Exhibit 2005 Page 1
`
`Globus Medical, Inc. v.
`Bonutti Skeletal Innovations LLC
`Case IPR2015-00417
`Bonutti Skeletal Innovations LLC - Ex. 2005
`
`

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`Vlichelson
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`Paul
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`4,2
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`5,2
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`5,2
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`............................ ,. 606/250
`872
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`21,2
`Dahners ........................ .. 606/69
`4,2
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`5,2
`Thramann et al,
`71,2
`Garden et al.
`27,2
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`Sherman et al.
`4,2
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`7,2
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`772
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`US 7,963,981 B2
`Page 2
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`6,730,093
`6.730,127
`617551555
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`6755553
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`6j795:679
`618081557
`61814756
`6875215
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`2/0147450
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`4/0075218
`4/0097940
`470153205
`570053294
`570071013
`570085812
`570149026
`570165400
`570254455
`5/0261681
`5/0261690
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`\Vrit,Opn. PCT/US05/13253,
`Haid et al., “The Cervical Spine Study Group anterior cervical plate
`nomenclature,” Neurosurg. Focus/Vol. 12, Jan. 2002.
`
`*citedby examiner
`
`Exhibit 2005 Page 2
`
`U.S. PATENT DOCUMENTS
`.
`12/2000 \l1cheson
`2/2001
`son et al.
`2/2001
`son
`3/2001
`son
`4/2001
`5/2001
`6/2001
`6/2001
`7/2001
`8/2001
`8/2001
`10/2001
`10/2001
`11/2001
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`4/2002
`5/2002
`6/2002
`7/2002
`7/2002
`8/2002
`8/2002
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`11/2002
`12/2002
`1/2003
`2/2003
`3/2003
`3/2003
`3/2003
`5/2003
`6/2003
`7/2003
`8/2003
`8/2003
`9/2003
`9/2003
`11/2003
`“/2003
`12/2003
`1/2004
`2/2004
`2/2004
`2/2004
`2/2004
`3/2004
`3/2004
`4/2004
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`6,257,459
`6,269,974
`6,270,498
`6,299,030
`6,306,139
`6,318,602
`6,350,283
`6,364,880
`6,383,186
`6,398,783
`6,413,259
`6,416,528
`6,428,542
`6,436,098
`6,440,139
`6,447,547
`6,454,769
`6,454,771
`6,478,823
`6,500,205
`6,503,250
`6,517,544
`6,527,776
`6,537,279
`6,537,320
`6,561,388
`6,575,977
`6,592,586
`6,602,256
`6,605,090 31
`6,616,666 31
`6,620,163 31
`6,652,525 31
`65527584 32
`676667890 32
`6,679,883 32*
`6,692,501 32
`6,692,503 32
`6,695,846 32
`6,595,349 32
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`Exhibit 2005 Page 2
`
`

`
`U.S. Patent
`
`Jun. 21, 2011
`
`Sheet 1 of 10
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`US 7,963,981 B2
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`4 113
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`Exhibit 2005 Page 3
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`Exhibit 2005 Page 3
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`

`
`U.S. Patent
`
`Jun. 21, 2011
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`Sheet 2 of 10
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`US 7,963,981 B2
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`Exhibit 2005 Page 4
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`Exhibit 2005 Page 4
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`

`
`U.S. Patent
`
`Jun. 21, 2011
`
`Sheet 3 of 10
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`US 7,963,981 B2
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`‘X
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`
`Exhibit 2005 Page 5
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`Exhibit 2005 Page 5
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`

`
`U.S. Patent
`
`Jun. 21, 2011
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`Sheet 4 of 10
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`US 7,963,981 B2
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`..mhXE
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`6e9aP5002.4“
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`Exhibit 2005 Page 6
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`

`
`U.S. Patent
`
`Jun. 21, 2011
`
`Sheet 5 of 10
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`US 7,963,981 B2
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`Exhibit 2005 Page 7
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`Exhibit 2005 Page 7
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`

`
`U.S. Patent
`
`Jun. 21, 2011
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`Sheet 6 of 10
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`US 7,963,981 B2
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`FIG. 10B
`
`Exhibit 2005 Page 8
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`Exhibit 2005 Page 8
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`

`
`U.S. Patent
`
`Jun. 21, 2011
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`Sheet 7 of 10
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`US 7,963,981 B2
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`..mhXE
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`9e9aP5002.1“
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`Exhibit 2005 Page 9
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`

`
`U.S. Patent
`
`Jun. 21, 2011
`
`Sheet 8 of 10
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`US 7,963,981 B2
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`FIG. 14
`
`Exhibit 2005 Page 10
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`Exhibit 2005 Page 10
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`

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`AMm.F
`
`FIG. 15B
`
`as.B.3:2.8.e3Scms§..§:3
`
`Exhibit 2005 Page 11
`
`

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`U.S. Patent
`
`Jun. 21, 2011
`
`Sheet 10 0110
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`US 7,963,981 B2
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`1 FIG. 16
`
`Exhibit 2005 Page 12
`
`Exhibit 2005 Page 12
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`

`
`US 7,963,981 B2
`
`2
`
`1
`BONE FLYATION PLATE
`
`FIELD OF THE INVENTION
`
`The present invention relates to a bone fixation plate used 3
`to stabilize vertebrae and other bony anatomy. More specifi-
`cally, the present invention relates to a cervical plate having a
`minimized profile that easily and reliably prevents backout of
`fastening devices.
`
`BACKGROUND OF THE INVENTION
`
`Bones and bony structures are susceptible to a variety of
`weaknesses that can affect their ability to provide support and
`structure. Weaknesses in bony structures may have many
`causes, including degenerative diseases, tumors, fractures,
`and dislocations. Advances in medicine and engineering have
`provided doctors with a plurality of devices and techniques
`for alleviating or curing these weaknesses.
`The cervical spine has presented the most challenges for
`doctors, partially due to the small size ofthe vertebrae and the
`spacing between adj acent vertebrae. Typically, weaknesses in
`the cervical spine are corrected by using devices that fuse one
`or more vertebrae together. Common devices involve plate
`systems that align and maintain adjacent cervical vertebrae in
`a desired position, with a desired spacing.
`These devices, commonly referred to as bone fixation plat-
`ing systems, typically include one or more plates and screws
`for aligning and holding vertebrae i11 a fixed position with
`'espect to one another. Initial devices used stainless steel
`olates and screws. I11 order to remain fixed in place, the screws
`were required to pass completely through the vertebrae and
`into the spinal canal. These devices caused many complica-
`ions and involved significant risks. To allow a screw to pass,
`drilling and then tapping of the vertebrae was required. In the
`orocess, instruments came withi11 close proximity of the spi-
`ial cord, which required extreme care on the part of the
`surgeon.
`In addition to the risks of surgically applying bone fixation
`plates, othercomplications arose. Commonly, these problems
`involve loosening and failure of the hardware. Two common
`failures are the breakage of the plates, a11d the backing out of
`he screws into soft tissues ofthe patient’ s body. The backing
`out of the screws is typically a result of the screws failure to
`achieve a sufiicient purchase in the bone, although the strip-
`ping ofthe screws has also been known to cause this problem.
`Regardless of the cause of the hardware failures, a surgeon
`must repair or replace the broken parts, which requires unde-
`sirable invasive procedures.
`Advances in material science allowed engineers to manu-
`facture bone fixation plates out of materials that would resist
`breakdown within a body. However, the backing out of screws
`remained a problem. Many solutions were devised in an
`attempt to prevent this from occurring. One prevalent solution
`involved minimizing the length of the screw in order to pre-
`vent screw to plate junction breakage of the screw. However,
`the shortened screw is typically unable to achieve a sufficient
`purchase in the bo11e. Shortened screws often provide very
`little holding power and inadequate tactile feedback to the
`surgeon. Tactile feedback to the surgeon is important to signal
`completion oftightening prior to stripping ofthe screw within
`the bone.
`
`An alternate solution involves increasing the length of the
`screws in order to achieve sufficient purchase to hold the plate
`in place. While the use of longer screws can provide bicortical
`fixation, this method also has its drawbacks. Primarily, long
`screws increase the chances of interference with each other
`
`when they are screwed into bony tissue at an angle. In addi-
`
`tion, many bone fixation plating systems place bone grafts
`between vertebrae. The bone grafts are eventually supposed
`to spur the growth of bone between the vertebrae, so that the
`vertebrae become fiised together naturally.
`In order for this to occur, the bone fixation plating needs to
`maintain a desired spacing between the vertebrae, which is
`filled by the bone grafts. However, it is common for the bone
`grafts to experience compression, which separates at least one
`of the adjacent vertebrae from the bone graft. Cervical plates
`that employ long screws do not allow for sufficient movement
`ofthe vertebrae to accommodate the compression ofthe bone
`graft, because the purchase of the screws is too great. Thus,
`the vertebrae camrot move and are unable to adjusting to the
`compression of the bone graft.
`Another method of preventing the backing out of screws
`involves placing a second plate over the screws. This second
`plate functions to interlock the screws, preventing them from
`backing out. However, this method of securing screws often
`becomes bulky, resulting in a large and undesirable profile. In
`addition, these configurations require carrying out multiple
`steps or using a multi-piece assembly in order to block an
`opening through which a loose fastener head may pass. For
`instance, the use of a c-ring that can expand as the fastener
`head is inserted requires additional components and assembly
`time to form a plate. Moreover, n1ulti-component designs
`may lose their ability to retain a fastener over time due to
`material failure, relaxation, or the like. Additionally, multi-
`component configurations may not provide sufficient ability
`to lag the plate to the vertebral body.
`One additional drawback of many designs is that they add
`to the overall height of the plate. It is desirable to maintain a
`low profile design for many reasons, such as to minimize
`irritation to surrounding tissue. For example a plate design
`having a high overall height or a receptacle design that does
`not prevent screw backout may cause a patient to suffer from
`dysphasia. Ultimately, the screw or plate may irritate or wear
`through neighboring tissue. In addition, a high height plate or
`unretained loose screw in the lumbar spine may be abrasive to
`the aorta or vena cava. Severe abrasion by the plate or screw
`in this instance may puncture the aorta or vena cava and cause
`internal bleeding.
`In addition, many of these plates were not designed to
`allow for the locki11g of all of the screws, which left some of
`the screws susceptible to backout caused by tiny vibrations, or
`micromotion. Some methods attempted to reduce the profile
`of the total system by using small parts. However, this led to
`the small parts falling off and getting lost. In addition, the
`smaller parts are fragile and require special instruments i11
`order to insert or manipulate them. In addition, because of
`their small size, incorrect placement relative to the axis ofthe
`plate often causes sharp and jagged shavings to be formed as
`a locking screw contacts an improperly seated bone screw.
`Prior attempts at
`increasing the screw purchase have
`resulted in risky procedures, or an insufficient ability to adapt
`to movement. Attempts and decreasing the profile of bone
`fixation plates have resulted in lost parts, or insufficient pur-
`chase. A continuing need exists for an apparatus that is able to
`quickly and reliably lock a plurality of screws into place while
`maintaining a low profile.
`
`SUMMARY OF THE INVENTION
`
`The present invention relates to an apparatus for connect-
`ing a plate to a bone. This may be desirable in order to
`immobilize, for example,
`two cervical vertebrae. In one
`embodiment, the present invention comprises at least one
`screw and a plate having at least one opening. As the screw
`passes through the opening and is tightened, it begins to lag
`
`Exhibit 2005 Page 13
`
`Exhibit 2005 Page 13
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`

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`US 7,963,981 B2
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`3
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`4
`
`the plate to the bone. When the screw head interferes with the
`pate at an interference point, there is a slight resistance force
`that insertion forces can easily overcome. When the screw is
`advanced further, it s11aps into the sliding fit area and is
`allowed to move freely. Forces which can cause the screw to
`back out of from the plate are preferably not strong enough to
`pass the screw head past the interference section. In some
`embodiments, it may be desirable to use a set screw to aid in
`preventing backout. Alternately, a clan1p applied to the head
`of the screw to prevent rotation may be desired.
`In one embodiment, the present invention comprises an
`apparatus for fixing a plate to bony material, comprising at
`least one opening having a spherical curvature. Also included
`is at least one fastener having a head that interferes with the
`spherical curvature at an interference point. In this embodi-
`ment, the head is capable of engaging with and passing the
`interference point to communicate with the spherical curva-
`ture.
`
`In son1e embodiments, the spherical curvature includes at
`least one engagement area and at least one relief area. The
`tangents to the spherical curvature preferably intersect to
`form an angle. Preferably, the angle of intersection of the
`tangents is between about 1 and about 5 degrees. More pref-
`erably, the angle of intersection of the tangents is between
`about 1 and about 3 degrees.
`It is desirable to limit the relief areas in some embodiments
`
`to prevent a screw from passing through the interference
`Joint. Accordingly, it is preferred that the relief area com-
`arises less than about 40% ofthe circumference ofthe spheri-
`cal curvature. More preferably, the relief area comprises less
`than about 30% of the circumference of the spherical curva-
`ure. In son1e embodiments, it may be desirable to provide an
`additional opening that is configured and dimensioned to
`increase the magnitude of interference at the interference
`point.
`In another embodiment, the present invention comprises an
`apparatus for stabilizing at least two bony structures, com-
`ori sing a plate where n1ore than one aperture is configured and
`adapted to include an interference area. The interference area
`is integrally fonned in the plate to prevent a fastener from
`Jacking out of the interference area.
`In this embodiment, a fastener, such as a screw, is capable
`of engaging with and passing through the interference area.
`The interference area is part of spherical curvature, which has
`at least one engagement area and at least one relief area.
`Preferably, the tangents to the spherical curvature intersect.
`It is desirable to have the angle of intersection ofthe tangents
`between about 1 and 5 degrees. In some embodiments, it is
`also preferable to include another opening that is selectively
`positioned to increase the magnitude of interference at the
`interference point. The opening may be configured and
`adapted such that it is able to pass a wedge shaped screw.
`In another embodiment, the present invention comprises an
`apparatus for fixing a plate to bony material consisting essen-
`tially of at least one opening having a spherical curvature. At
`least one fastener having a head capable of engaging with and
`passing through an interference point of the spherical curva-
`ture is also included. In this embodiment, the fastener is
`prevented from backing out ofthe opening by the interference
`point. In this embodiment, the tangents to the spherical cur-
`vature intersect. As described above, another opening may be
`selectively positioned to increase the magnitude of interfer-
`ence at the interference point.
`
`BRIEF DESCRIPTION OF THE DRAWINGS
`
`FIG. 1 is a diagram showing one embodiment of the bone
`fixation plate according to the present invention;
`FIG. 2 is a diagram showing a side view of exemplary
`openings according to the present invention;
`
`FIG. 3A is a diagram showing one embodiment of the
`spring loaded plate according to the present invention;
`FIG. 3B is a diagram showing an exemplary ramped sur-
`face included in the spring loaded plate of FIG. 3A;
`FIGS. 4A and 4B are diagrams showing an exemplary
`embodiment ofa set screw according to the present invention;
`FIGS. 5A and 5B are diagrams showing an exemplary
`embodiment of a bone screw according to the present inven-
`tion;
`FIG. 6 is a diagram showing another embodiment of the
`bone fixation plate according to the present i11ventio 1;
`FIG. 7 is a diagram showing one embodiment ofthe sphe1i-
`cal curvature according to the present invention;
`FIG. 8 is a diagram showing the forces exertec by the
`screws according to the embodiment shown in FIG. 6;
`FIG. 9 is a diagram showing another embodiment of the
`bone fixation plate according to the present i11ventio 1;
`FIGS. 10A and 10B are illustrations of additional e bodi-
`
`ments of bone fixation plates of the present inventio 1;
`FIG. 11 is a diagram showing a one embodiment of the
`bone fixation plate according to the present i11ventio 1;
`FIG. 12 is a diagram showing a drill guide i11 com111mica-
`tion with a bone fixation plate of the present invention;
`FIG. 13 is a magnified view of a drill guide in communi-
`cation with a bone fixation plate of the present invention;
`FIG. 14 is a side View of a drill guide in communication
`with a bone fixation plate of the present invention;
`FIGS. 15A-C are diagrams showing an exemplary embodi-
`ment ofa rigid bone screw according to the present invention;
`and
`
`FIG. 16 is an illustration of one embodiment ofa drill guide
`capable ofrotating about an axis of a receptacle or depression
`formed in the plate.
`
`DETAILED DESCRIPTION OF THE PREFERRED
`EMBODIMENTS
`
`The present invention relates to a bone fixation plate that
`minimizes the problems associated with prior bone fixation
`plates while maintaining a small profile. In one embodiment,
`as a screw is tightened, it will beginto lag the plate to the bone.
`When the screw head interferes with the plate at an interfer-
`ence point, a slight resistance is generated. The insertion
`forces can easily overcome this resistance. When the screw is
`advanced further, it snaps into a sliding fit area and is allowed
`to move freely. The forces which can cause the screw to back
`out from the plate are preferably not strong enough to pass the
`screw head back past the interference section. It may be
`desirable to include a set screw to prevent backout of the
`screws due to micromotion. In other embodiments, the head
`of the screw may be clamped to prevent rotation, when such
`a restriction on the movement of the screw is desirable.
`
`The present invention provides a locking mechanism that
`allows one or n1ore bone screws used for attaching a plate to
`vertebrae to be easily and reliably locked in place at the same
`time by a single operation. When fully installed, the locking
`mechanism has a low profile and maintains its ability to
`prevent breakout of screws due to micromotion. The present
`invention may be used on the anterior or posterior of the
`vertebrae. Although the present invention is described with
`respect to two bone fixation vertebrae, it will be understood
`that the following embodiments are capable of being used
`with any number of vertebra, in any spinal location.
`Turning now to the drawings, FIG. 1 shows one embodi-
`ment of a bone fixation plate 101 according to the present
`
`Exhibit 2005 Page 14
`
`Exhibit 2005 Page 14
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`

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`US 7,963,981 B2
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`5
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`6
`
`'
`
`invention. The plate may be secured to two vertebrae in order
`to maintain the vertebrae integrally with respect to one
`another in a desired orientation and at a desired spacing from
`one another. Plate 1 01 includes two fastening devices, such as
`screws 103-105 or the like, which are operatively communi-
`cable with spring loaded plates 107-109. The plate also
`includes four openings 111-117, through which screws (not
`shown) may be used to fasten the plate 101 to the vertebrae.
`The plate 101 and the screws may be comprised of any
`material, such as a metal, alloy, or any combination ofthe two.
`Preferably, the material used to construct the plate and the
`screws allows the plate 101 to maintain its structural integrity
`while allowing for a desired amount of resiliency. Further-
`more, the material used is preferably bio-compatible and
`capable of withstanding the conditions of a body over a
`desiredperiod oftime. In some embodiments, this is achieved
`by manufacturing the plate 101 and screws using metals such
`as titanium or stainless steel. Titanium has sufficient ductility
`to permit a desired amount of curving of the plate 101 to
`conform to the shape of the vertebrae, yet has the strength to
`maintain its structural integrity.
`In the FIG. 1 embodiment, the bone fixation plate 101
`comprises a center portion 119 and two distal portions 121-
`123. Each distal portion 121-123 may be attached to a differ-
`ent vertebra using fasteners, such as screws, that pass through
`openings 111-117. Because distal portions 121-123 are simi-
`lar, only the operation of distal portion 121 is described in
`detail.
`
`FIG. 2 is a diagram showing a side view of openings 111
`and 1 13. In one embodiment, each opening has a substantially
`circular shape, as shown in FIG. 1. In this embodiment, the
`inner portion of openings 111-113 have substantially spheri-
`cal curvatures. Accordingly, the radius ofthe inner portion of
`openings 111-113 decrease in diameter from the top 201 of
`the openings, to the bottom 203 of the openings. Preferably, 35
`the spherical curvature of the openings 111-113 may accom-
`modate a screw having a spherical head. However, the present
`invention is not limited to spherical curvatures or spherical
`heads. In other embodiments, any complementary head and
`receptacle may be used. Preferably, the complementary head
`and receptacle are capable of preventing the breakout of the
`screw.
`
`As shown in FIG. 2, the openings 111-113 are not continu-
`ous. It is desirable that the openings 111-113 comprise only a
`portion ofthe circumference ofthe spherical curvature. In one
`embodiment, the remaining portion 205 ofthe circumference
`ofthe spherical curvature ofthe openings 11 1 -1 13 is provided
`by spring loaded plate 107, shown in FIG. 1. The portion of
`the circumference ofthe spherical curvature that is completed
`by spring loaded plate 107 may be varied as desired, for 50
`example, according to the amount ofresistance that is desired
`by the spring loaded plate 107. In one embodiment, the open-
`ings 111-113 comprise at least 60 percent or more of the total
`circumference of the spherical curvature. In another embodi-
`ment, the openings 111-113 comprise at least 70 percent or 55
`more of the total circumference of the spherical curvature. In
`yet another embodiment, the openings 111-113 comprise at
`least 80 percent or more of the total circumference of the
`spherical curvature.
`FIG. 3A is a diagram showing one embodiment of the
`spring loaded plate 107. In this embodiment,
`the spring
`loaded plate 107 includes arm 301. When a force causes arm
`301 to be deflected towards the body 303 of the spring loaded
`plate 107, potential energy is stored i11 the arm 301. This
`potential energy causes the arm 307 to generate spring-like
`forces that have a tendency to force it away from the body
`303, and back to its natural resting position shown in FIG. 3A.
`
`When the deflection force is removed, the potential energy is
`converted to kinetic energy, and forces the body 303 away
`from the arm 307. In other embodiments, the spring loaded
`plate 107 does not have to have a free cantilever load such as
`the arm 301 shown in FIG. 3A. For example,
`it may be
`desirable to use a loop, or the like, to resist movement of the
`spring loaded plate 107.
`The inner portion of plate 107 preferably comprises a
`ramped surface 305. In one embodiment, the ramped surface
`305 is selectively engageable with screw 103, shown in FIG.
`1. When the screw 103, is engaged by the ramped surface
`shown in FIG. 3B, outward forces are generated on the screw,
`preventing it from backing out. As the angle of the ramped
`surface increases, the forces that are exerted on the screw 103
`increase. Thus, the angle of the ramped surface may be cho-
`sen based on the amount of force that is desired to keep the
`screw 103 from backing out.
`In one embodiment, the angle ofthe ramp is between about
`5 and 50 degrees. In another embodiment, the angle of the
`ramp is between about 10 and about 30 degrees. In yet another
`embodiment, the angle of the ramp is between about 15 and
`25 degrees.
`The spring loaded plate 107 comprises two spherical cur-
`vatures 307 and 309. Spherical curvatures 307 and 309 com-
`plete the spherical curvatures of openings 111 and 113. Each
`curvature 307-309 comprises a spherical curvature having a
`radius that decreases from top to bottom, as discussed with
`respect to the curvatures ofopenings 111 and 113 . The spheri-
`cal curvatures 307-309 may comprise any desired percentage
`of the circumference of the total spherical curvature. In one
`embodiment, each curvature 307-309 may comprise 20 per-
`cent or less of the total circumference of the spherical curva-
`ture. In another embodiment, each curvature 307-309 may
`comprise 30 percent or less of the total circumference of the
`spherical curvature. In yet another embodiment, each curva-
`ture 307-309 may comprise 40 percent or less of the total
`circumference of the spherical curvature.
`Spring loaded plate 107 also includes two edges 311 and
`313, shown in FIG. 3A. Each edge is preferably configured
`and dimensioned to be engageable with a depression 125 in
`plate 101. In one embodiment, the spring loaded plate 107 is
`positioned within the depression 125. Depression 125 is con-
`figured and dimensioned such that there is sufficient space for
`plate 107 to move between its compressed and relaxed states,
`described with respect to FIGS. 3A and 3B. In one embodi-
`ment, plate 107 is prevented from horizontally exiting depres-
`sion 125 by the protrusion formed by openings 111-113.
`In one embodiment, shown in FIGS. 4A and 4B, the screw
`103 may have an angled head 401. It may be desirable for
`screw 103 to have threads along its elongate shaft 403. In
`order to aid in tightening screw 103, it preferably includes a
`projection 405 with a curved surface to aid in gripping the
`screw. The length of the elongate shaft may be varied as
`desired. In one embodiment, the length of the elongate shaft
`is about 5 rim or less. In another embodiment, the ler1gth of
`the elongate shaft is about 3 mm or less. In yet another
`embodiment, the length ofthe elongate shaft is about 1 mm or
`less.
`
`FIGS. 5A and 5B are diagrams showing one embodiment
`of the screw that is used to connect plate 101 to vertebrae.
`Screw 501 preferably has a spherical head 503 that is selec-
`tively engageable with the spherical curvature. An elongate
`shaft 505 is connected to the spherical head 503 to allow it to
`penetrate bony tissue of the vertebrae. Preferably, the elon-
`gate shaft 505 includes threads that aid in fixing the plate 101
`to a vertebra. As shown in FIG. 5B, it is desirable to have a
`hexagonal projection 507 to aid in gripping the screw.
`
`Exhibit 2005 Page 15
`
`Exhibit 2005 Page 15
`
`

`
`US 7,963,981 B2
`
`7
`
`8
`
`The length of the elongate shaft 505 may be varied as
`desired. 111 one embodiment, the length of the elongate shaft
`is about 20 mm or less. In another embodiment, the length of
`the elongate shaft is about 10 mm or less. In yet another
`embodiment, the length ofthe elongate shaft is about 5 mm or
`less.
`
`5
`
`In one embodiment, screw 103 is inserted into a receptacle
`in depression 125. It is desirable to have a threaded receptacle
`such that the screw is capable of being fixed to the plate 101.
`The screw 103 also passes over plate 107, and prevents it from
`vertically exiting depression 125. The placement of the screw
`receptacle is preferably chosen such that it is engageable with
`the ramped surface 305 of plate 107 when the plate is in its
`relaxed state, with its arm 301 extended.
`Preferably, two screws 501 are inserted into openings 111
`and 113. As the screws 501 are tightened, they will begin to
`lag the plate 101 to the bone. When the screw head 503
`interferes with plate 107, it forces it to move towards the
`center of the plate 101. As the screws 501 are advanced
`further, the plate 1 07 forces its way back into its relaxed state.
`This causes the spherical curvatures 307-309 to form a com-
`plete spherical curvature around the screw head 503. When
`plate 107 is in its relaxed state, it prevents screw 501 from
`backing out. It may be desirable to tighten screw 103, such
`thatplate 107remains fixed in its relaxed state. In this manner,
`the screw 501 is prevented fron1 backing out.
`Screws 501 may be screwed into bony tissue at any desired
`angle. In other words, screw 501 does not have to be inserted
`perpendicular to the plate 101. The spherical properties of the
`head of the screw 503 and the spherical curvature of the
`openings 111-117 are preferably sufflcient to prevent the
`screw from backing out. Thus, the largest diameter ofthe head
`of the screw is larger than the diameter of the narrowest
`portion of the opening in the top our outer side of the plate
`through which the screw head is placed. The interference
`difference between the fastener head diameter and the outer
`
`narrow opening may be describe in different ways depending
`on the size of the plate, openings, and fastener heads being
`used. For example the interference difference between the
`fastener head and the narrowest opening may be about 0.01
`mm or greater, about 0.03 mm or greater, or about 0.10 or
`greater, or even about 0.20 mm or greater. Preferably, how-
`ever, in each instance the interference is less than about 2 mm.
`Altematively, the interference between the fastener head
`and the narrow outer opening may be described relative to the
`outer diameter of the fastener head itself. For example, the
`interference may be about 0.5% or greater of the diameter of
`the fastener head, about 5% or greater of the diameter of the
`fastener head, or even about 10% or greater of the outer
`diameter of the fastener head. Preferably, however, in each
`instance the interference is less than about 40% of the outer
`diameter of the fastener head.
`
`While openings 111-117 prevent the screws 501 from
`backing out, they do allow it to rotate freely within the spheri-
`cal curvature. One advantage of allowing the screw 501 to
`rotate freely is that the bone fixation plate according to the
`present invention is able to accommodate for movements in
`the vertebrae or accommodate for compression of the bone
`grafts that are placed between vertebrae. Another advantage
`of allowing the screws to be inserted at any angle is that it
`allows relatively close spacing of the screws, without the risk
`of interference with one another.
`
`FIG. 6 shows another embodiment ofthe present invention.
`As shown in FIG. 6, an exemplary bone fixation plate accord-
`ing to the present invention comprises four openings 601-607.
`In one embodiment, openings 601-603 are connected to one
`vertebra, and openings 605-607 are connected to a second
`
`vertebra. Also included are two additional openings 609-611,
`which are located at a desired point between points 601-603
`and 605-607, respectively. One advantage of the FIG. 6
`embodiment is that a screw does not have to be inserted into
`
`opening 609 until after screws are inserted into openings
`601-603. Thus, opening 609 serves as a window for a surgeon
`to view the vertebra, or space between adjacent vertebrae.
`This is often desirable to the surgeon.
`Because all ofthe corresponding openings are similar, only
`openings 601-603 and 609 are described in detail. In one
`embodiment, openings 601 and 603 are spherical curvatures
`having the same properties discussed with respect to FIGS.
`1-5. Thus, a complete description of the openings 601-603 is
`not repeated. The openings are substantially similar in size,
`shape, and diameter to the openings 111-117 described with
`respect to FIG. 1. There are some differences between the
`openings shown in FIG. 6 embodiment and the openings
`shown in the FIG. 1 embodiment, which are discussed below.
`In one embodiment, the spherical curvature of openings
`601-603 is substantially circular. The opening 601-603 com-
`prises the majority of the circumference of the spherical cur-
`vature for the screw 613. This is in contrast to the spherical
`curvatures described with reference to FIGS. 1 -5, which were
`formed by both the openings and the spring loaded plate 107.
`Therefore, the spherical curvature of each opening 601-603
`houses substantially entire head of screw 613. In one embodi-
`ment, screw 613 is substantially similar to screw 501, dis-
`cussed with reference to FIGS. 5A and 5B.
`
`In one embodiment, the spherical curvature of the opening
`601-603 comprises 90% or more ofthe total circumference of
`the curvature. In another embodiment, the spherical curvature
`of the opening 601-603 comprises 95% or more of the total
`circumference of the curvature. In yet another embodiment,
`the spherical curvature of the opemng 601-603 comprises
`99% or more of the total circumference of the curvature.
`
`In one embodim