1、Designation: F 1719 96 (Reapproved 2002)Standard Specification forImage-Interactive Stereotactic and Localization Systems1This standard is issued under the fixed designation F 1719; the number immediately following the designation indicates the year oforiginal adoption or, in the case of revision, t
2、he year of last revision. A number in parentheses indicates the year of last reapproval. Asuperscript epsilon (e) indicates an editorial change since the last revision or reapproval.1. Scope1.1 This specification covers the combined use of stereotac-tic instruments or systems with imaging techniques
3、, to direct adiagnostic or therapeutic modality into a specific target withinthe brain, based on localization information derived from suchimaging techniques.1.2 For the purpose of this specification, a stereotacticinstrument or system is a guiding, aiming, or viewing deviceused in human neurosurger
4、y for the purpose of manuallydirecting a system or treating modality to a specific pointwithin the brain by radiographic, imaging, or other visualiza-tion or identification of landmarks or targets or lesions.1.3 Definition of Stereotactic Imaging SystemsTypes ofimaging-guided systems all require thr
5、ee components: animaging system, a stereotactic frame, or other physical deviceto identify the position of a point in space, and a method torelate image-generated coordinates to frame or device coordi-nates. See Performance Specification F 1266. The imagingtechnique must reliably and reproducibly ge
6、nerate data con-cerning normal or abnormal anatomic structures, or both, thatcan interface with the coordinate system of the stereotacticframe or other stereotactic system. The imaging-guided sys-tems must allow accurate direction of therapeutic, viewing ordiagnostic modalities to a specific point o
7、r volume or along aspecific trajectory within the brain or often accurate estimationof structure size and location allowing biopsy, resection,vaporization, implantation, aspiration, or other manipulation,or combination thereof. The standards of accuracy, reproduc-ibility, and safety must be met for
8、the imaging modality, thestereotactic system, and the method of interface between thetwo, and for the system as a whole. The mechanical parts of theimaging modality and the stereotactic system should be con-structed to allow maximal interaction with minimal interfer-ence with each other, to minimize
9、 imaging artifact and distor-tion, and minimize potential contamination of the surgicalfield.1.4 General Types of Imaging that May Be Used WithStereotactic SystemsCurrently employed imaging modalitiesused in imaging-guided stereotactic systems include radiogra-phy, angiography, computed tomography,
10、magnetic resonanceimaging, ultrasound, biplane and multiplane digital subtractionangiography, and positron emission scanning. However, it isrecognized that other modalities may be interfaced withcurrently available and future stereotactic systems and that newimaging modalities may evolve in the futu
11、re. Standards forimaging devices will be dealt with in documents concerningsuch devices, and will not be addressed herein.1.5 General types of diagnostic modalities include biopsyinstruments, cannulas, endoscopes, electrodes, or other suchinstruments. Therapeutic modalities include, but are not limi
12、tedto, heating, cooling, irradiation, laser, injection, tissue trans-plantation, mechanical or ultrasonic disruption, and any mo-dality ordinarily used in cerebrospinal surgery.1.6 ProbeAny system or modality directed by stereotactictechniques, including mechanical or other probe, a device thatis in
13、serted into the brain or points to a target, and stereotacti-cally directed treatment or diagnostic modality.NOTE 1Examples presented throughout this specification are listedfor clarity only; that does not imply that use should be restricted to theprocedures or examples listed.1.7 RobotA power-drive
14、n servo-controlled system forcontrolling and advancing a probe according to a predeter-mined targeting program.1.8 DigitizerA device that is directed to indicate theposition of a probe or point in stereotactic or other coordinates.1.9 Frameless SystemA system that does not require astereotactic fram
15、e, that identifies and localizes a point orvolume in space by means of data registration, and a method torelate that point or volume to its representation derived from animaging system.1.10 The values stated in SI units are to be regarded as thestandard.1.11 The following precautionary caveat pertai
16、ns only to thetest method portion, Section 3, of this specification: Thisstandard does not purport to address all of the safety concerns,if any, associated with its use. It is the responsibility of the userof this standard to establish appropriate safety and healthpractices and determine the applica
17、bility of regulatory limita-tions prior to use.1This specification is under the jurisdiction of ASTM Committee F04 onMedical and Surgical Materials and Devices and is the direct responsibility ofSubcommittee F04.31 on Neurosurgical Standards.Current edition approved June 10, 1996. Published October
18、1996.1Copyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.2. Referenced Documents2.1 ASTM Standards:F 1266 Performance Specification for Cerebral StereotacticInstruments23. Types of Imaging-Guided Stereotactic Systems3.1 Any type of stere
19、otactic apparatus may be adapted toimaging-guided stereotactic surgery. A stereotactic system canbe based on one or more of the following concepts:3.1.1 Arc-Centered TypeA target centered arc with recti-linear adjustments is constructed according to the sphericalradius principle so that the target p
20、oint lies at the center of anarc along which the probe holder moves, so that when a probeis inserted into the probe holder perpendicular to a tangent ofthe arc and for a distance equal to the radius of the arc, the tipof the probe arrives at a single point in space, that is, thestereotactic target.3
21、.1.2 Rectilinear TypeThe rectilinear type provides indi-vidually for the longitudinal, transverse, and vertical move-ments of the probe holder or the patient, or both, perpendicularto or at an angle to the planes along which the probe holder ismoved.3.1.3 Aiming Type of Stereotactic ApparatusA devic
22、e thatis referenced to a specific entry point so the probe can bepointed to the desired target point and then advanced to it.3.1.4 Multiple-Arc TypeAn arc system that is not targetcentered and is a system of interlocking arcs, pivots, or jointsarranged so that the orientation of the probe is control
23、led andcan be directed to the target by independent movement of theelements. As the depth of each target may be different relativeto the arc system, means for determining target depth must beprovided.3.1.5 An articulated arm that allows accurate determinationof the position in space of a probe or ot
24、her device held by thearm. Such a system ordinarily is coupled with computergraphics to allow identification of the location of the probe inrelation to the position of the head in space. By relating theposition of the head and the graphic image, the position of theprobe relative to the head or struc
25、tures within the head can bedemonstrated.3.1.6 A probe whose position and movement in space can bedetected, calibrated, and related to the position on the patientshead or intracranial target by a nonmechanical modality, suchas infrared, visual light, sound, or ultrasound.3.1.7 The above represents a
26、 general classification of cur-rent systems and does not preclude future developments. Anygiven system may represent any of the above types ofstereotactic device or may be a combination of two or moresystems.3.2 Image Interactive Localization Systems:3.2.1 Any type of stereotactic apparatus may be a
27、dapted tofunction as an image interactive localization system. For suchto occur, it is necessary for the stereotactic apparatus to beequipped with a means for relating its location in three-dimensional space with the computerized image display sys-tem. These means of communication may include the fo
28、llow-ing:3.2.1.1 Optical encoders that record the amount of displace-ment on the set of coordinates axis and arcs that are used toposition the probe of the stereotactic system.3.2.1.2 Mechanical encoders that record the amount ofdisplacement set on the coordinate axis and arcs that are usedto positi
29、on the probe of the stereotactic system.3.2.1.3 Other means of recording the amount of displace-ment set on the coordinate axis and arcs that are used toposition the probe of the stereotactic system.3.2.2 Systems may be designed for image interactive local-ization that do not incorporate the stereot
30、actic apparatusconcepts discussed in 9.1.1. Regardless of whether thesesystems are framed-based, table-based or room-(space) based,they employ a means for generating a probe orientation inthree-dimensional space that can be used by the computerizedimage display system. Intraoperative calibration of
31、the systemis desirable, and it should be incorporated where practical.Means for generating a probe orientation in three-dimensionalspace may include the following:3.2.2.1 Multiple-degree-of-freedom “robotic” arms that useoptical, mechanical, or other types of encoders to register theposition/orienta
32、tion of each joint. Calibration of the arm withrespect to the known location of reference points in three-dimensional space is usually required.3.2.2.2 Systems that use optical or sonic information totriangulate the location and orientation of the probe. Calibra-tion of the system with respect to th
33、e known location ofreference points in three-dimensional space is usually required.3.2.2.3 Six-degree-of-freedom electromagnetic receiver/transmitters that may or may not require intraoperative cali-bration of the three-dimensional space.3.2.2.4 Other alignment by means of generated informationmay b
34、e used by the computerized image display system, withor without three-dimensional space calibration.3.2.3 The above represents a general classification of cur-rent systems or systems currently in development and does notpreclude future development.4. Applications of Imaging Techniques to Stereotacti
35、cInstruments4.1 Some of the means used to relate an imaging system tostereotactic apparatus may be mated by:4.1.1 Attaching the apparatus to the table during imagingand relating the position of the slice to fiducials on theapparatus,4.1.2 Relating the height of the image to the stereotacticapparatus
36、 by attaching an indicator to the table, that can then beused as a phantom to adjust the apparatus,4.1.3 Employing a translational imaging technique to relatethe position of the image to the head or to the apparatus,4.1.4 Including in the scanner plane markers or fiducialswhich can be used to calcul
37、ate the position and inclination ofthe imaging slice,4.1.5 Using three-dimensional computer reconstructiontechniques to determine both the position of the target and theposition of the apparatus, so these two positions might be2Annual Book of ASTM Standards, Vol 13.01.F 1719 96 (2002)2correlated. Su
38、ch techniques may make possible the visualiza-tion of the volume and shape of the target in space, so that eachpoint in the entire target can be defined by stereotacticcoordinates.4.2 Imaging Systems:4.2.1 The region of interest may either be constituted byabnormal structures (brain lesions) identif
39、ied with imagingsystems or normal anatomical structures (functional stereo-taxis), or both, to which the sensitivity of the imagingtechnique should be addressed. In case of normal structures,the location may need the use of standard atlases or tables andthe method of transposition and its accuracy s
40、hould be ad-dressed. Previously, the conversion of X-ray coordinates tostereotactic space was performed with manual triangulation.With the development of computed tomography and magneticresonance imaging technology, most conversion is often nowperformed utilizing computer software.4.2.2 The interfac
41、e between imaging and stereotactic spacemay be performed by several methods; the identification of thelocation of normal structures within stereotactic space and thenthe use of standard atlases or other tables to define a givenanatomical location, the identification of the relationship ofnormal and
42、abnormal structures using an imaging techniquewith subsequent reconstruction of this relationship within thestereotactic system, digitization and conversion of analogimaging data to stereotactic space, and transformation ofimaging data generated within the stereotactic system usingmanual transfer wh
43、ere indicated.4.2.3 Imaging may be based on visualization in a slice, areconstructed plane, or be represented by a volume, and theaccuracy may vary depending of which system is used. Thesystem should incorporate, wherever feasible, an alternate orback-up method to compensate for possible primary sys
44、temfailure or distortion. It is recognized that, in the future, changesare likely to occur in both imaging and technology andcomputer technology, and these standards should not beinterpreted in such a manner as to impair development of newsystems, as long as accuracy and safety requirements are met.
45、4.3 Stereotactic Frame RequirementsIt should be possibleto use the frame with an imaging system or systems for whichit has been designed or adapted, as verified by the calibrationconsiderations outlined in 4.3 and 4.4.4.4 AccuracyIn addition to concerns of accuracy of eachof the components of the st
46、ereotactic systems, enumerated inother sections of this specification, the components shouldinterrelate in such a way that accuracy of the overall system isnot compromised.4.5 Application Accuracy:4.5.1 Each system should include information from themanufacturer indicating the reproducible accuracy
47、of the entiresystem in use for each imaging modality with which the systemis to be used, how such accuracy was determined, andinstructions so the surgeon might test the entire system toensure that the indicated accuracy and degree of confidence hasbeen preserved.4.5.2 MR-stereotactic Application Acc
48、uracySince non-linear distortion is an inherent property of magnetic resonancescanning, the surgeon should be aware of potential inaccura-cies imposed in an individual case. Also, since accuracy ofmagnetic resonance imaging scanners varies from one scannerto another and from one technique to another
49、, such user testingmight demonstrate inaccuracies inherent in an individualMR-stereotactic system.5. Anesthesia and Operating Room Safety5.1 ScopeThis specification is concerned with the defini-tions and standards that are required in the design of imaging-guided stereotactic systems to ensure patient and operatingroom personnel safety during the administration of anesthesiafor imaging-guided stereotactic procedures.5.2 DefinitionFor the purpose of this specification, gen-eral anesthesia may be defined as a state of altered conscious-ness occurring as a result of drug ad
