U.S. patent number 3,754,700 [Application Number 05/119,292] was granted by the patent office on 1973-08-28 for surgical pouches.
This patent grant is currently assigned to Rollprint Packaging Products, Inc. Invention is credited to Joseph Paul Bonk.
United States Patent |
3,754,700 |
Bonk |
August 28, 1973 |
**Please see images for:
( Certificate of Correction ) ** |
SURGICAL POUCHES
Abstract
Surgical pouches having a back wall of sheet polyethylene and a
front wall of sheet polyethylene with a header piece of
sterilizable, surgical kraft paper or other gas permeable, sheet
material having bacteria holdout properties are disclosed wherein
the instrument contained within the pouch may be sterilized after
the pouch is sealed.
Inventors: |
Bonk; Joseph Paul (Des Plaines,
IL) |
Assignee: |
Rollprint Packaging Products,
Inc (Chicago, IL)
|
Family
ID: |
26817197 |
Appl.
No.: |
05/119,292 |
Filed: |
February 26, 1971 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
Issue Date |
|
|
836332 |
Jun 25, 1969 |
3627611 |
Dec 14, 1971 |
|
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Current U.S.
Class: |
206/439;
383/210 |
Current CPC
Class: |
B65D
75/5855 (20130101); B65D 75/30 (20130101); A61B
50/30 (20160201); B65B 9/02 (20130101); A61M
5/002 (20130101); A61B 2050/3015 (20160201); A61B
2050/314 (20160201); B65D 75/46 (20130101); A61B
2050/316 (20160201) |
Current International
Class: |
A61B
19/02 (20060101); A61B 19/00 (20060101); A61M
5/00 (20060101); B65D 75/28 (20060101); B65D
75/52 (20060101); B65D 75/30 (20060101); B65D
75/58 (20060101); B65B 9/02 (20060101); B65B
9/00 (20060101); B65D 75/00 (20060101); B65D
75/46 (20060101); B65d 031/00 () |
Field of
Search: |
;206/63.2R,56AA
;229/62,66 |
References Cited
[Referenced By]
U.S. Patent Documents
Primary Examiner: Norton; Donald F.
Parent Case Text
CROSS-REFERENCE TO RELATED APPLICATION
This application is a continuation-in-part of my application
entitled "Method and Apparatus for the Manufacture of Surgical
Pouches", Ser. No. 836,332, filed on June 25, 1969 which issued as
U.S. Pat. No. 3,627,611 on Dec. 14, 1971.
Claims
I claim:
1. A surgical package comprising:
a first wall of plastic sheet material;
a second wall comprising a piece of flexible plastic sheet material
and a header, said header forming a gas penetrable wall area and
being in partial overlapping relationship with said piece of
flexible plastic sheet material and sealed thereto in the area of
overlap; and
means for securing said second wall to said first wall comprising a
corrugated, tortuous seal between the plastic sheet material of
said first wall and the header of said second wall.
2. The surgical package of claim 1 wherein the plastic sheet
material and the header of said second wall are sealed together
with a corrugated, tortuous seal.
3. The surgical package of claim 2 wherein a portion of said second
seal has the shape of a chevron.
4. The surgical package of claim 2 wherein said header is of spun
bonded polyolefin material.
5. The surgical package of claim 1 wherein said header is of spun
bonded polyolefin material.
6. The surgical package of claim 1 wherein a portion of said seal
has the shape of a chevron.
7. The surgical package of claim 1 wherein said header is of
paper.
8. A surgical pouch comprising:
a first layer of plastic sheeting;
a gas permeable header in overlapping relationship with a portion
of said first layer;
a first area of seal between said header and said first layer
forming a front wall of said package;
a second layer of plastic sheeting underlying said front wall
forming a back wall of said package; and
means for sealing said front wall to said back wall comprising a
tortuous, corrugated seal between said header and said second layer
of plastic sheeting.
9. The surgical pouch of claim 8 wherein said first area of seal is
a second tortuous, corrugated seal.
10. The surgical pouch of claim 9 wherein a portion of said
second
tortuous, corrugated seal is in the shape of a chevron. 12. The
surgical
pouch of claim 11 wherein said header is of spun bonded polyolefin.
13. The surgical pouch of claim 9 wherein said header is of spun
bonded
polyolefin. 14. The surgical pouch of claim 8 wherein a portion of
said
tortuous, corrugated seal is in the shape of a chevron. 15. The
surgical pouch of claim 14 wherein said first and second layers of
plastic sheeting
are of polyethylene. 16. The surgical pouch of claim 8 wherein said
header
is of paper. 17. The surgical pouch of claim 8 wherein said header
is of spun bonded polyolefin.
Description
BACKGROUND OF THE INVENTION
This invention relates to pouches or containers for packaging of
surgical or pharmaceutical instruments. More particularly, this
invention relates to surgical pouches or packages which permit the
pouch interior and the instrument contained therein to be
conveniently sterilized after the pouch is sealed and the
instrument to be aseptically removed therefrom when the instrument
is to be used.
It has been found desirable in the past to pack surgical
instruments in packages or pouches which may be easily opened
during the course of an operation and from which the instrument may
be removed without contamination. Specifically, at a central
instrument supply station a pouch is provided in which a surgical
instrument is placed and the pouch sealed. The instrument is
sterilized while it is in the pouch so that the interior of the
pouch is sterilized simultaneously. The pouch and instrument are
then transported to the operating room. When it is desired to use
the instrument during the course of an operation, the pouch is
opened and the instrument removed. Preferably, the pouch should be
capable of being opened in such a way that the instrument may be
removed without contacting any exterior, perhaps non-sterile,
surface of the pouch.
It has further been found desirable to use surgical pouches which
permit packaging of the instrument and subsequent sterilization
thereof with sufficient ease that, at the conclusion of a surgical
operation and in the actual operating room, the used instruments
may be sealed into a new pouch, sterilized, and thereby made ready
for use again. A convenient sterilizing method used in the past,
commonly referred to as the gas sterilization process, has required
the use of paper pouches. There, the pouch with the instrument
sealed therein is placed in a pressure chamber and ethyloxide is
introduced into the chamber under pressure so that it penetrates
the paper and sterlizes the instrument. The chamber is then
partially evacuated to withdraw the ethyloxide from the pouch. The
pouch is then removed from the chamber, and the contained
instrument is sterilized and ready for use. This gas sterilization
process is relatively quick and does not require high
temperatures.
Various surgical pouches have heretofore been proposed but they
have had many weaknesses associated therewith. Many did not permit
use of the described gas sterilization method. The pouches of the
prior art were often either relatively difficult to open or had
seals which did not adequately protect the contained instruments
from contamination. They were often of complex design or made of
expensive material. Further, some of the prior art pouches were of
insufficient strength to withstand repeated handling without
rupturing and resultant contamination of the contents, or did not
allow for easy identification of the instrument within the
pouch.
SUMMARY OF THE INVENTION
Surgical pouches of transparent plastic sheeting and gas permeable
sheet material are provided by this invention. Polyethylene front
and back pieces form the pouch walls and a header of paper or other
gas permeable, sheet material having bacteria holdout properties is
supplied to form a portion of the pouch front wall. The pouch
components are heat sealed together and the pouch configured so
that the header may easily be torn away to permit aseptic removal
of the instrument.
Accordingly, it is an object of this invention to provide a
surgical pouch which permits gas sterilization of the pouch
interior and its contents which is both durable and allows easy
identification of the contained instrument.
It is an object of this invention to provide a surgical pouch which
may be easily opened and the contents aseptically removed
therefrom.
It is an object of this invention to provide a surgical pouch which
may be sealed shut once the contents have been placed therein in a
relatively simple manner using relatively economical equipment.
It is an object of this invention to provide a surgical pouch which
is of simple design and construction which can be made from
inexpensive materials.
Further and additional objects will appear from the description,
accompanying drawings and appended claims.
DESCRIPTION OF THE DRAWINGS
FIG. 1 is a partial top plan view of a surgical pouch of a first
embodiment of this invention;
FIG. 2 is a partial side view of the surgical pouch of FIG. 1;
FIG. 3 is a partial cross section of the surgical pouch of FIG. 1
taken along the line 3--3 of FIG. 1;
FIG. 4 is a partial top plan ivew of a surgical pouch of a second
embodiment of this invention;
FIG. 5 is a partial top plan view of a surgical pouch of a third
embodiment of this invention;
FIG. 6 is a perspective view showing the use of the surgical pouch
of FIG. 5; and
FIG. 7 is a partial top plan view of a surgical pouch of a fourth
embodiment of this invention.
DESCRIPTION OF THE PREFERRED EMBODIMENTS
Referring now to the drawings, and more particularly to FIGS. 1, 2
and 3, a surgical pouch or package 10 of one of the preferred
embodiments of the present invention is there disclosed. The pouch
10 is comprised generally of a front piece 12, a header 14, and a
back piece 16, and has an insertion opening 18 at one end and a
removal opening 20 at the other end. The front piece, header, and
back piece are so disposed that the pouch rear wall is formed by
the back piece and the pouch front wall is formed by the front
piece and header. In the finished pouch, the removal opening area
20 is closed by a tortuous, corrugated chevron seal 22, which will
be described in greater detail hereinafter. The instrument to be
packaged may be inserted into the pouch through insertion opening
18 which would then be heat-sealed shut. When it is desired to use
the instrument, the pouch is opened at removal opening 20 and the
instrument removed.
Front piece 12 and back piece 16 are preferably of transparent
polyethylene sheet and in one application a thickness of 0.004 inch
has been found to be desirable. Header 14 should be made of sheet
material which is gas permeable, yet will not permit the
reintroduction of bacteria or other contaminating agents through
the header into the pouch after the contents have been sterilized
by the above-described gas sterilization process. Paper headers
have been used with this invention and in one application 42-pound
sterilizable, surgical kraft has been found useful. This paper is
gas penetrable allowing proper performance of gas sterilization
processes. However, header 14 is preferably made of a spun bonded
polyolefin material commercially available from the E. I. du Pont
de Nemours & Company, designated by that company with the
number 1073B, and sold under the trade name Tyvek. A conventional
heat seal coating, such as a polyvinyl acetate, must be applied to
the side of that material which is sealed to the remainder of the
pouch before the pouch is assembled. The coated, spun bonded
polyolefin material has been found to have greater resistance to
recontamination of the pouch interior than paper, especially if the
pouch should accidentally become damp. The desired overall
dimensions of the illustrated pouch are 7 inches wide by 13 inches
long.
Back piece 16 underlies the entire area of the pouch. Front piece
12 partially overlies back 16 and is coextensive therewith and
heat-sealed thereto by two side seals 24 and 26. Front 12 is
preferably disposed on back 16 so that the back extends beyond the
front a short distance, perhaps 1/2 inch, at one end of the pouch
to form a lip 28 and a greater distance, perhaps 4 inches, at the
other end of the pouch to expose a header mating area 30 where the
header 14 and back 16 may be sealed at removal opening 20. Header
14 partially overlies both front 12 and back 16. It is coextensive
with front 12 and back 16 along the sides of the pouch.
Header 14 is heat-sealed to front 12 at seal 32 along their area of
overlap leaving a loose flap of header 34. Header 14 is
additionally sealed to back 16 at chevron seal 22 and side seals 36
and 38. Chevron seal 22 must be such that the pouch is sufficiently
sealed to maintain required sterility, yet is still capable of
being easily opened for removal of the enclosed sterilized
instrument. In the preferred embodiment shown, the chevron seal 22
consists of four parallel V-shaped seal strips 40, 42, 44 and 46,
separated by three parallel nonseal strips or ridges 48, 50 and 52.
The header 14 and back 16 are heat-sealed together at the V-shaped
strips, but are not sealed at the ridges. As may best be seen in
FIG. 3, header 14 may separate from back 16 in the area of ridges
48, 50 and 52.
It has been found that the angle included within the chevron,
indicated at 53, is critical and should be within a certain range
in order to insure both proper sealing and the desired ease of
opening. In the described embodiment, angle 53 should be in the
range of 110.degree.-120.degree. and is preferably 114.degree.. The
chevron-shaped seal additionally provides two triangular-shaped
gripping portions 54 and 55. At these portions, header 14 and back
16 are separately exposed so that they may be gripped and torn
apart to open the pouch. Once the chevron seal 22 is broken, the
bag is normally disposed of.
A second embodiment of this invention is disclosed in FIG. 4. In
general configuration, the pouch of FIG. 4 is similar to that of
FIGS. 1-3; it is comprised of a back piece 60 with a front piece 62
partially overlying it and a gas permeable header 64 overlying the
remainder of the back piece and in overlapping relationship with
the front piece. The header and front piece are sealed together in
their area of overlap at seal 66 to form the pouch front wall. A
corrugated, tortuous seal 68, similar to that used in the
embodiment of FIGS. 1-3, is used to seal the front wall to the rear
wall. Seal 68 extends generally about three sides of the pouch so
as to leave an insertion opening 70 at the end of the pouch removed
from the header. Seal 68 is brought inward from the sides of the
pouch in the area of the upper left-hand corner of the pouch shown
to form a gripping portion 72 where the back 60 and header 64 are
separately exposed so that they may be gripped and torn apart to
open the pouch. Seal 68 may advantageously have an outwardly
pointing, chevron seal area 74 similar to that described in
relation to the embodiment of FIG. 1.
A third embodiment of this invention is disclosed in FIGS. 5 and 6.
This embodiment also has a general configuration similar to that of
the embodiment of FIGS. 1-3 in that it includes a back piece 80
with a front piece 82 partially overlying it and a gas permeable
header 84 overlying the remainder of the back piece and in
overlapping relationship with the front piece. The header and front
piece are sealed together in their area of overlap at seal 86 to
form the pouch front wall. A corrugated, tortuous seal 88, similar
to that used in the embodiment of FIGS. 1-3, is used to seal the
front wall to the rear wall. Seal 88, extends generally about three
sides of the pouch so as to leave an insertion opening 90 at the
end of the pouch removed from the header. In this embodiment, seal
86 is also a corrugated, tortuous seal similar to that used in the
embodiment of FIGS. 1-3. The embodiment of FIGS. 5 and 6 is also
characterized by the presence of a flap 92 of header material
overlying front piece 82 and extending substantially beyond seal
86. Flap 92 is then used as a gripping portion and the pouch is
opened by pulling flap 92 in an upward direction.
FIG. 6 shows how the embodiment of this invention disclosed in FIG.
5 is used. There a syringe 94 has previously been placed in the
pouch, the insertion opening 90 closed by a seal 96, and the pouch
interior and the syringe sterilized. To remove the syringe, flap 92
is grasped and pulled upwards peeling the header off the front
piece 82 and the back piece 80 in turn. The syringe may then be
removed from the opening thus formed. In the embodiments of FIGS.
1-4, the instrument contained in the pouch may accidentally come in
contact with the external, non-sterile areas of the pouch,
particularly those portions of the back piece which form gripping
portions 54 and 55 in the embodiment of FIGS. 1-3, and gripping
portion 72 in the embodiment of FIG. 4, as the instrument is being
removed therefrom. In the embodiments of FIGS. 5 and 6, however,
only sterile surfaces are presented for contact with the
instrument, the interior surface of back piece 80 and the interior
surface of header 84. Header 84 may also be completely removed from
the pouch, leaving only the sterile, interior surface of back piece
80 for contact with the instrument. The instrument may thus be
removed from the pouch completely aseptically with no danger from
contamination by contact with non-sterile surfaces of the
pouch.
FIG. 7 discloses a fourth embodiment of this invention similar to
that of FIGS. 5 and 6. In this embodiment, however, the corrugated,
tortuous seal 86 is made in the shape of a downward pointing
chevron. Such a seal provides increased ease in opening over the
embodiment of FIGS. 5 and 6.
All four of the embodiments described above include an opening,
shown at 18 in FIG. 1, 70 in FIG. 4, and 90 in FIGS. 5 and 7, for
insertion of an instrument into the pouch. That opening may
conveniently be sealed shut using presently available heat sealers.
Alternatively, the insertion opening may be sealed shut using
conventional autoclave tape. It should be observed that if the
front and back polyethylene pieces are transparent, the contents of
the pouches may be easily identified and there will be no need to
label them.
It will thus be seen that a plurality of surgical pouches have been
provided which are of relatively simple design and construction,
permit gas sterilization of the pouch interior and contents, are
very durable, allow for easy identification of the contained
instrument, and which may be easily opened and the contents
aseptically removed therefrom. It will be obvious that certain
modifications of the specific embodiments shown may be made without
departing from the spirit and scope of this invention. Different
materials might be used for the front, back and header pieces,
different methods of sealing might be used, and many different
configurations for the pouch could be devised.
While several particular embodiments of this invention are
disclosed above, it will be understood, of course, that the
invention is not to be limited thereto since many modifications may
be made. It is contemplated, therefore, by the appended claims, to
cover any such modifications as fall within the true spirit and
scope of this invention.
* * * * *