Note: Descriptions are shown in the official language in which they were submitted.
106~ZZ~Z40
i
BACRGRo~ZJD OF THE INVEN~ZZION
The present invention relates to absorbent articles,
and more particularly to surgical sponges.
~i Surgical sponges are commonly used during surgical pro-
cedures to absorb body fluids of the patient both inside the
incision and around the site of surgery. Sponges of this nature
are usually made of an open-meshed absorbent fabric, such as
woven cotton.
It is important, of course, that all of such sponges be
10 removed from the patient's body after surgery is complçte and
before the incision has been closed. Accordingly, it is a stand- !`~
ard procedure for the surgical team to carefully count the
sponges to reduce the possibiiity that a spZonae may be left in
; the patient. ~
~ 15 In spite of such safety measures, sponges have been ;
,..................................................................... ..
occasionally lost, particularly when an unexpected emergency ais- -
.; ....
rupted the normal operative routine such as counting, which is
subject to human error. When saturated by body fluids, such as
blood! the sponges become significantly reduced in size and ~ ;
assume a color the same as body tissue, thus making visual detec-
tion of the sponges extremely difficult. As a result, it has ¦~
been required to provide the sponges with a flexible inqert ¦~-
which is opaque to X-rays. In case of a disputed or non-tallying 1 `
:. . .
sponge count in the operating room, or in case of unexpected or
unexplainable post-operative discomfort on the part of the
patient, a portable X-ray unit is brought to the patient and an
-~ X-ray exposure should reveal the presence or absence of a loQt ~`
sponge. A nega~ive plate should be reassurance to the surgeon
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that he and his operative team have not left a sponge in the
patient. Nevertheless, it is desirable that the patient be pro-
vided additional assurance a sponge d~es not remain in his body,
and that the number of instances an X-ray is necessary be mini-
mized, whether or not additional surgery would ultimately be
required to remove a lost sponge.
SUMMARY OF THE INVENTION
A principal feature of the present invention is the
-
provision of a surgical sponge of simplified construction which
prevents mishaps in reclaiming sponges from a patient's body.
The sponge of the present invention comprises, a sheet .
' of an absorbent material, and an elongated visually detectable ` -
element at least partially located on an outer surface of the ~- - . -
,,~ . ,~,: . ,
sheet.
A feature of the present invention is that the element -~
substantially increases the visibility of the sponge in the -
patient's body.
; Another feature of the present invention is that the ;
element permits visual detection of the sponge even when the
sheet is saturated with body fluids. I
Yet another feature of the invention is that the ele-
ment may be radiopaque for detection by an X-ray unit.
!
j Thus, a feature of the present invention is that the
reflective element minimizes the possibility that the sponge may
~ 25 be left in a patient's body during an operation.
'l A further feature of the invention i9 that the element
may comprise a relatively narrow thread which is sewn in a stitch-
~^ ing pattern onto the sheet.
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'~' 1064Z40
Another feature of the invention is that the element
may comprise an elongated ribbon of radiopaque material having
a visually detectable surface.
A feature of the invention is that the element may be
an integral part of the sheet structure.
Yet another feature of the invention i8 that the element
may be made from highly reflective, fluorescent, phosphore~cent,
or iridescent materials.
Further features will become more fully apparent in the
10 following description of the embodiments of this invention and ~-
from the appended claims.
DESCRIPTION OF THE DRAWINGS
In the drawings~
Fig. 1 is a perspective view of a surgical sponge of `
. - . .
the present invention have a visually detectable element;
Fig. 2 is a fragmentary sectional view taken substan- ~-
tially as indicated along the line 2-2 of Fig. l;
Fig. 3 is a fragmentary sectional view on an enlarged -
scale of an element suitable for the sponge of Fig. l; ~;
Fig. 4 is a fragmentary elevational view of a partially ~ ~-
formed element for the sponge of the present invention; `
Fig. 5 is a fragmentary plan view of a surgical sponge
having an element as constructed in accordance with the element
of Fig. 4;
Figs. 6 and 7 are plan views of absorbent sponges hav-
ing differing patterns formed by visually detectable element9t
and
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Fig. 8 is a fragmentary plan view of a fabric in which
the element is formed as an integral part of the fabric structure.
DESCRIPTION OF THE PREFERRED ENBODIMENTS
.. ...
Referring now to Figs. 1 and 2, there i8 shown a --
surgical sponge generally designated 10 having a sheet 12 of an
absorbent material, e.g., a low-count gauze-like or open-mesh
fabric, such as woven cotton, or a nonwoven material. The sheet
12 has a plurality of folds defining a multiple ply of the sponge -
10, with the folded sponge having a pair of opposed outer surfaces - ~-
14a and 14b, a pair of side edges 16a and 16b, and a pair of end
edges 18a and 18b connecting the side edges 16a and b. The sponge
10 may have an elongated radiopaque filament 20 located between ` ~ -
plies of the sheet 12 to prevent dislodgement of the filament 20
from the sponge 10 during use in surgery. The filament 20 may be ;~
;}~ 15 made of a thermoplastic polymeric material containing a radiopaque -
material, such as barium sulfate, such that it may be detected on
an X-ray photograph. ;
The sponge 10 also has an elongated visually detectable -
element 22 secured at least partially on an outer surface o the
. ~`-:~ ,.. . .
absorbent sheet or fabric 12. In a preferred form, the element 22
is highly reflective and may be made from a metallic material hav- -
ing a highly reflective surface and a color, e.g., gold or sil~er, `
which contrasts with the color of body fluids, such as blood, -~
and is non-wetting. A suitable material for the element 22 is
a thread sold by Netlon Corporation, Providence, Rhode Island.
::' ~ . -
~ With reference to Fig. 3, a suitable thread ha~ a central layer
i 24 of metallic material, such as aluminum foil or stainless
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1064Z~O
steel, a pair of outer layers 26 of transparent plastic material,
such as polypropylene or Mylar, a trademark of E. I. du Pont de
Nemours, on opposed sides of the central layer 24, and layers 28
of a thermoplastic adhesive bonding the outer transparent layer~
26 to opposed surfaces of the central metallic layer 24. If the
adhesive 28 in the laminate is transparent, then the element 22
assumes the color of the metallic layer 24, e.g., a highly
reflective silver color which is suitable for the element 22 on
the sponge 10. Alternatively, the adhesive 28 may be provided -
with a dye in order to color the thread in a desired manner,
such as a gold color, while providing the thread with a highly
reflective colored surface due to the metallic base of central
layer 24 which underlies the colored adhesive layers 28. In use,
the outer plastic layers 26 protect the dye in the adhesive and
prevent the element from becoming colored by body fluids, such
. . .
as blood. Of course, any other suitable material may be utilized -- -
for the element 22 which provides a highly reflective and color
. . . .
' contrasting appearance for the sponge during use, and the element -~
! ~- .:
may have a generally flat or round configuration. If desired a
suitable radiopaque material, such as barium sulfate, may be
~ included in the adhesive layers 28 which, in addition to the
i metallic central layer 24, results in the element 22 being more ~ -
radiopaque, thus possibly eliminating the necessity for the sepa-
!~ rate radiopaque filament 20. Also the outer surface of the ele-
ment may be metallic and may be formed by dipping or vacuum
deposition. `
In a preferred form, the element 22 is relatively flex- ~ -
ible and thin in order that it may be sewn into the fabric or ~
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gauze sheet 12 by a sewing machine as the thread in a sewing pat- -
tern. With reference to Fig. 2, in a lock stitch metallic threads
may be sewn through the machine needle and from the bobbin, such
that the sewn sponge 10 has a pair of visually detectable elements
22a and 22b on the opposed surfaces 14a and b of the sponge.
Alternatively, a visually detectable thread may be utilized in a
chain stitch to provide the sponge with portions of the thread on
the opposed surfaces of the sponge. Of course, the element 22
may be attached to the outer surface of the sponge by any suitable
~ 10 means, such as lines of stitching, but in a preferred form the
; element may be conveniently sewn into the fabric in a simplified
; manner during construction of the sponge and preventing dislodge-
ment of the element during use of the sponge.
In accordance with the present invention, the sponge
10 has a highly reflective element 22 at least partially on an
outer surface of the sponge, such that the reflective element is
readily visible even when the sheet 12 of absorbent material has
been saturated by body fluids, such as blood. Accordingly, the
'- reflective element 22 permits visibility of the sponge in the
patient's body in order to minimize the possibility that the
sponge may become lost during surgery and to reduce the number
of instances in which an X-ray unit must be utilized to locate
a lost sponge. In this regard, it is noted that the radiopaque
elements commonly used in surgical sponges are normally located
within plies of the sponge material, and are not normally visible
on the outside of the sponge. Further, even if positioned on the
outer surface of the sponge, such radiopaque element~ do not have
a sufficiently reflective surface to enhance visual recognition
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lQ64Z40
of the sponge, particularly when saturated by body fluids.
In a preferred form, the reflective element 22 extends
throughout a substantial area of the folded sponge 10. As shown
in Fig. 1, the element 22 may extend the length of the folded
sponge between the end edges 18a and b. Other suitable configu-
rations of the element 22 comprise a plurality of spaced line~,
a pattern generally in the shape of a Z, as shown in F$g. 6, or
a pattern in the shape of an X, as shown in Fig. 7, such that the
reflective element 22 extends substantially the width and length
of the sponge between its side and end edges in order to insure ~`
that the reflective element is readily visible on the outer sur-
face of the sponge.
In an alternative form, the element 22 may be made from
a light emitting material, such as a fluorescent or phosphorescent
material, or from an iridescent material. As known, a fluorescent
material, such as a film sold by Appleton Papers, Appleton, Wis-
consin, emits electromagnetic radiation as a result of energy
flow, such as light, into the emitting body so long as the
excitationcontinues, while a phosphorescent material is lumines-
cent after the source of excitation ceases. An iridescent mate-
rial, such as a film sold by The Mearl Corporation, Peekskill,
New York, displays a rainbow color effect as a result of inter-
ference in a thin film or diffraction of light reflected from a
ribbed surface. In either event, an element 22 made of such
materials significantly increases the visibility of the sponge
when wetted with body fluids during use.
Another embodiment of the present invention is illus-
trated in Figs. 4 and 5, in which like reference numerals de~ign-
lO~D,tZ40
.,
nate like parts. In this embodiment, the visually detectable
element 22 comprises an elongated ribbon 30 of radiopaque material,
such as a thermoplastic material impregnated with barium sulfate,
which has a highly reflective outer surface, or other visually
detectable surface, as previously described. The surface may be
- formed in any suitable manner, such as by winding a thread or yarn
34,with the desired detectable surface characteristics, around and
covering an outer surface 36 of the radiopaque ribbon 30. The
yarn 34 may be of any suitable type, such as the element or thread
previously discussed in connection with Figs. 1-3, and the visu- - -
ally detectable element 22 may be secured on the outer surface of
the sheet 12 by suitable means, such as by stitching 32 shown in
Fig. 5. Thus, the element 22 has an inner radiopaque ribbon 30 `
which may be utilized, if necessary, for detection of the sponge
by an X-ray unit. Additionally, the element 22 has a visually
detec~able outer surface defined by the yarn 34 to significantly
enhance visual detection of the sponge when located in the
patient's body and saturated with body fluids, thus minimizing
the possibility that the sponge may become lost in the body and
that an X-ray exposure of the body may be required. ~
Another embodiment of the present invention is illus- .
trated in Fig. 8, in which like reference numerals designate like
parts. In this embodiment, the visually detectable element 22 may -
be woven into the fabric or sheet 12 as a yarn, while the remain-
ing yarns 40, such as cotton, provide absorbency for the sponge 10. ~ h
Alternatively, the element 22 may be utilized as a yarn in a
; knitted fabric.
The foregoing detailed description is given for clear-
ness of understanding only, and no unnecessary limitations should
be understood therefrom, as modifications will be obvious to those
skilled in the art.
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