(12) United States Patent
`(10) Patent No.:
`US 8,343,224 B2
`
`Lynn et al.
`(45) Date of Patent:
`Jan. 1, 2013
`
`USOO8343224B2
`
`INTERVERTEBRAL IMPLANTS AND GRAFT
`DELIVERY SYSTEMS AND METHODS
`
`FOREIGN PATENT DOCUMENTS
`WO 2011/116136
`9/2011
`
`W0
`
`OTHER PUBLICATIONS
`International Search Report for International Application No. PCT/
`U820 l l/02873l (a PCT counterpart ofthe present application) dated
`May 18, 2011.
`
`(Continued)
`
`Primary Examiner 7 Ellen C Hammond
`(74) Attorney, Agent, or Firm 7 Knobbe, Martens, Olson &
`Bears LLP
`
`(57)
`
`ABSTRACT
`
`According to some embodiments, a method for promoting
`spinal fusion using a spinal implant comprises providing a
`spinal implant, wherein the spinal implant comprises an ante-
`rior wall, a posterior wall and two lateral walls configured to
`extend between the anterior wall and the posterior wall. In
`some embodiments, the spinal implant further comprises at
`least one internal chamber generally positioned between the
`anterior wall, the posterior wall and the two lateral walls,
`wherein the internal chamber being is adapted to receive at
`least one graft and/or other fill material. In some arrange-
`ments, the anterior wall of the spinal implant comprises at
`least one opening or hole that places the internal chamber in
`fluid communication with an exterior area or portion of the
`spinal implant. In one embodiment, at least one of the two
`lateral walls comprises an access port. The method addition-
`ally includes positioning the spinal implant between two
`adjacent vertebrae of a patient and directing at least one graft
`and/or other fill material into the internal chamber of the
`
`spinal implant through the access port. In some embodiments,
`at least a portion of the graft and/or other fill material deliv-
`ered into the internal chamber is configured to exit through
`the one or more of the openings of the anterior wall.
`
`20 Claims, 27 Drawing Sheets
`
`(54)
`
`(75)
`
`Inventors: Jim R. Lynn, San Clemente, CA (US);
`Russell W. Nelson, Westlake Village, CA
`(US)
`
`( * ) Notice:
`
`(73) Assignee: Pinnacle Spine Group, LLC, Dallas,
`TX
`S
`(U )
`Subject to any disclaimer, the term of this
`51586513 11552331135165?) (:1; :djusted under 35
`.
`i
`i
`y
`y i
`(21) Appl. No.: 13/049,693
`
`(22)
`
`Filed:
`
`Mar. 16, 2011
`
`(65)
`
`P151015 Publlcatlon Data
`US 2011/0230970Al
`Sep. 22, 2011
`
`Related U-S- Application Data
`(60) Provisional application No. 61/314 509 filed on Mar.
`16 2010 provisional application5 No5 61/389 671
`filed on Oct 4 2010
`i
`5
`i
`5
`
`5
`
`.
`
`(51)
`
`(56)
`
`(2006.01)
`
`See a
`
`pp
`
`ry.
`
`Int. Cl.
`A61F 2/44
`623/17 16‘ 606/99
`(52) U S Cl
`(58) Field of Class1ficatlon Search..... 623/17 115717 16'
`' 606/246
`lication file for com lete search histo
`p
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`

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`
`Butterman et al., Interbody device endplate engagement eflects on
`motion segment biomechanics, The Spine Journal 9, 2009, pp. 564-
`573.
`Product information in 1 page for an implant named Cross—Fuse®
`Lateral Option System by Pioneer Surgical Technology, Inc. (dated
`201 1 and retrieved on or aboutAug. 2012 from wwwpioneersurgical.
`com/international/indeX.php?option:comicontent&view:article&
`id:72&Itemid:72).
`
`2
`
`

`

`US 8,343,224 B2
`Page 3
`
`named
`implant
`an
`for
`page
`1
`in
`information
`Product
`TransContinental® Spacer System by Globus Medical,
`Inc.
`(retrieved on or about Aug. 2012 from www.globusmedical.com/
`intervertebral-fusion/220-transcontinental).
`Product information in 1 page for an implant named CoRoent®
`Interbody/VBR Implant by NuVasive, Inc. (retrieved on or about Aug.
`2012 as a partial image (screenshot) capture from wwwnuvasive.
`com/health-providers/innovative-solutions/).
`Wright, N.M., MD, Biomechanical Testing of XLIF Constructsi
`Stand—Alone Interbody Versus Interbody Supplemented with Lateral
`
`or Posterior Instrumentation, Digital Poster presented at the Con-
`gress of Neurological Surgeons (CNS) Annual Conference 2005 in
`Boston, Massachusetts (Oct. 8, 2005-Oct. 13, 2005), which illus-
`trates and discusses,
`inter alfa, an implant named CoRoent by
`NuVasive, Inc.
`DeWald, R.L., “Spinal Deformities: The Comprehensive Text,” (par—
`tial excerptfrom book), published Mar. 15, 2003.
`
`* cited by examiner
`
`3
`
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`US 8,343,224 B2
`
`1
`INTERVERTEBRAL IMPLANTS AND GRAFT
`DELIVERY SYSTEMS AND METHODS
`
`PRIORITY DATA
`
`This application claims the priority benefit under 35 U.S.C.
`§119(e) of US. Provisional Application No. 61/314,509,
`filed Mar. 16, 2010, and U.S. Provisional Application No.
`61/389,671, filed Oct. 4, 2010, the entire contents ofboth of
`which are hereby incorporated by reference herein.
`
`BACKGROUND
`
`1. Field
`
`This application generally relates to spinal fusion, and
`more specifically, to spinal implants and related systems,
`tools and methods.
`
`2. Description of the Related Art
`Intervertebral discs can degenerate or otherwise become
`damaged over time. In some instances, an intervertebral
`implant can be positioned within a space previously occupied
`by a disc. Such implants can help maintain a desired spacing
`between adjacent vertebrae and/or promote fusion between
`adjacent vertebrae. The use of bone graft and/or other mate-
`rials within spinal implants can facilitate the fusion of adja-
`cent vertebral bodies. Accordingly, a need exists for an
`improved intervertebral implant, as well as related instrumen-
`tation, tools, systems and methods.
`
`SUMMARY
`
`According to some embodiments, a spinal implant config-
`ured for placement within an intervertebral space of a patient
`comprises an anterior wall, a posterior wall, a first lateral wall
`and a second lateral wall, such that the first and second lateral
`walls generally extend between the anterior wall and the
`posterior wall. The spinal implant additionally comprises at
`least one internal chamber defined, at least in part, by the
`anterior wall, the posterior wall and the first and second lateral
`walls. In some embodiments, the implant comprises a top
`surface having a plurality of teeth configured to at least par-
`tially engage a lower surface of a first vertebral body and/or a
`bottom surface comprising a plurality ofteeth configured to at
`least partially engage an upper surface of a second vertebral
`body, the second vertebral body being adjacent to said first
`vertebral body. In some embodiments, the at least one internal
`chamber extends at least partially from the top surface to the
`bottom surface of the implant. The implant further comprises
`at least one opening extending through the anterior wall,
`wherein such an opening is in fluid communication with the
`internal chamber. In some embodiments, the spinal implant
`additionally comprises at least one access port located in the
`anterior wall, the first lateral wall and/or the second lateral
`wall. In some embodiments, the implant is configured to
`releasably secure to an insertion tool using the access port. In
`some embodiments, the implant is configured to span across
`an entire width or substantially an entire width ofthe adjacent
`vertebral bodies. In one embodiment, the access port is con-
`figured to receive at least one graft material delivered into the
`at least one internal chamber. In some embodiments, the
`posterior wall does not comprise any openings.
`According to some embodiments, excess graft material
`delivered into the at least one internal chamber through the
`access port is configured to exit the implant through one or
`more openings of the anterior wall. In one embodiment, the
`access port is threaded, so that a delivery tool comprising a
`corresponding thread pattern can be selectively attached and
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`detached to the spinal implant. In some embodiments, the
`implant comprises one or more recesses and/or other features
`configured to mate with corresponding flanges or other pro-
`truding members of an implant delivery tool. In one embodi-
`ment, each ofthe first and second lateral walls is configured to
`generally align with peripheral bearing areas of the adjacent
`vertebral members. In other embodiments, the teeth along the
`top and/or bottom surfaces of the implant are configured to
`slant toward a lateral center of the implant. In some embodi-
`ments, the slanted teeth help retain the implant within the
`target intervertebral space after implantation and/or help
`reduce the likelihood the migration of grafting materials out
`of the at least one internal chamber of the implant along the
`top and bottom surfaces of the implant.
`According to some embodiments, the first lateral wall and/
`or the second lateral wall comprises a tapered portion to
`facilitate insertion ofthe implant into the intervertebral space.
`In one embodiment, the spinal implant further comprises a
`plurality of prongs that extend into the internal chamber for
`retaining a graft or other member positioned therein. In some
`embodiments, such prongs are configured to retain at least
`one of a sponge, a porous foam and cured grafting materials
`within the at least one internal chamber of the implant. In
`some embodiments, the implant is configured for placement
`within a lumbar or thoracic portion of a patient’s spine. In
`some embodiments, the implant is configured for lateral or
`anterior insertion into the intervertebral space. In several
`embodiments, the implant comprises polyether etherketone
`(PEEK) and/or any other material.
`According to some embodiments, the length of each of the
`first and second lateral walls is approximately 10% to 20% of
`an overall length of the implant. In other embodiments, the
`length of each of the first and second lateral walls is less than
`about 10% or greater than about 20% of an overall length of
`the implant. In one embodiment, the teeth along at least one of
`the top and/or bottom surfaces of the implant are oriented, at
`least in part, in a concentric manner. In one embodiment, a
`radius ofcurvature ofthe teeth along at least one ofthe top and
`bottom surfaces of the implant increases with increasing dis-
`tance from a center ofthe implant. In some arrangements, the
`top and/or bottom surfaces of the implant are generally pla-
`nar. In other embodiments, the top and/or bottom surfaces of
`the implant are generally curved, fluted, rounded and/or non-
`planar.
`According to some embodiments, the implant comprises a
`lordotic implant, such that a height of the first lateral wall is
`greater than a height of the second lateral wall. In some
`embodiments, the internal chamber does not comprise any
`interior walls orbaffles. In alternative embodiments, the inter-
`nal chamber comprises at least two internal sub-chambers
`divided by at least one interior wall or baffle. In one embodi-
`ment,
`the implant comprises at
`least one radio-opaque
`marker. In several embodiments, the access port is generally
`circular. In other embodiments, the access port is non-circular
`(e.g., square, other rectangular or polygonal, oval, elliptical,
`irregular, etc .).
`According to some embodiments, the access port com-
`prises a minimum diameter of approximately 6 mm. In other
`embodiments, the diameter or other cross-sectional dimen-
`sion ofthe access port is greater or less than about 6 mm (e. g.,
`4 mm, 5 mm, 7 mm, 8 mm, etc.). In some embodiments, the
`access port is adapted to receive a fill tube, catheter or other
`conduit therethrough, wherein such fill tube, catheter or other
`conduit is configured to selectively deliver a grafting or fill
`material into the internal chamber of the implant. In some
`embodiments, a ratio of a diameter of the at least one access
`port to a height of the first or second lateral wall through
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`US 8,343,224 B2
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`3
`which the at least one access port is located is between
`approximately 0.4 and 0.8 (e.g., about 0.4, 0.45, 0.5, 0.55, 0.6,
`0.65, 0.7, 0.75, 0.8, 0.85, 0.9, etc.). In one embodiment, a
`minimum ratio of a diameter of the at least one access port to
`a height ofthe first or second lateral wall through which the at
`least one access port is located is approximately 0.5, 0.6, 0.7
`or 0.8.
`
`According to some embodiments, the access port com-
`prises a valve or other flow blocking device or feature to help
`retain grafting materials within the at least one internal cham-
`ber of the implant. In some embodiments, an exterior profile
`of the anterior wall is generally curved. In some arrange-
`ments, an exterior profile of the posterior wall is generally
`planar.
`According to some embodiments, a method for promoting
`spinal fusion comprises providing a spinal implant (e. g., such
`as one ofthe implants disclosed herein or equivalents thereof)
`and positioning the spinal implant between two adjacent ver-
`tebral bodies or vertebrae of a patient. The method further
`comprises directing at least one graft material into the internal
`chamber ofthe spinal implant through a port ofthe implant. In
`some embodiments, at least a portion ofthe graft and/or other
`filler material (e.g., materials in excess of the capacity of the
`implant) delivered into the at least one internal chamber is
`configured to exit through one or more openings of the ante-
`rior wall when a sufficient amount of the at least one graft
`material has been delivered into the at least one internal
`chamber.
`
`According to some embodiments, positioning the spinal
`implant between two adjacent vertebrae comprises remov-
`ably securing the spinal implant to the distal end of an inser-
`tion tool assembly, wherein the insertion tool assembly is
`secured to, at least in part, to the access port of the spinal
`implant. In some embodiments, the access port is used to both
`secure the implant to an implant delivery tool and to deliver
`grafting and/or other materials to the inside of the implant. In
`some embodiments, directing graft and/or other materials
`into the internal chamber comprises passing such materials
`through a cannulated portion ofthe insertion tool assembly. In
`other embodiments, directing the material into the internal
`chamber comprises passing the materials through a separate
`conduit adapted to be removably positioned within the access
`port of the spinal implant. In one embodiment, directing the
`graft and/or other materials into the internal chamber com-
`prises injecting such materials through tubing using a syringe.
`According to some embodiments, the tubing is routed
`through an internal passage of a fill tube assembly, wherein
`fill tube assembly is configured to engage at least a portion of
`the spinal implant while the graft and/or other materials are
`directed into the internal chamber of the implant. In some
`embodiments, at least a portion ofthe graft material delivered
`into the internal chamber is configured to exit through an
`interface between the upper and/or lower surface of the
`implant and the adjacent endplate surfaces of the vertebral
`bodies. In some embodiments, at least a portion ofthe internal
`chamber comprises a graft material prior to positioning the
`spinal implant between the two adjacent vertebrae. In some
`embodiments, an additional volume of a graft material is
`delivered into the internal chamber of the implant after the
`spinal implant has been secured between the two adjacent
`vertebrae.
`
`the method further
`According to some embodiments,
`includes preparing at least one adjacent vertebral body sur-
`face for the delivery of the spinal implant, wherein preparing
`an adjacent vertebral body surface comprises abrading said
`surface using a rasping and/or other abrading or roughening
`tool. In some embodiments, such tools comprise one or more
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`roughened surfaces or features configured to abrade bone
`and/or other tissue. In some embodiments, the method addi-
`tionally comprises placing a sizing tool within a target inter-
`vertebral space prior to positioning the spinal
`implant
`between two adjacent vertebrae of a patient in order to deter-
`mine the appropriate size of said spinal implant. In some
`embodiments, the sizing tool is configured to distract the
`adjacent vertebrae by a desired distance.
`According to some embodiments, a kit includes a spinal
`implant (e. g., such as any of those disclosed herein or equiva-
`lents thereof), an implant delivery tool configured to remov-
`ably secure to the spinal implant and a graft material delivery
`system configured to selectively deliver at least one graft
`and/or other filler material into an interior (e.g.,
`internal
`chamber) of the spinal implant. In some arrangements, the
`graft material delivery system comprises a syringe, a sizing
`tool and a conduit configured to pass through the at least one
`access port of the spinal implant.
`According to some embodiments, a method for promoting
`spinal fusion using a spinal implant comprises providing a
`spinal implant, wherein the spinal implant comprises an ante-
`rior wall, a posterior wall and two lateral walls configured to
`extend between the anterior wall and the posterior wall. In
`some embodiments, the spinal implant further comprises at
`least one internal chamber generally positioned between the
`anterior wall, the posterior wall and the two lateral walls,
`wherein the internal chamber being is adapted to receive at
`least one graft and/or other fill material. In some arrange-
`ments, the anterior wall of the spinal implant comprises at
`least one opening or hole that places the internal chamber in
`fluid communication with an exterior area or portion of the
`spinal implant. In one embodiment, at least one of the two
`lateral walls comprises an access port. The method addition-
`ally includes positioning the spinal implant between two
`adjacent vertebrae of a patient and directing at least one graft
`and/or other fill material into the internal chamber of the
`
`spinal implant through the access port. In some embodiments,
`at least a portion of the graft and/or other fill material deliv-
`ered into the internal chamber is configured to exit through
`the one or more of the openings of the anterior wall.
`implant
`In some embodiments, positioning the spinal
`between two adjacent vertebrae comprises removably secur-
`ing the spinal implant to the distal end of an insertion tool
`assembly, wherein the insertion tool assembly is secured to, at
`least in part, to the access port of the spinal implant. In one
`embodiment, directing the graft material into the internal
`chamber comprises passing the graft material through a can-
`nulated portion of the insertion tool assembly. In some
`embodiments, directing the graft material into the internal
`chamber comprises injecting one or more graft materials
`through flexible tubing using a syringe. In some embodi-
`ments, the flexible tubing is routed through an internal pas-
`sage of a fill tube assembly, wherein the fill tube assembly is
`configured to engage at least a portion of the spinal implant
`while the graft material is being directed into the internal
`chamber. In some arrangements, at least a portion of the graft
`and/or other fill material delivered into the internal chamber is
`
`configured to exit through an interface between the upper
`surface and/or lower surface of the spinal implant and an
`adjacent endplate surface of a vertebral body. In one embodi-
`ment, at least a portion of the internal chamber comprises a
`graft material prior to positioning the spinal implant between
`the two adjacent vertebrae. In some embodiments, such a
`pre-loaded graft material or item comprises a graft, an absor-
`bent sponge or other member and or the like.
`According to some embodiments, an implant configured
`for placement within an intervertebral space of a patient com-
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`US 8,343,224 B2
`
`5
`prises an anterior wall, a posterior wall, a first lateral wall and
`a second lateral wall, whereinthe first and second lateral walls
`are configured to extend between the anterior wall and the
`posterior wall. The implant further includes a top surface
`having a plurality of teeth adapted to at least partially engage
`a lower surface of a first vertebral body and a bottom surface
`having a plurality of teeth adapted to at least partially engage
`an upper surface of a second vertebral body, wherein the
`second vertebral body is adjacent to the first vertebral body.
`The implant further comprises one or more internal chambers
`positioned between the anterior wall, the posterior wall, the
`first lateral wall and the second lateral wall, wherein the
`internal chamber at least partially extends from the top sur-
`face to the bottom surface of the implant.
`In some embodiments, the implant additionally includes at
`least one opening extending through the anterior wall,
`wherein the opening is in fluid communication with the inter-
`nal chamber. In one embodiment, the implant further com-
`prises at least one access port located in the anterior wall, the
`first lateral wall and/or the second lateral wall, wherein the
`implant is configured to releasably secure to an insertion tool
`using the access port. In some embodiments, the access port
`is configured to receive a graft material that is delivered into
`the internal chamber after the implant has been secured
`within the intervertebral space. In one embodiment, the pos-
`terior wall does not comprise any openings. In some arrange-
`ments, the graft material delivered into the internal chamber is
`configured to exit the implant through at least one opening of
`the anterior wall.
`
`According to some embodiments, the implant comprises
`polyether etherketone (PEEK). In several arrangements, the
`length of each of the first and second lateral walls is approxi-
`mately 10-20% of the overall length of the implant. In some
`embodiments, each of the first and second lateral walls is
`configured to generally align with the peripheral bearing
`areas of the adjacent vertebral members. In some embodi-
`ments, the plurality of teeth situated along the top and/or
`bottom surfaces of the implant are configured to slant to
`toward a lateral center ofthe implant. In one embodiment, the
`first lateral wall and/or the second lateral wall comprises a
`tapered portion to facilitate insertion of the implant into the
`intervertebral space. In some arrangements, the implant is
`configured for lateral, anterior or posterior insertion into the
`targeted intervertebral space. In some embodiments,
`the
`implant is configured for placement within a lumbar or tho-
`racic portion of a patient’s spine. In one embodiment, the
`implant additional comprises a plurality of prongs extending
`into the interior chamber for retaining a graft or other member
`positioned therein.
`
`BRIEF DESCRIPTION OF THE DRAWINGS
`
`These and other features, aspects and advantages of the
`present application are described with reference to drawings
`of certain embodiments, which are intended to illustrate, but
`not to limit, the present disclosure. It is to be understood that
`these drawings are for the purpose of illustrating concepts of
`the present disclosure and may not be to scale.
`FIG. 1A illustrates a front perspective view of a spinal
`implant according to one embodiment;
`FIG. 1B illustrates a rear perspective view ofthe implant of
`FIG. 1A;
`FIG. 2 illustrates a top view of the implant of FIG. 1A;
`FIG. 3A illustrates a side view of the implant of FIG. 1A;
`FIGS. 3B and 3C illustrate detailed side views of the
`
`implant of FIG. 1A;
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`FIGS. 4 and 5 illustrate different side views of the implant
`of FIG. 1A;
`FIG. 6A illustrates perspective views of an implant and an
`insertion tool configured to engage the implant according to
`one embodiment;
`FIG. 6B illustrates a partial top view of a spinal implant
`according to one embodiment;
`FIG. 6C illustrates a perspective view of a spinal implant
`according to one embodiment;
`FIG. 6D illustrates a top view of a spinal implant according
`to one embodiment;
`FIG. 7A illustrates an anterior side view of an implant
`within a targeted intervertebral space and secured to an inser-
`tion tool assembly, according to one embodiment;
`FIG. 7B illustrates lateral side view of the implant of FIG.
`7A;
`FIG. 8 illustrates two embodiments of sizing and distrac-
`tion tools;
`FIG. 9 illustrates one embodiment of a rasping or abrading
`tool for use as a preparatory tool in advance of implantation of
`a spinal implant;
`FIGS. 10A and 10B illustrate perspective views of another
`embodiment of a rasping or abrading tool for preparing an
`intervertebral space;
`FIG. 11 illustrates a perspective view of an insertion tool
`assembly attached to a spinal implant, according to one
`embodiment;
`FIG. 12A illustrates an exploded perspective view of the
`insertion tool assembly and implant of FIG. 11;
`FIG. 12B illustrates a partial cross-sectional view of an
`insertion tool assembly secured to an implant, according to
`one embodiment;
`FIG. 13 illustrates a perspective view of various compo-
`nents of a graft fill kit, according to one embodiment;
`FIG. 14 illustrates an anterior side view of a fill tool assem-
`
`bly engaged with a spinal implant positioned within a targeted
`intervertebral space, according to one embodiment;
`FIG. 15 illustrates a syringe assembly configured for post-
`filling a spinal implant with graft and/or other fill materials,
`according to one embodiment;
`FIGS. 16A-16C illustrate various view of time-sequential
`steps related to positioning a syringe assembly within a fill
`tool assembly, according to one embodiment;
`FIGS. 17A and 17B illustrates different side views of
`
`excess graft and/or other fill material that has exited the
`interio