(12) United States Patent
`Frey et al.
`
`(10) Patent No.:
`(45) Date of Patent:
`
`US 6,830,570 B1
`Dec. 14, 2004
`
`USOO683057OB1
`
`(54) DEVICES AND TECHNIQUES FOR A
`POSTERIOR LATERAL DISC SPACE
`APPROACH
`
`(75) Inventors: George Frey, Englewood, CO (US);
`Mingyan Liu, Bourg-la-Reine (FR);
`Loic Josse, Palaja (FR); Lawrence M.
`Boyd, Durham, NC (US)
`
`(73) ASSignee: sts Holdings, Inc., Wilmington, DE
`
`(*) Notice:
`
`Subject to any disclaimer, the term of this
`patent is extended or adjusted under 35
`U.S.C. 154(b) by 461 days.
`
`(21) Appl. No.: 09/694,521
`(22) Filed:
`Oct. 23, 2000
`
`Related U.S. Application Data
`(60) Provisional application No. 60/160,667, filed on Oct. 21,
`1999.
`7
`
`DE
`DE
`
`2Y- Y-2
`
`aSa
`
`4,834,757 A 5/1989 Brantigan
`4,877,020 A 10/1989 Vich
`4878,915 A 11/1989 Brantig
`4,898,161 A 2/1990 Grundei
`4904.261 A 2/1990 Dove et al.
`2- Y
`-
`4,917,704 A
`4/1990 Frey et al.
`(List continued on next page.)
`FOREIGN PATENT DOCUMENTS
`27 32 325 A1
`1/1979
`299 O1 611 U1
`6/1999
`(List continued on next page.)
`OTHER PUBLICATIONS
`Horst G. Blume, M.D., Unilateral PLIF, Unilateral Posterior
`Lumbar Interbody Fusion: Simplified Dowel Technique, pp
`75-84, Clinical Ortopaedics and Related Research; 1984.
`Sofamor Danek The Spine Specialist, Surgical Technique
`Using Bone Dowel Instrumentation for Anterior Approach,
`1996.
`Primary Examiner Kevin Shaver
`
`- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - Ali. Assistant Examiner Michael B. Priddy
`
`Fi la f s- - - - - - - -h. 606/61,99, 623, 17.11 17.16
`(58) Field of Search ........
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`(56)
`References Cited
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`
`
`(74). Attorney, Agent, or Firm Woodard, Emhardt,
`Moriarty McNett & Henry LLP
`(57)
`ABSTRACT
`This invention relates to methods and instruments for per
`forming disc Space preparation and implant insertion from a
`unilateral approach to the spine through a posterior lateral
`opening to the disc Space. The instruments include
`Spreaders, distractors, reamers, Scrapers, cutters, chisels,
`pushers and implant inserters. A Surgical procedure is pro
`vided that allows bilateral support of the adjacent vertebrae
`with at least one interbody fusion device inserted into the
`disc Space via a unilateral approach. Implants for insertion
`into the disc space are also provided.
`
`73 Claims, 40 Drawing Sheets
`
`NUVASIVE - EXHIBIT 2004
`Alphatec Holdings Inc. et al. v. NuVasive, Inc.
`IPR2019-00362
`
`

`

`US 6,830,570 B1
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`
`

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`10180,
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`

`1
`DEVICES AND TECHNIQUES FOR A
`POSTERIOR LATERAL DISC SPACE
`APPROACH
`
`CROSS-REFERENCE TO RELATED
`APPLICATIONS
`The present application claims the benefit of the filing
`date of Provisional application Ser. No. 60/160,667, filed
`Oct. 21, 1999, entitled INSTRUMENTS AND METHODS
`FOR UNILATERAL DISC SPACE PREPARATION AND
`IMPLANT INSERTION. The referenced application is
`incorporated herein by reference in its entirety.
`
`BACKGROUND OF THE INVENTION
`The present invention relates to techniques for use in
`interbody fusion procedures, instruments for performing
`Such procedures, and implants insertable in the Spinal disc
`Space. More Specifically, but not exclusively, the present
`invention relates to implants, methods and instruments for
`use in a posterior lateral approach to the disc Space, Such as
`a transforaminal approach.
`Normally intervertebral discs, which are located between
`endplates of adjacent vertebrae, Stabilize the Spine and
`distribute forces between the vertebrae and cushion vertebral
`bodies. The Spinal discS may be displaced or damaged due
`to trauma, disease or aging. Aherniated or ruptured annulus
`fibrosis may result in nerve damage, pain, numbness, muscle
`weakness, and even paralysis. Furthermore, as a result of the
`normal aging processes, discS dehydrate and harden, thereby
`reducing the disc Space height and producing instability of
`the Spine and decreased mobility. Most typically Surgical
`correction of a collapsed disc Space includes a discectomy
`(Surgical removal of a portion or the entire intervertebral
`disc). The discectomy is often followed by restoration of
`normal disc Space height and bony fusion of the adjacent
`vertebrae to maintain the disc Space height.
`Access to a damaged disc Space may be accomplished
`from Several approaches to the Spine. One approach is to
`gain access to the anterior portion of the Spine through a
`patient's abdomen. However, extensive vessel retraction is
`often required and many vertebral levels are not readily
`accessible from this approach. A posterior approach may
`also be utilized. However, this typically requires that both
`Sides of the disc Space on either Side of the Spinal cord be
`Surgically exposed. This may require a Substantial incision
`or multiple access locations, as well as extensive retraction
`of the spinal cord. To alleviate problems associated with
`both anterior and posterior approaches to the Spine, a poS
`terior lateral approach, Such as a transforaminal approach, to
`the disc space may be utilized. While it is desirable to place
`one or more implants in the disc space So that the load of the
`Spinal column is evenly distributed, accurate placement of
`implants in the disc Space from a single posterior lateral
`approach has heretofore been extremely difficult. Thus, this
`approach to the Spine is Seldom used in practice.
`Therefore, there remains a need for improved instruments,
`implants and techniques for use in a posterior lateral
`approach to the disc Space that allows unilateral disc Space
`preparation and implant insertion to provide bilateral Stabil
`ity to the Subject disc Space.
`
`SUMMARY OF THE INVENTION
`The present invention provides implants, instruments and
`methods particularly adapted for unilateral disc Space prepa
`ration and implant insertion from a posterior lateral
`
`15
`
`25
`
`35
`
`40
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`approach to the disc Space, Such as is provided with a
`transforaminal approach.
`In one aspect a lamina Spreader is provided. The lamina
`Spreader has arms pivotally connected with one another. The
`arms each include a lamina engaging portion at the distal end
`of the arm. In a preferred form, the arms are hinged So that
`the proximal ends of the arms can be rotated out of the
`operative field while the spreader is engaged to the lamina.
`In another aspect, a disc space spreader is provided. The
`Spreader has a pair of branches pivotally connected to one
`another. The branches have a spreading portion attached to
`the distal end of each arm. Each arm includes a lateral offset
`extending between the spreading portion and the articulating
`arm. A spreading mechanism is provided to assist in Sepa
`rating the Spreading portions. In a further form, a pusher is
`provided to assist the Surgeon in inserting the spreading
`portions into the disc space.
`In further aspect of the invention, rotatable distractors are
`provided with distractor heads configured for insertion into
`the disc Space via a unilateral approach. A lever arm can be
`Secured to the distractor Shaft to assist in rotation of the
`distractor.
`In Still a further aspect of the invention, cutting tools for
`unilateral disc Space preparation are provided. Cutting
`instruments according to the present invention preferably
`have a longitudinal Shaft with a cutting blade disposed at the
`distal end of the Shaft. The cutting instruments include
`Straight and curved reamers, cutting blades that are movable
`along or around a guide shaft, pull ScraperS and push
`Scrapers, Straight chisels, and curved chisels movable along
`a guide shaft.
`In yet another aspect, the present invention provides
`improved devices for implant insertion. An implant template
`is provided for the Surgeon to determine the required implant
`size. Implant insertion devices according to the present
`invention comprise a shaft having a longitudinal axis and an
`implant connector at the distal end of the shaft. The shafts
`can be Straight, curved, or flexible. In one form, the distal
`end of the shaft includes a bend for implant insertion to the
`distal portion of the disc Space. In another form, the inserter
`shaft has a lateral offset. According to a further aspect of the
`invention, a pusher is provided and useable with the inserter
`to facilitate implant placement in the disc Space.
`In Still a further aspect, the present invention provides
`methods for disc Space preparation and implant insertion
`from a unilateral transforaminal approach to the Spine. The
`method contemplates accessing the disc Space and providing
`a posterior lateral opening into the disc Space. The lamina
`can be spread to facilitate access. The disc Space is then
`distracted with disc space spreaders. Cutting instruments are
`inserted through the opening to remove disc material and
`bony material from the endplates to prepared the disc Space
`for implant insertion. The implant is then inserted through
`the opening and into the distal portion of the disc Space. In
`one form, the unilateral approach utilizes at least two
`bilaterally positioned implants, with one of the implants in
`the distal portion of the disc space. In a Second form, a Single
`implant laterally spanning the disc Space is positioned
`through the opening.
`Further aspects, forms, embodiments, objects, features,
`benefits, aspects and advantages of the present invention
`shall become apparent from the detailed drawings and
`descriptions provided herein.
`BRIEF DESCRIPTION OF THE DRAWINGS
`FIG. 1 is a perspective view of a lamina Spreader accord
`ing to the present invention.
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`FIG. 2 is a perspective view of the lamina spreader of
`FIG. 1 with the handle portions rotated to a folded position.
`FIG. 3 is an elevational view of a spinal column Segment
`showing the distal portion of the lamina spreader of FIG. 1
`engaged to the lamina on either Side of a disc Space.
`FIG. 4 is a perspective view of a disc Space spreader
`according to the present invention.
`FIGS. 5(a) and 5(b) are perspective views of the disc
`Space spreader of FIG. 4 with a lever arm and a perspective
`View of the lever arm, respectively.
`FIG. 6 shows the sequence of the insertion of the disc
`Space spreader of FIG. 4 into a disc Space.
`FIG. 7 is a perspective view of a distractor according to
`the present invention.
`FIG. 8 is a perspective view of an alternative distractor
`having application in the present invention.
`FIG. 9 is a top plan view of a vertebra with the distractor
`of FIG. 7 inserted in the disc space.
`FIG. 10 is a perspective view of a straight reamer accord
`ing to the present invention having the Outer shaft partially
`cut-away to show the inner Shaft.
`FIG. 11 is a perspective view of a curved reamer accord
`ing to the present invention having the Outer shaft partially
`cut-away to show the inner Shaft.
`FIG. 12 is an end view of the reamer cutting head used
`with the reamers of FIGS. 10 and
`FIG. 13 is a top plan view of a vertebra with the straight
`reamer of FIG. 10 inserted in the disc space.
`FIG. 14 is a top plan view of a vertebra with the curved
`reamer of FIG. 11 inserted in the disc space.
`FIG. 15 is a perspective view of a guided rotary cutter
`according to the present invention.
`FIG. 16 is an enlarged view of the distal end portion of the
`cutter of FIG. 15.
`FIG. 17 is a top plan view of a vertebra with the cutter of
`FIG. 15 inserted in the disc space.
`FIG. 18 is a perspective View of a guided rotary cutting
`tool according to the present invention.
`FIG. 19 is an enlarged perspective view of the distal end
`portion of the cutting tool of FIG. 18.
`FIG. 20 is a top plan view of a vertebra with the cutting
`tool of FIG. 18 in the disc space.
`FIG.21 is a perspective view of an alternative cutting tool
`head.
`FIG. 22 is a further perspective view of the cutting tool
`head of FIG. 21.
`FIG. 23 is a perspective view of a push Scraper according
`to the present invention.
`FIG. 23(a) is section view taken through line 23(a)-23
`(a) of FIG. 23.
`FIG. 24 is a perspective view of a pull Scraper according
`to the present invention.
`FIG. 24(a) is section view taken through line 24(a)-24
`(a) of FIG. 24.
`FIG. 25 is a top plan view of a vertebra with the push
`scraper of FIG. 23.
`FIG. 26 is a top plan view of a vertebra with the pull
`scraper of FIG. 24.
`FIG. 27 is a perspective view of a straight chisel accord
`ing to the present invention.
`FIG. 28 is a lateral elevational view of a spinal column
`segment with the chisel of FIG.27 inserted in the disc space.
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`FIG.29 is a posterior elevational view of a spinal column
`Segment showing the disc Space entrance created by the
`chisel of FIG. 27.
`FIG. 30 is a perspective view of an alternate embodiment
`guided chisel according to the present invention.
`FIG.31 is an enlarged perspective view of the chisel head
`and shaft with the chisel head in the position of FIG. 30.
`FIG. 32 is a top plan view of a vertebra with the chisel of
`FIG. 30.
`FIG. 33 is a perspective view an implant sizing guide
`according to one aspect of the present invention.
`FIG. 34 is the implant sizing guide of FIG. 33 with the
`handle detached.
`FIG. 35 shows a perspective view of an implant insertion
`guide according to the present invention.
`FIG.35(a) is an enlarged view of the distal end portion of
`the implant insertion guide of FIG. 35.
`FIG. 36 is a perspective view of a straight implant inserter
`according to the present invention having the outer shaft
`partially cut-away to show the inner Shaft.
`FIG.37 is a perspective view of a curved implant inserter
`according to the present invention having the outer shaft
`partially cut-away to show the inner Shaft.
`FIG. 38 is a perspective view of an impaction tool
`according to the present invention.
`FIG. 39 is a top plan view of the disc space showing the
`sequence of the curved inserter of FIG. 37 inserting an
`implant into the disc Space.
`FIG. 40 is a perspective view of an alternate embodiment
`guided implant inserter according to the present invention.
`FIG. 41 is an enlarged perspective view of the distal
`portion of the implant inserter of FIG. 40.
`FIG. 42 is an enlarged plan view of the distal portion of
`the implant inserter of FIG. 40 and an implant.
`FIG. 43 is the view of FIG. 42 showing the implant and
`insertion tool moved distally along the guide shaft.
`FIG. 44 is a top plan view of a vertebra with the implant
`inserter of FIG. 40 in the disc space.
`FIG. 45 is a top plan view of a vertebra with an implant
`inserted into the distal portion of the disc Space.
`FIG. 46 is a top plan view of a vertebra with a pair of
`implants bi-laterally positioned in the disc Space to provide
`bi-lateral Support to the Spinal column Segment.
`FIG. 47 is a top plan view of a vertebra with a single
`implant positioned in the disc Space to provide bi-lateral
`Support to the Spinal column Segment.
`FIG. 48 is a perspective view of an alternate embodiment
`implant inserter.
`FIG. 49 is a perspective view of a still a further embodi
`ment of an implant inserter.
`FIG. 50 is a top plan view of an implant and instrument
`Set for inserting the implant into the disc Space.
`FIG. 51 is a top plan view of the implant and instrument
`set of FIG. 50 with the implant partially inserted in the disc
`Space.
`FIG. 52 is an end elevational view of an implant accord
`ing to another aspect of the present invention.
`FIG. 53 is a top plan view of the implant of FIG. 52.
`FIG. 54 is a perspective of the implant of FIG. 52 oriented
`towards the posterior face.
`FIG.55 is another perspective view of the implant of FIG.
`52 oriented towards the anterior face.
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`FIG. 56 is an elevational view of the implant of FIG. 52
`looking towards the posterior face.
`DETAILED DESCRIPTION OF THE
`PREFERRED EMBODIMENTS
`For the purposes of promoting an understanding of the
`principles of the present invention, reference will now be
`made to the embodiments illustrated in the drawings, and
`Specific language will be used to describe the same. It will
`nevertheless be understood that no limitation of the scope of
`the invention is intended thereby. Any alterations and further
`modification in the described processes, Systems, or devices,
`and any further applications of the principles of the inven
`tion as described herein are contemplated as would normally
`occur to one skilled in the art to which the invention relates.
`In a posterior lateral approach to the disc Space, Such as
`is provided with a transforaminal approach, it is often
`difficult to prepare the proper locations in the disc Space to
`receive an implant. The instruments and techniques of the
`present invention provide for improved unilateral disc Space
`preparation in both the distal and proximal portions of the
`disc Space through a single opening. Another difficulty in
`posterior lateral approaches to the disc Space is related to the
`proper positioning of the implant in the portion of the disc
`Space most distal from the posterior lateral opening. While
`it is desirable that the implant be positioned in the distal
`portion of the disc Space, it is often too difficult to move the
`implant across the disc Space to the distal portion. Thus, the
`present invention further provides implant inserters, implant
`templates, implant insertion guides, and implants that facili
`tate implant positioning in the distal and proximal portions
`of the disc from a posterior lateral approach.
`Referring now to FIG. 1, there is provided a lamina
`Spreader 500 according to one aspect of the present inven
`tion. Lamina spreader 500 includes a first arm 502 pivotally
`joined to a second arm 504 by pin 506. Arms 502, 504
`extend generally along a central axis 501 when in a first
`Spreading position. Extending distally from pin 506 are
`distal portions 515 and 516 of arms 502 and 504, respec
`tively. Distal portions 515 and 516 include lamina engaging
`portions 508 and 510, respectively. Lamina engaging por
`tions 508 and 510 are generally U-shaped and configured to
`engage the lamina of an upper Vertebra V2 and the lamina
`of a lower vertebra V1, respectively, on either side of the
`Subject disc Space, as shown in FIG. 3. Spreading portion
`508 includes an outer portion 508a configured to reside on
`the outer Side of the lamina connected to an inner portion
`508b configured to reside on the inner side of the lamina.
`Spreading portion 510 similarly includes an outer portion
`510a configured to reside on the outer side of the lamina
`connected to an inner portion 510b configured to reside on
`the inner Side of the lamina.
`The lamina can be spread by the Surgeon grasping handle
`502a of arm 502 and handle 504a of arm 504, and forcing
`arms 502, 504 towards one another in the direction towards
`axis 501. There is also provided a mechanism to force and/or
`maintain spreading portions 508 and 510 apart. The spread
`ing mechanism includes an externally threaded rod 512
`threadingly engaged to branch 502 and a hand nut 514
`received on rod 512. Arms 502 and 504 may be forced
`together by action of threading nut 514 to force rod 512 into
`threaded opening 503 in arm 502, thereby forcing spreading
`portions 508 and 510 apart and separating the lamina to open
`access to the disc space. Nut 514 can also be used to thread
`rod 512 into opening 503 after manually spreading the
`lamina via handles 502a, 504a, until nut 514 contacts arm
`504 to maintain the engaging portions 508, 510 in a spread
`condition.
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`In a preferred form, arm 502 has handle portion 502a that
`is hinged to rotate with respect to a non-rotating portion
`502b about a pin 516, and arm 504 has handle portion 504a
`hinged to rotate with respect to a non-rotating portion 504b
`about a pin 518. A first Spring loaded locking mechanism
`520 resides in cut-out 524 formed in handle portion 502a,
`and a Second Spring loaded locking mechanism 522 resides
`in a similar cut-out (not shown) formed in handle portion
`504a. Locking mechanism 520 includes a finger 528 spring
`biased into notch 530 formed in non-rotating portion 502b.
`The Surgeon or attendant can release handle portion 502a by
`pulling proximally on grasping portion 532 to pull finger
`528 out of notch 530, and then rotate handle portion 502a
`transversely to axis 501 about pin 516 to a position oriented
`about 90 degrees with respect to non-rotating portion 502b.
`Similarly, locking mechanism 522 includes a finger Spring
`biased into a notch formed in non-rotating portion 504b. The
`Surgeon or attendant can release handle portion 504a by
`pulling proximally on grasping portion 534 to pull the finger
`out of the notch, and then rotate handle portion 504a
`transversely to axis 501 about pin 518 to a position oriented
`about 90 degrees with respect to non-rotating portion 504b.
`Rotating handle portions 502a, 504a moves this portion of
`lamina Spreader out of the way of the Surgeon and avoids
`interference with other instruments to be inserted in the disc
`Space.
`It is contemplated that spreader 500 can be used to assist
`the Surgeon in gaining access to the disc Space. The rotating
`handles allow lamina spreader 500 to remain in place during
`Subsequent procedures. It is further contemplated that the
`Surgeon may not desire to use lamina Spreader 500, and
`therefore proceed with disc space distraction after gaining
`access to the disc Space.
`Referring to FIG. 4 and FIGS. 5(a) and 5(b), a disc space
`Spreader according to the present invention is shown. Disc
`Space spreader 70 has a proximal portion that includes a first
`branch 72 pivotally joined to a second branch 74 by pin 76.
`Extending distally from pin 76 are distal portions 85 and 86
`of branches 72 and 74, respectively. Distal portions 85 and
`86 have a distal working end that includes spreading por
`tions 80 and 78 that contact the endplates of the adjacent
`vertebrae to apply a distraction force thereto. Distal portions
`85 and 86 further include lateral offset portions 81 and 79,
`respectively, that laterally offset the arms 72, 74 from the
`spreading portions 80, 78. Offset portions 79 and 81 have a
`Straight portion extending generally parallel to axis 88 and
`a bend forming a first offset angle A2 with axis 88. Spread
`ing portions 78 and 80 form a second overall offset angle
`A22 with axis 88. In a preferred embodiment, offset angle
`A2 is about 120 degrees, but it is contemplated that offset
`angle A2 can range from 90 degrees to 160 degrees. Offset
`angle A22 is about 110 degrees. The offset portions 79, 81
`laterally offset branches 72, 74 from spreading portions 78,
`80, allowing arms 72, 74 to be further pivoted across the
`Spinous process S, as shown by disc Space spreader 70 in
`FIG. 6, than would be possible without offset portions 79,
`81. In a preferred form, the lateral offset distanced between
`axis 88 and the center of the straight portion is between 10
`to 20 millimeters. This allows the distal tip of spreader 70 to
`be properly oriented into posterior lateral opening 35 formed
`in disc Space D1.
`To separate spreading portions 78, 80 a force can be
`applied to the proximal ends of branches 72, 74. In a
`preferred embodiment, disc Space spreader 70 includes a
`mechanism to force and/or maintain the Separation of
`spreading portions 78 and 80. The spreading mechanism
`includes an externally threaded rod 82 pivotally joined to
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`branch 72 and positionable in notch 83 formed