U.S. patent application number 10/454044 was filed with the patent office on 2003-10-16 for sterile packaging for flexible endoscopes.
Invention is credited to Addy, Tralance, Timm, Debra, Wu, Su Syin.
Application Number | 20030192799 10/454044 |
Document ID | / |
Family ID | 22354350 |
Filed Date | 2003-10-16 |
United States Patent
Application |
20030192799 |
Kind Code |
A1 |
Addy, Tralance ; et
al. |
October 16, 2003 |
Sterile packaging for flexible endoscopes
Abstract
A packaging enclosure for receiving a flexible endoscope during
a sterilization procedure and sterile storage thereafter has a
portion thereof which is semi-permeable. Provision is made for
hanging the packaging enclosure over a hook or peg. In one
embodiment the packaging enclosure conforms to the endoscope so
that its two flexible portions may hang over opposite sides of the
hook. Alternatively, a hook or aperture may be provided on the
packaging enclosure for hanging it over the hook.
Inventors: |
Addy, Tralance; (Trabuco
Canyon, CA) ; Wu, Su Syin; (Irvine, CA) ;
Timm, Debra; (Foothill Ranch, CA) |
Correspondence
Address: |
AUDLEY A. CIAMPORCERO JR.
JOHNSON & JOHNSON
ONE JOHNSON & JOHNSON PLAZA
NEW BRUNSWICK
NJ
08933-7003
US
|
Family ID: |
22354350 |
Appl. No.: |
10/454044 |
Filed: |
June 4, 2003 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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10454044 |
Jun 4, 2003 |
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09474141 |
Dec 29, 1999 |
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6594971 |
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60114288 |
Dec 30, 1998 |
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Current U.S.
Class: |
206/364 ;
206/363; 206/438; 206/439; 422/28 |
Current CPC
Class: |
A61B 1/00144 20130101;
B65D 75/32 20130101; A61B 1/00142 20130101; B65D 75/30 20130101;
B65D 25/22 20130101 |
Class at
Publication: |
206/364 ;
206/363; 206/438; 206/439; 422/28 |
International
Class: |
A61B 019/02; A61L
002/20 |
Claims
What is claimed is:
1. A Packaging enclosure for a flexible endoscope having first and
second flexible tubes, said packaging enclosure comprising a wall
forming an interior space impervious to microorganisms for
receiving the endoscope, at least a portion of the wall being
semi-permeable, and a hanging means for hanging the packaging
enclosure with the endoscope therein over a hook.
2. A packaging enclosure according to claim 1 wherein the packaging
enclosure comprises a pouch having first and second films adhered
to each other to form the interior space.
3. A packaging enclosure according to claim 1 wherein the hanging
means comprises an aperture in the packaging enclosure.
4. A packaging enclosure according to claim 1 wherein the hanging
means comprises the first flexible tube being receivable within one
portion of the packaging enclosure and the second flexible tube
being receivable within a second portion of the packaging enclosure
and the packaging enclosure with the endoscope therein is drapable
over the hook.
5. A packaging enclosure according to claim 1 wherein the packaging
enclosure comprises a thermoformed tray covered with a permeable
lidstock.
6. A packaging enclosure according to claim 1 wherein the packaging
enclosure comprises a sterile container having at least one
semi-permeable port.
7. A method for sterilizing and storing an endoscope having first
and second flexible tubes, said method comprising the steps of:
placing the endoscope within a packaging enclosure comprising a
wall forming an interior space for receiving the endoscope, at
least a portion of the wall being semi-permeable; passing a
sterilizing gas into the packaging enclosure; and hanging the
packaging enclosure with the sterile endoscope therein over a
hook.
8. A method according to claim 7 wherein the packaging enclosure
comprises an aperture and the hook is placed in the aperture.
9. A method according to claim 7 wherein the first flexible tube is
received within one portion of the packaging enclosure and the
second flexible tube is received within a second portion of the
packaging enclosure and the packaging enclosure with the endoscope
therein is draped over the hook.
10. A method according to claim 7 wherein the packging enclosure
comprises a pouch.
11. A method according to claim 7 wherein the packging enclosure
comprises a thermoformed tray with a permeable lid stock
12. A method according to claim 7 wherein the packging enclosure
comprises a sterile container with at least one semi-permeable
port.
Description
[0001] This application claims priority from U.S. Ser. No.
60/114,288 filed Dec. 30, 1998.
FIELD
[0002] The preset invention is directed to the field of coverings
used to cover medical instruments during sterilization and in
storage thereafter.
BACKGROUND
[0003] An endoscope typically comprises two flexible tubes
connected to a body. One of the tubes is for insertion into a
bodily orifice and the other typically connects to a light source.
After a cleaning of an endoscope such as a sigmoidoscope or
colonoscope, the endoscope is typically hung over a peg with the
two flexible tubes hanging to opposite sides of the peg. This
allows the flexible tubes to hang in a straight configuration. Due
to the delicate nature of the fiber-optics in such tubes it is not
recommended to coil them for storage.
[0004] A typical endoscope configuration comprises a small rigid
control section connected to two flexible tubes. One tube comprises
an insertion tube that contains a fiber-optic bundle and is usually
covered with a sheath of polyurethane or other biocompatible
material and contains a bending section that allows articulation or
angulation of the insertion tube within human cavities. Connected
to the control head, and hanging on the other side, is a universal
cord that also contains a fiber-optic bundle and an air-water
channel.
[0005] In a sterilization procedure, instruments are typically
placed into a sterile barrier having a semi-permeable membrane. One
popular form thereof comprises a pouch having at least one layer of
a semi-permeable polymer such as TYVEK (registered trademark of E.
I. dupont de Nemours Co., Inc.) brand polyethylene nonwoven fabric
and a secon layer which may comprise a layer of clear impermeable
polymer or another layer of the same or a different semi-permeable
polymer. The two layers are sealed together at their edges to
enclose an instrument. Such pouches are typically rectangular in
shape. Such a system allows sterilizing gases, such as hydrogen
peroxide vapor, ethylene oxide or steam, to pass through the
semi-permeable barrier to effect sterilization of the instrument
therein but prevent microorganisms from entering the pouch after
the sterilization process is complete thus allowing storage of the
instrument in the packaging enclosure in a sterile manner. Those of
skill in the art will recognize that many alternative package
designs accomplish a similar function. For instance, such packages
may comprise a layer of foam or other material which is rigid or
semi-rigid and which may or may not be semi-permeable. The package
may merely contain a small window or several small windows of
semi-permeable material to allow sterilizing gases to enter.
[0006] Endoscopes such as sigmoidoscopes or colonoscopes have
previously been only disinfected and the peg storage system was
acceptable in such condition. Many users now demand that such
instruments be sterilized, not merely subjected to a high level
disinfection. The preferred barrier packaging enclosure for
sterilization is a pouch, such as the aforementioned pouch, with
heat or adhesive sealed boundaries that provides a sterile barrier
with mechanical integrity, thereby preserving the sterility of the
endoscope during storage of the endoscope after the sterilization
procedure. However, such known pouches place the two flexible tubes
of the endoscope together in a coiled pattern, and provide no
method for storing a sterilized endoscope in an uncoiled or bent
configuration. Some operators have even removed sterile endoscopes
from rectangular pouches or other barrier systems to hang them on
their old peg systems, thus compromising sterility.
SUMMARY OF THE INVENTION
[0007] The present invention overcomes these limitations to provide
a sterile package which allow an endoscope to be sterilized therein
and subsequently be stored in an uncoiled configuration by hanging
over a peg while still in the package.
[0008] A packaging enclosure according to the present invention
packages a flexible endoscope having first and second flexible
tubes. The packaging enclosure comprises a wall forming an interior
space impervious to microorganisms for receiving the endoscope. At
least a portion of the wall is semi-permeable. A hanging means is
provided for hanging the packaging enclosure, with the endoscope
therein, over a hook.
[0009] Preferably, the packaging enclosure comprises a pouch having
first and second films adhered to each other to form the interior
space. The hanging means can comprise an aperture in the packaging
enclosure. Alternatively, the hanging means can comprise the first
flexible tube being receivable within one portion of the packaging
enclosure and the second flexible tube being receivable within a
second portion of the packaging enclosure and the packaging
enclosure with the endoscope therein being drapable over the
hook.
[0010] In one embodiment, the packaging enclosure comprises a
thermoformed tray covered with a permeable lidstock.
[0011] Preferably, one side of the pouch or the entire lidstock of
the tray is formed of a semi-permeable material pervious to
sterilizing gases yet impervious to microorganisms. However, such
pouch side or lidstock may merely have one or more semi-permeable
ports.
[0012] A method according to the invention for sterilizing and
storing an endoscope having first and second flexible tubes is also
provided. The method comprises the steps of:
[0013] placing the endoscope within a packaging enclosure
comprising a wall forming an interior space for receiving the
endoscope, at least a portion of the wall being semi-permeable;
[0014] passing a sterilizing gas into the packaging enclosure;
and
[0015] hanging The packaging enclosure with the sterile endoscope
therein over a hook.
BRIEF DESCRIPTION OF THE DRAWINGS
[0016] FIG. 1 shows a perspective view of a first embodiment of a
packaging enclosure according to the invention;
[0017] FIG. 2 is a section view taken along lines 2-2 of FIG.
1;
[0018] FIG. 3 is a perspective view of a second embodiment of a
packaging enclosure according to the invention;
[0019] FIG. 4 is a section view taken along lines 4-4 of FIG.
3;
[0020] FIG. 5 is a perspective view of a third embodiment of a
packaging enclosure according to the invention;
[0021] FIG. 6 is a perspective view of a fourth embodiment of a
packaging enclosure according to the invention;
[0022] FIG. 7 is a perspective view of a roll of packaging
enclosures, each of which comprise a fifth embodiment of the
invention;
[0023] FIG. 8 is a front view of one of the packaging enclosures of
FIG. 7;
[0024] FIG. 9 is a top plan view of a sixth embodiment of a
packaging enclosure according to the invention;
[0025] FIG. 10 is a side view of the embodiment of FIG. 9;
[0026] FIG. 11 is a perspective view showing the film of a seventh
embodiment of a packaging enclosure according to the invention;
and
[0027] FIG. 12 is a perspective view of the embodiment of FIG. 11
with the film removed to show the interior construction.
DETAILED DESCRIPTION
[0028] FIGS. 1 and 2 illustrate an elongated pouch 10 having a
front film 12 of a clear impermeable polymer and a rear film 14 of
a semi-permeable material such as TYVEK brand nonwoven polyethylene
fabric or a medical grade paper. An adhesive seal 16 about the
outer edges 18 and 20 of the front film and rear film respectively
forms a sealed interior space 22. The interior space 22 contains an
endoscope 24 having a first flexible tube 26 and second flexible
tube 28 attached to a body 30. A portion of the edges 18 and 20 is
expanded and contains an aperture 32 therethrough whereby the pouch
10 can be hung on a hook 34. The elongated pouch 10, would also
allow the pouch 10 to merely be draped over the hook 34 as is
conventional for endoscopes not in pouches.
[0029] FIG. 3 illustrates a further embodiment in which a pouch 40
in which a front film 42 and rear film 44 are not elongated.
However, a support member 46, preferably a rigid polymer, is formed
into the pouch 40 and allows the endoscope 24 to hang thereover
within the pouch 40. The pouch has an aperture 48 for hanging and
the support member 46 has a reinforcing loop 50 which extends
around the aperture 48 so as to provide additional strength.
[0030] FIG. 5 shows an elongated pouch 60 which allows the first
and second endoscope flexible tubes 26 and 28 to be separate to
allow draping of the pouch 60 with the endoscope therein over a peg
or hook (not shown in FIG. 5). Additionally, a separate hanger 62
with a support bar 64 with an upstanding central hook 66 and two
depending clips 68 is provided for hanging the pouch 60 with the
endoscope therein.
[0031] In a preferred embodiment shown in FIG. 6, a pouch 70
conforms closely to the shape of the endoscope 24, having a first
portion 72 extending over and conforming to the first flexible tube
26 and a second portion 74 extending over and conforming to the
second flexible tube. It is shown without the flat seals such as
the seal 16 shown in FIG. 1, but such could be substituted.
Preferably in the prior embodiments at least a portion of the seal
16 would completed by the user after inserting the endoscope 24.
Such portion could be protected with a release liner over the
adhesive prior to use. This embodiment illustrates such principle
by having a flap 76 covering an opening 78 between the first and
second portions 72 and 74 through which the endoscope 24 is
inserted. After the endoscope 24 is inserted, the flap 76 is folded
over the opening 78 and adhesive 80 thereon seals the endoscope 24
within the pouch.
[0032] FIGS. 7 and 8 show how pouches 90 according to the present
invention may be provided on a convenient roll 92. Any of the prior
embodiments could be so provided. The pouch 90 has a wider upper
portion 94 for receiving the endoscope body 30 and a narrower lower
portion 96 for receiving the flexible tubes 26 and 28. A hanger 100
such as the hanger 62 is provided.
[0033] Other packaging designs may accomplish the same objectives.
For instance, although pouches are convenient, one may desire to
package the endoscope 24 within a more rigid container, yet
nevertheless allow it to be draped over the hook 34. Preferably
such a rigid structure would be polymer based, such as a
thermoformed or cold formed plastic material as is generally used
for sterile packaging of medical devices. FIGS. 9, 10 and 11 show a
package 110 comprising a thermoformed base 112 having an upper
surface 114 and a recess 116. The recess 116 is shaped to
accommodate the endoscope 24 having a first portion 118 for
receiving the first flexible tube 26 and a second portion 119 for
receiving the second flexible tube 28. A hook receiving aperture
120 is provided for hanging the package with the endoscope 24
therein. A semi-permeable film 122 seals to the upper surface 114
of the base 112 to seal the endoscope 24 in the package to allow
ingress of sterilizing gases yet impede ingress of contaminating
microorganisms.
[0034] FIGS. 11 and 12 show an alternative embodiment of a package
126 wherein rather than provide a shaped recess the package 126 has
internal peg-like supports 128 formed therein and over which the
endoscope 24 may be draped. Further a film 130 comprises a
non-permeable substance with a window 132 of semi-permeable
material to allow ingress of sterilizing gases. However, the film
122 could be formed entirely of a semi-permeable material.
[0035] Rather than sealing the endoscope 24 within a pouch prior to
sterilization, the seal can be effected during the sterilization
process, such as by drawing a vacuum in the sterilization
environment which draws the adhesive opening closed. The effect
could be enhanced by providing an inflatable ring around the
opening which inflates under the vacuum to draw the adhesive edges
closed.
[0036] It should be noted that the present invention is not limited
to only those embodiments described in the Detailed Description.
Any embodiment which retains the spirit of the present invention
should be considered to be within its scope. However, the invention
is only limited by the scope of the following claims.
* * * * *