DePuy Synthes Products, Inc. & DePuy Synthes Sales, Inc.
`Exhibit 1010
`1 of 14
`
`
`Exhibit 1010
`1 of 14
`
`
`
`
`
`
`
`FRENCH REPUBLIC
`19.
`______
`
` NATIONAL INSTITUTE OF
` INTELLECTUAL PROPER-
`TY
`______
`
`PARIS
`12.
`
`
`
`22. Date of filing: 04/03/1996
`
`30. Priority:
`
`
`
`43. Date application made available to the public:
`10/10/1997 Bulletin 97/41
`
`
`
`73. Holder(s):
`
`
`56. List of documents cited in the preliminary
`search report: Refer to the end of this specifica-
`tion.
`
`
`
`74. Attorney(s): DE PASTORS ALICE
`
`
`
`60. References to other related national docu-
`ments:
`
`
`
`
`
`
`
`
`
`
`54. Intersomatic setting and fusion system
`
`
`57. Intersomatic vertebra setting and fusion system
`including at least one open internal cage for receiving
`the spongy bone and intended to be interposed be-
`tween two vertebrae during discectomy, character-
`ized in that said cage (1) includes on its anterior face
`(5) an external element forming a plate (12) extend-
`ing in a plane substantially perpendicular to the plane
`of insertion of the cage (1), on either side thereof,
`and having at each of its ends means for anchoring
`(13, 14) to at least two adjacent vertebrae to be se-
`cured to each other by means of the cage (1).
`
`The system can be separated into two parts: cage
`and plate.
`
`
`.
`
` FR 2 747 034– A1
`
`2 747 034
`
`
`
`96 04196
`
`
`A1
`
`
`11. Publication No.:
`(to be used only for
`ordering copies)
`
`
`
`21. National Registration No.:
`
`51.
`
`APPLICATION FOR PATENT
`
`Int Cl6: A 61 F 2/44; A 61 B 17/70
`
`
`71. Applicant(s): SCIENT’X LIMITED LIABILITY
`COMPANY – FR
`
`
`
`72. Inventor(s): ALBY ALBERT P and BENEZECH
`JACQUES
`
`DePuy Synthes Products, Inc. & DePuy Synthes Sales, Inc.
`Exhibit 1010
`2 of 14
`
`
`
`2747034
`
` 1
`
`
`
`
`INTERSOMATIC SETTING AND FUSION SYSTEM
`
`
`
`
`5
`
`10
`
`15
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`20
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`25
`
`30
`
`
`The present invention concerns an intersomatic vertebrae setting
`
`and fusion system including at least one open internal cage for receiving
`the spongy bone and intended to be interposed between two vertebrae dur-
`ing discectomy in order to be able to proceed with the installation of a
`bone graft or a material favoring inter somatic fusion which will favor the
`fusion of the two vertebrae concerned.
`
`Such cages are known, for example, from patent applications
`FR2703580, EP493698, EP599419, FR2124815, EP307241, EP615428.
`These cages are generally parallelepipedal or ovoid in shape. They
`are rigid, of metal or biocompatible material and are intended to receive
`the spongy bone by means of open upper and lower faces.
`Although cages of the aforementioned type generally give good re-
`sults, it nonetheless remains true that in some cases it is necessary to en-
`sure the positioning and “non- mobility” of the cage in order to ensur e
`protection from possible migration or avoid any risk of secondary move-
`ment of the cage.
`The invention seeks to achieve these objectives and for that purpose
`concerns an intersomatic vertebrae setting and fusion system including at
`least one open internal cage receiving the spongy bone or a bone substi-
`tute and intended to be interposed between two vertebrae during discec-
`tomy, characterized in that said cage includes on its anterior face an ex-
`ternal element forming a flange (plate) extending in a plane substantially
`perpendicular to the plane of insertion of the cage, on either side thereof,
`and
`
`
`
`
`
`
`DePuy Synthes Products, Inc. & DePuy Synthes Sales, Inc.
`Exhibit 1010
`3 of 14
`
`
`
`2747034
`
`
`
` 2
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`
`5
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`10
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`15
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`20
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`25
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`having at each of its ends means for anchoring to at least two adjacent
`vertebrae to be secured to each other.
`Said cage is rigid, made of metal or biocompatible plastic material,
`generally parallelepipedal in shape adapted to the intervertebral space and
`intended to receive the spongy bone or bone substitute material by means
`of its open upper and lower faces and/or by a frontal opening.
`Depending on need, the invention is achieved in the form of a one-
`piece cage- plate or in the form of an internal cage and an external plate,
`including means of assembling the plate to the cage.
`The present invention also concerns the characteristics that will be
`seen in the following description and which should be considered sepa-
`rately or in any of their possible technical combinations.
`This description provided by way of non- limiting example will al-
`low the invention to be better understood with reference to the appended
`drawings, in which:
`- figure 1 is an exploded view in perspective of a setting system ac-
`cording to a first embodiment of the invention;
`- figure 2 is an exploded view in perspective of a setting system ac-
`cording to a second embodiment of the invention;
`- figure 3 is a view of a single-part setting system.
`By way of a non- limiting example, the cage 1 represented in figure
`1 generally consists of a rigid parallelepiped, the lateral walls 2, 3, 4, 5 of
`
`
`
`
`
`
`DePuy Synthes Products, Inc. & DePuy Synthes Sales, Inc.
`Exhibit 1010
`4 of 14
`
`
`
`2747034
`
`
`
` 3
`
`
`
`
`which are intended to enclose the spongy bone or bone substitute, and the
`upper face 8 and lower face 9 of which are open towards two successive
`vertebrae.
`The anterior face 5 and posterior face 3 have specific heights in or-
`der to ensure preservation of an appropriate intervertebral space.
`Again according to the present example, the lateral walls 2 and 4 of
`the cage 1 are provided with wide openings 10 and 11 of a shape similar
`to those of the corresponding lateral walls 2 and 4 in which they are
`made.
`The cage 1 is thus provided with openings on four of its faces.
`Moreover, the cage 1 includes on its anterior face 5 an external element
`forming a flange 12 (hereinafter referred to as plate) extending in a plane
`substantially perpendicular to the plane of insertion of the cage 1, on ei-
`ther side thereof, and having at each of its ends means of anchoring 13
`and 14 to at least two adjacent vertebrae to be secured to each other by
`means of the cage 1.
`Of course, the external flange or plate 12 could be obtained as a
`single unit with the internal cage 1, for example by molding the cage-
`plate unit.
`Nevertheless, according to the present embodiment it was preferred
`to have a plate 12 and an internal cage 1 produced separately and subse-
`quently secured to each other by assembly means.
`Again according to the example of figure 1, said assembly means of
`the plate 12 onto the cage 1 consist of a cylindrical assembly pin 15 pro-
`vided on a vertical anterior face 5 of said cage and a peripheral groove 17
`made beneath the circular head 16 of said assembly pin 15, said head 16
`being capable of being inserted into a corresponding part of an enlarged
`zone 18 of an oblong buttonhole -shaped opening 19 made in the plate 12,
`
`
`4
`
`5
`
`10
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`15
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`20
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`25
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`30
`
`DePuy Synthes Products, Inc. & DePuy Synthes Sales, Inc.
`Exhibit 1010
`5 of 14
`
`
`
`
`
`2747034
`
`
`
`
`
`and said groove 17 being of a size so as to be able to slide between the
`lateral edges of a narrowed zone 20 of said buttonhole opening until the
`head 16 of the assembly pin 15 cooperates in axial locking with the outer
`face 21 of the plate 12.
`It can be anticipated that such engagement of the assembly pin in
`the buttonhole opening be done by force in the narrowed zone.
`Of course, the cage that has just been described above can have dif-
`ferent dimensions in terms of height, width and depth.
`It can also have, as in the following example, a preferred anatomi-
`cal shape.
`It can also be assumed that the placing of the spongy bone or other
`bone substitute will be done prior to or after positioning the cage 1 be-
`tween the vertebrae.
`The embodiment represented in figure 2 differs essentially from the
`preceding one in that the means of assembling the plate 12A onto the cage
`1A consist of a dovetail, the mortise 30 part of which is produced on the
`inner face 31 of the plate 12A in a vertically sliding direction and the cor-
`responding tenon 32 on the outer front face 5A of the cage 1A, or vice
`versa.
`It is noted that according to the present embodiment, the cage 1A
`no longer has lateral openings as in the preceding example.
`Indeed, the outer front face 5A of the cage 1A and the correspond-
`ing face 31 of the plate 12A with which it cooperates each include identi-
`cal oblong openings 33, 34 intended to be placed to coincide, during as-
`sembly of the plate 12A onto the cage 1A, in such a way as to allow for
`the insertion of the spongy bone from the front after installation of the
`cage 1A.
`
`
`
`
`
`5
`
`10
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`15
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`20
`
`25
`
`30
`
`DePuy Synthes Products, Inc. & DePuy Synthes Sales, Inc.
`Exhibit 1010
`6 of 14
`
`
`
`2747034
`
`
`
` 5
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`
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`
`
`5
`
`10
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`15
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`20
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`25
`
`It is also noted that the shape and particular profile of the cage 1A
`according to the example of figure 2 allow for a perfect adaptation to the
`intervertebral space.
`The embodiment represented in figure 3 differs from the example of
`figure 2 in that it is achieved by a single part.
`The anterior face 5A of the cage- plate includes an oblong opening
`33 so as to allow for the frontal insertion of the spongy bone into the cage
`part after installation of said cage-plate.
`In a manner common to the embodiments of figures 1, 2 and 3 that
`have just been cited, the means of anchoring the plate 12, 12A onto the
`vertebrae, after securing the cage 1, 1A, is achieved by means of pedicle
`screws (not shown) passing through corresponding holes 13, 14 made in
`the ends of said flange 12, 12A.
`According to another characteristic of the invention, it should be
`noted that the attachment holes 13, 14 of the plate 12, 12A are disposed
`on either side of a median vertical axis X, X' of the assembly, on a diago-
`nal Y, Y'.
`According to an embodiment not shown, the setting system can im-
`plement two or more internal cages 1, 1A, secured to each other, for three
`or more successive vertebrae by means of a plate 12, 12A having two as-
`sembly means 15, 18 or 30, 32 with said cages 1, 1A and two end attach-
`ment holes 13, 14 and an intermediate hole cooperating with three or more
`pedicle anchoring screws on the vertebrae.
`The plates are shown with one attachment screw per vertebra, but
`they can include more, two for example.
`
`
`
`
`DePuy Synthes Products, Inc. & DePuy Synthes Sales, Inc.
`Exhibit 1010
`7 of 14
`
`
`
`2747034
`
`
`
` 6
`
`
`
`
`
`It is obvious that the setting system can also consist of two or more
`cage-plate sets as defined in the examples of figures 1, 2 or 3 that are i n-
`terconnected by said plates, whether or not they are overlapping, two by
`two.
`
`The setting systems of the invention are produced from titanium al-
`loy or equivalent material, or of a biocompatible plastic material.
`
`
`
`5
`
`10
`
`DePuy Synthes Products, Inc. & DePuy Synthes Sales, Inc.
`Exhibit 1010
`8 of 14
`
`
`
`2747034
`
`
`
`
`
` 7
`
`
`
`5
`
`10
`
`15
`
`20
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`25
`
`30
`
`CLAIMS
`
`1 - Intersomatic vertebra setting and fusion system including at
`least one open internal cage for receiving the spongy bone and intended to
`be interposed between two vertebrae during discectomy, characterized in
`that said cage (1, 1A) includes on its anterior face (5, 5A) an external el-
`ement forming a plate (12, 12A) extending in a plane substantially per-
`pendicular to the plane of insertion of the cage (1, 1A), on either side
`thereof, and having at each of its ends means (13, 14) for anchoring to at
`least two adjacent vertebrae to be secured to each other by means of the
`cage (1, 1A).
`2 - System according to claim 1, characterized in that the external
`plate (12, 12A) is obtained by means of a single part with the internal
`cage (1, 1A).
`3 - System according to claim 2, characterized in that the outer
`front face (5A) of the cage-plate includes an oblong opening (33) to allow
`for the insertion of the spongy bone from the front after the installation of
`the cage- plate.
`4 - System according to claim 1, characterized in that the external
`plate (12) and the internal cage (1) are produced separately and joined to-
`gether subsequently by assembly means.
`5 - System according to claim 4, characterized in that the assembly
`means of the plate (12) onto the cage (1) consist of a cylindrical assembly
`pin (15) provided on a vertical anterior face (5) of said cage and a periph-
`eral groove (17) made beneath a circular head (16) of said assembly pin
`(15), said head (16) being capable of being inserted into a corresponding
`part of an enlarged zone (18) of an oblong buttonhole-shaped opening ( 19)
`
`
`
`
`
`
`DePuy Synthes Products, Inc. & DePuy Synthes Sales, Inc.
`Exhibit 1010
`9 of 14
`
`
`
`2747034
`
`
`
` 8
`
`
`
`
`
`5
`
`10
`
`15
`
`20
`
`25
`
`made in the plate ( 12), and said groove ( 17) being of a size so as to be
`able to slide between the lateral edges of a narrowed zone (20) of said
`buttonhole opening until the head (16) of the assembly pin ( 15) cooper-
`ates in axial locking with the outer face (21) of the plate ( 12).
`6 - System according to claim 5, characterized in that the internal
`cage (1) includes, in addition to the open upper face (8) and open lower
`face (9), lateral walls (2, 4) provided with openings (10, 11) for insertion
`of the spongy bone.
`7 - System according to claim 4, characterized in that the means of
`assembling the plate (12A) onto the cage (1A) consist of a dovetail, the
`mortise (30) part of which is produced on the inner face (31) of the plate
`(12A) in a vertically sliding direction and the corresponding tenon (32)
`part on the outer front face (5A) of the cage (1A), or vice versa.
`8 - System according to claim 7, characterized in that the outer
`front face (5A) of the cage (1A) and the corresponding face (31) of the
`plate (12A) with which it cooperates each include identical oblong open-
`ings (33, 34) intended to be placed to coincide, during assembly of the
`plate (12A) onto the cage (1A), in such a way as to allow for the insertion
`of the spongy bone from the front after installation of the cage (1A).
`9 - System according to any one of the preceding claims, character-
`ized in that the means of anchoring the plate (12, 12A) onto the vertebrae,
`after securing the cage (1, 1A), are achieved by means of pedicle screws
`(not shown) passing through corresponding holes (13, 14) made in the
`ends of said flange (12, 12A).
`
`
`
`
`
`DePuy Synthes Products, Inc. & DePuy Synthes Sales, Inc.
`Exhibit 1010
`10 of 14
`
`
`
`2747034
`
`
`
`
`
` 9
`
`
`
`5
`
`10
`
`10 - System according to claim 9, characterized in that the attach-
`ment holes (13, 14) of the plate (12, 12A) are disposed on either side of a
`median vertical axis (X, X') of the assembly, on a diagonal (Y, Y').
`11 - System according to any one of the preceding claims, charac-
`terized in that it implements two or more internal cages (1, 1A), secured
`to each other, for three or more successive vertebrae by means of a plate
`(12, 12A) having two assembly means (15, 18 or 30, 32) with said cages
`(1, 1A) and two end attachment holes (13, 14) and an intermediate hole
`cooperating with three or more pedicle anchoring screws on the vertebrae.
`
`
`
`DePuy Synthes Products, Inc. & DePuy Synthes Sales, Inc.
`Exhibit 1010
`11 of 14
`
`
`
`
`
`
`
`2747034
`
`
`
`
`
`
`
`DePuy Synthes Products, Inc. & DePuy Synthes Sales, Inc.
`Exhibit 1010
`12 of 14
`
`
`
`
`
`
`
`2747034
`
`
`
`
`
`
`
`DePuy Synthes Products, Inc. & DePuy Synthes Sales, Inc.
`Exhibit 1010
`13 of 14
`
`
`
`2747034
`
`National registration number
`
`FA 527760
`
`FR 9604196
`
`
`PRELIMINARY SEARCH REPORT
`prepared on the basis of the most recent claims
`filed before the search began
`
`
`
`FRENCH REPUBLIC
`
`NATIONAL INSTITUTE
`of
`INTELLECTUAL PROPERTY
`
` Y
`
`
`
` Y
`
`
`A
`
` A
`
`
`
` A
`
`
`
`
`
`CATEGORY OF DOCUMENTS CITED
`
`X: particularly pertinent in and of itself
`Y: particularly pertinent in combination with another docu-
`ment of the same category
`A : pertinent with respect to at least one general technological
`claim or background
`O: unwritten disclosure
`interim document
`P:
`
`EPO FORM 1503 03.82 (P04C13) 1
`
`
`
`Date of completion of search
`November 21, 1996
`
`Examiner
`Kanal, P
`
`
`
`T: theory or principal on which the invention is based
`E: prior patent document, but published on or after the date of
`filing
`D: cited in the application
`L: cited for other reasons
`&: member of the same family, corresponding document
`
`
`
`
`
`TECHNICAL DO-
`MAINS SEARCHED
`(Int. CL.6)
`
`A61f
`
`
`
`Claim(s) concerned of
`the application
`examined
`
` 1
`
` 1
`
`
`
`
`2,9
`
`1,2,9
`
`
`
`1,4,9,11
`
`
`
`1,2,4,9
`
`
`
`1,2,9
`
`
`DOCUMENTS CONSIDERED TO BE PERTINENT
`Category
`Citation of the document with indication, if needed,
`of the pertinent parts
`
`WO-A-95 08306 (SYNTHESES AG)
`* claims 1, 13; figures 3, 8 *
`- - -
`EP-A-0 179 695 (KEHR)
`* abstract; figures 1-4 *
`- - -
`EP-A-0 298 233 (GEBRÜDER SULZER AG)
`* abstract; figures *
`- - -
`US-A-4 599 086 (DOTY)
`* column 4, line 47 – line 58; figures 1, 7, 9 *
`- - -
`DE-A-43 02 397 (ASAHI KOGAKU KOGYO K.K.)
`* figures 1, 13 *
`- - -
`DE-U-88 07 485 (MECRON MEDIZINISCHE
`PRODUKTE GMBH)
`* figure 2 *
`- - - - -
`
` A
`
`
`
`
`
` A
`
`DePuy Synthes Products, Inc. & DePuy Synthes Sales, Inc.
`Exhibit 1010
`14 of 14
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