United States Patent (19)
`Boriani et al.
`
`54). STACKABLE CAGE SYSTEM FOR
`CORPECTOMYIVERTEBRECTOMY
`75 Inventors: Stefano Boriani, Bologna, Italy; Mark
`H. Bilsky; Patrick J. Boland, both of
`New York, N.Y.; T. Glenn Pait, Little
`Rock, Ark., Dawn Abens Lissy, Seven
`Hills, Ohio; Paul J. Mraz, Cleveland
`Heights, Ohio; Daniel S. Savage,
`Brecksville, Ohio
`73 Assignee: Depuy Acromed, Inc., Raynham, Mass.
`
`21 Appl. No.: 09/177,645
`22 Filed:
`Oct. 22, 1998
`(51) Int. Cl." ..................................................... A61B 17/56
`52 U.S. Cl. .................................. 606/61; 606/72; 623/17
`58 Field of Search .................................. 606/61, 72, 73,
`606/69; 623/17
`
`56)
`
`References Cited
`U.S. PATENT DOCUMENTS
`4,696.290 9/1987 Moreland.
`2.5 R
`4,878,915 11/1989 Brantigan.
`4,887,595 12/1989 Heinig et al..
`5,192,327 3/1993 Brantigan.
`5,217,461
`6/1993 Asher et al..
`5,246,458 9/1993 Graham.
`5,257,993 11/1993 Asher et al..
`5,261,910 11/1993 Warden et al..
`5,294,391
`3/1994 McMillin.
`5,306,309 4/1994 Wagner et al..
`5,397.364 3/1995 Kozak et al..
`5.425,772 6/1995 Brantigan.
`5,429,863
`7/1995 McMillin.
`5,443,514 8/1995 Steffee.
`5,522,899 6/1996 Michelson.
`5,571,190 11/1996 Ulrich et al..
`5,571,192 11/1996 Schonhoffer.
`5,609,635 3/1997 Michelson.
`5,658.337 8/1997 Kohrs et al..
`5,665,122 9/1997 Kambin.
`5,702,453 12/1997 Rabbe et al..
`
`
`
`USOO615921 1A
`Patent Number:
`11
`(45) Date of Patent:
`
`6,159,211
`Dec. 12, 2000
`
`OTHER PUBLICATIONS
`Boriani et al., “Scelta Della Strumentazione Nei Tumori
`Primitivi E Secondari Del Rachide,” Lo Scalpello, vol. 10,
`Fascicola 1, pp. 49-51, 1996.
`Boriani et al., “En Bloc Resections of Bone Tumors of the
`Thoracolumbar Spine,” Spine, vol. 21, No. 16, pp.
`1127–1131, 1996.
`Boriani et al., “Indicazioni E. Risultati Della Vertebrectomia
`Nel Trattamento DeiTumori Del Rachide Dorso-Lombare,”
`Giornale Italiano di Orthopedia e Traumatologia, vol.
`XXII, Fascicola 4, pp. 473–483, Dec. 1996.
`Boriani et al., “Differential Diagnosis and Surgical Treat
`ment of Primary Benign and Malignant Neoplasms,” The
`Adult Spine Principles and Practice, 2nd edition, Chapter
`48, pp. 951-987, 1997.
`Boriani et al., “La Chirurgia Di Resezione Nel Trattamento
`Dei Tumori Vertebrali IndicazioniE Limiti, Aulo Gaggi
`fligiopsid, II Rachide, pp. 41-52, vol. G.I.S.-Suppl.
`s
`
`(List continued on next page.)
`Primary Examiner Michael Buiz
`ASSistant Examiner Julian W. Woo
`Attorney, Agent, or Firm Barnes & Thornburg
`57
`ABSTRACT
`Surgical prosthetic modular devices used singularly O
`Stacked together C provided for use to replace excised
`vertebral tissue. The devices are rigid plugs, dimensionally
`Similar to normal vertebral bodies, and have ridged faces to
`engage adjacent vertebral bodies or to interdigitate when
`Stacked. Ridges extend in both the medial/lateral and
`anterior/posterior directions to prevent Slipping in the
`anterior/posterior and medial/lateral directions respectively.
`A locking Screw may be used to Secure a Stack to form a
`Singular rigid prosthetic device. The devices are also pro
`vided with a plurality of threaded openings. In the method
`of this invention, a device is used to replace excised verte
`bral tissue, threaded bolts are inserted into the threaded
`openings, and other spine Stabilization devices are attached
`to the bolts. In corporectomies, the device can be bolted to
`a plate, which in turn is fixed to adjacent vertebrae. In
`spondylectomies, the device can be fixed to a Series of
`posteriorly placed rods.
`
`29 Claims, 6 Drawing Sheets
`
`NUVASIVE - EXHIBIT 2006
`Alphatec Holdings Inc. et al. v. NuVasive, Inc.
`IPR2019-00362
`
`

`

`6,159,211
`Page 2
`
`OTHER PUBLICATIONS
`Hart et al., “A System for Surgical Staging and Management
`of Spine Tumors,” Spine, vol. 22, pp. 1773–1782, No. 15,
`1997.
`Boriani et al., “Spine Update: Primary Bone Tumors of the
`Spine,” Spine, vol. 22, No. 9, pp. 1036-1044, 1997.
`Ciappetta et al., “A Carbon Fiber Reinforced Polymer Cage
`for Vertebral Body Replacement: Technical Note,” Neuro
`surgery, vol. 41, No. 5, pp. 1203–1206, Nov., 1997.
`
`Biagini et al., “Reconstruction techniques in the treatment of
`vertebral neoplasms,” Chir. Organi Mov., LXXXII,
`341-355, Oct.-Dec., 1997.
`Brochure, AcroMed Carbon Fiber Interbody Fusion
`Devices, Jan., 1998.
`Boriani et al., “Resection Surgery in the treatment of verte
`bral tumors,” Chir. Organi Mov., LXXXIII, 53–65, 1998.
`Biagini et al., “Protesi Vertebrali In Oncologia Orthope
`dica,” CioSm, p. 22, Apr. 1998.
`
`

`

`U.S. Patent
`
`Dec. 12, 2000
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`Sheet 1 of 6
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`6,159,211
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`U.S. Patent
`US. Patent
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`Dec. 12, 2000
`Dec. 12, 2000
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`U.S. Patent
`US. Patent
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`Dec. 12, 2000
`Dec. 12,2000
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`Sheet 3 of 6
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`U.S. Patent
`US. Patent
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`Dec. 12, 2000
`Dec. 12,2000
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`U.S. Patent
`US. Patent
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`Dec. 12, 2000
`Dec. 12,2000
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`F1045
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`AIG-16
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`U.S. Patent
`US. Patent
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`Dec. 12, 2000
`Dec. 12,2000
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`

`1
`STACKABLE CAGE SYSTEM FOR
`CORPECTOMYIVERTEBRECTOMY
`
`6,159,211
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`2
`rolateral plate or rod System could be anchored to the cage
`by threading a connecting Screw into a laterally placed hole,
`and the plate or rods could then be Secured to adjacent
`vertebrae. Similarly, the cages could be used in conjunction
`with posterior Spinal rods or plate Systems. Examples of
`such plates and rod systems are disclosed in U.S. Pat. Nos.
`4,696,290; 5,261,910; 4,887,595; 5,217,461; and 5,257,993.
`When posterior Spinal rods are used, the connecting Screws
`which connect the cage with the posterior osteosynthetic
`System act as true artificial pedicles. The devices and meth
`ods disclosed in the above cited patents are hereby incor
`porated by reference.
`The invention comprises a set of cages of various sizes.
`The cages are provided in various heights for use individu
`ally. Also, Several cages may be Stacked to produce a
`prosthetic device of appropriate height to meet Specific
`Surgical demands. The ridges of the Stacked cages
`interdigitate, and a locking Screw and nut may be used to
`Secure the Stack to produce a singular rigid prosthetic device.
`Recesses in the ridged faces of the cages allow the locking
`Screw to be sized Such that the Screw does not extend beyond
`the top and bottom Surfaces of the Stack. Thus, the Screw
`does not interfere with placement of the Stack into the
`vertebral column, and it does not assume any axial loading
`from adjacent vertebrae. Also, Smaller cages may be used to
`replace partially damaged discs, or a Stack of Smaller cages
`may be used when vertebrae are partially excised.
`Additionally, wedge-shaped cages are provided for Surgical
`applications where anatomical curvature is needed. By pro
`Viding Such a variety, the Surgeon can choose the proper
`combination of cages to accommodate a myriad of different
`Surgical Situations.
`The cages are preferably made of radiolucent materials
`Such as a carbon fiber reinforced high temperature thermo
`plastic. Preferred polymers are polyether ether ketone, poly
`ether ketone ketone, polyether ketone ether ketone ketone,
`and carbon fiber reinforced polyether ketone ether ketone
`ketone. Additionally, polycarbonate, polyprophylene,
`polyethylene, polysulfone, and polyphenylsulfone type plas
`tic material filled with glass or carbon fibers can be used.
`Other orthopaedic implant materials Such as Stainless Steel,
`titanium, and cobalt-chromium alloys may be used.
`The invention further comprises a method of use. In this
`method, the vertebral column is prepared to receive the
`prosthetic device, a Stack of at least one of the cages is
`formed to fit into the vertebral column, graft material is
`placed within an aperture in the Stack, and the Stack is
`inserted into the vertebral column. Following insertion, one
`or more connecting Screws may be used to Secure the Stack
`to other Spinal Stabilization devices, Such as plates or rods.
`BRIEF DESCRIPTION OF THE DRAWINGS
`FIG. 1 is a top and Side perspective of a prosthetic device
`of this invention;
`FIG. 2 is a top and Side perspective of a Stack of prosthetic
`devices in Stacked relation;
`FIG. 3 is a side perspective of a locking Screw;
`FIG. 4 is a top and Side perspective of a locking nut,
`FIG. 5 is a view similar to FIG.2, but showing the locking
`Screw in place;
`FIG. 6 is a top view of the device of FIG. 1;
`FIG. 7 is a sectional view along the line of 7-7 of FIG.
`6;
`FIG. 8 is a side view of the device, showing three threaded
`openings,
`
`BACKGROUND AND SUMMARY OF THE
`INVENTION
`This invention relates to inert rigid vertebral prosthetic
`devices and methods for implanting the devices between
`adjacent vertebrae to treat or prevent back or neck pain in
`patients with ruptured or degenerated intervertebral discs
`and for replacing vertebral bodies damaged by fracture,
`tumor or degenerative process.
`The surgical implant devices and methods of U.S. Pat.
`Nos. 4,743.256; 4,834,757; and 4,878,915 have greatly
`improved the Success rate and have Simplified the Surgical
`15
`techniques in interbody Vertebral fusion. In the procedures
`covered by these patents, biologically acceptable but com
`pletely inert bodies are bottomed in channels or grooves of
`adjoining vertebrae and receive bone ingrowth which
`quickly fuses the Structure to the bone and forms a living
`bone bridge across the fusion area. The materials and
`methods which are disclosed in these patents are hereby
`incorporated by reference.
`A more recent invention provides interbody fusion with
`out cutting grooves or channels in the vertebrae and is well
`Suited for anterior cervical and lumbar fusion. The invention
`of U.S. Pat. No. 5,192,327 provides ring-like prosthetic
`plugs or discS bottomed on end faces of adjoining vertebrae
`and constructed and arranged So that they can be used Singly
`or Stacked plurally to accommodate individual Surgical
`requirements. These rings can replace excised discS and
`vertebrae and can also be mounted inside the fibrous disc
`column connecting adjoining vertebrae. The annular units
`are oval or partial oval shaped, to conform with vertebral
`disc shapes, have ridged or peaked Surfaces for biting into
`the vertebrae on which they are Seated, for receiving bone
`ingrowth in Valleys between the peaks, and for interdigitat
`ing when Stacked. The open central portion of the ring is
`preferably packed with bone graft or other Osteobiologic
`materials to facilitate bone ingrowth. The methods and
`materials disclosed in the 327 patent are hereby incorpo
`rated by reference.
`The present invention includes a plurality of inert rigid
`vertebral prosthetic devices (“cages”) and methods for use.
`Each of these cages is a generally rectangular shaped body,
`conforming in Shape and size with the hard end plates of the
`vertebrae on which the prosthetic device is to be seated.
`Each of the cages has ridged Surfaces for gripping the
`vertebrae to resist expulsion, forming Valleys to facilitate
`bone ingrowth, and interdigitating with adjacent cages for
`Stacking. The cages of the current invention have ridges
`which run in both the anterior/posterior and medial/lateral
`directions respectively. Such ridges prevent Slipping in the
`medial/lateral and anterior/posterior directions, whether
`implanted Singly or Stacked with other cages of this inven
`tion. Also, the anterior/posterior and medial/lateral ridges
`interSect in the corners of the Surfaces to produce a crisscroSS
`pattern, which further resists rotation or other torsional type
`forces.
`Also, each cage is provided with a plurality of threaded
`openings in the side walls. While it is known in the art to
`provide an opening for use with an insertion tool, this
`invention includes a plurality of additional threaded
`openings, at various locations around the Side walls. These
`threaded openings are positioned and sized to receive
`threaded components of other Spine Stabilization devices.
`For example, in corpectomies or vertebrectomies, an ante
`
`65
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`3
`FIG. 9 is a sectional view along the line 9–9 of FIG.8;
`FIG. 10 is a side view of a connecting screw for attaching
`additional Spinal Stabilization devices,
`FIG. 11 is a protective sleeve for covering the threaded
`portion of the connecting Screw;
`FIG. 12 is similar to FIG. 6, except that it shows several
`connecting Screws threaded into the device;
`FIG. 13 shows the device after insertion into a vertebral
`column following corpectomy;
`FIG. 14 is similar to FIG. 13 except that it shows a plate
`attached to the device and the plate is Screwed into adjacent
`vertebrae;
`FIG. 15 shows the device connected to spinal rods, as
`used in Vertebrectomies,
`FIG. 16 shows the device inserted into a spinal column
`following excision of disc material;
`FIG. 17 is a top and side perspective of a tall device;
`FIG. 18 is a top and Side perspective of a wedge shaped
`device;
`FIG. 19 is similar to FIG. 9, except that it is a sectional
`View of a wedge shaped device;
`FIG. 20 is a top and side perspective of a small device;
`and
`FIG. 21 is similar to FIG. 9, except that it is a sectional
`view of a small device.
`
`DETAILED DESCRIPTION OF THE DRAWINGS
`In FIG. 1, the reference numeral 10 designates generally
`a prosthetic device of this invention, composed of a rigid
`biologically acceptable and inactive material, preferably a
`radiolucent plastic material, inert metal, and the like. The
`device 10 is a generally rectangular body 12 which is shaped
`and sized to conform with the disc Space between adjoining
`vertebrae in a vertebral column. The body 12 has a top face
`14 and a bottom face 16 and side walls 18 therebetween. The
`side walls 18 define an aperture 20 which extends through
`the top and bottom faces 14, 16.
`Ridges 24, 25 are provided on the top and bottom faces
`14, 16. Ridges 24 run generally in the anterior/posterior
`direction and ridges 25 run generally in the medial/lateral
`direction, and they meet in the corners to form a crisscroSS
`pattern 26. The ridges 24, 25 are designed to interdigitate to
`form a stack 40, as shown in FIG. 2. The ridges 24, 25 are
`also designed to bite into the vertebrae on which the device
`is to be seated. The anterior/posterior ridges 24 provide
`Stability from movement in the medial/lateral direction, and
`the medial/lateral ridges 25 provide stability from movement
`in the anterior/posterior direction.
`Body 12 also is provided with a fastener opening 30. As
`shown in FIG. 1, an integral crossbar 28 bisects the aperture
`20, and the fastener opening 30 extends through the cross
`bar 28. Also, as shown, recesses 35 and 36 are provided so
`that the fastener opening 30 is recessed from the top and
`bottom faces 14, 16. A plurality of threaded openings 22 are
`provided in the side walls 18, to allow for attachment to
`other Spine Stabilization devices.
`FIG. 2 shows a stack 40 of bodies 12. The ridges 24, 25
`of the adjacent bodies 12 have been allowed to interdigitate.
`Such a stack 40 can be created to replace a vertebral body,
`with the size of the stack conforming with the open vertebral
`Space.
`FIGS. 3 and 4 show a locking screw 32 and locking nut
`34 which can be used to secure the stack 40. The head 33 of
`the locking Screw 32 and the locking nut 34 are sized to fit
`
`4
`within the recesses 35 and 36. The locking screw 32 is sized
`Such that it can extend through the fastener opening 30 of the
`stack 40, without extending beyond the top face 14 at the top
`of the stack 40 and the bottom face 16 at the bottom of the
`stack 40. FIG. 5 shows the stack 40 with the locking screw
`in place.
`FIGS. 6-9 illustrate the features of the body 12. FIG. 6 is
`a top view of the body 12, showing the anterior/posterior and
`medial/lateral grooves 24, 25, the crisscroSS pattern 26, the
`cross bar 28, and the fastener opening 30. The aperture 20,
`which has been bisected by the cross bar 28, can be packed
`with bone graft material Such as bone fragments or other
`Osteobiologic materials. Such bone fragments can be har
`Vested from the iliac crests of the patient's pelvic bones or
`from the patient's ribs. FIG. 7, a sectional view along line
`7-7 of FIG. 6, shows the recesses 35 and 36, which are
`designed to receive the locking Screw 32 and locking nut 34
`and the fastener opening 30 passing through. FIG. 7 also
`illustrates the location of two of the threaded openings 22.
`FIGS. 8 and 9 show the location of the threaded openings
`22 in the illustrated embodiment. FIG. 8 is a front view,
`showing three of the openings 22, and FIG. 9 is a Sectional
`view along line 9-9, showing the placement of the eight
`threaded openings 22 of the illustrated embodiment. AS can
`be seen in FIG. 9, the threaded openings 22 are provided in
`various locations along the side walls 18 to enable a wide
`variety of applications. Beveled cornerS 23 of various angles
`allow the threaded openings 22 to be placed at a multitude
`of different angles, thus increasing the likelihood that the
`device will have a threaded opening 22 which is at the angle
`necessary for a specific application.
`FIG. 10 is an example of a connecting screw 42 which is
`designed to thread into one of the threaded openings 22 of
`the device 10. Examples of screws of this type are disclosed
`in U.S. Pat. No. 5,261,910, incorporated herein by reference.
`FIG. 11 shows a protective sleeve 44 which may be placed
`over the threads 43 of the connecting Screw 42, to protect
`soft tissue. FIG. 12 shows the body 12, with two connecting
`ScrewS 42 threaded into Several of the threaded openings.
`Such a configuration may be used in corpectomies or
`vertebrectomies.
`FIGS. 13 and 14 illustrate the method of this invention
`following a corpectomy. FIG. 13 shows body 12 after
`insertion into a vertebral column 60 following a corpectomy.
`A connecting Screw 42 extends from one of the threaded
`openings 22. FIG. 14 shows a stack 40, which has been
`inserted into a vertebral column 60. As with the body 12 in
`FIG. 13, a connecting screw 42 extends from one of the
`threaded openings 22 of stack 40. A plate 64 has been
`inserted over the connecting Screw 42 and has been fixed to
`Several adjacent vertebrae 62 by use of Standard bone Screws
`66. The plate may be of the type disclosed in U.S. Pat. Nos.
`4,696,290 and 5,261,910, also incorporated herein by ref
`erence. It should be understood that a single body 12 or Stack
`40 could be used to fill disc and vertebral body space,
`depending on the geometry of the individual patient.
`The prosthetic device 10 of this invention could also be
`used for vertebral reconstruction and fixation following
`vertebrectomies, as shown in FIG. 15. As illustrated, Such
`Surgeries would involve a construct Such as the one illus
`trated in FIG. 12. Spinal rods 68 would be fixed to the
`vertebral column 60 using standard techniques. Then, fol
`lowing vertebrectomy, a body 12 and Several connecting
`ScrewS 42 are used to replace the excised vertebral tissue.
`The connecting ScrewS 42 are then Secured to the Spinal rods
`68. Rods of the type disclosed in U.S. Pat. Nos. 4,887,595
`
`15
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`and 5,217,461 may be used, which are incorporated herein
`by reference. AS illustrated, the connecting ScrewS 42 act as
`artificial pedicles.
`In the above illustrated reconstructions, the prosthetic
`device 10 of this invention has been fixed to additional spine
`stabilization devices. However, it should be noted that
`because the ridges 24, 25 are designed to bite into the
`adjacent vertebrae 62, the prosthetic device of this invention
`may not require Screws or other fixation devices to anchor
`the prosthetic device 10 to the vertebrae. As seen in FIG. 16,
`a single body 12 could be used for disc replacement without
`use of Screws. Also, it should be understood that the above
`uses are provided for illustrative purposes. Other reconstruc
`tions using the device of this invention employing other
`Spine Stabilization devices are within the Scope of this
`invention.
`Because Surgical needs vary from patient to patient, the
`body 12 would be provided in a variety of sizes. Ideally, for
`lumbar use, the body 12 would measure 30 mmx40 mm, and
`it would be available in various heights, for example, of 9,
`12, and 24 mm. The 9 and 12 mm high devices could appear
`as illustrated in FIG. 1, and the 24 mm tall body 80 could be
`provided with an additional row of threaded openings 22, as
`Seen in FIG. 17. Also, for thoracic applications, a medium
`25
`body of the same configuration as shown in FIG. 1 could be
`provided. Such a device ideally would measure 20 mmx30
`mm and would be available in the same heights as the 30
`mmx40 mm body 12.
`Various applications may require other shapes and Sizes of
`the device 10 of this invention. A wedge-shaped body 82 is
`illustrated in FIG. 18. It is tapered to be thicker at its first end
`88 than at its second end 90. The wedge-shaped body 82 has
`ridged top and bottom faces 84 and 86 similar to those of the
`body 12, and are designed to interdigitate with the top and
`bottom faces 14, 16 of the body 12. By way of example, the
`wedge-shaped body 82 may taper at an angle of 11 from its
`first end 88 to its second end 90. Such wedge-shaped bodies
`82 would Suit Surgical applications where the Space between
`adjacent vertebrae is wider at one end than the other or
`where anatomical curvature needs to be corrected, repro
`duced or created. As shown in FIG. 19, the threaded open
`ings 22 may be provided on the first end 88 only, due to the
`reduced height of the second end 90.
`Finally, a small body 92 could be provided for Surgical
`applications in which only a portion of a vertebral body is
`involved. As illustrated in FIGS. 20 and 21, the small body
`92 has all of the features of the body 12, except that the small
`body 92 does not have a cross bar 28. Correspondingly, the
`recesses 35 and 36 and fastener opening 30 have been
`moved closer to a side wall 18. Also, because of size
`limitations, the number of threaded openings 22 has been
`reduced. Such a small body 92 could measure 20 mmx25
`mm, while an extra-Small body of the same configuration
`could measure 15 mmx20 mm. These Small and extra-small
`bodies could be provided in a variety of heights, Similar to
`the larger bodies described above. Other shapes and sizes
`may be provided while remaining within the Scope of this
`invention.
`The following operative procedure may be used. Surgical
`removal of Vertebral tissue is performed according to Stan
`dard techniques. The Surgeon Selects the appropriate com
`bination of prosthetic devices 10 to be inserted into the
`vertebral column 60. If more than one device 10 is used to
`form a stack 40, the stack 40 is secured with a locking screw
`32 to form a rigid prosthetic device. Alternatively, a Singular
`body 10 may be used as the prosthetic device. The aperture
`
`35
`
`6
`20 may then be packed with graft material, often bone
`fragments. The prosthetic device is then inserted into the
`vertebral column 60 using tools which are known in the art.
`If the excised vertebral tissue is the body portion of a
`vertebra, the inserted prosthetic device may then be Secured
`to a plate 64, which in turn can be fixed to adjacent vertebrae
`62. If the Surgery involved a vertebrectomy, attachment to
`rods 60, which had already been placed in the vertebral
`column 60 during a posterior procedure, may be appropriate.
`Individual circumstances may require use of other Spine
`Stabilization devices, or a combination of Such devices. It
`should be understood that the procedures described herein
`are for illustrative purposes, and that use of the prosthetic
`device of this invention in conjunction with other Spine
`Stabilization devices is within the Scope of this invention.
`Ideally, the threaded openings 22 would be sized to engage
`any fixation device which accepts a 4 mm Screw.
`What is claimed is:
`1. A prosthetic device to integrate with and Support
`vertebrae in a vertebral column, comprising:
`a plurality of inert bodies conforming in shape and Size
`with hard end plates of vertebrae on which the pros
`thetic device is to be seated,
`each of the bodies having ridged top and bottom faces
`adapted to Selectively interdigitate with faces of adja
`cent bodies and to bite into adjoining vertebrae, the
`ridged top and bottom faces having anterior/posterior
`and medial/lateral ridges to provide Stability in the
`medial/lateral and anterior/posterior directions
`respectively,
`each of the bodies also having Side walls disposed
`between the ridged top and bottom faces to define an
`aperture which opens through the faces, and a plurality
`of threaded openings disposed within the Side walls,
`Said plurality of threaded openings positioned and
`designed to receive threaded components of additional
`Spine Stabilization devices.
`2. The device of claim 1, further comprising a fastener
`opening positioned through the top and bottom faces and
`extending generally in the same direction as the vertebral
`column, the fastener opening positioned to receive a fastener
`to Secure a Stack of the bodies.
`3. The device of claim 2, wherein the fastener opening is
`further defined by recesses in the ridged top and bottom
`faces and a passageway extending there between.
`4. The device of claim 3, wherein the fastener comprises
`a locking Screw and is sized Such that it does not protrude
`beyond the stack of bodies.
`5. The device of claim 1, wherein the threaded component
`is a connecting Screw and the device further comprises a
`protective sleeve to cover an end of the connecting Screw.
`6. The device of claim 1, wherein the anterior/posterior
`and medial/lateral ridges intersect to form a crisscroSS
`pattern.
`7. The device of claim 1, wherein the device is comprised
`of radiolucent material.
`8. The device of claim 7, wherein the radiolucent material
`comprises a carbon fiber reinforced polymer.
`9. A prosthetic device for vertebral fusion, comprising: a
`plurality of inert bodies conforming in shape and Size with
`hard end plates of vertebrae on which the prosthetic device
`is to be seated,
`each of Said bodies having ridged top and bottom faces
`adapted to Selectively interdigitate with faces of adja
`cent bodies to form a Stack and to bite into adjoining
`Vertebrae, the ridged top and bottom faces having
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`anterior/posterior and medial/lateral ridges to provide
`Stability in the medial/lateral and anterior/posterior
`directions respectively,
`Side walls disposed between the ridged top and bottom
`faces to define an aperture which opens through the
`faces, and
`a fastener opening extending from the top face to the
`bottom face and extending through each body generally
`in the same direction as the vertebral column but
`recessed from the top and bottom faces, the fastener
`opening positioned to receive a fastener therein, and the
`fastener is sized to Secure the Stack of bodies without
`protruding from the Stack.
`10. A device of claim 9 wherein the fastener comprises a
`locking Screw.
`11. A prosthetic device adapted for fusing together adjoin
`ing vertebrae, comprising:
`an inert body conforming in shape and Size with hard end
`plates of vertebrae on which the prosthetic device is to
`be seated,
`the body having ridged top and bottom faces, Side walls
`disposed between the ridged top and bottom faces, the
`Side walls having a plurality of beveled corners defin
`ing a plurality of Side faces at varying angles to each
`other and a plurality of threaded openings disposed
`25
`within the Side faces, said plurality of threaded open
`ings positioned and designed to receive threaded com
`ponents of an additional Spine Stabilization device.
`12. A device of claim 11 wherein the additional spine
`Stabilization device comprises an anterior plate or rod SyS
`tem.
`13. A device of claim 11 wherein the additional spine
`Stabilization device comprises a posterior rod or plate SyS
`tem.
`14. A method of vertebral fusion comprising the steps of
`providing a plurality of inert bodies shaped to fit opposed
`end faces of vertebrae in a vertebral column, each of the
`bodies having ridged top and bottom faces adapted to
`Selectively interdigitate with faces of adjacent bodies to
`form a Stack and to bite into adjoining vertebrae, the
`ridged top and bottom faces having anterior/posterior
`and medial/lateral ridges to provide Stability in the
`medial/lateral and anterior/posterior directions
`respectively, each of the bodies also having Side walls
`disposed between the ridged top and bottom faces to
`define an aperture which opens through the faces, and
`each of the bodies having a fastener opening extending
`through each body from the top face to the bottom face
`and extending generally in the same direction as the
`vertebral column,
`Selecting the appropriate combination of bodies for fusion
`within the vertebral column,
`Stacking the appropriate combination of bodies by allow
`ing the ridged top and bottom faces of adjacent bodies
`to interdigitate,
`providing a fastener,
`fastening the Stacked bodies by extending the fastener
`through the fastener opening in each of the bodies to
`form a rigid prosthetic device,
`preparing the vertebral column to receive the rigid proS
`thetic device, and inserting the rigid prosthetic device
`into the vertebral column.
`15. The method of claim 14 wherein the fastener opening
`is further defined by recesses in the ridged top and bottom
`faces and extends there between, and the fastener is sized
`Such that it does not protrude from the rigid prosthetic
`device.
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`16. The method of claim 15 wherein the fastener com
`prises a locking Screw.
`17. The method of claim 14 wherein each of the bodies
`further comprises a plurality of threaded openings disposed
`within the side walls, and the method further comprises the
`Steps of
`providing an additional Spine Stabilization device, includ
`ing a threaded component thereof, and
`threading the threaded component into one of the threaded
`openings disposed within the Side walls.
`18. The method of claim 14, further comprising the step
`of placing bone graft material in the aperture prior to
`inserting the rigid prosthetic device into the vertebral col
`U.
`19. A method of vertebral fusion comprising the steps of
`providing a plurality of inert bodies shaped to fit opposed
`end faces of Vertebrae in a vertebral column, each of the
`bodies having ridged top and bottom faces adapted to
`bite into adjoining vertebrae, the ridged top and bottom
`faces having anterior/posterior and medial/lateral
`ridges to provide Stability in the medial/lateral and
`anterior/posterior directions respectively, each of the
`bodies also having Side walls disposed between the
`ridged top and bottom faces to define an aperture which
`opens through the faces, and a plurality of openings
`disposed within the Side walls,
`preparing a Stack of at least one of the bodies,
`preparing the vertebral column to receive the Stack,
`inserting the Stack into the vertebral column,
`providing an additional Spine Stabilization device, and
`attaching the additional Spine Stabilization device to one
`of the openings disposed within the Side walls.
`20. The method of claim 19 wherein the plurality of
`openings disposed within the Side walls are threaded.
`21. The method of claim 20 wherein the additional spine
`Stabilization device includes a plate and a Screw, the Step of
`preparing the vertebral column to receive the Stack includes
`performing a corpectomy, the attaching Step involves
`extending the Screw through an opening in the plate and
`threading the Screw into one of the openings disposed within
`the Side walls, and the method includes the additional Step
`of Securing the plate to a vertebra.
`22. The method of claim 20 wherein the additional spine
`Stabilization device includes a rod and a Screw, the Step of
`preparing the vertebral column to receive the Stack includes
`performing a vertebrectomy, the attaching Step involves
`Securing the rod to the Stack by threading the Screw into one
`of the openings disposed within the Side walls, and the
`method includes the additional Step of Securing the rod