U.S. patent application number 11/156825 was filed with the patent office on 2007-01-04 for surgical gown with a film sleeve for glove retention and wearer protection.
Invention is credited to Ajay Yashvantrao Houde, Michael P. Mathis, John Rotella.
Application Number | 20070000014 11/156825 |
Document ID | / |
Family ID | 36889221 |
Filed Date | 2007-01-04 |
United States Patent
Application |
20070000014 |
Kind Code |
A1 |
Rotella; John ; et
al. |
January 4, 2007 |
Surgical gown with a film sleeve for glove retention and wearer
protection
Abstract
A protective garment, such as a surgical gown, includes a
garment body defining sleeves. A cuff may be secured at respective
ends of the sleeves. A film is disposed on the sleeves beginning at
the sleeve or cuff. The film has a high friction surface such that
an end of a glove pulled over the film is inhibited from rolling or
sliding back over the film and down the sleeve. The film also
provides improved fluid barrier properties to the sleeve. The film
may be formed of a polyurethane or other polymers according to
known processes and may include a dye or colorant that may be used
to indicate the fluid protection level of, for example, a surgical
gown.
Inventors: |
Rotella; John; (Marietta,
GA) ; Houde; Ajay Yashvantrao; (Duluth, GA) ;
Mathis; Michael P.; (Marietta, GA) |
Correspondence
Address: |
KIMBERLY-CLARK WORLDWIDE, INC.
401 NORTH LAKE STREET
NEENAH
WI
54956
US
|
Family ID: |
36889221 |
Appl. No.: |
11/156825 |
Filed: |
June 20, 2005 |
Current U.S.
Class: |
2/114 |
Current CPC
Class: |
A41D 19/0089 20130101;
A41D 13/1227 20130101 |
Class at
Publication: |
002/114 |
International
Class: |
A41D 10/00 20060101
A41D010/00 |
Claims
1. A protective garment, comprising: a garment body, said garment
body defining sleeves; a cuff secured at respective ends of said
sleeves; and a film outerlayer on said sleeves, said film
comprising a high friction surface such that an end of a glove
pulled over said film is inhibited from rolling or sliding back
over said film.
2. The protective garment as in claim 1, wherein said garment body
is a surgical gown.
3. The protective garment as in claim 1, wherein said film further
comprises a dye or colorant.
4. The protective garment as in claim 1, wherein said film extends
from about 20 cm from said cuff.
5. The protective garment as in claim 1, wherein said film is made
from a material selected from the group consisting of ethylene
vinyl acetate copolymers, styrene-butadiene, cellulose acetate
butyrate, ethyl cellulose, synthetic rubbers, Kraton.RTM. block
copolymers, natural rubber, polyurethanes, polyethylenes,
polyamides, flexible polyolefins, and amorphous polyalphaolefins
(APAO).
6. The protective garment as in claim 1, wherein the film is a
low-tack film.
7. A protective garment, comprising: a garment body, said garment
body defining sleeves; and a film outerlayer on said sleeves from a
distal end of said sleeves, said film comprising a high friction
surface such that an end of a glove pulled over said film is
inhibited from rolling or sliding back over said film, wherein said
film further provides improved liquid barrier properties to said
sleeve.
8. The protective garment as in claim 7, wherein said film further
comprises a dye or colorant.
9. The protective garment as in claim 7, wherein said garment body
is a surgical gown.
10. The protective garment as in claim 7, further comprising a cuff
configured at the distal end of said sleeves, said film disposed
proximal to said cuffs.
11. The protective garment as in claim 7, wherein the film is a
low-tack film.
12. A surgical gown, comprising: a gown body with sleeves; a cuff
secured at respective ends of said sleeves; and a polyurethane film
having a thickness between about a positive amount and 2 mils on
said sleeves proximal to said cuff such that an end of a glove
pulled over said film is inhibited from rolling or sliding back
over said film.
13. The surgical gown as in claim 12, wherein said film further
comprises a dye or colorant.
14. The surgical gown as in claim 12, wherein the film is a
low-tack film.
Description
[0001] The present invention relates generally to protective
garments for use with gloves, for example surgical gowns used with
surgical gloves.
[0002] Protective garments, such as coveralls and gowns, designed
to provide barrier protection to a wearer are well known in the
art. Such protective garments are used in situations where
isolation of a wearer from a particular environment is desirable,
or it is desirable to inhibit or retard the passage of hazardous
liquids and biological contaminates through the garment to the
wearer.
[0003] In the medical and health-care industry, particularly with
surgical procedures, a primary concern is isolation of the medical
practitioner from patient fluids such as blood, saliva,
perspiration, etc. Protective garments rely on the barrier
properties of the fabrics used in the garments, and on the
construction and design of the garment. Openings or seams in the
garments may be unsatisfactory, especially if the seams or openings
are located in positions where they may be subjected to stress
and/or direct contact with the hazardous substances.
[0004] Gloves are commonly worn in conjunction with protective
garments, particularly in the medical industry. Typically, the
gloves are pulled up over the cuff and sleeve of a gown or garment.
However, the interface between the glove and the protective garment
can be an area of concern. For example, a common issue with
surgical gloves is glove "roll-down" or slippage resulting from a
low frictional interface between the interior side of the glove and
the surgical gown sleeve. When the glove rolls down or slips on the
sleeve, the wearer is at greater risk of exposure to patient fluids
and/or other contaminants.
[0005] An additional problem associated with the use of surgical
gloves is that as a result of the gloves being pulled up over the
cuff and sleeve of the gown, a phenomenon known as "channeling"
occurs. That is, the sleeve of the gown is bunched up under the
glove as a result of pulling and rolling the glove up over the cuff
and sleeve. Channels may develop along the wearer's wrist which may
become accessible to patient fluids running down the outside of the
sleeve of the gown. Such fluids may enter the channels and work
down along the channels between the outer surface of the gown and
inner surface of the surgical glove. The fluids may then
contaminate the gown cuff, which lies directly against the wearer's
wrist or forearm, particularly if the cuff is absorbent or fluid
pervious.
[0006] Surgeons and other medical personnel have attempted to
address concerns with the glove and gown interface in different
ways. For example, it has been a common practice to use adhesive
tape wrapped around the glove portion extending over the gown
sleeve to prevent channels and roll down of the glove on the
sleeve. This approach unfortunately has some drawbacks. Many of the
common adhesives utilized in tapes are subject to attack by water
and body fluids and the seal can be broken during a procedure.
Another approach has been to stretch a rubber band around the glove
and sleeve. This practice is, however, awkward to implement and
difficult to adjust or to vary the pressure exerted by the rubber
band other than by using rubber bands of different sizes and
tensions, which of course necessitates having a variety of rubber
bands available for use. Yet another approach has been to
incorporate a band of elastomeric polymer on the gown around the
sleeve just above the cuff to provide a surface for the glove to
cling to. This approach has also proved less than completely
satisfactory.
[0007] A need exists for an improved device and method for
providing an effective sealing interface between a glove and sleeve
of a protective garment, wherein the device is easily incorporated
with the protective garment and economically cost effective to
implement. A further need exists for a gown sleeve that provides a
more effective barrier to fluid while retaining a glove.
SUMMARY
[0008] The present invention provides a protective garment
incorporating an effective and economical mechanism for improving
the interface area between the sleeves of the garment and a glove
pulled over the sleeves. The improvement inhibits the proximal end
of the glove from rolling or sliding back down the garment sleeves
once the wearer has pulled the gloves on. In this way, the garment
according to the invention addresses at least certain of the
disadvantages of conventional garments discussed above. The
improvement also provides a better barrier to fluid
penetration.
[0009] It should be appreciated that, although the present
invention has particular usefulness as a surgical gown, the
invention is not limited in scope to surgical gowns or the medical
industry. The protective garment according to the present invention
has wide application and can be used in any instance wherein a
protective coverall, gown, robe, etc., is used with gloves. All
such uses and garments are contemplated within the scope of the
invention.
[0010] In an embodiment of the invention, a protective garment is
provided having a garment body. The garment may be, for example, a
surgical gown, a protective coverall, etc. The garment body
includes sleeves, and the sleeves may have a cuff disposed at the
distal end thereof. The cuffs may be formed from or include an
elastic material, and may be liquid retentive or liquid impervious.
The garment further includes a mechanism for improving the
interface area between the sleeves of the garment and a glove
pulled over the sleeves.
[0011] In one embodiment, the sleeve is formed with a film layer on
the outside, where it may be contacted by a glove. The film may
extend for the entire length of the sleeve or may cover a half or a
quarter of the sleeve, provided it covers the area where a glove
would normally contact a sleeve. This film may be of a type to
enhance (increase) surface friction between the glove and garment
and also increases the fluid penetration barrier properties of the
sleeve. Desirably, this film may be a "low-tack" or tack-supressed
film that has a relatively low level of stickiness or
adhesiveness.
[0012] The "low-tack" film applied to the sleeve is desirably an
inherently low-tack film with high friction characteristics so as
to prevent glove roll-down while not causing the sleeves to adhere
to the gown body when the gown is folded.
[0013] Embodiments of the protective garment according to the
invention are described below in greater detail with reference to
the appended figures.
BRIEF DESCRIPTION OF THE FIGURES
[0014] FIG. 1 is a partial side view of an embodiment of a portion
of a protective garment according to the present invention.
[0015] FIG. 2 is a cut-away or "see-through" side view of a hand
within a glove on a garment sleeve.
[0016] FIG. 3 is a drawing of a sleeve before it is bonded together
and onto the body of the gown.
DETAILED DESCRIPTION
[0017] Reference will now be made in detail to one or more examples
of the invention depicted in the figures. Each example is provided
by way of explanation of the invention, and not meant as a
limitation of the invention. For example, features illustrated or
described as part of one embodiment may be used with another
embodiment to yield still a different embodiment. Other
modifications and variations to the described embodiments are also
contemplated within the scope and spirit of the invention.
[0018] FIG. 1 illustrates a portion of a protective garment 10
according to the invention. The garment 10 includes a main body
portion 12, a neck portion 14, and sleeves 16 (one sleeve shown).
The sleeves 16 may be made separately and attached at to the main
body portion 12 at a seam 18 or formed as an integral component
with the main body portion 12. Each sleeve 16 may include an upper
or proximal end 20, a lower of distal end 22, and an exterior
surface 24.
[0019] The garment 10 is depicted as a surgical gown for
illustrative purposes only. The garment 10 may be any type or style
of protective covering that is generally worn about the body and
includes sleeves.
[0020] The terms "lower" or "distal" are used herein to denote
features that are closer to the hands of the wearer. The terms
"upper" or "proximal" are used to denote features that are closer
to the shoulder of the wearer.
[0021] It should be appreciated that the type of fabric or material
used for garment 10 is not a limiting factor of the invention. The
garment 10 may be made from a multitude of materials, including
nonwoven materials suitable for disposable use. For example, gown
embodiments of the garment 10 may be made of a stretchable nonwoven
material so that the gown is less likely to tear during donning or
wearing of the gown. A material particularly well suited for use
with the present invention is a three-layer nonwoven polypropylene
material known as SMS. "SMS" is an acronym for Spunbond, Meltblown,
Spunbond, and includes the process by which the three layers are
constructed and then laminated together. See for example U.S. Pat.
No. 4,041,203 to Brock et al. One particular advantage is that the
SMS material exhibits enhanced fluid barrier characteristics. It
should be noted, however, that other nonwovens as well as other
materials including wovens, films, foam/film laminates, and
combinations thereof may be used to construct the garment of the
present invention.
[0022] It is also contemplated that the garment may include a
liquid impervious film to inhibit fluid absorption into the garment
material. Examples of this include laminates of spunbond, film and
SMS that, by nature of the inclusion of the internal film layer,
are even more impervious to the passage of liquids than SMS
gowns.
[0023] The sleeves 16 may incorporate a cuff 26 attached to the
distal end 22 thereof. The cuff 26 also has a distal end 28 and a
proximal end 30. The configuration and materials used in the cuff
26 may vary widely. For example, short, tight-fitting cuffs made
from a knitted material may be provided. The cuff 26 may be formed
with or without ribs. The cuff may be formed of a liquid repellant
material or a liquid retentive material. Cuffs suitable for use
with garments according to the present invention are described in
U.S. Pat. Nos. 5,594,955 and 5,680,653, both of which are
incorporated herein in their entirety for all purposes.
[0024] As shown for example in FIG. 2, protective garments are
frequently used with gloves, such as a surgical glove 32 that is
pulled over the hand of the wearer and has a sufficient length so
that a proximal portion of the glove 32 overlaps the cuff 26 and a
portion of the sleeve 16. An interface is thus established between
the glove interior surface and the exterior surface 24 of the
sleeve 16 and cuff 26. This interface region preferably inhibits
undesirable fluids or other contaminants from running down the
sleeve 16 to the cuff 26 or hand 34 of the wearer. However, glove
slippage or roll-down occurs if the frictional interface between
the glove interior surface and the sleeve exterior surface is
insufficient to maintain the glove in position above the cuff 26.
When glove roll-down occurs, the wearer is at greater risk of
exposure to contaminants, particularly during a surgical
procedure.
[0025] Many types of protective gloves, particularly elastic
synthetic or natural rubber surgical gloves, have a thickened bead
or region at the open proximal end 36. This thickened portion or
bead is intended to strengthen the glove 32 and provide an area of
increased elastic tension to aid in holding the glove 32 up on the
sleeve 16.
[0026] According to one embodiment of the invention, the garment 10
includes a film layer 40 formed on the outside of the sleeves 16
from the proximal end 30 of the cuff 26 (FIGS. 1 and 2). The film
40 thus acts as a high friction surface against which the thickened
proximal end 36 of the glove 32 contacts if the glove tends to slip
down the exterior surface 24 of the glove. The film 40 inhibits
further slippage or roll-down of the glove 32. The film also
provides increased fluid barrier properties to the lower part of
the sleeve where there is a generally increased risk of liquid
penetration during surgery because of increased liquid contact
time.
[0027] The film 40 may extend up the sleeve 16 a distance greater
than the proximal end 36 of the glove 32 extends when the glove is
normally donned. The dimensions of the film area may vary as the
size of the gown may also vary. As shown in FIG. 3, the film area
may extend away from the cuff 26 for a distance of about 20 inches
(51 cm), more particularly about 10 inches (25 cm).
[0028] It should be appreciated that the film 40 can take on many
different configurations. FIG. 3 shows a flat sleeve piece before
it is formed into a separate sleeve 16. The sleeve 16 may be formed
by bonding, for example ultrasonically, the two edges 50, 52 to
each other and thereafter bonding the sleeve 16 to the main body
portion 12 at the sleeve's distal end 20 to form a seam 18 (seam
shown in FIG. 1). The film 40 may be continuous around the sleeve
16.
[0029] The inventors have surprisingly found that a relatively
uniform film of a low-tack, high-friction polymer is quite
effective and lends itself easily to modern manufacturing
techniques. The film 40 may be formed on the sleeve in various
known ways and from a variety of materials. For example, a film
compatible with the sleeve material may be applied directly to the
sleeve in a co-extrusion or adhesive process or other processes
known to those skilled in the art.
[0030] The film 40 may be formed of an inherently low-tack or
tack-supressed material with high frictional characteristics. This
type of film increases slip resistance between the glove and sleeve
16 and may be applied directly onto the exterior surface 24 of the
sleeve to form the film 40. In general, the film could be any
polymer that is sufficiently soft and pliable so as to cling to the
inside surface of the glove 32 but at the same time should not have
too high a tack level (e.g., level of stickiness or adhesiveness)
so as to cause the garment sleeve 16 to stick to the garment body
12 or to itself (i.e. blocking) when the garment 10 is folded,
hence the term "low-tack". Blocking is the tendency for thin film
faces to adhere to each other and it is important that the films
used herein do not "block". For example, the film 40 may be formed
of a material such as a Kraton.RTM. polymer or Kraton.RTM. polymer
blend that has some pressure-sensitive adhesive properties. To fit
within the definition of "low-tack", the Kraton.RTM. polymer should
not have an "aggressive" initial adhesive quality that instantly
creates a level of tack that would make it difficult to remove or
readjust a glove or re-separate a sleeve portion that is folded
over upon itself. When the film is formed from polymer blends that
include tackifying agents such as, for example, tackifying resins,
it is desirable to use relatively lower levels of tackifying resins
or other agents such as fillers or the like to reduce or "suppress"
the initial tack of the material. Importantly, the "low-tack"
materials should be capable of providing slip resistance without
forming a permanent bond between the sleeve portion and the glove
during the time the glove is in contact with the film 40 covering
the exterior portion of the sleeve during normal room temperature
conditions (e.g., 20.degree. C. and 50% relative humidity) and
contact pressures. Typically, this time can range from less than an
hour to several hours (e.g., 3 hours, 4 hours, 5 hours or more). It
is contemplated that the contact time without permanent bonding
under such conditions can be more than 10 or 12 hours.
[0031] The term "high frictional characteristics" means that one or
more of the the peak load, the average load, the dynamic
coefficient of friction and the static coefficient of friction of
the fabric having the film is higher (i.e., greater) than the same
fabric without a film when measured generally in accordance with
ASTM D 1894. Desirably, all these measure are greater for the
fabric having the film. In some instances, it is satisfactory for
at least two of these measures to be greater for the fabric having
the film. For example, the difference for a single measure (e.g.,
peak load, the average load, the dynamic coefficient of friction or
the static coefficient of friction) may be at least from about 30
percent to about twice as great. The difference may be three (3)
times as great or more. As another example, the difference may be
five (5) times as great to ten (10) times as great. As yet another
example, the difference may be fifteen (15) times as great. It is
contemplated that ever greater differences may be satisfactory
provided the "low-tack" properties of the film are maintained.
[0032] Polymers such as metallocene based polyolefins are suitable
examples of acceptable film formers. Other suitable surface films
include, for example, ethylene vinyl acetate copolymers,
styrene-butadiene, cellulose acetate butyrate, ethyl cellulose,
synthetic rubbers including, for example, Kraton.RTM. block
copolymers, natural rubber, polyurethanes, polyethylenes,
polyamides, flexible polyolefins, and amorphous polyalphaolefins
(APAO). A number of multilayer films such as those available from
Pliant Corp. of Schaumburg, Ill., are suitable for use. These
include film laminates having a polypropylene core and a
metallocene polypropylene or a Kraton.RTM. polymer outer layer.
Suitable films also include those known as "microporous films" and
particularly stretch-thinned laminate (STL) microporous films.
[0033] The film may have a thickness of between a positive amount
and 2 mils, desirably between about 0.5 and 1.5 mils, more
desirably between 0.7 and 1.1 mils.
[0034] Other materials may be added to the film to provide
particular characteristics. These optional materials may include,
for example, tackifying resins, dyes, pigment or other colorants.
Colorants, for example, may be used to give the film area a
visually perceptible color such as yellow, green, red or blue (e.g.
Sudan Blue 670 from BASF). These colors may be used to indicate the
protection level accorded by the gown according to, for example,
the standards of the Association for the Advancement of Medical
Instrumentation (AAMI), e.g., ANSI/AAMI PB70:2003. A user would
thus be able to select a gown for a surgical procedure where the
sleeve color corresponded to or indicated the fluid protection
level of the gown.
[0035] Tackifying resins may be added to the extrudable films to
provide tackified films. The tackifying resins and tackified
extrudable compositions as disclosed in U.S. Pat. No. 4,787,699,
hereby incorporated by reference, are suitable. Any tackifier resin
can be used which is compatible with the polymer being used and can
withstand the high processing (e.g., extrusion) temperatures. If
the polymer (e.g., block copolymer) is blended with processing aids
such as, for example, polyolefins or extending oils, the tackifier
resin should also be compatible with those processing aids.
Generally, hydrogenated hydrocarbon resins are preferred tackifying
resins, because of their better temperature stability.
REGALREZ.RTM. and ARKON.RTM. P series tackifiers are examples of
hydrogenated hydrocarbon resins. ZONATAK.RTM. 501 lite is an
example of a terpene hydrocarbon. REGALREZ.RTM. hydrocarbon resins
are available from Hercules Incorporated. ARKON.RTM. P series
resins are available from Arakawa Chemical (U.S.A.) Incorporated.
Other tackifying resins which are compatible with the other
components of the composition and can withstand the high processing
temperatures, can also be used.
[0036] In order to validate the superiority of the inventive
garment sleeve film in the retention of gloves, testing was carried
out on a variety of films and "control" sleeves without film. The
coefficient of testing (COF) was done according the ASTM testing
method D1894 and the fabric was tested against the inside surface
of a market leading latex glove (Biogel Surgical glove by Regent)
in order to gain a more realistic picture of the sleeve's
performance. The testing was done using the outside surface of each
gown or example fabric, dry, with the fabric oriented in the
machine direction, as it would be orientated on a wearer.
[0037] In Table 1 below, gown A (Ultra.RTM. gown from
Kimberly-Clark Corporation) is a commercially available gown with
sleeves made from two 1.0 osy (33.9 gsm) propylene SMS layers glued
together. Gown B (MicroCool.RTM. gown from Kimberly-Clark
Corporation) has a 0.6 osy (20.3 gsm) polypropylene spunbond layer
over a film and polypropylene SMS fabric with the spunbond on the
outside. Gown C (from Kimberly-Clark Corporation) has a 0.75 mil
film on a polypropylene SMS fabric with the film on the outside.
Gown D (Astound.RTM. gown from Cardinal Healthcare) has 1.6 osy
(54.3 gsm) polypropylene SMS sleeves. Gown E (Proxima.RTM. gown
from Medline Manufacturing) has 2.1 osy (71.1 gsm) spunlace
sleeves. The next four are examples of a polypropylene (PP) core
film having Kraton.RTM. G1657 SEBS polymeric or metallocene
polyethylene (mPE) outerlayers. Two different thicknesses were
tested, as indicated. An example of highly breathable stretch thin
laminate (HBSTL) is given as well as an example similar to a gown B
sleeve but without the spunbond outer layer. The film of gown B is
a stretch thinned laminate and has a skin layer made of a blend of
random copolymer polypropylene from Basell North America,
polypropylene and calcium carbonate. TABLE-US-00001 TABLE 1 ASTM
D1894 ASTM D1894 ASTM D1894 ASTM D1894 COF Peak Load COF Static COF
Dynamic COF Avg. Load Face MD Dry Face MD Dry Face MD Dry Face MD
Dry Gown A Average 26.846 0.135 0.114 22.61 Std. Dev. 11.992 0.06
0.056 11.171 Gown B Average 44.445 0.223 0.204 40.564 Std. Dev.
4.648 0.023 0.016 3.178 Gown C Average 86.257 0.433 0.404 80.362
Std. Dev. 18.303 0.092 0.082 16.318 Gown D Average 47.166 0.237
0.22 43.842 Std. Dev. 4.951 0.025 0.021 4.23 Gown E Average 75.974
0.382 0.343 68.277 Std. Dev. 11.48 0.058 0.054 10.803 PP w Kraton
skin film - 1.0 mil Average 374.509 1.911 1.744 341.75 Std. Dev.
31.674 0.162 0.221 43.337 PP w Kraton skin film - 0.75 mil Average
325.237 1.659 1.54 301.866 Std. Dev. 34.426 0.175 0.207 40.594 PP w
mPE skin film - 1.0 mil Average 216.936 1.107 0.971 190.324 Std.
Dev. 28.888 0.147 0.185 36.249 PP w mPE skin film - 0.75 mil
Average 195.446 0.997 0.864 169.334 Std. Dev. 22.383 0.114 0.166
32.566 HBSTL SF Concept Average 128.635 0.656 0.611 119.723 Std.
Dev. 17.167 0.088 0.099 19.376 Gown B without SB (SMS/film) Average
98.293 0.501 0.446 87.39 Std. Dev. 3.999 0.02 0.011 2.261
[0038] This data shows that the exemplary materials had a much
higher coefficient of friction in all areas than any of the
competitive, commercially available gowns. These materials had a
peak load above 90, a static load above 0.5, dynamic load above
0.44, and average load above 85, more desirably the films should
have a peak load above 100, static and dynamic loads above 0.6 and
an average load above 100. (Note that peak and average loads are in
units of grams and the static and dynamic loads are unitless.)
Gowns having the film according to the invention thus have a much
higher ability to retain gloves and avoid slip down and roll
down.
[0039] In order to validate the superiority of the inventive
garment sleeve, testing was carried out on a variety of films and a
"control" sleeve without film.
[0040] The control was a sleeve made from 1.7 osy (58 gsm) SMS made
from polypropylene. Three samples of sleeves of the same 1.7 osy
SMS material had film added to them; sample one had a metallocene
polyethylene film extending away from the cuff for 4 inches (11
cm), sample two had a metallocene polyethylene film extending away
from the cuff for 6 inches (16 cm), and sample three had a
Kraton.RTM. G1657 SEBS polymer film extending away from the cuff
for 4 inches (11 cm). The four sleeves were tested using human
subjects and an experimental protocol designed to simulate tasks
performed by medical personnel in an operating room. During and
after the protocol, measurements of glove location were taken for
comparison. The subjects' opinions were also solicited for a
qualitative indication of gown preference. A total of 47 subjects
tested the gowns.
The protocol was as follows:
1. Acclimate for 10 minutes. Review Survey Questions.
2. Have the subjects wash and dry their hands using the following
procedure:
[0041] 1 pump of triangle lotion soap [0042] 15 second lather
[0043] 15 second rinse [0044] dry until there are no visible signs
of moisture 3. Have the subject don a surgical gown. 4. Ask the
subject to don gloves (Biogel Surgical glove by Regent). Record the
glove size. Remind subjects NOT to adjust gloves once the exercises
have started. Note: Be sure that the gloves are completely
extended/unrolled at the cuff and snug around the wrist. Each glove
should have the same starting point. 5. Mark the surgical glove in
a straight line with a black marker at the bend of the wrist.
Record baseline measurement from the inside of the glove bead to
the wrist mark. 6. Record the measurement from the inside of the
glove bead to the end of the gown cuff interface (the `white
mark`). Note whether the gown cuff interface is on the hand or the
wrist. This is for both the left and right hand. [0045] Ask the
subject to handle the following items (dry): [0046] at the wrist,
flex hands palm down, up and down 10 times using both hands [0047]
at the wrist, flex hands palm up, up and down 10 times using both
hands [0048] rotate wrists to the outside 10 times using both hands
[0049] rotate wrists to the inside 10 times using both hands.
[0050] remove and replace stopper in test tube 5 times using each
hand [0051] turn stop cock clockwise a full rotation 5 times using
each hand [0052] wrap gauze 5 wraps around an artificial arm and
cut gauze with scissors--unwrap, then re-wrap gauze and unwrap
using other hand [0053] twist wrist to remove and replace top on a
water bottle 5 times using each hand (exaggerate movements) [0054]
pass a block back and forth from right hand to left hand 5 times
[0055] twist the length of a long threaded rod 2 times using each
hand [0056] twist the length a rope 2 times using each hand to the
knot 7. Measure from the wrist mark to inside of the glove cuff
(bead) and record `After Exercise Measurement` in mm. 8. Check for
flip over. Mark yes or no. If yes, measure from inside of the bead
to the end of the glove fold. 9. Have the subject remove and
discard gloves and gown. Wait 5 minutes and repeat with next
sample. 10. After all gowns have been evaluated, have them complete
Preference Survey. 11. Record on each subject's preference sheet,
the order of the Concept Gown Display. 12. Change the order of the
Concept Gown Display after each team has completed their Concept
Preference.
[0057] Results of the testing protocol were as follows:
[0058] Average movement (slip-down) measured from the starting
point was, for the control: 42 mm, for sample 1: 12 mm, for sample
2: 12 mm, and for sample 3: 9 mm. This indicates a significant
advantage for the sleeves with film over the sleeve without
film.
[0059] Qualitative survey responses were also gathered. The areas
of inquiry were "cuff stays in place", "acceptability of glove
slip-down", "how well to protect from fluid", "gown acceptability".
The gown sleeves were preferred by the subjects for each category
respectively in the following order: 3, 1, 2, control; 1, 3, 2,
control; 1, 2, 3, control; 3, 1, 2, control. This again shows the
performance and acceptability of the film sleeves was better than
the sleeve without film.
[0060] It should be appreciated by those skilled in the art that
various modifications and variations can be made to the embodiments
of the present invention described and illustrated herein without
departing from the scope and spirit of the invention. The invention
includes such modifications and variations coming within the
meaning and range of equivalency of the appended claims.
* * * * *