ASTM F1266-89(1998)

Standard Performance Specification for Cerebral Stereotactic Instruments

SCOPE
1.1 This specification covers stereotactic instruments used by neurosurgeons to assist in the placement of probes, such as cannulae, needles, forceps, or electrodes or to direct radiation into brain regions or anatomical targets that are not visible on the surface. The general location of these regions is determined by measurements from landmarks visualized by X ray or other means, such measurements being based on atlases derived from anatomical studies and autopsy. Because of the anatomical variability, more precise location in any single patient may be determined by physiological responses in that patient. The degree of success in stereotactic surgery depends upon the experience of the surgeon as well as the precision of the stereotactic instrument. Nevertheless, minimum standards of accuracy for stereotactic instruments that are within the range of variability of human anatomy must be maintained.
1.2 For the purpose of this specification, a stereotactic instrument is a guiding device used in human neurosurgery for the purpose of directing an instrument or treating modality to a specific point within the brain by radiographic or other visualization of landmarks.
1.3 Stereotactic instruments must be constructed to afford the surgeon reliably reproducible accuracy in placing instruments into target areas. Proper positioning of the probe is often verified by X rays to control errors in calculation and to correct deflection of the probe during insertion. Physiological parameters may be used to further define the optimal target.
1.4 At the present time, stereotactic instruments are used most frequently, but not exclusively in the following operations. The list is presented only to present examples and should not be construed to restrict advances or developments of new procedures. For some applications it is not required to hit a point in space, but to hit a volume or make a lesion within a mass. For that purpose, devices other than those covered by this specification may be employed, but should be restricted to such uses.
1.4.1 Thalamotomy for parkinsonism and other types of tremor,
1.4.2 Electrode implantation for epilepsy,
1.4.3 Needle or magnetic insertion, or both, for aneurysm thrombosis,
1.4.4 Thalamic or subthalamic operations for dystonia,
1.4.5 Thalamic or subthalamic operations for involuntary movements such as chorea or hemiballismus,
1.4.6 Ablation of deep cerebellar nuclei for spasticity,
1.4.7 Cingulotomy and thalamic or subthalamic surgery for pain,
1.4.8 Mesencephalotomy or tractotomy for pain,
1.4.9 Ablations of subcortical temporal lobe structures for treatment of epilepsy,
1.4.10 Psychosurgical procedures,
1.4.11 Implantation of depth stimulating electrodes for pain,
1.4.12 Insertion of forceps or needle for obtaining biopsy specimens,
1.4.13 Foreign body removal,
1.4.14 Implantation of radioactive material, and
1.4.15 Biopsy or treatment of tumors.
1.5 This standard may involve hazardous materials, operations, and equipment. This standard does not purport to address all of the safety problems 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 limitations prior to use.

General Information

• Status: Historical
• Publication Date: 31-Dec-1997
• Technical Committee: F04 - Medical and Surgical Materials and Devices
• Drafting Committee: F04.31 - Neurosurgical Standards

Relations

• Replaced By: ASTM F1266-89(2002) - Standard Performance Specification for Cerebral Stereotactic Instruments
• Effective Date: 27-Nov-1989

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: F 1266 – 89 (Reapproved 1998)
AMERICAN SOCIETY FOR TESTING AND MATERIALS
100 Barr Harbor Dr., West Conshohocken, PA 19428
Reprinted from the Annual Book of ASTM Standards. Copyright ASTM
Standard Performance Specification for
Cerebral Stereotactic Instruments
This standard is issued under the fixed designation F 1266; 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 1.4.4 Thalamic or subthalamic operations for dystonia,
1.4.5 Thalamic or subthalamic operations for involuntary
1.1 This specification covers stereotactic instruments used
movements such as chorea or hemiballismus,
by neurosurgeons to assist in the placement of probes, such as
1.4.6 Ablation of deep cerebellar nuclei for spasticity,
cannulae, needles, forceps, or electrodes or to direct radiation
1.4.7 Cingulotomy and thalamic or subthalamic surgery for
into brain regions or anatomical targets that are not visible on
pain,
the surface. The general location of these regions is determined
1.4.8 Mesencephalotomy or tractotomy for pain,
by measurements from landmarks visualized by X ray or other
1.4.9 Ablations of subcortical temporal lobe structures for
means, such measurements being based on atlases derived
treatment of epilepsy,
from anatomical studies and autopsy. Because of the anatomi-
1.4.10 Psychosurgical procedures,
cal variability, more precise location in any single patient may
1.4.11 Implantation of depth stimulating electrodes for pain,
be determined by physiological responses in that patient. The
1.4.12 Insertion of forceps or needle for obtaining biopsy
degree of success in stereotactic surgery depends upon the
specimens,
experience of the surgeon as well as the precision of the
1.4.13 Foreign body removal,
stereotactic instrument. Nevertheless, minimum standards of
1.4.14 Implantation of radioactive material, and
accuracy for stereotactic instruments that are within the range
1.4.15 Biopsy or treatment of tumors.
of variability of human anatomy must be maintained.
1.5 This standard does not purport to address all of the
1.2 For the purpose of this specification, a stereotactic
safety concerns, if any, associated with its use. It is the
instrument is a guiding device used in human neurosurgery for
responsibility of the user of this standard to establish appro-
the purpose of directing an instrument or treating modality to
priate safety and health practices and determine the applica-
a specific point within the brain by radiographic or other
bility of regulatory limitations prior to use.
visualization of landmarks.
1.3 Stereotactic instruments must be constructed to afford
2. Referenced Documents
the surgeon reliably reproducible accuracy in placing instru-
2.1 NFPA Standard:
ments into target areas. Proper positioning of the probe is often
NFPA 99 Health Care Facilities Code (56A and 76B-T)
verified by X rays to control errors in calculation and to correct
2.2 UL Standard:
deflection of the probe during insertion. Physiological param-
UL 544 Electrical, Medical, and Dental Equipment
eters may be used to further define the optimal target.
1.4 At the present time, stereotactic instruments are used
3. Terminology
most frequently, but not exclusively in the following opera-
3.1 Descriptions of Terms—The following descriptions of
tions. The list is presented only to present examples and should
terms are for the purposes of this specification only. Other
not be construed to restrict advances or developments of new
nomenclature may be used throughout the literature and by
procedures. For some applications it is not required to hit a
various manufacturers:
point in space, but to hit a volume or make a lesion within a
3.1.1 anatomical accuracy—the reliability or accuracy with
mass. For that purpose, devices other than those covered by
which the tip of a probe can be introduced into a given
this specification may be employed, but should be restricted to
anatomical target. Because of anatomical variability, a given
such uses.
anatomical structure or anatomical target may vary relative to
1.4.1 Thalamotomy for parkinsonism and other types of
the position of the reference atlas position of that structure.
tremor,
Consequently, it is not possible to relate the reliability of a
1.4.2 Electrode implantation for epilepsy,
stereotactic apparatus to anatomical accuracy, but only to
1.4.3 Needle or magnetic insertion, or both, for aneurysm
mechanical accuracy.
thrombosis,
1 2
This specification is under the jurisdiction of ASTM Committee F-4 on Medical Available from National Fire Protection Association, Batterymarch Park,
and Surgical Materials and Devices and is the direct responsibility of Subcommittee Quincy, MA 02269.
F04.50 on Neurosurgical Standards. Available from Underwriters Laboratories, 333 Pfingsten Rd., Northbrook, IL
Current edition approved Nov. 24, 1989. Published January 1990. 60062.
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 1266
3.1.2 anatomical target—that anatomical structure within frame either directly or indirectly, depending on the type of
the central nervous system into which it is intended to insert a apparatus.
probe. 3.1.18 simulated skull—any device to which a stereotactic
3.1.3 anatomic variability—a variation in position, size or apparatus might be attached to simulate the stresses imparted to
the apparatus when it is attached to the patient’s skull. Because
configuration of an anatomical structure from one human brain
to another. of the differences in how various stereotactic apparatus are
attached to the skull, no universal simulated skull can be
3.1.4 angular accuracy—the accuracy to which the probe
described.
holder can be adjusted to a given angle from reference planes.
3.1.19 stereotactic apparatus—any guiding device used in
3.1.5 angular scale—the scale on the stereotactic apparatus
human neurosurgery for the purpose of directing a probe into
which indicates at which angle the electrode probe holder
the brain, under guidance of radiographic visualization of
directs a probe in relation to one or more reference planes of
landmarks, direct radiographic visualization, or other means.
the coordinate system of the apparatus.
3.1.20 stereotactic target—that point in space, defined by
3.1.6 atlas—a topographical map of the brain or spinal cord
the coordinate system of some types of stereotactic apparatus,
based on autopsy studies, used to define the relationship
to which it is desired to insert a probe.
between anatomical structures and landmarks, sometimes in-
3.1.21 undamaged—in regard to electrodes—not damaged
cluding information about the anatomical variability.
to an extent where the electrical properties would be affected as
3.1.7 direct visualization—the visualization of an anatomi-
to make an electrode unacceptable for clinical use.
cal target by direct visual observation or roentgenographically
with or without the assistance of air or contrast material.
4. Classification of Stereotactic Apparatus
3.1.8 disconnect system—a system to afford adequate access
4.1 Four basic types of stereotactic instruments, or a com-
to the patient.
bination thereof are presently used and will be referred to
3.1.9 electrode—a probe usually insulated except for a
herein as the arc (polar coordinate), rectilinear type, (c) aiming
specific portion or portions, commonly the end, which is
type, and (d) interlocking arc type. Types with comparable or
stereotactically inserted into a desired anatomical target for the
greater accuracy should be recognized as they are developed.
purpose of recording electrical activity, stimulating nervous
4.1.1 Arc Type—The arc type apparatus is constructed
tissue, producing a lesion in nervous tissue by passage of a
according to the spherical radius principle so that the target
direct or rapidly alternating electrical current, or measuring
point lies at the center of an arc along which the probe holder
impedance.
moves so that when a probe inserted into the probe holder
3.1.10 frame—that part of the stereotactic apparatus which
perpendicular to a tangent of the arc and for a distance equal to
is attached to the skull.
the radius of the arc, the tip of the probe arrives at a single
3.1.11 guide tube—a tube through which an electrode or
point in space, the center of the circle defined by the arc, that
probe can be directed to a target. The tube imparts additional
is, the stereotactic target. This occurs regardless of the position
strength and less likelihood of deviation from a true trajectory.
of the probe holder along the arc or the angle the arc subtends
The guide tube can be attached to the electrode probe holder or
with the base of the apparatus. Generally, the apparatus is
stereotactic apparatus or attached to the electrode or insertional
adjusted so that the stereotactic target point corresponds to the
probe in a sleeve-like fashion.
anatomical target point, so the probe might be introduced at
3.1.12 landmark—a structure than can be visualized radio-
any angle yet accurately find the stereotactic target.
graphically, with or without contrast material or air, from
4.1.2 Rectilinear Type—The rectilinear type provides indi-
which measurements are made to define the position of the
vidually for the longitudinal, transverse and vertical move-
stereotactic target.
ments of the probe and probe holder. Ordinarily, a rectilinear
3.1.13 linear accuracy—the positioning accuracy of a linear
stereotactic apparatus also provides for sagittal and transverse
movement of the probe holder in the direction of one or more
angle adjustment as well. Calculations can be made so the
of the reference planes of the stereotactic apparatus.
probe can be adjusted to the scales to aim and advance the
3.1.14 linear scale—the scale on the stereotactic apparatus
probe to the desired target point along a predetermined
which indicates linear movement of the electrode probe holder
trajectory.
in relation to one or more of the reference planes, or a point
4.1.3 Aiming Type—The aiming type of stereotactic appa-
within the coordinate system.
ratus is attached to a burr hole in the skull. The angles of
3.1.15 mechanical accuracy—the accuracy with which a
insertion can be adjusted and the depth of insertion of the
stereotactic apparatus can bring the tip of a straight probe to a
electrode or probe controlled so the probe can be pointed to the
given coordinate within the stereotactic coordinate system.
desired target point and then advanced to it.
3.1.16 probe—any type of long, thin device stereotactically
5. Significance and Use
inserted into a desired anatomical target. The most common
type of probe is an electrode, but probes can also be cryo-
5.1 The purpose of a stereotactic apparatus is to guide the
probes, leukotomes, needles, biopsy devices, devices to insert advance of an electrode or other probe accurately and in a
radioactive or other material, magnetic probes, needles or
controlled fashion to a given point in space, relative to the
injection devices, cannulae, forceps, etc. apparatus, to the stereotactic target. Thus, when the apparatus
3.1.17 probe holder—that part of the stereotactic apparatus is attached to the skull, the electrode or probe can be advanced
that holds the electrode or probe. It is ordinarily attached to the to a given geographical point within the cranial cavity, near the
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 1266
base of the skull or in the spinal canal. general, the mechanical precision of a stereotactic apparatus
5.1.1 As generally employed, the ventricles or cavities should be sufficient to place a probe at a given point in space
within the brain or other neurosurgical landmarks are identified one half the diameter of the probe. Since most electrodes or
roentgenographically by other means and, by consulting an probes are larger than 1.2 mm in diameter, a mechanical
atlas or other table, the mean distance and direction between accuracy of 0.6 mm at the 99 % confidence level would ensure
the visualized landmark and a given anatomical target are that a given point is generally included within the probe tract.
measured. The electrode or probe is then inserted to the Although probes less than 1.2 mm in diameter are sometimes
stereotactic target, that is, the point in space which is calculated employed, they are generally used for specialized purposes
from the distance and direction between the visualized land- which require direct visualization of the target.
mark and the desired target in relation to the coordinate system 6.4 Probe Holder—The probe holder shall be designed so
of the stereotactic apparatus. that it mechanically grasps the electrode or probe along
5.1.2 It is recognized that there is considerable anatomical sufficient length to prevent deviation, so the accuracy of the
variability in the size and shape of the central nervous system instrument is maintained, and so that its insulation is undam-
so that the target point that is identified from the atlas or table aged. A system to identify the appropriate target length of the
is only approximate. Usually, where possible, physiological electrode or probe, either on a depth scale or by a system
verification may also be obtained. One must distinguish be- preventing electrode overtravel shall be employed. If the
tween the anatomical accuracy, which is inexact because of the procedure requires that the probe be advanced only to the target
variability of brains, and the mechanical accuracy, which is a point, the system shall be designed so that the probe can be
function of the precision of the stereotactic instrument. stopped accurately at the chosen target so that penetration
5.1.3 The requirements set forth herein are concerned only beyond the target can be avoided. If the system is designed to
with the mechanical accuracy of stereotactic instruments. It is advance the electrode along a calculated trajectory, a mechani-
also recognized that once minimum standards for mechanical cal or other drive system shall be employed so that the
accuracy have been obtained, increased mechanical precision millimetre-by-millimetre advance can be controlled.
will not necessarily lead to increased anatomical precision. 6.5 Adjustability of Probe Holder—The apparatus shall be
designed so that
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