ASTM F1719-96(2008)

Standard Specification for Image-Interactive Stereotactic and Localization Systems (Withdrawn 2017)

ABSTRACT
This specification covers the different types, appropriate applicability, and safety and sterilizability requirements that pertain to 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. 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.
SIGNIFICANCE AND USE
The following uses of imaging-guided stereotactic surgery have been documented in the literature, and are presented as examples. This list is not inclusive of all the techniques presently being used, and certainly does not reflect nor intend to impede the development of new techniques in the future:
Biopsy of intracranial tissue,
Implantation of radioisotopes by various techniques,
Aspiration of cysts,
Aspiration of abcesses,
Instillation of therapeutic agents, including antibiotics, chemotherapeutic agents, tissue, drugs, and neurotransmitters,
Insertion of electrodes for recording of electrical activity or impedance,
Insertion of probes for lesion production in functional neurosurgery,
Insertion of electrodes for stimulation,
Aspiration of hematomas,
Resection of mass lesions,
Laser vaporization or removal of intracranial tissue,
Guidance of externally delivered radiation therapy,
Adjunct to open surgical procedures,
Placement of catheters into ventricles, cysts, and so forth, and
Hyperthermia.
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, co...

General Information

• Status: Withdrawn
• Publication Date: 31-Jan-2008
• Withdrawal Date: 16-Jul-2017
• ICS: 11.040.99 - Other medical equipment
• Technical Committee: F04 - Medical and Surgical Materials and Devices
• Drafting Committee: F04.31 - Neurosurgical Standards

Relations

• Replaces: ASTM F1719-96(2002) - Standard Specification for Image-Interactive Stereotactic and Localization Systems
• Effective Date: 01-Feb-2008

Standards Content (Sample)

NOTICE: This standard has either been superseded and replaced by a new version or withdrawn.
Contact ASTM International (www.astm.org) for the latest information
Designation: F1719 −96 (Reapproved 2008)
Standard Specification for
Image-Interactive Stereotactic and Localization Systems
This standard is issued under the fixed designation F1719; 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 (´) indicates an editorial change since the last revision or reapproval.
1. Scope 1.4 General Types of Imaging that May Be Used With
Stereotactic Systems—Currently employed imaging modalities
1.1 This specification covers the combined use of stereot-
used in imaging-guided stereotactic systems include
actic instruments or systems with imaging techniques, to direct
radiography, angiography, computed tomography, magnetic
a diagnostic or therapeutic modality into a specific target
resonance imaging, ultrasound, biplane and multiplane digital
within the brain, based on localization information derived
subtraction angiography, and positron emission scanning.
from such imaging techniques.
However, it is recognized that other modalities may be inter-
1.2 For the purpose of this specification, a stereotactic
faced with currently available and future stereotactic systems
instrument or system is a guiding, aiming, or viewing device
and that new imaging modalities may evolve in the future.
used in human neurosurgery for the purpose of manually
Standards for imaging devices will be dealt with in documents
directing a system or treating modality to a specific point
concerning such devices, and will not be addressed herein.
within the brain by radiographic, imaging, or other visualiza-
tion or identification of landmarks or targets or lesions. 1.5 General types of diagnostic modalities include biopsy
instruments, cannulas, endoscopes, electrodes, or other such
1.3 Definition of Stereotactic Imaging Systems—Types of
instruments.Therapeuticmodalitiesinclude,butarenotlimited
imaging-guided systems all require three components: an
to, heating, cooling, irradiation, laser, injection, tissue
imaging system, a stereotactic frame, or other physical device
transplantation, mechanical or ultrasonic disruption, and any
to identify the position of a point in space, and a method to
modality ordinarily used in cerebrospinal surgery.
relate image-generated coordinates to frame or device coordi-
nates. See Performance Specification F1266. The imaging
1.6 Probe—Any system or modality directed by stereotactic
technique must reliably and reproducibly generate data con-
techniques, including mechanical or other probe, a device that
cerning normal or abnormal anatomic structures, or both, that
is inserted into the brain or points to a target, and stereotacti-
can interface with the coordinate system of the stereotactic
cally directed treatment or diagnostic modality.
frame or other stereotactic system. The imaging-guided sys-
tems must allow accurate direction of therapeutic, viewing or NOTE1—Examplespresentedthroughoutthisspecificationarelistedfor
clarity only; that does not imply that use should be restricted to the
diagnostic modalities to a specific point or volume or along a
procedures or examples listed.
specific trajectory within the brain or often accurate estimation
of structure size and location allowing biopsy, resection,
1.7 Robot—A power-driven servo-controlled system for
vaporization, implantation, aspiration, or other manipulation,
controlling and advancing a probe according to a predeter-
or combination thereof. The standards of accuracy,
mined targeting program.
reproducibility, and safety must be met for the imaging
1.8 Digitizer—A device that is directed to indicate the
modality, the stereotactic system, and the method of interface
position of a probe or point in stereotactic or other coordinates.
between the two, and for the system as a whole. The mechani-
cal parts of the imaging modality and the stereotactic system
1.9 Frameless System—A system that does not require a
should be constructed to allow maximal interaction with
stereotactic frame, that identifies and localizes a point or
minimal interference with each other, to minimize imaging
volume in space by means of data registration, and a method to
artifactanddistortion,andminimizepotentialcontaminationof
relatethatpointorvolumetoitsrepresentationderivedfroman
the surgical field.
imaging system.
1.10 The values stated in SI units are to be regarded as the
standard.
This specification is under the jurisdiction of ASTM Committee F04 on
Medical and Surgical Materials and Devices and is the direct responsibility of
1.11 Thefollowingprecautionarycaveatpertainsonlytothe
Subcommittee F04.31 on Neurosurgical Standards.
test method portion, Section 3, of this specification: This
Current edition approved Feb. 1, 2008. Published March 2008. Originally
standard does not purport to address all of the safety concerns,
approved in 1996. Last previous edition approved in 2002 as F1719 – 96 (2002).
DOI: 10.1520/F1719-96R08. if any, associated with its use. It is the responsibility of the user
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
F1719 − 96 (2008)
of this standard to establish appropriate safety and health 3.2 Image Interactive Localization Systems:
practices and determine the applicability of regulatory limita- 3.2.1 Any type of stereotactic apparatus may be adapted to
tions prior to use.
function as an image interactive localization system. For such
to occur, it is necessary for the stereotactic apparatus to be
2. Referenced Documents
equipped with a means for relating its location in three-
dimensional space with the computerized image display sys-
2.1 ASTM Standards:
tem. These means of communication may include the follow-
F1266 Performance Specification for Cerebral Stereotactic
ing:
Instruments
3.2.1.1 Optical encoders that record the amount of displace-
ment on the set of coordinates axis and arcs that are used to
3. Types of Imaging-Guided Stereotactic Systems
position the probe of the stereotactic system.
3.1 Any type of stereotactic apparatus may be adapted to
3.2.1.2 Mechanical encoders that record the amount of
imaging-guided stereotactic surgery. A stereotactic system can
displacement set on the coordinate axis and arcs that are used
be based on one or more of the following concepts:
to position the probe of the stereotactic system.
3.1.1 Arc-Centered Type—A target centered arc with recti-
3.2.1.3 Other means of recording the amount of displace-
linear adjustments is constructed according to the spherical
ment set on the coordinate axis and arcs that are used to
radius principle so that the target point lies at the center of an
position the probe of the stereotactic system.
arc along which the probe holder moves, so that when a probe
3.2.2 Systems may be designed for image interactive local-
is inserted into the probe holder perpendicular to a tangent of
ization that do not incorporate the stereotactic apparatus
the arc and for a distance equal to the radius of the arc, the tip
concepts discussed in 9.1.1. Regardless of whether these
of the probe arrives at a single point in space, that is, the
systems are framed-based, table-based or room-(space) based,
stereotactic target.
they employ a means for generating a probe orientation in
3.1.2 Rectilinear Type—The rectilinear type provides indi-
three-dimensional space that can be used by the computerized
vidually for the longitudinal, transverse, and vertical move-
image display system. Intraoperative calibration of the system
ments of the probe holder or the patient, or both, perpendicular
is desirable, and it should be incorporated where practical.
to or at an angle to the planes along which the probe holder is
Means for generating a probe orientation in three-dimensional
moved.
space may include the following:
3.1.3 Aiming Type of Stereotactic Apparatus—Adevice that
3.2.2.1 Multiple-degree-of-freedom “robotic” arms that use
is referenced to a specific entry point so the probe can be
optical, mechanical, or other types of encoders to register the
pointed to the desired target point and then advanced to it.
position/orientation of each joint. Calibration of the arm with
3.1.4 Multiple-Arc Type—An arc system that is not target
respect to the known location of reference points in three-
centered and is a system of interlocking arcs, pivots, or joints
dimensional space is usually required.
arranged so that the orientation of the probe is controlled and
3.2.2.2 Systems that use optical or sonic information to
can be directed to the target by independent movement of the
triangulate the location and orientation of the probe. Calibra-
elements. As the depth of each target may be different relative
tion of the system with respect to the known location of
to the arc system, means for determining target depth must be
reference points in three-dimensional space is usually required.
provided.
3.2.2.3 Six-degree-of-freedom electromagnetic receiver/
3.1.5 An articulated arm that allows accurate determination
transmitters that may or may not require intraoperative cali-
of the position in space of a probe or other device held by the
bration of the three-dimensional space.
arm. Such a system ordinarily is coupled with computer
3.2.2.4 Other alignment by means of generated information
graphics to allow identification of the location of the probe in
may be used by the computerized image display system, with
relation to the position of the head in space. By relating the
or without three-dimensional space calibration.
position of the head and the graphic image, the position of the
3.2.3 The above represents a general classification of cur-
probe relative to the head or structures within the head can be
rent systems or systems currently in development and does not
demonstrated.
preclude future development.
3.1.6 Aprobewhosepositionandmovementinspacecanbe
detected, calibrated, and related to the position on the patient’s
4. Applications of Imaging Techniques to Stereotactic
head or intracranial target by a nonmechanical modality, such
Instruments
as infrared, visual light, sound, or ultrasound.
3.1.7 The above represents a general classification of cur-
4.1 Some of the means used to relate an imaging system to
rent systems and does not preclude future developments. Any
stereotactic apparatus may be mated by:
given system may represent any of the above types of
4.1.1 Attaching the apparatus to the table during imaging
stereotactic device or may be a combination of two or more
and relating the position of the slice to fiducials on the
systems.
apparatus,
4.1.2 Relating the height of the image to the stereotactic
apparatusbyattachinganindicatortothetable,thatcanthenbe
For referenced ASTM standards, visit the ASTM website, www.astm.org, or
used as a phantom to adjust the apparatus,
contact ASTM Customer Service at [e-mail]. For Annual Book of ASTM
4.1.3 Employing a translational imaging technique to relate
Standards volume information, refer to the standard’s Document Summary page on
the ASTM website. the position of the image to the head or to the apparatus,
F1719 − 96 (2008)
4.1.4 Including in the scanner plane markers or fiducials is to be used, how such accuracy was determined, and
which can be used to calculate the position and inclination of instructions so the surgeon might test the entire system to
the imaging slice, ensurethattheindicatedaccuracyanddegreeofconfidencehas
4.1.5 Using three-dimensional computer reconstruction been preserved.
4.5.2 MR-stereotactic Application Accuracy—Since non-
techniques to determine both the position of the target and the
position of the apparatus, so these two positions might be linear distortion is an inherent property of magnetic resonance
scanning, the surgeon should be aware of potential inaccura-
correlated. Such techniques may make possible the visualiza-
tionofthevolumeandshapeofthetargetinspace,sothateach cies imposed in an individual case. Also, since accuracy of
magnetic resonance imaging scanners varies from one scanner
point in the entire target can be defined by stereotactic
coordinates. to another and from one technique to another, such user testing
might demonstrate inaccuracies inherent in an individual
4.2 Imaging Systems:
MR-stereotactic system.
4.2.1 The region of interest may either be constituted by
abnormal structures (brain lesions) identified with imaging 5. Anesthesia and Operating Room Safety
systems or normal anatomical structures (functional
5.1 Scope—This specification is concerned with the defini-
stereotaxis), or both, to which the sensitivity of the imaging
tions and standards that are required in the design of imaging-
technique should be addressed. In case of normal structures,
guided stereotactic systems to ensure patient and operating
the location may need the use of standard atlases or tables and
room personnel safety during the administration of anesthesia
the method of transposition and its accuracy should be ad-
for imaging-guided stereotactic procedures.
dressed. Previously, the conversion of X-ray coordinates to
5.2 Definition—For the purpose of this specification, gen-
stereotactic space was performed with manual triangulation.
eral anesthesia may be defined as a state of altered conscious-
With the development of computed tomography and magnetic
ness occurring as a result of drug administration by
resonance imaging technology, most conversion is often now
intravenous, intramuscular, inhalational, or oral routes.
performed utilizing computer software.
5.3 The choice of type of anesthesia (general versus moni-
4.2.2 The interface between imaging and stereotactic space
tored versus local) is the responsibility of the operating
may be performed by several methods; the identification of the
surgeon, with consultation with the anesthesiologist as indi-
location of normal structures within stereotactic space and then
cated. The choice of anesthetic agent and means of adminis-
the use of standard atlases or other tables to define a given
tration is the responsibility of the anesthesiologist after con-
anatomical location, the identification of the relationship of
sultation with the operating surgeon.
normal and abnormal structures using an imaging technique
with subsequent reconstruction of this relationship within the
5.4 General Requirements—The standards for the use of
stereotactic system, digitization and conversion of analog anesthesthetics with imaging-guided stereotactic surgery are
imaging data to stereotactic space, and transformation of
the same as indicated in Performance Specification F1266.
imaging data generated within th
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