
`
`Jan.29,2013
`
`Sheet 2of20
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`US 8,361,156 B2
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`IPR2019-00362, Ex. 1001, p. 5 of 30
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`

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`U.S. Patent
`
`Jan.29,2013
`
`Sheet 3of20
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`US 8,361,156 B2
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`IPR2019-00362, Ex. 1001, p. 6 of 30
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`U.S. Patent
`
`Jan.29,2013
`
`Sheet 4of20
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`ALPHATEC HOLDINGS, INC., ALPHATEC SPINE INC.
`IPR2019-00362, Ex. 1001, p. 7 of 30
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`

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`U.S. Patent
`
`Jan.29,2013
`
`Sheet 5of20
`
`US 8,361,156 B2
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`FIG. 5
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`ALPHATEC HOLDINGS, INC., ALPHATEC SPINE INC.
`IPR2019-00362, Ex. 1001, p. 8 of 30
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`

`

`U.S. Patent
`
`Jan.29,2013
`
`Sheet 6of20
`
`US 8,361,156 B2
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`ALPHATEC HOLDINGS, INC., ALPHATEC SPINE INC.
`IPR2019-00362, Ex. 1001, p. 9 of 30
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`

`U.S. Patent
`
`Jan.29,2013
`
`Sheet 7of20
`
`US 8,361,156 B2
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`FIG. 7
`
`ALPHATEC HOLDINGS, INC., ALPHATEC SPINE INC.
`IPR2019-00362, Ex. 1001, p. 10 of 30
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`

`U.S. Patent
`
`Jan.29,2013
`
`Sheet 8of20
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`IPR2019-00362, Ex. 1001, p. 11 of 30
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`U.S. Patent
`
`Jan.29,2013
`
`Sheet 9of20
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`ALPHATEC HOLDINGS, INC., ALPHATEC SPINE INC.
`IPR2019-00362, Ex. 1001, p. 12 of 30
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`U.S. Patent
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`Jan.29,2013
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`Sheet 10 of 20
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`US 8,361,156 B2
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`FIG. 10
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`ALPHATEC HOLDINGS, INC., ALPHATEC SPINE INC.
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`U.S. Patent
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`Jan.29,2013
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`US 8,361,156 B2
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`ALPHATEC HOLDINGS, INC., ALPHATEC SPINE INC.
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`U.S. Patent
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`Jan.29,2013
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`Sheet 12 of 20
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`US 8,361,156 B2
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`ALPHATEC HOLDINGS, INC., ALPHATEC SPINE INC.
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`U.S. Patent
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`Jan.29,2013
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`Sheet 13 of 20
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`US 8,361,156 B2
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`ALPHATEC HOLDINGS, INC., ALPHATEC SPINE INC.
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`U.S. Patent
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`Jan.29,2013
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`Sheet 14 of 20
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`US 8,361,156 B2
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`ALPHATEC HOLDINGS, INC., ALPHATEC SPINE INC.
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`U.S. Patent
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`Jan.29,2013
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`Sheet 15 of 20
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`US 8,361,156 B2
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`110
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`U.S. Patent
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`Jan.29,2013
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`US 8,361,156 B2
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`ALPHATEC HOLDINGS, INC., ALPHATEC SPINE INC.
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`U.S. Patent
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`Jan.29,2013
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`Sheet 17 of 20
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`US 8,361,156 B2
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`ALPHATEC HOLDINGS, INC., ALPHATEC SPINE INC.
`IPR2019-00362, Ex. 1001, p. 20 of 30
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`U.S. Patent
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`Jan.29,2013
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`US 8,361,156 B2
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`ALPHATEC HOLDINGS, INC., ALPHATEC SPINE INC.
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`U.S. Patent
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`Jan.29,2013
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`ALPHATEC HOLDINGS, INC., ALPHATEC SPINE INC.
`IPR2019-00362, Ex. 1001, p. 22 of 30
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`U.S. Patent
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`Jan.29,2013
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`Sheet 20 of 20
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`US 8,361,156 B2
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`IPR2019-00362, Ex. 1001, p. 23 of 30
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`US 8,361,156 B2
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`1
`SYSTEMS AND METHODS FOR SPINAL
`FUSION
`
`CROSS-REFERENCE TO RELATED
`APPLICATION
`
`This application is continuation of U.S. patent application
`Ser. No. 13/440,062 filed Apr. 5, 2012, which is a continua(cid:173)
`tion of U.S. patent application Ser. No. 13/079,645 filed Apr.
`4, 2011, which is continuation of U.S. patent application Ser.
`No. 11/093,409 filed Mar. 29, 2005 (now U.S. Pat. No. 7,918,
`891 ), which claims the benefit of the filing date under 35 USC
`119( e) of United States Provisional Application entitled
`"Systems and Methods for Spinal Fusion," Ser. No. 60/557,
`536 filed Mar. 29, 2004, the entire contents of these prior
`applications are incorporated herein by reference.
`
`BACKGROUND OF THE INVENTION
`
`2
`methods involving the use of a spinal fusion implant of non(cid:173)
`bone construction. The non-bone construction of the spinal
`fusion implant of the present invention overcomes the draw(cid:173)
`backs of the prior art in that it is not supply limited (as with
`allograft) and does not require harvesting bone from the
`patient (as with autograft). The spinal fusion implant of the
`present invention may be comprised of any suitable non-bone
`composition, including but not limited to polymer composi(cid:173)
`tions (e.g. poly-ether-ether-ketone (PEEK) and/orpoly-ether-
`10 ketone-ketone (PEKK)), ceramic, metal or any combination
`of these materials.
`The spinal fusion implant of the present invention may be
`provided in any number of suitable shapes and sizes depend(cid:173)
`ing upon the particular surgical procedure or need. The spinal
`15 fusion implant of the present invention may be dimensioned
`for use in the cervical and/or lumbar spine without departing
`from the scope of the present invention. For lumbar fusion,
`the spinal fusion implant of the present invention may be
`dimensioned, by way of example only, having a width rang-
`20 ing between 9 and 18 mm, a height ranging between 8 and 16
`mm, and a length ranging between 25 and 45 mm. For cervi(cid:173)
`cal fusion, the spinal fusion implant of the present invention
`may be dimensioned, by way of example only, having a width
`about 11 mm, a height ranging between 5 and 12 mm, and a
`25 length about 14 mm.
`The spinal fusion implant of the present invention may be
`provided with any number of additional features for promot(cid:173)
`ing fusion, such as apertures extending between the upper and
`lower vertebral bodies which allow a boney bridge to form
`30 through the spinal fusion implant of the present invention.
`Such fusion-promoting apertures may be dimensioned to
`receive any number of suitable osteoinductive agents, includ(cid:173)
`ing but not limited to bone morphogenic protein (BMP) and
`bio-resorbable polymers, including but not limited to any of a
`35 variety of poly (D,L-lactide-co-glycolide) based polymers.
`The spinal fusion implant of the present invention is prefer(cid:173)
`ably equipped with one or more lateral openings which aid it
`provides in visualization at the time of implantation and at
`subsequent clinical evaluations.
`The spinal fusion implant of the present invention may be
`provided with any number of suitable anti-migration features
`to prevent spinal fusion implant from migrating or moving
`from the disc space after implantation. Suitable anti-migra(cid:173)
`tion features may include, but are not necessarily limited to,
`45 angled teeth formed along the upper and/or lower surfaces of
`the spinal fusion implant and/or spike elements disposed
`partially within and partially outside the upper and/or lower
`surfaces of the spinal fusion implant. Such anti-migration
`features provide the additional benefit of increasing the over-
`50 all surface area between the spinal fusion implant of the
`present invention and the adjacent vertebrae, which promotes
`overall bone fusion rates.
`The spinal fusion implant of the present invention may be
`provided with any number of features for enhancing the visu-
`55 alization of the implant during and/or after implantation into
`a spinal target site. According to one aspect of the present
`invention, such visualization enhancement features may take
`the form of the spike elements used for anti-migration, which
`may be manufactured from any of a variety of suitable mate-
`60 rials, including but not limited to a metal, ceramic, and/or
`polymer material, preferably having radiopaque characteris(cid:173)
`tics. The spike elements may also take any of a variety of
`suitable shapes, including but not limited to a generally elon(cid:173)
`gated element disposed within the implant such that the ends
`65 thereof extend generally perpendicularly from the upper and/
`or lower surfaces of the implant. The spike elements may each
`comprise a unitary element extending through upper and
`
`I. Field of the Invention
`The present invention relates generally to spinal surgery
`and, more particularly, to a system and method for spinal
`fusion comprising a spinal fusion implant of non-bone con(cid:173)
`struction releasably coupled to an insertion instrument
`dimensioned to introduce the spinal fusion implant into any of
`a variety of spinal target sites.
`II. Discussion of the Prior Art
`Currently there are nearly 500,000 spine lumbar and cer(cid:173)
`vical fusion procedures performed each year in the United
`States. Such procedures are commonly performed to correct
`problems, such as chronic back or neck pain, which result
`from degenerated intervertebral discs or trauma. Generally,
`spinal fusion procedures involve removing some or all of the
`diseased or damaged disc, and inserting one or more inter(cid:173)
`vertebral implants into the resulting disc space. Introducing
`the intervertebral implant serves to restore the height between
`adjacent vertebrae ("disc height"), which reduces ifnot elimi(cid:173)
`nates neural impingement commonly associated with a dam(cid:173)
`aged or diseased disc.
`Autologous bone grafts are widely used intervertebral
`implant for lumbar fusion. Autologous bone grafts are
`obtained by harvesting a section ofbone from the iliac crest of 40
`the patient and thereafter implanting the article of autologous
`bone graft to effect fusion. While generally effective, the use
`of autologous bone grafts suffers certain drawbacks. A pri(cid:173)
`mary drawback is the morbidity associated with harvesting
`the autologous graft from the patient's iliac crest. Another
`related drawback is the added surgical time required to per(cid:173)
`form the bone-harvesting.
`Allograft bone grafts have been employed with increased
`regularity in an effort to overcome the drawbacks of autolo(cid:173)
`gous bone grafts. Allograft bone grafts are harvested from
`cadaveric specimens, machined, and sterilized for implanta(cid:173)
`tion. While allograft bone grafts eliminate the morbidity asso(cid:173)
`ciated with iliac crest bone harvesting, as well as decrease the
`overall surgical time, they still suffer certain drawbacks. A
`primary drawback is supply constraint, in that the tissue
`banks that process and produce allograft bone implants find it
`difficult to forecast allograft given the inherent challenges in
`forecasting the receipt of cadavers. Another related drawback
`is that it is difficult to manufacture the allograft with consis(cid:173)
`tent shape and strength characteristics given the variation
`from cadaver to cadaver.
`The present invention is directed at overcoming, or at least
`improving upon, the disadvantages of the prior art.
`
`SUMMARY OF THE INVENTION
`
`The present invention overcomes the drawbacks of the
`prior art by providing a spinal fusion system and related
`
`ALPHATEC HOLDINGS, INC., ALPHATEC SPINE INC.
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`US 8,361,156 B2
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`3
`lower surfaces or, alternatively, each spike element may com(cid:173)
`prise a shorter element which only extends through a single
`surface (that is, does not extend through the entire height of
`the implant). In any event, when the spike elements are pro(cid:173)
`vided having radiodense characteristics and the implant is
`manufactured from a radio lucent material (such as, by way of
`example only, PEEK and/or PEKK), the spike elements will
`be readily observable under X-ray or fluoroscopy such that a
`surgeon may track the progress of the implant during implan(cid:173)
`tation and/or the placement of the implant after implantation. 10
`The spinal implant of the present invention may be intro(cid:173)
`duced into a spinal target site through the use of any of a
`variety of suitable instruments having the capability to releas(cid:173)
`ably engage the spinal implant. In a preferred embodiment, 15
`the insertion instrument permits quick, direct, accurate place(cid:173)
`ment of the spinal implant of the present invention into the
`intervertebral space. According to one embodiment, the
`insertion instrument includes a threaded engagement element
`dimensioned to threadably engage into a receiving aperture 20
`formed in the spinal fusion implant of the present invention.
`According to another embodiment, the insertion instrument
`includes an elongate fork member and a generally tubular
`lock member.
`
`BRIEF DESCRIPTION OF THE DRAWINGS
`
`4
`FIG. 9 is a perspective exploded view of the insertion
`instrument of FIG. 1, illustrating the component parts of the
`insertion instrument according to one embodiment of the
`present invention;
`FIG. 10 is a perspective view of a spinal fusion system of
`the present invention, including a cervical fusion implant
`releasably coupled to a cervical insertion instrument accord(cid:173)
`ing to one embodiment of the present invention;
`FIG. 11 is a perspective view of the proximal side of the
`cervical fusion implant of FIG. 10, illustrating (among other
`things) fusion apertures extending between top and bottom
`surfaces, a plurality of visualization apertures extending
`through the lateral walls, a plurality of receiving apertures,
`and a variety of anti-migration features according to one
`embodiment of the present invention;
`FIG. 12 is a perspective view of the distal side cervical
`fusion implant of FIG. 10, illustrating (among other things)
`the visualization apertures and anti-migration features;
`FIG.13 is a top view of the cervical fusion implant of FIG.
`10, illustrating (among other things) the fusion apertures and
`anti-migration features according to one embodiment of the
`present invention;
`FIG.14 is a side view of the cervical fusion implant of FIG.
`10, illustrating (among other things) the visualization aper-
`25 tures, the anti-migration features, and one of two receiving
`apertures provided in the proximal end for releasably engag(cid:173)
`ing the cervical insertion instrument of FIG. 10 according to
`one embodiment of the present invention;
`FIG. 15 is a perspective view of the cervical fusion implant
`30 of the present invention just prior to attachment to the cervical
`insertion device according to one embodiment of the present
`invention;
`FIG.16 is a perspective view of the insertion instrument of
`FIG. 10 in a fully assembled form according to one embodi(cid:173)
`ment of the present invention;
`FIG. 17 is a perspective exploded view of the insertion
`instrument of FIG. 10, illustrating the component parts of the
`insertion instrument according to one embodiment of the
`present invention;
`FIGS. 18 and 19 are perspective and side views, respec(cid:173)
`tively, illustrating the "enhanced visualization" feature of the
`present invention as employed within a lumbar fusion implant
`according to one embodiment of the present invention;
`FIGS. 20 and 21 are perspective and side views, respec(cid:173)
`tively, illustrating the "enhanced visualization" feature of the
`present invention as employed within a lumbar fusion implant
`according to one embodiment of the present invention; and
`FIGS. 22 and 23 are perspective and side views, respec(cid:173)
`tively, illustrating the "enhanced visualization" feature of the
`50 present invention as employed within a cervical fusion
`implant according to one embodiment of the present inven(cid:173)
`tion.
`
`35
`
`Many advantages of the present invention will be apparent
`to those skilled in the art with a reading ofthis specification in
`conjunction with the attached drawings, wherein like refer(cid:173)
`ence numerals are applied to like elements and wherein:
`FIG. 1 is a perspective view of a spinal fusion system of the
`present invention, including a lumbar fusion implant releas(cid:173)
`ably coupled to an insertion instrument according to one
`embodiment of the present invention;
`FIG. 2 is a perspective view of the lumbar fusion implant of
`FIG. 1, illustrating (among other things) fusion apertures
`extending between top and bottom surfaces, a plurality of
`visualization apertures extending through the side walls, and 40
`a variety of anti-migration features according to one embodi(cid:173)
`ment of the present invention;
`FIG. 3 is a top view of the lumbar fusion implant of FIG. 1,
`illustrating (among other things) the fusion apertures and the
`anti-migration features according to one embodiment of the 45
`present invention;
`FIG. 4 is a side view of the lumbar fusion implant of FIG.
`1, illustrating (among other things) the visualization aper(cid:173)
`tures, the anti-migration feature, and a receiving aperture for
`releasably engaging the insertion instrument of FIG. 1
`according to one embodiment of the present invention;
`FIG. 5 is an end view of the lumbar fusion implant of FIG.
`1, illustrating (among other things) the receiving aperture
`formed in the proximal end, the anti-migration features, and
`the visualization apertures according to one embodiment of 55
`the present invention;
`FIG. 6 is an enlarged side view of the lumbar fusion
`implant of FIG. 1 releasably coupled to the distal end of the
`insertion instrument of FIG. 1 according to one embodiment 60
`of the present invention;
`FIG. 7 is a perspective view of the insertion instrument of
`FIG. 1 in a fully assembled form according to one embodi(cid:173)
`ment of the present invention;
`FIG. 8 is an enlarged perspective view of the distal region 65
`of the insertion instrument of FIG. 1 according to one
`embodiment of the present invention;
`
`DESCRIPTION OF THE PREFERRED
`EMBODIMENTS
`
`Illustrative embodiments of the invention are described
`below. In the interest of clarity, not all features of an actual
`implementation are described in this specification. It will of
`course be appreciated that in the development of any such
`actual embodiment, numerous implementation-specific deci(cid:173)
`sions must be made to achieve the developers' specific goals,
`such as compliance with system-related and business-related
`constraints, which will vary from one implementation to
`another. Moreover, it will be appreciated that such a develop(cid:173)
`ment effort might be complex and time-consuming, but
`would nevertheless be a routine undertaking for those of
`
`ALPHATEC HOLDINGS, INC., ALPHATEC SPINE INC.
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`US 8,361,156 B2
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`5
`ordinary skill in the art having the benefit of this disclosure.
`The system to facilitate bone fusion and related methods
`disclosed herein boasts a variety of inventive features and
`components that warrant patent protection, both individually
`and in combination.
`FIG. 1 illustrates, by way of example only, a spinal fusion
`system 5 for performing spinal