ASTM F1719-96

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.

General Information

• Status: Historical
• Publication Date: 31-Dec-1995
• Technical Committee: F04 - Medical and Surgical Materials and Devices
• Drafting Committee: F04.31 - Neurosurgical Standards

Relations

• Replaced By: ASTM F1719-96(2002) - Standard Specification for Image-Interactive Stereotactic and Localization Systems
• Effective Date: 10-Jun-1996

Standards Content (Sample)

NOTICE: This standard has either been superseded and replaced by a new version or discontinued.
Contact ASTM International (www.astm.org) for the latest information.
Designation: F 1719 – 96
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 angiography, and positron emission scanning. However, it is
recognized that other modalities may be interfaced with
1.1 This specification covers the combined use of stereotac-
currently available and future stereotactic systems and that new
tic instruments or systems with imaging techniques, to direct a
imaging modalities may evolve in the future. Standards for
diagnostic or therapeutic modality into a specific target within
imaging devices will be dealt with in documents concerning
the brain, based on localization information derived from such
such devices, and will not be addressed herein.
imaging techniques.
1.5 General types of diagnostic modalities include biopsy
1.2 For the purpose of this specification, a stereotactic
instruments, cannulas, endoscopes, electrodes, or other such
instrument or system is a guiding, aiming, or viewing device
instruments. Therapeutic modalities include, but are not limited
used in human neurosurgery for the purpose of manually
to, heating, cooling, irradiation, laser, injection, tissue trans-
directing a system or treating modality to a specific point
plantation, mechanical or ultrasonic disruption, and any mo-
within the brain by radiographic, imaging, or other visualiza-
dality ordinarily used in cerebrospinal surgery.
tion or identification of landmarks or targets or lesions.
1.6 Probe—Any system or modality directed by stereotactic
1.3 Definition of Stereotactic Imaging Systems—Types of
techniques, including mechanical or other probe, a device that
imaging-guided systems all require three components: an
is inserted into the brain or points to a target, and stereotacti-
imaging system, a stereotactic frame, or other physical device
cally directed treatment or diagnostic modality.
to identify the position of a point in space, and a method to
relate image-generated coordinates to frame or device coordi-
NOTE 1—Examples presented throughout this specification are listed
nates. See Performance Specification F 1266. The imaging
for clarity only; that does not imply that use should be restricted to the
procedures or examples listed.
technique must reliably and reproducibly generate data con-
cerning normal or abnormal anatomic structures, or both, that
1.7 Robot—A power-driven servo-controlled system for
can interface with the coordinate system of the stereotactic
controlling and advancing a probe according to a predeter-
frame or other stereotactic system. The imaging-guided sys-
mined targeting program.
tems must allow accurate direction of therapeutic, viewing or
1.8 Digitizer—A device that is directed to indicate the
diagnostic modalities to a specific point or volume or along a
position of a probe or point in stereotactic or other coordinates.
specific trajectory within the brain or often accurate estimation
1.9 Frameless System—A system that does not require a
of structure size and location allowing biopsy, resection,
stereotactic frame, that identifies and localizes a point or
vaporization, implantation, aspiration, or other manipulation,
volume in space by means of data registration, and a method to
or combination thereof. The standards of accuracy, reproduc-
relate that point or volume to its representation derived from an
ibility, and safety must be met for the imaging modality, the
imaging system.
stereotactic system, and the method of interface between the
1.10 The values stated in SI units are to be regarded as the
two, and for the system as a whole. The mechanical parts of the
standard.
imaging modality and the stereotactic system should be con-
1.11 The following precautionary caveat pertains only to the
structed to allow maximal interaction with minimal interfer-
test method portion, Section 3, of this specification: This
ence with each other, to minimize imaging artifact and distor-
standard does not purport to address all of the safety concerns,
tion, and minimize potential contamination of the surgical
if any, associated with its use. It is the responsibility of the user
field.
of this standard to establish appropriate safety and health
1.4 General Types of Imaging that May Be Used With
practices and determine the applicability of regulatory limita-
Stereotactic Systems—Currently employed imaging modalities
tions prior to use.
used in imaging-guided stereotactic systems include radiogra-
2. Referenced Documents
phy, angiography, computed tomography, magnetic resonance
imaging, ultrasound, biplane and multiplane digital subtraction
2.1 ASTM Standards:
F 1266 Performance Specification for Cerebral Stereotactic
Instruments
This specification is under the jurisdiction of ASTM Committee F-4 on Medical
and Surgical Materials and Devices and is the direct responsibility of Subcommittee
F04.50 on Neurosurgical Standards.
Current edition approved June 10, 1996. Published October 1996. Annual Book of ASTM Standards, Vol 13.01.
Copyright © ASTM, 100 Barr Harbor Drive, West Conshohocken, PA 19428-2959, United States.
NOTICE: This standard has either been superseded and replaced by a new version or discontinued.
Contact ASTM International (www.astm.org) for the latest information.
F 1719
3. Types of Imaging-Guided Stereotactic Systems ment set on the coordinate axis and arcs that are used to
position the probe of the stereotactic system.
3.1 Any type of stereotactic apparatus may be adapted to
3.2.2 Systems may be designed for image interactive local-
imaging-guided stereotactic surgery. A stereotactic system can
ization that do not incorporate the stereotactic apparatus
be based on one or more of the following concepts:
concepts discussed in 9.1.1. Regardless of whether these
3.1.1 Arc-Centered Type—A target centered arc with recti-
systems are framed-based, table-based or room-(space) based,
linear adjustments is constructed according to the spherical
they employ a means for generating a probe orientation in
radius principle so that the target point lies at the center of an
three-dimensional space that can be used by the computerized
arc along which the probe holder moves, so that when a probe
image display system. Intraoperative calibration of the system
is inserted into the probe holder perpendicular to a tangent of
is desirable, and it should be incorporated where practical.
the arc and for a distance equal to the radius of the arc, the tip
Means for generating a probe orientation in three-dimensional
of the probe arrives at a single point in space, that is, the
space may include the following:
stereotactic target.
3.2.2.1 Multiple-degree-of-freedom “robotic” arms that use
3.1.2 Rectilinear Type—The rectilinear type provides indi-
optical, mechanical, or other types of encoders to register the
vidually for the longitudinal, transverse, and vertical move-
position/orientation of each joint. Calibration of the arm with
ments of the probe holder or the patient, or both, perpendicular
respect to the known location of reference points in three-
to or at an angle to the planes along which the probe holder is
dimensional space is usually required.
moved.
3.2.2.2 Systems that use optical or sonic information to
3.1.3 Aiming Type of Stereotactic Apparatus—A device that
triangulate the location and orientation of the probe. Calibra-
is referenced to a specific entry point so the probe can be
tion of the system with respect to the known location of
pointed to the desired target point and then advanced to it.
reference points in three-dimensional space is usually required.
3.1.4 Multiple-Arc Type—An arc system that is not target
3.2.2.3 Six-degree-of-freedom electromagnetic receiver/
centered and is a system of interlocking arcs, pivots, or joints
transmitters that may or may not require intraoperative cali-
arranged so that the orientation of the probe is controlled and
bration of the three-dimensional space.
can be directed to the target by independent movement of the
3.2.2.4 Other alignment by means of generated information
elements. As the depth of each target may be different relative
may be used by the computerized image display system, with
to the arc system, means for determining target depth must be
or without three-dimensional space calibration.
provided.
3.2.3 The above represents a general classification of cur-
3.1.5 An articulated arm that allows accurate determination
rent systems or systems currently in development and does not
of the position in space of a probe or other device held by the
preclude future development.
arm. Such a system ordinarily is coupled with computer
graphics to allow identification of the location of the probe in
4. Applications of Imaging Techniques to Stereotactic
relation to the position of the head in space. By relating the
Instruments
position of the head and the graphic image, the position of the
4.1 Some of the means used to relate an imaging system to
probe relative to the head or structures within the head can be
stereotactic apparatus may be mated by:
demonstrated.
4.1.1 Attaching the apparatus to the table during imaging
3.1.6 A probe whose position and movement in space can be
and relating the position of the slice to fiducials on the
detected, calibrated, and related to the position on the patient’s
apparatus,
head or intracranial target by a nonmechanical modality, such
4.1.2 Relating the height of the image to the stereotactic
as infrared, visual light, sound, or ultrasound.
apparatus by attaching an indicator to the table, that can then be
3.1.7 The above represents a general classification of cur-
used as a phantom to adjust the apparatus,
rent systems and does not preclude future developments. Any
4.1.3 Employing a translational imaging technique to relate
given system may represent any of the above types of
the position of the image to the head or to the apparatus,
stereotactic device or may be a combination of two or more
4.1.4 Including in the scanner plane markers or fiducials
systems.
which can be used to calculate the position and inclination of
3.2 Image Interactive Localization Systems:
the imaging slice,
3.2.1 Any type of stereotactic apparatus may be adapted to
4.1.5 Using three-dimensional computer reconstruction
function as an image interactive localization system. For such
techniques to determine both the position of the target and the
to occur, it is necessary for the stereotactic apparatus to be
position of the apparatus, so these two positions might be
equipped with a means for relating its location in threedimen-
correlated. Such techniques may make possible the visualiza-
sional space with the computerized image display system.
tion of the volume and shape of the target in space, so that each
These means of communication may include the following:
point in the entire target can be defined by stereotactic
3.2.1.1 Optical encoders that record the amount of displace-
coordinates.
ment on the set of coordinates axis and arcs that are used to
4.2 Imaging Systems:
position the probe of the stereotactic system.
4.2.1 The region of interest may either be constituted by
3.2.1.2 Mechanical encoders that record the amount of
abnormal structures (brain lesions) identified with imaging
displacement set on the coordinate axis and arcs that are used systems or normal anatomical structures (functional stereo-
to position the probe of the stereotactic system.
taxis), or both, to which the sensitivity of the imaging
3.2.1.3 Other means of recording the amount of displace- technique should be addressed. In case of normal structures,
NOTICE: This standard has either been superseded and replaced by a new version or discontinued.
Contact ASTM International (www.astm.org) for the latest information.
F 1719
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 feasible, an alternate or
cardiopulmonary failure during either the imaging or surgical
back-up method to compensate for possible primary system
part of the procedure.
failure or distortion. It is recognized that, in the f
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