PCT
`INTERNATIONAL APPLICATION PUBLISHED UNDER THE PATENT COOPERATION TREATY (PCT)
`
`WORLD INTELLECTUAL PROPERTY ORGANIZATION
`International Bureau
`
`(51) International Patent Oassification 5 :
`
`(11) International Publication Number:
`
`WO 93/25157
`
`A61B 17/56
`
`Al
`
`(43) International Pllblication Date:
`
`23 December 1993 (23.12.93)
`
`(21) International Application Number:
`
`PCT/EP93/0l540
`
`(22) International Filing Date:
`
`17 June 1993 (l 7.06.93)
`
`(81) Designated States: CA, DE, US, European patent (AT,
`BE, CH, DE, DK. ES, FR, GB, GR, IE, IT, LU, MC,
`NL, PT, SE).
`
`Published
`With international search report.
`Before the expiration of the time limit for amending the
`claims and to be republished in the event of the receipt of
`amendments.
`
`(30) Priority data:
`p 42 19 939.5
`
`18 June 1992 (18.06.92)
`
`DE
`
`(71)(72) Applicant and Inventor: RADERMACHER, Klaus
`[DE/DE]; Ludwigsallee 21, D-5100 Aachen (DE).
`
`(72) Inventors; and
`(75) Inventors/Applicants (for US only) : RAU, Gunter [DE/
`DE]; Fuchserde 50, D-5100 Aachen (DE). STAUDTE,
`Hans-Walter [DE/DE]; Neue Furth 28, D-5102 Wiirsel(cid:173)
`en (DE).
`
`(74)Agents: HILLERINGMANN, Jochen et al.; Deichmann(cid:173)
`haus am Hauptbahnhof, D-5000 KOln I (DE).
`
`(54)Title: TEMPLATE FOR TREATMENT TOOLS AND METHOD FOR THE TREATMENT OF OSSEOUS STRUC(cid:173)
`TURES
`
`(57) Abstract
`
`Of an osseous structure to be treated, a reconstruction is pro(cid:173)
`duced. On the basis of the contact points of this reconstruction, abut(cid:173)
`ment points are defined for a template for guidance, alignment and
`positioning of a treatment tool. The contact points are defined in such
`a manner that the template can be mounted on the osseous structure
`in form-closed manner in exactly one spatially uniquely defined posi(cid:173)
`tion. On such a template, the treatment tool is fastened and guided in
`such a manner that the treatment of the osseous structure can be per(cid:173)
`formed corresponding to the previous planning of the surgical inter(cid:173)
`vention.
`
`Patient
`
`Sava, drill•, millin9
`devices guided and
`positioned in well-de(cid:173)
`fined manner according to
`the surgical planning
`
`TC1109raphic imaqea
`(CT, MR, ••• )
`
`(
`
`Surgical intervention
`
`)
`
`( ~qe processing,
`l3D reconstruction
`
`\,:'~
`
`I
`
`'~
`
`Individual templates
`
`!
`
`Visualization,
`aurqical planning,
`CAD
`
`(
`
`CNC manufacture
`
`'.----
`
`)
`
`( Individual proethe•i• ;,_.-_
`
`___.
`
`)
`
`)
`
`J
`
`-i-
`
`Smith & Nephew Ex. 1003
`IPR Petition - USP 9,295,482
`
`

`
`FOR THE PURPOSES OF INFORMATION ONLY
`
`Codes used to identify States pany to the PCT on the front pages of pamphlets publishing international
`applications under the PCT.
`
`AT
`AU
`BB
`BE
`BF
`BG
`BJ
`BR
`CA
`CF
`CG
`CH
`Cl
`CM
`cs
`CZ
`OE
`OK
`ES
`Fl
`
`Au~tria
`Australia
`l:larhados
`Belgium
`l:lurkina l'aso
`Bulgaria
`Benin
`Hra,.il
`Canada
`Central African Rcpuhlic
`Congo
`Swi~erland
`C 'otc d 'lvuire
`("iLHUCf()Oll
`( .·:1.cchosluvak iJ
`C:zcch Repuhlil
`(jcrmJn)'
`Dcnm\lrk
`Spain
`Finland
`
`FR
`GA
`GB
`GN
`GR
`HU
`IE
`IT
`JP
`KP
`
`KR
`KZ
`I.I
`I.I\
`1.lJ
`MC
`MG
`Ml.
`MN
`
`...-raru.:c
`Gabon
`United Kingdom
`Guinea
`Greece
`Hungary
`Ireland
`Italy
`Japm1
`Democratic People'> Repuhlic
`of Korea
`Repuhlic of Korea
`K;l1.al..hst01n
`l.icchtcnstcin
`Sri I .m~a
`I .u>-.cmhourg
`Mu11aco
`Mildaga!\Car -
`M;ili
`Mongolia
`
`MR
`MW
`NL
`NO
`NZ
`PL
`PT
`RO
`RU
`SU
`SE
`SK
`SN
`SU
`TO
`TG
`lJA
`lJS
`VN
`
`MauriLania
`Malawi
`Netherlands
`Norway
`New Zealand
`Poland
`Portugal
`Romania
`Rus:-.iun Fc<lcrntion
`Sudan
`Sweden
`Slovak Repuhlk
`Senegal
`Soviet Union
`Chad
`Togo
`Ukraine
`UniLcd SWLc:-. uf Amcrh.:(i
`Viel Nam
`
`,
`
`-ii-
`
`

`
`WO 93/25157
`
`PCT/EP93/01540
`
`•
`
`Template for treatment tools and method for the
`treatment of osseous structures
`
`The invention is directed to a template for treat(cid:173)
`ment tools for the treatment of osseous structures
`and a method for the definition and reproduction of
`the positional relationship of a treatment tool rel(cid:173)
`ative to an osseous structure.
`
`Using image producing methods such as computertomo(cid:173)
`graphy and computer-based image-processing systems,
`it is possible to record osseous structures of the
`living organism in slices by a non-invasive tech(cid:173)
`nique, to reconstruct them three-dimensionally and
`to visualize them through an output medium. Further,
`such systems frequently permit already a three-di(cid:173)
`mensional planning of surgical interventions with
`regard to incisions, drilling, puncture, positioning
`of individual implants or other surgical interven(cid:173)
`tions~ Intraoperatively, i.e. during the actual sur-
`
`-1-
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`1
`
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`
`gical procedure, there often occur orientation prob(cid:173)
`lems because no adequate technical means exist for a
`consequent, exact three-dimensional transfer of the
`steps of the intervention which have been planned
`with a waste of technical support. Therefore, the
`accuracy of execution depends exclusively on the
`experience, the three-dimensional perceptivity and
`the technical skill of the surgeon, which, depending
`on the type and the anatomical site of the interven(cid:173)
`tion can involve extreme risks even with experienced
`surgeons. Generally, only freehand-guided instru(cid:173)
`ments, two-dimensional tomographic images and pre(cid:173)
`or intraoperative X-ray images are available.
`
`For some interventions, standard tool guides have
`been provided. These are mostly cutting, boring or
`sinking templates for preparing and/or fixing the
`seat of a knee or hip joint prosthesis (as e.g. US
`4,567,885, us 4,703,751, us 4,822,362, us 4,721,104,
`DE-33 39 259, EP 380 451, EP 415 837, EP 231 885, EP
`228 339, DE 39 25 488, DE 79 14 280) or for reposi(cid:173)
`tioning osteotomies in the region of the proximal
`head of the femur or tibia (e.g. US 4,565,191, DE
`38 42 645, DE 32 11 153). The intraoperative posi(cid:173)
`tioning of these templates relative to the bone is
`performed free-handed and even in case of special
`solutions allowing limited adaptation to the anatom(cid:173)
`ical conditions, as e.g.
`in US 4,846,161, DE
`34 47 163 or DE 40 16 704, can generally not be car(cid:173)
`ried out exactly and clearly according to the plan(cid:173)
`ning of the intervention. In some approaches, intra(cid:173)
`operative measurement and positioning under X-ray
`control are provided. This causes an increased expo-
`
`-2-
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`WO 93/25157
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`
`sure to radiation for the patient and the medical
`staff, prolongs the duration of the surgical inter(cid:173)
`vention and again is just an indirect and not clear(cid:173)
`ly defined transfer of the treatment strategy de(cid:173)
`fined in the surgical planning.
`
`There also exist devices for stereotactical inter(cid:173)
`ventions. Principally, these devices can be divided
`into two categories. The first category comprises
`devices which, designed as rigid frames, are attach(cid:173)
`ed directly (e.g. by screws) on/in the bone and are
`adapted for rigid mechanical coupling
`a posi(cid:173)
`tioning or coordinate measuring syste:· , with the
`reference points c;{' said devices being re:. reduced in
`a tomographic image (e.g. stereotaxic apparatuses as
`described in Riechert et al.: Beschreibung und An(cid:173)
`wendung eines Zielgerates flir stereotaktische Hirn(cid:173)
`operationen, Acta neurochir., Vienna, Austria,
`Suppl. III (1955), 308; and in DE 37 17 871, DE
`39 02 249 and EP 312 568). The second category com(cid:173)
`prises methods wherein individual reference bodies
`(marking elements, at least three of them) are fixed
`in or on the bone or the overlying skin surface al(cid:173)
`ready prior to tomographic scanning of the respec(cid:173)
`tive part of the body and subsequently are imaged in
`the tomographic pictures. These reference bodies und
`markers are then detected, as to their position and
`orientation, through a mechanically rigid construc(cid:173)
`tion or 3D coordinate measurement and evaluation for
`detection of the transformation relation between the
`coordinate systems of the bone structure, the tomo(cid:173)
`graphic images and the environment (Adams et al.: A
`navigation support for surgery. In: Hohne et al.:
`
`-3-
`
`

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`
`3D-Imaging in Medicine. Nato ASI Series F.; Computer
`and System Science Vol. 60, Springer, 1990; Kosugi
`et al.: An articulated neurosurgical navigation sys(cid:173)
`tem using MRI and CT images. IEEE Transactions on
`Biomedical Engineering, Vol. 35, No. 2, Feb.1988).
`
`Since the relative position of the reference bodies
`or points relative to the osseous structures is
`known or can be obtained from the tomographic imag(cid:173)
`es, it is possible to use a 3D coordinate measuring
`or adjusting device, coupled to these reference bod(cid:173)
`ies (or points) fixedly or through defined transfor(cid:173)
`mation re~ationships, for the positioning of coordi(cid:173)
`nate measurement pins or guide devices for punctur(cid:173)
`ing cannulae and drills.
`
`Generally, these methods suffer from the following
`disadvantages:
`
`The reference bodies (markings, frames, other
`devices) can be fixed on the skin surface only
`in special cases (in the skull region or in the
`region of palpable sites on osseous structures),
`and even there only with restricted accuracy.
`
`A fixing directly on or in the osseous tissue
`requires that the patient has to undergo an ad(cid:173)
`ditional surgical intervention.
`
`(and possibly the whole
`The reference bodies
`rigid device) must remain fixed to the patient
`in an unchanged position from the time of image
`pick-up to the surgical intervention. In case of
`
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`WO 93/25157
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`a non-rigid or non-physical connection, time(cid:173)
`consuming (and again failure-prone) intraopera(cid:173)
`tive measuring and aligning work has to be per(cid:173)
`formed.
`
`Generally, application is restricted to inter(cid:173)
`ventions in the region of easily accessible os(cid:173)
`seous structures and thus is normally unsuited
`for orthopedic surgery.
`
`In the skull region, the systems described by Adams
`et al. and Kosugi et al. are suitable only with lim(cid:173)
`ited accuracy as freehand-guided intraoperative 3D
`position measuring devices for navigational purpos(cid:173)
`es. These systems rely on ~rtificial reference mark(cid:173)
`ers on the skin surface. (Natural landmarks normally
`cannot be unambiguously
`identified as
`reference
`points, neither in the tomographic image nor in the
`site of the operation) No possibilities exist for
`the planning and storing of orthopedic interventions
`and,
`further,
`only
`freehand-guided measurement
`probes are available). Thus, these systems cannot be
`employed as suitable devices in orthopedic bone sur(cid:173)
`gery.
`
`To sum up, it is to be noted that, presently, only
`relatively primitive
`intraoperative devices are
`available
`for
`a
`consequent
`transfer
`of
`an
`individually planned orthopedic-surgical interven(cid:173)
`tion in osseous structures. Consequently, an indi(cid:173)
`vidually adapted hip-joint endoprosthesis,
`to be
`implanted without cement, is rendered absurd by a
`freehand-guided cutting in the intraoperative prepa-
`
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`
`ration of the seat of the prosthesis. The technology
`of bone treatment has been lagging behind the tech(cid:173)
`nology of implant manufacture. This has resulted in
`imprecise preparations of the seat of prostheses
`with point-shaped force transmission and movement
`between bone and prosthesis. The same applies to
`individually
`planned
`repositioning
`osteotomies
`(being nonetheless relatively uncritical
`in
`the
`region of tibia and femur). For some considerably
`more complicated and critical interventions, e.g. in
`the region of the spinal column and the pelvis),
`there are no orientation and positioning devices
`available at all.
`
`Further, efforts are being made to make use of robot
`technology for thus obtaining improved devices for
`faster, more accurate and less burdensome interven(cid:173)
`tions also in the region of osseous structures.
`
`Most of the known methods work after the above out(cid:173)
`lined reference body principle with preoperative
`image acquisition and are principally impaired by
`the above mentioned disadvantages. The endeffector
`is moved and positioned by a robot or manipulator
`(cf. e.g. Kwoh et al.: A robot with improved abso(cid:173)
`lute positioning accuracy for CT-guided stereotactic
`brain surgery. IEEE Transactions on Biomedical Engi(cid:173)
`neering, Vol. 35, No. 2, Feb. 1988; Taylor et al.:
`Robot total hip replacement surgery in dogs.
`IEEE
`Engineering in Medicine & Biology Society 11th annu(cid:173)
`al international conference 1989, pp. 887-889; Rein(cid:173)
`hardt et al.: Robotik filr Hirnoperationen, Polyscope
`plus No. 6, pp. 1, 5-6).
`
`-6-
`
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`
`Some methods are executed with intraoperative image
`acquisition (particularly biplanar X-ray projection
`images) and suitable targeting and calibrating de(cid:173)
`vices which appear in the image. By use of the known
`relationship between the targeting device and the
`robot (the targeting device being fixed e.g. in the
`robot gripper) and the relationship
`- defined by
`intraoperative X-ray images -
`between the targeting
`device and the X-rayed part of the body (the "ob(cid:173)
`ject", as e.g. an osseous structure), it becomes
`possible to transform positioning processes or move(cid:173)
`ments, having been defined in the coordinate system
`fixed to the object, into movements or positional
`vectors in the basic coordinate system of the robot
`(cf. e.g. Lavallee: A new system for computer as(cid:173)
`sisted neurosurgery. IEEE Engineering in Medicine &
`Biology Society 11th annual international conference
`1989, pp. 887-889; Jakobi et al.: Diagnosegesteuerte
`Therapierobotertechnik - medizinische und biomedi(cid:173)
`zinische Aspekte, Z. Klin. Med. 45 Vol. 6, 1990, pp.
`515-519).
`
`In the region of soft tissues, the principal system(cid:173)
`atics of a fixedly defined spatial relationship be(cid:173)
`tween the image acquisition device and the position(cid:173)
`ing device for the endef f ector has already become
`established in two cases (extracorporal shock wave
`lithotripsy, i.e. ultrasonic tomographic imaging or
`bipolar X-ray imaging with selection of the intra(cid:173)
`corporal target point in the image and semiautomatic
`positioning of the shock wave focus; mammabiopsy,
`i.e. bipolar X-ray imaging with identification of
`the target point in the image and semiautomatic po-
`
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`
`the biopsy cannula). No comparable
`sitioning of
`techniques are known in the field of orthopedic sur(cid:173)
`gery of osseous structures.
`
`In a further approach, it is tried to accomplish the
`identification and positional detection of osseous
`structures in orthopedic interventions by optical
`pattern detection and then, using a robot, to dis(cid:173)
`play cutting paths by a laser beam, to position tool
`guiding devices, to perform work on the bone direct(cid:173)
`ly etc. (Prasch: Computergestlitzte Planung von chir(cid:173)
`urgischen Eingriffen in der Orthopadie, Springer
`Verlag 1990). To this purpose, contours of the re(cid:173)
`spective osseous structure which have been detected
`with the aid of a computer in biplanar intraopera(cid:173)
`tive X-ray projection images, are compared to and,
`as far as possible, made congruent with 30-CAD mod(cid:173)
`els of this structure which have been reconstructed
`from tomographic images and stored in the computer.
`If the orientation of the basic coordinate system of
`the robot and that of the X-ray device relative to
`each other are known, the robot can be moved accord(cid:173)
`ing to its programming made corresponding to the 30
`model in the CAD system. In the above mentioned pub(cid:173)
`lication, repositioning osteotomy is mentioned as an
`exemplary application. This system has not been re(cid:173)
`alized yet.
`
`In conclusion, it is to be stated that none of the
`above mentioned robot systems is suited for routine
`use in the field of orthopedic surgery of osseous
`structures. Systems which demand intraoperative X(cid:173)
`ray images are disadvantageous for the above rea-
`
`-8-
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`9
`
`sons. Due to the inherent technical (including also
`safety measures), organizational and economic neces(cid:173)
`sities, the use of robots has to be limited to sur(cid:173)
`gical interventions which require spatially complex
`treatment movements which can be carried out only
`via narrow access openings, or to interventions
`which for some other medical or surgical reasons
`cannot or not efficiently be performed without the
`aid of manipulators and robots.
`(The much-quoted
`repositioning osteotomy in the femur or tibia region
`does not count among these).
`
`It is an object of the invention to allow a treat(cid:173)
`ment of osseous structures for any desired orthope(cid:173)
`dic interventions (i.e. also complex and possible
`novel interventions) which is safe, fast, exact and
`is defined according to the surgical planning. The
`term "treatment" is understood to comprise not only
`the treatment of an osseous structure by suitable
`tools (cutting, boring, milling device) but also
`other forms of treatment such as e.g. invasive mea(cid:173)
`suring and scanning of osseous structures by corre(cid:173)
`sponding measuring devices.
`
`For solving the above object, there are proposed, in
`accordance with the invention, a method according to
`claim 1 and a template according to claim 3 which is
`preferably produced according to claim 5.
`
`By the invention, intraoperative measuring and posi(cid:173)
`tioning periods shall be minimized by shifting them
`into the preoperative planning phase and working
`steps requiring X-ray imaging shall generally be
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`rendered unnecessary. For complex surgical interven(cid:173)
`tions, quick and easy intraoperative access to a ma(cid:173)
`nipulator or robot as a tool for assistance in the
`surgical intervention shall be made possible.
`
`According to the invention, the central functional
`element is a so-called individual template by which
`parts of the surface of an arbitrary osseous struc(cid:173)
`ture which is to be treated and is intraoperatively
`accessible to the surgeon, are copied as a negative
`image without undercut and in a mechanically rigid
`manner, so that the individual template can be set
`onto the osseous structure in a clearly defined po(cid:173)
`sition and with mating~engagement.
`
`According to the inventive method, there is used a
`split-field device (e.g. a computer or a nuclear
`spin tomograph) by which split images are produced
`of the layers extending through the body of the liv(cid:173)
`ing organism and containing the osseous structure,
`and from these split images, data regarding the
`three-dimensional shape of the osseous structure and
`the surface thereof are obtained. In the preopera(cid:173)
`tive planning phase, these data are used as a basis
`for defining, within the coordinate system fixedly
`positioned relative to the osseous structure, a rig(cid:173)
`id individual template which, completely or by seg(cid:173)
`ments (but at least by three intraoperatively clear(cid:173)
`ly identifiable abutting points), copies the surface
`of the osseous structure in such a manner that the
`individual template can be intraoperatively set onto
`these
`-
`then freely exposed -
`contact faces or
`points in exclusively one clearly defined position
`
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`in form-closed manner. Thus, when mounting the indi(cid:173)
`vidual template, an individual abutting behavior is
`observed in all six spatial degrees of freedom.
`Therefore, quick and reliable identification and
`detection of position is possible intraoperatively.
`In the invention, the inter- and intra-individual
`variants of the shape of osseous structures, which
`pose a problem in other systems, guarantee a safe
`and clear intraoperative identification and detec(cid:173)
`tion of position.
`
`Further, the invention is characterized in that the
`cutting, boring, milling and other treatment steps
`which in the preoperative surgical planning phase
`are three-dimensionally charted in said coordinate
`system fixed relative to the osseous structure, can
`be clearly defined in or on the individual template
`in form of guide means or reference or flange en(cid:173)
`gagement points for standardized tool guides, which
`can be performed directly in or on the template body
`relative to the bone. Intraoperatively, this situa(cid:173)
`tion, which in surgical planning is precisely de(cid:173)
`fined in three dimensions and simulated, is realized
`by simply setting the individual template onto the
`exposed surface of the bone. Time-consuming measur(cid:173)
`ing and aligning work is thus shifted into the pre(cid:173)
`operative phase. Working steps which involve intra(cid:173)
`operative X-ray control can be omitted.
`
`Using the template of the invention allows a treat(cid:173)
`ment of osseous structures for any orthopedic inter(cid:173)
`vention (i.e. also complex and possible novel inter(cid:173)
`ventions) which is carried out in a safe, fast and
`
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`
`precise manner and is defined according to the sur(cid:173)
`gical planning while it is not necessary anymore to
`intraoperatively check the orientation of the treat(cid:173)
`ment tool. Intraoperative measuring and positioning
`periods are minimized by being shifted into the pre(cid:173)
`operative planning phase and working steps requiring
`X-ray imaging have become unnecessary. For complex
`surgical interventions, a possibility is created for
`quick and easy intraoperative access to a manipula(cid:173)
`tor or robot employed as an auxiliary tool in the
`surgical intervention.
`
`The invention comprises the following features and
`characteristics:
`
`1. By 3D reconstruction of a tomographically imaged
`object, particularly of the osseous structures
`of a living human, and by visualizing this re(cid:173)
`construction on an output medium, particular~y a
`computer monitor, and particularly by using a
`computer system or a computer-based display and
`construction system, there is generated a three(cid:173)
`dimensional negative mold of parts of the indi(cid:173)
`vidual natural (i.e. not pre-treated) surface of
`the osseous structure intraoperatively accessed
`by the surgeon.
`
`2. The above negative mold can reproduce a cohesive
`region or a plurality of geometrically non-abut(cid:173)
`ting partial segments of a bone surface and is
`constructed in a cohesive, mechanically rigid
`basic body (the individual template). The over(cid:173)
`all geometry of the basic body is also adapted
`
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`to the spatial conditions of the surgical access
`so that it will not overlap with any structure.
`
`3. By use of the computer-based representation of
`the three-dimensional reconstruction of the os(cid:173)
`seous structure, the treatment of the bone can
`be planned. For this treatment, any suitable
`tool guides, particularly drill sleeves, paral(cid:173)
`lel guides, saw templates, 20- and 30-profiling
`milling devices can be provided. These tool
`guides, connecting elements, surfaces or points
`can be provided in/on the basic body of the in(cid:173)
`dividual template, which relative to the 3D re(cid:173)
`construction of the osseous structure are ori(cid:173)
`ented or constructed in such a manner that the
`tool guides, which here
`can be
`coupled
`(releasably or non-releasably) in a mechanically
`rigid manner, will effect a
`three-dimensional
`guiding of the treatment tools or measuring de(cid:173)
`vices exactly as provided by the surgical plan(cid:173)
`ning.
`
`4. According to the course of procedure described
`above under item 3, also the basic body of the
`individual template can have connecting ele(cid:173)
`ments,
`surfaces or points arranged
`thereon,
`which can be releasably coupled in mechanically
`rigid manner to the gripper piece of a manipula(cid:173)
`tor and thus preoperatively define the position
`of the gripper piece of the manipulator relative
`to the three-dimensional reconstruction of the
`osseous structure.
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`14
`
`5. Prior to the intervention and starting from the
`home position described above under item 4, a
`spatial treatment or moving program for the
`gripper piece of the manipulator can be defined
`in the gripper piece coordinate system in a spa(cid:173)
`tially determined relation to the three-dimen(cid:173)
`sional reconstruction of the osseous structure
`and be programmed in a computer-based procedure.
`
`6. Further, prior to the intervention and starting
`from the home position described above under
`item 4 and also in a spatially determined rela(cid:173)
`tion to the three-dimensional reconstruction of
`the osseous structure, it is possible that, for
`the gripper piece of the manipulator, a desired
`spatial and chronological dependence on the 3D
`position and the mechanical 6D impedance can be
`defined in the gripper piece coordinate system
`and be programmed in a computer-based procedure.
`
`7. The basic body of the individual template men(cid:173)
`tioned above under item 2., comprising the nega(cid:173)
`tive mold, the connecting elements, surfaces or
`points is produced preoperatively by use of a
`computer-based manufacturing device (particular(cid:173)
`ly by NC milling and/or stereolithography). Dur(cid:173)
`ing the preparation of the surgical procedure,
`the tool guides provided in the surgical plan(cid:173)
`ning are preoperatively mounted on the basic
`body of the individual template.
`
`the above
`intervention,
`the surgical
`8. During
`treatment steps defined in the phase of surgical
`
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`
`planning can be exactly transferred since, rela(cid:173)
`tive to the osseous structure, the tool guides
`can be brought exactly into the positions de(cid:173)
`fined during the surgical planning phase (i.e.
`the manipulator gripper piece can be brought
`into the home position defined in the surgical
`planning phase). To this purpose, the individual
`template with the faces of the negative mold is
`set under mating engagement onto the then ex(cid:173)
`posed bone surface, which is done without any
`further
`intraoperative devices
`(particularly
`without measuring devices such as 3D measuring
`arms or the like) and without intraoperative
`measuring and positioning work.
`
`9. When optionally using a manipulator, the moving
`program defined during the preoperative planning
`phase in the computer system through gripper and
`workpiece coordinates, or, respectively, the 6D
`impedance variation space defined in the same
`manner, is converted after the intraoperative
`mounting of the individual template coupled to
`the gripper piece, and then will be available
`during the surgical intervention.
`
`10. As outlined under item 9. above, the treatment
`and moving program defined under item 5 can be
`automatically reproduced in an exactly defined
`manner relative to the osseous structure or be
`manually released by pieces. The moving and
`treatment space defined according to items 6 and
`9 is intraoperatively reproduced in an exactly
`defined manner relative to the bone through the
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`spatial and chronological dependence on the var(cid:173)
`iation of the mechanical 6D
`impedance of the
`manipulator guided by the surgeon on its gripper
`piece.
`
`11. The guide means of the template for limiting the
`movement of a treatment device during the treat(cid:173)
`ment of an osseous structure as provided by the
`surgical planning allows e.g. vertebral osteo(cid:173)
`tomy using a vertebral-osteotomy template with a
`rear contour analogous limitation for the cut(cid:173)
`ting depth. This
`limitation for the cutting
`depth, which requires a guide path for the guide
`means which corresponds to that limiting edge of
`the cut through the osseous structure which fac(cid:173)
`es away from the template, can guarantee suffi(cid:173)
`cient accuracy by exact positioning and guidance
`of the tool simply by employment of an (individ(cid:173)
`ual) template conforming with the osseous struc(cid:173)
`ture in mating engagement.
`
`12. The consideration of the spatially diametrical
`bone surface with respect to the "rear contour
`analogous limitation for the cutting depth" by
`which, when guiding the cutting, the rear bound(cid:173)
`ary of the bone is considered corresponding to
`the projected cutting curve and the rear side of
`the bone, and is not exceeded by the saw blade.
`What is again of functional importance here is
`the use of an individual-template basic body so
`as to exactly and clearly position the cutting
`depth limitation during the surgical interven(cid:173)
`tion.
`
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`17
`
`13. 3D copying milling device for the cleansing of
`medullary space or for the milling of predeter(cid:173)
`mined shapes in osseous structures, character(cid:173)
`ized in that the geometrical data provided for
`the 3D copying milling device reproduce individ(cid:173)
`ual geometrical conditions of the threr:-dimen(cid:173)
`sional reconstruction of
`the
`tomographically
`imaged osseous structure. Also here, it is func(cid:173)
`tionally important to use an individual-template
`basic body so as to exactly and clearly position
`the 3D copying milling device during the surgi(cid:173)
`cal intervention.
`
`Embodiments of the invention will be explained in
`greater detail hereunder with reference to the draw(cid:173)
`ings. Throughout the Figures, identical reference
`numbers are used for identical parts in the differ(cid:173)
`ent embodiments. The Figures show some exemplary
`embodiments which are merely provided for explaining
`the invention but, due to the various possible ap(cid:173)
`plications of the invention, cannot depict the in(cid:173)
`vention in an all-inclusive manner.
`
`Figs. 1 to 5
`
`show a first embodiment of the invention
`with an individual template, adapted to a
`vertebra, for guiding a tool, which in this
`case is a drill for application of bores for
`pedicle-screws into the vertebra,
`
`Figs. 6 to 8
`
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`18
`
`show a further embodiment of an individual
`template and its intraoperative handling and
`use,
`
`Fig. 9
`
`shows an individual template which is an al(cid:173)
`ternative to the embodiment according to
`Figs. 6 to 8,
`
`Figs. lOa to lOd
`
`show a further embodiment of an individual
`template for hip-joint individual endopros(cid:173)
`theses,
`
`Fig. lOe
`
`shows an alternative to the individual tem(cid:173)
`plate according to Figs. lOa to lOd,
`
`Figs. lla to lld
`
`show a further possible application of an
`individual
`template for use in scoliosis
`correction by repositioning osteotomy in the
`region of individual vertebrae,
`
`Fig. lle
`
`shows a further possibility for using an
`individual template for scoliosis correction
`by repositioning osteotomy in the region of
`individual vertebrae,
`
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`
`Fig. 12 shows the use of an individual template for
`osteotomy in the region of the thoracic
`limb,
`
`Figs. 13a to 13d
`
`show a further individual template for prep(cid:173)
`aration of a prosthesis seat of a knee-joint
`head prosthesis,
`
`Figs. 14a to 14c
`
`show an individual template provided with a
`copying milling device,
`
`Fign. 15 and 15b
`
`show an example of the use of an individual
`template for robot-assisted treatment of
`osseous structures,
`
`Figs. 16a to 16e
`
`show a further example of the use of an in(cid:173)
`dividual template for robot-assisted treat(cid:173)
`ment of osseous structures,
`
`Fig. 17 shows a further example of robot-assisted
`treatment,
`
`Fig. 18 is a flow chart for illustrating the method
`of computer-aided and computer-integrated
`alignment of treatment tools for the treat-
`
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`
`ment of osseous structures in orthopedic
`surgery, and
`
`Fig. 19 is a flow chart for illustrating the method
`for alignment of treatment tools for the
`robot-assisted treatment of osseous struc(cid:173)
`tures in orthopedic surgery.
`
`Figs. la, lb, 2a, 2b, 2c, 3a, 3b, 4, Sa, Sb, Sc show
`an individual template 4 for application of
`two
`bores in a vertebra. Each of the bores serves for
`the mounting of a pedicle screw which shall be
`screwed trough the (left or right) pedicle into the
`.body of the vertebra, ..as it is usually done for the
`anchoring of a fixateur-intern within a scoliosis
`operation. For reasons of stability, the