CA2373691C - Method for generating patient-specific implants - Google Patents
Method for generating patient-specific implants Download PDFInfo
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- CA2373691C CA2373691C CA002373691A CA2373691A CA2373691C CA 2373691 C CA2373691 C CA 2373691C CA 002373691 A CA002373691 A CA 002373691A CA 2373691 A CA2373691 A CA 2373691A CA 2373691 C CA2373691 C CA 2373691C
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- 239000007943 implant Substances 0.000 title claims abstract description 67
- 238000000034 method Methods 0.000 title claims abstract description 32
- 230000007547 defect Effects 0.000 claims abstract description 33
- 238000004519 manufacturing process Methods 0.000 claims abstract description 14
- 238000005481 NMR spectroscopy Methods 0.000 claims description 6
- 238000002591 computed tomography Methods 0.000 claims description 6
- 238000004422 calculation algorithm Methods 0.000 claims description 5
- 230000011218 segmentation Effects 0.000 claims description 5
- 238000012545 processing Methods 0.000 claims description 4
- 238000003325 tomography Methods 0.000 claims description 4
- 210000000988 bone and bone Anatomy 0.000 claims description 3
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- 238000003384 imaging method Methods 0.000 abstract description 5
- 238000005516 engineering process Methods 0.000 abstract description 4
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- 239000000463 material Substances 0.000 description 9
- 238000013461 design Methods 0.000 description 5
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- 230000008569 process Effects 0.000 description 3
- RTAQQCXQSZGOHL-UHFFFAOYSA-N Titanium Chemical compound [Ti] RTAQQCXQSZGOHL-UHFFFAOYSA-N 0.000 description 2
- 230000008901 benefit Effects 0.000 description 2
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- 230000013011 mating Effects 0.000 description 2
- 229910052751 metal Inorganic materials 0.000 description 2
- 239000002184 metal Substances 0.000 description 2
- 238000007493 shaping process Methods 0.000 description 2
- 238000004088 simulation Methods 0.000 description 2
- 238000011477 surgical intervention Methods 0.000 description 2
- 238000001356 surgical procedure Methods 0.000 description 2
- 239000010936 titanium Substances 0.000 description 2
- 229910052719 titanium Inorganic materials 0.000 description 2
- 238000011282 treatment Methods 0.000 description 2
- 206010028980 Neoplasm Diseases 0.000 description 1
- 230000006978 adaptation Effects 0.000 description 1
- 230000002146 bilateral effect Effects 0.000 description 1
- 210000000746 body region Anatomy 0.000 description 1
- 238000004364 calculation method Methods 0.000 description 1
- 239000000919 ceramic Substances 0.000 description 1
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- 238000004590 computer program Methods 0.000 description 1
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- 238000002059 diagnostic imaging Methods 0.000 description 1
- 238000012407 engineering method Methods 0.000 description 1
- 238000000605 extraction Methods 0.000 description 1
- 230000036541 health Effects 0.000 description 1
- 238000003780 insertion Methods 0.000 description 1
- 230000037431 insertion Effects 0.000 description 1
- 210000000056 organ Anatomy 0.000 description 1
- 238000002360 preparation method Methods 0.000 description 1
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Classifications
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/28—Bones
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/30—Joints
-
- G—PHYSICS
- G05—CONTROLLING; REGULATING
- G05B—CONTROL OR REGULATING SYSTEMS IN GENERAL; FUNCTIONAL ELEMENTS OF SUCH SYSTEMS; MONITORING OR TESTING ARRANGEMENTS FOR SUCH SYSTEMS OR ELEMENTS
- G05B19/00—Programme-control systems
- G05B19/02—Programme-control systems electric
- G05B19/18—Numerical control [NC], i.e. automatically operating machines, in particular machine tools, e.g. in a manufacturing environment, so as to execute positioning, movement or co-ordinated operations by means of programme data in numerical form
- G05B19/4097—Numerical control [NC], i.e. automatically operating machines, in particular machine tools, e.g. in a manufacturing environment, so as to execute positioning, movement or co-ordinated operations by means of programme data in numerical form characterised by using design data to control NC machines, e.g. CAD/CAM
- G05B19/4099—Surface or curve machining, making 3D objects, e.g. desktop manufacturing
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/28—Bones
- A61F2/2875—Skull or cranium
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/30—Joints
- A61F2/30767—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth
- A61F2/30771—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth applied in original prostheses, e.g. holes or grooves
- A61F2002/30772—Apertures or holes, e.g. of circular cross section
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/30—Joints
- A61F2/3094—Designing or manufacturing processes
- A61F2/30942—Designing or manufacturing processes for designing or making customized prostheses, e.g. using templates, CT or NMR scans, finite-element analysis or CAD-CAM techniques
- A61F2002/30948—Designing or manufacturing processes for designing or making customized prostheses, e.g. using templates, CT or NMR scans, finite-element analysis or CAD-CAM techniques using computerized tomography, i.e. CT scans
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/30—Joints
- A61F2/3094—Designing or manufacturing processes
- A61F2/30942—Designing or manufacturing processes for designing or making customized prostheses, e.g. using templates, CT or NMR scans, finite-element analysis or CAD-CAM techniques
- A61F2002/30952—Designing or manufacturing processes for designing or making customized prostheses, e.g. using templates, CT or NMR scans, finite-element analysis or CAD-CAM techniques using CAD-CAM techniques or NC-techniques
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- G—PHYSICS
- G05—CONTROLLING; REGULATING
- G05B—CONTROL OR REGULATING SYSTEMS IN GENERAL; FUNCTIONAL ELEMENTS OF SUCH SYSTEMS; MONITORING OR TESTING ARRANGEMENTS FOR SUCH SYSTEMS OR ELEMENTS
- G05B2219/00—Program-control systems
- G05B2219/30—Nc systems
- G05B2219/35—Nc in input of data, input till input file format
- G05B2219/35016—Analyse model, decide on number of sections to take
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- G—PHYSICS
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- G05B—CONTROL OR REGULATING SYSTEMS IN GENERAL; FUNCTIONAL ELEMENTS OF SUCH SYSTEMS; MONITORING OR TESTING ARRANGEMENTS FOR SUCH SYSTEMS OR ELEMENTS
- G05B2219/00—Program-control systems
- G05B2219/30—Nc systems
- G05B2219/35—Nc in input of data, input till input file format
- G05B2219/35062—Derive mating, complementary, mirror part from computer model data
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- G—PHYSICS
- G05—CONTROLLING; REGULATING
- G05B—CONTROL OR REGULATING SYSTEMS IN GENERAL; FUNCTIONAL ELEMENTS OF SUCH SYSTEMS; MONITORING OR TESTING ARRANGEMENTS FOR SUCH SYSTEMS OR ELEMENTS
- G05B2219/00—Program-control systems
- G05B2219/30—Nc systems
- G05B2219/35—Nc in input of data, input till input file format
- G05B2219/35533—Use, input 2-D data, sectional profile to machine 3-D surface
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- G—PHYSICS
- G05—CONTROLLING; REGULATING
- G05B—CONTROL OR REGULATING SYSTEMS IN GENERAL; FUNCTIONAL ELEMENTS OF SUCH SYSTEMS; MONITORING OR TESTING ARRANGEMENTS FOR SUCH SYSTEMS OR ELEMENTS
- G05B2219/00—Program-control systems
- G05B2219/30—Nc systems
- G05B2219/49—Nc machine tool, till multiple
- G05B2219/49008—Making 3-D object with model in computer memory
-
- Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
- Y10S—TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y10S623/00—Prosthesis, i.e. artificial body members, parts thereof, or aids and accessories therefor
- Y10S623/901—Method of manufacturing prosthetic device
Abstract
The invention relates to a method for generating patient-specific implants from the results of an examination of a patient arising from an imaging method in medical technology. The aim of the invention is to generate an implant which is functionally and aesthetically adapted to the patient with a greater degree of precision, irrespective of the size, form and complexity of the defect, whereby said implant can be produced and operatively inserted into the patient over a short time period and in a simple manner. According to the invention, a virtual three-dimensional model of the patient which is formed from existing recorded (two-dimensional) image data of a patient known per se is compared with real medical reference data. Said comparison which is, for example, carried out using a data bank with test person data enables a reference model object which is most suited to the patient or closest to the patient model to be selected or formed and a virtual implant model is generated accordingly.
CNC control data is directly generated from the implant model which is generated virtually in the computer for program-assisted production of said implant.
CNC control data is directly generated from the implant model which is generated virtually in the computer for program-assisted production of said implant.
Description
METHOD FOR GENERATING PATIENT-SPECIFIC
IMPLANTS
BACKGROUND OF THE INVENTION
s The present invention relates to the generation of patient-specific implants based on the examination findings on a patient obtained by imaging methods in medical technology.
It has been possible for long to use, to a limited degree, exogenic i o material (implants) to close organ defects. The recent state of art is to generate hard-tissue implants specifically adapted to a patient either by obtaining the implants during a surgical operation under use of existing intermediate models or, more recently, under use of CAD/CAM
technologies as an aid in computer-aided reconstruction. Imaging i s methods of the medical technology, such as computer tomography, nuclear magnetic resonance tomography, and sonography increasingly form the basis for generation.
It is common medical practice (refer to, for example, US 4,097,935 and US 4,976,737) to use as implants plastic and workable, respectively, Zo metal webs and metal plates, easily to form materials that have a short curing time (for example, synthetic resin) and endogenic material from the patient by which the defects are closed during the surgical operation, i. e. the implant is obtained during the operation, formed and adapted to the defect. However, metallic implants such as webs and Zs plates etc. can be very disturbing at later diagnosises on the patient and can even render impossible to carry out future special methods of examination, in particular, when larger defect areas are concerned. The progress of operation is usually dependent on the situation of treatment itself, and the experience of the surgeon. In such cases it is scarcely possible to have a specific operation planning for the insertion of the s implant in advance. Therefore the operated on patient occasionally has to undergo follow-up treatments that are an additional physical and psychological strain for the patient. Moreover, some materials, such as synthetic materials which are easily to form and/or can be produced at comparatively low expenditures, can only be utilized in a limited to degree with respect to their loadability and endurance. Additionally, there is the desire of the patient to get an aesthetic appearance which in many cases is very hard to realize.
Furthermore, "Stereolithographic biomodelling in cranio-maxillofacial surgery, a prospective trial", Journal of Cranio-Maxillofacial Surgery, is 27, 1999 or US 5.370.692 or US 5.452.407 or US 5.741.215), it is possible to start the design of the implant by generating a physical three-dimensional intermediate model, for example, by stereolithographic methods based on medical imaging methods mentioned at the beginning. Then the implant is manually modeled in zo the defect site by use of plastic workable materials and only then the implant is finally manufactured from the implant material. Thereby the implant preferably is produced from materials of a higher strength, such as titanium.
Furthermore, there is known ("Schadelimplantate - computergestiitzte Zs Konstruktion and Fertigung", Spektrum der Wissenschaft, Febniar 1999; "Die Rekonstruktion kraniofazialer Knochendefekte mit individuellen Titanimplantaten", Deutsches Arzteblatt, September 1997), to generate a simple three-dimensional CAD patient model from the data obtained by applying imaging methods on a patient, and to use these data to manually design the implant by computer under use of s simple design engineering methods. Subsequently the implant is manufactured for the surgical operation by a computer numeric control {CNC) process.
The methods mentioned hereinbefore, however, have the common disadvantage that the result of the implant-modelling predominantly io depends on the experience, the faculty and the "artistic" mastership of the person generating respectively producing said implant. The manufacturing, starting from the data obtained and up to the operationally applicable and mating implant, requires high expenditures of time and cost which are still increased when there is manufactured a is so-called intermediate model. The manufacture of an implant during an operation requires correspondingly high expenditures of time and executive routine for the surgical intervention and, thus, means a very high physical and psychological strain, last not least for the patient.
Moreover, it is still more difficult to operatively and form-fittingly Zo insert an implant, non-mating to the defect site on the patient, while attending to medical and aesthetic aspects. Also here the special skill and experience of the surgeon very often will be decisive for the outcome of the operation. Practically and in the frame of the clinical routine, the first-mentioned methods can only be used with narrow ?s and/or lowly structurized defects and they will very soon reach their technological limits with complicated defects and implants as concerns shaping and fitting.
The operative expenditure is greatly dependent on the adaptability of the implant to the defect site. But with a manufacture of an implant via s intermediate models this precision can be additionally deteriorated due to copying the intermediate model.
In complicated cases the implants have to be manufactured in lengthy and extremely time-consuming processes and, if necessary, via a plurality of intermediate stages. Within this comparatively long period Io the defect area on the patient can possibly change in the meantime.
These changes, in practice, cannot be sufficiently taken into consideration as concerns the adaptability of the implants and additionally increase the operation expenditures.
From the viewpoint of the surgeon as well as of the patient it will be is desirable that the implants should be manufactured in the shortest possible time, also with respect to the surgical intervention, and with a high adaptability to the defect site on the patient. Concrete infom~ation not only about the defect site on the patient but also to the size and shape of the implant to be inserted should be available to the attending Zo surgeon for planning the operation in advance and before the intervention on the patient.
SUMMARY OF THE INVENTION
It is an object of the present invention to provide an implant generated as to be functionally and aesthetically more precisely adaptable to a defect site on a patient, said implant being independent of the size, shape and complexity of said defect site, whereby said implant can be manufactured and inserted into a patient in one operation process in a shorter time and with less expenditures. The method should be applicable with a same accuracy for all shapes, sizes and for all suitable s implant materials.
The present invention provides a virtual three-dimensional model of the patient which is compared to actual medical reference data, whereby the model is formed from known (two-dimensional) image data taken at to least from its implant area and environment. The model best suited for the patient and a reference model object, respectively, best resembling the model of the patient are selected from this comparison and a virtual implant model is generated according to this model. From the virtual implant model data present in the computer, computer numeric i s controlled (CNC) data are on-line produced for a program controlled manufacture of the implant. The real-medical reference data can be compared in a database to the medical data taken from a number of probands (third persons) as well as to the data from the patient hirn/herself, whose body symmetry (in particular mirror-symmetrical Zo body regions, doubly present) is taken into consideration with respect to the selection for and generation of, respectively, a patient reference model. Even data, which do not show this defect or are indicative of changes in the same, can be used for this comparison.
In this way the implant is virtually customized modeled in a very short ?s time under aesthetic and functional aspects and only by computational expenditures (software). Furthermore, the implant is very accurately adapted to the shape of the defect site on the patient as concerns any desired form, size and degree of complexity of the required implant. By means of the virtual implant model, which has been generated and adapted to the defect site and to typical reference data, respectively, by s CAD/CAM, the attending surgeon can obtain very concrete data for a physical planning of the operation on the virtual model. He can already simulate the progress of an operation in advance of the intervention so that the proper operation and its progress can be better prepared, carried out and its success evaluated more realistically and, if i o necessary, to have it discussed with the patient a priori and agreed upon. The implant model is extracted from the virtual reference model of the patient by employing mathematical algorithms. 'hherefrom the control data for the implant, which has to fill respectively to close the defect site, are on-line deduced.
is Thus, the implant can be physically and program controlled manufactured on-line by exploiting the advantages of CNC which ~is known per se. Thereby it is not necessary to have any intermediate models or test models (in particular for copying, for tests, for improvements and for corrections as well as for a new manufacture, if Zo necessary). Implants of nearly any desired form and size as well as made of any desired material, including ceramics and titanium, can be manufactured by computer numerical controlled (CNC) production machines into which the data input is computer aided. Thus the implant can be selected for each patient with respect to the required properties ~s (function, strength, absorbability, endurance, aesthetic appearance, biological compatibility etc.). The generation of the implant, which is thus obtained in a very short time and which can be repeated just as quickly under new or changed aspects of the operative intervention, thus reduces the time and routine schedule in the clinical work.
Furthermore, the stress for the surgeon and the health risk for the s patient are reduced, too. In particular, from the viewpoint of the patient it is a further advantage that a high aesthetic of the implanted defect area is obtained by the accurate adaptation of the implant to be generated to the defective range, and that surgical corrections, refinements as well as other follow-up operations are avoided or at to least reduced as to their extent and number.
DETAILED DESCRIPTION OF THE INV ELATION
In the following, the invention will be explained in more detail by virtue of the embodiments by reference to the following drawings, in which:
is Fig. 1 is a general view of the method according to the present invention, Fig. 2 shows more detail of the general view of the method according to the present invention, Zo Fig. 3 shows the preparation of medical two-dimensional image data, Fig. 4 shows the generation of a three-dimensional patient model, Fig. 5 shows an inversion model, Fig. 6 shows a three-dimensional reference model, and zs Fig. 7 shows a three-dimensional implant model.
As an example, the case of a patient will be illustrated who has a complicated large area defect (for example, resulting from an accident, a tumor etc.) in the upper half of the cranium. In Fig. 1 and 2 there are represented both, a general block diagrarnmatical overview and a s detailed block diagrammatical overview to illustrate the method according to the present invention.
For a precise diagnosis and for a later implant generation medical two-dimensional image data 1 (two-dimensional tomograms) of a defect area 5 and of the environment of the same (refer to Fig. 3) are taken io from a patient in' a radiological hospital department (for example by computer tomography or by nuclear magnetic resonance tomography).
By use of a mathematical image processing algorithm at first a contour detection is made in the two-dimensional image data 1 and subsequently a segmentation is carried out with the airn to detect the is hard tissue ranges (bones). As a result of the contour detection and segmentation two-dimensional image data 2 are obtained via which, by a respective spatial arrangement, a virtual three-dimensional patient model 3 (dotted model) is formed at least of the defect area 5 and environment.
Zo In a cooperation between a physician and a design engineer the defect area is precisely defined and marked in this virtual three-dimensional patient model 3 by utilizing user-specific computer programs especially applicable for this purpose.
Zs In the next step, the implant design engineer has several methods at his disposal for generating precisely fitting implants. These methods are:
1. When in a three-dimensional patient model 4 (shown in a cross-sectional view in Fig. 5), the defect area 5 is completely located in one body half, that is, entirely in one head side, then the data of this body side with the defect area 5 can, by inversion, be reconstructed, s making use of the bilateral symmetry of the human body, from the data of the undamaged side 7 of the three-dimensional patient model 4 (imaging of the undamaged side 7 at the plane of symmetry 6).
After inversion, an extraction of a virtual implant model 9 is carried out by use of mathematical algorithms which will here not be io referred to in more detail.
2. When in a three-dimensional patient model IO (shown in a lateral view in Fig. 6), the defect area 5 is located in the plane of symmetry of the human body or the data of the undamaged side cannot be is utilized, somehow or other, then the virtual implant model 9 can be generated via a three-dimensional reference model 11. To this end, specific features of the three-dimensional patient model 10 are compared to a reference database and a selection of similar models is made under consideration of mathematical, functional, medical Zo and aesthetic aspects. Then, the three-dimensional reference model 11 is selected from this range of models, preferably under particular consideration of the medical expert opinion. By superimposing the three-dimensional reference model 11 and the three-dimensional patient model 10 to one another, a virtual three-dimensional patient ?s model 12 will be obtained, from which, in turn, the virtual implant model 9 will be generated by computer, as described under item 1.
3. In special cases, when for example the defect partially lies in the plane of symmetry, both methods {inversion according to item 1 and database comparison according to item 2) can be used one after the s other and the results will be combined to a three-dimensional reference model for the implant modeling.
The selection and/or the shaping of the three-dimensional reference model after at least one of the methods mentioned hereinabove and the io generation of the virtual implant model from the three-dimensional reference model are performed merely by computation. By this processing both, a very rapid and a very precisely fitting generation and subsequent manufacture of the implant for the operative insert on the patient is given.
is The present virtual implant model 9 (Fig. 7) is subjected to various procedures after its generation. Said procedures may include, for example, strength calculations, simulations for the medical operation planning and the manufacture, as well as providing markings (bore holes, fixings or the like), quality control etc.
?o . After designing the virtual implant model 9, a generation/simulation of the CNC-data for the physical implant manufacture and the transfer of the virtual implant model into a usable implant are carried out.
LIST OF
REFERENCE
NUMERALS
1 - medical two-dimensional image data 2 - contour detection and segmentation two-dimensional image data 3 - three-dimensional patient model (dotted model) s 4 - three-dimensional patient model (cross-section) - - defect area 6 - plane of symmetry of human body 7 - undamaged side of the three-dimensional patient model 8 - inversion of undamaged side 7 io 9 - (virtual) implant model - three-dimensional patient model (lateral view) 11 - three-dimensional reference model 12 - . (virtual) three-dimensional patient model
IMPLANTS
BACKGROUND OF THE INVENTION
s The present invention relates to the generation of patient-specific implants based on the examination findings on a patient obtained by imaging methods in medical technology.
It has been possible for long to use, to a limited degree, exogenic i o material (implants) to close organ defects. The recent state of art is to generate hard-tissue implants specifically adapted to a patient either by obtaining the implants during a surgical operation under use of existing intermediate models or, more recently, under use of CAD/CAM
technologies as an aid in computer-aided reconstruction. Imaging i s methods of the medical technology, such as computer tomography, nuclear magnetic resonance tomography, and sonography increasingly form the basis for generation.
It is common medical practice (refer to, for example, US 4,097,935 and US 4,976,737) to use as implants plastic and workable, respectively, Zo metal webs and metal plates, easily to form materials that have a short curing time (for example, synthetic resin) and endogenic material from the patient by which the defects are closed during the surgical operation, i. e. the implant is obtained during the operation, formed and adapted to the defect. However, metallic implants such as webs and Zs plates etc. can be very disturbing at later diagnosises on the patient and can even render impossible to carry out future special methods of examination, in particular, when larger defect areas are concerned. The progress of operation is usually dependent on the situation of treatment itself, and the experience of the surgeon. In such cases it is scarcely possible to have a specific operation planning for the insertion of the s implant in advance. Therefore the operated on patient occasionally has to undergo follow-up treatments that are an additional physical and psychological strain for the patient. Moreover, some materials, such as synthetic materials which are easily to form and/or can be produced at comparatively low expenditures, can only be utilized in a limited to degree with respect to their loadability and endurance. Additionally, there is the desire of the patient to get an aesthetic appearance which in many cases is very hard to realize.
Furthermore, "Stereolithographic biomodelling in cranio-maxillofacial surgery, a prospective trial", Journal of Cranio-Maxillofacial Surgery, is 27, 1999 or US 5.370.692 or US 5.452.407 or US 5.741.215), it is possible to start the design of the implant by generating a physical three-dimensional intermediate model, for example, by stereolithographic methods based on medical imaging methods mentioned at the beginning. Then the implant is manually modeled in zo the defect site by use of plastic workable materials and only then the implant is finally manufactured from the implant material. Thereby the implant preferably is produced from materials of a higher strength, such as titanium.
Furthermore, there is known ("Schadelimplantate - computergestiitzte Zs Konstruktion and Fertigung", Spektrum der Wissenschaft, Febniar 1999; "Die Rekonstruktion kraniofazialer Knochendefekte mit individuellen Titanimplantaten", Deutsches Arzteblatt, September 1997), to generate a simple three-dimensional CAD patient model from the data obtained by applying imaging methods on a patient, and to use these data to manually design the implant by computer under use of s simple design engineering methods. Subsequently the implant is manufactured for the surgical operation by a computer numeric control {CNC) process.
The methods mentioned hereinbefore, however, have the common disadvantage that the result of the implant-modelling predominantly io depends on the experience, the faculty and the "artistic" mastership of the person generating respectively producing said implant. The manufacturing, starting from the data obtained and up to the operationally applicable and mating implant, requires high expenditures of time and cost which are still increased when there is manufactured a is so-called intermediate model. The manufacture of an implant during an operation requires correspondingly high expenditures of time and executive routine for the surgical intervention and, thus, means a very high physical and psychological strain, last not least for the patient.
Moreover, it is still more difficult to operatively and form-fittingly Zo insert an implant, non-mating to the defect site on the patient, while attending to medical and aesthetic aspects. Also here the special skill and experience of the surgeon very often will be decisive for the outcome of the operation. Practically and in the frame of the clinical routine, the first-mentioned methods can only be used with narrow ?s and/or lowly structurized defects and they will very soon reach their technological limits with complicated defects and implants as concerns shaping and fitting.
The operative expenditure is greatly dependent on the adaptability of the implant to the defect site. But with a manufacture of an implant via s intermediate models this precision can be additionally deteriorated due to copying the intermediate model.
In complicated cases the implants have to be manufactured in lengthy and extremely time-consuming processes and, if necessary, via a plurality of intermediate stages. Within this comparatively long period Io the defect area on the patient can possibly change in the meantime.
These changes, in practice, cannot be sufficiently taken into consideration as concerns the adaptability of the implants and additionally increase the operation expenditures.
From the viewpoint of the surgeon as well as of the patient it will be is desirable that the implants should be manufactured in the shortest possible time, also with respect to the surgical intervention, and with a high adaptability to the defect site on the patient. Concrete infom~ation not only about the defect site on the patient but also to the size and shape of the implant to be inserted should be available to the attending Zo surgeon for planning the operation in advance and before the intervention on the patient.
SUMMARY OF THE INVENTION
It is an object of the present invention to provide an implant generated as to be functionally and aesthetically more precisely adaptable to a defect site on a patient, said implant being independent of the size, shape and complexity of said defect site, whereby said implant can be manufactured and inserted into a patient in one operation process in a shorter time and with less expenditures. The method should be applicable with a same accuracy for all shapes, sizes and for all suitable s implant materials.
The present invention provides a virtual three-dimensional model of the patient which is compared to actual medical reference data, whereby the model is formed from known (two-dimensional) image data taken at to least from its implant area and environment. The model best suited for the patient and a reference model object, respectively, best resembling the model of the patient are selected from this comparison and a virtual implant model is generated according to this model. From the virtual implant model data present in the computer, computer numeric i s controlled (CNC) data are on-line produced for a program controlled manufacture of the implant. The real-medical reference data can be compared in a database to the medical data taken from a number of probands (third persons) as well as to the data from the patient hirn/herself, whose body symmetry (in particular mirror-symmetrical Zo body regions, doubly present) is taken into consideration with respect to the selection for and generation of, respectively, a patient reference model. Even data, which do not show this defect or are indicative of changes in the same, can be used for this comparison.
In this way the implant is virtually customized modeled in a very short ?s time under aesthetic and functional aspects and only by computational expenditures (software). Furthermore, the implant is very accurately adapted to the shape of the defect site on the patient as concerns any desired form, size and degree of complexity of the required implant. By means of the virtual implant model, which has been generated and adapted to the defect site and to typical reference data, respectively, by s CAD/CAM, the attending surgeon can obtain very concrete data for a physical planning of the operation on the virtual model. He can already simulate the progress of an operation in advance of the intervention so that the proper operation and its progress can be better prepared, carried out and its success evaluated more realistically and, if i o necessary, to have it discussed with the patient a priori and agreed upon. The implant model is extracted from the virtual reference model of the patient by employing mathematical algorithms. 'hherefrom the control data for the implant, which has to fill respectively to close the defect site, are on-line deduced.
is Thus, the implant can be physically and program controlled manufactured on-line by exploiting the advantages of CNC which ~is known per se. Thereby it is not necessary to have any intermediate models or test models (in particular for copying, for tests, for improvements and for corrections as well as for a new manufacture, if Zo necessary). Implants of nearly any desired form and size as well as made of any desired material, including ceramics and titanium, can be manufactured by computer numerical controlled (CNC) production machines into which the data input is computer aided. Thus the implant can be selected for each patient with respect to the required properties ~s (function, strength, absorbability, endurance, aesthetic appearance, biological compatibility etc.). The generation of the implant, which is thus obtained in a very short time and which can be repeated just as quickly under new or changed aspects of the operative intervention, thus reduces the time and routine schedule in the clinical work.
Furthermore, the stress for the surgeon and the health risk for the s patient are reduced, too. In particular, from the viewpoint of the patient it is a further advantage that a high aesthetic of the implanted defect area is obtained by the accurate adaptation of the implant to be generated to the defective range, and that surgical corrections, refinements as well as other follow-up operations are avoided or at to least reduced as to their extent and number.
DETAILED DESCRIPTION OF THE INV ELATION
In the following, the invention will be explained in more detail by virtue of the embodiments by reference to the following drawings, in which:
is Fig. 1 is a general view of the method according to the present invention, Fig. 2 shows more detail of the general view of the method according to the present invention, Zo Fig. 3 shows the preparation of medical two-dimensional image data, Fig. 4 shows the generation of a three-dimensional patient model, Fig. 5 shows an inversion model, Fig. 6 shows a three-dimensional reference model, and zs Fig. 7 shows a three-dimensional implant model.
As an example, the case of a patient will be illustrated who has a complicated large area defect (for example, resulting from an accident, a tumor etc.) in the upper half of the cranium. In Fig. 1 and 2 there are represented both, a general block diagrarnmatical overview and a s detailed block diagrammatical overview to illustrate the method according to the present invention.
For a precise diagnosis and for a later implant generation medical two-dimensional image data 1 (two-dimensional tomograms) of a defect area 5 and of the environment of the same (refer to Fig. 3) are taken io from a patient in' a radiological hospital department (for example by computer tomography or by nuclear magnetic resonance tomography).
By use of a mathematical image processing algorithm at first a contour detection is made in the two-dimensional image data 1 and subsequently a segmentation is carried out with the airn to detect the is hard tissue ranges (bones). As a result of the contour detection and segmentation two-dimensional image data 2 are obtained via which, by a respective spatial arrangement, a virtual three-dimensional patient model 3 (dotted model) is formed at least of the defect area 5 and environment.
Zo In a cooperation between a physician and a design engineer the defect area is precisely defined and marked in this virtual three-dimensional patient model 3 by utilizing user-specific computer programs especially applicable for this purpose.
Zs In the next step, the implant design engineer has several methods at his disposal for generating precisely fitting implants. These methods are:
1. When in a three-dimensional patient model 4 (shown in a cross-sectional view in Fig. 5), the defect area 5 is completely located in one body half, that is, entirely in one head side, then the data of this body side with the defect area 5 can, by inversion, be reconstructed, s making use of the bilateral symmetry of the human body, from the data of the undamaged side 7 of the three-dimensional patient model 4 (imaging of the undamaged side 7 at the plane of symmetry 6).
After inversion, an extraction of a virtual implant model 9 is carried out by use of mathematical algorithms which will here not be io referred to in more detail.
2. When in a three-dimensional patient model IO (shown in a lateral view in Fig. 6), the defect area 5 is located in the plane of symmetry of the human body or the data of the undamaged side cannot be is utilized, somehow or other, then the virtual implant model 9 can be generated via a three-dimensional reference model 11. To this end, specific features of the three-dimensional patient model 10 are compared to a reference database and a selection of similar models is made under consideration of mathematical, functional, medical Zo and aesthetic aspects. Then, the three-dimensional reference model 11 is selected from this range of models, preferably under particular consideration of the medical expert opinion. By superimposing the three-dimensional reference model 11 and the three-dimensional patient model 10 to one another, a virtual three-dimensional patient ?s model 12 will be obtained, from which, in turn, the virtual implant model 9 will be generated by computer, as described under item 1.
3. In special cases, when for example the defect partially lies in the plane of symmetry, both methods {inversion according to item 1 and database comparison according to item 2) can be used one after the s other and the results will be combined to a three-dimensional reference model for the implant modeling.
The selection and/or the shaping of the three-dimensional reference model after at least one of the methods mentioned hereinabove and the io generation of the virtual implant model from the three-dimensional reference model are performed merely by computation. By this processing both, a very rapid and a very precisely fitting generation and subsequent manufacture of the implant for the operative insert on the patient is given.
is The present virtual implant model 9 (Fig. 7) is subjected to various procedures after its generation. Said procedures may include, for example, strength calculations, simulations for the medical operation planning and the manufacture, as well as providing markings (bore holes, fixings or the like), quality control etc.
?o . After designing the virtual implant model 9, a generation/simulation of the CNC-data for the physical implant manufacture and the transfer of the virtual implant model into a usable implant are carried out.
LIST OF
REFERENCE
NUMERALS
1 - medical two-dimensional image data 2 - contour detection and segmentation two-dimensional image data 3 - three-dimensional patient model (dotted model) s 4 - three-dimensional patient model (cross-section) - - defect area 6 - plane of symmetry of human body 7 - undamaged side of the three-dimensional patient model 8 - inversion of undamaged side 7 io 9 - (virtual) implant model - three-dimensional patient model (lateral view) 11 - three-dimensional reference model 12 - . (virtual) three-dimensional patient model
Claims (10)
1. Method for manufacturing a patient-specific implant, comprising:
obtaining medical two-dimensional image data of a defect area in a patient requiring an implant and an environment thereof for a patient by computer tomography (CT) or nuclear magnetic resonance (NMR) tomography;
using a mathematical image processing algorithm to form a surface using the two-dimensional image data;
performing a segmentation to detect bones and hard tissue ranges;
generating a virtual three-dimensional model from the image data of at least the defect area in the patient requiring an implant and the environment thereof;
comparing the virtual three-dimensional model to real medical reference data;
selecting from the real medical reference data a set of said reference data best suited for the patient and forming a three-dimensional reference model object therefrom, the step of selecting the set of said reference data best suited for the patient and forming a reference model object therefrom comprising:
first selecting a plurality of sets of the reference data and forming a corresponding plurality of three-dimensional reference model objects therefrom most resembling the patient considering mathematical, functional, medical and aesthetic parameters; and then selecting one of said plurality of three-dimensional reference model objects best suited for the patient;
generating a virtual implant model from said selected one of said plurality of three-dimensional reference model objects by superimposing said selected one of said plurality of three-dimensional reference model objects with the virtual three-dimensional model; and manufacturing the implant by computer numeric control based on data from the virtual implant model.
obtaining medical two-dimensional image data of a defect area in a patient requiring an implant and an environment thereof for a patient by computer tomography (CT) or nuclear magnetic resonance (NMR) tomography;
using a mathematical image processing algorithm to form a surface using the two-dimensional image data;
performing a segmentation to detect bones and hard tissue ranges;
generating a virtual three-dimensional model from the image data of at least the defect area in the patient requiring an implant and the environment thereof;
comparing the virtual three-dimensional model to real medical reference data;
selecting from the real medical reference data a set of said reference data best suited for the patient and forming a three-dimensional reference model object therefrom, the step of selecting the set of said reference data best suited for the patient and forming a reference model object therefrom comprising:
first selecting a plurality of sets of the reference data and forming a corresponding plurality of three-dimensional reference model objects therefrom most resembling the patient considering mathematical, functional, medical and aesthetic parameters; and then selecting one of said plurality of three-dimensional reference model objects best suited for the patient;
generating a virtual implant model from said selected one of said plurality of three-dimensional reference model objects by superimposing said selected one of said plurality of three-dimensional reference model objects with the virtual three-dimensional model; and manufacturing the implant by computer numeric control based on data from the virtual implant model.
2. Method as claimed in claim 1, wherein the real medical reference data comprise a database.
3. Method as claimed in claim 1 or 2, wherein the real medical reference data comprises data from the patient.
4. Method as claimed in claim 1, wherein the virtual implant model is a three-dimensional virtual implant model.
5. Method as claimed in claim 1, wherein the selection of one of said plurality of three-dimensional reference model objects best suited for the patient is made in consideration of an expert medical opinion.
6. Method for manufacturing a patient-specific implant, comprising:
obtaining medical two-dimensional image data of a defect area in a patient requiring an implant and an environment thereof for a patient by computer tomography (CT) or nuclear magnetic resonance (NMR) tomography;
using a mathematical image processing algorithm to form a surface using the two-dimensional image data;
performing a segmentation to detect bones and hard tissue ranges;
generating a virtual three-dimensional model from the image data of at least the defect area in the patient requiring an implant and the environment thereof;
comparing the virtual three-dimensional model to real medical reference data;
selecting from the real medical reference data a set of said reference data best suited for the patient and forming a three-dimensional reference model object therefrom, the step of selecting the set of said reference data best suited for the patient and forming a reference model object therefrom comprising:
first selecting a plurality of three-dimensional reference model objects similar to the virtual three-dimensional model considering mathematical, functional, medical and aesthetic parameters; and then selecting one of said plurality of three-dimensional reference model objects best suited for the patient;
generating a virtual implant model from said selected one of said plurality of three-dimensional reference model objects by superimposing said selected one of said plurality of three-dimensional reference model objects with the virtual three-dimensional model; and manufacturing the implant by computer numeric control based on data from the virtual implant model.
obtaining medical two-dimensional image data of a defect area in a patient requiring an implant and an environment thereof for a patient by computer tomography (CT) or nuclear magnetic resonance (NMR) tomography;
using a mathematical image processing algorithm to form a surface using the two-dimensional image data;
performing a segmentation to detect bones and hard tissue ranges;
generating a virtual three-dimensional model from the image data of at least the defect area in the patient requiring an implant and the environment thereof;
comparing the virtual three-dimensional model to real medical reference data;
selecting from the real medical reference data a set of said reference data best suited for the patient and forming a three-dimensional reference model object therefrom, the step of selecting the set of said reference data best suited for the patient and forming a reference model object therefrom comprising:
first selecting a plurality of three-dimensional reference model objects similar to the virtual three-dimensional model considering mathematical, functional, medical and aesthetic parameters; and then selecting one of said plurality of three-dimensional reference model objects best suited for the patient;
generating a virtual implant model from said selected one of said plurality of three-dimensional reference model objects by superimposing said selected one of said plurality of three-dimensional reference model objects with the virtual three-dimensional model; and manufacturing the implant by computer numeric control based on data from the virtual implant model.
7. Method as claimed in claim 6, wherein the real medical reference data comprise a database.
8. Method as claimed in claim 6 or 7, wherein the real medical reference data comprises data from the patient.
9. Method as claimed in claim 6, wherein the virtual implant model is a three-dimensional implant model.
10. Method as claimed in claim 6, wherein the selection of one of said plurality of three-dimensional reference model objects best suited for the patient is made in consideration of an expert medical opinion.
Applications Claiming Priority (3)
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DE19922279A DE19922279A1 (en) | 1999-05-11 | 1999-05-11 | Procedure for generating patient-specific implants |
DE19922279.7 | 1999-05-11 | ||
PCT/EP2000/004166 WO2000068749A1 (en) | 1999-05-11 | 2000-05-10 | Method for generating patient-specific implants |
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CA2373691A1 CA2373691A1 (en) | 2000-11-16 |
CA2373691C true CA2373691C (en) | 2007-03-20 |
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CA002373691A Expired - Fee Related CA2373691C (en) | 1999-05-11 | 2000-05-10 | Method for generating patient-specific implants |
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US (1) | US6932842B1 (en) |
EP (1) | EP1208410B1 (en) |
JP (1) | JP2002543860A (en) |
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AT (1) | ATE285595T1 (en) |
AU (1) | AU5064800A (en) |
CA (1) | CA2373691C (en) |
DE (2) | DE19922279A1 (en) |
WO (1) | WO2000068749A1 (en) |
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DE19710273C1 (en) * | 1997-03-13 | 1998-08-20 | Heraeus Kulzer Gmbh | Method and device for processing workpieces in dental technology |
IL120892A (en) * | 1997-05-22 | 2000-08-31 | Cadent Ltd | Method for obtaining a dental occlusion map |
DE19724881A1 (en) * | 1997-06-12 | 1998-12-24 | Fraunhofer Ges Forschung | Manufacture of body with heterogeneous material structure, e.g. medical implant |
-
1999
- 1999-05-11 DE DE19922279A patent/DE19922279A1/en not_active Ceased
-
2000
- 2000-05-10 EP EP00934997A patent/EP1208410B1/en not_active Expired - Lifetime
- 2000-05-10 US US10/009,881 patent/US6932842B1/en not_active Expired - Fee Related
- 2000-05-10 JP JP2000616471A patent/JP2002543860A/en active Pending
- 2000-05-10 CN CN00807348A patent/CN1350667A/en active Pending
- 2000-05-10 AT AT00934997T patent/ATE285595T1/en not_active IP Right Cessation
- 2000-05-10 WO PCT/EP2000/004166 patent/WO2000068749A1/en active IP Right Grant
- 2000-05-10 DE DE50009047T patent/DE50009047D1/en not_active Expired - Lifetime
- 2000-05-10 CA CA002373691A patent/CA2373691C/en not_active Expired - Fee Related
- 2000-05-10 AU AU50648/00A patent/AU5064800A/en not_active Abandoned
Also Published As
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CA2373691A1 (en) | 2000-11-16 |
ATE285595T1 (en) | 2005-01-15 |
DE19922279A1 (en) | 2000-11-16 |
AU5064800A (en) | 2000-11-21 |
CN1350667A (en) | 2002-05-22 |
JP2002543860A (en) | 2002-12-24 |
EP1208410A1 (en) | 2002-05-29 |
WO2000068749A1 (en) | 2000-11-16 |
EP1208410B1 (en) | 2004-12-22 |
US6932842B1 (en) | 2005-08-23 |
DE50009047D1 (en) | 2005-01-27 |
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