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`Europaisches Patentamt
`European Patent Office
`Office européen des bTEVEtS
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`Hllm
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`@ Publication number: 0 567 424 A1
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`@
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`EUROPEAN PATENT APPLICATION
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`@ Application number: 935000513
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`@ Int. Cl.5: A61F 2/44, A61B 17/60
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`@ Date of filing: 23.04.93
`
`® Inventor: Barbera Alacreu, José Vicente
`Joan Martorell 1, bajo
`E46010 Valencia (ES)
`
`Representative : Blumbach Weser Bergen
`Kramer Zwirner Hoffmann Patentanwalte
`Radeckestrasse 43
`D-81245 Miinchen (DE)
`
`Priority: 24.04.92 ES 9200869
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`Date of publication of application :
`27.10.93 Bulletin 93/43
`
`Designated Contracting StateS'
`g; BE CH DE DK FR GB GR IT LI LU MC NL PT
`
`@ Applicant : Bilbao Ortiz de Zarate, José Ramon
`Juan Martorell 1, bajo
`E-46010 Valencia (ES)
`
`® Applicant: Aparici Marin, José J.
`Juan Martorell 1, bajo
`E-46010 Valencia (ES)
`
`@ Applicant: Barbera Alacreu, José Vicente
`Juan Martorell 1, bajo
`E-46010 Valencia (ES)
`
`
`
`Vertebral prosthesis for the substitution of a vertebra in malignant tumour surgery.
`
`@ The tumour-affected vertebra is removed and
`the prosthesis (2) is inserted in the closed posi-
`tion, with the minimum height thereof. Thereaf-
`ter it
`is opened up until a sufficient height
`is
`obtained to restore the anatomical continuity of
`the column to make it capable of supporting the
`load and allow mobility of
`the patient. The
`prosthesis is made of steel and comprises three
`_
`parts, a centre part (4) and an upper and a lower
`Fig.8
`platform (5) and (6) which are moveable in
`opposite directions to extend the height of the ‘
`assembly, until
`they bite into the body of the
`neighbouring vertebra.
`surgery of
`in
`The
`invention is applicable
`malignant
`tumours of
`the dorsal and lumbar
`portions of the spinal column.
`
`
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`EP0567424A1
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`Jouve, 18, rue Saint-Denis, 75001 PARIS
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`NUVASIVE 1009
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`EP 0 567 424 A1
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`FIELD OF THE INVENTION
`
`The present invention relates to a process forthe
`substitution of a prosthesis for a vertebra in malignant
`tumour surgery and to a prosthesis forthe practice of
`said process, providing for the purpose to which it is
`directed various advantages which will be listed here-
`inafter, apart from others inherent in the organization
`and constitution thereof.
`
`BACKGROUND OF THE INVENTION
`
`It is known that the most appropriate technique
`and the one currently most used by spinal column sur-
`geons in the treatment of malignantvertebral tumours
`is anterolateral decompression, by resecting the af-
`fected vertebra. Therewith, further to freeing the spi-
`nal cord, the volume of the tumour is significantly re-
`duced, making it more accessible to post-operative
`radiotherapy and/or chemotherapy.
`But resection of the vertebra of necessity causes
`a maximum instability which must be corrected during
`the operation itself, although at a later stage, in a sec-
`ond session it may be desirable to complete the sta-
`bilization with posterior instrumentation.
`Stabilization involves a reconstruction of the ana-
`
`tomical continuity ofthe column, making it capable of
`supporting the load and allowing the patient freedom
`of movement, without complications such as pain, de-
`formity or new nerve compression deriving there-
`from.
`
`The methods currently used in surgery for verte-
`bral reconstruction are:
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`1) bone graft, associated with anterior instrumen-
`tation.
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`2) methyl methacrylate, associated with anterior
`instrumentation
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`3) vertebral prosthesis.
`In the particular case of vertebral prostheses,
`which is the field ofthe present invention, experimen-
`tal prostheses of very complex design are currently
`known for benign tumours of the cervical, thoracic
`and lumbar portions of the spinal column, but have
`not been used on human patients.
`
`SUMMARY OF THE INVENTION
`
`In the belief that fitting of a prosthesis should,
`theoretically, not suffer from any of the drawbacks of
`the current techniques, the present inventors have
`designed a process for fitting a vertebral prosthesis
`in the surgery of malign tumours of the dorsal and
`lumbar portions ofthe spinal column, as well as a ver-
`tebral prosthesis for the practice of the said process.
`The process contemplates, in the first place, re-
`moval of the vertebra, by way of an appropriate sur-
`gical technique and once the cavity for receiving the
`prosthesis has been prepared, the latter is inserted in
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`the closed position with a minimum height thereof.
`The prosthesis is held in position with the aid of ap-
`propriate clips and it is opened up with a spanner so
`as to achieve the necessary heightfor the prosthesis
`to bite at both the top and bottom ends into the field
`of the neighbouring vertebra. The system is locked in
`place by a plate which is attached by screws laterally
`to the next above and the next below vertebras, con-
`tributing to stabilization by preventing the antero—pos-
`terior translation, lateral rotation and twisting move-
`ments.
`
`The process of the invention offers the advantag-
`es that have been described above, apartfrom others
`that will be readily gathered from the more detailed
`description of an embodiment given hereinafter to fa-
`cilitate an understanding of the features mentioned
`above, while at the same time disclosing sundry de-
`tails. The specification is accompanied for this pur-
`pose by drawings in which, only as an example and
`not as a limitation of the scope of the invention, one
`embodiment of the subject matter is given.
`
`BRIEF DESCRIPTION OF THE DRAWINGS
`
`In the drawings:
`Figure 1 shows the prosthesis in closed position.
`Figure 2 shows the prosthesis assembly in the
`extended state;
`Figure 3 is an elevation view of the external hex-
`agonal body forming part of the prosthesis as-
`sembly;
`Figure 4 shows threaded cylinders forming part
`of the prosthesis assembly;
`Figure 5 is a view of one of the cylinders, seen
`from "A";
`Figure 6 is a view of the said cylinder, seen from
`"Bu;
`Figures 7, 8, 9, 10 and 11 show the different suc-
`cessive steps of the surgical process.
`
`DESCRIPTION OF ONE EMBODIMENT OF THE
`INVENTION
`
`As shown in the drawings, the process comprises
`a first step in which the tumorous vertebra 1 (Figure
`7) is removed; the prosthesis, generally indicated at
`2, is inserted in a second step, in the closed state,
`with the minimum height thereof (Figure 8); the pros-
`thesis 2 is opened out in a third step with appropriate
`tools, so that the moving components thereof may
`move apartand bite into the body ofthe neighbouring
`vertebra, as shown in Figure 9, corresponding to a
`side view, and Figure 10, corresponding to an ante-
`roposteriorview. In a fourth step, the system is locked
`in place by way of a plate 3 which is screwed laterally
`into the upper and lower vertebras and compressed,
`as shown in figures 11 and 12, corresponding to side
`and antero-posterior views.
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`EP 0 567 424 A1
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`tive position with the aid of appropriate clips; there-
`after the prosthesis is opened up with aid of an ap-
`propriate spanner allowing a centre component of
`said prosthesis to be rotated, which rotation causes
`the outward movement relative to the said compo-
`nent of further axially movable components capable
`of moving in opposite directions until the necessary
`height is obtained for the said moving components to
`bite above and below into the body of the neighbour-
`ing vertebra; to be followed thereafter by locking of
`the moving components relative to the centre compo-
`nent of the prosthesis to prevent further movement;
`and in that in a final step there is added a plate con-
`tributing to stabilize the system to prevent anteropos-
`terior translation movements,
`lateral rotations and
`twisting, which plate is screwed laterally into the ver-
`tebra above and below and into the centre component
`of the prosthesis.
`2.- A process for the substitution of a prosthesis
`for a vertebra in malignant tumour surgery and a pros-
`thesis for the practice of said process, according to
`claim 1, characterized in that the prosthesis is formed
`by a centre component with which there are associ-
`ated a further two components formed with upper
`and lower platforms and in that the said centre com-
`ponent is formed by an internally threaded tubular
`body member which is externally configured as a cy-
`linder at the two ends, with an hexagonal waist, while
`the said platforms comprise two parts, one of which
`is a flat peripheral sheet having a roughened sheet on
`the outer surface thereof, the other part being a lower
`hollow cylinder having an external screw thread for
`screwing into the centre body member, said threads
`being formed in such a way that rotation of the centre
`body member causes an axial movement ofthe cylin-
`ders carrying the platforms outwardly, lengthening
`the height ofthe prosthesis.
`3.- A process for the substitution of a prosthesis
`for a vertebra in malignant tumour surgery and a pros-
`thesis for the practice of said process, according to
`claims 1 and 2, characterized in that the prosthesis
`is provided at both ends of the centre body member
`with small transverse threaded through holes for the
`screwing of appropriate screws which bear against
`the threads of the platform cylinders,
`locking the
`movement thereof, to set the height of the prosthesis
`assembly.
`
`The prosthesis 2, used for the practice of the
`process described, is made from steel and consists of
`three portions: a centre body member 4 and upper
`and lower platforms 5 and 6.
`The centre body member 4 is a hollow tube hav-
`ing an internal thread 7. It is cylindrical on the outside
`at both ends and has a hexagonal waist in the middle.
`Each platform 5 and 6 consists of two parts: a
`peripheral flat plate 8 having a roughened sheet 9 at-
`tached to the outer surface thereof; and a lower hol-
`low cylinder 10, provided with a thread 11 on the out-
`side thereof, which screws into the inside of the cen-
`tre body member.
`The internal thread 7 of the centre body member
`4 and the external threads 11 of the cylinders 10 of
`the respective platforms 5 and 6 are made in such as
`way that when the centre body member 4 is rotated
`clockwise with a hexagonal spanner, the two cylin-
`ders 10 of the platforms simultaneously move axially
`outwards, thereby extending the height of the assem-
`bly. When the centre body member is rotated in the
`opposite direction, the cylinders retractsimultaneous-
`ly into the body member4, shortening the total height.
`The centre body member 4 is provided with four
`small threaded holes 12 at each end. After rotating
`the centre body member in the desired direction, to
`set the desired height of the prosthesis assembly 2,
`two small Allen screws are screwed up, one in each
`of the small holes of the centre body member. In this
`way, the Allen screws bear against the thread 11 of
`the cylinders 10 of the platforms 5 and 6 and lock
`them against further movement.
`A plate 3, provided with countersunk self-
`compression holes 13 for spongiosa screws 14 and a
`normal centre hole 15 for the bolt 16 which passes
`through the diametral threaded holes 17 ofthe centre
`body member 4 in combination with a nut 18, is at-
`tached to the prosthesis.
`The centre body member 4 is provided with
`grooves 19 facilitating the seating of the end of a
`small chisel with a view to rotating the prosthesis
`body member on the cylinders 10. The said body
`member 4 is manipulated with the aid of a spanner,
`not shown, having wide jaws to take in almost the
`whole length of the body member 4, facilitating the
`screwing thereof on the upper and lower cylinders.
`
`Claims
`
`1.- A process for the substitution of a prosthesis
`fora vertebra in malignant tumour surgery and a pros-
`thesis for the practice of said process, characterized
`essentially in that it comprises a first step in which the
`tumour-affected vertebra is removed so that once the
`
`cavity for receiving the prosthesis has been pre-
`pared, the latter is inserted in the closed position with
`a minimum height thereof, it being held in the opera-
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`EP 0 567 424 A1
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`EP 0 567 424 A1
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`EP 0 567 424 A1
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`0’) European Patent
`
`Olfice
`
`PARTIAL EUROPEAN SEARCH REPORT
`
`which under Rule 45 of the European Patent Convention
`shall he considered, for the purposes of subsequent
`proceedings, as the European search report
`
`ApplicationNumber
`
`93 50 0051
`EP
`Page 1
`
`,,
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`pocuwi Ems CONSII)ERED TO BE RELEVANT
`
`CLASSIFICATION OF THE
`
`APPLICATION (Int Cl. 5)
`Catcgorfl
`Citation of doctrlmclnt with indication, where appropriate,
`Relelvant
`_‘
`0 re cvnnt passages
`toil: aim
`X
`GB-A-Z 083 754 (REZAIAN)
`2,3
`* page 1,
`line 65 - line 105; figures *
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`A61F2/44
`A6lBl7/60
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`
`X
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`X
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`X
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`X
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`A
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`A
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`A
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`DE-U-9 112 176 (HOWMEDICA)
`* page 7,
`line 4 - page 9,
`figures *
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`line 23;
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`DE-U-9 107 494 (WEBER)
`* page 3,
`line 12 - page 4,
`claims; figures *
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`line 32;
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`EP-A-0 188 954 (DEHER)
`* page 4,
`line 20 - page 6,
`figures *
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`line 32;
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`US-A-4 553 273 (WU)
`* the whole document *
`
`EP-A-0 179 695 (KEHR)
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`DE-A-3 023 942 (WALDEMAR)
`___
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`US-A-4 932 975 (MAIN ET AL.)
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`'/"
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`INCOMPLETE SEARCH
`
`‘
`
`'l'he SearchTiEision considers that the preselit Europifin patent application does not comply with
`the provisions ot the European Patent Convention to such an extent that it is not possible to any
`out a meaningful search into the slate of the an on the basis of some of the claims
`Claims searched completely :
`Claims searched incompletely :
`Claims not searched :
`Rason tor the limitation of the search:
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`see sheet C
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`
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`TECHNKMLFELDS
`SEARCHED (Int. Cl, 5)
`
`
`A61F
`A613
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`
`7
`7 M7 Plate of search
`Date of ounplellou ol’ the search
`Exmaer 77777
`THE HAGUE
`27 JULY 1993
`SANCHEZ Y SANCHEZ J.
`
`I
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`T : theory or principle underlying the invention W
`CATEGORY OI" (1” El) I)0(,TLMl-Jl\ I'S
`E : earlier patent document, but published on, or
`after the filing date
`X : particularly relevant It taken alone
`D : document cited in the application
`Y : particularly relevant if combined with another
`L : document cited for other rusons
`document of the same category
`.....................................................................................................
`A : technological background
`0 : non-written disclosure
`& : member of the same patent family, corresponding
`P : intermediate document
`document
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`EPOFORM150303.82lPDflEO’l)
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`EP 0 567 424 A1
`
`PARTIAL EUROPEAN SEARCH REPORT
`
`Applicalian Number
`
`a)
`
`European Patent
`()flicc
`
`DOCUMENTS CONSIDERED TO BE RELEVANLT
`Relevant
`Citation of document with indication, where appropriate,
`Category
`to claim
`
`of relevant pmaga
`
`
`
`93 50 0051
`EP
`Page 2
`CLASSIFICATION OF THE
`APPLICATION (Int. Cl. 5)
`
`T 'I'ECIINICAI. FIELDS
`SEARCHED (Int. Cl. 5)
`
`
`
`
`A
`
`FR-A-Z 636 227 (SOCIETE DE FABRICATION DE
`MATERIEL ORTHOPEDIQUE)
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`##7##," ,,
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`10
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`EPOFOR!“150303.52[PMEIOI
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`10
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`EP 0 567 424 A1
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`EP 93 50 0051
`
`_C_
`
`INCOMPLETE SEARCH
`
`Claims searched incompletely:
`Claim not searched:
`1
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`2,3 (only the prosthesis)
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`11
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`11
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`11
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`