ASTM F1719 - 96(2008) Standard Specification for Image-Interactive Stereotactic and Localization Systems (Withdrawn 2017).pdf

1、Designation: F1719 96 (Reapproved 2008)Standard Specification forImage-Interactive Stereotactic and Localization Systems1This standard is issued under the fixed designation F1719; the number immediately following the designation indicates the year oforiginal adoption or, in the case of revision, the

2、 year of last revision. A number in parentheses indicates the year of last reapproval. Asuperscript epsilon () indicates an editorial change since the last revision or reapproval.1. Scope1.1 This specification covers the combined use of stereot-actic instruments or systems with imaging techniques, t

3、o directa diagnostic or therapeutic modality into a specific targetwithin the brain, based on localization information derivedfrom such imaging techniques.1.2 For the purpose of this specification, a stereotacticinstrument or system is a guiding, aiming, or viewing deviceused in human neurosurgery f

4、or 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 three

5、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 F1266. The imagingtechnique must reliably and reproducibly genera

6、te 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 or vo

7、lume 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,reproducibility, and safety must be met for the im

8、agingmodality, the stereotactic system, and the method of interfacebetween the two, and for the system as a whole. The mechani-cal parts of the imaging modality and the stereotactic systemshould be constructed to allow maximal interaction withminimal interference with each other, to minimize imaging

9、artifact and distortion, and minimize potential contamination ofthe surgical field.1.4 General Types of Imaging that May Be Used WithStereotactic SystemsCurrently employed imaging modalitiesused in imaging-guided stereotactic systems includeradiography, angiography, computed tomography, magneticreso

10、nance imaging, ultrasound, biplane and multiplane digitalsubtraction angiography, and positron emission scanning.However, it is recognized that other modalities may be inter-faced with currently available and future stereotactic systemsand that new imaging modalities may evolve in the future.Standar

11、ds for imaging devices will be dealt with in documentsconcerning such 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 limitedto, hea

12、ting, cooling, irradiation, laser, injection, tissuetransplantation, mechanical or ultrasonic disruption, and anymodality ordinarily used in cerebrospinal surgery.1.6 ProbeAny system or modality directed by stereotactictechniques, including mechanical or other probe, a device thatis inserted into th

13、e brain or points to a target, and stereotacti-cally directed treatment or diagnostic modality.NOTE 1Examples presented throughout this specification are listed forclarity only; that does not imply that use should be restricted to theprocedures or examples listed.1.7 RobotA power-driven servo-contro

14、lled 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 frame, that identi

15、fies 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 pertains only to the

16、test 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 user1This specification is under the jurisdiction of ASTM Committee F04 onMedical and Surgical Materials and Dev

17、ices and is the direct responsibility ofSubcommittee F04.31 on Neurosurgical Standards.Current edition approved Feb. 1, 2008. Published March 2008. Originallyapproved in 1996. Last previous edition approved in 2002 as F1719 96 (2002).DOI: 10.1520/F1719-96R08.Copyright ASTM International, 100 Barr Ha

18、rbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United StatesNOTICE: This standard has either been superseded and replaced by a new version or withdrawn.Contact ASTM International (www.astm.org) for the latest information1of this standard to establish appropriate safety and healthpractice

19、s and determine the applicability of regulatory limita-tions prior to use.2. Referenced Documents2.1 ASTM Standards:2F1266 Performance Specification for Cerebral StereotacticInstruments3. Types of Imaging-Guided Stereotactic Systems3.1 Any type of stereotactic apparatus may be adapted toimaging-guid

20、ed 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 point lies at the center of anarc along which th

21、e 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.3.1.2 Rectilinear TypeThe rectilinear type provi

22、des 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 device thatis referenced to a specific entry point s

23、o 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 controlled andcan be directed to the target by indepen

24、dent 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 other device held by thearm. Such a system ordina

25、rily 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 structures within the head can bedemonstrated.3.1.6

26、Aprobe 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 general classification of cur-rent systems and

27、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 adapted tofunction as an image interactive locali

28、zation 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 follow-ing:3.2.1.1 Optical encoders that record th

29、e 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 position the probe of the stereotactic system.3.2.1.3

30、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 stereotactic apparatusconcepts discussed in 9.1.1. Rega

31、rdless 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 the systemis desirable, and it should be incorpo

32、rated 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/orientation of each joint. Calibration of the arm withr

33、espect 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 the known location ofreference points in three-dim

34、ensional 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 be used by the computerized image display system,

35、 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 StereotacticInstruments4.1 Some of the means used to relate

36、 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 by attaching an indicator to the table, that ca

37、n 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,2For referenced ASTM standards, visit the ASTM website, www.astm.org, orcontact ASTM Customer Service at serviceastm.org. For Annual

38、 Book of ASTMStandards volume information, refer to the standards Document Summary page onthe ASTM website.F1719 96 (2008)24.1.4 Including in the scanner plane markers or fiducialswhich can be used to calculate the position and inclination ofthe imaging slice,4.1.5 Using three-dimensional computer r

39、econstructiontechniques to determine both the position of the target and theposition of the apparatus, so these two positions might becorrelated. Such 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

40、 by stereotacticcoordinates.4.2 Imaging Systems:4.2.1 The region of interest may either be constituted byabnormal structures (brain lesions) identified with imagingsystems or normal anatomical structures (functionalstereotaxis), or both, to which the sensitivity of the imagingtechnique should be add

41、ressed. In case of normal structures,the location may need the use of standard atlases or tables andthe method of transposition and its accuracy should be ad-dressed. Previously, the conversion of X-ray coordinates tostereotactic space was performed with manual triangulation.With the development of

42、computed tomography and magneticresonance imaging technology, most conversion is often nowperformed utilizing computer software.4.2.2 The interface between imaging and stereotactic spacemay be performed by several methods; the identification of thelocation of normal structures within stereotactic sp

43、ace and thenthe use of standard atlases or other tables to define a givenanatomical location, the identification of the relationship ofnormal and abnormal structures using an imaging techniquewith subsequent reconstruction of this relationship within thestereotactic system, digitization and conversi

44、on of analogimaging data to stereotactic space, and transformation ofimaging data generated within the stereotactic system usingmanual transfer where 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 depend

45、ing of which system is used. Thesystem should incorporate, wherever feasible, an alternate orback-up method to compensate for possible primary systemfailure or distortion. It is recognized that, in the future, changesare likely to occur in both imaging and technology andcomputer technology, and thes

46、e standards should not beinterpreted in such a manner as to impair development of newsystems, as long as accuracy and safety requirements are met.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 ve

47、rified by the calibrationconsiderations outlined in 4.3 and 4.4.4.4 AccuracyIn addition to concerns of accuracy of eachof the components of the stereotactic systems, enumerated inother sections of this specification, the components shouldinterrelate in such a way that accuracy of the overall system

48、isnot compromised.4.5 Application Accuracy:4.5.1 Each system should include information from themanufacturer indicating the reproducible accuracy 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

49、might test the entire system toensure that the indicated accuracy and degree of confidence hasbeen preserved.4.5.2 MR-stereotactic Application AccuracySince 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, such user testingmight demonstrate inaccuracies inherent in an individualMR-stereotactic system.5. Anesthesia and Op