US 8,361,156 B2
`(10) Patent No.:
`(12) Unlted States Patent
`
`Curran et a].
`(45) Date of Patent:
`Jan. 29, 2013
`
`IISOO8361156B2
`
`(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)
`>1:
`‘
`.
`~
`~
`~
`~
`) NOtlce'
`subJeCt.tO any ddlsglalmeé’. the aermefthls
`patent 1s exten e or a Juste un er 35
`U.S.C. 154(b) by 0 days.
`
`(
`
`(21) Appl. No.: 13/441,092
`
`.
`~
`Ffled‘
`
`(22)
`(65)
`
`APE 6’ 2012
`_
`_
`_
`Prlor Publlcatlon Data
`
`US 2012/0209388 A1
`
`Aug. 16, 2012
`
`Related US. Application Data
`(63) Continuation of application No. 13/440,062, filed on
`Apr. 5, 2012, HOW Pat. No. 8,246,686, which is a
`continuation of application No. 13/079,645, filed on
`Apr. 4, 2011, HOW Pat. No. 8,187,334, which is a
`continuation 0f application N0~ 11/093,409, filed on
`Mar. 29: 2005: now Pat' No' 759185891'
`(60) Provisional application No. 60/557,536, filed on Mar.
`29: 2004.
`
`(51)
`
`Int Cl
`(200601)
`A61F 2/44
`................................... 623/17.16
`(52) US. Cl.
`........
`(58) Fleld of .Class1ficatlon Search ..... 623/17.11717.19
`See appl1cat1on file for complete search h1story.
`_
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`(Continued)
`Primary Examiner 7 Ellen C Hammond
`Assistant Examiner 7 Stuart S Bray
`(74) Attorney, Agent, or Firm 7 Fish & Richardson PC.
`
`(57)
`
`ABSTRACT
`
`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
`
`
`
`
`M83 1013
`
`

`

`US 8,361,156 B2
`
`Page2
`
`'
`
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`

`

`US 8,361,156 B2
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`
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`
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`
`* cited by examiner
`
`

`

`US. Patent
`
`Jan. 29, 2013
`
`Sheet 1 of 20
`
`US 8,361,156 B2
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`
`
`FIG. 1
`
`

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`US. Patent
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`Jan. 29, 2013
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`Jan. 29, 2013
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`US 8,361,156 B2
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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 US. patent application
`Ser. No. 13/440,062 filed Apr. 5, 2012, which is a continua-
`tion of US. patent application Ser. No. 13/079,645 filed Apr.
`4, 201 1, which is continuation of US. patent application Ser.
`No. 11/093,409 filed Mar. 29, 2005 (now US. Pat. No. 7,918,
`891), which claims the benefit ofthe 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
`
`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-
`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 PriorArt
`Currently there are nearly 500,000 spine lumbar and cer-
`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-
`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-
`nates neural impingement commonly associated with a dam-
`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
`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-
`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-
`form the bone-harvesting.
`Allograft bone grafts have been employed with increased
`regularity in an effort to overcome the drawbacks of autolo-
`gous bone grafts. Allograft bone grafts are harvested from
`cadaveric specimens, machined, and sterilized for implanta-
`tion. While allograft bone grafts eliminate the morbidity asso-
`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-
`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
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`methods involving the use of a spinal fusion implant of non-
`bone construction. The non-bone construction of the spinal
`fusion implant of the present invention overcomes the draw-
`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-
`tions (e. g. poly-ether-ether-ketone (PEEK) and/or poly-ether-
`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-
`ing upon the particular surgical procedure or need. The spinal
`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-
`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-
`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
`length about 14 mm.
`The spinal fusion implant of the present invention may be
`provided with any number of additional features for promot-
`ing fusion, such as apertures extending between the upper and
`lower vertebral bodies which allow a honey bridge to form
`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-
`ing but not limited to bone morphogenic protein (BMP) and
`bio-resorbable polymers, including but not limited to any of a
`variety of poly (D,L-lactide-co-glycolide) based polymers.
`The spinal fusion implant of the present invention is prefer-
`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-
`tion features may include, but are not necessarily limited to,
`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-
`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-
`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-
`rials, including but not limited to a metal, ceramic, and/or
`polymer material, preferably having radiopaque characteris-
`tics. The spike elements may also take any of a variety of
`suitable shapes, including but not limited to a generally elon-
`gated element disposed within the implant such that the ends
`thereof extend generally perpendicularly from the upper and/
`or lower surfaces ofthe implant. The spike elements may each
`comprise a unitary element extending through upper and
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`US 8,361,156 B2
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`3
`lower surfaces or, alternatively, each spike element may com-
`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-
`vided having radiodense characteristics and the implant is
`manufactured from a radiolucent 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 ofthe implant during implan-
`tation and/or the placement of the implant after implantation.
`The spinal implant of the present invention may be intro-
`duced into a spinal target site through the use of any of a
`variety of suitable instruments having the capability to releas-
`ably engage the spinal implant. In a preferred embodiment,
`the insertion instrument permits quick, direct, accurate place-
`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
`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
`
`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-
`ence numerals are applied to like elements and wherein:
`FIG. 1 is a perspective view of a spinal fusion system ofthe
`present invention, including a lumbar fusion implant releas-
`ably coupled to an insertion instrument according to one
`embodiment of the present invention;
`FIG. 2 is a perspective view ofthe 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
`a variety of anti-migration features according to one embodi-
`ment of the present invention;
`FIG. 3 is a top view ofthe lumbar fusion implant ofFIG. 1,
`illustrating (among other things) the fusion apertures and the
`anti-migration features according to one embodiment of the
`present invention;
`FIG. 4 is a side view of the lumbar fusion implant of FIG.
`1, illustrating (among other things) the visualization aper-
`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
`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
`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-
`ment of the present invention;
`FIG. 8 is an enlarged perspective view of the distal region
`of the insertion instrument of FIG. 1 according to one
`embodiment of the present invention;
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`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-
`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 ofthe 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 ofthe cervical fusion implant of FIG.
`10, illustrating (among other things) the visualization aper-
`tures, the anti-migration features, and one of two receiving
`apertures provided in the proximal end for releasably engag-
`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
`ofthe present inventionjust 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-
`ment of the present invention;
`FIG. 17 is a perspective exploded view of the insertion
`instrument of FIG. 10, illustrating the component parts ofthe
`insertion instrument according to one embodiment of the
`present invention;
`FIGS. 18 and 19 are perspective and side views, respec-
`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-
`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-
`tively, illustrating the “enhanced visualization” feature of the
`present
`invention as employed within a cervical fusion
`implant according to one embodiment of the present inven-
`tion.
`
`DESCRIPTION OF THE PREFERRED
`EMBODIMENTS
`
`Illustrative embodiments of the invention are described
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`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-
`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-
`ment effort might be complex and time-consuming, but
`would nevertheless be a routine undertaking for those of
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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 fusion between adjacent lum-
`bar vertebrae, including an exemplary spinal fusion implant
`10 and an exemplary insertion instrument 20 provided in
`accordance with the present invention. The spinal fusion
`implant 10 may be comprised of any suitable non-bone com-
`position having suitable radiolucent characteristics, includ-
`ing but not limited to polymer compositions (e. g. poly-ether-
`ether-ketone
`(PEEK)
`and/or
`poly-ether-ketone-ketone
`(PEKK)) or any combination of PEEK and PEKK. The spinal
`fusion implant 10 of the present invention may be dimen-
`sioned, by way of example only, having a width ranging
`between 9 and 18 mm, a height ranging between 8 and 16 mm,
`and a length ranging between 25 and 45 mm.
`As will be described in detail below, the insertion instru-
`ment 20 is configured to releasably maintain the exemplary
`spinal fusion implant 10 in the proper orientation during
`insertion into a lumbar disc space and thereafter release to
`deposit the implant 10. The exemplary spinal fusion implant
`10, having been deposited in the disc space, facilitates spinal
`fusion over time by maintaining a restored disc height as
`natural bone growth occurs through and/or past the implant
`10, resulting in the formation of a boney bridge extending
`between the adjacent vertebral bodies. The implant 10 is
`particularly suited for introduction into the disc space via a
`lateral (trans-psoas) approach to the spine, but may be intro-
`duced in any of a variety of approaches, such as posterior,
`anterior, antero -lateral, and postero-lateral, without departing
`from the scope of the present invention (depending upon the
`sizing of the implant 10).
`The spinal fusion implant 10 of the present invention may
`be provided with any number of additional features for pro-
`moting fusion, such as apertures 2 extending between the
`upper and lower vertebral bodies which allow a boney bridge
`to form through the spinal fusion implant 10. According to a
`still further aspect ofthe present invention, this fusion may be
`facilitated or augmented by introducing or positioning vari-
`ous osteoinductive materials within the apertures 2 and/or
`adjacent to the spinal fusion implant 10. Such osteoinductive
`materials may be introduced before, during, or after the inser-
`tion of the exemplary spinal fusion implant 10, and may
`include (but are not necessarily limited to) autologous bone
`harvested from the patient receiving the spinal fusion implant
`10, bone allograft, bone xenograft, any number of non-bone
`implants (e.g. ceramic, metallic, polymer), bone morpho-
`genic protein, and bio-resorbable compositions, including but
`not limited to any of a variety of poly (D,L-lactide-co-gly-
`colide) based polymers.
`The spinal fusion implant 10 of the present invention is
`preferably equipped with one or more visualization apertures
`4 situated along the lateral sides, which aid in visualization at
`the time of implantation and at subsequent clinical evalua-
`tions. More specifically, based on the generally radiolucent
`nature ofthe implant 10, the visualization apertures 4 provide
`the ability to visualize the interior of the implant 10 during
`X-ray and/or other suitable imaging techniques which are
`undertaken from the side (or “lateral”) perspective of the
`implant 10. If fusion has taken place, the visualization aper-
`tures 4 will provide a method for the surgeon to make follow
`up assessments as to the degree of fusion without any visual
`interference from the spinal fusion implant 10. Further, the
`visualization apertures 4 will provide an avenue for cellular
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`migration to the exterior ofthe spinal fusion implant 10. Thus
`the spinal fusion implant 10 will serve as additional scaffold-
`ing for bone fusion on the exterior ofthe spinal fusion implant
`10.
`
`FIGS. 2-5 depict various embodiments of the exemplary
`spinal fusion implant 10. Some common attributes are shared
`among the various embodiments. More specifically, each spi-
`nal fusion implant 10 has a top surface 31, a bottom surface
`33, lateral sides 14, a proximal side 22, and a distal side 16. In
`one embodiment, the top and bottom surfaces 31, 33 are
`generally parallel. It can be appreciated by one skilled in the
`art that although the surfaces 31, 33 are generally parallel to
`one another, they may be provided