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`US008623088B1
`
`(12) United States Patent
`Tohmeh et al.
`
`(10) Patent N0.:
`(45) Date of Patent:
`
`US 8,623,088 B1
`Jan. 7, 2014
`
`(54) SPINAL FUSION IMPLANT AND RELATED
`METIIODS
`
`(75)
`
`Inventors: Antoine G. Tohmeh, Spokane, WA
`(US); Joseph Clark, San Diego, CA
`(U S)
`
`(73) Assignee: NuVasive, Inc., San Diego, CA (US)
`
`*
`
`Notice:
`
`J
`Y
`Sub'ect to an disclaimer, the term ofthis
`patent is extended or adjusted under 35
`U.S.C. l54(b) by 132 days.
`
`(21) Appl.No.: 12/329,195
`
`(22) Filed:
`
`Dec. 5, 2008
`
`Related U.S. Application Data
`
`(63) Continuation-in-part of application No. 11/488,744,
`filed on Jul. 17, 2006, now Pat. No. 7,867,277.
`
`(60) Provisional application No. 60/699,597, filed on Jul.
`15,2005.
`
`(51)
`
`Int. Cl.
`A6IF 2/44
`
`(2006.01)
`
`(52) U.S. Cl.
`USPC ..................................................... .. 623/17.11
`(58) Field of Classification Search
`USPC ................... .. 623/17.11-17.16; 606/247—249
`See application file for complete search history.
`
`(56)
`
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`
`(Continued)
`
`Primary Exaininer — Mary Hoflinan
`(74) Attornej’, Agent, or Firm — Jonathan Spangler; Jennifer
`Russell; Heather Prado
`
`(57)
`
`ABSTRACT
`
`A spinal fusion implant ofnon—bone construction to be intro-
`duced into any variety of spinal target sites. The spinal fusion
`implant of the present invention includes a top surface, a
`bottom surface, first and second lateral sides, a proximal
`(posterior) end and a distal (anterior) end. The spinal fusion
`implant of the present invention may be used to provide
`temporary or pennanent fixation within an orthopedic target
`site. To do so, the spinal fusion implant may be introduced
`into a disc space while locked to a surgical insertion instru-
`ment and thereafier employed in the proper orientation and
`released. Once deposited in the disc space, the spinal fusion
`implant of the present invention effects spinal fusion over
`time as the natural healing process integrates and binds the
`implant.
`
`11 Claims, 12 Drawing Sheets
`
`10W 40
`/
`
`16
`
`
`
`H3
`
`MSD 1 131
`|PR2013—00506
`
`|PR2013—00508
`
`

`
`US 8,623,088 B1
`Page-2
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`2010/0152853 A1 "‘
`6/2010 Kirschman .............. .. 623/17.11
`
`----------- »- 523/1715
`
`............ .. 623/ 17.16
`
`'
`
`EP
`EP
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`51’
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`517030
`667127
`706876
`716340
`737443
`795393
`339938
`3333;‘;
`811356
`737093
`7
`1504732
`
`2313519
`91/0626]
`94/04100
`94/10928
`95/01810
`96/08205
`96/17564
`96/41582
`97/20513
`
`5/1992
`8/1995
`4/1996
`6/1996
`10/1996
`9/1997
`331993
`331333
`421998
`1 H7004
`/7
`52007
`9/201 1
`3/2002
`5/1991
`3/ 1994
`5/1994
`1/1995
`3/1996
`3/1996
`12/1996
`6/1997
`
`9/[1997
`97/33525
`1031997
`97/37520
`431'/{gag
`gfiflljfifig
`4:,l99§
`9%/17208
`6/1998
`98/25539
`2/1999
`99/08627
`3,1999
`99,38461
`8//2000
`00/45712
`3/zogg
`00/45713
`11/2000
`00/55045
`6/2001
`01/41681
`7/2001
`01/49333
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`8/2002
`02/058593
`10/2002
`02/076335
`OTHER PUBLICATIONS
`
`Benini et a1., “Undercurting decompression andposterior fusion with
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`stenosis:Technique and results,”Net/1'0-Orlllapedics, 1995, 159-172.
`Kambin et
`01., “History and current
`status of percutaneous
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`Vamvzmij et :11, “Surgical treatment of internal disc disruption: An
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`tiers, 4. 1998, 375-382.
`
`* cited by examiner
`
`

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`U.S. Patent
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`Jan. 7, 2014
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`Sheet 1 of 12
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`US 8,623,088 B1
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`FIG. 1
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`FIG. 7
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`FIG. 11
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`US 8,623,088 B1
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`l
`SPIN‘-\I. FUSION IMPLANT AND Rl*ILA'l‘lCl)
`NIETHODS
`
`CROSS REFERENCES TO RELATED
`APPLICATIONS
`
`The present application is a continuation-in-part of appli-
`cation Ser. No. ll/488,744, filed on Jul. I7, 2006 now US.
`Pat. No. 7,867,277, which claims the benefit ofpriority from
`US. Provisional Application Ser. No. 60/699,597, filed on
`Jul. 15, 2005, the entire contents ofeach are hereby expressly
`incorporated by reference into this disclosure as if set forth
`fully herein.
`
`BACKGROUND OF THE INVENTION
`
`I. Field of the Invention
`The present invention relates generally to spinal surgery
`and, more particularly, to a device for spinal fusion compris-
`ing a spinal fusion implant of non-bone construction to be
`introduced into any variety of spinal target sites.
`11. Discussion of the Prior Art
`/ Currently there are somewhere between 500,000 and 750,
`000 lumbar and cervical spinal fusion procedures performed
`each year in the United States. One ofthe causes of back pain
`and disability derives, from the rupture or degeneration ofone
`or more intervertebral discs in the spine. Surgical procedures
`are commonly performed to correct problems with displaced,
`damaged, or degenerated intervertebral discs due to trauma,
`disease, or aging. Generally, spinal fusion procedures involve
`removing some or the all ofthe diseased or damaged disc, and
`inserting one or more intervertebral implants into the result-
`ing disc space.
`Minimally invasive methods of performing spinal fusion
`have gained popularity in recent years due to the many ben-
`efits of the procedure which include diminished dissection of
`body tissue and lower blood loss during surgery resulting in
`reduced surgery time, lower postoperative pain and a quicker
`recovery for patients. Trans foraminal
`lumbar interbody
`fusion (TLIF) procedures provide unilateral access to a
`desired target site. The TLIF technique involves approaching
`the spine in a similar manner as a posterior approach but more
`from the left or right of the spine througi a midline incision in
`a patient’s back. This procedure requires only one incision in
`the back ofa patient and involves placing a fusion device into
`the intervertebral disc space. introducing the intervertebral
`implant serves to restore the height between adjacent verte-
`brae (“disc height” , which reduces if not eliminates neural
`impingement commonly associated with a damaged or dis-
`eased disc. Distraction of the disc space with subsequent
`decompression of nerve roots can be accomplished by rotat-
`ing a device between the adjacent vertebrae.
`Current spinal fusion implants utilize either bone grafts or
`artificial implants to fill the intervertebral disc space. Artifi-
`cial implants may be made of metal, plastic composites,
`ceramics, bone, or any combination thereof. Natural bone
`grafts have also been developed including autologous and
`allograft bone. Other bone grafts may include certain inan-
`made substances including binder joining bone chips and
`composite bone structures.
`While generally effective, the use of bone grafts presents
`several disadvantages. Autologous bone grafts are obtained
`from bone material surgically removed from the iliac crest of
`a patient. This method can be detrimental because it may not
`yield a sufficient quantity of graft material, requires addi-
`tional surgery, and increases the risk of infection and blood
`loss. Moreover, the structural integrity at the donor site can be
`
`vi
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`reduced and significant morbidity associated with harvesting
`the autologous bone graft may occur.
`Allograft bone is obtained from cadaveric specimens,
`machined, and sterilized for implantation. Production of
`allograft bone implants may be difficult because of the inher-
`ent challenges in forecasting the receipt of cadavers. Further-
`more, allograft may only provide temporary support as it is
`difficult to manufacture the allograft with consistent shape
`and strength given the differing characteristics of cadavers.
`Graft material usually has a smooth surface which does not
`provide good friction between the adjacent vertebrae and
`slippage of the graft may occur which can cause neural and
`vascular injury as well as collapse of the disc space.
`A need remains for fusion implants that preserve the intra-
`discal space and support the vertebral column until the adja-
`cent vcrtebrae are fused and still encourage bone ingrowth to
`achieve a solid fusion. A need also remains for implants
`which maximize conical ring contact (both anteriorly and
`posteriorly), better facilitate self distraction of the vertebrae
`during insertion, avoid dural impingement and provide a bet-
`ter ftt between anterior edge portions of vertebral endplates.
`The present invention is directed at overcoming, or at least
`minimizing, 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 implant of non-bone
`construction. The non—bone construction of the spinal fusion
`implant provides an advantage in that it is not supply limited
`and does not require harvesting bone from the patient (as with
`allograft). The present invention better facilitates cortical ring
`contact and fit between anterior ring portions of vertebral
`endplates, provides-selfdistraction during insertion and rota-
`tion, and avoids dural impingement.
`The spinal fusion implant of the present invention may be
`comprised of any suitable non-bone composition, including
`but not limited to polymer compositions (e.g. poly-ether-
`ether-ketone
`(PEEK)
`and/or
`poly-ether-ketone-ketone
`(PEKK)), ceramic, metal, or any combination of these mate-
`rials. The spinal fusion implant of the present invention may
`be provided in any number of suitable shapes and sizes
`depending upon the particular surgical procedure or need.
`The spinal fusion implant may be dimensioned for use in any
`part of the spine (e.g. cervical, ltunbar and/or thoracic) with-
`out departing from the scope of the present invention. The
`implant may be dimensioned, by way ofexample only, having
`a width ranging between 8 and 14 mm, a height ranging
`between 8 and 18 mm, and a length ranging between 25 and
`45 mm.
`
`According to one broad aspect ofthe present invention, the
`spinal fusion implant includes a top surface, a bottom surface,
`lateral sides, a proximal end, and a distal end. The spinal
`fusion implant of the present invention may be used to pro-
`vide temporary or permanent fixation along an orthopedic
`target site. To do so, the spinal fusion implant may be intro-
`duced into a disc space while locked to a surgical insertion
`instrument and thereafter manipulated in the proper orienta-
`tion and released. Once deposited in the disc space, the spinal
`fusion implant of the present invention effects fusion over
`time as the natural healing process integrates and binds the
`implant.
`The spinal fusion implant ofthe present invention may be
`provided with any number ofadditional features for promot-
`ing fusion, such as one or more apertures extending between
`the top and bottom surfaces which allow a boney bridge to
`form through the spinal fusion implant. The spinal implant
`
`

`
`US 8,623,088 B1
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`3
`may also be prelembly equipped with one or more lateral
`openings which facilitate visualization at the time of implan-
`tation and at subsequent clinical evaluations.
`The spinal fusion implant may also be provided with any
`number of suitable anti-migration features to prevent
`the
`implant from migrating or moving from tl1e disc space after
`implantation. Suitable anti—migration features may include,
`but are not necessarily limited to, angled teeth or ridges
`formed along the top and bottom surfaces of the implant
`and/or rod elements disposed within the distal and/or proxi-
`mal ends.
`According to a further aspect of the present invention, the
`spinal fusion implant may be provided with a variable height
`along at least a portion ofthe implant. In one embodiment, the
`variable height tapers in a direction oblique to both the length
`and width of the implant. The oblique taper imparts a greater
`height to the anterior aspect of the intervertebral disc space
`when the spinal fusion implant is positioned obliquely within
`the disc space. Imparting a greater height to the anterior
`aspect of the disc space restores the natural lordotic curvature
`of the lumbar (as well as cervical) spine.
`According to a further aspect of the present invention, the
`spinal fusion implant may be provided with one or more
`radiographic markers at the proximal and/or distal ends.
`These markers allow for a more detailed visualization of the
`implant after insertion (through radiography) and allow for a
`more accurate and effective placement of the implant.
`According to a still further aspect of the present invention,
`the proximal end of the spinal fusion implant has a surface
`that is tapered (angled) to avoid dural impingement after
`implantation. Additionally, the tapered nature ofthe proximal
`surface can aid in overall fit of the spinal fusion implant
`within the intervertebral disc space. Significantly, the tapered
`proximal surface on the proximal end enables the spinal
`fusion implant 10 to maximize contact with the posterior
`portion of the cortical ring of each adjacent vertebral body.
`According to a still further aspect of the present invention,
`the distal end ofthe spinal fusion implant has a conical (bul-
`let-shaped) shape including a pair of first tapered (angled)
`surfaces and a pair of second tapered (angled) surfaces. The
`first tapered surfaces extend between the lateral surfaces and
`the distal end of the implant, and fimction to distract the
`vertebrae adjacent to the target intervertebral space during
`insertion of the spinal fusion implant. The second tapered
`surfaces extend between the top and bottom surfaces and the
`distal end of the spinal fusion implant, and function to maxi-
`mize contact with the anterior portion of the cortical ring of
`each adjacent vertebral body. Furthennore,
`the second
`tapered surfaces provide for a better fit with the contour ofthe
`vertebral body endplates, allowing for a more anterior posi-
`tioning of the spinal fusion implant and thus advantageous
`utilization of the cortical rings of the vertebral bodies.
`According to a still further aspect of the present invention,
`the spinal fusion implant may be introduced into a spinal
`target site through use of any ofa variety of suitable surgical
`instruments having the capability to engage the implant. The
`spinal fusion implant is capable of being used in minimally
`invasive surgical procedures, needing only a relatively small
`operative corridor for insertion.
`According to a still further aspect of the present invention,
`once the implant has been positioned in its desired location
`within the intervertebral space, the user will then rotate the
`implant 90° such that the top and bottom surfaces face in a
`caudad/cephalad direction and the anti—migration features
`engage the vertebral bodies. Significantly, the direction of
`rotation is critical to ensure proper placement of the implant
`such that the edges ofthe proximal surface rest on the cortical
`
`'1»
`
`l (J
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`30
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`35
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`40
`
`in
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`J! J:
`. ..
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`4
`ring of the vertebral bodies and the proximal surface does not
`protrude into the spinal canal. For example, if the spinal
`fusion implant approaches a patient’s spine posteriorly from
`the right with the (longer) first lateral side facing caudally,
`then implant must be rotated in a counter-clockwise direction
`to achieve proper positioning.
`According to a still further aspect of the present invention,
`one or more of the spinal fusion implants of the present
`invention may be used in a variety of configurations in a
`fusion procedure, including but not limited to (and by way of
`example only) unilateral, paired unilateral and bilateral.
`In a unilateral configuration, a single spinal fusion implant
`of the present invention is inserted into an intervertebral disc
`space and positioned obliquely across the disc space such that
`the proximal and distal ends are on opposite sides of the
`midline of the intervertebral space.
`In a paired unilateral configuration, a first spinal fusion
`implant
`is inserted into the disc space and positioned
`obliquely within the intervertebral space, but not necessarily
`directly across the midline. A second spinal fusion implant is
`then inserted directly adjacent to the first implant such that the
`implants are in a side-by-side position.
`In a bilateral configuration, a first spinal fusion implant is
`inserted into the disc space, positioned obliquely, and dis-
`posed entirely on one side of the midline of the intervertebral
`space. A second spinal fusion implant is the inserted into the
`disc space from the mirror-image postero-lateral approach
`such that the second spinal fusion implant occupies the por-
`tion of the intervertebral space on the opposite side of the
`midline from the first spinal fusion implant.
`
`BRIEF DESCRIPTION OF THE DRAWINGS
`
`2;
`
`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 an example of a spinal
`fusion implant according to one embodiment of the present
`invention;
`FIG. 2 is a perspective View of an example of a spinal
`fusion implant according to an alternative embodiment ofthe
`present invention;
`FIG. 3 is a top View of the spinal fusion implant of FIG. 2;
`FIG. 4 is a bottom view of the spinal fusion implant o fFIG.
`—
`FIG. 5 is a side View of the spinal fusion implant of FIG. 2;
`FIG. 6 is a plan view ofa distal end of the spinal fusion
`implant ofFIG. 2;
`FIG. 7 is a plan view ofa proximal end View of the spinal
`fusion implant ofFIG. 2;
`FIG. 8 is a perspective view of an example of a spinal
`fusion implant according to an alternative embodiment ofthe
`present invention;
`'
`FIG. 9 is aside View ofthe spinal fusion implant ofFIG. 8;
`FIG. It) is a plan view ofa proximal end view ofthe spinal
`fusion implant of FIG. 9;
`FIG. 11 is a top plan ViC\V of an example ofa spinal fusion
`implant ofthe present invention inserted into an intervertebral
`space in a unilateral configuration;
`FIG. 12 is a top plan view ofan example ofa spinal fusion
`implant ofthe present invention inserted into an intervertebml
`space in a paired unilateral configuration;
`FIG. 13 is a top plan view ofan example ofa spinal fusion
`implant ofthe present invention inserted into an intervertebral
`space in a bilateral configuration; and
`
`

`
`US 8,623,088 Bl
`
`5
`FIG. 14 is a perspective view ofa spinal fusion implant of
`the present invention inserted into an intervertebral space in a
`unilateral oblique fashion
`
`DESCRIPTION OF THE PREFERRED
`EMBODIMENT
`
`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—specilic deci-
`sions rnust 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
`ordinary skill in the