US008021398B2
`
`(12) United States Patent
`Sweeney et al.
`
`(10) Patent No.:
`(45) Date of Patent:
`
`US 8,021,398 B2
`Sep. 20, 2011
`
`(54) SPINAL FIXATION SYSTEM
`(75) Inventors: Patrick J. Sweeney, Flossmoor, IL (US);
`Michael S. Butler, Fishers, IN (US);
`Michael J. Milella, Jr., Schaumburg, IL
`(US)
`(73) Assignee: Life Spine, Inc., Hoffman Estates, IL
`(US)
`Subject to any disclaimer, the term of this
`patent is extended or adjusted under 35
`U.S.C. 154(b) by 958 days.
`(21) Appl. No.: 11/461,987
`(22) Filed:
`Aug. 2, 2006
`
`(*) Notice:
`
`(65)
`
`Prior Publication Data
`US 2007/OO55239 A1
`Mar. 8, 2007
`
`Related U.S. Application Data
`(63) Continuation-in-part of application No. 1 1/071,604,
`filed on Mar. 3, 2005, which is a continuation-in-part
`of application No. 10/864,673, filed on Jun. 9, 2004.
`(60) Provisional application No. 60/705,580, filed on Aug.
`4, 2005.
`
`(51) Int. Cl.
`(2006.01)
`A6B 7/70
`(52) U.S. Cl. ......................... 606/269: 606/268: 606/272
`(58) Field of Classification Search .................... 606/60,
`606/246,250 279, 300–321: 403/84, 97
`See application file for complete search history.
`
`(56)
`
`References Cited
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`Primary Examiner — Eduardo C Robert
`Assistant Examiner — Jerry Cumberledge
`(74) Attorney, Agent, or Firm — Foley & Lardner LLP
`
`ABSTRACT
`(57)
`According to one embodiment of the invention, a spinal fixa
`tion system includes a bone screw having a longitudinal
`access and a fixation rod configured to connect the bone screw
`to at least one additional bone screw. The fixation rod is lateral
`to the longitudinal axis. A coupling mechanism includes a
`bone screw securing device configured to secure the coupling
`mechanism to the bone screw and a fixation rod securing
`device configured to secure the coupling mechanism to the
`fixation rod. The spinal fixation system further includes a
`fastening mechanism. Rotation of the fastening mechanism
`secures the bone screw securing device to the bone screw and
`the fixation rod securing device to the fixation rod.
`16 Claims, 18 Drawing Sheets
`
`
`
`14
`
`10
`
`18
`
`Globus Medical, Inc. Exhibit 2009, Page 1 of 27
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`US 8,021,398 B2
`Page 2
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`
`* cited by examiner
`
`Globus Medical, Inc. Exhibit 2009, Page 2 of 27
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`U.S. Patent
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`Sep. 20, 2011
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`Sheet 1 of 18
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`US 8,021,398 B2
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`Sheet 3 of 18
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`US 8,021,398 B2
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`W JEW
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`22
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`FIG. 3
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`FIG. 4
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`FIG. 5
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`FIG. 6
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`Sheet 6 of 18
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`US 8,021,398 B2
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`FIG. 13
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`ar
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`w
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`22.
`at SN
`SN Sb
`ad W 'SANY
`N: N
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`20 -----.
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`SNI
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`SN
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`Sheet 8 of 18
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`152XSS R QN
`Ey22, S
`N C4Ny
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`U.S. Patent
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`U.S. Patent
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`Sheet 10 of 18
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`FIG. 25
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`U.S. Patent
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`Sheet 11 of 18
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`Sheet 13 of 18
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`1)-36
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`f39% 2
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`U.S. Patent
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`Sheet 14 of 18
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`US 8,021,398 B2
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`34
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`FIG. 34
`
`or) cº
`L-i-
`
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`FIG. 36
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`U.S. Patent
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`U.S. Patent
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`Sheet 16 of 18
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`Globus Medical, Inc. Exhibit 2009, Page 18 of 27
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`U.S. Patent
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`U.S. Patent
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`FIG. 43
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`No.
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`FIG. 44
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`

`1.
`SPINAL FXATION SYSTEM
`
`US 8,021,398 B2
`
`This application claims the benefit of U.S. Provisional
`Application No. 60/705,580, filed Aug. 4, 2005, which is
`incorporated by reference herein. This application is a con
`tinuation-in-part of U.S. application Ser. No. 1 1/071,604,
`filed Mar. 3, 2005, which is a continuation-in-part of appli
`cation Ser. No. 10/864,673, filed Jun. 9, 2004, both of which
`are incorporated by reference herein.
`
`10
`
`FIELD OF THE INVENTION
`
`The present invention relates to instrumentation and meth
`ods used in the performance of spinal fusion procedures. In
`particular, the present invention relates to a spinal fixation
`system and related Surgical methods.
`
`15
`
`BACKGROUND OF THE INVENTION
`
`25
`
`30
`
`35
`
`45
`
`The spinal column is comprised of twenty-six interlocking
`vertebrae. The vertebrae are separated by disks. The spine
`provides load-bearing support for one-half of the body's mass
`and it protects the nerves of the spinal column. The disks
`provide shock absorption and facilitate the bending of the
`spine.
`The combination of the vertebrae and disks at each verte
`bral segment allows for motion of the spine, in particular,
`flexing, rotation, and extension. The motion and Support
`functions of the spine, in combination with the many inter
`locking parts and nerve roots associated with the spinal col
`umn can result in back pain due to various reasons. Such back
`pain may result from the degeneration of disks due to age,
`disease, or injury. Further, vertebral bodies may be compro
`mised due to disease or defect, Such as a tumor, or injury, Such
`as fracture.
`Spinal fusion or fixation Surgery is one way to treat back
`pain. Further, spinal fusion or fixation may be used to correct
`an abnormal curvature of the spine or stabilize the spine due
`to injury or disease affecting one or more disks or vertebrae.
`In a spinal fusion procedure, two or more adjacent vertebrae
`40
`in the spine are fused together. The fusion is typically accom
`plished by the utilization of spinal instrumentation including
`pedicle screws and associated rods or plates used to mechani
`cally fix the vertebrae together. Pedicle screws are typically
`used in spinal fusion Surgery because the pedicle serves as a
`strong mechanical attachment point to the spine. Bone graft
`material may be utilized to aid in the creation of bone struc
`ture between the fused vertebrae to create a single bone.
`Spinal fixation components vary depending on the system
`being utilized but typically include pedicle screws that are
`inserted through the pedicle and into the vertebral body. The
`pedicle Screws are typically attached to one another by a
`linking device, such as a rod or plate, that extends vertically
`along the row of pedicle screws that are inserted. Several
`coupling systems are known in the art that are used for cou
`pling the pedicle Screws to the linking device, which is ori
`ented parallel to the spinal column. Typically two columns of
`pedicle Screws and linking devices are used, one on each side
`of the spinal column. After installation, the two linking
`devices may be attached to one another to provide additional
`stabilization of that portion of the spine. As an alternative or
`in addition to pedicle Screws, spinal hooks may be used, each
`spinal hook being coupled to a vertebra via a portion of the
`vertebral arch.
`Because of anatomical variations, the pedicle Screws that
`are fixed to one another in a spinal fusion procedure may not
`be in longitudinal alignment with one another. Accordingly,
`
`50
`
`55
`
`60
`
`65
`
`2
`spinal fixation systems, whether utilizing a rod or a plate,
`strive to allow some variability in the placement of the pedicle
`screws while still accomplishing the goal of fixation with a
`single rod or plate along the pedicle Screws.
`One challenge associated with the design of a spinal fixa
`tion system is the connection between the pedicle Screws and
`the linking device. Ideally, the number of components
`involved should be minimized, especially the number of com
`ponents that must be threaded together (Such as nuts and rods)
`in order to ease the assembly process and minimize the over
`all time of the Surgical procedure.
`There is also a need for a spinal fixation system that may be
`utilized with a minimally invasive Surgical approach, such as
`one that utilizes Smaller access apertures or ports rather than
`a large incision along the entire portion of the spine being
`treated. A spinal fixation system that addresses the need for a
`minimally invasive approach may also address the desire to
`utilize bone graft material along the fixation site to enhance
`bony in-growth.
`Further, there is a need for a spinal fixation system that not
`only utilizes fewer components but that requires fewer steps
`for assembly onto the spine, thus shortening the overall time
`of the Surgical procedure.
`It would be desirable to provide a system and/or method
`that provides one or more of these or other advantageous
`features or addresses one or more of the above-identified
`needs. Other features and advantages will be made apparent
`from the present specification. The teachings disclosed
`extend to those embodiments that fall within the scope of the
`claims, regardless of whether they accomplish one or more of
`the aforementioned needs.
`
`SUMMARY OF THE INVENTION
`
`The invention relates to a spinal fixation system having a
`bone screw with a longitudinal axis and a fixation rod con
`figured to connect the bone screw to at least one additional
`bone screw. The fixation rod is lateral to the longitudinal axis.
`A coupling mechanism includes a bone screw securing device
`configured to secure the coupling mechanism to the bone
`screw and a fixation rod securing device configured to secure
`the coupling mechanism to the fixation rod. The spinal fixa
`tion system further includes a fastening mechanism. Rotation
`of the fastening mechanism secures the bone screw securing
`device to the bone screw and the fixation rod securing device
`to the fixation rod.
`The invention further relates to a spinal fixation system
`having a screw, a body received on the screw, a collet received
`on the Screw, and a nut received on the screw and secured to
`the body. The spinal fixation system further includes fixation
`rod holder coupled to the body and a pin slidably coupled to
`the body and the fixation rod holder. The nut operatively
`engages the pin to secure the fixation rod holder to a fixation
`rod and operatively engages the collet to secure the collet to
`the screw.
`The invention further relates to a bone screw and fixation
`rod coupling mechanism for a spinal fixation system having a
`bone screw securing device configured to secure the coupling
`mechanism to a bone screw and a fixation rod securing device
`configured to secure the coupling mechanism to a fixation
`rod. The fixation rod securing device includes a rod holder
`having a plurality of teeth and a retaining ring coupled to the
`rod holder, the retaining ring having a plurality of teeth. The
`plurality of teeth on the retaining ring interlock with the
`plurality of teeth on the rod holder to prevent rotation of the
`rod holder relative to the retaining ring.
`
`Globus Medical, Inc. Exhibit 2009, Page 21 of 27
`Life Spine, Inc. v. Globus Medical, Inc.
`IPR2022-01602
`
`

`

`US 8,021,398 B2
`
`3
`The invention is capable of other embodiments and of
`being practiced or being carried out in various ways. Alter
`native exemplary embodiments relate to other features and
`combinations of features as may be generally recited in the
`claims.
`
`BRIEF DESCRIPTION OF THE DRAWINGS
`
`4
`FIG. 27 is an enlarged portion of the sectional view of FIG.
`26 as generally defined by line 27-27;
`FIG. 28 is a partial sectional view of the spinal fixation
`system of FIG. 25 taken generally along line 28-28 of FIG.
`26;
`FIG. 29 is an enlarged partial sectional view of an
`assembled FIG. 25:
`FIG. 30 is a partial exploded perspective view of a spinal
`fixation system according to a forth embodiment of the inven
`tion;
`FIG. 31 is a partial sectional view of the spinal fixation
`system of FIG. 30:
`FIG. 32 is a partial exploded perspective view of a spinal
`fixation system according to a fifth embodiment of the inven
`tion;
`FIG. 33 is a partial sectional view of the spinal fixation
`system of FIG. 32:
`FIG. 34 is a partial sectional view of the spinal fixation
`system of FIG. 32:
`FIG. 35 is a partial sectional view of the spinal fixation
`system of FIG. 32:
`FIG. 36 is a partial sectional view of the spinal fixation
`system of FIG. 32 taken generally along line 36-36 of FIG.
`33;
`FIG. 37 is partial exploded perspective view of a spinal
`fixation system according to a sixth embodiment of the inven
`tion;
`FIG. 38 is a partial sectional view of the spinal fixation
`system of FIG. 37;
`FIG. 39 is an enlarged partial sectional view of the spinal
`fixation system of FIG. 37;
`FIG. 40 is a partial exploded perspective view of a spinal
`fixation system according to a seventh embodiment of the
`invention;
`FIG. 41 is a perspective view of a retaining ring of the
`spinal fixation system of FIG. 40;
`FIG. 42 is a perspective view of a the rod holder of the
`spinal fixation system of FIG. 40;
`FIG. 43 is a partial sectional view of the spinal fixation
`system of FIG. 40:
`FIG. 44 is a partial sectional view of the spinal fixation
`system of FIG. 40.
`
`DESCRIPTION OF PREFERRED
`EMBODIMENTS
`
`Referring to FIG. 1, a spinal fixation system according to
`an exemplary embodiment of the invention includes a bone
`coupling element or bone screw, shown as pedicle Screw 10,
`a linking device or fixation element, shown as fixation rod 12.
`and a coupling mechanism, generally shown as coupling
`mechanism 14. The pedicle screw 10 is coupled to the fixation
`rod 12 via the coupling mechanism 14. In use, the pedicle
`screw 10 may be inserted through a pedicle and into a vertebra
`and linked to other pedicle screws by the fixation rod 12. The
`length of the fixation rod 12 is chosen to accommodate the
`total distance along the pedicle screws that are linked
`together.
`Referring to the embodiment of FIGS. 2-12, the pedicle
`screw 10 includes a threaded portion 16 and a non-threaded
`upper portion, shown as post 18. At the top of the post 18, an
`engagement mechanism for a screwdriver or power drill,
`shown as recess 20, may be utilized. Referring to FIG.3, at the
`bottom of the threaded portion 16, a tip 22 may be configured
`to be self-tapping. Referring to FIG. 4, the pedicle screw 10
`may be cannulated, as shown by the passage 24 extending the
`
`5
`
`10
`
`The invention will become more fully understood from the
`following detailed description, taken in conjunction with the
`accompanying drawings, wherein like reference numerals
`refer to like elements, in which:
`FIG. 1 is a perspective view of a spinal fixation system
`connected to a spine;
`FIG. 2 is an partial exploded perspective view of a spinal 15
`fixation system;
`FIG.3 is a front elevation view of the spinal fixation system
`of FIG. 2:
`FIG. 4 is a sectional view of the spinal fixation system of
`FIG. 2 taken generally along line 4-4 of FIG.3:
`FIG. 5 is a side elevation view of the spinal fixation system
`of FIG. 2:
`FIG. 6 is a sectional view of the spinal fixation system of
`FIG. 2 taken generally along line 6-6 of FIG. 5;
`FIG. 7 is an enlarged portion of the sectional view of FIG.
`6 as generally defined by line 7-7 of FIG. 6;
`FIG. 8 is a enlarged portion of the sectional view of FIG. 4
`as generally defined by line 8-8 of FIG. 4;
`FIG. 9 is a top view of the spinal fixation system of FIG. 2;
`FIG. 10 is an enlarged portion of the sectional view of FIG.
`7 as generally defined by line 10-10;
`FIG.11 is an enlarged portion of the sectional view of FIG.
`8 as generally defined by line 11-11:
`FIG. 12 is an partial sectional view of the spinal fixation
`system of FIG. 2 taken generally along line 12-12 of FIG. 8:
`FIG. 13 is a partial exploded perspective view of a spinal
`fixation system according to a second embodiment of the
`invention;
`FIG. 14 is a front elevation view of the spinal fixation
`system of FIG. 13:
`40
`FIG. 15 is a sectional view of the spinal fixation system of
`FIG. 13 taken generally along line 15-15 of FIG. 14;
`FIG. 16 is a side elevation view of the spinal fixation
`system of FIG. 13:
`FIG. 17 is a sectional view of the spinal fixation system of 45
`FIG. 13 taken generally along line 17-17 of FIG. 16;
`FIG. 18 is an enlarged portion of the sectional view of FIG.
`17 as generally defined by line 18-18:
`FIG. 19 is a sectional view of the spinal fixation system of
`FIG. 13 taken generally along line 19-19 of FIG. 16;
`50
`FIG. 20 is an enlarged portion of the sectional view of FIG.
`19 as generally defined by line 20-20;
`FIG. 21 is an enlarged portion of the sectional view of FIG.
`15 as generally defined by line 21-21;
`FIG. 22 is a partial sectional view of the spinal fixation
`system of FIG. 13 taken generally along line 22-22 of FIG.
`21;
`FIG. 23 is an enlarged portion of the sectional view of FIG.
`21 as generally defined by line 23-23;
`FIG. 24 is a partial sectional view of the spinal fixation
`system of FIG. 13 taken generally along line 24-24 of FIG.
`21;
`FIG. 25 is a partial exploded perspective view of a spinal
`fixation system according to a third embodiment of the inven
`tion;
`FIG. 26 is partial sectional view of the spinal fixation
`system of FIG. 25:
`
`25
`
`30
`
`35
`
`55
`
`60
`
`65
`
`Globus Medical, Inc. Exhibit 2009, Page 22 of 27
`Life Spine, Inc. v. Globus Medical, Inc.
`IPR2022-01602
`
`

`

`5
`length of the pedicle screw 10, with an opening at both the
`proximal end and the distal end of the pedicle screw 10.
`Referring back to FIG. 2, prior to adding the coupling
`mechanism 14 and fixation rod 12, the pedicle screw 10 is first
`installed into the vertebra by screwing the pedicle screw 10
`into place, with the use of the self-tapping configuration of
`pedicle screw 10 or other installation methods known in the
`art. Recess 20 may be used as the engagement point for
`drilling the pedicle screw 10 into the chosen vertebra.
`Further referring to FIG. 2, the coupling mechanism 14
`includes a body 26, a bone screw securing device, shown as
`collet 28, an engagement or fastening device, shown as split
`ring 30, and a fastening mechanism, shown as nut 32. Refer
`ring to FIGS. 5-7, the body 26 includes a passage sized to
`receive the pedicle screw 10 and another passage sized to
`receive a fixation rod holder, shown as rod holder 34, a fixa
`tion rod securing device, shown as pin 36, ball bearings 38
`and anti-spin balls 40. While the two passages extend
`orthogonally to one another, the two passages may extend in
`other directions relative to one another in other embodiments
`of the invention. The two passages are connected by an aper
`ture allowing the split ring 30 to act upon the pin 36 to secure
`the fixation rod 12 to the pedicle screw 10. In other embodi
`ments, the split ring 30 may be replaced by a cam, slidingpin,
`or a nut with a pin engagement structure.
`Referring back to FIG. 2, the collet 28 includes an internal
`aperture designed to be fitted over post 18 and a set of com
`pressible arms 42 designed to engage the pedicle screw 10.
`The split ring 30 includes an exterior groove 44 configured to
`mate with a semi-spherical end 62 of the pin 36. Referring to
`FIGS. 8 and 9, the nut 32 includes external threads 46 con
`figured to mate with internal threads 48 on the body 26 and an
`engagement design 50 at the top of the nut 32 may be engaged
`by a tightening tool. Such as a wrench having an interlocking
`design, that may be used to rotate the nut 32 to utilize the
`coupling mechanism 14 to couple the fixation rod 12 to the
`pedicle screw 10.
`Further referring to FIG. 8, the rod holder 34 has two
`passages, one sized to receive the fixation rod 12 and the other
`sized to receive the pin 36. Referring to FIGS. 10 and 11, the
`rod holder 34 also has two grooves, an axial internal groove
`52 that aligns with an external groove 54 on the pin 36 and a
`circumferential external groove 56 that aligns with an internal
`groove 58 on the body 26. Anti-spin balls 40 are inserted into
`the first pair of grooves 52, 54 to prevent the pin 36 from
`rotating freely with respect to the rod holder 34. However,
`referring to FIG. 11, the anti-spin balls 40 permit the pin 36 to
`be slidably coupled to the rod holder 34. Ball bearings 38 (e.g.
`titanium ball bearings) are inserted into the second pair of
`grooves 56, 58 through a ball bearing hole 60 in the body.
`According to an alternative embodiment, external groove 56
`may be replaced with a plurality of discreet holes. Once the
`ball bearings 38 are in place, the ball bearing hole 60 is closed
`by a method known in the art (e.g. laser weld, set screw, plug)
`to maintain the ball bearings 38 in place. Referring to FIG. 12,
`the design and arrangement of the circumferential external
`groove 56 on the rod holder 34, the internal groove 58 on the
`body 26, and the ball bearings 38 allow the rod holder 34 to be
`rotationally coupled to the body 26.
`Referring to back FIG. 2, in order to utilize the coupling
`mechanism 14 to couple the fixation rod 12 to the pedicle
`screw 10, the collet 28, split ring 30, and body 26 are placed
`over the post 18 after installation of the pedicle screw 10 into
`the chosen vertebra. The various components of the coupling
`mechanism 14 are slidable with respect to the fixation rod 12
`and the post 18 prior to tightening to allow for proper adjust
`
`25
`
`30
`
`35
`
`40
`
`45
`
`50
`
`55
`
`60
`
`65
`
`US 8,021,398 B2
`
`5
`
`10
`
`15
`
`6
`ment of the various components. Once the desired placement
`is achieved, the nut 32 may be rotationally secured to the body
`26.
`Further referring to FIG. 2, the nut 32 acts as a fastening
`device by performing two functions. First, rotation of the nut
`32 into the body 26 forces the compressible arms 42 of the
`collet 28 onto the post 18, thus securing the pedicle screw 10
`to the body 26. Second, the rotation of the nut forces the
`peripheral surface of the split ring 30 outward such that the
`split ring 30 engages and forces the pin 36 against the fixation
`rod 12, thus securing the fixation rod 12 with respect to the
`body 26.
`Referring to FIGS. 13-24, a spinal fixation system accord
`ing to another embodiment of the invention includes a bone
`coupling element, shown as pedicle screw 110, a linking
`device or fixation element, shown as fixation rod 112, and a
`coupling mechanism 114. Referring to FIG. 13, the pedicle
`screw 110 is coupled to the fixation rod 112 via the coupling
`mechanism 114. In use, the pedicle screw 110 may be inserted
`through a pedicle and into a vertebra and linked to other
`pedicle screws by the fixation rod 112. The length of the
`fixation rod 112 is chosen to accommodate the total distance
`along the pedicle Screws that are linked together.
`Further referring to FIG. 13, the pedicle screw 110 includes
`a threaded portion 116 and a non-threaded upper portion,
`shown as post 118. At the top of the post 118, an engagement
`mechanism for a screwdriver or power drill, shown as recess
`120, may be utilized. Referring to FIGS. 14 and 15, at the
`bottom of the threaded portion 116, a tip 122 may be config
`ured to be self-tapping. The pedicle screw 110 may be can
`nulated, as shown by the passage 124 extending the length of
`the pedicle screw 110, with an opening at both the proximal
`end and the distal end of the pedicle screw 110.
`Referring back to FIG. 13, prior to adding the coupling
`mechanism 114 and fixation rod 112, the pedicle screw 110