`
`WORLD INTELLECTUAL PROPERTY ORGANIZATION
`International Bureau
`
`
`
`
`INTERNATIONAL APPLICATION PUBLISHED UNDER THE PATENT COOPERATION TREATY (PCT)
`
`
`(51) International Patent Classification 6 :
`(11) International Publication Number:
`WO 99/38461
`
`AGIF 2/44
`
`
`
`
`5S August 1999 (05.08.99)
`(43) International Publication Date:
`
`
`
`
`(21) International Application Number: PCT/EP99/00433|(81) Designated States: CA, JP, European patent (AT, BE, CH, CY,
`
`DE, DK, ES, FI, FR, GB, GR, IE, IT, LU, MC, NL, PT,
`22 January 1999 (22.01.99)
`
`(22) International Filing Date:
`SE).
`
`
` Published
`(30) Priority Data:
`30 January 1998 (30.01.98)
`US
`60/073 ,271
`Without international search report and to be republished
`
`5 August 1998 (05.08.98)
`US
`60/095 ,425
`
`upon receipt of that report.
`
`CHUR [CH/CH], Grabenstrasse 15, CH-7002 Chur (CH).
` (71) Applicant(for all designated States except CA): SYNTHES AG
`Russell Road, P.O. Box 1766, Paoli, PA 19301-1222 (US).
` (71) Applicant (for CA only): SYNTHES (U.S.A.) [US/US]; 1690
`
`
`(72) Inventors: PAUL, David, C.; 1513 Valley Road, Drexel Hill,
`PA 19026 (US). EMCH, Hansjuerg, W.; 1527 Spruce
`
`Street, Philadelphia, PA 19102 (US).
`SCHENK, Beat;
`
`
`59 Cobblestone Drive, Paoli, PA 19301 (US). CARVER,
`Jeffrey, L.; 1011 Welsh Ayres Way, Downington, PA 19335
`
`
`(US). BAKER,Kelly, J; 1878 Shadyside Road, Coatesville,
`PA 19320 (US).
`
`
`
`(74) Agent:
`LUSUARDI, Werther;
`Dr.
`Lusuardi AG,
`Kreuzbiihistrasse 8, CH-8008 Ziirich (CH).
`
`
`
`(54) Title: ALLOGENIC INTERVERTEBRAL IMPLANT
`
`14
`
`10
`'
`
`‘0
`
`ia
`
`10
`fe
`
`
`
`18
`
`16
`
`r\4 20 18
`
`16
`
`
`
`14
`
`22
`
`24
`
`(57) Abstract
`
`Anallogenic intervertebral implant (10) for fusing vertebrae is disclosed. The implant (10) is an annular plug conforming in size and
`shape with end plates of vertebrae. The implant has either an exterior surface identical to that of the harvest bone or an exterior surface
`machined to have a uniform shape such as an oval or a rectangle. The top and bottom surfaces (14, 16) of the implant (10) have a plurality
`of teeth (12) to resist expulsion and provide initial stability. The top and bottom surfaces (14, 16) can be either flat planar surfaces or
`curved surfaces. Preferably, the anterior height of the implant is greater than the posterior height so that the implant is wedge-shaped
`profile to help restore disc height and the natural curvature of the spine.
`In one embodiment, the top and bottom surfaces each have a
`channeloriented in the anterior, lateral, or antero—lateral direction for receiving a surgical instrument. The implant can also have a hole for
`attachment of an inserter. Although the interior space formed by the annular plug can be the natural shape defined by the medullary canal,
`the medullary canal walls can be machined so that the implant has a uniform interior space.
`
`
`
`
`
`Codes used to identify States party to the PCT on the front pages of pamphlets publishing international applications under the PCT.
`Albania
`ES
`LS
`Lesotho
`SI
`Slovenia
`Armenia
`FI
`LT
`Lithuania
`SK
`Slovakia
`FR
`Austria
`LU
`SN
`Luxembourg
`Senegal
`Australia
`LV
`GA
`Latvia
`Swaziland
`SZ
`GB
`Monaco
`TD
`MC
`Chad
`Azerbaijan
`GE
`MD
`TG
`Bosnia and Herzegovina
`Republic of Moldova
`Togo
`Barbados
`GH
`MG
`TJ
`Madagascar
`Tajikistan
`GN
`MK
`Turkmenistan
`Belgium
`The former Yugoslav
`GR
`Burkina Faso
`Republic of Macedonia
`Turkey
`HU
`Mali
`Bulgaria
`Trinidad and Tobago
`IE
`Benin
`Ukraine
`Mongolia
`IL
`Brazil
`Mauritania
`Uganda
`Belarus
`IS
`Malawi
`United States of America
`Canada
`IT
`Mexico
`Uzbekistan
`JP
`Viet Nam
`Central African Republic
`Niger
`KE
`Netherlands
`Congo
`Yugoslavia
`Switzerland
`KG
`Zimbabwe
`Norway
`KP
`Céte d'Ivoire
`New Zealand
`Cameroon
`Poland
`China
`Portugal
`Cuba
`Romania
`Russian Federation
`Czech Republic
`Sudan
`Germany
`Denmark
`Sweden
`Estonia
`Singapore
`
`™T
`
`R
`TT
`UA
`UG
`US
`UZ
`VN
`YU
`ZW
`
`ML
`MN
`MR
`MW
`MX
`NE
`NL
`NO
`NZ
`PL
`PT
`RO
`RU
`SD
`SE
`SG
`
`
`FOR THE PURPOSES OF INFORMATION ONLY
`
`AL
`AM
`AT
`AU
`AZ
`BA
`BR
`BE
`BF
`BG
`BJ
`BR
`BY
`CA
`CF
`CG
`CH
`cI
`cM
`CN
`cu
`CZ
`DE
`DK
`EE
`
`Spain
`Finland
`France
`Gabon
`United Kingdom
`Georgia
`Ghana
`Guinea
`Greece
`Hungary
`Treland
`Israel
`Tceland
`Ttaly
`Japan
`Kenya
`Kyrgyzstan
`Democratic People’s
`Republic of Korea
`Republic of Korea
`Kazakstan
`Saint Lucia
`Liechtenstein
`Sri Lanka
`Liberia
`
`KR
`KZ
`LC
`LI
`LK
`LR
`
`
`
`
`
`WO 99/38461
`
`PCT/EP99/00433
`
`ALLOGENIC
`
`INTERVERTEBRAL
`
`IMPLANT
`
`This
`
`invention concerns
`
`a device
`
`in
`
`accordance with the
`
`pre-characterising portion of Claim 1. More particularly, it
`
`refers
`
`to
`
`an allogenic intervertebral
`
`implant for use
`
`in the
`
`treatment of back pain.
`
`A number of medical conditions such as compression of spinal cord
`
`nerve
`
`roots,
`
`degenerative disc disease,
`
`and trauma can cause
`
`severe back pain.
`
`Intervertebral fusion is a surgical method of
`
`alleviating back pain.
`
`In intervertebral fusion,
`
`two adjacent
`
`vertebral bodies
`
`are fused together by
`
`removing
`
`the affected
`
`intervertebral disc and inserting an implant that would allow for
`
`bone to grow between the two vertebral bodies
`
`to bridge the gap
`
`left by
`
`the disc
`
`removal.
`
`A number of different
`
`implants and implant materials have been
`
`used
`
`for fusion with varying success.
`
`Current
`
`implants used
`
`include titanium cages and allografts.
`
`Titanium cages suffer
`
`from the disadvantage of requiring drilling and tapping of the
`
`vertebral endplates for insertion.
`
`In addition,
`
`the incidence of
`
`subsidence
`
`in long
`
`term use
`
`is
`
`not
`
`known.
`
`Due
`
`to MRI
`
`
`
`WO 99/38461
`
`PCT/EP99/00433
`
`determining fusion is problematic.
`titanium,
`incompatibility of
`Finally,
`restoration of lordosis, i.e.,
`the natural curvature of
`
`the cervical and lumbar spine
`
`is very difficult when
`
`a titanium
`
`cage is used.
`
`bone
`of
`Allografts are sections
`long bone,
`such as the radius,
`
`taken from the diaphysis of a
`ulna, fibula, humerus,
`tibia, or
`
`femur of
`
`a donor.
`
`A
`
`cross section of
`
`the bone
`
`is taken and
`
`processed using known techniques to preserve the allograft until
`implantation and reduce
`the
`risk of
`an
`adverse immunological
`response when implanted.
`For example, U.S. Patent No. 4,678,470
`discloses a method for processing a bone grafting material which
`
`a non-antigenic,
`produce
`to
`tanning
`uses glutaraldehyde
`have mechanical properties
`biocompatible material. Allografts
`which are similar to the mechanical properties of vertebrae even
`
`after processing.
`
`This prevents stress shielding that occurs
`
`with metallic
`
`implants.
`
`They
`
`are also MRI
`
`compatible so that
`
`fusion can be more
`
`accurately ascertained and
`
`promote
`
`the
`
`formation
`
`of
`
`bone,
`
`i.e.,
`
`osteoconductive.
`
`Although the
`
`a biological
`the allograft provides
`osteoconductive nature of
`interlocking between the allograft
`and
`the vertebrae
`for long
`
`term mechanical
`strength,
`initial
`and
`short
`term mechanical
`strength of the interface between the allograft and the vertebrae
`are
`lacking such that there
`is a possibility of the allograft
`
`being expelled after
`
`implantation.
`
`
`
`WO 99/38461
`
`PCT/EP99/00433
`
`5,728,159 discloses an allograft having grooves
`U.S. Patent No.
`on end faces in an attempt
`to try to promote stability, but there
`are more effective ways for resisting expulsion.
`
`published April 30, 1998,
`For example,
`WO 98/17209,
`is directed
`one embodiment which
`to a spinal spacer and has
`is an allograft
`cortical ring having teeth on superior
`and/or inferior surfaces.
`These
`teeth provide the initial,
`secure
`interlocking with the
`vertebrae.
`
`although cut
`of bone which,
`Most allografts are simply sections
`to the approximate height
`of
`the disc being replaced, have not
`been sized and/or machined
`the exterior
`surface to have a
`
`on
`
`uniform shape.
`
`As a result,
`
`the fusion of the vertebral bodies
`
`does not occur
`
`in optimal
`
`anatomic position in a consistent
`
`the endplates. While a surgeon may
`manner along the surface of
`do some minimal intraoperative
`shaping and sizing to customize
`the allograft for the patient's anatomy, Significant shaping and
`sizing of the allograft is not possible due to the nature
`of the
`
`allograft.
`
`Even if extensive shaping and sizing were possible, a
`
`surgeon's ability to manually shape and size the allograft to the
`
`desired dimensions is
`
`severely limited.
`
`As the discussion above illustrates,
`
`there
`
`is
`
`a
`
`need
`
`for an
`
`and relieving
`fusing vertebrae
`for
`improved allogenic implant
`back pain.
`The invention as claimed aims at
`solving the
`above
`
`described problems.
`
`
`
`WO 99/38461
`
`PCT/EP99/00433
`
`intervertebral
`an allogenic
`invention provides
`The present
`fusion of vertebral bodies is
`implant
`for use when
`surgical
`indicated as defined in Claiml.
`
`dimensioned in such a way
`The annular plug of allogenic bone is
`that it conforms
`in size and shape with end plates
`of adjacent
`vertebrae, i.e. a rounded or appriximately circular form.
`
`the three-dimensional structure of the
`In a preferred embodiment
`intervertebral implant
`includes a plurality of teeth. Preferably
`the
`three-dimensional structure has a minimum height of 0,5 mm
`and a maximum height
`of
`1,5
`mm relative to the top and bottom
`surfaces of the implant.
`
`saw-tooth shape.
`a
`The teeth preferably have a pyramid shape or
`surface machined
`In one embodiment,
`the implant has an exterior
`to have
`a uniform shape,
`such as an oval ora rectangle.
`The
`interior space delineated by
`the annular plug also can have a
`machined wall
`to provide the implant with a uniform interior
`
`The interior space delineated by the annular plug can be
`space.
`filled with spongiosa,
`bone graft substitutes or artificial bone
`
`material.
`
`The top and bottom surfaces may be flat planar surfaces or curved
`
`to mimic the
`surfaces
`adjacent vertebrae.
`
`of the
`end plates
`the
`topography of
`In a preferred embodiment,
`the anterior
`
`
`
`- WO 99/38461
`
`PCT/EP99/00433
`
`height of the implant is greater than the posterior height of the
`implant so
`that the implant
`has a wedge-shaped profile to help
`restore disc height and the natural curvature of the spine.
`
`the implant has channels on the top and bottom
`In one embodiment,
`surfaces for receiving a surgical tool, e.g. a distractor.
`These
`
`channels can run
`
`in the anterior,
`
`lateral,
`
`or antero-lateral
`
`direction to accommodate a variety of different tools
`
`used in
`
`a threaded hole on the anterior,
`Finally,
`surgical procedures.
`antero-lateral,
`or lateral side can be provided for
`receiving a
`threaded arm of
`an
`insertion tool.
`
`The allogenic bone is preferably in the form of
`
`a cross section
`
`typically
`transverse to the longitudinal axis a human long bone,
`with a height
`of 5
`to 8 mm. Preferably the allogenic bone has
`been process frozen or freeze dried.
`The allogenic bone may also
`be treated with an antiseptic solution.
`
`In the drawings:
`
`FIG.
`
`1
`
`is atop view of
`
`a first
`
`embodiment
`
`of
`
`the implant
`
`according to the present invention;
`
`FIG.
`
`2
`
`is a front view of the implant of FIG. 1;
`
`FIG.
`
`3 is a top view of a second embodiment of the implant;
`
`FIG.
`
`4
`
`is a side view of the implant of FIG. 1;
`
`
`
`WO 99/38461
`
`PCT/EP99/00433
`
`FIG.
`
`5 is a side view of a third embodiment of the implant ;
`
`FIG.
`
`6 is a close up of region A from FIG.
`
`4 and FIG. 8;
`
`a fourth embodiment of the implant
`is atop view of
`7
`FIG.
`according to the present
`invention;
`
`FIG.
`
`8
`
`1s a side view of the implant of FIG.
`
`7;
`
`FIG.
`
`9 is a top view of a sixth embodiment of the implant; and
`
`FIG.
`
`10
`
`shows an alternative tooth configuration.
`
`an allogenic
`shows a top view of a first embodiment of
`1
`FIG.
`intervertebral implant 10
`according to the present invention.
`
`Implant 10 is annular and conforms in size and shape with the end
`
`plates of
`
`the vertebrae
`
`between which
`
`implant
`
`10
`
`is
`
`to be
`
`implanted.
`
`Because implant 10
`
`is annular, new bone can form in
`
`or any
`can be filled with bone chips
`Interior 11
`interior 11.
`other osteoconductive material to promote the formation of bone.
`Although implant 10 will probably be predominantly used
`in the
`lumbar region of
`the spine,
`implant 10
`can be
`configured for
`implantation in any region of
`the
`spine.
`Implant
`10
`has a
`
`plurality of teeth 12
`
`on
`
`superior and inferior surfaces
`
`14, 16
`
`which provide a mechanical interlock between implant
`
`10
`
`and the
`
`end plates.
`
`These teeth 12 provide the mechanical interlock by
`
`
`
`WO 99/38461
`
`PCT/EP99/00433
`
`initial mechanical stability
`The
`penetrating the end plates.
`the
`risk of post-operative
`afforded by
`teeth 12 minimizes
`expulsion of implant 10. Preferably,
`teeth 12 are pyramid-shaped
`in which the angle formed from the tip to the base may be between
`
`about
`
`45
`
`and 75° and is preferably about 60°.
`
`The details of
`
`teeth 12
`
`are best seen in FIG. 6.
`
`The teeth provide an enhanced
`
`interlock with the adjacent vertebrae compared
`
`to the use of
`
`channels,
`
`because the teeth impale
`
`the vertebrae
`
`surfaces.
`
`In
`
`comparison,
`
`channels impart grooves into the vertebrae surfaces
`
`and the implant can slide out along the direction of the channels
`
`Or grooves.
`
`In an alternative embodiment,
`
`teeth 12
`
`have a
`
`Saw-tooth shape (FIG. 10).
`
`As shown in FIG.
`
`land FIG. 2, superior surface 14 has a channel
`
`18
`
`and inferior surface 16 has a channel 20 which is parallel to
`
`20
`18,
`Channels
`18.
`channel
`instrument such as an inserter
`
`are sized to receive a surgical
`and/or distractor. As the names
`
`imply,
`
`an inserter
`
`is
`
`a
`
`surgical
`
`instrument used to insert
`
`implant
`
`10 anda distractor
`
`is
`
`a surgical
`
`instrument used to
`
`separate the adjacent vertebrae so that the surgeon has access to
`
`the
`
`intervertebral space.
`
`If the inserter has a
`
`threaded arm,
`
`In
`can be provided with optional threaded hole 21.
`implant 10
`FIG.
`1
`and FIG.
`2,
`channels
`18
`and 20
`are oriented in the
`
`anterior/posterior direction.
`
`This orientation is useful if the
`
`surgeon prefers an anterior
`
`surgical
`
`approach.
`
`
`
`- WO 99/38461
`
`PCT/EP99/00433
`
`FIG.
`
`3
`
`shows a second embodiment of an allogenic intervertebral
`
`implant 110 according to the present invention.
`
`In general, most
`
`of the structure of
`
`implant
`
`110
`
`(as well
`
`as
`
`the embodiments
`
`described below)
`
`is
`
`like or
`
`comparable
`
`to the structure of
`
`implant
`
`10
`
`and,
`
`accordingly the same reference numeral is used
`
`like components is
`like components and discussion of those
`for
`not believed necessary.
`As shown in FIG. 3, channels 18, 20 can
`
`run in the antero-lateral direction to facilitate use of implant
`
`110 with an antero-lateral
`
`surgical
`
`approach.
`
`As
`
`another
`
`alternative embodiment,
`
`channels 18, 20 could run in the lateral
`
`direction for a lateral approach.
`
`Similarly, a threaded hole 21
`
`optionally can be located on the lateral or antero-lateral side
`
`of implant 10.
`
`In order to restore the natural curvature of the
`
`spine after the
`
`affected disc
`
`has been removed,
`
`implant 10
`
`is provided with a
`
`wedge-shaped profile.
`
`As shown in FIG.
`
`4, one way to achieve
`
`this wedge shape results from a gradual decrease
`
`in height from
`
`the anterior
`
`side
`
`22
`
`to the posterior side 24.
`
`In anatomical
`
`terms,
`
`the natural curvature of the lumbar spine is
`
`referred to
`
`as lordosis. When implant 10 is to be used in the lumbar region,
`
`angle a should be approximately 4,2° so that the wedge shape is a
`lordotic
`shape which mimics
`the anatomy of
`the
`lumbar spine.
`Furthermore, when used
`in the
`lumbar region,
`the ratio of the
`
`height of anterior side 22
`
`(hz)
`
`to the height of posterior side
`
`24
`
`10
`
`(hz) should be approximately 1,1-2 with the length of implant
`
`(1)
`
`being approximately 22 - 30 mm.
`
`
`
`WO 99/38461
`
`PCT/EP99/00433
`
`4, superior and inferior surfaces 14, 16 are flat planar
`In FIG.
`so
`that
`if the
`surgeon prepares the
`endplates to be
`surfaces
`surfaces with a burr,
`implant 10
`fits tightly between
`parallel
`the bone surfaces.
`
`5 illustrates that superior and inferior surfaces 14, 16 of
`FIG.
`a third embodiment of an allogenic intervertebral implant 210 can
`be
`curved
`surfaces
`and still retain the wedge-shaped profile.
`The curved surface of superior and inferior surfaces 14,
`16 isa
`mirror-image of
`the
`topography of
`the vertebral
`end plates.
`Thus,
`the
`curved
`surfaces conform to the contours of
`the end
`
`plates.
`
`an allogenic
`shows a top view of a fourth embodiment of
`7
`FIG.
`intervertebral implant 310
`according to the present invention.
`Although implant 310 will probably be predominantly used in the
`cervical region of the spine,
`implant 310
`can be configured for
`implantation in any region of
`the spine.
`Interior 11 can be
`
`the medullary canal as was the
`defined by the natural shape of
`case
`for implant 10,
`110,
`210. Alternatively,
`the medullary
`canal can be machined so that
`the wall that formed
`interior 11
`
`are uniform in shape and texture.
`
`are preferably pyramid-shaped in
`teeth 12
`As previously noted,
`from the tip to the base
`is preferably
`which the angle formed
`about 60°.
`Pyramid-shaped teeth help prevent expulsion of the
`
`implant in all directions.
`
`The prevention of movement between
`
`
`
`WO 99/38461
`
`PCT/EP99/00433
`
`10
`
`implant 310
`
`and the vertebrae is particularly important when the
`
`Surgeon removes all of the annulus
`
`fibrosis,
`
`as may be the case
`
`for cervical vertebrae.
`
`Most allografts
`machining of
`the
`
`significant
`are processed and used without
`exterior
`surface.
`In other words,
`the
`
`allografts
`
`have substantially the
`
`shape of the
`
`bone from which
`
`the allograft was harvested.
`
`As shown in FIG.
`
`7,
`
`an exterior
`
`surface 26
`
`of
`
`implant 310
`
`has been machined to have
`
`a uniform
`
`initial
`promotes
`The uniform shape
`shape.
`biological fixation is achieved with bony fusion.
`
`stability until
`
`the exterior surface 26
`7,
`As shown in FIG.
`The oval shape preferably is
`arranged to have
`
`has an oval shape.
`lateral sides 28
`
`sides 22,
`along the smaller oval axis and anterior and posterior
`24 along the longer axis.
`In another embodiment of the invention
`
`shown
`
`in FIG.
`
`32,
`
`the exterior surface 26
`
`of
`
`implant 410 is
`
`rectangular in shape with lateral sides 28 shorter in length than
`
`22,
`anterior and posterior sides
`shape and size of implants 310,
`
`and rectangle
`The oval
`24.
`410 can be made to closely match
`
`the shape and size of the affected vertebrae. Typically,
`
`lateral
`
`and anterior
`28
`sides
`approximately 8-18
`mn
`
`and posterior
`ain
`length.
`
`sides
`
`22,
`
`24 would be
`
`In order to restore the intervertebral
`
`space to the proper size
`
`after the affected disc
`
`has been
`
`removed,
`
`implant
`
`310
`
`has a
`
`height,
`
`h,
`
`sized to match the height of the removed disc, as
`
`shown in FIG.
`
`8.
`
`The matched height helps
`
`promote fusion by
`
`
`
`- WO 99/38461
`
`PCT/EP99/00433
`
`Ll
`
`providing direct
`
`contact
`
`between
`
`the
`
`bone
`
`and
`
`implant 310.
`
`Typically,
`
`h would
`
`be
`
`approximately 4-20
`
`mm
`
`for cervical
`
`vertebrae.
`
`Implant 310 has a uniform height so that the profile
`
`of implant 310 is rectangular. Alternatively, as shown in FIG. 4
`
`and
`
`FIG.
`
`5,
`
`implant 310
`
`can have a wedge shaped profile with
`
`either flat planar surfaces or curved surfaces.
`
`It should be noted that
`
`implants
`
`310,
`
`410 can be configured so
`
`that h would be
`
`approximately 10-100 mm.
`
`These
`
`larger sizes
`
`could be used
`
`in corpectomy,
`
`a surgical procedure
`
`in which a
`
`section of several vertebrae is removed.
`
`Implants 310, 410 would
`
`be inserted in the space created by the removed
`
`section of bone.
`
`Due
`
`to the nature
`
`of
`
`corpectomy,
`
`an
`
`accurate preoperative
`
`determination of the size of the implant needed is not possible.
`
`Thus,
`
`implant 310,
`
`410
`
`can
`
`be cut
`
`to the proper size
`
`by the
`
`surgeon.
`
`In such cases,
`
`the implants 310,
`
`410 would only have
`
`teeth on either superior surface 14 or inferior surface 16.
`
`
`
`WO 99/38461
`
`PCT/EP99/00433
`
`12
`
`CLAIMS
`
`1.
`
`Intervertebral implant
`
`(10)
`
`comprising an
`
`annular plug of
`
`allogenic bone conforming
`
`in size and shape with end plates of
`
`vertebrae, wherein top and bottom surfaces (14,16) of the implant
`
`(10)
`
`include
`
`a
`
`three-dimensional
`
`structure
`
`(12)
`
`positioned
`
`thereon for interlocking with adjacent vertebrae.
`
`2. Intervertebral implant
`
`(10) according to claim 1, wherein said
`
`three-dimensional structure (12)
`
`includes a plurality of teeth.
`
`3. Intervertebral implant
`
`(10) according to claim 1 or 2, wherein
`
`said three-dimensional structure (12) has a minimum height of 0,5
`
`mm relative to the top and bottom surfaces (14,16).
`
`4.
`
`Intervertebral implant
`
`(10)
`
`according to one of the claims 1
`
`to 3, wherein said three-dimensional structure (12) has a maximum
`
`height of 1,5 mm relative to the top and bottom surfaces (14,16).
`
`5.
`Intervertebral implant
`(10)
`according to one of the claims 1
`to 4, wherein said allogenic bone has been obtained from a human
`
`long bone, preferably from a femur,
`fibula.
`
`humerus,
`
`radius,
`
`ulna or
`
`6. Intervertebral implant
`
`(10) according to claim 5, wherein said
`
`allogenic bone is a cross section transverse to the longitudinal
`
`axis of said long bone, preferably with a height of 5 to 8 mm.
`
`
`
`WO 99/38461
`
`PCT/EP99/00433
`
`13
`
`7.
`Intervertebral implant
`(10)
`according to one of the claims 1
`to 6, wherein said allogenic bone is treated with an antiseptic
`solution.
`
`8.
`
`Intervertebral implant
`
`(10)
`
`according to one of the claims 1
`
`to 7, wherein said allogenic bone
`freeze dried.
`
`has been process frozen or
`
`9.
`
`Intervertebral implant
`
`(10)
`
`according to one of the claims 1
`
`to 8, wherein the allogenic bone comprises glutaraldehyde.
`
`10.
`
`Intervertebral implant
`
`(10) according to one of the claims i
`
`the annular plug
`to 9, wherein the interior space delineated by
`is
`filled with spongiosa,
`bone graft
`substitutes or artificial
`
`bone material.
`
`ll. Intervertebral implant
`
`(10)
`
`according to one of the claims 1
`
`to 10, wherein the top and bottom (14,16)
`
`surfaces each have a
`
`channel
`
`(18,20) for receiving a surgical instrument.
`
`12.
`
`the
`
`Intervertebral implant
`
`(10)
`
`according to claim 11, wherein
`
`channels (18,20)
`
`run in an anterior-posterior direction.
`
`13.
`
`Intervertebral implant
`
`(10)
`
`according to claim 11, wherein
`
`the channels (18,20)
`
`run in an antero-lateral direction.
`
`14.
`
`Intervertebral implant
`
`(10)
`
`according to claim 11, wherein
`
`the channels (18,20)
`
`run in a lateral direction.
`
`
`
`WO99/38461
`
`PCT/EP99/00433
`
`14
`
`i5. Intervertebral implant
`
`(10) according to one of the claims
`
`1
`
`to 14, wherein the implant has a wedge-shaped profile to help
`
`restore disc height and spine curvature.
`
`16.
`
`Intervertebral implant
`
`(10)
`
`according to claim 15, wherein
`
`said implant has an anterior height which
`
`is greater
`
`than a
`
`posterior height to produce the wedge-shaped profile.
`
`17.
`
`Intervertebral implant
`
`(10) according to one of the claims 1
`
`to 16, wherein the teeth (12) have a pyramidal shape.
`
`18.
`
`Intervertebral implant
`
`(10) according to one of the claims 1
`
`to 17, wherein at
`
`least one side
`
`of
`
`the implant
`
`(10)
`
`has at
`
`least one hole for attachment of an inserter.
`
`19.
`
`Intervertebral implant
`
`(10)
`
`according to claim 18, wherein
`
`the at least one hole is threaded.
`
`20.
`
`Intervertebral implant
`
`(10)
`
`according to claim 19, wherein
`
`the at least one hole is provided in an anterior, antero-lateral,
`
`or lateral side.
`
`21.
`
`Intervertebral implant
`
`(10) according to one of the claims 1
`
`to 20, wherein the top and bottom surfaces
`
`(14,16)
`
`are flat
`
`planar surfaces.
`
`
`
`WO 99/38461
`
`PCT/EP99/00433
`
`15
`
`22.
`
`Intervertebral implant
`
`(10) according to one of the claims 1
`
`to 20, wherein
`
`the top and bottom surfaces
`
`(14,16) are curved
`
`surfaces which are contoured to mimic
`
`the
`
`end plates of the
`
`adjacent vertebrae.
`
`23.
`
`Intervertebral implant
`
`(10) according to one of the claims 1
`
`to 22, wherein the exterior surface of said implant has a uniform
`
`shape.
`
`24.
`
`Intervertebral implant
`
`(10)
`
`according to claim 23, wherein
`
`the exterior surface has an oval shape.
`
`25.
`
`Intervertebral implant
`
`(10)
`
`according to claim 23, wherein
`
`the exterior surface has a rectangular shape.
`
`26.
`
`Intervertebral implant
`
`(10) according to one of the claims 1
`
`to 25, wherein the annular plug includes an interior surface of a
`
`machined wall.
`
`27.
`
`Intervertebral implant
`
`(10) according to one of the claims 1
`
`to 26, wherein,
`
`the teeth have a saw tooth shape.
`
`
`
`- WO 99/38461
`
`PCT/EP99/00433
`
`1/2
`
`FIG.
`
`1
`
`FIG. 2
`
`12
`Q
`
`20
`
`16
`
`10
`12
`
`e
`
`18
`
`14
`
`
`FIG. S
`40
`14 yee
`“24
`
`12
`
`16
`
`22
`
`FIG. 6
`le
`fk
`
`60"
`
`SUBSTITUTE SHEET (RULE 26)
`
`
`
`~- WO 99/38461
`
`PCT/EP99/00433
`
`2/2
`
`
`
`SUBSTITUTE SHEET (RULE 26)
`
`
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