PCP
`
`WORLD INTELLECTUAL PROPERTY ORGANIZATION
`International Bureau
`
`
`
`INTERNATIONAL APPLICATION PUBLISHED UNDER THE PATENT COOPERATION TREATY (PCT)
`
`(51) International Patent Classification 5 =
`
`(11) International Publication Number:
`
`WO 93/25157
`
`A613 17/55
`
`(43) International Publication Date:
`
`23 December 1993 (2312.93)
`
`(21) International Application Number:
`
`PCT/EP93/01540
`
`(22) International Filing Date:
`
`17 June 1993 (17.06.93)
`
`(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 (l8.06.92)
`
`DE
`
`RADERMACHER,
`(71)(72) Applicant and Inventor:
`[DE/ DE]; Ludwigsallee 21, D—5l00 Aachen (DE).
`
`Klaus
`
`(72) Inventors; and
`: RAU, Giinter [DE/
`(75) Inventors/Applicants (for US only)
`DE]; Fuchserde 50, D-5100 Aachen (DE). STAUDTE,
`Hans-Walter [DE/ DE]; Neue Furth 28, D-5102 WI'irsel-
`en (DE).
`
`(74) Agents: HILLERINGMANN, Jochen et al.; Deichmann-
`haus am Hauptbahnhof, D—5000 Kdln 1 (DE).
`
`(54) Title: TEMPLATE FOR TREATMENT TOOLS AND METHOD FOR THE TREATMENT OF OSSEOUS STRUC-
`TURES
`
`(57) Abstract
`
`Of an osseous structure to be treated, a reconstruction is pro-
`duced. On the basis of the contact points of this reconstruction, abut-
`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-
`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-
`.
`formed corresponding to the previous planning of the surgical inter-
`
`:::ié.:‘§:i§L4“f,1.§“”
`‘,’§§:§‘::,fa:“‘:;§:;‘,‘;; to
`the -“rvical Planning
`
`Individual templates
`
`Individual prosthesis
`
`e.,..,,.,,.P,,,,, “M9,,
`‘°" ""'
`'--’
`
`§
`In G
`
`ocen
`
`1
`
`,
`
`Visualization,
`surgical planning,
`CAD
`
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`
`FOR THE PURPOSES OF INFORMATION ONLY
`
`Codes usctl to identify States party to the PCI’ on the front pages of‘pamphlct‘s publishing international
`applications under the PCT.
`
`AT
`AU
`BB
`BE
`BF
`BC
`8.!
`BR
`CA
`CF
`CG
`CH
`Cl
`CM
`CS
`CZ
`DE
`DK
`ES
`Fl
`
`~
`
`Auatriu,
`Australia
`Barbados
`Belgium
`Burkinu Fnsu
`Bulgaria
`Bi.-nin
`Brazil
`(Innndu
`Central African: Rupuhlit:
`(‘ongo
`SwitJ.crl;tnd
`('61: d‘lvniru
`('umcmun
`(,’7.t:t.fhusluvulr.iu ‘
`(Tzcult Rcpubllt.
`-licrmuuy
`Dcnrnairlt
`Spain
`Finlzmtl
`
`-
`
`Mongolia
`
`Frunct:
`Gabon
`United Kingdom
`Guinca
`Grcucc
`Hungary
`Ireland
`Italy
`Japan
`Dcmocratii: People‘: Republic
`til’ Korea
`Republic of Korea
`K.'v.'tLhslun
`l.it.'t:lncnsIcin
`Sri l.mLat
`Luuzmhourg
`Monaco
`Mudtignscar ~
`Mali
`
`.
`
`'
`
`'
`
`_
`
`_
`
`.
`
`Mauritania
`Malawi
`Ncthcrlamds
`Norway
`New Zuatlantl
`Poland
`Portugal
`Rimmniu
`Russian Ft:t.lt:rution
`Sudan
`Swcdcn
`Slovak Republic
`Scncgul
`Soviet Union
`Chad _.
`Togo
`Ultrztim:
`Unit.t:d_.Stuu.::. of America
`Vic! Nam
`
`'
`
`.
`
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`
`W0 93/25157
`
`PC!‘IEP93/01540
`
`Template for treatment tools and method for the
`‘treatment of osseous structures
`
`The invention is directed to a template for treat-
`
`mént tools for the treatment of osseous structures
`
`and a method for the definition and reproduction of
`
`the positional relationship of a treatment tool rel-
`ative to an osseous structure.
`
`Using image producing methods such as computertomor
`
`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-
`
`nique,
`
`to reconstruct them three—dimensionally and
`
`to visualize them through an output medium. Further,
`such systems frequently permit already a three-di-
`
`mensional planning of surgical
`
`interventions with
`
`regard to incisions, drilling, puncture, positioning
`
`of individual
`
`implants or other surgical
`
`interven-
`
`tions; Intraoperatively, i.e. during the actual sur—
`
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`PC!‘/EP93/01540
`
`gical procedure, there often occur orientation prob-
`
`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, dependingu
`
`on the type and the anatomical site of the interven-
`
`tion can involve extreme risks even with experienced
`
`surgeons. Generally, only freehand-guided« instru-
`
`ments,
`
`two—dimensional
`
`tomographic images and pre-
`
`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-1-33 390 259, EP 380 451, EP 415 8437, EP 231 885, EP
`
`228 339, DE 39 25 488, DE 79 14 280) or for reposi-
`
`tioning osteotomies in the region of
`
`the proximal
`
`the femur or tibia (e.g. US 4,565,191, DE
`head of
`38 42 645, DE 32 11 153). The intraoperative posi—
`
`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-
`
`ical
`
`conditions,
`
`as e.g.
`
`in US
`
`4,846,161,
`
`DE
`
`34 47 163 or DE 40 16 704, can generally not be car-
`
`ried out exactly and clearly according to the plan-
`
`ning of the intervention. In some approaches, intra~
`
`operative measurement and positioning under X-ray
`
`control are provided. This causes an increased expo-
`
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`wo 93/25157
`
`PCI‘/EP93/01540 _
`
`sure to radiation for the patient and the medical
`
`staff, prolongs the duration of the surgical inter-
`
`vention and again is just an indirect and not clear-
`
`ly defined transfer of the treatment strategy de-
`
`fined in the surgical planning.
`
`There also exist devices for stereotactical inter-
`
`ventions, Principally,
`
`these devices can be divided
`
`into two categories. The first category comprises
`
`devices which, designed as rigid frames, are attach-
`
`ed directly (e.g. by screws) on/in the bone and are
`
`adapted for rigid mechanical coupling ta; a posi—
`
`tioning or coordinate measuring system, with the
`
`reference points of said devices being reproduced in
`
`a tomographic image (e.g. stereotaxic apparatuses as
`
`:described in Riechert et a1.;4Beschreibung und Ane
`
`lwendung eines Zielgerates ffir stereotaktische Hirn—
`
`operationen, Acta neurochir., Vienna, Austria,
`Suppl.
`111
`(1955), 3.08; and in DE 37 17 871, DE
`
`39 02 249 and EP 312 568). The second category com-
`
`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-
`
`ready prior to tomographic scanning of the respec-
`
`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-
`
`tion or 3D coordinate measurement and evaluation for
`
`detection of the transformation relation between the
`
`coordinate systems of the bone structure,
`the tomo-
`graphic images and the environment
`(Adams et al.: A
`
`navigation support for surgery.
`
`In: Hahne et al.:
`
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`
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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-
`
`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-
`
`es, it is possible to use a 3D coordinate measuring
`
`or adjusting device, coupled to these reference bod-
`
`ies (or points) fixedly or through defined transfor-
`
`mation relationships, for the positioning of coordi-
`
`nate measurement pins or guide devices for punctur—
`
`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-
`ditional surgical intervention.
`
`—
`
`The
`
`reference bodies
`
`(and possibly the whole
`
`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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`
`a non—rigid or non—physical connection,
`
`time-
`
`consuming (and again‘failure—prone) intraopera-
`
`tive measuring and aligning work has to be per-
`formed.
`
`— Generally, application is restricted to inter-
`ventions in the region of easily accessible os-
`
`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-
`ited accuracy as freehand-guided intraoperative 3D
`
`éposition measuring devices for navigational purpos-
`
`-es. These systems rely on artificial reference mark-
`
`'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-
`
`- 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~
`
`tion in osseous structures. Consequently, an indi-
`
`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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`W0 93/25157
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`PCTEP93/01 540
`
`ration of the seat of the prosthesis. The technology
`
`of bone treatment has been lagging behind the tech-
`
`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 burdenfifime interven-
`
`tions also in the region of osseous structures.
`
`Most of the known methods work after the above out-
`
`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-
`
`lute positioning accuracy for CT—guided stereotactic
`
`brain surgery.
`
`IEEE Transactions on Biomedical Engi-
`
`neering, Vol. 35, No. 2, Feb. 1988; Taylor et al.:
`
`Robot total hip replacement surgery in dogs.
`
`IEEE
`
`Engineering in Medicine & Biology Society llth annu-
`
`al international conference 1989, pp. 887-889; Rein-
`
`hardt et al.: Robotik ffir Hirnoperationen, Polyscope
`
`_plus No. 6, pp. 1, 5-6).
`
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`Some methods are executed with intraoperative image
`
`acquisition (particularly biplanar X-ray projection
`
`images) and suitable targeting and calibrating de-
`
`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-
`
`ject", as e.g.
`
`an osseous structure), it becomes
`
`possible to transform positioning processes or move-
`
`ments, having been defined in the coordinate system
`
`fixed, to the Obje.C‘-I;
`
`into movements or positional
`
`vectors in the basic coordinate system of the robot
`
`(cf. e.g. Lavalléez A new system for computer as-
`
`.sisted neurosurgery;
`IEEE Engineering in Medicine &
`Biology Society 11th annual international conference
`
`1989, pp. 887-889; Jakobi et a1.: Diagnosegesteuerte
`
`Therapierobotertechnik * medizinische und biomedi-
`
`zinische Aspekte, 2. Klin. Med. 45 Vol. 6, 1990, pp.
`
`515-519).
`
`In the region of soft tissues,
`
`the principal system-
`
`.atics of a fixedly defined spatial relationship be-
`
`tween the image acquisition device and the position-
`ing device for the endeffector 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-
`
`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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`
`sitioning of
`
`the biopsy cannula). No
`
`comparable
`
`techniques are known in the field of orthopedic sur-
`
`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-
`
`play cutting paths by a laser beam, to position tool
`guiding devices, to perform work on the bone direct-
`
`ly etc- (Prasch: Computergestfitzte Planung Von chir-
`
`urgischen, Eingriffen in der Orthopadie, Springer
`
`Verlag 1990). To this purpose, contours of the re-
`
`spective osseous structure which have been detected
`
`'with the aid of a computer in biplanar intraopera-
`
`tive X-ray projection images, are compared to and,
`
`as far as possible, made congruent with 3D~CAD mod~
`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-
`
`” ing to its programming made corresponding to the 3D
`
`model in the CAD system.
`
`In the above mentioned pub-
`
`lication, repositioning osteotomy is mentioned as an
`
`exemplary application. This system has not been re-
`
`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-
`
`ray images are disadvantageous for the above rea-
`
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`sons. Due to the inherent technical (including also
`
`safety measures), organizational and economic neces-
`
`sities,
`
`the use of robots has to be limited to sur-
`
`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 nanipulators and robots.
`
`(The nmch-quoted
`
`repositioning osteotomy in the femur or tibia region
`
`does not count among these).
`
`1
`
`It is an object of the invention to allow a treat-
`
`ment of osseous structures for any desired orthope-
`
`;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—
`
`suring and scanning of osseous structures by corre-
`
`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-
`
`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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`10
`
`rendered unnecessary. For complex surgical interven-
`
`tions, quick and easy intraoperative access to a ma-
`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-
`
`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-
`
`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-
`
`ing organism and containing the osseous structure,
`
`images, data regarding the
`and from these split
`three-dimensional shape of the osseous structure and
`
`the surface thereof are obtained.
`
`In the preopera-
`
`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-
`id individual template which, completely or by seg-
`
`ments (but at least by three intraoperatively clear-
`
`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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`
`11
`
`in form-closed manner. Thus, when mounting the indi-
`
`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-
`
`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
`vare 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-
`
`gagement points for standardized tool guides, which
`can be performed directly in or on the template body
`
`relative to the bone. Intraoperatively, this situa-
`
`tion, which in surgical planning is precisely de-
`
`fined in three dimensions and simulated, is realized
`
`by simply setting the individual template onto the
`
`exposed surface of the bone. Time-consuming measur-
`
`ing and aligning work is thus shifted into the pre-
`operative phase. working steps which involve intra-I
`
`operative X-ray control can be omitted.
`
`Using the template of the invention allows a treat-
`
`ment of osseous structures for any orthopedic inter-
`
`vention (i.e. also complex and possible novel inter-
`
`ventions) which is carried out in a safe, fast and
`
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`12
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`precise manner and is defined according to the sur-
`
`gical planning while it is not necessary anymore to
`intraoperatively check the orientation of the treat-
`
`ment tool. Intraoperative measuring and positioning
`
`periods are minimized by being shifted into the pre-
`
`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-
`
`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-
`
`construction on an output medium, particularly a
`icomputer monitor,
`and particularly by using a
`
`computer system or a computer-based display and
`
`construction system, there is generated a three-
`
`dimensional negative mold of parts of the indi-
`
`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—
`
`ting partial segments of a bone surface and is
`
`constructed in a cohesive, mechanically rigid
`
`basic body (the individual template). The over~
`
`all geometry of the basic body is also adapted
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`13
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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-
`
`seous structure,
`
`the treatment of the bone can
`
`be planned. For
`
`this treatment,
`
`any suitable
`
`tool guides, particularly drill sleeves, paral-
`
`lel guides,
`
`saw templates, 2D- and 3D-profiling
`
`milling devices
`
`can ibe provided. These tool
`
`guides, connecting elements, surfaces or points
`
`can be provided in/on the basic body of the in-
`
`dividual template, which relative to the 3D re-
`
`construction of the osseous structure are ori-
`
`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-
`
`vices exactly as provided by the surgical plan-
`
`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-
`
`ments,
`
`surfaces or points
`
`arranged thereon,
`
`which can be releasably coupled in mechanically
`
`rigid manner to the gripper piece of a manipula-
`
`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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`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-
`
`tially determined relation to the three-dimen-
`
`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-
`
`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—basedjprocedure;
`
`7,- The basic body of the individual template men-
`
`tioned above under item 2., comprising the nega-
`
`tive mold,
`
`the connecting elements, surfaces or
`
`points is produced preoperatively by use of a
`
`computer—based manufacturing device (particular-
`
`ly by NC milling and/or stereolithography). Dur-
`
`ing the preparation of the surgical procedure,
`
`the tool guides provided in the surgical plan-
`ning are preoperatively mounted on the basic
`
`body of the individual template.
`
`8. During the surgical
`
`intervention,
`
`the above
`
`treatment steps defined in the phase of surgical
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`planning can be exactly transferred since, rela-
`
`tive to the osseous structure,
`
`the tool guides
`
`can be brought exactly into the positions de-
`
`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-
`
`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.
`
`the moving
`9. when optionally using a manipulator,
`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-
`
`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-
`
`ment of an osseous structure as provided by the
`
`surgical planning allows e.g. vertebral osteo-
`
`tomy using a vertebral-osteotomy template with a
`
`rear contour analogous limitation for the cut-
`
`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-
`
`es away from the template, can guarantee suffi-
`
`cient accuracy by exact positioning and guidance
`
`of the tool simply by employment of an (individ-
`
`ual) template conforming with the osseous struc-
`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-
`
`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-
`tion.
`
`,
`
`x
`
`
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`WMT 1007-18
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`17
`
`13. 3D copying milling device for the cleansing of
`
`medullary space or for the milling of predeter-
`
`mined shapes in osseous structures, character-
`ized in that the geometrical data provided for
`
`the 3D copying milling device reproduce individ-
`ual geometrical conditions of the three—dimen-
`sional
`reconstruction, of
`the tomographically
`
`imaged osseous structure. Also here, it is func-
`
`tionally important to use an individual—template
`
`basic body so as to exactly and clearly position
`
`the 3D copying milling device during the surgi-
`cal intervention.
`
`Embodiments of the invention will be explained in
`greater detail hereunder with reference to the draw-
`
`ings; Throughout
`
`the Figures,
`
`identical
`
`reference
`
`numbers are used for identical parts in the differ-
`
`ent embodiments. The Figures
`
`show some exemplary
`
`embodiments which are merely provided for explaining
`
`the invention but, due to the various possible ap-
`
`plications of the invention, cannot depict
`vention in an all—inclusive manner.
`
`the in-
`
`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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`
`show a further embodiment of an individual
`
`template and its intraoperative handling and
`use,
`
`Fig.
`
`9
`
`shows an individual template which is an al-
`ternative to the embodiment according to
`
`Figs.
`
`6 to 8,
`
`Figs. 10a to 10d
`
`show a further embodiment of an individual
`
`template for hip-joint individual endopros-
`
`theses,
`
`Fig. 10e
`
`shows an alternative to the individual tem-
`
`plate according to Figs. 10a to 10d,
`
`Figs. 11a to 11d
`
`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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`WMT 1007-20
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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-
`
`aration of a prosthesis seat of a knee—joint
`
`head.prosthesis,
`
`Figs. 14a to 14¢
`
`show an individual template provided with a
`
`copying :m“5.1n1ing device ,
`
`'
`
`.15. and 151:
`
`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-
`
`dividual template for robot-assisted treat-
`
`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-
`
`WMT 1007-21
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`20
`
`ment of osseous structures in orthopedic
`
`surgery, and
`
`Fig. 19 is a flow chart for illustrating the method
`
`tools for the
`treatment
`for alignment of
`robot-assisted treatment of osseous struc-
`
`tures in orthopedic surgery.
`
`Figs. la, 1b, 2a, 2b, 2c, 3a, 3b, 4, 5a, 5b, 5c show
`
`an individual
`
`template 4
`
`for application of
`
`two
`
`bores in a vertebra. Each of the bores serves for
`
`a pedicle screw which shall be
`the .mounting of
`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
`
`opera:tion.. For reasonsr of stability, the screw shall.
`
`be secured in the cortical substance (i.e. the out-
`
`er, more compact osseous layer). On the other hand,
`
`the bore and the screw shall injure neither the spi—
`
`nal cord extending in the adjacent spinal canal nor
`
`the spinal nerves issuing from the intervertebral
`
`canal, and penetrate through the cortical substance
`
`of the ventral side of the vertebra only so far that
`
`it does not yet ventrally issue from the boy of the
`
`vertebra. According to these requirements, the bores
`
`are preoperatively clearly defined in space by the
`
`entrance and end points and the diameter, and the
`
`screw is defined by the diameter and the length,
`
`which is done e.g. using CT images.‘
`
`The method of the invention will be described here-
`under by way of an example_which also stands for
`
`. other, comparable interventions:
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`WMT 1007-22
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`
`The vertebra and the regions of the structure rele-
`
`vant for the surgical planning (the osseous struc-
`
`ture l7 in general) are scanned by a tomographic
`
`method as already described, are reconstructed in
`
`three dimensions, and the thus obtained 1:1 model is
`
`visualized by a suitable medium (e.g. CAD system).
`Also a model of the osseous structure 17 made from
`
`any mechanically