ASTM F1266-89(2008)
(Specification)Standard Performance Specification for Cerebral Stereotactic Instruments (Withdrawn 2017)
Standard Performance Specification for Cerebral Stereotactic Instruments (Withdrawn 2017)
SIGNIFICANCE AND USE
The purpose of a stereotactic apparatus is to guide the advance of an electrode or other probe accurately and in a controlled fashion to a given point in space, relative to the apparatus, to the stereotactic target. Thus, when the apparatus is attached to the skull, the electrode or probe can be advanced to a given geographical point within the cranial cavity, near the base of the skull or in the spinal canal.
As generally employed, the ventricles or cavities within the brain or other neurosurgical landmarks are identified roentgenographically by other means and, by consulting an atlas or other table, the mean distance and direction between the visualized landmark and a given anatomical target are measured. The electrode or probe is then inserted to the stereotactic target, that is, the point in space which is calculated from the distance and direction between the visualized landmark and the desired target in relation to the coordinate system of the stereotactic apparatus.
It is recognized that there is considerable anatomical variability in the size and shape of the central nervous system so that the target point that is identified from the atlas or table is only approximate. Usually, where possible, physiological verification may also be obtained. One must distinguish between the anatomical accuracy, which is inexact because of the variability of brains, and the mechanical accuracy, which is a function of the precision of the stereotactic instrument.
The requirements set forth herein are concerned only with the mechanical accuracy of stereotactic instruments. It is also recognized that once minimum standards for mechanical accuracy have been obtained, increased mechanical precision will not necessarily lead to increased anatomical precision.
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....
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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:F1266 −89(Reapproved 2008)
Standard Performance Specification for
Cerebral Stereotactic Instruments
This standard is issued under the fixed designation F1266; 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 1.4.1 Thalamotomy for parkinsonism and other types of
tremor,
1.1 This specification covers stereotactic instruments used
1.4.2 Electrode implantation for epilepsy,
by neurosurgeons to assist in the placement of probes, such as
1.4.3 Needle or magnetic insertion, or both, for aneurysm
cannulae, needles, forceps, or electrodes or to direct radiation
thrombosis,
into brain regions or anatomical targets that are not visible on
1.4.4 Thalamic or subthalamic operations for dystonia,
the surface.The general location of these regions is determined
1.4.5 Thalamic or subthalamic operations for involuntary
by measurements from landmarks visualized by X ray or other
movements such as chorea or hemiballismus,
means, such measurements being based on atlases derived
1.4.6 Ablation of deep cerebellar nuclei for spasticity,
from anatomical studies and autopsy. Because of the anatomi-
1.4.7 Cingulotomy and thalamic or subthalamic surgery for
cal variability, more precise location in any single patient may
pain,
be determined by physiological responses in that patient. The
1.4.8 Mesencephalotomy or tractotomy for pain,
degree of success in stereotactic surgery depends upon the
1.4.9 Ablations of subcortical temporal lobe structures for
experience of the surgeon as well as the precision of the
treatment of epilepsy,
stereotactic instrument. Nevertheless, minimum standards of
1.4.10 Psychosurgical procedures,
accuracy for stereotactic instruments that are within the range
1.4.11 Implantation of depth stimulating electrodes for pain,
of variability of human anatomy must be maintained.
1.4.12 Insertion of forceps or needle for obtaining biopsy
1.2 For the purpose of this specification, a stereotactic
specimens,
instrument is a guiding device used in human neurosurgery for
1.4.13 Foreign body removal,
the purpose of directing an instrument or treating modality to
1.4.14 Implantation of radioactive material, and
a specific point within the brain by radiographic or other
1.4.15 Biopsy or treatment of tumors.
visualization of landmarks.
1.5 This standard does not purport to address all of the
1.3 Stereotactic instruments must be constructed to afford
safety concerns, if any, associated with its use. It is the
the surgeon reliably reproducible accuracy in placing instru-
responsibility of the user of this standard to establish appro-
ments into target areas. Proper positioning of the probe is often
priate safety and health practices and determine the applica-
verified by X rays to control errors in calculation and to correct
bility of regulatory limitations prior to use.
deflection of the probe during insertion. Physiological param-
eters may be used to further define the optimal target.
2. Referenced Documents
1.4 At the present time, stereotactic instruments are used
2.1 NFPA Standard:
most frequently, but not exclusively in the following opera-
NFPA 99 Health Care Facilities Code (56A and 76B-T)
tions.The list is presented only to present examples and should
2.2 UL Standard:
not be construed to restrict advances or developments of new
UL 544 Electrical, Medical, and Dental Equipment
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
3. Terminology
mass. For that purpose, devices other than those covered by
3.1 Descriptions of Terms—The following descriptions of
this specification may be employed, but should be restricted to
terms are for the purposes of this specification only. Other
such uses:
nomenclature may be used throughout the literature and by
various manufacturers:
This specification is under the jurisdiction of ASTM Committee F04 on
Medical and Surgical Materials and Devices and is the direct responsibility of
Subcommittee F04.31 on Neurosurgical Standards. Available from National Fire Protection Association (NFPA), 1 Batterymarch
Current edition approved Feb. 1, 2008. Published March 2008. Originally Park, Quincy, MA 02169-7471, http://www.nfpa.org.
approved in 1989. Last previous edition approved in 2002 as F1266 – 89 (2002). Available from Underwriters Laboratories (UL), 333 Pfingsten Rd.,
DOI: 10.1520/F1266-89R08. Northbrook, IL 60062-2096, http://www.ul.com.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
F1266−89(2008)
3.1.1 anatomical accuracy—the reliability or accuracy with 3.1.15 mechanical accuracy—the accuracy with which a
which the tip of a probe can be introduced into a given stereotactic apparatus can bring the tip of a straight probe to a
anatomical target. Because of anatomical variability, a given given coordinate within the stereotactic coordinate system.
anatomical structure or anatomical target may vary relative to
3.1.16 probe—any type of long, thin device stereotactically
the position of the reference atlas position of that structure.
inserted into a desired anatomical target. The most common
Consequently, it is not possible to relate the reliability of a
type of probe is an electrode, but probes can also be
stereotactic apparatus to anatomical accuracy, but only to
cryoprobes, leukotomes, needles, biopsy devices, devices to
mechanical accuracy.
insert radioactive or other material, magnetic probes, needles
or injection devices, cannulae, forceps, and so forth.
3.1.2 anatomical target—that anatomical structure within
the central nervous system into which it is intended to insert a
3.1.17 probe holder—that part of the stereotactic apparatus
probe.
that holds the electrode or probe. It is ordinarily attached to the
3.1.3 anatomic variability—a variation in position, size or frame either directly or indirectly, depending on the type of
apparatus.
configuration of an anatomical structure from one human brain
to another.
3.1.18 simulated skull—any device to which a stereotactic
apparatusmightbeattachedtosimulatethestressesimpartedto
3.1.4 angular accuracy—the accuracy to which the probe
the apparatus when it is attached to the patient’s skull. Because
holder can be adjusted to a given angle from reference planes.
of the differences in how various stereotactic apparatus are
3.1.5 angular scale—the scale on the stereotactic apparatus
attached to the skull, no universal simulated skull can be
which indicates at which angle the electrode probe holder
described.
directs a probe in relation to one or more reference planes of
3.1.19 stereotactic apparatus—any guiding device used in
the coordinate system of the apparatus.
human neurosurgery for the purpose of directing a probe into
3.1.6 atlas—a topographical map of the brain or spinal cord
the brain, under guidance of radiographic visualization of
based on autopsy studies, used to define the relationship
landmarks, direct radiographic visualization, or other means.
between anatomical structures and landmarks, sometimes in-
3.1.20 stereotactic target—that point in space, defined by
cluding information about the anatomical variability.
the coordinate system of some types of stereotactic apparatus,
3.1.7 direct visualization—the visualization of an anatomi-
to which it is desired to insert a probe.
cal target by direct visual observation or roentgenographically
3.1.21 undamaged—in regard to electrodes—not damaged
with or without the assistance of air or contrast material.
toanextentwheretheelectricalpropertieswouldbeaffectedas
3.1.8 disconnect system—a system to afford adequate access
to make an electrode unacceptable for clinical use.
to the patient.
3.1.9 electrode—a probe usually insulated except for a
4. Classification of Stereotactic Apparatus
specific portion or portions, commonly the end, which is
4.1 Four basic types of stereotactic instruments, or a com-
stereotactically inserted into a desired anatomical target for the
bination thereof are presently used and will be referred to
purpose of recording electrical activity, stimulating nervous
herein as the arc (polar coordinate), rectilinear type, (c) aiming
tissue, producing a lesion in nervous tissue by passage of a
type, and (d) interlocking arc type. Types with comparable or
direct or rapidly alternating electrical current, or measuring
greater accuracy should be recognized as they are developed.
impedance.
4.1.1 Arc Type—The arc type apparatus is constructed
3.1.10 frame—that part of the stereotactic apparatus which
according to the spherical radius principle so that the target
is attached to the skull.
point lies at the center of an arc along which the probe holder
moves so that when a probe inserted into the probe holder
3.1.11 guide tube—a tube through which an electrode or
perpendicular to a tangent of the arc and for a distance equal to
probe can be directed to a target. The tube imparts additional
the radius of the arc, the tip of the probe arrives at a single
strength and less likelihood of deviation from a true trajectory.
point in space, the center of the circle defined by the arc, that
The guide tube can be attached to the electrode probe holder or
is, the stereotactic target. This occurs regardless of the position
stereotactic apparatus or attached to the electrode or insertional
of the probe holder along the arc or the angle the arc subtends
probe in a sleeve-like fashion.
with the base of the apparatus. Generally, the apparatus is
3.1.12 landmark—a structure than can be visualized
adjusted so that the stereotactic target point corresponds to the
radiographically, with or without contrast material or air, from
anatomical target point, so the probe might be introduced at
which measurements are made to define the position of the
any angle yet accurately find the stereotactic target.
stereotactic target.
4.1.2 Rectilinear Type—The rectilinear type provides indi-
3.1.13 linear accuracy—the positioning accuracy of a linear
vidually for the longitudinal, transverse and vertical move-
movement of the probe holder in the direction of one or more
ments of the probe and probe holder. Ordinarily, a rectilinear
of the reference planes of the stereotactic apparatus.
stereotactic apparatus also provides for sagittal and transverse
3.1.14 linear scale—the scale on the stereotactic apparatus angle adjustment as well. Calculations can be made so the
which indicates linear movement of the electrode probe holder probe can be adjusted to the scales to aim and advance the
in relation to one or more of the reference planes, or a point probe to the desired target point along a predetermined
within the coordinate system. trajectory.
F1266−89(2008)
4.1.3 Aiming Type—The aiming type of stereotactic appara- applied to the patient, shall be arranged in such a way that
tus is attached to a burr hole in the skull. The angles of radiographs can be made in more than one plane or other
insertion can be adjusted and the depth of insertion of the visualization obtained. Means shall also be available to repo-
electrode or probe controlled so the probe can be pointed to the sition the X-ray tubes accurately and conveniently. The ste-
desired target point and then advanced to it. reotactic apparatus shall be constructed in such a way that no
mechanical part interferes with X-ray, computerized tomogra-
5. Significance and Use
phy or other necessary visualization of landmarks during the
part of the procedure when radiographs are being made.
5.1 The purpose of a stereotactic apparatus is to guide the
advance of an electrode or other probe accurately and in a
6.3 Accuracy of the Probe Placement—The accuracy of
controlled fashion to a given point in space, relative to the
placement in an anatomical target is dependent on anatomical
apparatus, to the stereotactic target. Thus, when the apparatus
variability which exceeds the mechanical inaccuracies of the
is attached to the skull, the electrode or probe can be advanced
stereotactic system. Nevertheless, specifications for mechani-
to a given geographical point within the cranial cavity, near the
cal precision, to a practical extent, are appropriate to obtain
base of the skull or in the spinal canal.
maximum target accuracy with an electrode or other probe. In
5.1.1 As generally employed, the ventricles or cavities
general, the mechanical precision of a stereotactic apparatus
within the brain or other neurosurgical landmarks are identified
should be sufficient to place a probe at a given point in space
roentgenographically by other means and, by consulting an
one half the diameter of the probe. Since most electrodes or
atlas or other table, the mean distance and direction between
probes are larger than 1.2 mm in diameter, a mechanical
the visualized landmark and a given anatomical target are
accuracy of 0.6 mm at the 99 % confidence level would ensure
measured. The electrode or probe is then inserted to the
that a given point is generally included within the probe tract.
stereotactictarget,thatis,thepointinspacewhichiscalculated
Although probes less than 1.2 mm in diameter are sometimes
from the distance and direction between the visualized land-
employed, they are generally used for specialized purposes
mark and the desired target in relation to the coordinate system
which require direct visualization of the target.
of the stereotactic apparatus.
6.4 Probe Holder—The probe holder shall be designed so
5.1.2 It is recognized that there is considerable anatomical
that it mechanically grasps the electrode or probe along
variability in the size and shape of the central nervous system
sufficient length to prevent deviation, so the accuracy of the
so that the target point that is identified from the atlas or table
instrument is maintained, and so that its insulation is undam-
is only approximate. Usually, where possible, physiological
aged. A system to identify the appropriate target length of the
verification may also be obtained. One must distinguish be-
electrode or probe, either on a depth scale or by a system
tween the anatomical accuracy, which is inexact because of the
preventing electrode overtravel shall be employed. If the
variability of brains, and the mechanical accuracy, which is a
procedurerequiresthattheprobebeadvancedonlytothetarget
function of the precision of the stereotactic instrument.
point, the system shall be designed so that the probe can be
5.1.3 The requirements set forth herein are concerned
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