Note: Descriptions are shown in the official language in which they were submitted.
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SURGICAL PAD
SUBJECT MATI-ER
The present invention relates to surgical pads
or sponges.
BACKGROUND OF INVENTION
The visu,al identification of surgical pads or
sponges inserted bod~'"~cavities has been a constant
problem for surgeons because the white material
conventionally used for these pads, blends into the ' -
surrounding body tissues when the pad is covered
with or absorbs blood. ~hile care is ordinarily ~' ~
taXen in the operating room to remove pads and ~ ~'
sponges from body cavities prior to closure, there ~-
have been numerous instances in which these sponges'
and pads are inadvertently left in the cavity.
These errors arise from the difficulty in keeping
track of the exact number of sponges or pads
'employed, notwithstanding the existence of elaborate .
counting systems in the operating room. On
occasion, the errors arise when the surgical team's
attention is'focu'sed onla particularly serious '
problem during surgery, necessitating reliance on -~
others in the surgical team to maintain the count.
Frequently, the problems are exacerbated during
emergency operations when time factors are involved
and an incision has to be closed ~uickly.
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The results of these inadvertencies can be
serious and often require the reopening of the
incision with subsequent added danger to the patient.
There have been a number of attempts to
address and solve this problem. For example,
surgical dressings or pads have been made with x-ray
opaque threads or visible threads. Such a surgical
pad or dressing is described in the U.S. Letters
Patent 2,698,270, which issued December 24, 1954.
In the pad described in that patent, the x-ray
opaque threads function only to identify and locate -~
a surgical pad;after the patient has an x-ray. Such
a procedure may not~-occur until long after the ~
surgery has been completed. Even when portable ~ ;
x-ray eguipment is used, such procedures
unnecessarily delay the completion of the surgery.
The use of some visible threads such as carbon black
threads, as described in that patent, have also -
limited utility in providing a fail-safe system for
detecting the presence of sponges and pads in body
cavities. The value of individual threads in such
absorbent material is limited, because the surface
area of thread to pad is small. This limited value
is particularly apparent when using very small
sponges, as the individual stitch lines are short
and easily covered with blood. Thus, despite their `
purpose, such sponges`can easily be overlookèd. In
addition, the x-ray opaque and carbon black threads
are ordinarily secured in absorbent pads by standard
two thread lock stitches. During surgery, these
stitches may accidentally be cut by the surgeon and
removed in whole or in part, thus, further obscuring
the sponge. In some instances, as suqgested in U.S.
Letters 4,244,369, which issued January 13, 1981,
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the x-ray opaque threads are chain stitched into the
pad, thereby making their accidental removal even
easier. Furthermore, the use of these identifying
threads in absorbent pads is also of limited value,
because the pads not only absorb the color of blood,
but also shrink in size and are folcled and refolded
in the body cavity, making the observation of
identifying threads even more difficult.
The use of wavy patterns, strips, or other
arrangements, such as suggested in U.S. Letters
Patent 2,698,270, to enhance the visibility of the
pad or sponge is not satisfactory, because these
wavy patterns can be--mistaken for blood vessels.
Other efforts to solve this problem involve
the use of radiographically opaque rings attached by
loops to the surgical pads, as illustrated in U.S.
Letters Patent 3,698,393, issued October 17, 1972.
Such a proposed solution is not altogether
satisfactory for a variety of reasons, including the
cost of manufacture and the requirement for
radiographic detection and the possibility that the
ring itself may be concealed. As a consequence, the
design of surgical pads and sponges that are easily ~;
visible in a body cavity continues to be a chronic
problem.
SUMMARY OF INVENTION "
It is an object of the present invention to
provide an improved means for detecting surgical
pads and sponges in body cavi~ies during surgery. A
further object of the present invention is to ~-
provide a readily visible surgical pad or sponge
that is simple to manufacture, sterilize, store and
use.
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A further object of the present invention is
to provide improved means for visually identifying
the surgical sponges in which the sponge is
uniformly colored with an appropriate non-toxic,
non-reactive and stable dye that will not take on
the color of blood when immersed in it.
A further object of the present inventisn is
to provide a surgical sponge or pad that is readily
visible during surgery, regardless of the size of
the sponge.
A still further object of the present
invention is t~ provide an improved surgical pad or
sponge in which reflective glare from operating room
illumination is reduced.
The objects and advantages of the present
invention are achieved by use of surgical pads and
sponges made of conventional materials, but suitably
dyed with non-toxic and non-reactive dyes having a
color that contrasts with body tissues when
satura~ed with blood. ~
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DETAILED DESCRIPTION OF INVENTION
;~ The present invention is directed to surgical
sponges and pads that may be absorbent or
non-absorbent. The sponge or pad material may
typically be made of cotton, cellulose, rayon, nylon
- polyolefins or simila~ synthetic fibers alone, or in ' ;
combination. The pads and sponges may be woven or
non-woven, absorbent, non-absorbent or wettable.
The shape and the size of the pads and sponges may
vary. The sponges may be small for microsurgery or
neurosurgery, or in the form of cover stock for
sponges that are intended to be maintained in dry
conditions as barriers to adjacent tissues or
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fluid. Sponges, as small as 1/4" x 1/4", are
contemplated, and may be shaped in the form of
balls, rolls, cubes and sheets. These pads or
sponges are appropriately dyed.
In the manufacture of these sponges and pads,
the fibers are made of material sùch as cellulose,
polyesters, olefins, nylon and cotton, or mixtures
in various combinations. The fibers are dyed after
the pad or sponge has been formed. The pad or
sponge may be formed by any well-known technique
including random matt, knitting or wearing.
A wide variety of FDA-approved dye colors may
be used, including,-specifically, D & C 5-Green, D &
C 6-Green, Logwood Black and Brown, D & C 6-Blue, D
& C 9-Blue and D & C 2-Blue, as well as others.
When appropriately dyed into the fibers or the
sponge or pad, a black dye, ordinarily, remains
black in the present of blood, green dye turns
blackish in the present of blood and a blue dye
yields a distinct black color. While a wide range
of dyes may be selected, the dye should obviously
not be toxic and should not bleed in the presence of -
body fluids or saline solutions. Many of ~hese FDS
approved dyes are identified in the Corase Cherweal
and Technical Dictionary (edited by H. Bennitt).
In the preferred form of the present
invention, th`e pad or'sponge is totally dyed with
the appropriate dye as set forth above.
While conventional dying technigues may be
used, some precautions should be taken. Obviously,
care must be taken to ensure that ~he end product is
sterile.
After initial dying of the pads or sponges,
excess dye must be removed by appropriate washing
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techniques., Dyes applied to the pads and sponges -
must be color-fast and non-toxic. ~yes must not be
subject to bleeding, chemical reaction with body
fluids, saline solution or other chemicals that may
be used during surgical procedure.
In a preferred form. D & C 5-Green dye is used
for polyester, D & C 6-Green is used for nylon 66,
polyester or nylon 6; Logwood Black dye may be used
for nylon 66 or silk fibers; D & C 6-Blue or Logwood
Brown may be used for gut; D ~ C 9-Blue may be used
for cotton, polyster or silk; and D & C 2-Blue may
also be used for nylon.
These color con~trasting sponges also
materially absorb rays from surgical lights. This
cuts the glare which would otherwise occur in the
presence of highly reflective white surgical pads or
sponges. Additionally, these color contrasting
sponges assist the surgeon in distinguishing tissue
from blood impregnated sponges.
Use of contrasting color sponges also
functions as a secondary examination system when cat
scans, ultrasonic and other systems are used.
While the present invention primarily
contemplates the use of visible dyes, these dyes may
also have incorporated into them materials that
render the sponges readily identifiable by x-ray.
The pads or sponges ma~ be!dyed in different
groups of different colors for purposes of
color-coding the sponges~ This color-coding may
take several forms. For example, small sponges, in
the order of a 1/4" x 1/4", may be dyed one color,
while larger sponges may be dyed another color.
During surgical use, these dye- impregnated
sponges or pads may also be used as a block for
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various types of laser rays, which are absorbed by
black dyes. Thus, a black surgical pad or sponge
surrounding a target area absorbs r;lys from a carbon
dioxide or YAG laser. The absorption of these
scattered rays safeguards not only the patient, but
operating room personnel.
By appropriately selecting a particular dye
color, a change in color of the blood-saturated
sponge or pad will give some indication of the
amount of blood saturation. This may provide the
surgeon with an on-going means to determine when it
would be appropriate to change or add sponges during
a surgical procedure~ Dyes that may be used to
impregnate the fibers forming ~he present invention
depend, in some degree, upon the type of fibers
being used.
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