U.S. patent number 3,738,359 [Application Number 05/163,636] was granted by the patent office on 1973-06-12 for non-slip instrument pad.
This patent grant is currently assigned to Johnson & Johnson. Invention is credited to Julius A. Lindquist, Jay R. Sommers.
United States Patent |
3,738,359 |
Lindquist , et al. |
June 12, 1973 |
**Please see images for:
( Certificate of Correction ) ** |
NON-SLIP INSTRUMENT PAD
Abstract
A non-slip instrument pad is disclosed, which is composed of a
synthetic polymer foam material applied to a substrate. The foam
material is highly absorbent, has a high coefficient of friction
and a low surface resistivity. The polymers used in making the foam
are either styrene butadiene polymers or carboxylated styrene
butadiene polymers. The foamed polymer contains an anti-static
agent.
Inventors: |
Lindquist; Julius A.
(Somerville, NJ), Sommers; Jay R. (East Brunswick, NJ) |
Assignee: |
Johnson & Johnson (New
Brunswick, NJ)
|
Family
ID: |
22590888 |
Appl.
No.: |
05/163,636 |
Filed: |
July 19, 1971 |
Current U.S.
Class: |
128/852; 521/115;
428/131; 521/148 |
Current CPC
Class: |
A61B
46/23 (20160201); Y10T 428/24273 (20150115) |
Current International
Class: |
A61B
19/00 (20060101); A61B 19/10 (20060101); A61f
013/00 () |
Field of
Search: |
;128/132R,132D,155,156,292 ;161/39,190 ;206/2.5 |
References Cited
[Referenced By]
U.S. Patent Documents
Primary Examiner: Rosenbaum; Charles F.
Claims
What is claimed is:
1. An instrument receiving pad which is capable of holding surgical
instruments placed thereon and which is highly absorbent, has a
coefficient of friction greater than 1, and has a surface
resistivity of less than 5 .times. 10.sup.11 ohms/unit square, said
pad comprising a surface of a foam formed from a rubbery polymer
selected from the group consisting of polymers of butadiene and
styrene and polymers of butadiene, styrene and an ethylenically
unsaturated carboxylic acid, said foam containing from 0.05 to 0.25
percent, based on the weight of the foam, of an antistatic agent,
said antistatic agent comprising the reaction product of a
polyalkoxylated polyamine with epichlorohydrine.
2. The instrument pad of claim 1 in which the foam is adhered to an
open mesh fibrous substrate.
3. The instrument pad of claim 2 in which there is an impervious
film underlying the fibrous substrate.
4. The instrument pad of claim 3 in which the foam surface is a
discontinuous series of circular mounds on the substrate, said
circular mounds covering between 10 and 25 percent of the total
surface area of the upper surface of said pad.
5. The instrument pad of claim 3 in which the foam surface is a
continuous sheet.
6. A surgical drape having secured to the upper surface thereon an
instrument receiving pad which is capable of holding surgical
instruments placed thereon and which is highly absorbent, has a
coefficient of friction greater than 1, and has a surface
resistivity of less than 5 .times. 10.sup.11 ohms/unit square, said
pad comprising a surface of a foam formed from a polymer selected
from the group consisting of polymers of butadiene and styrene and
polymers of butadiene, styrene and an ethylenically unsaturated
carboxylic acid, said sheet containing from 0.05 to 0.25 percent,
based on the weight of the foam, of an antistatic agent, said
antistatic agent comprising the reaction product of a
polyalkoxylated polyamine with epichlorohydrine.
7. The surgical drape of claim 6 in which the foam surface is
adhered to an open mesh fibrous substrate.
8. The instrument pad of claim 6 in which there is an impervious
film underlying the fibrous substrate.
9. The surgical drape of claim 8 in which the foam surface of said
instrument pad is a discontinuous series of circular mounds on the
substrate, said circular mounds covering between 10 and 25 percent
of the total surface area of the upper surface of said pad.
10. The surgical drape of claim 8 in which the foam surface is a
continuous sheet.
11. The surgical drape of claim 8 in which the instrument pad is
secured to the drape with an adhesive which is applied inward of
the outer edges of said pad, and in which said pad has apertures
through the pad which lie between the point where the pad is
adhesively secured to said drapes and the outer edge of said pad.
Description
BACKGROUND OF THE INVENTION
The present invention relates to an instrument pad which may be
used in the operating room to provide a surface upon which surgical
instruments and other implements normally used in the operating
room may be securely placed during surgical procedures.
It is relatively common practice during surgical or obstetrical
procedures for a surgeon or an obstetrician to place instruments
and other implements, to be used during the procedure, on the
surface of the drape which is used to cover the patient. The
surface of commonly used linen or disposable paper drapes are not
adequate to retain the instruments in the position in which they
are placed. The surfaces of these linen or paper drapes are too
smooth to positively hold an instrument in place. The problem is
sometimes magnified by the tendency of individual surgeons to drop
instruments onto the drape. The linen and disposable paper drapes,
being too smooth, do not provide an adequate gripping or holding
surface to insure that these instruments will stay in the position
in which they are placed. The instruments, therefore, may fall from
the drape onto the floor of the operating room or may fall into the
operative field.
It has been suggested that magnets be incorporated into both linen
and disposable surgical drapes to provide a positive holding action
of surgical instruments. However, the placement of the magnets in
the drape also requires that the instrument be positioned on a
magnet before it would remain in place which is a time consuming
and distracting procedure under the conditions existing in the
operating room. In addition, some of the stainless steels used in
surgical instruments do not have adequate magnetic properties to
insure that the instruments will stay in place on the magnets. It
has also been suggested that a portion of the drape be provided
with a roughened surface which would be sufficient to hold
instruments in place. The roughened surface, in the case of a
disposable drape, would be obtained by heavily embossing the paper
from which said drapes are constructed. An embossed paper surface
has been found to be inadequate to provide the holding
characteristics that are necessary for an instrument.
Another prior art attempt to solve the problem has been the use of
a thin layer of a polyurethane foam. The polyurethane foam does not
provide the surface characteristics necessary to hold an instrument
in place and has also failed to provide any additional
benefits.
In addition to the deficiencies in the surface characteristics
pointed out above, the prior art instrument pads or drapes suffered
from a lack of absorbency. The instrumentS that are placed on an
instrument pad or drape are often wet with body fluids, water or
other liquids commonly used in an operating room such as
sterilizing or disinfecting solutions. The wet instrument placed on
a linen drape can cause an immediate strikethrough of the liquid to
the patient, thereby causing possible contamination of the patient
by any bacteria which might be present on the instrument. The
previously used polyurethane foam pad also did not have sufficient
absorbency to adequately absorb the liquids that might be on the
inStrument. If the liquid was present in sufficIent quantity, it
would have a tendency to pool on the surface of the foam before it
could be absorbed and present the danger that the liquid could run
off the foam and onto the patient or the surgeon.
An additional problem with polyurethane foams was the high surface
resistivity of the foam. In order to be acceptable for use in an
operating room, the electrical resistivity of a surgical drape or
instrument pad must be below 5.times.10.sup.11 ohm/unit.sup.2. The
surface structure of the polyurethane or its chemical composition
has been found to be such that it is extremely difficult to add
presently available anti-static agents to the foam in order to
obtain the desired surface resistivity.
THE INVENTION
The non-slip instrument pad provided by the present invention has a
combination of the desirable characteristics of having a high
coefficient of friction, is highly absorbent, has a low surface
resistivity and has additional properties to provide a
significantly improved non-slip instrument pad that is suitable for
use under the conditions found in an operating room. We have
discovered that these characteristics can be achieved by the use of
foam made from a synthetic rubbery polymer such as a
styrene-butadiene polymer or a carboxylated styrene-butadiene
polymer. Using foams made of these rubbery polymers, it is possible
to incorporate an effective antistatic agent into the foam which
will eliminate the static electricity problems found in
polyurethane foams. In addition, the rubbery polymer foams are more
absorbent, and have a higher coefficient of friction and a greater
capability of retaining instruments than found in polyurethane
foams.
These rubbery polymer foams also offer an advantage in that they
are more esthetically pleasing in appearance than the polyurethane
foams. The polyurethane foams have a relatively rough course
surface when compared to the smooth surface of the present rubbery
polymer foams. Although it would be expected that the rough surface
of the polyurethane foams would produce a high coefficient of
friction when compared to the smooth rubbery polymer foams, the
reverse has been found to be true. The smooth rubbery polymer foams
have a higher coefficient of friction than the polyurethane
foams.
The foams that we employ may be made with either a
styrene-butadiene polymer or a carboxylated styrene-butadiene
polymer such as that disclosed in Dunn U.S. Pat. No. 3,215,647. The
carboxylated butadiene-styrene polymer foams offer an additional
advantage over the styrene-butadiene polymer foams in that they can
be made with a non-discoloring vulcanizing system and the color of
the finished product can be more accurately controlled. The actual
color of the instrument pad is of some significance as it is
necessary that the surfaces used on the drapes covering the patient
should not reflect excessive light into the eyes of the
surgeon.
In addition to the characteristics pointed out above, the rubbery
polymer foams also offer an advantage in that they are readily
compressible and act to cushion any instrument on the body of the
patient. This aids in providing the positive placement of the
instrument on the drape as well as allowing the instrument to be
readily lifted from the drape when reuse is required.
As previously stated, the instrument pad must have a low surface
resistivity in order to be used in an operating room. The
requirement is that the surface resistivity be less than
5.times.10.sup.11 ohms/unit square. The rubbery polymer foams of
the present invention do not inherently possess a low enough
surface resistivity. It has been found to be necessary to modify
the resistivity characteristics of the foam by incorporating an
antistatic agent into the foam composition. Of the many antistatic
agents commercially available, we have discovered only one antistat
that will give the desired surface resistivity to the rubbery
polymer foams. This antistat is the reaction product of a
polyalkoxylated polyamine with epichlorohydrin and is marketed
under the name STANAX. The antistat is present in the foam
composition in an amount of from 0.05 to 0.25 percent by weight
based on the dry weight of the foam.
There are a substantial number of commercially available rubbery
styrene butadiene and carboxylated styrene-butadiene polymer
latices that can be employed in the practice of the present
invention. Generally, any rubbery polymer latex normally used to
make general purpose foams may be employed to make the foam
employed in the present invention. These latices may be compounded
with the standard fillers, thickeners, curatives and other
compounding ingredients normally employed by those skilled in the
art. However, the foam composition and the ingredients employed
therein must be capable of accepting the antistat without reacting
with the antistat or otherwise reducing its effect as an antistatic
agent in the cured foam.
A typical formulation of a carboxylated styrene-butadiene polymer
foam composition is as follows:
Parts by Weight Carboxylated styrene butadiene 174.0 polymer (37.5%
solids) Frothing Aid (30% solids of sodium 8.3 lauryl sulfate)
Lubricant 1.0 Ammonium hydroxide (28% active) 1.0 Filler
(CaCo.sub.3) 80.0 Froth stabilizer (2.5% solids) 10.0 Melamine
formaldehyde 11.25 curing agents (55% solids) Water 2.0 Sodium
bicarbonate 0.009 Antistat (STANAX)* (50% solids) 0.4 Dyes Variable
*Reaction product of a polyalkoxylated polyamine with
epichlorohydrin.
The above ingredients were foamed in a commercially available
foamer and spread on a gauzed substrate and leveled with a doctor
blade and cured at a temperature of 300.degree. to 350.degree. F.
for 5 to 11 minutes. The foam had the following properties as
compared with a polyurethane foam.
TABLE I
Carboxylated Polyurethane Polymer Coefficient 0.60 2.75 of friction
Time to wet (seconds) 120 10 (1 drop of fluid) Surface Resistivity
1.63 .times. 10.sup.11 5.9 .times. 10.sup.9 ohms/square
ohms/square
It has also been determined that the thickness of the rubbery
polymer foam layer is particularly significant in the ability of
the instrument drape to retain instruments. If the instrument drape
is too thin, of a thickness of less than 20 mils, the instrument
will not adhere to the drape. If the foam layer is too thick, i.e.,
greater than 150 mils, there is a tendency of the instrument to
bounce off the instrument drape. It is therefore desirable that the
foam layer of the instrument drape be between 40 and 150 mils in
thickness.
A test was devised to determine the instrument holding efficiencies
of foam materials. A piece of the foam to be tested 51/2 inches by
12 inches was mounted on a wooden board set at a 40.degree. angle
horizontal. Various instruments were lobbed on the foam from a
distance of approximately 2 feet. The instruments were lobbed onto
the foam so that they would fall flat on the foam and not hit the
foam on the side or end of the instrument. The holding ability of
the foam was considered adequate if it would retain an instrument
in 3 of 5 lobs. The results were as follows:
Instrument -- 71/2 inch scissors weighing 105 grams
Thickness of Foam Pass (P) or Fail (F) 13 mils F 15 mils F 25 mils
P 32 mils P 55 mils P
a polyurethane foam of 123 mils in thickness failed the same
test.
The relationship of the pad to the surgical drape will be better
understood with reference to the following drawings in which:
FIG. 1 is a top view of a draped patient showing the instrument pad
on the present invention in place on the surface of a drape.
FIG. 2 is an enlarged view of the drape of FIG. 1 showing a
fragmentary view of the various components of the instrument
pad.
FIG. 3 is a cross sectional view along the lines 3--3 of FIG.
2.
FIG. 4 is an alternate form of the instrument pad of the present
invention.
FIG. 5 is a cross sectional view of the instrument pad with FIG. 4
along lines 5--5.
FIG. 1 shows a surgical drape in a normal position over a surgical
patient.
The main portion of the drape 10 has secured thereto the instrument
pad 11 of the present invention. The main drape 10 also has a
reinforced area 12 in the drape through which there is a
fenestration 13 which extends through the drape and through which
the surgeon will perform the surgical procedure.
The instrument pad of the present invention is composed of a
rubbery polymer foam layer 15 which has been cast or applied on a
substrate 16. The substrate may be gauze or any other open mesh
woven or non-woven fabric. The rubbery polymer foam tends to
penetrate into the interstices of the fabric and when cured is
securely affined to the fabric substrate. To prevent liquid from
penetrating through the instrument pad and onto the main drape,
there may be provided a thin impervious film 17 between the
instrument pad and the main drape. This film may be polyethylene,
polypropylene, vinyl chloride or other similar plastic. In an
alternate construction of the pad, the rubbery polymer foam may be
cast directly on the surface of the impervious film. The rubbery
polymer foam may also be cast on a release coated surface, cured,
removed from the coated surface and adhesively bonded to the
impervious film. The preferred construction is that shown in cross
section in FIG. 3 in which the foam is cast on an open mesh
fabric.
The instrument pad may be secured to the main body of the drape 10
by overall glueing as indicated by FIG. 18 in FIG. 3, or it may be
secured by any pattern of line glueing as will be readily apparent
to one skilled in the art. The glue lines shown in FIG. 3 and in
the dotted lines in FIG. 2 are inward of the outer edge of the
instrument pad. This allows the instrument pad to be lifted and the
apertures 14 in the pad utilized to hold tubing, that would be used
in the surgical procedure, in position. The tubing could be suction
tubing, which is employed to remove fluids from the operative site,
or tubing carrying gases or other fluids used during the surgical
procedure.
FIG. 4 shows an alternate construction of the drape in which a
discontinuous surface of the rubbery polymer foam is employed
rather than a continuous sheet of the foam. The foam may be printed
on the substrate in the form of bumps or protuberances which are
shown by number 19 in FIG. 5. The rubbery polymer foam would be the
same composition as previously described but would be printed in a
discontinuous pattern on the surface of the substrate 16. Although
the form of the protuberances 19 in FIG. 4 and FIG. 5 are shown as
mounds in a circular form, it would be readily apparent to one
skilled in the art that they could also be printed as squares,
triangles, or in any other pattern. When such a printed pattern of
foam is employed, it should be present and cover at least 10
percent and preferably about 25 percent of the total surface area
of one surface of the instrument pad.
The drape in FIG. 1 is shown in what is called a transverse
lapatoromy position. It should be understood that drapes employed
in other procedures have other configurations and the instrument
pad could be placed in another area on the surface of the drape. It
is, however, desirable that the instrument pad drape not be placed
immediately adjacent the fenestration.
It is common practice in the manufacture of disposable surgical
drapes to reinforce the fenestration or opening through which the
surgeon operates. Such a reinforcement is shown as element 12 in
FIGS. 1 and 2. When the instrument pad of the present invention is
placed adjacent the reinforcement area of the main body of the
drape, it is preferred that the reinforced area overlap the
instrument drape. This will prevent any liquid which might be
present on the instrument pad from flowing into the reinforcement
area of the main drape and through the fenestration and possibly
contaminating the patient.
* * * * *