U.S. patent number 3,762,404 [Application Number 05/165,146] was granted by the patent office on 1973-10-02 for positioning aid.
Invention is credited to Tadao Sakita.
United States Patent |
3,762,404 |
Sakita |
October 2, 1973 |
POSITIONING AID
Abstract
A positioning aid for restraining or immobilizing a part of the
body of a medical patient comprising an air-tight bag of flexible,
impervious material; a charge of elastically deformable spherulic
beads of expanded polystyrene confined within the bag; and a
self-closing valve communicating with the interior of said bag for
evacuating air therefrom. Material proportions of the beads are of
respectively different diameters. The bag is divided into a
plurality of compartments by partitions extending obliquely between
opposing walls of the bag. The partitions, which maintain the
particles evenly distributed in the bag, are adapted to permit
air-flow between the compartments and to prevent passage of the
beads therebetween. When the positioning aid is evacuated after
having been conformed to a portion of a patient's body, the aid
becomes rigid while maintaining its pre-evacuation shape.
Inventors: |
Sakita; Tadao (Setagaya-ku,
Tokyo, JA) |
Family
ID: |
13833605 |
Appl.
No.: |
05/165,146 |
Filed: |
July 22, 1971 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
Issue Date |
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853661 |
Aug 28, 1969 |
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Foreign Application Priority Data
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Aug 21, 1969 [JA] |
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44/845545 |
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Current U.S.
Class: |
602/6; 5/913;
128/DIG.20; 137/855; 206/524.8; 383/38; 383/102; 383/103; 602/13;
5/630; 5/633; 5/655.4 |
Current CPC
Class: |
A43B
17/035 (20130101); A61G 7/05753 (20130101); A61B
6/0421 (20130101); Y10S 128/20 (20130101); Y10T
137/7891 (20150401); Y10S 5/913 (20130101) |
Current International
Class: |
A43B
17/03 (20060101); A43B 17/00 (20060101); A61G
7/057 (20060101); A61B 6/04 (20060101); A61f
005/02 () |
Field of
Search: |
;128/78,87,DIG.20,89
;137/525.3,614.2 ;251/362 |
References Cited
[Referenced By]
U.S. Patent Documents
Foreign Patent Documents
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926,722 |
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May 1963 |
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GB |
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1,215,859 |
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May 1966 |
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DT |
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252,729 |
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Sep 1961 |
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AU |
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Primary Examiner: Gaudet; Richard A.
Assistant Examiner: Yasko; J.
Parent Case Text
CROSS REFERENCE TO RELATED APPLICATION
This application is a continuation-in-part of my copending
application Ser. No. 853,661, filed Aug. 28, 1969, for "Positioning
Aid" now abandoned.
Claims
What is claimed is:
1. A vacuum-actuated positioning aid comprising a flexible,
impervious bag; a charge of elastically deformable spherulic beads
confined within said bag, said beads having diameters of from about
1 to about 5 millimeters and specific gravities of from about 0.1
to about 0.6, said charge being comprised of a mixture of at least
two portions of beads, each portion comprising at least ten percent
of the volume of said charge and the beads in one portion being at
least one millimeter smaller in diameters than the beads in the
other portion; and a valve communicating with the interior of said
bag for evacuating air therefrom whereupon said beads interengage
to form a rigid structure.
2. The positioning aid of claim 1 wherein said beads are comprised
of an expanded plastic material.
3. The positioning aid of claim 1 wherein said beads are comprised
of an expanded plastic material containing an elastomer.
4. A positioning aid of claim 1 wherein said beads are comprised of
expanded polystyrene.
5. The positioning aid of claim 1 wherein said charge is comprised
of a mixture of beads with predetermined fractional proportions of
the charge being of beads having different diameters distributed
substantially across the range of from 1 to 5 millimeters.
6. The positioning aid of claim 5 wherein by volume the proportions
of beads of low- and mid-range diameters predominate.
7. The positioning aid of claim 1 wherein by volume the proportions
of beads of low- and mid-range diameters predominate.
8. The positioning aid of claim 1 wherein said flexible, impervious
material is comprised of a mixture of polyvinyl chloride and
synthetic rubber.
9. The positioning aid of claim 1 wherein said bag includes a pair
of opposing walls and a partition secured to and extending
obliquely between said walls, said partition dividing the interior
of said bag into two, overlapping compartments, portions of said
charge of beads being confined within each of said compartments,
and said partition being adapted to permit the flow of air and
prevent the flow of beads from one bag compartment to another.
10. The positioning aid of claim 9 wherein said beads are comprised
of an expanded plastic material.
11. The positioning aid of claim 9 wherein said charge is comprised
of a mixture of beads with predetermined fractional proportions of
the charge being of beads having different diameters distributed
substantially across the range of from 1 to 5 millimeters.
12. A vacuum-actuated positioning aid comprising a flexible,
impervious bag; a charge of elastically deformable spherulic beads
confined within said bag, said beads having diameters of from about
1 to about 5 millimeters and specific gravities of from about 0.1
to about 0.6, said charge being comprised of a mixture of at least
two substantial portions of beads having materially different
diameters; and a valve communicating with the interior of said bag
for evacuating air therefrom whereupon said beads interengage to
form a rigid structure, said valve comprising a soft, flexible
cylindrical valve body having first and second ends, means for
opening and closing said first end, a soft flexible inner cylinder
extending within said valve body and having first and second ends
respectively proximate said first and second ends of said valve
body, said second end of said inner cylinder communicating with the
interior of said bag, a lid secured to a segment of the periphery
of said first end of said inner cylinder, said lid being
resiliently movable about said segment between a closed position
abutting against and closing said first end of said inner cylinder
and an open nonabutting position, movement of said lid being
responsive to pressure differentials on opposite sides thereof, and
means for forming an air-tight seal between the inside of said
valve body and the outside of said inner cylinder proximate the
respective second ends thereof.
13. A vacuum-actuated positioning aid comprising a flexible,
impervious bag, said bag having first and second opposing walls; a
charge of elastically deformable spherulic beads confined within
and partially filling said bag; a partition secured to and
extending obliquely between said walls, said partition dividing the
interior of said bag into two, overlapping compartments, portions
of said charge of beads being disposed within each of said
compartments, and said partition being adapted to permit the flow
of air and prevent the flow of said beads from one bag compartment
to another; and a valve communicating with the interior of said bag
for evacuating air therefrom whereupon said beads interengage to
form a rigid structure.
14. A vacuum-actuated positioning aid comprising an air-tight bag
of flexible, impervious sheet material; a charge of elastically
deformable spherulic beads disposed within said bag; and a valve
communicating with the interior of said bag for evacuating air
therefrom, said valve comprising a soft, flexible cylindrical valve
body having first and second ends; means for opening and closing
said first end; a soft flexible inner cylinder extending within
said valve body and having first and second ends respectively
proximate said first and second ends of said valve body; said
second end of said inner cylinder communicating with the interior
of said bag; a lid secured to a segment of the periphery of said
first end of said inner cylinder, said lid being resiliently
movable about said segment between a closed position abutting
against and closing said first end of said inner cylinder and an
open non-abutting position, movement of said lid being responsive
to pressure differentials on opposite sides thereof; and means for
forming an air-tight seal between the inside of said valve body and
the outside of said inner cylinder proximate the respective second
ends thereof.
15. The positioning aid of claim 14 wherein said valve is of a
substantially one-piece molded construction.
16. A positioning aid comprising a substantially flat, flexible,
impervious bag comprised of first and second opposing walls secured
together about their respective peripheries, and a flexible
partition extending across the interior of said bag, said partition
being secured along its length to each of said walls and being
oriented obliquely to each of said walls so as to divide the
interior of said bag into first and second compartments, which
compartments are mutually overlapping along said partition; a
charge of elastically deformable spherulic beads confined within
said bag, portions of said charge of beads being disposed within
and partially filling each of said compartments, said partition
being adapted to permit the flow of air and prevent the flow of
beads from one compartment to another; and a valve communicating
with the interior of said bag for evacuating air therefrom,
whereupon said beads interengage to form a rigid structure.
Description
BACKGROUND AND SUMMARY OF THE INVENTION
This invention relates to an improved positioning aid for
supporting, restraining and/or immobilizing a portion of the body
of a medical patient as long as may be needed for conducting
radiography, therapy, surgery, patient transport and the like.
Vacuum-actuated positioning aids consisting of a flexible
impervious bag containing small particles which consolidate into a
rigid mass when the bag is evacuated are known in the art. See, for
example, U. S. Pat. No. 3,212,497 to Dickinson.
It is an object of this invention to provide a vacuum-actuated
positioning aid of an improved construction. An important object of
this invention is to devise a positioning aid of the general type
described which is readily formable into any of varying
configurations and yet is so constituted as to provide a higher
degree of form stability upon evacuation than is obtainable with
prior positioning aids. Additionally, it is an object to provide an
improved positioning aid capable of assuming and rigidly
maintaining minute variations of contour by corresponding
arrangements and rearrangements of small spherulic beads. To such
ends, the invention includes charging the bag with spherulic beads
within a predetermined general range of sizes and, within that
range, assuring that substantial proportions of the total are
respectively each of materially different sizes. For practical
optimum results several sizes are contemplated and the proportions
of beads in the lower and mid-range sizes should be substantially
greater than that of beads at the high end of the range. Mobility
of the bead to conform to minutely varying shapes and stable
interfit (both bead-to-bead and bead-to-bag) with uniform stress
distribution among the beads are materially improved over
positioning aids containing beads of substantially equal size.
Another object hereof is to improve the compartmentation of a
positioning aid bag with respect to cooperative distribution of the
masses of beads in the respective compartments. More particularly,
it is an object to provide a simple bag construction wherein the
compartments may be only partially filled with beads so that before
evacuation the bag is highly flexible and readily conformable to
various shapes and after evacuation does not present difficulty
with lack of solidity due to void spaces in the partially filled
compartments. To this end, partitions extending obliquely between
and interjoining opposing walls of the bag held assure mutual
reinforcing overlap of the bead masses in adjacent
compartments.
Still another object hereof is to provide a safe, reliable,
inexpensive and readily operable vacuum valve for positioning aids
of the types described. Moreover, it is an object to achieve such a
valve which will not scratch or injure a patient and which may be
made without exterior metal parts that can create sparks in a
surgical operating room. A related object is to provide such a
valve which can be opened manually by pinching it in a certain
manner, which will automatically become and remain firmly sealed
against loss of vacuum in the bag until so operated, and which is
so constructed as to preclude accidental operation by reason of
normal pressures and stresses applied to it in the handling or use
of the positioning aid.
BRIEF DESCRIPTION OF THE DRAWINGS
FIG. 1 is an isometric view, with parts broken away, of one
embodiment of the positioning aid according to this invention.
FIG. 2 is an enlarged section view along line 2--2 of FIG. 1.
FIG. 2a is a section view of the positioning aid of FIG. 1 oriented
vertically.
FIG. 3 is an enlarged side view of the valve on the positioning aid
of FIG. 1.
FIG. 4 is a section view along line 4--4 of FIG. 5 showing the
valve in its closed mode.
FIG. 5 is a section view along line 5--5 of FIG. 3.
FIG. 6 is a partial section view of the valve of FIG. 3 in its open
mode.
FIGS. 7 and 8 are isometric views of two other embodiments of the
positioning aid according to this invention.
FIG. 9 is a perspective view of the positioning aid of FIG. 1 as
applied to the postoperative orthotic restraint of a child after
desmotomy of myogenic torticollis.
FIGS. 10a to 10d illustrate the preparation of a recurvature bed in
dorsal decubitus using a positioning aid of this invention.
FIG. 11 shows dorsal spine curves for (a) normal standing position,
(b) dorsal decubitus with a positioning aid of this invention and
(c) dorsal decubitus with a plaster of Paris bed.
FIG. 12 is a graph showing results of comparative tests on the
pressure of the dorsal surface of a patient lying on a mattress, a
plaster of Paris bed and a positioning aid of this invention.
DETAILED DESCRIPTION OF THE INVENTION
Referring to FIGS. 1 - 3, there is shown one embodiment of the
positioning aid of this invention. It comprises a generally
rectangular, air-tight bag 1 of flexible, impervious material,
containing a charge of elastically deformable spherulic beads 2.
The bag is equipped with a self-closing valve 3. The interior of
the bag is divided into three compartments by two partitions 4
extending lengthwise of the bag and obliquely between the bag
walls. Each compartment contains a fraction of the total charge of
beads. So that the aid is readily conformable to various portions
of a patient's body, each compartment is only partially filled with
beads. Screened openings 5 are Provided in the partitions so that
air can flow between compartments while the beads cannot. The
partitions maintain the beads more or less evenly distributed
throughout the bag. As shown in FIG. 2a, orientation of the
partitions obliquely to the bag walls reduces the effective
thickness of each compartment along the partitions and thereby
assures a more even distribution of beads in each compartment when
the bag is so positioned that the beads tend to accumulate along
the partitions.
FIGS. 3 - 6 show the details of a self-closing valve which is
especially preferred for use in the positioning aid of this
invention. Except as indicated, all of the valve parts are made of
the same soft, flexible material, such as polyvinyl chloride. The
valve consists of a cylindrical body 6 having an integral plug 7
secured to one end and the circular valve base 8 to the other, the
valve base being sealed to the inner side of the bag wall 9. An
inner cylinder 10 having one flat side 11 (FIG. 5) extends within
and is enclosed by the valve body. The inner cylinder is provided
at one end with an integral circular lid 12. The lid is hinged to
the flattened part of the periphery of the inner cylinder so as to
be moveable thereabout. The other end of the inner cylinder is
joined with the valve base 8 and is in communication with the
interior of the bag through an opening in the base. A layer of fine
mesh wire screen 13 and a layer of loosely woven cloth 14 are
positioned over this hole and are secured to the base. The screen
and cloth prevent the beads from being drawn from the bag when a
vacuum is applied to the valve.
In FIGS. 3 and 4 the valve is in its closed position with the plug
7 being inserted in the end of the valve body and the hinged lid 12
abutting against and closing the free end of the inner cylinder.
When the positioning aid is to be evacuated, plug 7 is removed from
the opening in the valve body (FIG. 6) and the valve is then
connected to a vacuum source. Application of the vacuum causes the
pressure on the outer side of the lid to become less than on the
inner side and the lid moves to its open position as shown in FIG.
6. When the externally applied vacuum is interrupted, the lid 12
automatically returns to its closed position because of its own
resilience and the greater pressure on its outer side. The plug 7
is then inserted into the valve body providing a second seal.
When it is desired to release the vacuum within the positioning
aid, the plug 7 is removed and the square, raised areas 15 on the
outside of the valve body are squeezed with the thumb and index
finger. Sufficient pressure is applied to deform both the valve
body and the inner cylinder, deformation of the latter causing the
lid 12 to open (as shown in FIG. 6), causing the vacuum to be
released. The plug 7, when inserted in the valve body, prevents the
vacuum from being released even if the valve body and inner
cylinder should be accidentally compressed sufficiently to open the
lid.
The valve of this invention is especially dependable and convenient
to operate, provides a substantial margin of safety against
accidental release of the vacuum within the bag and, because of its
soft, flexible construction, cannot injure the patient.
Furthermore, the valve can be inexpensively manufactured as an
integral unit, except for the screen and cloth, by well-known
injection molding techniques.
The material from which the bag portion of the aid of this
invention is manufactured should have good flexibility, durability
and air-tightness. Suitable sheet materials include soft polyvinyl
chloride, nylon, polypropylene, polyethylene, tetrafluoroethylene
resins, urethane, copolymers of ethylene and vinyl acetate, soft
A.B.S. resin acrylic esters, silicon rubber, and mixtures of
polyvinyl chloride and synthetic rubber. Plasticizers, flame
retardants, pigments and lubricants can also be included. A
preferred sheet material comprises a mixture of from 70 to 80 parts
by weight of polyvinyl chloride and from 20 to 30 parts by weight
of synthetic rubber. A 75:25 ratio is especially preferred. Sheets
of this composition exhibit excellent flexibility and a high
coefficient of friction. Flexibility is of importance because the
bag must conform well to the shape of a patient's body. The high
coefficient of friction of the bag material increases the friction
between the beads and the bag wall which in turn increases the
stability of the rigid structure formed when the positioning aid is
evacuated.
The beads used in the positioning aid of this invention must be
sufficiently rigid to withstand the stresses which result when they
interengage upon evacuation of the bag. The beads must also have a
high mechanical strength so that the aid can be repeatedly used
without accompanying attrition or fracture of the beads, and should
also be elastically deformable such that when the bag is evacuated
they can move freely into close engagement to thereby form a
stable, rigid structure.
Beads of expanded plastic materials, such as polystyrene and
polyvinyl chloride, are preferred because of their high mechanical
strength, elastic deformability and low specific gravity. Beads of
expanded polystyrene are especially preferred. The expression
"specific gravity" is intended herein to mean a true specific
gravity. Thus, when such beads are made hollow, the specific
gravity of the bead is represented by its weight divided by its
total volume including the hollow spaces therein. According to the
invention, the specific gravity of bead should be in the range of
from about 0.1 and about 0.6. Such values are readily attainable
with foamed synthetic resins, although other materials can be used
for granules when they have a low specific gravity in the range
specified above and satisfy the mechanical strength and elastic
deformability requirements. A specific gravity of foamed synthetic
resin materially less than 0.1 is only achievable when the resin is
excessively foamed, and the resulting beads are soft and not
effective for the purpose of the invention. When the specific
gravity materially exceeds 0.6, the formability of the aid, its
form stability when evacuated and its transparency to X-rays are
diminished, and the aid cannot be conveniently handled because of
its increased weight.
In order to insure that the positioning aid fits well to the
patient and remains stable when evacuated, the beads should be from
about 1 to about 5 millimeters in diameter. Beads which are uniform
in size and shape can be used, but it has been found that an aid
containing a mixture of substantial portions of beads of at least
two materially different sizes within the indicated range provides
more uniform and stable support to the patient than does an
identical aid containing beads which are all of one size.
Preferably, the beads are of differing sizes distributed across the
range of from 1 to 5 millimeters, with sizes in the lower and
middle portions of this range predominating. The following is an
especially preferred distribution of bead sizes:
Diameter (mm.) % by Volume 1 20 2 30 3 30 4 10 5 10
The vacuum pump used to evacuate the positioning aid may be either
manually operated or power driven, and preferably has a
displacement capability better than 20 liters per minute so that
the aid can be evacuated within a short period of less than thirty
seconds. Desirably the pump is one capable of attaining a degree of
vacuum on the order of 10 to 50 mm Hg.
In one instance, an aid of this invention was initially evacuated
to a pressure of between 10 and 50 mm Hg and remained below half an
atmosphere pressure after 3 days of use. It was found that repeated
use had a tendency to maintain the vacuum over an increasing time
period. Also, expanded plastic beads which has been kept in storage
for an extended period, for example 1 month, were charged into the
positioning aid, the aid maintained a usable degree of vacuum over
an increased period as compared with a corresponding aid in which
freshly prepared beads were charged. Therefore, it should be
understood that the particular pressure to which the interior space
of the positioning aid is evacuated depends upon various factors,
including the material for the bead and bag body as well as the
particular applications intended. It has been found that the
positioning aid of the invention is operable with its internal
pressure below half an atmosphere pressure, even though it should
be obvious that the lower the pressure, the better the aid
maintains its form.
FIGS. 7 and 8 show two other useful shapes in which the positioning
aid of this invention can be constructed. The valves 3 and
partition walls 4 in these two embodiments are the same as in the
embodiment discussed above. The aid shown in FIG. 7 is particularly
useful for supporting the torso of a patient in a normal lateral
position, one shoulder of the patient being situated in the recess
16 on one end of the aid and sides of the aid 17 being folded
upwardly along the patient's front and back. The aid shown in FIG.
9 is useful for supporting the torso of a patient in a 3/4 lateral
or kidney position with the sides of the aid 18 folded upwardly
along the patient's front and back and the narrow area of the aid
22 supporting the patient's head and shoulder.
FIG. 9 illustrates a positioning aid of this invention applied to
the restraint of a child after desmotomy of myogenic torticollis.
It will be noted that the aid shown facilitates postoperative
traumatotherapy and daily strengthening through orthotherapy.
FIGS. 10a - 10d illustrate the preparation of a recurvature bed in
dorsal decubitus using a positioning aid according to this
invention. The positioning aid 19 is placed on a board 20 and is
first evacuated so as to be essentially rigid (FIG. 10a). Then a
hard pillow 21 is inserted between the rigid aid and board at a
location where it is desired to provide recurvature (FIG. 10b). A
patient is caused to lie down on the aid in dorsal decubitus
(FIG.10c) and air is allowed to enter the interior of the aid
through the valve (not shown). The aid thereby becomes limp so that
the body of the patient sinks into the aid, whereupon parts of the
aid are fitted around the shoulders and waist of the patient (FIG.
10d). After any required correction of the patient's position, the
valve of the aid is connected to a vacuum pump to evacuate the aid.
It is also possible to evacuate and solidify the aid during the
interval of correcting the patient's position. The purpose of
initially evacuating the aid is to prevent beads from being
displaced away from the space directly below the patient's body
when the aid is limp. However, if partition walls are provided in
the interior of the bag body as described previously, the initial
evacuation is unnecessary.
In order to examine the state of a spine and blood circulation
during the dorsal fixation on the positioning aid, a patient's
spinal curve (FIG. 11) and back pressure (FIG. 12) were measured
for five cases indicated below.
Body Weight Case Disease Age Sex (kg) 1 Normal 27 Male 65 2 Nerve
paralysis of arm 21 " 55 3 Hernia of intervertebral disc 15 " 53 4
Spondylolysis 21 " 54 5 Spondylolysis 28 " 51
In FIG. 11, curve (a) refers to normal standing position, curve (b)
to dorsal position on the positioning aid of the invention, and
curve (c) to dorsal position on plaster of Paris bed. It will be
noted that the curve (b) has a lower backward curvature of thoracic
vertebra (.beta./.alpha.) than curve (a), but the point (.gamma.),
the transition from backward curvature of the thoracic vertebra to
forward curvature of lumbar vertebra, remains unchanged. In the
curve (c), the backward curvature becomes even less and the point
of transition shifts upwardly. All of five cases showed similar
results. It is known that backward curvature of spinal curves
measured in dorsal and ventral decubitus is less than that in
standing position and that the point of transition measured in
standing position remains unchanged in dorsal decubitus, but shifts
toward the head in ventral decubitus. This fact indicates that the
curve (b) represents physiological dorsal decubitus, while the
curve (c) physiological ventral decubitus. Thus, it will be
appreciated that dorsal fixation by means of the positioning aid of
the invention maintains the physiological curvature fairly well so
that a patient does not suffer from pain due to forced
fixation.
FIG. 12 shows pressure per 20 cm.sup.2 on a patient's dorsal
surface with an ordinary mattress (broken lines), plaster of Paris
bed (clain lines) and the positioning aid of the invention (solid
lines). An electro-manometer was used to measure pressure at 15
points, namely, five points on the dorsomedian line and five points
on the right and left scapular lines, as indicated below.
Number of Points Position Measured 1. Spinous process on vertebra
prominens, median line 2. Spinous process on 5th thoracic vertebra,
median line 3. Spinous process on 12th thoracic vertebra, median
line 4. Spinous process on basilar vertebra, median line 5. Lower
sacrum, median line 6. Infraspinous scapula, scapular line 7.
Anguluinferior scapula, scapular line 8. Floating rib, scapular
line 9. Ilium, scapular line 10. Upper buttock, scapular line
FIG. 12 shows that the pressure varies considerably along the
vertebra when the patient lies on a mattress (broken lines), and
that extremely high pressures were observed at positions where
bedsores are often found. The amplitude of oscillation or variation
of pressure is greatly decreased with the positioning aid when
compared with a mattress, and is still less than that in a plaster
of Paris bed. Though the difference of pressure between the
positioning aid and the plaster of Paris bed is small as
illustrated in FIG. 12, it was observed that the patient feels more
comfortable in the positioning aid than in the plaster of Paris bed
because of the softer texture of the positioning aid.
It will be noted that the positioning aid according to the
invention can be applied to many fields of medical treatments and
diagnosis. A patient supported and restrained by the positioning
aid can be X-rayed while the portion of his body to be examined is
covered by the aid. Little or no shadowing influence is observed in
the X-ray photograph.
* * * * *