GLOBUS MEDICAL, INC.
`EXHIBIT 1008
`IPR2015-to be assigned
`(Globus v. Flexuspine)
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`1 of 9
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`U.S. Patent
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`Sep. 9, 1997
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`Sheet 1 of 3
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`5,665,122
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`Sep. 9, 1997
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`Sheet 2 of 3
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`5,665,122
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`U.S. Patent
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`Sep. 9, 1997
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`Sheet 3 of 3
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`5,665,122
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`1
`EXPANDABLE INTERVERTEBRAL CAGE
`AND SURGICAL METHOD
`
`BACKGROUND OF THE ]NVEN'I'ION
`
`1. Field of the Invention
`
`The present invention relates to orthopedic prosthetic
`devices and particularly to an improved spinal cage pros-
`thesis. Even more particularly the present invention relates
`to an expandable generally cylindrically shaped spinal cage
`prothesis that includes upper and lower components that can
`be incrementally separated from one another by an advanc-
`ing screw until they are in contact with the vertebral plates
`of the involved spinal unit for use in vertebral fusion
`procedures. The present invention also relates to a surgical
`method for installing the spinal cage prothesis.
`2. General Background
`Surgical prosthetic implants have been developed for use
`in a surgical fusion of the vertebral column. These implants
`have been provided are in the form of a plug that is placed
`between two adjacent vertebrae. The plug contacts adjacent
`vertebral plates to achieve vertebral fusion. thus treating or
`preventing back pain in patients that have discogenic pain.
`Many spinal implants in the form of a cage or plug have been
`patented. An example of a patent for a surgical prosthetic
`implant that is used in vertebral interbody fusion is the
`Brantigan U.S. Pat. N0. 4,743 .256. The ’256 patent discloses
`a surgical prosthetic implant for the vertebral column in the
`form of a rigid, preferably ina't metal plug having a porous
`metal surface allowing ingrowth of bone cells for biologic
`fixation is provided to achieve vertebral interbody fusion for
`treating or preventing back pain. The plug forms a strut
`spanning and maintaining t:he disc space between adjoining
`vertebrae and has opposite ends bottomed in channels that
`are cut into the opposing faces of the vertebrae or opposed
`faces bottomed on the end faces of adjoining vertebrae.
`Bone ingrowth into the porous surface of the plug achieves
`long term biological fixation with living bone. Local bone
`graft harvested from the channel cuts into the vertebrae to
`receive the plug supplements the fusion. "I'he implant mini-
`mizes or eliminates the need for bone graft material obtained
`from a second surgical site or from a bone bank and
`simplifies the method of achieving the interbody fusion.
`In the Shepperd U.S. Pat. No. 4,863,476, there is dis-
`closed a spinal implant that has an elongated body which is
`divided into two portions with mutually opposed contact
`surfaces and is for insertion into the Joint space between two
`adjacent vertebrae. A cam device or cam devices are mov-
`able between the contact stufaces to expand or increase the
`spacing between the body portions so as to increase the
`spacing between the adjacent vertebrae.
`The Brantigan U.S. Pat. No. 4,878,915 entitled “Surgical
`Prosthetic Implant Facilitating Vertebral Interbody Fusion”
`discloses a prosthesis plug forming transverse stnrts between
`adjacent vertebrae.
`The Michelson U.S. Pat. No. 5,015,247 entitled
`‘Threaded Spinal Implant” discloses an artificial implant
`which when placed between two adjacent vertebrae directly
`participates and is incorporated in the ensuing fusion.
`The Ray U.S. Pat. No. 5,026,373 discloses a fusion cage
`having an external thread that can be surgically inserted into
`threaded bore extending laterally between the adjacent bony
`structures such as two vertebrae with the thread penetrating
`into cancellous bone of each of the vertebrae. The cage is
`easily screwed into place by hand without damage to bony
`structures. The cage is then packed with a bone-growth-
`inducing substances such as cancellous bone.
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`2
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`A middle expandable intervertebral disc implant is the
`subject of U.S. Pat. No. 5,171,278. The ’278 patent discloses
`an artificial disc implant having a member for adapting in
`size and shape to an anatomical space between vertebrae and
`apparatus for expanding the member to conform to the
`space.
`
`A Canadian Patent Application 2.015.507 discloses a
`spinal implant for use in surgical procedures for stabilizing
`the spine.
`
`SUMMARY OF THE INVENTION
`
`The present invention is an improvement to cage type
`expandable spinal prostheses. The apparatus includes an
`expandable spinal cage that is in an elongated cylindrical
`form for use in vertebral fusion procedures.
`The expandable cage includes upper and lower compo-
`nent and includes an expansion screw. The expandable cage
`includes an exterior cylindrical extension that contains an
`external thread for attachment of a T-wrench inserter.
`The interior of the extension is threaded to accommodate
`
`the expansion screw. The lower component includes an
`upwardly extending posterior protrusion which fits into and
`slides in a corresponding recess of the upper component.
`When the expansion screw is turned clockwise using a
`wrench. the upper and lower components are separated from
`one another until they are in contact with the vertebral plates
`of adjacent vertebrae.
`The cage components can have passageways for packing
`with bone-inducing-growth material allowing the cage to
`become part of the fusion. The cage components can have
`bone graft or other osteoinductive or osteoconductive sub-
`stance thereon for the purpose of enhancing bone fusion.
`Also disclosed is a method for surgically installing the
`expandable spiral prcthesis comprising the steps of prepar-
`ing a space between two vertebrae for receiving the
`prothesis. surgically inserting the pmthesis into the resulting
`space and advancing a screw member to separate incremen-
`tally the upper and lower cage components.
`
`BRIEF DESCRIPTION OF THE DRAWINGS
`
`For a further understanding of the nature and objects of
`the present invention, reference should be had to tire fol-
`lowing detailed description, taken in conjunction with the
`accompanying drawings. in which like parts are given like
`reference numerals, and wherein:
`FIG. 1 is a sectional elevational view of a patient’s spine
`showing placement of the preferred embodiment of the
`apparatus of the present invention;
`FIG. 2 is an elevational frontal view of the preferred
`embodiment of the apparatus of the present invention;
`FIG. 3 is a top view of the preferred embodiment of the
`apparatus of the present invention;
`FIG. 4 is a sectional view of the preferred embodiment of
`the apparatus of the present invention;
`FIG. 5 is a sectional view of the preferred embodiment of
`the apparatus of the present invention;
`FIG. 6 is sectional View taken along lines 6-6 of FIG. 5;
`FIG. 7 is a sectional view taken along lines 7—7 of FIG.
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`FIG. 8 is a side view of the preferred embodiment of the
`apparatus of the present invention;
`FIG. 9 is a side sectional view of the preferred embodi-
`ment of the apparatus of the present
`invention shown
`attached to a T-wrench inserter; and
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`FIG. 10 is an exploded perspective view of the preferred
`embodiment of the apparatus of the present invention.
`DETAILED DESCRIPTION OF THE
`PREFERRED EMBODIMENT
`
`FIGS. 1-10 show the preferred embodiment of the appa-
`ratus of the present invention designated generally by the
`numeral 10. In FIG. 1. spinal cage prosthesis 10 is shown
`applied to a patient’s spine 11 between adjacent vertebrae
`12, 13. Two of the spinal cages 10 are shown placed in the
`intervertebral space 14 between vertebrae 12, 13. The cage
`can be implanted via a variety of surgical techniques. These
`techniques include both open procedures from the anterior
`or posterior aspect of the body. In concept, these surgical
`approaches would be similar to existing anterior or posterior
`lumbar interbody fusion procedures (ALIF, PLIF) with the
`exception of the boney preparation. In addition, the device
`could be implanted in a closed surgical technique through a
`transcutaneous cannula system. This cannula could enter the
`body cavity from a variety of directions, including posterior-
`lateral, or anterior.
`After implantation, the cage prosthesis 10 is expanded so
`that it contacts the vertebral plates of adjacent vertebrae 12,
`13 as part of a vertebral fusion procedure.
`Spinal cage apparatus 10 is shown in FIGS. 2 and 3 as
`placed during a spinal fusion procedure. In FIGS. 4-10.
`spinal cage prosthesis 10 is shown more particularly. The
`apparatus 10 includes a two part cage body 15 having upper
`and lower cage sections 16. 17. The overall cage 15 presents
`a cylindrical shape. The upper cage section 16 provides a
`half cylinder shaped outer surface 18. The cage section 17
`provides a similarly shaped, curved half cylinder outer
`surface 19. The smfaces 18, 19 are preferably roughened.
`Examples of roughened surfaces include for example a
`threaded or hurled surface, or a surface covaed with short
`spikes that would engage the end plates of the vertebral
`bodies. The purpose of the roughening of the surfaces 18, 19
`is to enhance fixation of cage body 15.
`Each of the cage sections 16, 17 provides abutting flat
`surfaces 20. 21, the surfaces 20, 21 aligning in face-to-face
`relation upon assembly as shown in FIGS. 4-9.
`Socket 22 of cage section 16 cooperates with projection
`23 of cage section 17 to form a sliding and telescoping
`connection. In FIG. 5, the cage sections 16, 17 are shown in
`a collapsed position. In FIG. 9, the cage sections 16, 17 are
`shown in an expanded position, wherein the projection 23
`slides in a direction away from socket 22 as shown.
`A pair of corresponding, conically shaped surfaces 24. 25
`cooperate with the conically shaped end 26 of expansion
`screw 27. As the screw 27 advances, the conical end 26
`engages conically shaped recess 24, 25 of cage sections 16.
`17 respectively. The conical end 26 forces the two cage
`sections 16. 17 apart as the expansion screw 27 advances in
`the direction of arrow 45 in FIG. 9. In FIG. 9, arrows 44
`illustrate the expansion of cage member 16, 17 apart as
`expansion screw 27 advances in the direction of arrow 45.
`Expansion screw 27 has a cylindrically shaped section
`covered with external threads 28 and a hexagonal socket 29
`that receives a hexagonal wrench 39.
`Anterior fitting 30 provides external threads 31 for receiv-
`ing a T-wrench inserter 35 as shown in FIG. 9. Anterior
`fitting 30 includes a cylindrical bore 32 with internal threads
`33 receptive of the external threads 28 of expansion screw
`27 as shown in FIGS. 5 and 9. Upper cage section 16 has an
`arcuate recess 34 that accommodates anterior fitting 30. In
`the preferred embodiment. the fitting 30 can be a part of the
`lower cage section 17. being integral therewith.
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`T-wrench inserter 35 has a distal end 36 with an internally
`threaded section 37. The internally threaded section 37
`engages external threads 31 of fitting 30 during use. Inserter
`35 has a cylindrically shaped hollow bore 38 allowing
`hexagonal wrench 39 to extend therethrough so that it can
`engage the hexagonal socket 29 of expansion screw 27.
`Curved arrow 40 in FIG. 9 illustrates the rotation of
`hexagonal wrench 39 during an insertion of expansion screw
`27 in the direction of arrow 45.
`
`Cage 15 can include a pllnality of open ended bcres or
`passageways 41-43. These passageways 41-43 allow for
`packing with bone-inducing-growth material that allows the
`cage 15 to become part of the fusion. Other bone graft or
`other osteoinductive or osteoconductive substances could be
`included with cage 15 for the purpose of enhancing bone
`fusion.
`
`According to the method of the present invention for
`providing intervertebral interbody fusion in the vertebral
`column, the surgeon initially prepares the intervertebral
`space 14 shown in FIG. 2. The T-wrench inserter 35 may
`then be coupled to the antmior fitting 30 on the cage body
`15. The cage body 15 is surgically inserted into the intu-
`vertebral space 14. A hexagonal wrench 39 is inserted into
`the hexagonal socket 29 in the end of the expansion srrew
`27. Upon rotation of the hexagonal wrench in a clockwise
`manner, the expansion screw 27 transverses laterally in the
`direction indicated by arrow 45 in FIG. 9 as described above
`to separate incrementally the upper and lower cage sections
`16 and 17.
`
`The following table lists the parts numbers and parts
`descriptions as used herein and in the drawings attached
`hereto.
`
`Parts List
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`
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`Part Number
`
`Description
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`spinal cage prosthesis
`spine
`vertebrae
`vutebrae
`intervertebral space
`case body
`upper cage section
`lower cage section
`cylindrical outer surface
`cylindrical outer surface
`flat surface
`flat surface
`socket
`projection
`conically shaped surface
`conically shaped surface
`conical end
`expamiou screw
`external threads
`hexagonal socket
`anterior fitting
`external mark
`cylindrical bore
`internal threads
`arcuate recess
`T-wrench inserter
`distal end
`internal threaded section
`cylindrical bore
`hexagonal wremh
`arrow
`passageway
`passageway
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`Part Number
`44
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`Description
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`Because many varying and dilferent embodiments may be
`made within the scope of the inventive concept herein
`taught, and because many modifications may be made in the
`embodiments herein detailed in accordance with the descrip-
`tive requirement of the law. it is to be understood that the
`details herein are to be interpreted as illustrative and not in
`a limiting sense.
`What is claimed as invention is:
`1. A bio-compatible intervertebral prosthesis for implan-
`tation between adjacent vertebrae comprising:
`a) a cage body that includes a plurality of components
`including at least first and second separable cage sec-
`tions configured and sized to be inserted between
`adjacent vertebrae;
`b) said cage sections being separable along the longitu-
`dinal axis of said cage body;
`c) the cage body having an anterior section with an
`internally threaded bore;
`(1) the cage body having an internal recess defined by a
`recess surface;
`e) the cage body having anterior and posterior end por-
`tions;
`f) An expansion screw with proximal and distal end
`portions. the proximal end having means thereon for
`forming a connection with a rotary driver for rotating
`the screw. the distal end portion being sized and shaped
`to force the first and second cage sections apart as the
`screw advances longitudinally within the cage body to
`engage the recess surface along the length of the distal
`end of said expansion screw and in a direction from the
`anterior to the posterior end portions thereof;
`g) wherein said expansion screw has a length less than the
`length of the cage body and wherein said expansion
`screw does not extend beyond the end of said cage
`body; and
`h) wherein the first and second cage sections move apart
`incrementally as the screw advances into the internally
`threaded bore and recess surface.
`2. The apparatus of claim 1, wherein the cage body has an
`outer surface with a generally cylindrical shape.
`3. The apparatus of claim 1 wherein the cage body
`sections each have corresponding flat abutting surfaces.
`4. The apparatus of claim 1 wherein the cage body
`recesses are generally conically shaped.
`5. The apparatus of claim 1 wherein each of the cage
`sections has a recess portion that engages the expansion
`screw.
`
`6. The apparatus of claim 1 wherein the distal end of the
`expansion screw is conically shaped
`7. The apparatus of claim 1 wherein the anterior section
`includes an anterior fitting that carries the internally
`threaded bore.
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`8. The apparatus of claim 1 wherein the expansion screw
`has a cylindrically shaped threaded section and a conically
`shaped untlrreaded section.
`9.
`‘The apparatus of claim 1 wherein the cage body
`sections are slideably attached at the posterior end portion
`thereof.
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`10. A bio-compatible intervertebral prosthesis for irnplan-
`tation between adjacent vertebrae comprising:
`
`a) a cylindrically shaped cage body that includes at least
`first and second separable sections configured and sized
`to be insmted between adjacent vertebrae. each section
`having a flat inner surface portion that engages the flat
`inner surface of the other component;
`b) said separable sections being separable along the
`longitudinal axis of said cage body;
`c) the cage body having an anterior fitting integral thereto
`with an internally threaded bore;
`d) the cage body having anterior and posterior end por-
`tions;
`’
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`e) each of the cage body sections having a conically
`shaped internal recess with a bearing surface;
`i) an externally threaded expansion screw that engages the
`internal threads of the fitting. the screw having proxi-
`mal and distal end portions. the proximal end having a
`tool receptive socket thereon for fonning a connection
`with a rotary driver tool that can rotate the screw. the
`distal end portion being sized and shaped to force the
`first and second components apart as the screw
`advances longitudinally within the cage body to engage
`the recess surface along the length of the distal end of
`said expansion screw and in a direction from the
`anterior to the posterior end portions thereof;
`g) wherein said expansion screw has a length less than the
`length of the cage body and wherein said expansion
`screw does not extend beyond the end of said cage
`body; and
`h) wherein fire first and second sections move apart
`incrementally as the screw advances into the internally
`threaded bore and recess surface.
`
`11. The apparatus of claim 10 further comprising means
`for receiving bone graft material.
`12. The apparatus of claim 10 furtha comprising bore
`means for receiving bone fusion augnenting material.
`13. The apparatus of claim 10 further comprising rough-
`ened surface means on the outer bone engaging surface of at
`least one of the components for enhancing fixation of the
`cage body to the patents vertebral bodies.
`14. The apparatus of claim 10 wherein at least one of the
`components has a roughened surface for engaging the end
`plates of the patient’s vertebral bodies.
`15. The apparatus of claim 10 wherein the tool receptive
`portion is a socket.
`16. A bio-compatible intervertebral prothesis for implan-
`tation between adjacent vertebrae comprising:
`a) a cylindrically shaped cage body that includes at least
`first and second separable cage sections configured and
`sized to be inserted between adjacent vertebrae, each
`having
`‘
`b) a flat inner surface portion that engages the flat inner
`surface of the other component;
`c) said separable sections being separable along the
`longitudinal axis of said cage body;
`d) the cage body having an anterior fitting integral thereto
`with an internal bore;
`e) the cage body having anterior and posterior end por-
`tions;
`f) each of the cage body sections having a conically
`shaped internal recess surface with a bearing surface;
`g) An expansion pin that engages the bore of the anterior
`fitting. the pin having proximal and distal end portions,
`the proximal end having a tool receptive portion
`thereon for forming a connection with a driver tool that
`can manipulate the pin. the distal end portion being
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`sized and shaped to force the first and second sections
`apart as the pin advances longitudinally within the cage
`body to engage the recess surface along the length of
`the distal end of said expansion screw in a direction
`from the anterior to the posterior end portions thereof;
`h) wherein said expansion screw has a length less than the
`length of the cage body and wherein said expansion
`screw does not extend beyond the end of said cage
`body; and
`i) wherein the first and second sections move apart
`incrementally as the pin advances into the bore and
`recess surface.
`
`17. The apparatus of claim 16 wherein the expansion pin
`is a threaded expansion screw.
`18. The apparatus of claim 16 wherein the cage body bore
`is threaded.
`
`19. A method for providing bio-compatible vertebral
`interbody fusion in the vertebral column comprising the
`steps of:
`
`10
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`15
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`a) preparing a space for receiving an orthopedic prosthetic
`device between two vertebrae;
`
`b) surgically inserting a substantially cylindrically shaped
`spinal cage body into the space between the vertebrae,
`wherein the spinal cage includes upper and lower cage
`sections; each of the cage body sections having an
`internal recess with a bearing surface; and
`c) advancing a unitary screw member to separate incre-
`mentally the upper and lower cage sections; wherein
`said screw member has a length less than the length of
`the cage body and does not extend beyond the end of
`said cage body and wherein the screw member includes
`a distal end portion being sized and shaped to engage
`the recess surface of the first and second cage sections
`and to force the first and second cage sections apart as
`the screw advances longitudinally into the cage body.
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`UNITED STATES PATENT AND TRADEMARK OFFICE
`CERTIFICATE OF CORRECTION
`
`PATENTNO.
`
`:
`
`5,555,122
`
`5
`DATED
`'NVENT0R(s) 3
`
`September 9, 1997
`Parviz Kambin
`
`It is certified that error appears in the above-indentified patent and that said Letters Patent is hereby
`corrected as shown below:
`
`Front Page of Patent:
`
`Attorney, Agent or Firm—— James W. Pravel
`
`Signed and Sealed this
`
`Twenty-fifth Day of November, 1997
`
`MW
`
`BRUCE LEHMAN
`
`Arresting Officer
`
`Cmruvzixximyer of Parents and Trudenzurlax‘
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