ASTM F1719-96(2002)
(Specification)Standard Specification for Image-Interactive Stereotactic and Localization Systems
Standard Specification for Image-Interactive Stereotactic and Localization Systems
SCOPE
1.1 This specification covers the combined use of stereotactic instruments or systems with imaging techniques, to direct a diagnostic or therapeutic modality into a specific target within the brain, based on localization information derived from such imaging techniques.
1.2 For the purpose of this specification, a stereotactic instrument or system is a guiding, aiming, or viewing device used in human neurosurgery for the purpose of manually directing a system or treating modality to a specific point within the brain by radiographic, imaging, or other visualization or identification of landmarks or targets or lesions.
1.3 Definition of Stereotactic Imaging Systems—Types of imaging-guided systems all require three components: an imaging system, a stereotactic frame, or other physical device to identify the position of a point in space, and a method to relate image-generated coordinates to frame or device coordinates. See Performance Specification F 1266. The imaging technique must reliably and reproducibly generate data concerning normal or abnormal anatomic structures, or both, that can interface with the coordinate system of the stereotactic frame or other stereotactic system. The imaging-guided systems must allow accurate direction of therapeutic, viewing or diagnostic modalities to a specific point or volume or along a specific trajectory within the brain or often accurate estimation of 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 imaging modality, the stereotactic system, and the method of interface between the two, and for the system as a whole. The mechanical parts of the imaging modality and the stereotactic system should be constructed to allow maximal interaction with minimal interference with each other, to minimize imaging artifact and distortion, and minimize potential contamination of the surgical field.
1.4 General Types of Imaging that May Be Used With Stereotactic Systems—Currently employed imaging modalities used in imaging-guided stereotactic systems include radiography, angiography, computed tomography, magnetic resonance imaging, ultrasound, biplane and multiplane digital subtraction angiography, and positron emission scanning. However, it is recognized that other modalities may be interfaced with currently available and future stereotactic systems and that new imaging modalities may evolve in the future. Standards for imaging devices will be dealt with in documents concerning such devices, and will not be addressed herein.
1.5 General types of diagnostic modalities include biopsy instruments, cannulas, endoscopes, electrodes, or other such instruments. Therapeutic modalities include, but are not limited to, heating, cooling, irradiation, laser, injection, tissue transplantation, mechanical or ultrasonic disruption, and any modality ordinarily used in cerebrospinal surgery.
1.6 Probe—Any system or modality directed by stereotactic techniques, including mechanical or other probe, a device that is inserted into the brain or points to a target, and stereotactically directed treatment or diagnostic modality.
Note 1—Examples presented throughout this specification are listed for clarity only; that does not imply that use should be restricted to the procedures or examples listed.
1.7 Robot—A power-driven servo-controlled system for controlling and advancing a probe according to a predetermined targeting program.
1.8 Digitizer—A device that is directed to indicate the position of a probe or point in stereotactic or other coordinates.
1.9 Frameless System—A system that does not require a stereotactic frame, that identifies and localizes a point or volume in space by means of data registration, and a method to relate that point or volume to its representation derived from an imaging system.
1.10 The values stated in SI ...
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Standards Content (Sample)
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Designation: F 1719 – 96 (Reapproved 2002)
Standard Specification for
Image-Interactive Stereotactic and Localization Systems
This standard is issued under the fixed designation F 1719; the number immediately following the designation indicates the year of
original adoption or, in the case of revision, the year of last revision. A number in parentheses indicates the year of last reapproval. A
superscript epsilon (e) indicates an editorial change since the last revision or reapproval.
1. Scope used in imaging-guided stereotactic systems include radiogra-
phy, angiography, computed tomography, magnetic resonance
1.1 This specification covers the combined use of stereotac-
imaging, ultrasound, biplane and multiplane digital subtraction
tic instruments or systems with imaging techniques, to direct a
angiography, and positron emission scanning. However, it is
diagnostic or therapeutic modality into a specific target within
recognized that other modalities may be interfaced with
the brain, based on localization information derived from such
currentlyavailableandfuturestereotacticsystemsandthatnew
imaging techniques.
imaging modalities may evolve in the future. Standards for
1.2 For the purpose of this specification, a stereotactic
imaging devices will be dealt with in documents concerning
instrument or system is a guiding, aiming, or viewing device
such devices, and will not be addressed herein.
used in human neurosurgery for the purpose of manually
1.5 General types of diagnostic modalities include biopsy
directing a system or treating modality to a specific point
instruments, cannulas, endoscopes, electrodes, or other such
within the brain by radiographic, imaging, or other visualiza-
instruments.Therapeuticmodalitiesinclude,butarenotlimited
tion or identification of landmarks or targets or lesions.
to, heating, cooling, irradiation, laser, injection, tissue trans-
1.3 Definition of Stereotactic Imaging Systems—Types of
plantation, mechanical or ultrasonic disruption, and any mo-
imaging-guided systems all require three components: an
dality ordinarily used in cerebrospinal surgery.
imaging system, a stereotactic frame, or other physical device
1.6 Probe—Any system or modality directed by stereotactic
to identify the position of a point in space, and a method to
techniques, including mechanical or other probe, a device that
relate image-generated coordinates to frame or device coordi-
is inserted into the brain or points to a target, and stereotacti-
nates. See Performance Specification F 1266. The imaging
cally directed treatment or diagnostic modality.
technique must reliably and reproducibly generate data con-
cerning normal or abnormal anatomic structures, or both, that
NOTE 1—Examples presented throughout this specification are listed
can interface with the coordinate system of the stereotactic for clarity only; that does not imply that use should be restricted to the
procedures or examples listed.
frame or other stereotactic system. The imaging-guided sys-
tems must allow accurate direction of therapeutic, viewing or
1.7 Robot—A power-driven servo-controlled system for
diagnostic modalities to a specific point or volume or along a
controlling and advancing a probe according to a predeter-
specific trajectory within the brain or often accurate estimation
mined targeting program.
of structure size and location allowing biopsy, resection,
1.8 Digitizer—A device that is directed to indicate the
vaporization, implantation, aspiration, or other manipulation,
position of a probe or point in stereotactic or other coordinates.
or combination thereof. The standards of accuracy, reproduc-
1.9 Frameless System—A system that does not require a
ibility, and safety must be met for the imaging modality, the
stereotactic frame, that identifies and localizes a point or
stereotactic system, and the method of interface between the
volume in space by means of data registration, and a method to
two,andforthesystemasawhole.Themechanicalpartsofthe
relatethatpointorvolumetoitsrepresentationderivedfroman
imaging modality and the stereotactic system should be con-
imaging system.
structed to allow maximal interaction with minimal interfer-
1.10 The values stated in SI units are to be regarded as the
ence with each other, to minimize imaging artifact and distor-
standard.
tion, and minimize potential contamination of the surgical
1.11 Thefollowingprecautionarycaveatpertainsonlytothe
field.
test method portion, Section 3, of this specification: This
1.4 General Types of Imaging that May Be Used With
standard does not purport to address all of the safety concerns,
Stereotactic Systems—Currently employed imaging modalities
if any, associated with its use. It is the responsibility of the user
of this standard to establish appropriate safety and health
practices and determine the applicability of regulatory limita-
This specification is under the jurisdiction of ASTM Committee F04 on
tions prior to use.
Medical and Surgical Materials and Devices and is the direct responsibility of
Subcommittee F04.31 on Neurosurgical Standards.
Current edition approved June 10, 1996. Published October 1996.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.
F 1719 – 96 (2002)
2. Referenced Documents dimensional space with the computerized image display sys-
tem. These means of communication may include the follow-
2.1 ASTM Standards:
ing:
F 1266 Performance Specification for Cerebral Stereotactic
2 3.2.1.1 Optical encoders that record the amount of displace-
Instruments
ment on the set of coordinates axis and arcs that are used to
position the probe of the stereotactic system.
3. Types of Imaging-Guided Stereotactic Systems
3.2.1.2 Mechanical encoders that record the amount of
3.1 Any type of stereotactic apparatus may be adapted to
displacement set on the coordinate axis and arcs that are used
imaging-guided stereotactic surgery. A stereotactic system can
to position the probe of the stereotactic system.
be based on one or more of the following concepts:
3.2.1.3 Other means of recording the amount of displace-
3.1.1 Arc-Centered Type—A target centered arc with recti-
ment set on the coordinate axis and arcs that are used to
linear adjustments is constructed according to the spherical
position the probe of the stereotactic system.
radius principle so that the target point lies at the center of an
3.2.2 Systems may be designed for image interactive local-
arc along which the probe holder moves, so that when a probe
ization that do not incorporate the stereotactic apparatus
is inserted into the probe holder perpendicular to a tangent of
concepts discussed in 9.1.1. Regardless of whether these
the arc and for a distance equal to the radius of the arc, the tip
systems are framed-based, table-based or room-(space) based,
of the probe arrives at a single point in space, that is, the
they employ a means for generating a probe orientation in
stereotactic target.
three-dimensional space that can be used by the computerized
3.1.2 Rectilinear Type—The rectilinear type provides indi-
image display system. Intraoperative calibration of the system
vidually for the longitudinal, transverse, and vertical move-
is desirable, and it should be incorporated where practical.
ments of the probe holder or the patient, or both, perpendicular
Means for generating a probe orientation in three-dimensional
to or at an angle to the planes along which the probe holder is
space may include the following:
moved.
3.2.2.1 Multiple-degree-of-freedom “robotic” arms that use
3.1.3 Aiming Type of Stereotactic Apparatus—Adevice that
optical, mechanical, or other types of encoders to register the
is referenced to a specific entry point so the probe can be
position/orientation of each joint. Calibration of the arm with
pointed to the desired target point and then advanced to it.
respect to the known location of reference points in three-
3.1.4 Multiple-Arc Type—An arc system that is not target
dimensional space is usually required.
centered and is a system of interlocking arcs, pivots, or joints
3.2.2.2 Systems that use optical or sonic information to
arranged so that the orientation of the probe is controlled and
triangulate the location and orientation of the probe. Calibra-
can be directed to the target by independent movement of the
tion of the system with respect to the known location of
elements. As the depth of each target may be different relative
reference points in three-dimensional space is usually required.
to the arc system, means for determining target depth must be
3.2.2.3 Six-degree-of-freedom electromagnetic receiver/
provided.
transmitters that may or may not require intraoperative cali-
3.1.5 An articulated arm that allows accurate determination
bration of the three-dimensional space.
of the position in space of a probe or other device held by the
3.2.2.4 Other alignment by means of generated information
arm. Such a system ordinarily is coupled with computer
may be used by the computerized image display system, with
graphics to allow identification of the location of the probe in
or without three-dimensional space calibration.
relation to the position of the head in space. By relating the
3.2.3 The above represents a general classification of cur-
position of the head and the graphic image, the position of the
rent systems or systems currently in development and does not
probe relative to the head or structures within the head can be
preclude future development.
demonstrated.
4. Applications of Imaging Techniques to Stereotactic
3.1.6 Aprobewhosepositionandmovementinspacecanbe
Instruments
detected, calibrated, and related to the position on the patient’s
4.1 Some of the means used to relate an imaging system to
head or intracranial target by a nonmechanical modality, such
stereotactic apparatus may be mated by:
as infrared, visual light, sound, or ultrasound.
4.1.1 Attaching the apparatus to the table during imaging
3.1.7 The above represents a general classification of cur-
and relating the position of the slice to fiducials on the
rent systems and does not preclude future developments. Any
apparatus,
given system may represent any of the above types of
4.1.2 Relating the height of the image to the stereotactic
stereotactic device or may be a combination of two or more
apparatusbyattachinganindicatortothetable,thatcanthenbe
systems.
used as a phantom to adjust the apparatus,
3.2 Image Interactive Localization Systems:
4.1.3 Employing a translational imaging technique to relate
3.2.1 Any type of stereotactic apparatus may be adapted to
the position of the image to the head or to the apparatus,
function as an image interactive localization system. For such
4.1.4 Including in the scanner plane markers or fiducials
to occur, it is necessary for the stereotactic apparatus to be
which can be used to calculate the position and inclination of
equipped with a means for relating its location in three-
the imaging slice,
4.1.5 Using three-dimensional computer reconstruction
techniques to determine both the position of the target and the
Annual Book of ASTM Standards, Vol 13.01. position of the apparatus, so these two positions might be
F 1719 – 96 (2002)
correlated. Such techniques may make possible the visualiza- cies imposed in an individual case. Also, since accuracy of
tion of the volume and shape of the target in space, so that each magnetic resonance imaging scanners varies from one scanner
point in the entire target can be defined by stereotactic to another and from one technique to another, such user testing
coordinates. might demonstrate inaccuracies inherent in an individual
MR-stereotactic system.
4.2 Imaging Systems:
4.2.1 The region of interest may either be constituted by
5. Anesthesia and Operating Room Safety
abnormal structures (brain lesions) identified with imaging
5.1 Scope—This specification is concerned with the defini-
systems or normal anatomical structures (functional stereo-
tions and standards that are required in the design of imaging-
taxis), or both, to which the sensitivity of the imaging
guided stereotactic systems to ensure patient and operating
technique should be addressed. In case of normal structures,
room personnel safety during the administration of anesthesia
the location may need the use of standard atlases or tables and
for imaging-guided stereotactic procedures.
the method of transposition and its accuracy should be ad-
5.2 Definition—For the purpose of this specification, gen-
dressed. Previously, the conversion of X-ray coordinates to
eral anesthesia may be defined as a state of altered conscious-
stereotactic space was performed with manual triangulation.
ness occurring as a result of drug administration by intrave-
With the development of computed tomography and magnetic
nous, intramuscular, inhalational, or oral routes.
resonance imaging technology, most conversion is often now
5.3 The choice of type of anesthesia (general versus moni-
performed utilizing computer software.
tored versus local) is the responsibility of the operating
4.2.2 The interface between imaging and stereotactic space
surgeon, with consultation with the anesthesiologist as indi-
may be performed by several methods; the identification of the
cated. The choice of anesthetic agent and means of adminis-
location of normal structures within stereotactic space and then
tration is the responsibility of the anesthesiologist after con-
the use of standard atlases or other tables to define a given
sultation with the operating surgeon.
anatomical location, the identification of the relationship of
5.4 General Requirements—The standards for the use of
normal and abnormal structures using an imaging technique
anesthesthetics with imaging-guided stereotactic surgery are
with subsequent reconstruction of this relationship within the
the same as indicated in Performance Specification F 1266.
stereotactic system, digitization and conversion of analog
5.5 Specific Requirements:
imaging data to stereotactic space, and transformation of
5.5.1 Disconnect System—The mechanism to connect or
imaging data generated within the stereotactic system using
rapidly disconnect the patient from that part of the imaging-
manual transfer where indicated.
guided stereotactic apparatus as may be necessary in an
4.2.3 Imaging may be based on visualization in a slice, a
emergency must be easily accessible, quickly operative, and
reconstructed plane, or be represented by a volume, and the
independent of electrical supply, as may be necessary to
accuracy may vary depending of which system is used. The
manage any untoward drug reaction, excess secretions to
system should incorporate, wherever feasi
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