GLOBUS MEDICAL, INC.
`EXHIBIT 1011
`IPR2015-to be assigned
`(Globus v. Flexuspine)
`
`1 of 17
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`US 7,060,100 B2
`Page 2
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`U.S. PATENT DOCUMENTS
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`5,702,450 A
`
`12/1997 Bisserie ..................... .. 623/17
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`
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`62432/,1,/7,1;
`623/17
`623,17
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`1333:, gfflfi“
`§’;(3’;‘;5) :
`.‘ ‘Hm
`’
`’
`2/1998 L1n ........ ..
`5,716,416 A
`9/1998 Bao e, ,1
`5 800 549 A
`' """""""""" “
`.
`5
`r
`9/1998 Gm“ 9‘ 91‘
`~~~~~~~~~~ ~~ 623/2348
`5,814,084 A
`10/1998 Ray 9‘ a1~ ~~~~~~~~~~~~~~~~~~~ ~~ 523/17
`5,824,093 A
`10/1998 Serhan et al.
`............... .. 623/17
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`5,827,328 A * 10/1998 Burtorrnarm ~
`623/1713
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`5,865,845 A
`2/1999 Thalgott
`5,865,846 A
`2/1999 Bryan etal.
`................ .. 623/17
`5,888,226 A
`3/1999 Rogozinski
`................ .. 623/17
`5,893,889 A
`4/1999 Harrington ................. .. 623/17
`5,899,941 A
`5/1999 Nishijima etal.
`623/17
`5,905,515 A
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`5,964,807 A
`10/1999 Gan et a1.
`.............. .. 623/17.11
`5,976,186 A
`11/1999 B30 e131,
`,,,,,,,,,,,,,, ,, 623/17,16
`6,022,376 A
`2/2000 ASSe11e1a1,
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`623/17,16
`6,045,554 A
`4/2000 Grooms et al.
`............. .. 606/73
`6,090,112 A
`7/2000 Zucherman et 31,
`,,,,,,,, ,, 606/61
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`6,110,210 A
`8/2000 N01-ton et a1,
`,,
`623/17,16
`.............. .. 623/17.16
`6,113,639 A
`9/2000 Ray etal.
`6,132,465 A
`10/2000 Raye1a1,
`,,,,,,,,,,,,,, ,, 623/17,16
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`11/2000 McKay
`623/17,11
`2/2001 Milner et a1.
`.......... .. 623/17.12
`6,187,048 B1
`6,200,347 B1
`3/2001 Anderson et a1,
`,,,,,, ,, 623/11,11
`6,214,050 B1
`4/2001 Huene ,,,,,,,,,, ,,
`623/17,15
`
`............ .. 606/61
`6,245,072 B1
`6/2001 Zdeblick etal.
`6,258,126 B1 >x<
`7/2001 C011era_n ,,,,,,,,,,,,,,,, ,, 623/20,29
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`6,261,586 B1
`7/2001 McKay , , , , ,
`, , , , ,, 424/422
`8/2001 McKay .................. .. 623/16.11
`6,270,528 B1
`6,402,785 B1>x<
`6/2002 Zdeb11eketa1,
`,,,,,,, ,, 623/17,16
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`6,533,818 B1=x<
`3/2003 Weber et a1,
`623/17,16
`.......... .. 623/17.16
`2001/0020186 A1
`9/2001 Boyce etal.
`2001/0034553 A1
`10/2001 Michelson ............. .. 623/17.11
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`2001/0039458 A1
`11/2001 Boyer, 11 e131,
`623/23,63
`...... .. 623/17.15
`2001/0056302 A1
`12/2001 Boyer, 11 etal.
`2004/0225361 A1* 11/2004 G1enn etal.
`........... .. 623/17.12
`2005/0096744 A1*
`5/2005 Trieu etal.
`............ .. 623/17.11
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`* cited by examiner
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`4,917,704 A
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`4/1990 Frey etal.
`4,932,969 A
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`6/1990 Frey et al.
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`4,946,378 A
`8/1990 H1rayama etal.
`.......... .. 623/17
`5,002,576 A
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`.. 623/17
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`5,026,373 A
`................... .. 606/61
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`5,035,716 A
`7/1991 Downey .................... .. 623/17
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`5,047,055 A >x<
`,
`9/1991 Bao et a1,
`623/17,16
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`5,071,437 A * 12/1991 stefree .................. .. 623/17.16
`5,108,438 A
`4/1992 Stone ........................ .. 623/17
`5,123,925 A
`5/1992 pisharodi , , , , , , ,
`, , , ,, 523/17
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`5,171,280 A
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`12/1992 Parsons et a1.
`............. .. 623/17
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`.. 606/60
`5,192,326 A
`3/1993 Bao etal.
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`5,192,327 A
`5,245,773 A
`9/1993 Snyder ...................... .. 623/17
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`~~ 623/17
`5,246,458 A
`9/1993 Graham
`................. .. 623/17
`5,258,031 A
`11/1993 Salib et al.
`5,258,043 A
`11/1993 Stone ........................ .. 623/66
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`5,292,332 A
`3/ 1994 Lee ~~~~~~~ ~~
`606/213
`5/1994 Marnay ..................... .. 623/17
`5,314,477 A
`5,320,644 A
`6/1994 Baumgartner .............. .. 623/17
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`5,336,223 A
`8/1994 Rogers , , ~ ~ ~ ~ ~ , , ,
`~ ~ ~ ~ 606/61
`12/1994 Baumgartner .............. .. 623/17
`5,370,697 A
`5,375,823 A
`12/1994 Navas ...................... .. 267/195
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`~~ 623/17
`5,401,269 A
`3/1995 Buttnor-Janz or al,
`.................. .. 623/17
`5,458,642 A
`10/1995 Beer et al.
`11/1995 Wortrich ................... .. 606/213
`5,464,421 A
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`5/1996 Heggeness et a1,
`623/1711
`5,534,028 A
`7/1996 Bao et al.
`................... .. 623/17
`5,534,030 A
`7/1996 Navarro et al.
`............. .. 623/17
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`~~ 623/17
`5,545,229 A
`8/1996 Parsons er a1,
`~
`9/1996 Buttner-Janz .............. .. 623/17
`5,556,431 A
`5,571,192 A
`11/1996 Schonhoifer ............... .. 606/61
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`~~ 623/17
`5,609,635 A
`3/1997 Michelson
`7/1997 Rudd ota1~ ~~~~~~~~~~~~~~~ ~~ 606/213
`5,645,565 A
`5,645,596 A
`7/1997 Kim et al.
`.................. .. 623/17
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`~ 623/17
`5,645,597 A
`7/1997 KrapiYa ,,,,,,, ~
`10/1997 Barr1Vr11e eta1~ ~~~~~~~~~~~ ~~ 623/17
`5,674,294 A
`5,674,296 A
`10/1997 Bryan et a1,
`~~~~~~~~~~~~~~~~ ~~ 623/17
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`.. 623/17
`5,683,465 A
`11/1997 Shinn etal.
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`12/1997 Pisharodi ............... .. 623/17.16
`5,693,100 A
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`

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`U.S. Patent
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`Jun. 13,2006
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`Sheet 1 of 9
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`US 7,060,100 B2
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`Jun. 13,2006
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`US 7,060,100 B2
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`1
`ARTIFICIAL DISC AND JOINT
`REPLACEMENTS WITH MODULAR
`CUSHIONING COMPONENTS
`
`REFERENCE TO RELATED APPLICATIONS
`
`This application is a continuation-in-part of U.S. patent
`application Ser. No. 10/303,385, filed Nov. 25, 2002; which
`is a continuation-in-part of U.S. patent application Ser. No.
`10/191,639, filed Jul. 9, 2002; which is a continuation-in-
`part of U.S. patent application Ser. No. 09/415,382, filed
`Oct. 8, 1999, now U.S. Pat. Nos. 6,419,704, and 09/580,231,
`filed May 26, 2000, now U.S. Pat. No. 6,494,883. The entire
`content of each application and patent is incorporated herein
`by reference.
`
`FIELD OF THE INVENTION
`
`This invention relates generally to surgical techniques and
`prosthetic components therefore and, in particular, to inter-
`vertebral disc replacement apparatus and methods of
`implanting the same.
`
`BACKGROUND OF THE INVENTION
`
`Eighty-five percent of the population will experience low
`back pain at some point. Fortunately, the majority of people
`recover from their back pain with a combination of benign
`neglect, rest, exercise, medication, physical therapy, or chi-
`ropractic care. A small percent of the population will suffer
`chronic low back pain. The cost of treatment of patients with
`spinal disorders plus the patient’s lost productivity is esti-
`mated at 25 to 100 billion dollars annually.
`Seven cervical (neck), 12 thoracic, and 5 lumbar (low
`back) vertebrae form the normal human spine. Intervertebral
`discs reside between adjacent vertebra with two exceptions.
`First, the articulation between the first two cervical vertebrae
`does not contain a disc. Second, a disc lies between the last
`lumbar vertebra and the sacrum (a portion of the pelvis).
`The spine supports the body, and protects the spinal cord
`and nerves. The vertebrae of the spine are also supported by
`ligaments, tendons, and muscles which allow movement
`(flexion, extension, lateral bending, and rotation). Motion
`between vertebrae occurs through the disc and two facet
`joints. The disc lies in the front or anterior portion of the
`spine. The facet joints lie laterally on either side of the
`posterior portion of the spine.
`The human intervertebral disc is an oval to kidney bean
`shaped structure of variable size depending on the location
`in the spine. The outer portion of the disc is known as the
`annulus fibrosis. The annulus is formed of 10 to 60 fibrous
`bands. The fibers in the bands alternate their direction of
`
`orientation by 30 degrees between each band. The orienta-
`tion serves to control vertebral motion (one half of the bands
`tighten to check motion when the vertebra above or below
`the disc are turned in either direction).
`The annulus contains the nucleus. The nucleus pulpous
`serves to transmit and dampen axial loads. A high water
`content (70—80 percent) assists the nucleus in this function.
`The water content has a diurnal variation. The nucleus
`
`imbibes water while a person lies recumbent. Activity
`squeezes fluid from the disc. Nuclear material removed from
`the body and placed into water will imbibe water swelling to
`several times its normal size. The nucleus comprises roughly
`50 percent of the entire disc. The nucleus contains cells
`(chondrocytes and fibrocytes) and proteoglycans (chon-
`
`2
`
`droitin sulfate and keratin sulfate). The cell density in the
`nucleus is on the order of 4,000 cells per micro liter.
`Interestingly, the adult disc is the largest avascular struc-
`ture in the human body. Given the lack of vascularity, the
`nucleus is not exposed to the body’s immune system. Most
`cells in the nucleus obtain their nutrition and fluid exchange
`through diffusion from small blood vessels in adjacent
`vertebra.
`
`The disc changes with aging. As a person ages the water
`content of the disc falls from approximately 85 percent at
`birth to 70 percent in the elderly. The ratio of chondroitin
`sulfate to keratin sulfate decreases with age. The ratio of
`chondroitin 6 sulfate to chondroitin 4 sulfate increases with
`
`age. The distinction between the annulus and the nucleus
`decreases with age. These changes are known as disc
`degeneration.
`
`Generally Disc Degeneration is Painless.
`Premature or accelerated disc degeneration is known as
`degenerative disc disease. A large portion of patients suf-
`fering from chronic low back pain are thought to have this
`condition. As the disc degenerates, the nucleus and armulus
`functions are compromised. The nucleus becomes thinner
`and less able to handle compression loads. The armulus
`fibers become redundant as the nucleus shrinks. The redun-
`
`dant armular fibers are less effective in controlling vertebral
`motion. The disc pathology can result in: 1) bulging of the
`annulus into the spinal cord or nerves; 2) narrowing of the
`space between the vertebra where the nerves exit; 3) tears of
`the annulus as abnormal loads are transmitted to the armulus
`
`and the armulus is subjected to excessive motion between
`vertebra; and 4) disc herniation or extrusion of the nucleus
`through complete annular tears.
`Current surgical
`treatments of disc degeneration are
`destructive. One group of procedures removes the nucleus or
`a portion of the nucleus; lumbar discectomy falls in this
`category. A second group of procedures destroy nuclear
`material; Chymopapin (an enzyme) injection, laser discec-
`tomy, and thermal therapy (heat treatment to denature pro-
`teins) fall
`in this category. A third group, spinal fusion
`procedures either remove the disc or the disc’s function by
`connecting two or more vertebra together with bone. These
`destructive procedures lead to acceleration of disc degen-
`eration. The first two groups of procedures compromise the
`treated disc. Fusion procedures transmit additional stress to
`the adjacent discs. The additional stress results in premature
`disc degeneration of the adjacent discs.
`Prosthetic disc replacement offers many advantages. The
`prosthetic disc attempts to eliminate a patient’s pain while
`preserving the disc’s function. Current prosthetic disc
`implants, however, either replace the nucleus or the nucleus
`and the armulus. Both types of current procedures remove
`the degenerated disc component
`to allow room for the
`prosthetic component. Although the use of resilient materi-
`als has been proposed, the need remains for further improve-
`ments in the way in which prosthetic components are
`incorporated into the disc space, and in materials to ensure
`strength and longevity. Such improvements are necessary,
`since the prosthesis may be subjected to 100,000,000 com-
`pression cycles over the life of the implant.
`
`SUMMARY OF THE INVENTION
`
`This invention resides in an artificial joint or disc replace-
`ment (ADR) configured for placement between upper and
`lower vertebrae. The implant broadly includes a pair of
`opposing endplate components, each attached to one of the
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`upper and lower vertebrae, a cushioning component dis-
`posed between the endplate components, and a mechanism
`for coupling the cushioning component to one or both of the
`endplates.
`In the preferred embodiment, the cushioning component
`takes the form of a tire-like outer structure attached to an
`
`is also preferably contained
`inner hub. A filler material
`within the cushioning component. The filler material may be
`a gas, liquid, foam, or gel, including a hydrogel. If a solid,
`foam, gel or hydrogel is used, such material may be used as
`a single piece or as multiple pieces.
`One or both of the endplate components may include a
`modified surface to increase adherence to the respective
`vertebral endplates or opposing bone surfaces in the case of
`a joint replacement. Such surface modification may include
`spikes, barbs or other projections, and/or pores or roughen-
`ing conducive to bony ingrowth.
`
`BRIEF DESCRIPTION OF THE DRAWINGS
`
`FIG. 1 is a sagittal cross section of anADR (artificial disc
`replacement) according to the invention;
`FIG. 2 is a view of the anterior aspect of the spine with
`the ADR endplates attached to the vertebrae;
`FIG. 3 shows a removable device such as a clip used to
`hold the hub-like components to the tire-like components
`until the compressible component is inserted into the ADR
`endplates;
`FIG. 4 is an axial cross section through one embodiment
`of the ADR endplate;
`FIG. 5A is a sagittal cross section of a modular ADR
`during assembly;
`FIG. 5B is a sagittal cross section of the front of the ADR
`of FIG. 5A with a tool positioned over the projection from
`the hub;
`FIG. 6 is a sagittal cross section of the front of the ADR
`with an alternative mechanism to hold the modular com-
`
`pressible component between the ADR endplates;
`FIG. 7A is a sagittal cross section of another mechanism
`to connect the hubs to the ADR endplates;
`FIG. 7B is a sagittal cross section of the locking mecha-
`nism of FIG. 7A with the cam in the locked position;
`FIG. 8 is a view of the bottom of the top ADR endplate
`with a circular cushioning component;
`FIG. 9 is a sagittal cross section of the ADR with
`distraction tools;
`FIG. 10 is a sagittal cross section of the ADR with an
`alternative distraction mechanism;
`FIG. 11A is the first of a series of drawings showing
`insertion of the ADR from the anterior aspect of the spine;
`FIG. 11B shows the next step in the insertion of the ADR
`after FIG. 11A. The bottom ADR endplate is shown during
`insertion into the inferior vertebra;
`FIG. 11C shows the next step in the insertion of the ADR
`after FIG. 11B. Distraction tools are used to increase the
`
`4
`
`FIG. 12C is an axial cross section of the top tibial tray
`including circular pistons;
`FIG. 12D is a view of the top of the bottom tibial tray;
`FIG. 13 is a sagittal cross section of an alternative
`embodiment including a metal articulating surface;
`FIG. 14 is a sagittal cross section of an alternative cushion
`module;
`FIG. 15 is a sagittal cross section of the anterior portion
`of the spine and an alternative embodiment of the ADR
`wherein the endplates have been eliminated;
`FIG. 16A is an oblique, lateral view of an embodiment
`including projection from the hub which are releaseably
`attached to a projection from the ADR endplate;
`FIG. 16B is a view of the front of an alternative embodi-
`
`ment of the ADR endplate drawn in FIG. 16A;
`FIG. 16C is a view of the front of an alternative embodi-
`
`ment of the ADR endplate drawn in FIG. 16A;
`FIG. 17 is a sagittal cross section of the ADR with an
`alternative plate-hub locking mechanism. Projections from
`the hubs fit into holes in the ADR endplates;
`FIG. 18 is a sagittal cross section of another embodiment
`wherein a modular cushioning component is attached to a
`single ADR endplate;
`FIG. 19 is a sagittal cross section of an alternative
`embodiment of the ADR and a vertebra;
`FIG. 20 is a sagittal cross section of another embodiment
`including one ADR endplate component tether and a second
`ADR endplate without the cushioning component tether;
`FIG. 21A is an axial cross section of the top of the
`alternative embodiment of FIG. 16A;
`FIG. 21B is an axial cross section of the ADR drawn in
`FIG. 21A;
`FIG. 22A is a top view of a circular, tire-like component
`and a circular ADR endplate;
`FIG. 22B is a top view of an alternative, elliptically
`shaped ADR endplate component;
`FIG. 23 is a top view of the device of FIG. 22C including
`a removable member placed around the modular cushion
`component prior to insertion;
`FIG. 24A is a top view of a wedge-shaped ADR endplate
`with strategically spaced endplate penetration spikes;
`FIG. 24B is a side view of a wedge-shaped ADR endplate
`with strategically spaced endplate penetration spikes;
`FIG. 25A is a view of the side of a hoop-mesh skeleton
`used in another embodiment of the ADR;
`FIG. 25B is a view of the side of the ADR drawn in FIG.
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`25A, after its completion; and
`FIG. 25C is a view of the side of the spine and the ADR
`drawn in FIG. 25B.
`
`50
`
`DETAILED DESCRIPTION OF THE DRAWINGS
`
`55
`
`U.S. Pat. No. 6,419,704 discloses artificial replacements
`for natural
`intervertebral discs in humans and animals.
`
`space between the ADR endplates;
`FIG. 11D shows the next step in the insertion of the ADR
`after FIG. 11C. The cushioning module is positioned
`between the ADR endplates.
`FIG. 11E shows next step in the insertion of the ADR after
`FIG. 11D. The distraction tools have been removed;
`FIG. 12A is a sagittal cross section of an embodiment of
`the device for cushioning the tibial component of a Total
`Knee Replacement (TKR);
`FIG. 12B depicts the front of the tibial component of FIG.
`12A;
`
`60
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`
`Broadly, a shaped body assumes a final volume sized to
`consume at least a portion of the intervertebral disc space,
`and a material associated with the shaped body enabling the
`body to cyclically compress and expand in a manner similar
`to the disc material being replaced. The body may be
`composed of a compressible material, such as polymeric
`urethane or other suitable elastomers, or may include a
`filling to impart an appropriate level of compressibility. The
`superior and inferior surfaces may be convex, and may
`further include grooves, spikes, or other protrusions to
`maintain the body within the intervertebral space. The body
`may further be wedge-shaped to help restore or maintain
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`lordosis, particularly if the prosthesis is introduced into the
`cervical or lumbar regions of the spine.
`To enhance strength or longevity, the body may further
`include the use of fiber-reinforced materials on one or more
`
`outer surfaces or wall structures, as the case may be. Similar
`to commercial tire construction, such fiber-reinforced mate-
`rials may be of a bias-ply, radial-ply or bias-belted construc-
`tion. According to one configuration, an artificial disc
`according to the invention may further include an outer
`compressible member peripherally attached to a central
`“hub,” similar, at least in concept, to the which a tire is
`mounted onto a wheel.
`
`The instant invention extends the teachings of the ’704
`patent through the addition of metal endplates, bone-in-
`growth surfaces, and/or modular, interlocking components.
`Although the invention is described in terms of artificial disc
`replacement (ADR),
`the approach may also be used to
`dampen other artificial joints within the body, such as the
`tibial component of a knee replacement.
`As noted in the ’704 patent, the ADR may be filled with
`a gas,
`liquid, gel
`(including hydrogels), foam or other
`compressible material, and the material may be introduced
`or otherwise provided through the use of a valve, port,
`syringe, or, alternatively, by way of valveless means. The
`body in this case is preferably a sealed unit, and may include
`self-sealing means in the event of a leak or rupture.
`If a valve is used to inflate the ADR, it may be configured
`so as to be accessible during implantation, enabling the
`surgeon to expand the device in situ. A valve may also be
`provided in the form of a port enabling subcutaneous
`post-operative inflation or re-expansion. If a hydrogel is
`used as the filler material, it may introduced within the body
`in a dehydrated state prior to implantation, with water being
`added to expand the material. The liquid may be added
`through a valve, port or hypodermic in conjunction within a
`sealed structure or, alternatively, at least a portion of the
`surface of the body, preferably the superior end or inferior
`surfaces, may be at least semi-porous. As a further alterna-
`tive to a valveless structure, one or more reactants may be
`provided with the body, such that when mixed with one or
`more other reactants, a gas or foam is generated to expand
`and fill the body. As yet a further alternative, an ampule or
`cartridge operative to release a compressed gas or generate
`a gas, liquid or foam may be activated by an external source
`of energy such as ultrasound, heat, or other stimuli.
`Turning now to the figures, FIG. 1 is a sagittal cross
`section of an embodiment of an ADR according to this
`invention,
`including a tire-like component 102, hub-like
`component 104, and endplates 106.
`FIG. 2 is a view of the anterior aspect of the spine with
`the ADR endplates attached to the vertebrae 110. A sagittal
`cross section of the modular compressible member is also
`illustrated at 120. The ends of the hub have projections 122
`that slide into grooves 124 on the ADR endplates.
`FIG. 3 shows how a removable device such as a clip 302
`can be used to hold the hub-like components to the tire-like
`components until the compressible component is inserted
`into the ADR endplates. The clip 302 is especially important
`when the compressible component contains hydrated hydro-
`gel. In such embodiments, the hydrogel may be stored in
`fluid to allow the component to be inserted with the hydrogel
`fully hydrated or nearly fully hydrated. The hydrogel-con-
`taining embodiments further include pores for fluid transport
`through the ADR endplates, the hub-like component, and/or
`the tire-like component.
`FIG. 4 is an axial cross section through one embodiment
`of an ADR endplate according to the invention including a
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`recess 402 from the side of the endplate configured to trap
`the projection 122 from the hub-like component.
`FIG. 5A is a sagittal cross section of the ADR during
`assembly of the modular components. A tool 502 is used to
`push the projections 122 from the hub-like components into
`the grooves 124 of the ADR endplates, thus forcing the
`compressible component between the ADR endplates. FIG.
`5B is a sagittal cross section of the front of the ADR drawn
`in FIG. 5A with the tool positioned over the projection from
`the hub.
`
`FIG. 6 is a sagittal cross section of the front of the ADR
`with an alternative mechanism used to hold the modular
`
`compressible component between the ADR endplates. In
`this embodiment, screws 602 are threaded into the ADR
`endplates after insertion of the compressible component.
`Hub projections and ADR endplate grooves similar to those
`drawn in FIG. 2 can be used with the screws 602. Mecha-
`
`nisms to prevent screw back-out, such those used in plates
`associated with the cervical spine, can be incorporated into
`the endplate(s).
`FIG. 7A is a sagittal cross section of yet a different
`mechanism used to connect the hubs to the ADR endplates.
`An L-shaped projection 702 from the hub 704 slides into a
`corresponding groove in the ADR endplate. A cam lock 710
`may be used to hold the components together. In FIG. 7A,
`the cam is drawn in the unlocked position. FIG. 7B shows
`the cam in the locked position.
`FIG. 8 is a view of the bottom of the top ADR endplate
`802 with a circular cushioning component 804. The cush-
`ioning component can also be circular like the ADR endplate
`(FIG. 22A), or both can be elliptical (FIG. 22B), or other
`alternative shape. FIG. 9 is a sagittal cross section of the
`ADR with distraction tools 902 fitted in the area of the
`
`eclipse shaped ADR endplates that is not covered by the
`circularly shaped cushioning component 804. FIG. 10 is a
`sagittal cross section of an ADR with an alternative distrac-
`tion mechanism incorporating endplates with holes 1002 for
`the arms of a distraction device 1020 placed into the holes
`on the right side of the ADR.
`FIG. 11A is the first of a series of drawings showing
`insertion of the ADR from the anterior aspect of the spine.
`In this Figure, the top ADR endplate is forced into the
`superior vertebra. The endplate of the vertebra may be
`milled to improve the fit between the ADR endplate and the
`vertebra. FIG. 11B is a view of the next step in the insertion
`of the ADR after FIG. 11A. The bottom ADR endplate is
`shown during insertion into the inferior vertebra. A tool 11 02
`may be used to align the ADR endplates. The tool can also
`be wedge-shaped to help force the ADR endplates into the
`vertebrae as the tool is forced between the ADR endplates.
`FIG. 11C is a view of the next step in the insertion of the
`ADR after FIG. 11B. Distraction tools 1120 are used to
`
`increase the space between the ADR endplates. The tools
`can be twisted to cam open the disc space, as illustrated on
`the left side of the drawing. Alternatively, the distraction
`tools can be wedge-shaped to force the ADR endplates apart
`as the wedge shaped tools are driven between them.
`FIG. 11D is a view of the next step in the insertion of the
`ADR after FIG. 11C, with the cushioning module positioned
`between the ADR endplates. FIG. 11E is a view of the next
`step in the insertion of the ADR after FIG. 11D. The
`distraction tools have been removed, and locking screws
`1150 have been inserted into the ADR endplates.
`FIG. 12A is a sagittal cross section of an embodiment of
`the device for cushioning the tibial component of a Total
`Knee Replacement (TKR). FIG. 12B is the view of the front
`of the tibial component drawn in FIG. 12A. Item 1202
`
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`US 7,060,100 B2
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`7
`represents the polyethylene tray which is seated in a metal
`tray 1204 including projections that piston in and out of a
`metal tray 1206 in the tibia. The cushioning elements 1220,
`1222 are positioned between the two metal
`trays. The
`polyethylene component can be eliminated in embodiments
`of the device that have a metal articular surface. The trays
`and or the tire like component are porous to allow fluid
`movement in hydrogel-filled embodiments. FIG. 12C is an
`axial cross section of the top tibial tray. The circular pistons
`1230 are also drawn. FIG. 12D is a View of the top of the
`bottom tibial tray including cylinders 1240 for the pistons.
`FIG. 13 is a sagittal cross section of an alternative
`embodiment of a TKR device including a metal articulating
`surface. A large portion of the cushioning element is posi-
`tioned within the intramedullary canal of the tibia. The tibia
`is represented by the dotted area of the drawing. The
`embodiment of the device drawn eliminates the locking
`mechanism required with modular cushioning components.
`A single piston and cylinder are used in this embodiment of
`the device that mentions the option of using shape memory
`materials as a mechanism to lock the hub-like component to
`the projection from the ADR endplate.
`FIG. 14 is a sagittal cross section of a cushion module
`similar to that drawn in FIG. 2, with the exception that the
`hydrogel sides of the hub-like components have raised rims
`1402 that helps hold the tire like component 1404.
`FIG. 15 is a sagittal cross section of the anterior portion
`of the spine and a different alternative embodiment of the
`ADR with the endplates eliminated. In this case, a tire-like
`component 1502 cooperates directly with the hub-like com-
`ponents 1504 and the vertebral endplates.
`FIG. 16A is an oblique,
`lateral View of a preferred
`embodiment of the ADR. The projection 1602 from the hub
`1604 is releaseably attached to a corresponding receptacle in
`the ADR endplate 1606. A screw (not shown) is used to lock
`the seated hub in place. The threads of the screw preferably
`deform slightly to prevent back-out. The ADR endplate 1606
`is itself designed to slide into a previously milled vertebra.
`The modular cushioning component can cooperate with a
`single ADR endplate as drawn. Alternatively, the cushioning
`component can be placed between ADR endplates placed on
`the vertebral endplates on either side of the disc space. The
`raised circular area in the central portion of the hub, below
`the lockable projection,
`is smaller than the hole in the
`tire-like component to highlight the raised portion of the
`hub. The raised portion of the hub rests against the ADR
`endplate. A recess is created between the widest portion of
`the hub, which is inside the tire-like component, and the
`ADR endplate. The recess is slightly taller than the thickness
`of the tire-like component. The cooperation between the hub
`and the ADR endplate protects the portion of the tire-like
`component, above the extension of the hub, from axial
`compression. The smooth surface of the cushion side of the
`ADR endplate and the space between the hub and the ADR
`endplate facilitate radial expansion of the tire-like compo-
`nent. The tire-like hoop expands in a radial direction sec-
`ondary to the outward force transferred from the hydrogel
`within the tire-like hoop. The hydrogel applies outward
`force on the tire-like hoop secondary to axial forces on the
`spine.
`FIG. 16B is a view of the front of an alternative embodi-
`
`ment of the ADR endplate drawn in FIG. 16A. Two diverg-
`ing screws are placed through holes 1620, 1622 in the ADR
`endplate. The holes in the plate may include locking c-rings
`to prevent screw back-out. The screws are also recessed into
`the vertebrae to further decrease the risk of impingement of
`the screws on the soft tissues anterior to the spine.
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`FIG. 16C is a view of the front of an alternative embodi-
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`ment of the ADR endplate drawn in FIG. 16A. The embodi-
`ment of the ADR endplate drawn in FIG. 16C is press fit into
`the vertebra from the disc space. The side walls of the
`portion of the ADR endplate tether mechanism are flush with
`top of the tether mechanism to allow insertion from the disc
`space. Spikes 1660 are use to resist extrusion of the ADR in
`an anterior or posterior direction. The tether mechanism
`prevents lateral movement of the ADR relative to the
`vertebrae. The tether and spikes cooperate to limit rotation
`of the ADR relative to the vertebrae.
`
`FIG. 17 is a sagittal cross section of the ADR with an
`alternative plate-hub locking mechanism. In this embodi-
`ment, projections 1702 from the hubs fit into holes 1704 in
`the ADR endplates. The tire-like component was not drawn.
`Pressure from the hydrogel forces the projections from the
`hubs into the holes in the ADR endplates. The spikes on the
`vertebral side of the ADR endplates were not drawn. The
`recess between the widest portion of the hub and the ADR
`endplate is slightly wider than the thickness of the tire-like
`component.
`FIG. 18 is a sagittal cross section of another preferred
`embodiment of the ADR, wherein a modular cushioning
`component
`is attached to a single endplate 1802. The
`opposing side of the tire-like component cooperates directly
`with a vertebral endplate. The locking mechanism, similar to
`that drawn in FIG. 17, relies on a hydrogel, elastomer, or
`other appropriate filler material within the tire to exert force
`to the hub. A hole or recess in the center of the hub fits over
`
`a projection 1810 from the ADR endplate. The space
`between the hub and the ADR endplate is slightly larger than
`the thickness of the tire. FIG. 19 is a sagittal cross section of
`the embodiment of FIG. 18 showing the opposing endplate
`1804.
`
`FIG. 20 is a sagittal cross section of yet another ADR
`embodiment wherein one endplate 2002 has a cushioning
`component tether 2010 and a second ADR endplate 2020
`without the cushioning component tether. FIG. 21A is an
`axial cross section of the top of an alternative embodiment
`of the ADR drawn in FIG. 16A. FIG. 21