throbber
(12) United States Patent
`DOnner et al.
`
`(10) Patent No.:
`(45) Date of Patent:
`
`US 8,641,766 B2
`Feb. 4, 2014
`
`USOO864.1766B2
`
`(54) ARCUATE FIXATION MEMBER
`
`(75) Inventors: Thomas Donner. Thibodaux, LA (US),
`Jared Schoenly, West Chester, PA (US);
`David Evans, West Chester, PA (US);
`Andreas Gfeller, Oberdorf (CH)
`(73) Assignee: DePuy Synthes Products, LLC,
`Raynham, MA (US)
`y
`s
`-
`Subject to any disclaimer, the term of this
`patent is extended or adjusted under 35
`U.S.C. 154(b) by 119 days.
`
`(*) Notice:
`
`5,300,074 A
`5,899,905 A
`6,036,701 A
`6,231,610 B1
`6,235,059 B1
`6.258,089 B1
`6,364,880 B1
`6,383,186 B1
`6,423,063 B1
`6,468.309 B1
`6,527,774 B2
`6,551.319 B2
`6,558,423 B1
`6,620,163 B1
`
`4/1994 Frigg
`5/1999 Errico et al.
`3/2000 Rosenman
`5, 2001 Geisler
`5/2001 Benezech et al.
`7/2001 Campbell et al.
`4/2002 Michelson
`5/2002 Michelson
`7/2002 Bonutti
`10/2002 Lieberman
`3/2003 Lieberman
`4/2003 Lieberman
`5/2003 Michelson
`9, 2003 Michelson
`(Continued)
`
`(21) Appl. No.: 13/070,883
`
`(22) Filed:
`
`Mar 24, 2011
`
`(65)
`
`Prior Publication Data
`US 2011 FO230971 A1
`Sep. 22, 2011
`
`Related U.S. Application Data
`(63) Continuation-in-part of application No. 12/761,101,
`filed on Apr. 15, 2010.
`(60) Provisional application No. 61/169.461, filed on Apr.
`15, 2009.
`(51) Int. Cl.
`A6 IF 2/44
`A6B 7/70
`(52) U.S. Cl.
`USPC ......................... 623/17.16; 606/246; 606/279
`(58) Field of Classification Search
`USPC .............. 623/17.11-17.16; 606/300, 74,246,
`606,279, 301
`See application file for complete search history.
`References Cited
`
`(2006.01)
`(2006.01)
`
`(56)
`
`U.S. PATENT DOCUMENTS
`
`FOREIGN PATENT DOCUMENTS
`
`FR
`FR
`
`6, 2004
`28484.08
`12/2008
`291.6956
`(Continued)
`
`OTHER PUBLICATIONS
`
`U.S. Appl. No. 61/120,138, filed Dec. 5, 2008, Overes.
`(Continued)
`
`Primary Examiner — Pedro Philogene
`(74) Attorney, Agent, or Firm — Woodcock Washburn LLP
`
`(57)
`
`ABSTRACT
`
`Arcuate fixation members with Varying configurations and/or
`features are provided, along with additional components for
`use therewith in provided intervertebral implants. The arcuate
`fixation members may be of different lengths, cross sectional
`geometries, and/or cross sectional areas. Applications of
`intervertebral implants utilizing arcuate fixation members are
`particularly suitable when a linear line-of-approach for deliv
`ering fixation members is undesirable.
`
`4,790.303 A * 12/1988 Steffee .......................... 606,300
`5,263,953. A 1 1/1993 Bagby
`
`60 Claims, 18 Drawing Sheets
`
`
`
`Exhibit 1032
`LIFE SPINE, INC.
`IPR2022-01602
`
`000001
`
`

`

`US 8,641,766 B2
`Page 2
`
`(56)
`
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`Janowski ................... 623, 17.16
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`Farris et al.
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`
`FOREIGN PATENT DOCUMENTS
`
`WO
`WO
`WO
`WO
`WO
`WO
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`
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`WO 2008, 102174
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`
`2, 2002
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`
`OTHER PUBLICATIONS
`
`U.S. Appl. No. 61/169.461, filed Apr. 15, 2009, Laurence.
`International Patent Application No. PCT/US2010/031244: Interna
`tional Search Report dated Nov. 3, 2010, 10 pages.
`International Patent Application No. PCT/US2011/029738: Interna
`tional Search Report dated Jun. 29, 2011, 12 pages.
`* cited by examiner
`
`000002
`
`

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`U.S. Patent
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`Feb. 4, 2014
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`US 8,641,766 B2
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`U.S. Patent
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`Feb. 4, 2014
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`U.S. Patent
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`Feb. 4, 2014
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`US 8,641,766 B2
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`U.S. Patent
`U.S. Patent
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`Feb. 4, 2014
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`Sheet 4 of 18
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`US 8,641,766 B2
`US 8,641,766 B2
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`U.S. Patent
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`Feb. 4, 2014
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`U.S. Patent
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`Feb. 4, 2014
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`US 8,641,766 B2
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`U.S. Patent
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`Feb. 4, 2014
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`Feb. 4, 2014
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`306 305 38 305 36
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`U.S. Patent
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`Feb. 4, 2014
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`US 8,641,766 B2
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`Feb. 4, 2014
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`Feb. 4, 2014
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`000020
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`

`

`1.
`ARCUATE FXATION MEMBER
`
`CROSS-REFERENCE TO RELATED
`APPLICATIONS
`
`US 8,641,766 B2
`
`2
`plates. The intervertebral implant also includes an insert that
`defines a plate. The insert is configured to be coupled to the
`spacer body Such that the insert is disposed opposite at least a
`portion of the outer wall.
`
`This patent application is a continuation-in-part of and
`claims priority to U.S. patent application Ser. No. 12/761,
`101, filed Apr. 15, 2010. U.S. patent application Ser. No.
`12/761,101 claims priority to U.S. provisional patent appli
`cation No. 61/169,461, filed Apr. 15, 2009. The disclosures of
`U.S. patent application Ser. No. 12/761,101 and U.S. provi
`sional patent application No. 61/169.461 are hereby incorpo
`rated by reference as if set forth in their entireties herein.
`
`TECHNICAL FIELD
`
`10
`
`15
`
`The present disclosure relates generally to orthopedics,
`and in particular relates to fixation systems, intervertebral
`implants, and associated Surgical methods and procedures for
`using same.
`
`BACKGROUND
`
`Spinal fixation systems such as pedicle Screw and rod
`constructs are commonly used to promote fusion between
`intervertebral bodies. The insertion of pedicle screws typi
`cally requires a linear "line-of-approach' trajectory that is
`aligned with the longitudinal axis of the screw, in order to
`accommodate the access and delivery instruments. Similarly,
`anchors such as bone screws may be used to directly fix
`intervertebral implants to vertebral bodies, typically requir
`ing the insertion of several screws at unique angles oblique to
`the Sagittal and/or transverse plane, and thus multiple lines
`of-approach. However, in a variety of Surgical situations,
`achieving a desired trajectory for Screw insertion can be dif
`ficult due to the patients anatomy obstructing a linear line
`of-approach. For example, medially-directed placement of
`pedicle screws into the sacrum is desirable to prevent screw
`loosening and/or pullout, but can be prohibited due to the iliac
`crest obstructing the linear line-of-approach.
`
`25
`
`30
`
`35
`
`40
`
`SUMMARY
`
`In accordance with one embodiment, a bone fixation mem
`ber configured to be inserted in a vertebral body includes a
`45
`fixation body having opposing proximal and distal ends and a
`curved intermediate portion extending between the proximal
`and distal ends. A tip configured to cut into bone is defined at
`the distal end. A guidance member is disposed at the tip and
`extends toward the proximal end of the body. The guidance
`member is configured to guide the tip along an insertion
`trajectory as the fixation member is inserted into a vertebral
`body.
`The bone fixation member can be used with an interverte
`bral implant that includes a spacer body that is configured to
`be implanted into an intervertebral space. The spacer body
`has an outer wall that defines at least a first aperture extending
`into the spacer body. The intervertebral implant also includes
`an insert that defines a plate. The insert is configured to be
`coupled to the spacer body such that the insert and the outer
`wall of the spacer body define a second aperture therebe
`tWeen.
`An alternative intervertebral implant that can be used with
`the bone fixation member includes a spacer body that has
`upper and lower plates and an outer wall extending between
`the upper and lowerplates. The spacer body has a plurality of
`apertures extending through each of the upper and lower
`
`50
`
`55
`
`60
`
`65
`
`BRIEF DESCRIPTION OF THE DRAWINGS
`
`The foregoing Summary, as well as the following detailed
`description of the preferred embodiments of the application,
`will be better understood when read in conjunction with the
`appended drawings. For the purposes of illustrating the arcu
`ate fixation member and intervertebral implants for use there
`with, there are shown in the drawings preferred embodiments.
`It should be understood, however, that the instant application
`is not limited to the precise arrangements and/or instrumen
`talities illustrated in the drawings, in which:
`FIG. 1A is a side elevation view of an arcuate fixation
`member constructed in accordance with an embodiment;
`FIG. 1B is a perspective view of the arcuate fixation mem
`ber illustrated in FIG. 1A:
`FIG. 2A is a top elevation view of an intervertebral implant
`spacer for use with arcuate fixation members, constructed in
`accordance with an embodiment;
`FIG. 2B is a front elevation view of the intervertebral
`implant spacer illustrated in FIG. 2A;
`FIG. 2C is a side elevation view of the intervertebral
`implant spacer illustrated in FIG. 2A;
`FIG. 3A is a front elevation view of an insert plate for use
`with the intervertebral implant spacer illustrated in FIGS.
`2A-C;
`FIG.3B is a top elevation view of the insert plate illustrated
`in FIG. 3A:
`FIG. 4A is a front elevation view of a blocking plate for use
`with the insert plate illustrated in FIGS. 3A-B;
`FIG. 4B is a top elevation view of the blocking plate illus
`trated in FIG. 4A;
`FIG.4C is a front elevation view of a blocking plate similar
`to the blocking plate illustrated in FIG. 4A, but constructed in
`accordance with an alternative embodiment;
`FIG. 5 is a side elevation view of a locking screw for use
`with the insert plate and blocking plate illustrated in FIGS.
`3A-B and 4A-B, respectively;
`FIG. 6A is an exploded view of an intervertebral implant
`assembly constructed from the intervertebral implant system
`components illustrated in FIGS. 1A-5:
`FIG. 6B is a perspective view of the intervertebral implant
`assembly illustrated in FIG. 6A, in an assembled configura
`tion;
`FIG. 6C is a side elevation view of the intervertebral
`implant assembly illustrated in FIG. 6B, inserted into an
`intervertebral space;
`FIG. 7A is a side elevation view of an arcuate fixation
`member constructed in accordance with an alternative
`embodiment;
`FIG. 7B is a front perspective view of the arcuate fixation
`member illustrated in FIG. 7A:
`FIG. 7C is a rear elevation view of the arcuate fixation
`member illustrated in FIG. 7A:
`FIG. 7D is a rear perspective view of the arcuate fixation
`member illustrated in FIG. 7A:
`FIG. 7E is a front perspective view of a portion of the
`arcuate fixation member in FIG. 7A, showing a guidance
`member;
`FIG. 7F is a rear perspective view of the portion of the
`arcuate fixation member in FIG. 7E;
`FIG. 7G is a top elevation view of the arcuate fixation
`member illustrated in FIG. 7A:
`
`000021
`
`

`

`3
`FIG. 7H is a sectional front elevation view of the arcuate
`fixation member illustrated in FIG. 7G, taken along line
`7H-7H;
`FIG. 7I is a rear elevation view of an arcuate fixation
`member similar to the arcuate fixation member illustrated in
`FIG. 7A, but constructed in accordance with an alternative
`embodiment;
`FIG. 7J is a rear perspective view of the arcuate fixation
`member illustrated in FIG. 7I;
`FIG. 8A is a top elevation view of an intervertebral implant
`spacer for use with arcuate fixation members, constructed in
`accordance with an alternative embodiment;
`FIG. 8B is a perspective view of the intervertebral implant
`spacer illustrated in FIG. 8A:
`FIG. 8C is a front elevation view of the intervertebral
`implant spacer illustrated in FIG. 8A:
`FIG. 8D is a side elevation view of the intervertebral
`implant spacer illustrated in FIG. 8A:
`FIG.9A is a top elevation view of an intervertebral implant
`spacer for use with arcuate fixation members, constructed in
`accordance with another alternative embodiment;
`FIG.9B is a perspective view of the intervertebral implant
`spacer illustrated in FIG.9A;
`FIG. 9C is a front elevation view of the intervertebral
`implant spacer illustrated in FIG. 9A;
`FIG. 9D is a side elevation view of the intervertebral
`implant spacer illustrated in FIG. 9A;
`FIG. 10A is a top elevation view of an insert plate for use
`with the intervertebral implant spacers illustrated in FIGS.
`8A-D and 9A-D;
`FIG. 10B is a front elevation view of the insert plate illus
`trated in FIG. 10A:
`FIG. 10C is a rear elevation view of the insert plate illus
`trated in FIG. 10A:
`FIG.10D is a perspective view of the insert plate illustrated
`in FIG. 10A:
`FIG. 10E is a top elevation view of the insert plate illus
`trated in FIG. 10A, constructed in accordance with an alter
`native embodiment;
`FIG. 10F is a top elevation view of the insert plate illus
`trated in FIG. 10A, constructed in accordance with another
`alternative embodiment;
`FIG. 11A is a top elevation view of an intervertebral
`implant constructed with an alternative embodiment of the
`intervertebral implant spacer illustrated in FIGS. 8A-D and
`the insert plate illustrated in FIGS. 10A-D;
`FIG. 11B is a sectional elevation view of the intervertebral
`implant illustrated in FIG. 11A, taken along line 11B-11B:
`FIG. 12A is a top elevation view of the intervertebral
`implant illustrated in FIG. 11A, constructed in accordance
`with an alternative embodiment;
`FIG. 12B is a top elevation view of the intervertebral
`implant illustrated in FIG. 11A, constructed in accordance
`with another alternative embodiment;
`FIG. 12C is a top elevation view of the intervertebral
`implant illustrated in FIG. 11A, constructed in accordance
`with still another alternative embodiment;
`FIG. 13A is a side elevation view of an intervertebral
`implant constructed in accordance with an embodiment; and
`FIG. 13B is a side elevation view of the intervertebral
`implant illustrated in FIG. 12A, constructed in accordance
`with another embodiment.
`FIG. 14A is an exploded view of an intervertebral implant
`constructed from the intervertebral implant system compo
`nents illustrated in FIGS. 7A-8D and 10A-D; and
`FIG. 14B is a perspective view of the intervertebral implant
`illustrated in FIG. 14A, in an assembled configuration.
`
`40
`
`45
`
`50
`
`55
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`60
`
`65
`
`US 8,641,766 B2
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`5
`
`10
`
`15
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`25
`
`30
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`
`4
`DETAILED DESCRIPTION OF ILLUSTRATIVE
`EMBODIMENTS
`
`Certainterminology is used in the following description for
`convenience only and is not limiting. The words “right'.
`“left”, “top” and “bottom' designate directions in the draw
`ings to which reference is made. The words "inwardly” and
`"outwardly” refer to directions toward and away from,
`respectively, the geometric center of the device and desig
`nated parts thereof. The words, “anterior”, “posterior,
`“superior”, “inferior”, “lateral”, “medial”, “sagittal”, “axial”,
`"coronal,” “cranial,” “caudal and related words and/or
`phrases designate preferred positions and orientations in the
`human body to which reference is made and are not meant to
`be limiting.
`The words “arcuate” and "curved as used herein refer
`generally to the varying physical geometry of an object along
`an axis coincident to the object, for example the deviation
`from Straightness of the body of an arcuate fixation member
`along a central longitudinal axis defined within the body of
`the object between its proximal and distal ends. Generally,
`with reference to a straight axis projected from a first end of
`such an object, as distance from the first end of the object
`increases along the central longitudinal axis of the object,
`distance between the central longitudinal axis of the object
`and the straight axis increases more or less continuously, so
`that the body of the object defined along its central longitu
`dinal axis takes on a curved or arcuate shape. The resulting
`curvature of the central longitudinal axis may exhibit a con
`stant or uniform radius with respect to a point in space defined
`remotely from the body of the object. Alternatively, a non
`uniform or varying radius of curvature may be defined. The
`curvature of the body of the object defined by the longitudinal
`axis may also vary in direction with respect to a Cartesian
`coordinate system. The curvature may be uniformly distrib
`uted along the body of the object, for example between the
`proximal and distal ends of the object, or may be localized
`within one or more distinct segments of the body of the object.
`The curvature of the object may be significantly smooth and
`continuous along its central longitudinal axis, may be defined
`by a series of straight interconnected segments where each
`Successive segment defines an increasing angle between the
`central longitudinal axis of the body of the object and the
`straight axis, or any combination thereof.
`The words “vertebral body” as used herein should be inter
`preted broadly to include all the bones and bony structures
`found within and in the immediate proximity of the human
`spinal system, including but not limited to those found in the
`cervical region, the thoracic region, the lumbar region, and
`the sacral curve region.
`The terminology intended to be non-limiting includes the
`above-listed words, derivatives thereof and words of similar
`import.
`Referring initially to FIGS. 1A-6C, example embodiments
`of components of an intervertebral implant system 100 com
`prising a bone fixation member which can define an arcuate
`fixation member 12C as illustrated, an intervertebral implant
`spacer 108, an insert plate 116, a blocking plate 132, and a
`locking screw 138 are illustrated. Applications of the inter
`vertebral implant system 100 could include, but are not lim
`ited to, fixation of the endplate components of a total disc
`replacement to vertebral bodies, direct fixation of an interver
`tebral implant to vertebral bodies, fixation into osteoporotic
`bone, and the like. The use of the systems and/or methods
`utilizing arcuate fixation members disclosed herein are par
`ticularly suitable when a linear line-of-approach for deliver
`ing a fixation member is undesirable. It should be noted that
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`US 8,641,766 B2
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`5
`the physical characteristics of the arcuate fixation members
`disclosed herein may cause them to be alternately described
`as curved fixation members, arcuate or curved blades, arcuate
`or curved pins, arcuate or curved nails, or other terms of
`similar descriptive import.
`As will become appreciated from the description below,
`one or more fixation members 12C may be utilized to securely
`anchor an assembled configuration of intervertebral implant
`system 100 within an intervertebral space between adjacent
`vertebral bodies. Unless otherwise indicated, the interverte
`bral implant system 100 and its components can be manufac
`tured from any suitable biocompatible material known in the
`art including but not limited to titanium, titanium alloy Such
`as TAN, commercially pure titanium, stainless Steel, tanta
`lum, polymers such as polyether ether ketone (PEEK), rein
`forced plastics, allograft bone, and the like.
`Referring now to FIGS. 1A-B, the arcuate fixation member
`12C includes a body 102 defining a proximal end 102a and a
`distal end 102b opposite the proximal end. The distal end
`102b may comprise a tip 104 configured to cut into underly
`ing structure or bone. The body 102 may further define an
`intermediate portion between the proximal end 102a and the
`distal end 102b that is curved along a central curved axis L1.
`In an embodiment, the intermediate portion is curved along
`substantially the entire length of the body 102 between the
`proximal end 102a and the distal end 102b. Alternatively, one
`or more distinct portions of the intermediate portion between
`the proximal end 102a and the distal end 102b may be curved
`(not shown).
`In the illustrated embodiment, the intermediate portion is
`curved along the central curved axis L1 in accordance with a
`uniform radius of curvature R1. Alternatively, the intermedi
`ate portion may define a non-uniform radius of curvature
`along the central curved axis L1. In a preferred embodiment,
`the curvature of the intermediate portion may be smooth and
`continuous. Alternatively, the curvature of the intermediate
`portion may be defined by a series of substantially straight
`sections (not shown), with each Substantially straight section
`aligned along an individual longitudinal axis corresponding
`to the individual section, where the magnitude of an angle C.
`with respect to a perpendicular reference axis extended from
`the proximal end 102a increases in magnitude with the dis
`tance of each Subsequent straight section from the proximal
`end 102a.
`The arcuate fixation member 12C may have a head 106
`defined at the proximal end 102a of the body 102. The head
`106 may extend radially outward from the proximal end 102a
`of the body 102 in a direction perpendicular to the longitudi
`nal axis L1. In an example embodiment, the head 106 may
`extend from the body 102 in a direction generally opposite
`from the direction of curvature of the body 102, as depicted in
`FIGS. 1A-B. In alternative embodiments, the head 106 may
`extend from the body 102 in a direction generally towards the
`direction of curvature of the body 102. The head may define
`an upper Surface 106a configured for multi-angular engage
`ment with a complementary Surface of a delivery instrument,
`and a lower surface 106b opposite the upper surface 106a and
`configured to engage another component of the intervertebral
`implant system 100, for example the insert plate 116, when
`the arcuate fixation member 12C is in a fully inserted posi
`tion.
`Referring now to FIGS. 2A-C, the intervertebral implant
`spacer, or spacer 108 is defined by a posterior side 108a, an
`anterior side 108b opposite the posterior side, lateral sides
`108c, an upper surface 108d, and a lower surface 108e oppo
`site the upper Surface. In an example embodiment, a portion
`of the posterior side 108a between the lateral sides 108c may
`
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`
`6
`be curved inwardly in the direction of the anterior side 108b.
`defining a rounded, generally rectangular kidney-like foot
`print, as depicted in FIG. 2A. In an alternative embodiment, a
`portion of the posterior side 108a between the lateral sides
`108c may be curved outwardly in a direction away from the
`anterior side 108b (not shown). In another alternative
`embodiment, the posterior side 108a may be substantially
`straight between the lateral sides 108c, defining a rounded,
`generally rectangular footprint (not shown). The spacer 108
`may have a central bore 110 defined therethrough, the shape
`of which substantially conforms to the footprint of the spacer
`108 (e.g., a rounded, generally rectangular kidney-like foot
`print, or a rounded, generally rectangular footprint, depend
`ing upon the geometry of the posterior side 108a). The central
`bore 110 can be filled with bone growth inducing substances
`to allow bony ingrowth and to assist in fusion between the
`spacer 108 and adjacent vertebral bodies.
`In an example embodiment of the spacer 108, the upper and
`lower surfaces 108d and 108e may have gripping structures
`108h such as teeth, spikes, or similar structures, defined
`thereon and configured to facilitate gripping engagement
`between the upper and lower surfaces 108d and 108e and the
`end plates of adjacent vertebral bodies. The teeth 112 may be
`pyramidal, saw toothed or other similar shapes. In alternative
`embodiments of the spacer 108, portions of and/or the
`entirety of the upper and lower surfaces 108d and 108e may
`be substantially smooth and devoid of any protrusions. Upper
`and lower edges 108f and 108g, defined where the upper and
`lower surfaces 108d and 108e intersect with the posterior,
`anterior, and lateral sides 108a, 108b, and 108c respectively
`around the outer perimeter of the spacer 108, may be rounded
`(not shown). In an example embodiment, the upper and lower
`edges 108f and 108g may be rounded using a uniform radius
`of curvature around the perimeter of the implant. In an alter
`native embodiment, the upper and lower edges 108f and 108g
`may be rounded using a non-uniform radius of curvature
`around the perimeter of the implant. In another alternative
`embodiment, the upper and lower edges 108f and 108g along
`the anterior side 108b may be rounded with a greater radius
`than the remainder of the upper and lower edges 108f and
`108g, such that a bull nose outer surface (not shown) is
`created on the anterior side 108b of the implant. Rounding
`upper and lower edges 108f and 108g may facilitate easier
`insertion of the spacer 108, for example by minimizing
`required distraction of the end plates of adjacent vertebral
`bodies.
`In an example embodiment, the spacer 108 has a generally
`wedge-shaped side-view profile. As illustrated in FIG. 2C,
`this wedge shape is defined by a gradual decrease in the height
`of the spacer 108 (as measured between the upper and lower
`surfaces 108d and 108e) extending between the posterior side
`108a in the direction of the anterior side 108b. The spacer 108
`has a generally constant height between lateral sides 108c. In
`alternative embodiments, the spacer 108 may have a gradual
`increase in height followed by a gradual decrease in height
`extending from one lateral side 108c to the other, and/or may
`have a generally constant height between the posterior and
`anterior sides 108a and 108b, or may have convex and/or
`concave upper and lower surfaces 108d and 108e, thereby
`defining a gradual increase in height followed by a gradual
`decrease in height extending from the posterior side 108a to
`the anterior side 108b and from one lateral side 108c to the
`other.
`A plurality of grooves 112 may be defined on the spacer
`108 where the upper and lower surfaces 108d and 108e inter
`sect with the anterior side 108b. The grooves 112 may be
`concave and may be configured to align with arcuate grooves
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`US 8,641,766 B2
`
`10
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`7
`128 of the insert plate 116 when the spacer 108 and the insert
`plate 116 are in an assembled configuration. In an example
`embodiment, the grooves 112 may be substantially smooth
`and devoid of any protrusions. Retaining grooves 114 may be
`defined within the lateral sides 108c of the spacer 108
`between the upper and lower surfaces 108d and 108e. The
`retaining grooves 114 may be configured to releasably engage
`complementary engaging ribs 120 of the insert plate 116.
`Referring now to FIGS. 3A-B, the fixation plate, or insert
`plate, or insert 116 is defined by a generally C-shaped, chan
`nel-like body 118 that includes an anterior side 118a with
`upper and lower sides 118b and 118C opposite each other, and
`lateral sides 118d extending from opposite sides of the ante
`rior side 118a in a generally perpendicular direction from the
`anterior side 118a. The anterior, upper, lower, and lateral
`sides 118a, 118b, 118c, and 118d may form a generally
`channel-like structure (in essence, a cradle) which may be
`configured to receive the anterior side 108b and at least a
`portion of the lateral sides 108c in partial nested engagement.
`As such, the upper and lower sides 108b and 108c may define
`gradual increases and/or decreases in height in a posterior
`direction from the anterior side 118a and/or between the
`lateral sides 108d. in order to generally conform the insert
`plate 116 to the geometry of the spacer 108. The lateral sides
`118d may have engaging ribs 120 defined thereon at the ends
`opposite the anterior side 118a, the engaging ribs 120 con
`figured to be releasably received within the retaining grooves
`114 of the spacer 108.
`The anterior side 118a of the insert plate 116 may have a
`pair of apertures 122 defined therethrough configured to
`receive grasping members of a delivery instrument. In an
`example embodiment, the apertures 122 may be D-shaped, as
`illustrated in FIG. 3A. However any otheraperture shape may
`be defined as appropriate. The apertures 122 may have a
`retaining rib 124 defined therein configured to engage with a
`complementary grasping rib of the delivery instrument. The
`anterior side 118a of the insert plate 116 may also have a
`central bore 126 defined therethrough having an inner surface
`126a with threads configured to engage complementary
`threads of a locking screw 138. The anterior side 118a of the
`insert plate 116 may also have a concave recess 130 defined
`therein configured to receive a complementary convex Sur
`face 134d of the blocking plate 132.
`The anterior side 118a of the insert plate 116 may also have
`45
`a plurality of arcuate grooves 128 defined therethrough con
`figured to slidably receive the arcuate fixation members 12C
`and to define an insertion trajectory for each of the arcuate
`fixation members 12C. In an example embodiment, the arcu
`ate grooves 128 may have a generally uniform cross sectional
`geometry configured to closely conform to the cross sectional
`geometry of the body 102 of the arcuate fixation member 12C
`between the head 106 and the distal end 102b. When an
`arcuate fixation member 12C is in a fully inserted position
`within a respective arcuate groove 128, the lower surface
`55
`106b of the head 106 will be engaged with the outer surface of
`the anterior side 118a of the insert plate 116. Because the
`upper surface 106a of the head 106 will not be flush with the
`outer surface of the anterior side 118a of the insert plate 116
`in this configuration, it may be desirable to omit the blocking
`plate 132 and the locking screw 138. In an alternative embodi
`ment, the arcuate grooves 128 have a recessed ledge defined
`therein in the area where the arcuate grooves 128 intersect
`with the outer surface of the anterior side 118a of the insert
`plate 116, the recessed ledge being configured to receive the
`lower surface 106b of the head 106 when the arcuate fixation
`member 12C is in a fully inserted position, such that the upper
`
`8
`surface 106a of the head 106 is substantially flush with the
`outer surface of the anterior side 118a of the insert plate 116.
`The arcuate grooves 128 may be disposed about the central
`bore 126 in any desired c

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