United States Patent (19)
`Ray et al.
`m
`
`(54 SACRAL IMPLANT SYSTEM
`75 Inventors: R. Charles Ray, 5425 - 87th Ave.
`West, Tacoma, Wash.98467; Richard
`B. Ashman, Dallas, Tex.
`73 Assignee: R. Charles Ray, Tacoma, Wash.
`(21) Appl. No.: 593,196
`22 Filed:
`Oct. 5, 1990
`51) Int. Cl........................... A61F 5/01; A61F 2/44;
`A61F 5/00
`52 U.S.C. ......................................... 606/61; 623/17
`58 Field of Search ............... 606/61; 623/17; 128/69
`(56)
`References Cited
`U.S. PATENT DOCUMENTS
`4,641,636 2/1987 Cotrel ................................... 128/69
`4,719,905 1/1988 Steffee.....
`... 128/69
`4,743,260 5/1988 Burton ........
`... 62.3/7
`4,773,402 9/1988 Asher et al.
`... 28/69
`4,950,269 8/990 Gaines, Jr. ............................ 606/61
`FOREIGN PATENT DOCUMENTS
`030489 7/1988 European Pat. Off. .
`OTHER PUBLICATIONS
`Roy-Camilie, Raymond et al., "Internal Fixation of the
`Lumber Spine with Pedicle Screw Plating," Clinical
`Orthopedics de Related Research, No. 203 (Feb. 1986),
`pp. 7-17.
`Shipman, Pat et al., "The Human Skeleton,” Harvard
`University Press, Cambridge, Massachusetts, and Lon
`don, England (1985), pp. 81-93.
`Asher, Marc A. et al., "Anthropometric Studies of the
`Human Sacrum Relating to Dorsal Transsacral Implant
`
`
`
`|||||||||||||||||
`USOO52792A
`11
`Patent Number:
`5,127,912
`45
`Date of Patent:
`Jul. 7, 1992
`
`Designs," Clinical Orthopaedics and Related Research,
`No. 203 (Feb. 1986), pp. 58-62.
`Roy-Camille, Raymond et al., "Internal Fixation of the
`Lumbar Spine with Pedicle Screw Plating," Clinical
`Orthopaedics and Related Research, No. 203 (Feb. 1986),
`pp. 7-17.
`Louis, Rene, “Fusion of the Lumbar and Sacral Spine
`by Internal Fixation with Screw Plates," Clinical Ortho
`paedics and Related Research, No. 203 (Feb. 1986), pp.
`18-33.
`Berry, James L. et al., "A Morphometric Study of
`Human Lumbar and Selected Thoracic Vertebrae,'
`Spine, vol. 12, No. 4 (1987), pp. 362-367.
`Roy-Camille, R. et al., “Posterior Spinal Fixation with
`Transpedicular Screws and Plates,' Groupe Hospita
`lier, Paris, France.
`Primary Examiner-David J. Isabella
`Assistant Examiner-Elizabeth M. Burke
`Attorney, Agent, or Firm-Christensen, O'Connor,
`Johnson & Kindness
`57
`ABSTRACT
`A sacral implant system includes first and second sacral
`plates that are affixed on opposite sides of the sacrum
`adjacent the lumbosacral junction. Pedicle, lateral and
`oblique mounting means are provided for rigidly affix
`ing the sacral plates to the sacrum. First and second
`fixation rods extend in a superior direction along the
`lumbar portion of the spine. One or more connecting
`members tie the rods together. The superior most verte
`bra to be fixed is tied to the implant system with a spe
`cial offset fixation plate and pedicle screw. Conven
`tional vertebra hooks can also be used as necessary.
`Intermediate vertebra are tied to the system with a
`straight fixation plate and pedicle screw.
`
`27 Claims, 5 Drawing Sheets
`
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`U.S. Patent
`
`July 7, 1992
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`Sheet 1 of 5
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`5,127,912
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`U.S. Patent
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`July 7, 1992
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`Sheet 3 of 5
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`U.S. Patent
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`July 7, 1992
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`Sheet 4 of 5
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`5,127,912
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`U.S. Patent
`
`July 7, 1992
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`Sheet 5 of 5
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`5,127,912
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`
`
`thiti; i.:
`g-i-4444's-ul-...
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`1
`
`SACRAL IMPLANT SYSTEM
`
`10
`
`BACKGROUND OF THE INVENTION
`The present invention relates to sacral implants, and
`more particularly to an improved implant system for
`fixing a stabilizing appliance to the sacrum and to the
`lumbar vertebrae.
`Spinal fusion, especially in the lumbar and sacral
`region is regularly employed to correct and stabilize
`spinal curves, to prevent recurrence of spinal curves
`and to stabilize weakness in trunks that result from
`degenerative discs and joint disease, deficient posterior
`elements, spinal fracture, and other debiliating prob
`15
`lems. Spinal implant systems have been used regularly
`to stabilize the lumbar and sacral spine temporarily
`while solid spinal fusions develop.
`Several temporary stabilization systems are currently
`in use. All perform adequately, however leave room for
`20
`improvement. For example, an implant system for at
`taching the superior most lumbar vertebra (L1) to the
`implant without interfering with normal motion of the
`next superior vertebra needs to be developed. Addition
`ally, implant systems that achieve stronger sacral fixa
`25
`tion, easier use for multiple segment fixation, and easier
`use with spinal deformity are needed. Further, better
`implant systems for rigidly tying the base of the system
`to the sacrum must be developed.
`SUMMARY OF THE INVENTION
`30
`The present invention provides a sacral implant sys
`ten that rigidly affixes the base of the implant system to
`the sacrum while allowing ease of installation and flexi
`bility of design. Moreover, the present system provides
`apparatus for securing the upper portion of the implant
`system to, for example, the L-1 vertebra, without inter
`fering with the next superior most vertebra (T-2) and
`any or all vertebrae in between. The sacral implant
`system of the present invention comprises first and sec
`ond sacral plates for mounting on opposite sides of the
`sacrum adjacent the lumboscral junction. Each of the
`sacral plates have pedicle, lateral, and oblique mounting.
`means for rigidly affixing each of the sacral plates to the
`sacrum. The system also includes first and second rods
`extending in a superior direction and generally parallel
`relationship from respective ones of the sacral plates.
`The rods are situated on opposite sides of the sagittal
`plane. Means are also provided for rigidly affixing the
`rods to respective sacral plates. At least one crosslink
`plate is employed to rigidly interconnect the rods at a
`location superior to the sacral plates. Finally, a superior
`fixation plate having a lateral portion and a medial por
`tion is employed to affix the superior most vertebra to
`be fused to the implant system. A pedicle screw is fixed
`to and through the pedicle of the vertebra. The lateral
`portion of the fixation plate is rigidly affixed to the
`pedicle screw. The medial portion of the fixation plate
`is offset in an inferior direction sufficiently far so that it
`avoids the inferior articulate process of the next supe
`rior vertebra. In this manner the next superior vertebra
`can moved in a normal fashion relative to the vertebra
`to be fused during the temporary stabilization. Prefera
`bly, a lateral fixation plate is also used for pedicle fixa
`tion of intermediate vertebrae.
`In another aspect of the invention, a specialized pedi
`65
`cle screw is provided for attachment of the offset and
`lateral fixation plates to the vertebra. The screw in
`cludes a first threaded portion for threading into the
`
`5, 127,912
`2
`vertebra, a subhead portion and a second threaded por
`tion projecting above the subhead. The second threaded
`portion is adapted to receive a nut. The subhead has a
`diameter greater than the second threaded portion and
`an upwardly facing shoulder lying in a plane substan
`tially orthogonal to the axis of the screw. In use, the
`shoulder engages the anterior surface of the fixation
`plate while the nut is threaded on the second threaded
`portion and bears down against the posterior surface of
`the plate to secure the plate and screw together.
`BRIEF DESCRIPTION OF THE DRAWINGS
`A better understanding of the present invention can
`be derived by reading the ensuing specification in con
`junction with the accompanying drawings wherein:
`FIG. 1 is an isometric view of the spinal implant
`system of the present invention as applied to the lumbar
`spine;
`FIG. 2 is an isometric view of a right lateral sacral
`plate constructed in accordance with the present inven
`tion;
`FIG. 3 is a plan view (in the dorsal plane) of a sacral
`plate shown in FIG. 2;
`FIG. 4 is a cross-sectional view taken along section
`line 4-4 of FIG. 3;
`FIG. 5 is a cross-sectional line taken along broken
`cross-sectional line 5-5 of FIG. 3;
`FIG. 6 and FIG. 7 are elevation views of fixation
`screws for use with the sacral plate;
`FIG. 8 is a plan view of the offset fixation plate that
`is constructed in accordance with the present invention;
`FIG. 9 is a elevation view of a pedicle screw for use
`with the fixation plate of FIG. 8:
`FIG. 10 is an exploded isometric view of the fixation
`plate and screw of FIG. 9 shown in conjunction with a
`fixation rod and fastening system used in accordance
`with the present invention;
`FIG. 11 is a plan view of a straight fixation plate;
`FIG. 12 is an enlarged dorsal view of a superior por
`tion of the sacrum showing the sacral plates implanted
`in accordance with the present invention;
`FIG. 13 is an enlarged cross-sectional view taken
`along section line 13-13 of FIG. 1 through the sacrum
`looking in an inferior direction at the sacral implant
`system of the present invention;
`FIG. 14 is an enlarged cross-sectional view taken
`along section line 14-14 of FIG. 1 of the pedicle screw
`and offset fixation plate implanted in accordance with
`the present invention looking in an inferior direction;
`and
`FIG. 15 is a lateral view looking from right to left of
`the offset fixation plate shown in FIG. 14.
`DETAILED DESCRIPTION OF THE
`INVENTION
`Referring first to FIG. 1, the spinal implant system 20
`constructed in accordance with the present invention is
`affixed to the lumbar spine, generally designated 22.
`The implant system includes a pair of sacral plates 24
`and 26 affixed to the sacrum 28 adjacent the lumbosca
`ral joint. A pair of fixation rods 30 and 32 extend in a
`superior direction on opposite sides of the sagittal plane
`from the sacral plates posterior to the lumbar vertebrae
`L5, LA, L3, L2 and L1. Rods 30 and 32 terminate adja
`cent the superior portion of vertebra L1. Conventional
`fasteners 34 and 36 securely affix the rods 30 and 32
`respectively to the sacral plates 24 and 26.
`
`35
`
`45
`
`SO
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`The lateral bore 72 has a cylindrical section 84 having
`At the superior end of the rods, a pair of offset fixa
`an axis 86 extending in an anterior and lateral direction
`tion plates 40 and 42 affix the upper ends of the rods to
`that is preferably offset in the lateral direction at an
`the L1 vertebra. Inferior to that location, a pair of con
`angle of 30 degrees from a line orthogonal to the sacral
`ventional inferior hooks 44 and 46 grasp the inferior
`plane. If desired, one of ordinary skill may also vary the
`portion of the L1 vertebra to secure it relative to the
`lateral angle from 30 degrees up to 45 degrees. Prefera
`rods 30 and 32. At intermediate locations a straight
`bly the axis 86 is not canted in either an inferior or
`fixation plate 48 is employed to affix vertebra L3 to the
`superior direction relative to the sacral plate. However,
`rods 30 and 32. Immediately superior to the sacral plates
`depending upon the sacral anatomy, the axis can be
`a connecting member 50 rigidifies the rods 30 and 32
`canted from 0 degrees to 15 degrees in the superior
`relative to each other. One of ordinary skill in this tech
`direction when viewed in the sacral plane. A counter
`nique will readily recognize that one or more connect
`sink bore 85 is located posterior to the cylindrical sec
`ing members 50, straight fixation plates 48, and hooks 44
`tion 85 and emerges onto the posterior surface of the
`can be employed as needed.
`sacral plate.
`The implant system 20 constructed and employed in
`The oblique bore 74 also has a cylindrical section 88
`accordance with the present invention provides a rigid
`having an axis 90 having two offsets in the lateral and
`stabilization system for the lumbar spine. The system
`inferior directions. The axis 90 when viewed in the
`rigidly ties the sacrum to one or more of the lumbar
`sacral plane is first preferably offset 45 degrees from a
`vertebrae. Moreover the offset fixation plates 40 and 42
`lateral line, but may be varied from 30 degrees to 60
`allow the upper portion of the implant system to be
`degrees. Secondly, the axis 90 is offset in the lateral
`20
`rigidly affixed to the superior lumbar vertebra L1 while
`direction preferably 30 degrees from a line orthogonal
`avoiding contact with the inferior processes of the next
`to the sacral plane but again may be varied from 30
`superior vertebra T12. In this manner the T12 vertebra
`degrees to 45 degrees. A countersink 89 is located pos
`can move in a normal manner while stabilization of the
`terior to the cylindrical section 88 and also emerges
`lumbar spine occurs.
`onto the posterior surface of the sacral plate.
`25
`Referring now to FIGS. 2, 3, 4 and 5, the right sacral
`Referring now to FIG. 6, the pedicle screw 94 em
`plate is illustrated. The right sacral plate is a mirror
`ployed with the sacral plate has a unique construction.
`image of the left sacral plate, therefore, only the right
`It has a lower threaded portion 96, an upper flared head
`plate will be described in detail. The right sacral plate
`98 and a cylindrical section 100 immediately below the
`26 has a base 60 having a posterior surface and an ante
`head 98. The head also carries an allen socket 102 so
`30
`rior surface. The anterior surface of the plate is de
`that the screw can be rotated into a hole drilled in the
`signed to intimately contact the posterior surface of the
`pedicle. The bone engaging threads on the lower
`sacrum adjacent the lumbosacral joint. In position, the
`threaded portion 96 are of conventional design. The
`base 60 lies generally in a plane generally tangential to
`cylindrical section 100 has a diameter slightly less than
`the portion of the sacrum adjacent the lumbosacral
`the diameter of the cylindrical section 80 of pedicle bore
`35
`joint. For purposes of this description, that plane will be
`70. The diameters are chosen such that when the cylin
`referred to as the sacral or dorsal plane.
`drical section 100 is in the cylindrical section 80, the
`A U-shaped flange 62 extends posteriorly from the
`screw 94 can rotate and reciprocate. However, the
`medial portion of the base 60. The medial surface of the
`tolerances are such that the screw cannot angulate or
`flange 62 carries a groove 64 oriented in a superior/in
`toggle relative to the axis 82. The upper flared portion
`ferior direction for receiving a fixation rod 32. A con
`98 is configured to mate with countersink 81 when the
`ventional rod clamp 68 is employed to securely and
`screw is completely threaded into the sacrum.
`rigidly affix the rod 66 in the groove 64 on the flange 62.
`Referring to FIG. 7, the same screw 106 is employed
`The lateral portion of the sacral plate 26 carries three
`in both the lateral bore 72 and the oblique bore 74.
`bores that extend from the posterior surface of the base
`Screw 106 also has a lower threaded portion 108, a
`45
`60 in a generally anterior direction. These bores are the
`flared head 110 and a cylindrical section 112. Cylindri
`pedicle bore 70, the lateral bore 72 and the oblique bore
`cal section 112 is sized relative to the cylindrical sec
`74. The bores 70, 72 and 74, while extending in an ante
`tions 84 and 88 to allow rotation and reciprocation but
`rior direction, are not orthogonal to the sacral plane.
`not angulation. The flared head 110 is configured to
`Instead, the pedicle bore 70 has a cylindrical section
`mate with the countersinks 85 and 89 when the screws
`80 having an axis 82 extending in an anterior and medial
`are completely threaded into the sacrum.
`direction that is offset in the medial direction preferably
`Referring now to FIGS. 8 and 10, the offset fixation
`at an angle of 15 degrees to a line orthogonal to the
`plate 40 includes a medial portion 122 and a lateral
`sacral plane. A countersink bore 81 is located posterior
`portion 124. The fixation plate of FIG. 8 is employed on
`to the cylindrical section 80 and emerges onto the poste
`the left side of the fixation system. A similar fixation
`55
`plate, having the mirror image of plate 40, is employed
`rior surface of the sacral plate. This angle can be varied
`from 0 degrees to 20 degrees, depending upon the par
`on the right side; however, it is not shown in the draw
`ticular sacral anatomy being extends fixed. However, it
`ings. The lateral portion 124 carries a bore 126 that
`is understood that the screw that extends through this
`extends in a posterior/anterior direction when installed.
`opening extends through the pedicle of the sacrum and
`The medial portion 122 is offset in an inferior direction
`from the lateral portion. 124. The medial portion 122
`must always lie within the pedicle. It has been found
`that 15 degrees is the angle most universally acceptable
`carries a lateral slot 127. The anterior surface of the
`medial portion 122 carries a plurality of grooves 128
`for this orientation. In the present embodiment, the axis
`that extend in an inferior/superior direction and inter
`82 is not inclined in a superior or inferior direction
`relative to a plane perpendicular to the sacral plate. It
`sect the slot 127. These grooves have a diameter equiva
`lent to the fixation rod 30. A conventional rod to clamp
`however can be inclined superiorly so that the vertebral
`fastener 58 is employed to secure the fixation plate 40 to
`end plate, rather than the anterior cortex, can be en
`gaged by the end of the screw.
`the fixation rod 30.
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`to allow bicortical fixation lateral to the significant
`A special pedicle screw 129 is employed with the
`offset fixation plate. Referring to FIG. 9, the pedicle
`neurovascular strucutures.
`Referring now to FIGS. 14 and 15, offset fixation
`screw includes a lower threaded portion 130, a subhead
`plates 40 and 42 are shown affixed by conventional
`portion 132 and an upper threaded portion 134. The
`fasteners 58 to fixation rods 30 and 32 The pedicle
`upper threaded portion 134 has an allen socket 136
`screws 129 are threaded into suitable bores in the left
`extending axially into its upper end. The subhead has a
`and right pedicle 150 and 152 of the L1 vertebra. Nuts
`diameter larger than the upper threaded portion 134 and
`140 are threaded onto the upper portions of the pedicle
`terminates in its upward end in a shoulder 138 that is
`screws 129 and tightened against the anterior surfaces
`positioned in a plane orthogonal to the axis of the screw
`of the fixation plates 40. The fasteners 58 thereafter are
`129. Referring now to FIG. 10, the pedicle screw is
`tightened to secure the other end of the plate to the
`received by the bore 126, which is sized just slightly
`fixation rods 30 and 32. In this manner, the upper end of
`larger than the upper threaded portion 134 so that the
`the lumbar spine implant system can be secured to the
`pedicle screw can reciprocate relative to the offset fixa
`L1 vertebra without interfering with the next superior
`tion plate 40, but cannot angulate relative to the screw
`axis when engaging the bore 126. A conventional nut
`vertebra.
`The present invention has been described in connec
`140 is threaded onto the upper portion 134 of the pedi
`tion with the preferred embodiment. One of ordinary
`cle screw 129 securing the shoulder 138 against the
`sill will be able to effect various alterations, substitu
`anterior surface of the fixation plate while the nut 140
`tions of equivalents and other changes without depart
`Snugs against the posterior surface, thus rigidly inter
`ing from the broad concepts imparted herein. It is,
`locking the pedicle screw 129 and the fixation plate.
`therefore, intended that the letters' patent issued hereon
`A straight fixation plate 48 is illustrated in FIG. 11.
`be limited only by the definition contained in the ap
`The straight fixation plate is similar in construction to
`pended claims and equivalents thereof.
`the offset fixation plate 40 except that it does not con
`The embodiments of the invention in which an exclu
`tain the offset. It carries a similar bore 144 for receiving
`sive property or privilege is claimed are defined as
`a pedicle screw similar to screw 129, a lateral slot 146
`25
`and rod engaging grooves 148 for securing the plate 48
`follows:
`1. A sacral implant system comprising:
`to a fixation rod.
`first and second discrete sacral plates for mounting on
`Referring to FIGS. 12 and 13, in use the sacral plates
`opposite sides of said sacrum adjacent the lumbosa
`24 and 26 are affixed to the sacrum 28 adjacent the
`cral junction, each of said sacral plates having pedi
`lumboscral junction. As desired and as necessary, the
`cle, lateral and oblique mounting means for rigidly
`anterior surface of the sacrum can be smoothed so as to
`fixing each of said sacral plates independently to
`receive the anterior surface of the sacral plates 24 and
`opposite lateral portions of said sacrum,
`26 in snug relationship. The pedicle screws 94 and 94,
`first and second rods extending in a superior direction
`for use in the pedicle bores of the sacral plates, is
`in a generally parallel relationship from respective
`threaded into appropriate bores made by the surgeon
`ones of said sacral plates on opposite sides of the
`through the pedicle of the sacrum. The pedicle screws
`centerline of said lumbar spine, and means rigidly
`are snugged down so that the flared heads are seated
`fixing said rods to said sacral plates,
`firmly in the countersinks in the respective plates. A
`at least connecting member rigidly interconnecting
`torque ranging from 6 to 10 in/lb. can be used to snug
`said rods superior to said sacral plates, and
`the screws. The physician also makes appropriate bores
`a superior offset fixation plate rigidly affixed to at
`into the sacrum that are aligned with the lateral bores 72
`least one of said rods, a pedicle screw fixed to and
`and 72" and with the oblique bores 74 and 74". Screws
`through the pedicle of a vertebra, and means rig
`106 are inserted through the lateral and oblique bores 72
`idly affixing said pedicle screw to said offset fixa
`and 74 in the right plate, and bores 72" and 74" in the left
`tion plate,
`plate. All the screws 106 are snugged down so that the
`45
`each of said pedicle, lateral and oblique mounting
`flared heads seat snugly in the countersinks in the ante
`means including a fixation screw having a lower
`rior surface of the sacral plates. Again a torque of 6 to
`threaded portion, a head and a cylindrical section
`10 in/lb. is appropriate for snugging the screws into the
`adjacent said head, said sacral plate including cy
`plate.
`lindrical bores corresponding to each of said pedi
`In this manner, the three screws in each sacral plate
`50
`cle, lateral and oblique mounting means, each of
`all diverge from each other. As a result, the screws
`said bores having a diameter slightly greater than a
`cannot be easily pulled from the bores in the bone. A
`respective cylindrical section on a respective fixa
`force in the direction of the axis of one of the screws
`tion screw enabling said screw to rotate and recip
`will be partially distributed over the bone on which the
`rocate in said bore while substantially eliminating
`remaining two screws bear. In this manner, full force
`angular movement of said screw relative to said
`cannot be exerted in the direction of the axis of a single
`plate, said cylindrical bore of said pedicle mounting
`screw and thus a single screw cannot be sheared from
`means having an axis that extends in a medial and
`its bore in an easy manner. This construction provides
`anterior direction from said sacral plate, said cylin
`significant advantages over the prior art while allowing
`drical bore of said pedicle mounting means being
`independent placement of a sacral plate on each side of 60
`located medially from the cylindrical bores of said
`the sacrum. For example, screw placement is designed
`lateral and oblique mounting means.
`to achieve fixation in the proximal part of the sacrum,
`2. The system of claim 1 wherein said axis offset in the
`which has the strongest bone. The oblique screw is
`medial direction at an angle ranging from 0 to 20 de
`designed to be proximal to and parallel the S1 foramin,
`grees relative to a line orthogonal to the sacral plane.
`thereby avoiding damage to the S1 nerve. The medial
`3. The system of claim 1 wherein the axis is oriented
`screw is inclined medially to allow bicortical fixation
`an an angle of about 15 degrees relative to a line orthog
`while avoiding neurovascular structures directly ante
`onal to the sacral plane.
`rior to the S1 pedicle. The lateral screw is also designed
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`at least one connecting member rigidly interconnect
`4. The system of claim 1 wherein the cylindrical bore
`ing said rods superior to said sacral plates, a Supe
`of said lateral mounting means has an axis extending in
`rior offset fixation plate rigidly affixed to at least
`a lateral and anterior direction relative to said sacral
`plate.
`one of said rods, a pedicle screw fixed to and
`through the pedicle of a vertebra, and means rig
`5. A sacral plate for use in a sacral implant system
`idly affixing said pedicle screw to said offset fixa
`comprising:
`tion plate, said offset fixation plate having a medial
`a plate having a posterior surface and an anterior
`portion and an integral lateral portion offset in the
`surface, said anterior surface being configured to
`superior direction, the medial portion being posi
`the positioned against the posterior surface of the
`tioned below the interior processes of the next
`sacrum adjacent the lumbosacral junction, said
`superior vertebra relative to the vertebra to be
`sacral plate having means for attaching to a fixation
`fixed, the offset portion being positionable over the
`rod, said sacral plate also having a pedicle, lateral
`pedicle of the vertebra to be fixed.
`and oblique mounting means for rigidly fixing said
`15. The system of claim 14 wherein the medial por
`sacral plate to said sacrun at a location lateral from
`tion of said offset plate has a lateral slot, the anterior
`the sagittal plane, each of said pedicle, lateral and
`side thereof having a plurality of slots oriented in the
`oblique mounting means including a cylindrical
`superior/inferior direction for receiving said rod at a
`bore, of said pedicle mounting means having an
`plurality of lateral distances from an adjacent pedicle
`axis that extends in a medial and anterior direction
`fixation screw.
`relative to the sacral plane, the cylindrical bore of
`16. A sacral implant system comprising:
`said pedicle mounting means being positioned me
`first and second sacral plates for mounting on oppo
`dially relative to the cylindrical bores of said lateral
`site sides of said sacrum adjacent the lumbosacral
`and oblique mounting means.
`junction, each of said sacral plates having pedicle,
`6. The plate of claim 5 wherein said axis if offset in the
`lateral and oblique mounting means for rigidly
`medial direction at an angle of about 0 degrees to 20
`fixing each of said sacral plates to opposite lateral
`25
`degrees relative to a line orthogonal to the sacral plane.
`portions of said sacrum,
`7. The plate of claim 1 wherein said axis is oriented at
`first and second rods extending in a superior direction
`an angle of about 15 degrees relative to a line orthogo
`in a generally parallel relationship from respective
`nal to the sacral plane.
`ones of said sacral plates on opposite sides of the
`8. The plate of claim 5 wherein the cylindrical bore of
`centerline of said lumbar spine, and means rigidly
`30
`said lateral mounting means has an axis extending in a
`fixing said rods to said sacral plates,
`lateral and anterior direction relative to said sacral
`at least one connecting member rigidly interconnect
`plane.
`ing said rods superior to said sacral plates, a supe
`9. The plate of claim 8 wherein said axis if offset in the
`rior offset fixation plate rigidly affixed to at least
`lateral direction at an angle of about 30 degrees to about
`one of said rods, a pedicle screw fixed to and
`45 degrees relative to a line orthogonal to said sacral
`through the pedicle of a vertebra, and means rig
`plane.
`idly affixing said pedicle screw to said offset fixa
`10. The plate of claim 9 wherein said axis is oriented
`tion plate, and
`.
`at an angle of about 30 degrees relative to a line orthog
`a straight fixation plate for fixing an intermediate
`onal to the sacral plane.
`vertebra to one of said rods, said straight fixation
`11. The plate of claim 5 wherein the cylindrical bore
`plate having a medial portion and an integral lateral
`of said oblique mounting means has an axis extending in
`portion, said lateral portion including an aperture
`a lateral, anterior and inferior direction relative to said
`for receiving a pedicle fixation screw, said medial
`sacral plane.
`portion having a plurality of slots on its anterior
`12. The plate of claim 11 wherein said axis when
`side oriented in a superior/inferior direction for
`45
`viewed in the sacral plane, is offset in the inferior direc
`receiving a rod at plurality of lateral distances from
`tion at an angle of about 30 degrees to about 60 degrees
`an adjacent pedicle fixation screw.
`relative to a lateral line in said sacral plane and is offset
`17. A sacral implant system comprising:
`in the lateral direction from about 30 degrees to about
`first and second sacral plates for mounting on oppo
`45 degrees relative to a line orthogonal to said sacral
`site sides of said sacrum adjacent the lumbosacral
`plane.
`junction, each of said sacral plates having means
`13. The plate of claim 12 wherein said axis is offset
`for attaching to a fixation rod, each of said sacral
`inferiorly at an angle of about 45 degrees relative to a
`plates also having pedicle, lateral and oblique
`lateral line in the sacral plane and is offset laterally at an
`mounting means for rigidly fixing each of said sa
`angle of about 30 degrees relative to a line orthogonal to
`cral plates to opposite lateral portions of said sa
`the sacral plane.
`crum, each of said pedicle, lateral and oblique
`14. A sacral implant system comprising:
`mounting means including a fixation screw having
`first and second sacral plates mounting on opposite
`a lower threaded portion, a head and a cylindrical
`sides of said sacrum adjacent the lumbosacral junc
`section adjacent said head, said sacral plate includ
`tion, each of said sacral plates having pedicle, lat
`ing cylindrical bores corresponding to each of said
`eral and oblique mounting means for rigidly fixing
`pedicle, lateral and oblique mounting means, each
`each of said sacral plates to opposite lateral por
`of said bores having a diameter slightly greater
`than a respective cylindrical section on a fixation
`tions of said sacrum,
`first and second rods extending in a superior direction
`screw enabling said screw to rotate and reciprocate
`in a generally parallel relationship from respective
`in said bore while substantially eliminating angular
`ones of said sacral plates on opposite sides of the
`movement of said screw relative to said plate, said
`centerline of said lumbar spine, and means rigidly
`cylindrical bore of said lateral mounting means
`fixing said rods to said sacral plates,
`having an axis extending in a lateral and anterior
`
`50
`
`55
`
`65
`
`ALPHATEC HOLDINGS, INC., ALPHATEC SPINE INC. -
`IPR2019-00362, Ex. 1028, p. 10 of 14
`
`

`

`5, 127,912
`10
`about 45 degrees relative to a line orthogonal to
`direction relative to said sacral plate, said axis of
`said sacral plane.
`said cylindrical bore being offset in the lateral di
`rection at an angle of from 30 degrees to 45 degrees
`22. The plate of claim 21 wherein said axis is oriented
`at angle of about 30 degrees relative to a line orthogonal
`relative to a line orthogonal to the sacral plane.
`18. The system of claim 17 wherein