Note: Descriptions are shown in the official language in which they were submitted.
1049873
FIELD OF THE INVENTION
The present inventlon relate~ broadly to surglcal
cover means. In particular, the inventlon relates to new ~nd
lmproved surglcal drapes of the type which comprise a flexlble
sheet havlng a main portlon and wing portions whose inner
edges define a slit or gap (herelnafter "gap" for convenience)
which extends inwardly from an outer edge of the drape. Such
drapes are especlally useful ln orthopedic surgery, neuro-
surgery, and similar surgical procedures.
In preparlng for orthopedlc and related ~urgery
lt is common praCtice to cover the patlent and operatlng
table with a sterile drape, or drapes, in such a w~y that
only the limb (or portlons of the limb) on which surgery i8
to be performed-ls presented to the surgeon and hls assistants.
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DESCRIPTION OF THE PRIOR ART
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One drape that has been provided for orthopedlc
. . . ..
and slmilar surgery comprises a sterile sheet having a main
portlon and an elongated gap extending outwardly from R
central reglon thereof to an outer edee to provide two
spaced wing portlons. Such drapes aro frequently re~erred
to as "split sheet" drapes.
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One draplng proceduie for using these drapes in-
volves raising the patlent's llmb and putting lt through the
gap ln the sheet in such a way that, when the draping 18
completed, the limb on whlch the operation is to be performed
extends through the gap and lles on the upper surface of the
maln portlon of the drape. me wlng portlonæ of the drape
are then disposed to overlie parts of the patient's body at
a region adJacent the operative s1te.
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10498'73
It is necessary, of course, to in~ure that a
~terile surglcal field be provided at the out~et of the
eurgical procedure and that the integrity of the sterile
field be maintained until the surgical procedure i8 completed.
In order to establl~h the sterile field and to prevent the
contamination thereof in the event the wing portion6 of the
split ~heet ~hould 91ip or be accidentally moved during
surgery, it has been found necessary, prlor to placement of
the split 6heet, to cover the patient with an auxiliary surgical
drape. me auxiliary drape 1~ placed over that portion of the
patlent's body which wlll underlie the gap in the split sheet
when the latter has been posltioned.
The need for ùsing ~uch auxillary drapes represents
an lnconvenlence to the operating room staff ln that at least
two drapes must be handled and put into posltion. Furthermore,
the use of two or more drapes lncrease~ the t~me that must be
devoted to the draplng procedure and correspondingly delays
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the start of the surgical procedure.
~UMMURY OF THE INVENTION -~
'~! 20 In accordance with the present invention there i~
provided an improved surglcQl drape for use in orthopedic and
. ~ ,
similar surgery wh1ch eliminates the need for the aforementloned
auxiliary drape. The drape of the present invention thus
slmpllfles the~draping procedure, saves valuable time, and
reduces costs.
e improved drape of the lnventlon comprises a
flexlble unitary sheet, suitably of a plastic fllm or a woven
or nonwoven fabric, having a maln portion and two wing portlons.
The inner edges Or the wlng portions define an elongated gap
which extends inwardly of the drape from an outer edge thereof.
Attached to one of the wing portions, preferably at the lnner
,
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1049873
edge thereof ad~acent the gap, 1~ a flap-llke sheet of woven,
nonwoven, plastlc or slmllar materlal which is adapted to
overlle the aforesald g~p when the drape i8 in u~e. The ~lap-
like sheet of materlal may be extended "across" the gap, or a
part thereof, to lle in overlapping relation~hip with the
other of the two wing portions comprislng the sheet. The
flap-like sheet is wlde enough to cover the width of the gap
and at least part o~ the upper or lower surface of the other
wlng portlon. Preferably, the flap-like sheet, or at lea~t
the portlon thereof lntended to cover the gap, is Or
surflclent length to extend along a substantial portlon of
the length o~ the gap.
The gap in the drape of the present inventlon may
vary in wldth from substantially zero inches (as would be the
case lr a Bllt were formed ln the sheet by cuttlng lt with a
knl~e or sclssor~) up to the dlameter of the limb on which
surgery 18 to be performed. The latter dlmenslon depends on
the slze of the llmb on which surgery 18 to be performed, but
normally would be expected to be, for example, from about 3
lnches to about 5 lnches in the case Or an operatlon on the
thigh portlon Or the leg. A gap measurlng from about 2 inches
to about 4 lnches ln wldth would be sultable for arm surgery.
The gap extends from an outer edge of the drape and termlnates
lnwardly o~ the drape.
- 25 In another embodlment Or the present lnventlon,
each Or the wlng portlons of the drape has a flap-llke sheet
at lts lnner edge. Such a drape can be used? as wlll be seen
herelnafter, to provide a double layer of draplng materlal
~hlch can elther overlle parts of the body adJacent the slte of
surgery or whlch can be arranged under a llmb which 13 to be
subJected to surgery.
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1049873
According to a broad aspect of the present invention,
there is provided a surgical drape which comprises a sheet of
flexible, drapable material. The sheet has a main portion at
one end thereof and a pair of spaced wings at the other end
thereof. The wings extend outwardly from a central region of
the sheet and define a gap in the sheet. A flap is provided on
at least one of the wings and is transversely extendible from
the one wing so as to cover at least a portion of the gap and
to lie in contacting relationship with at least part of the
other of the pair oi wings when the drape i5 placed on a patient.
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1049873
As used herein, the term "nonwoven ~abric" includes
a layer of overlapplng, lntersectlng flberR which are bonded
by sultable adheslve mean~, as well a~ paper made from short
length rlbers using conventlonal paper making technlque~.
BRIEF DESCRIPTION OF THE DRAWINGS
The inventlon wlll be better under3tood upon reading
the following detailed de~criptlon and upon reference to the
appended drawings, in which:
Fig. l is a top plan vlew of a flr~t embodiment of
a surglcal drape ln accordance wlth the present inventlon, with
the drape being folded out ~lat and with the flap-like sheet of
the drape being folded back upon one wing portion to reveal the
gap in the drape;
Flg. 2 iB a cross-sectional vlew at an enlarged ~cale
thken along llnes 2-2 Or Fig. l and showing the manner ln which
the flap-llke sheet is attached to the wing;
Fig. 3 is a top plan vlew of the drape Or Fig. 1,
.
but sho~ing the ~lap-llke eheet ln a poeitlon overlying a
subetantlal portlon of the length of the gap and coverlng part
of the other wlng portion Or the drape;
Fige. 4a, 4b, and 4c are partial top plan vlews
showlng alternatire arrangements ror attaching tho flap-like
eheet to the wing portlon;
Flg. 5 18 a top plan vlew o~ a drape simllar to
that 6hown ln Flg. 1 with the addltion of a reinforclng panel
on lt8 upper eurface;
Fig. 6 i5 a top plan vlew o~ a second embodlment of
a surglcal drape wherein each of the wlng portlons has a
M ap-llke sheet;
Plg. 7 i8 ~ cro~s-sect~onal ~iew at an enlarged ~cale
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taken along llnes 7-7 of Flg. 6 and ~howlng the manner ln
which the flaps are attached to the wlngs;
Fig. 8 is a perspective view o~ the drape of Flg. 6
showing each flap-like ~heet folded and overlylng the wlng
portion to which lt is attached and showing in broken lines
the ~old lines for the longitudinal folding Or the drape;
Fig. 9 iB a plan vlew slmilar to Fig. 6, showing the
drape in an lntermediate stage of folding wherein the flap-llke
~heets have been folded transversely and the maln portlon Or
the drape has been folded longitudina~ly;
Fig. 10 is a diagrammatlcal cross-sectional view
taken along llnes 10-10 o~ Flg. 9;
Fig. 11 18 a top plan view, at an enlarged scale, of
the drape o~ Fig. 6 a~ter the longltudinal folding thereof has
been completed,
Fig. 12 is a dlagrammatical cross-sectlonal view
taken along llnes 12-12 of Flg. 11, and
Figs. 13-18 are perspective view3 showlng the
sequence of steps ln draplng a patlent ~or leg sur~ery wlth
a drape Or the type shown ln Figs. 6-12.
DOErAILED DESCRIPIqON OF T~E INVENTION
Whlle the invention will be described in connectlon
.; .
with lts preferred embodiments, lt will be understood that lt
is not intended to limit the invention to those embodiments.
On the contrary, lt 18 intended to cover all alternatives,
modlricatlons and equivalents as may be lncluded within the
splrlt-and scope o~ the ln~entlon as defined by the appended
clalms.
Referring more particularly to Flgs. 1-3, which show
one embodlment Or the pres-ént inventlon, surgical drape 10
comprises a flexlble sheet 11 made fro~ a ~ingle piece o~ a
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1049873
sultable drapable materlal. Preferably, the material 1~ a
drapable nonwoven fabrlc, such as a scrim rein~orced tl~sue
or a wet-formed nonwoven contalnlng long flbers. Flexlble
sheet ll comprises a maln portion 12 at one end thereo~, and
a palr Or ~paced wing~ 20 and 30 at the other end thereof.
The perimeter of the drape comprises opposed slde edges 16 and
17 and bottom edge 15.
Wing portlons 20 and 30 are lntegral with, and
extend outwardly from, maln portion 12. Wlng portion 20 has
an inner slde edge 24 and an upper edBe 26. Correspondingly,
wlng portion 30 has an lnner slde edge 34 and an upper edge 36.
The upper edges o~ the wlng portions deflne the uppèr edge of
the drapo.
Dr~pe lO has a g~p 45 at least part of whlch i8
deflned by the adJacent inner edges of the wing portion~ and
whlch extends from the upper edge o~ the drape inwardly to a
generally central portion thereof. me gap has an open end,
i.e., an end which communicates with the outer edge of the
drape, and a cloaed snd, i.e., an end whlch is located generally
centrally o~ the drape. The closed end o~ the gap may be of
any deslred configuratlon.
When, for ex~mple, the inner edges of the wlng
portionc are~linear, the gap will assume the conflguration
o~ an elongated rectangle ~the width of which will be determlned
by the distance between the ad~acent lnner edges of the wing
; portlon~) and the closed end of the gap will be "squared off."
Where the adJacent inner edges o~ the wing portlons have
curved portlons inwardly of the drape, the closed end of the
gap will as~ume a curved configuratlon. Preferably the closed
end o~ the gap has a curved configuration such as that shown in ~i~
Flg. 1 slnce, as wlll be seen herelnafter, thlD provides a
drape whlch more readily conforms to the contours of the body
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1049873
when the drape 18 in use.
Inner side edge 34 of wlng portlon 30 carrles a
flap 40 of drapable materlal, whlch, as lllustrated ln Fig.
3, may be folded acros~ gap 45 and lie in overlapplng re-
latlonshlp with wing portion 20. Although Flg. 3 showsflap 40 overlylng and coverlng part of the upper surface of
wlng 20, lt 1~ al~o contemplated that these two elements may
be arrsnged 80 that wlng 20 overlles sheet 40. Thls will be
; descrlbed in greater detall ln connection with the detailed
descrlption herelnafter Or the unfolding and use of the drape.
The term "overlapplng relatlonshlp" is used herein to describe
both Or the above mentloned arrangements of sheet 40 and wing
` portion 20.
Flap 40 has a lower edge 41, an upper edge 42, and
side edges 43 and 44. The lower and upper edges of flap 40
are substantially equal ln length and are sufflclently long
so that the n ap can be folded across gap 45 and lle in
o~erla?ping relationshlp wlth at least part o~ wing 20.
Referring especially to Fig. 3, it is eeen that the length of
.
the flap along side edges 43, 44 is somewhat less than the
length of gap 45. Flap 40 runs lnwardly along lnner edge 34
from a polnt lnward of the upper edge of wlng 30 to a point
near the clo~ed end of gap 45.
The partlcular part of wing 30 to which flap 40 i~ 25 attached 18 not critlcal, pro~ided, of course, that the flap
can be ~olded across the gap snd lle in the aforementloned
overlapplng relationshlp wlth wing 20. Preferably, however,
the ~lap i8 attached to the wlng at or near its inner ~lde edge
34, since a minimum amount of material is thus requlred and
unnecessary bulkiness ln the folded drape 18 eliminated. As
lllu~trated ln Figs. 2 and 3 flap 40 is fastened, along a line
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1049873
adJacent lts slde edge 44, to the upper surface of wlng 30 a
sllght distance from its inner side edge 34. Thi~ i~
convenlently accompllshed by stltchlng (indicated by dashed
llne 39 ln Flgs. 1 and 2), but other fastening means, such
as an adhesive, may be employed if so deslred.
The manner of attachlng the flap to the wing 1~
illustrated in Fig. 2. A marglnal portion of flap 40 ad~acent
lts slde edge 44 i8 rolled beneath the remainder of the flap
so that part of upper surrace 46 of the rlap is dispo~ed ln a
face-to-face relationship wlth upper ~urface 32 of wing 30.
As mentioned, the flap i8 convenlently secured to the wing by
stltching 39. When the M ap iB attached to the wing ln the
manner Just descrlbed, there will be no folds or bulky portlons
on the upper surface of the drape when the drape is in use.
15It wlll be apparent that the rlap can be attached to
the wing ln other ways. For exa~ple, a portlon of the flap
adJacent lts upper edge 42 could be secured by stltchlng 39,
or other securlng mean~, to wing 30 near its upper edge 36
(see Flg. 4a). Alternatively, the flap could be attached to
the wlng at, or near, side edge 16 Or the drape (Flg. 4b) or
~- at some point intermediate inner edge 34 ~nd the outer edge o~
the wlng (Flg. 4c).
The drape Or the present lnventlon may be made from
the well known "linen" materlals, such as woven cotton cloth,
comm~only used in ho~pitals. Preferably, however, flexlble
sheet 11 (comprising maln portion 12 and wing portions 20 an~
30) and ~lap 40 comprlse a nonwoven fabrlc Or adequate tenslle
and tear strength.~ me nonwoven fabric ~hould be relatively
soft and have good drOEplng and foldlng characteristics.
Addltlonally, oP course, the nonwoven fabrlc must be capable of
bèlng subJected to a sterlllzation treatment without belng
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1049873
adversely ef~ected thereby. The use of nonwoven fabrics
elimlnates the laundering, resterilizatlon, and handling
costs assoclated with llnen drapes, since drnpes made from
nonwoven fabrlcs are dl~carded after use. The use of nonwovens
in surgical drapes i8 well known and the selectlon of a non-
wo~en fabrlc havlng the above mentioned qualities iB withln
the skill of those working in thls art. More preferably, the
nonwoven fabric used ln con6tructlng the drape 18, or ig treated
to be, repellent to liquids such as water, body flulds and
other llquids commonly encountered during surgery. In this
way any liqulds which come into contact with the ma~or surfaces
Or the drape are pre7~ented from striking through the drape and
o~tabli~hlng a path for the transmlssion of bacterla. Methods
for renderlng nonwoven fabrics repellent to liquids are well
known ln the art and are not part of the present invention.
Reierring now to Flg. 5, there is shown a modiflca-
tlon of the surglcal drape of Figs. 1-3. me drape has a
reinforcing panel 48 on lts upper surface in the regions
adJacent gap 45. The relnforclng panél may comprise one or
more layers Or the aforementioned flexlble materials.
Preferably, however, the reinforclng panel has an absorbent
upper surface 48a and an impervious plastic film (shown as
dotted line 49 ln Flg. 5) between the absorbent surface and
the main sheet D~ the drape. me upper surface of the
reinforcing panel provides absorbency at the operation site
to absorb body and other fluids encountered during surgery.
me impervious~plastlc film ln the reinforcing panel prevents
j flulds from striklng through the drape to the patient. me
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relnforcing panel can be airixed to the drape by, for example,
a suitable adhesive.
Referrlng now to Flg. 6, there is shown another
embodlment of the present invention. ~rape 50 i~ generally
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1049873
the same as drape 10 Or Figs. 1-3 except that each of its
wlng portlons carries a flap-like sheet. ~rape 50 compri~e~
a sheet 51 of drapable materlal havlng a main portion 52 and
opposed wlng portlons 60 and 70 extending therefrom. The
drape has a gap 85 whlch extends lnwardly from the top edge
Or the drape and which is defined by lnner slde edges 64 and
74 of wlng~ 60 and 70, respectively. The drape also has a
bottom edge 55, a bottom portion 55' ad~acent sald bottom edge,
and slde edges 56 and 57. The drape has an upper surface
(the surrace expo~ed to the viewer in Fig. 6) and a lower
surface (the surrace not seen by the vlewer in Fig. 6).
Flap 80 i8 attached to wing 60 ln the manner illus-
trated in Fig. 7. A marginal portion o~ flap 80 is folded
over lnner edge 64 Or wing 60 and continued a short distance
along lower surrQce 63 Or the wing. me flap may be secured
to the lower surrace Or the wing by, for example, a sultable
adhe~ive 65. Simllarly, flap 80' i8 foldea over inner edge
74 and i8 secured to lower ~urface 73 of wing 70. If desired,
; the flaps may be secured to the wings ln the same manner as
flap 40 18 attached to wing 30, that i8, in the manner
illustrated in Flg. 2.
: FOLDING OF THE DRAPE
~ . .
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Drapes Or the present lnvention may be-folded into
a compact unit which facllitates handling durlng packaging and
storage and which permits the drape to be eas11y and qulckly
applled to the patient prlor to ~urgery.
As ueed hereln a "rorward fold" is a fold in which
the upper surface i~ turned toward the upper surface Or the
drape around a fold line. A "reverse fold" i8 a fold in which ~ ~-
the upper surrace o~ the drape is turned toward the bottom ~ -
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1049873
surface of the drape sround a fold llne. In the drawings,
the letter R indicates a rever~e fold and the letter F
indlcates a forw~rd fold. The numbers precedlng the letters
F And R refer to the order ln which the foldlng ls done.
m e preferred method for foldlng drape 50 from end
to end is illustrated ln Figs. 8-12. As seen in Flg. 8, flap~
80 and 80' are fan-rolded to form two stacks of folds overlying
wings 60 and 70, re~pectively. Maln portion 52 of the drape
i~ rolded next. ~ottom portlon 55' ad~acent bottom edge 55 o~
sheet 51 is forward ~olded, toward the center of the drape,
around ~old llne lF. The maln portlon iB then rever~e folded
around ~old ~lne 2R, forward ~olded around fold llne 3F,
reverse ~olded around fold llne 4R, and forward folded around
fold llne 5F.
; 15 As best seen in Fig. 8, upper end portlon 53 o~ maln
portlon 52 is defined by rold llne 5F, the sldes of the drape,
and tran~verso llne 54 (shown ln dot and dash) along which
tha wings extond from m~ln portlon 52.~ Thus, as illustrated
in Flg8. 9 ana 10, the ~bore descrlbed folding sequence
provides a stack A o~ ~olds whlch overlles a substantial part
Or the upp~r surface o~ ond portlon 53.
me wings (wlth their flaps already fan-folded as
shown ln ~ig.~ 8) are ~olded next. A part o~ wlng-70 ad~acent
upper odge 76 thereor i8 forward ~olded around ~old line 6F.
Therearter wing 70 iB roverse ~oldod around fold line 7R and
forward folded around rold llne 8F. It wlll be observed that
the clo~ed en4 o~ gap 85 18 dlspo~ed between fold llne 8F and
tr~nsverse llne 54. As seen in Fig. 12, thls oldlng of wing
70 (lncluding lts a~soclated flap 80') prorldes~a ~tack B of -
folds ~hlch overlles stack A Or folds. Wlng 60, with ltsflap 80, 18 then folded ln the mQnner Ju~t described for wing 70
.
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1049873
to provide a stack C of folds whlch overlles stack A of
folds. Fig. 11 shows drape 50 after it has been folded in
accordance with the above descrlbed foldlng procedure. It
will be notlced that the closed end of the ~ap i8 now exposed
to vlew at the upper portion of the folded unit. Thls
posltlonlng o~ the closed end of the gap greatly facllltates
placement of the drape prlor to surgery, a8 the llmb on whlch
surgery 18 to be performed will extend through thls portlon
of the gap when the patlent 1~ completely draped.
E~ch end of the drape in the elongated, longitudlnally
folded form shown ln Flg. 11 may then be folded, toward the
center, to glve a flnal compactly folded drape. Although an
ordinary fan fold i8 sultable for thls purpose, it 18 preferred
that a modi~ied fan fold be used. The term fan-folded refers
to a foldlng sequence ln which the material being folded has
alternate forward and reverse folds. The term modlfied fan
~ fold refers to a ~olding sequence whlch 18 slmilar to a fan
fold but ln whlch the flrst two folds thereof are of the same -
type. An example of a modlfied fan fold sequence is forwardJ
forward, reverse, forward, reverse, forward. -
Thus, the transverse folding of the partially folded
drape shown in Flg. 11 18 begun from siae edge 56 with a forward
fold. The second fold ls llkewise a forward fold while the ~- -
thlrd fold i8 a reverse fold. The forward and reverse fold
sequence may subsequently be repeated until the deslred degree
of compactness i8 obtained. The transverse folding of the
drape from slde edgé 57 toward the center 1~ accompllshed in
the same manner.
APPLICATION OF THE DRAPE TO T~ PATIENT
Referrlng now to Figs. 13-18, there is illustrated
in stepwlsè fQshlon a method of applylng the drape of Flg. 8,
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1049873
folded as described, to a patlent about to undergo surgery
on the rlght knee. Fig. 13 shows drape 50, unfolded from
side to side, placed across the upper thlgh portions Or the
patlent' 8 body with the gap thereof more or less lined up
with the patient's right leg. ~n a~sistant stationed at the
patient'~ left side unfold~ stack ~ of folds toward the
patient's feet to cover the patient's left leg. As shown ln
Fig. 14, this exposes flap 80 in it~ folded position overlying
wing 60. An assistant on the right side o~ the patient llrts
the patient's rlght leg upwardly (See Fig. 15) and unfolds
flap 80 across the operatlng table. While stlll holding the
patient's rlght leg ln the upralsed positlon shown in Fig. 15,
the asslstant on the rlght side o~ the patlent then unfolds
stack C o~ folds toward the patlent's rlght foot. AB shown ln
Fig. 16, wlng 70 now overlles flap 80 and flap 80' i~ exposed
; ln lts rolded conflguratlon overlying wing 70. Whlle the
patlent's rlght leg is ~till upwardly raised, the assistant
on the left of the patient unfolds flap 80' aoross the operating
table. As shown in Fig. 17J flap-like sheet 80' now o~erlies
part o~ wing~60 and there is advantageously pro~lded a double
thickness of draplng material between the operatlng table and
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the leg on whlch surgery i8 to be perrormed. Re~erring to
Fig. 18, the patlent's rlght leg i8 lowered 80 that it lies -~
on the upper sur~ace Or wing 70 (and possibly also on part of
flap 80'). The draplng procedure is compIeted b: un~olding
stack A Or ~olds toward the patient's head, 80 that the main
portion o~ the drape covers tho upper torso of the patlent.
It will be recognized that, once the draping is
completed, the llmb on whlch surgery i~ to be performed will
extend through the closed end of the gap and wlll be contacted
with the drape material. Thls arrangement advantageously
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10~9873
isolates the patient ~rom varlous rluids, such as blood Qnd
the llke, which are normally encountered durlng ~urgery. Thu~
the remalning portions of the patient' 8 body, that 1~, those
on which no surgery 18 to be performed, are protected from
bacterla orlginating in the operative area. Slmilarly, the
operative site 18 protected from contamination by bacterla
origlnating from areas remote from the operative slte.
It will be under~tood by tho~e skllled in the art
that drape lO Or Flg8. 1-3 may be folded ln the manner descrlbed
herein ~or drape 50. Drape lO, of cour~e, has two wings, but
only one Or the two wlngs has a rlap. Drape lO, when ~olded
longitudlnally, would look ~ubstantlally llke drape 50 ln the
folded ~orm illustrated in Fig. 11, each wlng being folded into
a stack of ~olds. If the wing havlng the rlap be fir~t unfolded
longitudlnally, and the flap attached thereto be next extended
transversely (whlle the llmb to be operated on 1~ uplifted),
then the rlap would be under the other wing after the latter
i8 subsequently unfolded longltudinally. Where the wing
without the flap is ~lr~t unfolded longitudlnally and the
wlng havlng the flap 18 next unfolded longitudinally, the
,
~lap, arter lt has been unfolded transversely, would lie over - --
tho wlng wlthout the flap
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