Note: Descriptions are shown in the official language in which they were submitted.
F I ELD OF THE I NVENT I ON
This inven~ion relates to means for securing surgical
drapes or towels to the body of a surgical patient, and more
particularly provides means by wh;eh surgical drapes and towels
may be secured to the patient withou~ injury to ~he patient or
damage ~o the bac~erial barrier provided by them; and without
additional trauma to the patient, beyond that caused by the
primary surgical procedure being carried out. Ihe invention
also provides a means for securing surgical tubing relative to
the field of surgery~ in either a moveable or immoveable
manner.
BACKGRI:)UND OF THE INVENTION
There have been several general approaches to preparing
("prepping") and draping any particular portion of a surgical
patient's body for surgery. Those procedures include the
preparation of a st~rile field, using surgical drapes or
towels, which may or may not be fenestrated, or otherwise, so
that the drapes or towels form a sterile field and present a
bacterial barrier aroulld the area. Of particular concern to
the present invention is the manner by which the surgical
drapes or towels are secured in place.
The most usu~l method by which surgical drapes and/or
26 towels are secured in place relative to the s~erile field of
the patient's body has been to secure the surgical drapes or
towels to the ~ocly by the use of locking forceps which not only
pierce the surgical drape or towel, they also pierce the skin
of the patient and thereby secure the drape or towel in place
relative to the sterile field. Tha~ securement is, of course,
by the mechanical attachment through the skin and subcutaneous
layers of the patient's body. This gives rise to secondary
wounds, additional trauma, and possible additional
disfigurement to the patient, due to further scarring that may
occur.
Moreover, the bacterial barrier which is supposedly
presented by the surgical drape or towel is broken due to the
piercing action of the pincers through the material of the
drape or towel, and after several uses -- as is common when the
drapes or towels are made of muslin or other reusable material
-- there may be a number of breaks or dlscontinuities in the
otherwise supposedly sterile and secure bacterial barrier.
The other general approach has been the use of adhesive
strips or areas which form a part of a surgical drape or towel,
for placement on the body of the patient. Generally, however,
such drapes or towels have needed to be disposable, as the
adhesives will not withstand washing, giving rise to
considerable costs of acquisition, and indeed of storage and
warehousing. Several prior art examples are particularly to be
noted. Each is very expensive, and none of the prior art
devices easily permits any readjustment or re-positioning of
26 the surgical drape or towel, once it is placed.
Bayer et al, in U.S. Patent 3,561,440, issued February 9,
1971, teach the use of several tabs of self-adhering adhesive
s
material which are incorporated into or secure~ ~o the r,la~erial
of a disposable surgical drape. }lowever, each of the a(~hesive
areas rnust have a release paper removed fro~ it, and each forms
an integrated part of the total drape that cannot be used with
any other drape.
Krzewynski, in U.SO Patent 3,871,369, issued March 1~,
1975, shows several embodiments of disposable surgical drapes
or towels, all of which require the placement of the drape or
towel and thereafter unfolding an edge, to which has been
secured an adhesive area having a releasable cover sheet. The
particular stated advantage of the Krzewynski device is that
correct placement with respect to the sterile field may be
assured.
Merry et al, in U.S. Patent 4,080,963, issued March 28,
1978, teach a fenestrated disposable drape which may be
unfolded to a number o~ differenlt configurations. However, as
before, the Merry et al device is yet another form of drape,
and not a securing means for retaining any drape ~n a fixed
portion.
Stoneback, in U.S. Patent 4,316,456, issued February 23,
1982, teaches a surgical drape system having a fenestrated
disposable drape similar to that previously taught by
Krzewynski, above. Indeed, Stoneback provides several drapes
one above the other, where the fenestration in the top drape is
substantially larger than in the bottom, and again creates the
26 problems of expense and re-positioning, discussed above, which
is common to all drapes.
While preparing for the surgical process, certain of the
operating room p~rsonnel -- at least one surgeon, at least on~
; nurse -- are "sterile" and are permittcd to work at the sterile
field where the operative wound is to be made. Other persons
within the operating room are "non-sterile", and perform such
functions as removing soiled sponges, used equiprnent, etc.,
away from the sterile area of the operating room. All of these
procedures, of course, are established to safeguard the health
of the patient, particularly against post~operative infection.
However, the risk of infection still exists where the bacterial
barrier surrounding the sterile field is broken or is not
intact at the time that it is put into place.
According to previous procedures, especially where
launderable and reusable surgical dr~pes and towels are used in
order to keep expenses down, the surgical barrier is broken
whenever the surgical drape or towel is secured to the patient
by piercing the material as well as piercing the skin of the
patient. Moreover, previous holes that have been made from
previous surgical procedures may, if the material has not been
previously patched, result in a broken or non-integral
bacterial barrier even before the surgical procedure begins.
The dI sadvantages mentioned above may be overcome using
the securing means tor surgical drapes or towels of the present
invention. Those disadvantages are particularly overcome
because there is no necessity for the material of the surgical
drape or towel to be pierced at any time, and yet a secure
26 attachment or placement of the surgical drape or towel with
respect to the steri~e field is a~sured.
Moreover, surgical tubing which may enter the sterile
field -- suction tubes or the like -- may also be secure~ in
place with respect to the sterile field, particularly easily
using certain embodiments of the securing means of the present
; invention, as discussed hereafter.
The securing means of the present invention, in its
simplest form, comprises an independent, movable and placeable
body ~hat may be moved and placed independently of any drape or
other similar securing means by the surgeon or sterile nurse as
the sterile field is being prepared. Each securing means has a
lower surface and an upper surface; and on the lower surface
; there is an adhesive layer and a releasable cover sheet which
is placed thereover. The aclhesive layer may be a pressure
` sensitive adhesive, such as polyacrylate or polymethacrylate,
or other approved surgical adhesive materials.
The upper surface of the securing means has at least one
portion which has an elevation relative to the lower surface
that is above the area which is in the vicinity of that at
least one portion. The at least one portion has a thickness
and a mechanical strength which is sufficient to accommodate a
- 20 clamping action thereagainst.
By the provision of such securing means, this invention
permi-ts the use of forceps or clamps that do not need to pierce
the drape, so that the bacterial barrier surrounding the
sterile Eield will not be broken. Moreover, as the seeuring
means is anchored to the patient by adhesive means~ no
26 additional wounds or trauma are caused to the patient~
Thus, this invention provides an inexpensive means Eor
securing surgical drapes or towels around the sterile field,
while assuring integrity of the bacterial ~arrier without
causing additional wouncls or trauma to the patient.
BRIEF DESCRIPTION OF THE DRAWINGS
These and other features and objects of the invention, and
several embodiments thereof, are more ful].y discussed hereafter
in association with ~he accompanying drawings, in which:
Figure 1 is a perspective view, but not to scale, of a
first embodiment of a securing means according to this
invention;
Figure 2 is a perspective view of a second embodiment of a
securing means according to this invention; and
Figure 3 is a perspective view showing two securing means
in use for the purpose of maintaining surgical tubing and tools
in place.
DESC~PTION OF THE PREFERRED EMBODIMENTS
As mentioned above~ the present invention is directed to
securi.ng means for use with surgi.cal drapes or towels~ several
embodiments of which are illustrated in Figures 1 to 3.
Indeed, Figure 2, as discussed hereafterg illustrates one
preferred embodiment and suggests an alternative to that
embodiment.
26 In any event, it is to be noted that surgical drapes or
towels may be secured to the surgical patient by other means
than piercing the drape or towel and piercing the skin of the
7~
patient; or by other me~ns than a self a~hesive strip
permanently forming a part of a disposable clrape or towel. Such
alternative me-~ns are particularly provided by the present
invention, whereby surgical drapes or towels may be used,
without damage to them or additional wounds or trauma to the
patient.
With reference to Figure 1, there is provided a first
embodiment of a securing means for use with surgical drapes or
towels~ which comprises a body 10 which is independant of any
other similar body -- i.e., ~he securing means are provided
(usually packaged in pairs) in such a manner that as many of
them may be used as are required, and each of the independent
bodies 10 or otherwise is movable and placeable on the surgical
patient, irrespective and independant of any other similar
body. Each of them comprises a lower surface 12 and an upper
14 surface.
On the lower surface 12, there is provided an adhesive
layer 16 which is generally also provided with a releasable
cover sheet 18 placed ~hereover. The releasable cover sheet 18
is removed by the sterile nurse or surgeon at the time that the
securing means 10 is placed by him on the patien~ (or elsewise
as described hereafter)~
The upper surface 14 of the securing means 10 of the
embodiment of Figure 1 has at least one portion; and in this
case two portions, designated as 20, each of which has an
26 elevation with respect to the lower surface 12 higher than the
area 22 which extends between the portions 20. The area 22
may, as described hereafter with respect to Figure 2, be
considerecl to be tha~ area of tile body l~ which is in the
vicinity of each of the portions 20.
The upstanding portions 20 of the securing body 10 of
Figure 1 each have a thickness and a mechanical strength which
is sufficient ~o accommodate a clamping action against them.
That is, each portion 20 may be clamped against by clamping
forceps or pincers, without collapsing or otherwise being
destroyed; and each portion has the mechanical strength to
withstand the clamping action and to withstand such other
reasonable forces as may be imposed on it, such as the weight
or a portion of the weight of the surgical drape or towel,
either dry or wet.
A different embodiment of securing means for use with
surgical drapes or towels, according to the present
invention, is shown at 24 in Figure 2. The securing means 24
of Figure 2 has a lower surface 26 having an adhesive layer 28
and releasable cover sheet 30 placed thereover. In the upper
surface of the securing means 24 of Figure 2, there are
provided a number of protuberances 32. Each of the
protuberances or portions 32 may have substantially straight
sides as the portions 20 of securing means 10 of Figure 1, or
they may have upwardly and inwardly directed sloped sides, as
illustrated. There may also be some further portions 34
similar to and contiguous with the portions 32, such that each
area 36 which is bounded in part by one of the portions 32 and
26 34 is lower in elevation relative to the lower surface 26 than
; the portions or protuberances 32 and 34. The securing Means 24
of Figure 2 may therefore have a generally waffled upper
7~
surface.
In utilizing securing means such as ~hose of either Figure
1 or 2 in their primary function~ the surgeon or sterile nurse
places at least one and usually a plurality of the securing
means on the skin of the patient surrounding the area which is
to be prepared as the sterile field. Of course, in each case
the releasable cover sheet is removed from the lower surface of
the securing means and discarded. As the surgical drapes or
towels are placed over the body of the surgical patient, it may
be necessary for the surgeon or sterile nurse to feel for and
determine the positioning of the securing means against the
body of the patient, through the surgical drape or towel.
However, the protuberances 20, 32 or 34 have a suffici.ently
high elevation above the lower surface by which they are
secured to the patient, so that they may be easily located.
Thereafter, clamping forceps or other clamps or pincers may be
used to secure the surgical drapes or towels in place, relative
to the sterile field where the surgical wound will be made,
without piercing the surgical drape or towel, and of course
without piercing the skin of the patient. Thus, no permanent
damage is done to the surgical drape or towel, and no damage or
trauma to the patient occurs.
In another function that the securing means of the present
invention serves, as illustrated in Figure 3, surgical tubing
or other devices or implements may be secured in place relative
26 to the sterile field by securing means according to the present
invention~ For those purposes, securing means 10 as shown
previously in Figure 1 and discussed above, are particularly
useful.
In Figure 3, a surgical drape or towel 3~ is shown
overlying a portion 40 of the patient's body, and has been
placed and secured using other securing means according to the
present invention. A pair of securing means lOA are placed on
the surgical drape 38 in superimposed relation one to the
other, such that the lower securing means lOA is secured by its
adhesive coating to the surgical drape or towel 38.
When the areas of the upper securing means or body lOA are
stripped of their releasable cover sheet, the two bodies may be
superimposed one on the other, with the upper body adhesively
secured ~o the lower body at the upper surface of its portions
20A. However, before the upper body is placed or superimposed
over the lower body, surgical tubing 42 and 44 -- such as
suction tubes or the like -- are placed between the
- protuberances 20A of the lower body lOA, so that they may be
held and secured in place by the placement of the upper body
lOA over the lower body lOAo
Also shown in Figure 3 is a further purpose for the
securing means of the present invention. It may sometimes
happen that the surgeon wishes to put down a surgical
implement, such as a forceps 46, without taki-ng them away ~rom
the surgical field, and in that case the thumb or finger hole
48 (or other convenient part of an implement) may be easily
placed over one of the protuberances 20 of any one of the
26 securing means 10 in use.
The materials from which the securing means of the present
invention may be formed include both woven and unwoven
materials, wllich may l~e i~oldecl and/or sti Lched in place,
particularly as shown in l~igure 2; or closed-cell or open-cell
foam material, such as polyethylene, polypropylene~
polyurathane and polyvinyl chloride.
Other embodiments of securing means according to the
present invention may be formed, and other materials used,
without departing from the spirit and scope of the appended
claims.
26
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