U.S. patent number 3,926,309 [Application Number 05/384,697] was granted by the patent office on 1975-12-16 for two layer sterile packaging.
This patent grant is currently assigned to Vicra Sterile, Inc.. Invention is credited to John L. Center.
United States Patent |
3,926,309 |
Center |
December 16, 1975 |
Two layer sterile packaging
Abstract
Two layer sterile packaging for separate articles such as a
catheter, disposable glove and rinse container, employing a plastic
sheet folded to bring the two opposite side edges adjacent, with
each end of the folded sheet sealed to form a first pouch, a
semi-permeable bacteria impermeable closure sheet overlying the
plastic sheet including the area in which the two opposite side
edges are disposed, such closure sheet being sealed about its
perimeter to the plastic sheet and being of sufficient width to
form a second pouch adjacent the plastic sheet; a catheter lies in
the first pouch formed by the plastic sheet and a disposable glove
and rinse container lies in the second pouch whereby the package
may be opened by tearing away the closure sheet to permit removal
of the container and glove from the second pouch so that the glove
can be donned by the user, whereupon the catheter may be removed
from the first pouch formed by the plastic sheet in a sterile
condition.
Inventors: |
Center; John L. (Dallas,
TX) |
Assignee: |
Vicra Sterile, Inc. (Dallas,
TX)
|
Family
ID: |
23518372 |
Appl.
No.: |
05/384,697 |
Filed: |
August 1, 1973 |
Current U.S.
Class: |
206/364; 206/438;
206/370 |
Current CPC
Class: |
B65D
75/30 (20130101); A61M 25/002 (20130101); A61B
50/30 (20160201) |
Current International
Class: |
A61B
19/02 (20060101); A61B 19/00 (20060101); A61M
25/00 (20060101); B65D 75/28 (20060101); B65D
75/30 (20060101); B65d 083/10 (); A61b 019/02 ();
B65d 031/17 () |
Field of
Search: |
;229/56
;206/364,363,438,440,370,441,63.5 |
References Cited
[Referenced By]
U.S. Patent Documents
Primary Examiner: Price; William I.
Assistant Examiner: Farrow; Douglas B.
Attorney, Agent or Firm: Richards, Harris & Medlock
Claims
What is claimed is:
1. Two layer sterile packaging for separate articles
comprising:
a plastic sheet folded along two fold lines generally parallel to
the two side edges of the sheet, the folded layers of the sheet
being sealed together across each end to form a first pouch to
which access may be had between the two side edges of the
sheet,
a closure sheet overlying the area in which the two opposite side
edges of the plastic sheet are disposed to form a second pouch
adjacent the plastic sheet, such closure sheet being sealed to the
plastic sheet around a perimeter encompassing at least a portion of
said two opposite side edges to complete sealing of the first and
second pouches from the atmosphere;
at least one sterile article lying in the first pouch; and
at least one sterile article lying in the second pouch whereby the
package may be opened by tearing away the closure sheet so that an
article in the second pouch may be readily removed from the second
pouch without contacting the interior or side edges of the first
pouch, and the contents of the first pouch may thereafter be
removed between the adjacent side edges of the first pouch.
2. The packaging of claim 1, wherein a gap is left between the two
side edges of the folded plastic sheet.
3. The packaging of claim 1 wherein the two side edges of the
folded plastic sheet overlap.
4. The packaging of claim 1, wherein a suction catheter lies in the
first pouch and a disposable glove lies in the second pouch.
5. The combination of claim 4 wherein a collapsible cup is also
positioned in the second pouch.
6. In a sterile package for a medical implement having a plastic
sheet folded along two lines generally parallel to two opposite
side edges of the sheet, the folded layers of the sheet being
sealed together across each end to form a first pouch to which
access may be had between such two opposite side edges, and a
closure sheet overlying the plastic sheet including the area in
which the two opposite side edges are disposed, such closure sheet
being sealed to the plastic sheet around a perimeter encompassing a
portion of said two opposite side edges; and a sterile implement
lying in the first pouch; the improvement comprising:
the closure sheet having sufficient width that a second pouch
formed by the closure sheet and the plastic sheet will readily
receive a disposable glove, said second pouch containing at least
one article comprising a disposable glove whereby the package may
be opened by tearing away the closure sheet so that the glove may
be readily removed from the second pouch without contacting the
sterile implement or the interior or side edges of the first pouch,
and placed on the user's hand, after which the hand having the
sterile glove thereon may be inserted into the first pouch to
remove the implement through the longitudinal opening.
7. The combination of claim 6, wherein the implement is a suction
catheter and wherein a collapsible cup is also situated in the
second pouch.
Description
This invention relates to sterile packaging of medical implements
and the like, and more particularly to a two layer packaging
assembly in which separate articles may be packaged in separate
sterile layers to permit sequential access to the separate
articles, without the necessity of breaking sterilization of the
last article or articles to be unwrapped by the removal of the
earlier article or articles.
The invention contemplates packaging which will provide an optimum
sterile condition for the articles to be used while admitting of
simple disengagement of the articles from the packaging and
reducing wrapping to be disposed of to a minimum and maintaining a
high storage density for reducing storage costs.
The invention has utility for a number of applications of
disposable packaging of sterile articles. It is particularly well
adapted to the packaging of a suction catheter with a disposable
glove and a collapsible rinse container which are used in
conjunction therewith. The invention will be described by way of
illustration in conjunction with such articles.
Suction catheters are used in intubation procedures in order to
remove secretions which accumulate in the mouth, throat,
endotracheal and tracheostomy tubes of a patient. The intubation
process serves to keep these passages clear of mucous collections
and, more importantly, to remove from the tracheal and lung
passages materials which interfere with oxygenation of the blood.
Such procedures ordinarily are used for patients who require
breathing assistance. A typical hospital often has a large number
of such patients, and thus a relatively large need for suction
catheters to employ these procedures.
Because of infection problems, there is a need for suction
catheters to be provided for single use after which they are
discarded, each such catheter separately packaged in a sterile
environment, and including in each package a sterile disposable
glove and rinse container also to be discarded after one use. In
the hospital room environment, it is most important that packaging
provide ready access to the needed materials without the necessity
of difficult or complicated procedures to obtain the articles in
the proper sterile condition. Moreover, since the patients
requiring this type of apparatus often need a very high volume of
such catheters, a hospital typically must maintain a large supply
of the catheters on hand. For example, some patients may require as
many as fifty suction catheters during the first 24 hour period of
treatment utilizing intubation procedures. Because of this large
volume, the necessity to reduce storage space to a minimum in
packaging such articles is often quite pressing. Moreover, as waste
disposal becomes a greater problem for our society as a whole, so
does it particularly with hospitals, which find it highly desirable
and indeed urgently necessary to reduce the amount of waste
involved in packaging of materials which they use to a minimum.
Accordingly, it is an object of this invention to provide a maximum
storage density packaging system for a medical implement such as a
suction catheter to be packaged in sterile form along with other
articles which are needed with the implement such as a sterile
glove and a collapsible rinse cup, in a package permitting
sequential access to the packaged articles.
It is highly important that the packaging be manipulatable so as to
maintain the highest possible degree of sterility in breaking open
of the packaging and utilization of the articles within.
Accordingly, it is another object of this invention to provide such
articles in packaging which will provide sequential access to the
articles while maintaining sterility. The packaging of this
invention may be readily opened to provide access to a rinse
container and sterile glove, without affecting the sterility of the
implement on the underlying layer in the package.
This invention provides an orderly packaging scheme for such
articles which simplifies and enhances the technique to be utilized
in insuring sterility of the articles used in medical procedures
and facilitates simplicity and rapidity of use, as well as
providing for high density storage and minimizing waste packaging
materials.
In many types of peel-open plastic pouches which have been utilized
in the prior art, it is necessary to coil the catheters and
restrain the coil in order to prevent the catheter from breaking
out of the package when the package is opened, and thus possible
breaking sterility. This results in a catheter which is kinked when
it comes out of the package, and thus prevents problems in usage.
On the other hand an extra large package can be provided to prevent
the catheter from breaking sterility on opening, but this increases
the amount of waste and increases the storage space required.
The prior art does disclose a type of packaging which permits
relatively high density packaging of sterile articles, but which
presents problems in preserving sterility of articles to be
sequentially removed from the package. Such a package is disclosed
in U.S. Pat. No. 3,472,369. A plastic sheet such as polyethylene is
folded over so that its sides are adjacent, and its ends are sealed
to form a pouch which may be opened by separating the opposite side
edges. The package is then sealed by the use of a paper peel tab
along these adjacent side edges, which tab may be torn away for
access to the package. The peel tab permits the package to be
sterilized after assembly because it is permeable to sterilizing
gases.
Unfortunately, the packaging disclosed in this patent had
disadvantages if it is desired to package a number of separate
articles, the sterility of which is important to the medical
procedure under consideration.
For example, in the case of a suction catheter where a sterile
glove is to be utilized, and a separate rinse cup provided, the
opening of the package and entry by the user with an unsterilized
hand to remove the glove gives unsterile contact with the edges of
the pouch and with the interior of the pouch, and indeed presents
the possibility of contacting the catheter itself with an
unsterilized hand. The gloved hand entering the package to extract
the catheter may be contaminated because the same package has
already been entered by an ungloved hand. Indeed the sterility of
the catheter itself may be broken simply in the procedure of
extracting the glove and the rinse cup from the package.
There is provided in accordance with this invention packaging which
is generally of the type shown in U.S. Pat. No. 3,472,369 utilizing
a folded plastic sheet forming a pouch and having an overlying
paper closure sheet, although with modifications resulting in
substantial mechanical and procedural advantages over the packaging
disclosed in the prior art.
In accordance with the invention, a plastic sheet is folded along
two generally parallel fold lines so that two side edges of the
sheet are generally adjacent, the folded layers of the sheet being
sealed together across each end to form a first pouch which may be
opened by separation of the two side edges of the sheet. A
semi-permeable bacteria impermeable closure sheet overlies the area
in which the two opposite side edges of the plastic sheet are
disposed to form a second pouch adjacent the plastic sheet to
receive a sterile article, such closure sheet being sealed around
its perimeter to the plastic sheet; a first sterile article lies in
the first pouch, and a second sterile article is disposed in the
second pouch whereby the package may be opened by tearing away the
closure sheet so that the second article may be readily removed
from its pouch without contacting the first article or the interior
or side edges of the first pouch, and the first article may
thereafter be removed between the adjacent side edges of the first
pouch, still in sterile condition.
For a more complete understanding of the present invention and for
further objects and advantages thereof, reference may now be had to
the following description taken in conjunction with the
accompanying drawings, in which:
FIG. 1 is a partially exploded view of packaging formed in
accordance with the present invention;
FIG. 2 is a cross-sectional view along the lines 2--2 of FIG. 1,
with the package shown assembled with some portions exaggerated to
permit the elements illustrated to be more easily seen;
FIG. 3 is a perspective view of the package of FIG. 1;
FIG. 4 is a perspective illustration of the package of FIG. 1 with
the initial closure sheet torn back to provide access to the top
layer of the packaging; and
FIG. 5 is a perspective view illustrating the removal of the
medical implement from the lower layer of the packaging.
Illustrated in the drawings is a two layer sterile packaging
assembly generally indicated by the reference numeral 10, to permit
sequential access to separately packaged articles in order to
preserve the sterility of the later unwrapped articles during
removal of the earlier removed articles. A first pouch 11 is formed
utilizing a plastic sheet 12 which is folded over along generally
parallel folded lines to bring opposite side edges 16 into
generally adjacent relationship. The opposite side edges 16 may be
brought into overlapping relationship, but preferably are disposed
so that a slight gap remains between the side edges 16, as
illustrated in the drawings.
The plastic sheet 12 is preferably formed from a heat sealable
plastic such as polyethylene. The folded layers of the sheet 12 are
sealed across each end as indicated by the stipled areas 18, so
that pouch 11 is formed with ends sealed at 18 and an access
opening provided along the juxtaposed side edges 16. In actual
assembly of the packaging, the sealing of one end of the sheet 12
in the stipled area 18 may conveniently be formed as the last step
in assembling the package, after the article or articles to be
packaged have been placed in the package.
A paper closure sheet 20 lies across plastic sheet 12 including
opposite side edges 16, forming in cooperation with sheet 12 a
second pouch 22. Pouch 22 has sufficient width to permit ready
insertion of a disposable glove and collapsible rinse container.
The closure sheet 20 is preferably formed from a thin paper
material which is impermeable to bacteria, but which is permeable
to a sterilizing gas so that the interior of the package may be
sterilized after assembly of the complete packaging with articles
enclosed therein. The closure sheet 20 is bonded by convenient
means such as heat sealing about its perimeter as indicated at the
stipled side areas 24 and stipled end areas 26, so that a complete
seal is provided for pouches 11 and 22. Once again, the seal on one
of the end areas 26 bonding the closure sheet 20 to the plastic
sheet 12 may conveniently be carried out as the last step in the
packaging procedure, after the articles to be placed in the package
have been implaced.
While the invention can be utilized in connection with a number of
articles to be packaged in a sterile environment for sequential
unwrapping, the drawing illustrates its utilization with a suction
catheter which is packaged with a sterile glove and collapsible
rinse container. The suction catheter 28 is placed in pouch 11 in
an unrestrained state. It is not necessary to coil or restrain the
catheter 28 in order to preserve sterility of the first pouch 11 on
breaking into the package. The disposable glove 30 and collapsible
rinse container 32 are shown folded and lying in the second pouch
22. The disposable glove may be any of a number available on the
market, a suitable one being the disposable glove adhered to paper
backing produced by Arbrook, Inc. under the trademark
"Dispos-a-Glove", which may be unfolded and donned by the user
without contaminating the outer surface of the glove. The
collapsible container 32 may be a container folded along the lines
of a typical grocery sack or air sickness bag, although of a
smaller size, which is storable in an essentially flat state.
In assembling the packaging illustrated, the plastic sheet 12 may
first be folded and then placed against the paper closure sheet 20
in aligned relationship. The heat sealing of one end of the plastic
sheet at 18 and one end of the paper closure sheet 20 to the
plastic sheet 12 as illustrated by stipled area 26 at one end may
be performed simultaneously with the sealing of the sides of the
paper sheet 20 to the plastic sheet 12 as shown in stipled area 24.
The incomplete packaging thus formed can be stored until ready for
introduction of the articles for preparation of a complete package.
The suction catheter 28 may be placed into pouch 11 at the unsealed
end of the package, and likewise the glove 30 and container 32
placed in the second pouch 22 through the unsealed end. Thereafter,
the seal of the plastic sheet to itself between layers as indicated
at the stipled area 18 and the paper sheet 20 to the plastic sheet
12 as indicated by stipled area 26 can be formed simultaneously to
complete the sealing of the package at the theretofore open end.
Thereafter the package and contents may be placed in an environment
of sterilizing gas to sterilize the package, and thereafter be
purged by vacuum so that the complete sterile package is ready for
shipment.
It will be appreciated that the utilization of the packaging herein
described permits use of a relatively small amount of packaging
space to accomplish the desired objective.
Once the article has been transported to its site of usage and is
ready for use, entry into the package is performed as indicated by
FIGS. 3-5. As illustrated in FIG. 3, an end of the paper closure
sheet 20 extending beyond the sealed area 26 is available for
grasping to tear the closure sheet 20 lengthwise of the package,
thus exposing pouch 22 and making the disposable glove 30 and rinse
container 32 readily accessible without contacting the interior of
pouch 11, the catheter 28 itself, or the side edges 16 which form
the pouch 11.
The glove 30 and container 32 may be removed from pouch 22. The
user places the glove 30 on his hand without touching the outer
surfaces of the glove, either before or after filling the rinse
container 32. With the donning of glove 30, entry into the lower
layer of the package at pouch 11 may proceed. The user's gloved
hand may be used to separate the opposite side edges 16 of the
sheet 12 to provide access to pouch 11, and thus remove the suction
catheter 28 for use.
Typically, the entire amount of waste materials remaining after use
may be wadded into a small ball and placed in the disposable glove
to provide a small and compact material to be disposed of.
Having described the invention in connection with certain specific
embodiments thereof, it is to be understood that further
modifications may now suggest themselves to those skilled in the
art and it is intended to cover such modifications as fall within
the scope of the appended claims.
* * * * *