(19) United States
`(12) Patent Application Publication (10) Pub. No.: US 2002/0165550 A1
`Nov. 7, 2002
`Frey et al.
`(43) Pub. Date:
`
`US 2002O165550A1
`
`(54)
`
`DEVICES AND TECHNIQUES FOR A
`POSTERIOR LATERAL DISC SPACE
`APPROACH
`
`(76)
`
`(21)
`(22)
`
`Inventors: George Frey, Englewood, CO (US);
`John L. White, Bartlett, TN (US);
`Steven D. DeRidder, Bartlett, TN (US);
`Harald Ebner, Deggendorf (DE)
`Correspondence Address:
`Woodard, Emhardt, Naughton, Moriarty and
`McNett
`Bank One Center/Tower
`Suite 3700
`111 Monument Circle
`Indianapolis, IN 46204-5137 (US)
`Appl. No.:
`10/120,104
`Filed:
`Apr. 10, 2002
`
`
`
`Related U.S. Application Data
`Continuation-in-part of application No. 09/858,197,
`filed on May 15, 2001, which is a continuation-in-part
`of application No. 09/694,521, filed on Oct. 23, 2000.
`Provisional application No. 60/160,667, filed on Oct.
`21, 1999.
`
`(63)
`
`(60)
`
`Publication Classification
`
`Int. Cl. ............................................. A61B 17/16
`(51)
`(52)
`U.S. Cl. ................................................................ 606/85
`(57)
`ABSTRACT
`This invention relates to devices and instruments for implant
`insertion through a posterior lateral opening to the disc
`Space. The instruments include an implant inserter, and the
`devices include a spinal fusion implant engageable by the
`implant inserter. The implant provides bilateral Support of
`the adjacent vertebrae when inserted into the disc Space from
`a postero-lateral approach.
`
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`US 2002/0165550 A1
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`Nov. 7, 2002
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`DEVICES AND TECHNIQUES FOR A POSTERIOR
`LATERAL DISC SPACE APPROACH
`
`CROSS-REFERENCE TO RELATED
`APPLICATIONS:
`0001. The present application is a continuation-in-part of
`patent application Ser. No. 09/858,197 filed May 15, 2001,
`which is a continuation-in-part of U.S. patent application
`Ser. No. 09/694,521, filed on Oct. 23, 2000, which claims
`the benefit of the filing date of Provisional Application No.
`60/160,667, filed Oct. 21, 1999.
`
`BACKGROUND OF THE INVENTION
`0002 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, includ
`ing a transforaminal approach.
`0003) 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. A herniated or
`ruptured annulus fibrosis may result in nerve damage, pain,
`numbness, muscle weakness, and even paralysis. Further
`more, 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 mobil
`ity. 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.
`0004. Access to a damaged disc space may be accom
`plished 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.
`0005 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
`Stability to the Subject disc Space.
`
`SUMMARY OF THE INVENTION
`0006 The present invention provides implants, instru
`ments and methods particularly adapted for disc Space
`preparation and implant insertion from a posterior lateral
`approach to the disc Space.
`
`BRIEF DESCRIPTION OF THE DRAWINGS
`0007 FIG. 1 is a perspective view of a lamina spreader
`according to the present invention.
`0008 FIG. 2 is a perspective view of the lamina spreader
`of FIG. 1 with the handle portions rotated to a folded
`position.
`0009 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.
`0010 FIG. 4 is a perspective view of a disc space
`Spreader according to the present invention.
`0011 FIG. 4(a) is a plan view of the distal end of an
`alternate embodiment disc Space Spreader.
`0012 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.
`0013 FIG. 6 shows the sequence of the insertion of the
`disc Space Spreader of FIG. 4 into a disc Space.
`0014 FIG. 7 is a perspective view of a distractor accord
`ing to the present invention.
`0.015 FIG. 8 is a perspective view of an alternative
`distractor having application in the present invention.
`0016 FIG. 9 is a top plan view of a vertebra with the
`distractor of FIG. 7 inserted in the disc space.
`0017 FIG. 10 is a perspective view of a straight reamer
`according to the present invention having the outer shaft
`partially cut-away to show the inner Shaft.
`0018 FIG. 11 is a perspective view of a curved reamer
`according to the present invention having the outer shaft
`partially cut-away to show the inner Shaft.
`0019 FIG. 12 is an end view of the reamer cutting head
`used with the reamers of FIGS. 10 and 11.
`0020 FIG. 13 is a top plan view of a vertebra with the
`straight reamer of FIG. 10 inserted in the disc space.
`0021 FIG. 14 is a top plan view of a vertebra with the
`curved reamer of FIG. 11 inserted in the disc space.
`0022 FIG. 15 is a perspective view of a guided rotary
`cutter according to the present invention.
`0023 FIG. 16 is an enlarged view of the distal end
`portion of the cutter of FIG. 15.
`0024 FIG. 17 is a top plan view of a vertebra with the
`cutter of FIG. 15 inserted in the disc space.
`0025 FIG. 18 is a perspective view of a guided rotary
`cutting tool according to the present invention.
`0026 FIG. 19 is an enlarged perspective view of the
`distal end portion of the cutting tool of FIG. 18.
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`0027 FIG. 20 is a top plan view of a vertebra with the
`cutting tool of FIG. 18 in the disc space.
`0028 FIG. 21 is a perspective view of an alternative
`cutting tool head.
`0029 FIG.22 is a further perspective view of the cutting
`tool head of FIG. 21.
`0030 FIG. 23 is a perspective view of a push scraper
`according to the present invention.
`0031 FIG. 23(a) is section view taken through line
`23(a)-23(a) of FIG. 23.
`0.032
`FIG. 24 is a perspective view of a pull scraper
`according to the present invention.
`0033 FIG. 24(a) is section view taken through line
`24(a)-24(a) of FIG. 24.
`0034 FIG. 25 is a top plan view of a vertebra with the
`push scraper of FIG. 23.
`0035 FIG. 26 is a top plan view of a vertebra with the
`pull scraper of FIG. 24.
`0.036
`FIG. 27 is a perspective view of a straight chisel
`according to the present invention.
`0037 FIG. 28 is a lateral elevational view of a spinal
`column segment with the chisel of FIG. 27 inserted in the
`disc Space.
`0038 FIG. 29 is a posterior elevational view of a spinal
`column Segment showing the disc Space entrance created by
`the chisel of FIG. 27.
`0039 FIG. 30 is a perspective view of an alternate
`embodiment guided chisel according to the present inven
`tion.
`0040 FIG. 31 is an enlarged perspective view of the
`chisel head and shaft with the chisel head in the position of
`FIG. 30.
`0041 FIG. 32 is a top plan view of a vertebra with the
`chisel of FIG. 30.
`0.042
`FIG. 33 is a perspective view an implant sizing
`guide according to one aspect of the present invention.
`0043 FIG.34 is the implantsizing guide of FIG.33 with
`the handle detached.
`0044 FIG. 35 shows a perspective view of an implant
`insertion guide according to the present invention.
`004.5 FIG. 35(a) is an enlarged view of the distal end
`portion of the implant insertion guide of FIG. 35.
`0.046
`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.
`0047 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.
`0.048
`FIG. 38 is a perspective view of an impaction tool
`according to the present invention.
`0049 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.
`
`0050 FIG. 40 is a perspective view of an alternate
`embodiment guided implant inserter according to the present
`invention.
`0051
`FIG. 41 is an enlarged perspective view of the
`distal portion of the implant inserter of FIG. 40.
`0052 FIG. 42 is an enlarged plan view of the distal
`portion of the implant inserter of FIG. 40 and an implant.
`0053 FIG. 43 is the view of FIG. 42 showing the
`implant and insertion tool moved distally along the guide
`shaft.
`0054 FIG. 44 is a top plan view of a vertebra with the
`implant inserter of FIG. 40 in the disc space.
`0055 FIG. 45 is a top plan view of a vertebra with an
`implant inserted into the distal portion of the disc Space.
`0056 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.
`0057 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.
`0.058 FIG. 48 is a perspective view of an alternate
`embodiment implant inserter.
`0059 FIG. 49 is a perspective view of a still a further
`embodiment of an implant inserter.
`0060 FIG. 50 is a plan view of an intradiscal rasp
`according to another aspect of the present invention.
`0061 FIG. 50(a) is an enlarged view of an alternate
`embodiment head for the intradiscal rasp of FIG. 50.
`0062 FIG. 51 is a side elevational view of the intradiscal
`rasp of FIG. 50.
`0063 FIG. 51(a) is an elevational view of the head of
`FIG. 50(a) looking in the direction of arrows 51(a)-51(a).
`0064 FIG. 52 is a top plan view of an implant and
`instrument Set for inserting the implant into the disc Space.
`0065 FIG. 53 is a top plan view of the implant and
`instrument set of FIG. 52 with the implant partially inserted
`in the disc Space.
`0066 FIG. 54 is an end elevational view of an implant
`according to another aspect of the present invention.
`0067 FIG.55 is a top plan view of the implant of FIG.
`54.
`0068 FIG. 56 is a perspective of the implant of FIG. 54
`oriented towards the posterior face.
`0069 FIG. 57 is another perspective view of the implant
`of FIG. 54 oriented towards the anterior face.
`0070 FIG. 58 is an elevational view of the implant of
`FIG. 54 looking towards the posterior face.
`0071 FIG. 59 is a perspective view looking toward the
`posterior wall of another embodiment implant of the present
`invention.
`0072 FIG. 60 is a perspective view looking toward the
`anterior wall of the implant of FIG. 59.
`
`ALPHATEC HOLDINGS, INC., ALPHATEC SPINE INC., IPR2019-00362, Ex. 1040, p. 52 of 70
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`US 2002/0165550 A1
`
`Nov. 7, 2002
`
`FIG. 61 is an elevation view looking at the poste
`0.073
`rior wall of the implant of FIG. 59.
`0.074
`FIG. 62 is an elevation view looking at the anterior
`wall of the implant of FIG. 59.
`0075 FIG. 63 is a plan view of the plant of FIG. 59.
`FIG. 64 is an end elevation view of the implant of
`0076)
`FIG. 59.
`0077 FIG. 65 is a sectional plan view of another embodi
`ment implant insertion instrument according to the present
`invention engaged to the implant of FIG. 59, the sectional
`View illustrating first and Second positions of a proximal
`portion of the implant insertion instrument.
`FIG. 65a is a perspective view of a pusher instru
`0078
`ment.
`FIG. 66 is an enlarged sectional plan view of the
`007.9
`implant insertion instrument and implant of FIG. 65.
`0080 FIG. 67 is a side elevation view of the implant
`insertion instrument and implant of FIG. 65.
`0081 FIG. 68 is an enlarged plan view of the implant
`insertion instrument and implant of FIG. 65 prior to engag
`ing the implant to the implant insertion instrument.
`0082 FIG. 69 is an enlarged plan view of the implant
`insertion instrument and implant of FIG. 65 after engage
`ment of the implant to the implant insertion instrument.
`0083 FIG. 70 is a partial elevation view the proximal
`portion of another embodiment inserter instrument and
`alignment instrument.
`0084 FIG. 71 is a section view through line 71-71 of
`FIG. 70 showing the attachment of the alignment instrument
`to the proximal portion of the inserter instrument.
`0085 FIG. 72 is an enlarged section view shown an
`alternate connection arrangement between the proximal por
`tion and the implant engaging portion of the insertion
`instrument of FIG. 65.
`
`DETAILED DESCRIPTION OF THE
`PREFERRED EMBODIMENTS
`For the purposes of promoting an understanding of
`0.086
`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.
`0087. 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.
`0088 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.
`0089. 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 spreading 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.
`0090. 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 mecha
`nism 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 grasp
`ing portion 534 to pull the finger out of the notch, and then
`
`ALPHATEC HOLDINGS, INC., ALPHATEC SPINE INC., IPR2019-00362, Ex. 1040, p. 53 of 70
`
`

`

`US 2002/0165550 A1
`
`Nov. 7, 2002
`
`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 instru
`ments to be inserted in the disc Space.
`0091. 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 contem
`plated 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.
`0092 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
`portions 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 branches 72, 74 from the
`spreading portions 80, 78. Offset portions 79 and 81 have a
`Straight portion extending generally parallel to central axis
`88 extending between branches 72, 74 and a bend forming
`a first offset angle A2 with axis 88. Spreading portions 78
`and 80 form a second overall offset angle A21 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 A21 is about
`110 degrees. The offset portions 79, 81 laterally offset
`branches 72, 74 from spreading portions 78, 80, allowing
`branches 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 one
`form, the lateral offset distance d 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.
`0093. 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
`branch 72 and positionable in notch 83 formed in the
`proximal end of branch 74. The spreading mechanism has an
`internally threaded hand nut 84 threadedly received on rod
`82. Branches 72 and 74 may be forced together by action of
`internally threaded nut 84 on branch 74 forcing it towards
`branch 72, thereby forcing spreading portions 78 and 80
`apart. A spring blade 89 attached to branches 72, 74 biases
`branches 72, 74 apart.
`0094 Branches 72 and 74 also define opposing grooves
`92 and 94 adjacent pin 76. A lever arm or pusher 90 may be
`provided having an elongated shaft 96 with a handle 98 on
`one end and an opposing Spreader engaging portion 99.
`Engaging portion 99 is configured for removable engage
`ment with opposing grooves 92 and 94 formed in branches
`
`72 and 74, respectively. In se, removal of bony structures to
`gain access to the disc Space and resection of disc material
`may be conducted by known methods. As shown in FIG. 6,
`the distal end of spreader 70 is positioned at opening 35, and
`pusher 90 can be used to provide a pushing force in the
`direction of arrow Pinto the disc Space during the Steps of
`inserting the spreading portions 78 and 80 into opening 35.
`Disc Space spreader 70 is pivoted Sequentially in the direc
`tion of arrow R about Spinous process S via the proximal end
`of branches 72, 74. This pivotal and distal movement from
`proximal portion 41 to distal portion 37 of disc space D1 is
`indicated by the relative sequential positions of spreader 70,
`70', 70", and 70" and spreader portions 78, 78', 78", and
`78". Thus, branches 72, 74 and pusher 90 enable the surgeon
`to have simultaneous two-handed control of spreader 70,
`with one hand contro