U.S. patent application number 10/029532 was filed with the patent office on 2003-07-24 for attachable container sterilization system.
Invention is credited to Lin, Szu-Min.
Application Number | 20030138347 10/029532 |
Document ID | / |
Family ID | 24984324 |
Filed Date | 2003-07-24 |
United States Patent
Application |
20030138347 |
Kind Code |
A1 |
Lin, Szu-Min |
July 24, 2003 |
Attachable container sterilization system
Abstract
A sterilization system employs an attachable/detachable
container to which is connected a source of sterilant for
sterilizing items within the container. When disconnected from the
source of sterilant the container is sealed from microbial
ingress.
Inventors: |
Lin, Szu-Min; (Laguna Hills,
CA) |
Correspondence
Address: |
AUDLEY A. CIAMPORCERO JR.
JOHNSON & JOHNSON
ONE JOHNSON & JOHNSON PLAZA
NEW BRUNSWICK
NJ
08933-7003
US
|
Family ID: |
24984324 |
Appl. No.: |
10/029532 |
Filed: |
December 21, 2001 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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10029532 |
Dec 21, 2001 |
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09742315 |
Dec 21, 2000 |
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Current U.S.
Class: |
422/28 ; 422/1;
422/124; 422/261; 422/292; 422/297; 422/30; 422/300; 422/305;
422/32; 422/33; 422/34; 422/40 |
Current CPC
Class: |
Y10T 436/196666
20150115; A61L 2/24 20130101; A61L 2/26 20130101; A61L 2202/122
20130101; A61L 2/28 20130101; A61L 2202/14 20130101; A61L 2/208
20130101 |
Class at
Publication: |
422/28 ; 422/1;
422/30; 422/32; 422/33; 422/34; 422/40; 422/124; 422/261; 422/292;
422/297; 422/300; 422/305 |
International
Class: |
A61L 009/00; B01J
019/00; A62B 007/08; B01D 011/02; A61L 002/00 |
Claims
What is claimed is:
1. A sterilization system comprising: a sealed sterilization
container for containing items to be sterilized, the container
having an inlet port and an outlet port; a source of sterilizing
fluid connectable to the inlet port and to the outlet port; and
wherein the inlet port and the outlet port comprise a passive
microorganism impermeable closure wherein the container is sealed
from microorganism ingress while disconnected from the source to
maintain sterility of the items therein.
2. A sterilization system according to claim 1 wherein the passive
closure mechanism comprises a covering of a vapor permeable,
microorganism impermeable material.
3. A sterilization system according to claim 1 wherein the passive
closure mechanism comprises a valve biased into a closed
position.
4. A sterilization system according to claim 1 wherein the
sterilizing fluid is a chemical vapor.
5. A sterilization system according to claim 4 wherein the
sterilizing fluid is hydrogen peroxide vapor.
6. A sterilization system according to claim 1 and further
comprising a pressure differential between the inlet and outlet
ports to create a flow of the sterilizing fluid through the
container.
7. A sterilization system according to claim 6 and further
comprising a fan for inducing a pressure differential between the
inlet and outlet ports.
8. A sterilization system according to claim 1 and further
comprising one or more baffles to lengthen a flow path between the
inlet port and the exit port.
9. A method of sterilizing items comprising the steps of: placing
the items into a sealed sterilization container; connecting a
source of sterilizing fluid to the container; flowing sterilizing
fluid into the container to sterilize the items; disconnecting the
container from the source of sterilizing fluid; and sealing the
container from microorganism ingress whereby to maintain sterility
of the items therein.
10. A method according to claim 9 wherein the step of sealing the
container comprises having a port thereon, which is connectable to
the source of sterilizing fluid, sealed with a microorganism
impermeable, vapor permeable material.
11. A method according to claim 10 wherein the step of sealing the
container comprises automatically closing a valve prior to
disconnecting the container from the source of sterilizing fluid,
the valve closing a port on the container which is connectable to
the source of sterilizing fluid.
12. A method according to claim 9 wherein the sterilizing fluid is
a chemical vapor.
13. A method according to claim 12 wherein the sterilizing fluid is
hydrogen peroxide vapor.
14. A method according to claim 9 wherein the container has a
second port and comprising the step of flowing the sterilizing
fluid from the port to the second port through the container.
15. A method according to claim 14 and comprising the step of
creating a continuous flow from the source of sterilizing fluid
into the container through the port, out of the container through
the second port and back to the source.
16. A method according to claim 15 and further comprising the step
of inducing the flow with a fan within the source.
Description
PRIORITIES CLAIMED
[0001] This application is a continuation-in-part of U.S. patent
application Ser. No. 09/742,315 filed Dec. 21, 2000.
BACKGROUND OF THE INVENTION
[0002] 1. Field of the Invention
[0003] The present invention generally relates to sterilization
processes, and more particularly, to attachable/detachable
sterilization container systems.
[0004] 2. Description of the Related Art
[0005] A sterilization process generally involves in exposing the
articles to be sterilized to a sterilizing medium that can kill
bacterial microorganisms. Such processes are typically performed in
sterilization chambers. The articles to be sterilized are often
delivered to the sterilization chambers within a sterilization
container in which the articles are both sterilized and
subsequently stored in their sterilized state. In some instances,
articles are merely disinfected, but are often nevertheless
delivered within a container.
[0006] The containers are generally permeable to a sterilizing
medium so that the sterilizing medium may enter the container
during the sterilization process. A sterilizing medium may be a
sterilant gas or vapor (e.g., hydrogen peroxide vapor) released by
a sterilant source which is placed into or delivered into the
sterilization container. As used hereinafter, the terms "gas" and
"vapor" are used interchangeably. Such gas permeable containers
may, for example, include pouches made of gas permeable materials
or rigid trays wrapped with gas permeable wraps. In fact, a
sterilization container may be configured as a sealable rigid
container having ports to deliver a sterilant after the container
has been sealed. In all above examples, however, the sterilization
containers prevent the entry of the microorganisms into the
container and thereby maintain the sterilized state of the articles
therein.
[0007] Typically, such containers are placed within a sterilization
chamber and the sterilization process occurs within the chamber.
However, construction of a sterilization chamber can be expensive.
Further, transport of the sterilizing gas into and out of the
container can be a challenge when simply placed within a chamber.
For some uses, as for instance within a doctor or dentist's office,
a simple, inexpensive yet highly effective sterilization system is
desired. While a traditional chamber based chemical vapor
sterilization system may effectively sterilize these user's
instruments, its cost may be prohibitive. At present, many such
users use liquid chemical disinfection, rather than chemical vapor
sterilization, for their instruments, particularly those which can
not tolerate the high heat of an autoclave.
SUMMARY OF THE INVENTION
[0008] A sterilization system according to the present invention
comprises a sealed sterilization container for containing items to
be sterilized, the container having an inlet port and an outlet
port. A source of sterilizing fluid is connectable to the inlet
port and to the outlet port. The inlet port and the outlet port
comprise a passive microorganism impermeable closure wherein the
container is sealed from microorganism ingress while disconnected
from the source to maintain sterility of the items therein.
[0009] The passive closure mechanism can comprise a covering of a
vapor permeable, microorganism impermeable material. Alternatively,
the passive closure mechanism can comprise a valve biased into a
closed position.
[0010] The sterilizing fluid is preferably a chemical vapor, and
more preferably hydrogen peroxide vapor.
[0011] Preferably, a pressure differential between the inlet and
outlet ports creates a flow of the sterilizing fluid through the
container. Such differential can be provided in many ways, such as
for example a fan.
[0012] One or more baffles can be provided in the container to
lengthen a flow path between the inlet port and the exit port.
[0013] A method of sterilizing items according to the present
invention comprises the steps of: placing the items into a sealed
sterilization container; connecting a source of sterilizing fluid
to the container; flowing sterilizing fluid into the container to
sterilize the items; disconnecting the container from the source of
sterilizing fluid; and sealing the container from microorganism
ingress whereby to maintain sterility of the items therein.
[0014] The step of sealing the container can comprise automatically
closing a valve prior to disconnecting the container from the
source of sterilizing fluid, the valve closing a port on the
container which is connectable to the source of sterilizing fluid.
Preferably, a continuous flow is induced from the source of
sterilizing fluid into the container through the port, out of the
container through a second port and back to the source, such as
with a fan.
BRIEF DESCRIPTION OF THE DRAWINGS
[0015] FIG. 1A is a schematic view of a system comprising a
sterilization container with an attachable process monitoring
device;
[0016] FIG. 1B is a schematic detail view of the attachable process
monitoring device;
[0017] FIG. 1C is a schematic view of a modified form of the first
embodiment of the system in which a process monitoring device is
provided within an openable housing;
[0018] FIG. 2 is a schematic view of a second embodiment of the
system wherein the sterilization container comprises a heating
source;
[0019] FIG. 3 is a schematic view of a third embodiment of the
system wherein the sterilization container is placed into an
oven;
[0020] FIG. 4 is a schematic view of a fourth embodiment of the
system wherein the sterilization container is placed into a vacuum
chamber;
[0021] FIG. 5 is a schematic view of a fifth embodiment of the
system wherein the sterilization container is placed into a vacuum
oven;
[0022] FIG. 6A is a schematic view of a sixth embodiment of the
system wherein the sterilization container comprises a separate
sterilant enclosure;
[0023] FIG. 6B is a schematic view of the system shown in FIG. 6A
wherein the sterilization container with the separate sterilant
enclosure is placed into a vacuum oven;
[0024] FIG. 7 is a schematic view of a seventh embodiment of the
system wherein the sterilization container is placed into another
container having an attached sterilant enclosure;
[0025] FIG. 8 is a schematic view of an eighth embodiment of the
system wherein the separate sterilant enclosure and the process
monitor device are placed over the opposite sides of the
sterilization container;
[0026] FIG. 9A is a schematic view of an alternative embodiment of
the system comprising a flexible container with an attachable
process monitor device and an attachable sterilant source
cartridge;
[0027] FIG. 9B is a schematic view of the attachable sterilant
source cartridge;
[0028] FIG. 9C is a schematic view of the attachable process
monitor device;
[0029] FIG. 9D is a schematic view of another alternative
embodiment of the system with one window and sterilant inside a
pouch behind a gas permeable membrane; and
[0030] FIG. 10 is a schematic view of a further embodiment of the
system;
[0031] FIG. 11 is a schematic view of an enclosure having hinged
lid with two areas separated with a partition;
[0032] FIG. 12 is a schematic view of an enclosure having removable
lid with two areas separated by a partition;
[0033] FIG. 13 is a schematic view of an enclosure having a
directional flow of antimicrobial agent through the article to be
processed and the indicator;
[0034] FIG. 14 is a schematic view of an enclosure having a fan to
circulate the antimicrobial agent within the enclosure;
[0035] FIG. 15 is a schematic view of an enclosure having
additional partition and interface for placing the lumen
device;
[0036] FIG. 15A is a schematic view of an attachable/detachable
container sterilization system;
[0037] FIG. 15B is a schematic view of an alternative
attachable/detachable container sterilization system;
[0038] FIG. 16 is a schematic view of an enclosure having
attachable/detachable compartment;
[0039] FIG. 17 is a schematic view of an enclosure having
additional partition within the enclosure to separate the articles
to be sterilized or disinfected;
[0040] FIGS. 18A, 18B, and 18C are schematic views of
attachable/detachable compartments for all components;
[0041] FIG. 19 is a schematic view of a pouch having a gas or vapor
permeable window and a partition to separate the indicator and the
article to be processed;
[0042] FIG. 20 is a schematic view of a pouch with a partition
having multiple openings between the area for the indicator and the
area for the article to be processed;
[0043] FIG. 21 is a schematic view of a pouch with a communication
path formed with two partially overlapped partitions;
[0044] FIG. 22 is a schematic view of a section of a role of pouch
having gas or vapor permeable windows and indicators separated with
a partition; and
[0045] FIG. 23 is a schematic view of another alternative
embodiment of the pouch.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT
[0046] As an improvement to conventional monitoring systems for
sterilization processes, the process of the preferred embodiments
are preferably capable of indicating the efficacy of the
sterilization process in an enclosed sterilization container while
still maintaining the sealed state of the sterilization container.
Reference will now be made to the drawings wherein like numerals
refer to like parts throughout.
[0047] As illustrated in FIG. 1, sterilization system of the
preferred embodiment comprises a first container 100. In the
preferred embodiment, the first container 100 is preferably a rigid
enclosed container comprising a top portion 101, a bottom portion
102 and a peripheral wall 104 which is preferably perpendicularly
attached to the periphery of the bottom portion 102.
[0048] Preferred materials for manufacturing the solid container
100 may be metals or polymers such as aluminum, stainless steel or
plastics. The bottom portion 102 and the peripheral wall 104 define
a container housing 106. The container housing 106 may be
preferably configured and dimensioned to receive at least one
optional second container 108. The second container 108 may be
configured as a tray having a perforated bottom 109 and a
peripheral wall 110. The perforated bottom 109 and the peripheral
wall 110 of the tray 108 define a second housing 112 to accommodate
articles (not shown) to be sterilized. Inside the container housing
106, the tray 108 may be removably placed on an optional rack 114
which may be made of a perforated plate. Preferably, the rack 114
is removably attached to the inside of peripheral wall 104 so as to
stay elevated from the bottom portion 102 of the container and so
as to define a sterilant housing 116. A sterilant source 118 may be
further placed into the sterilant housing 116 to produce a
sterilizing medium such as a vapor sterilant. An exemplary
sterilant source may be liquid hydrogen peroxide, solid hydrogen
peroxide complex and peracetic acid. A variety of solid peroxide
complexes are described in allowed U.S. patent application Ser. No.
08/549,425, filed Oct. 27, 1995, the complete disclosure of which
is hereby incorporated by this reference thereto. The top portion
101 of the container 100 comprises a removable container lid which
seals the container housing 106 when closed.
[0049] As illustrated in FIGS. 1A-1B, in the preferred embodiment,
a cartridge 120 comprising at least one process monitor device may
be removably positioned onto the lid 101 of the container 100. In
accordance with the principles of the present invention, these
process monitor devices may comprise at least one biological
indicator 122 and/or at least one chemical indicator 124. Either or
both of these indicators can be provided with a unique identifier,
such as a serial number, which pairs the indicator with the
container. Thus, the container can be provided with the same
identifier in order to pair it with the indicator.
[0050] As previously noted in the background section, the
biological indicator 122 is kept in a gas permeable pack which
permit the passage of the sterilizing gas but not the passage of
microorganisms. In the preferred embodiment, such packs may, for
example, be made of spun-bond polyethylene (e.g. Tyvek.TM.) or
non-woven polypropylene wrap (e.g. CSR-wrap) materials. The
cartridge 120 containing the biological and the chemical indicators
122 and 124 may be placed into a cartridge holder 126. The bottom
layer of the cartridge 120 can optionally comprise a gas permeable
material. The cartridge holder 126 may be configured to have a
recessed cavity having a bottom 128 portion and downwardly
extending into the container housing 106. The cartridge holder 126
may be dimensioned to receive at least one cartridge 120. In the
preferred embodiment, the bottom portion 128 of the cartridge
holder 126 is made of above-mentioned gas permeable and
microorganism impermeable materials (e.g., Tyvek.TM. or CSR-wrap)
so that the sterilant vapor from the housing 106 can pass through
the gas permeable material and reach indicators 122 and 124. The
gas or vapor permeable and microorganism impermeable material can
be heat sealed on the bottom portion 128. The cartridge 120 may be
secured in cartridge holder 126 by employing a number of fastening
mechanisms such as snap-on type connectors or the like. However,
with possible modifications in the cartridge 120 and the cartridge
holder 126, the cartridge 120 may be secured to the holder 126 by a
twist or a screw type of connector as well.
[0051] In the process of the preferred embodiment, the vapor
sterilant such as hydrogen peroxide vapor diffuses through the rack
114 and the perforated bottom 109 of the tray 108 (in the direction
of the arrows) and thereby contacting the articles and filling the
container housing 106. While the sterilization process progresses,
the sterilant vapor also diffuses through the gas permeable
membrane 128 and subsequently into the cartridge 120 having the
biological and/or chemical indicators 122 and 124. The sterilant
vapor entering the cartridge 120 exposes indicators to the same
sterilizing environment encountered by the articles in the tray
108. At this point, it is highly desirable that, on the container
100, the gas permeable membrane 128 of the holder 126 be
accommodated at a farthest possible location from the sterilant
source 118. As a result of this, the articles in the container 100
are treated with the sterilant vapor before the sterilant vapor
diffuses through the gas permeable membrane 128. Since the
indicators 122 and 124 are the last place for sterilant vapor to
reach, they provide an accurate method of monitoring the
sterilization status of the articles inside the container 100.
[0052] The sensitivity of the biological indicator and chemical
indicator can be adjusted by adding features well known to those
having ordinary skill in the art. A variety of such features are
known which slow down the diffusion of sterilant. One example would
be the STERRAD.RTM. Biological Indicator (BI) Test Pack, available
from Advanced Sterilization Products (Irvine, Calif.).
[0053] In the present embodiment, upon completion of the
sterilization cycle the cartridge 120 may be removed from the
cartridge holder 126 to determine chemical and biological efficacy
of the sterilization process. As opposed to prior art, however, the
biological and/or chemical indicators can be removed from the
container 100 without disturbing the sterilized state of the
articles inside the sterilization container 100. Since the gas
permeable layer 128 only allows the passage of the sterilant vapor,
removal of the cartridge 120 from the holder 126 will not break the
microorganism-impermeable seal of the container 100.
[0054] Referring now to FIG. 1C, there is shown a modified form of
the embodiment shown in FIG. 1A. In this embodiment, the biological
indicator 122 and/or chemical indicator 124 are placed into a
housing 126 with an openable or removable door 121. This modified
form of this first embodiment can otherwise be constructed and used
in accordance with the description provided above.
[0055] In addition, it is particularly advantageous to use the
biological and chemical indicators 122 and 124 in separate
cartridges. In such case, the chemical indicator may be furnished
with a translucent or clear window which can display a written
message, such as "PROCESSED" or a symbol when the sterilization
cycle is completed. Therefore, when the biological indicator is
removed for detection, the chemical indicator may remain on the
container and display the message to avoid any confusion during the
storage. Alternatively, if the sterilization process uses more than
one sterilant source, the number of chemical indicators can be
increased accordingly. For example, if two chemicals are used as
sterilant sources, the cartridge holder can be configured to have
two chemical cartridges indicators and one or more biological
indicator cartridges.
[0056] As will be explained more fully in the following
embodiments, the release of the sterilant gas can be enhanced using
heat or vacuum. FIGS. 2-9C illustrate alternative embodiments of
the present invention. FIG. 2 illustrates a second embodiment of
the sterilization system comprising the sterilization container 100
and a heat source 130. In accordance with the principles of the
present invention, the heat source 130 may be configured as a part
of the container 100 or positioned adjacent to the container 100
without being a part of the container 100. In this embodiment, the
heat source 130 may be a heat element comprising a resistant wire
which is attached to the bottom portion 102 of the sterilization
container 100. Heat from the heat element 130 enhances the
vaporization of the sterilant source 118 in the sterilant housing
116 and thereby enhancing the sterilization of the articles in the
container 100.
[0057] FIG. 3 illustrates a third embodiment of the sterilization
system comprising the sterilization container 100 placed into a
third container 132. The third container 132 may be an oven having
a heat source 134. In accordance with the principles of the present
invention, the heat source 134 of the oven 132 may comprise
infrared (IR) heating, radio frequency (RF) heating, microwave
heating or resistant heating by heating elements. In the preferred
embodiment, heating is provided by the heating elements 134.
[0058] FIG. 4 illustrates a fourth embodiment of the sterilization
system comprising the sterilization container 100 placed into a
vacuum chamber 136 which is connected to a vacuum source (not
shown) through a vacuum valve 138. The vacuum may also be used to
enhance the vaporization of the sterilant source 118. Once the
sterilization process is completed, the vacuum may also be used to
remove the sterilant residues left on the articles.
[0059] FIG. 5 illustrates a fifth embodiment of the sterilization
system comprising the sterilization container 100 placed into a
vacuum oven 140. The vacuum oven is connected to a vacuum source
(not shown) through a vacuum valve 144. The vacuum oven also
comprises a heat source 142. In this embodiment, the combined
effect of the vacuum and the heat enhances the vaporization of the
sterilant source 118.
[0060] FIG. 6A illustrates a sixth embodiment of the sterilization
system comprising the sterilization container 100. In this
embodiment, the sterilization container 100 is modified to include
an attachable sterilant enclosure 150 with the sterilant 118.
Therefore, in this embodiment, the rack 114 and the sterilant
housing 116 (See FIGS. 1A-5) shown in the previous embodiments are
excluded. Accordingly, the sterilization container 100 is connected
to the sterilant enclosure 150 by a connector 151. In this
embodiment, a first end 154 of the connector 151 is connected to an
opening 152 on the peripheral wall 104, while a second end 155 of
the connector 151 is connected to the sterilant enclosure 150
through an optional valve 156 on the enclosure 150. A gas permeable
membrane 158 further covers the opening 152 so that when the
sterilant enclosure 150 is detached from the container 100, the
sterility of the load in the container housing 106 is maintained.
In the process of the present embodiment, the sterilant vapor from
the sterilant source 118 passes through the valve 156 and gas
permeable membrane 158 and enters the container 100 for sterilizing
articles. For better diffusion, the inner tray 108 can have
perforated walls. Similar to the previous embodiments, the
biological and chemical indicators 122 and 124 can be attached to
or detached from the container 100 without disturbing the sterility
of the articles in the container 100.
[0061] Within the scope of this invention, it will be appreciated
that the present embodiment may also comprise all the features and
options of the previous embodiments. For example, as in the second
embodiment, the sterilant enclosure 150, as attached to the
container 100, may be heated by a heat source to enhance the
vaporization of the sterilant source 118 (See FIG. 2). Similar to
the third, the fourth and the fifth embodiments, the container can
be placed into a third container which may be an oven 132, vacuum
chamber 136 or a vacuum oven 140 (See FIGS. 3-5). In all above
embodiments, after the sterilization the sterilant enclosure 150
may be detached from the container 100 for storage purposes.
Similarly, by suitable modifications in the oven 132, the vacuum
chamber 136 and the vacuum oven 140, the sterilant enclosure may be
integrated with the containers 132, 136 and 140. As illustrated in
FIG. 6B, for example, when the container 100 is placed into the
third container, such as a vacuum oven 140, the sterilant enclosure
150 is connected to the container 100 through conductor 151 as in
the manner shown in FIG. 6B. The enclosure 150 can be heated to a
different temperature than the vacuum oven 140.
[0062] FIG. 7 shows a seventh embodiment of the sterilization
system comprising the sterilization container 100 placed into a
third container 160 and the enclosure 150 is attached to the
container 160, such as by being an integrated part thereof.
However, as opposed to previous embodiment, in this embodiment
there is no direct connection between the sterilant enclosure 150
and the sterilant container 100. A number of gas permeable membrane
covered inlets 164 are positioned on the peripheral wall 104 of the
container 100. Further, top of the cartridge holder 126 may be
sealed with a removable gas impermeable material 166 so as to
expose indicators 122 and 124 only to the sterilant vapor diffusing
through the gas permeable membrane 128. An exemplary gas
impermeable material can be Mylar, metal foil, glass or adhesive
tape. In the process of this embodiment, the sterilant gas first
diffuses into the container 160 through inlet 162 and fills the
container 160. The inlet 162 can be configured as a valve. As the
process progresses, the sterilant gas diffuses from the enclosure
150 through the inlet 162 and into the container 160. From the
container 160, the gas diffuses through the permeable membrane 164
into the container 100, through the permeable membrane 128 and into
the cartridge 120, so as to contact the indicators 122 and 124. At
the end of the process cycle, the gas impermeable material can be
removed and the cartridge can be taken out for inspecting
indicators 122 and 124.
[0063] As illustrated in FIG. 8, in an eighth embodiment, the
sterilization system comprises the sterilization container 100 and
the sterilant enclosure 150 as described in the sixth embodiment.
In an effort to enhance the accuracy of the information provided
from the indicators 122 and 124, in this embodiment, the cartridge
holder 126 is positioned at a remotest location from the sterilant
enclosure 150 containing sterilant source 118. Referring to FIG. 8,
this location is on the peripheral wall 104 and at the opposite
side of the container 100. A fan 160 can optionally be provided to
circulate sterilant throughout the container 100. As previously
explained, since the indicators 122 and 124 are the last place for
sterilant vapor to reach, they provide an accurate method of
monitoring the sterilization status of the articles inside the
container 100.
[0064] As illustrated in FIG. 9A, in a first alternative
embodiment, the sterilization system comprises an alternative
container 200. In this embodiment, the alternative container 200 is
preferably a flexible enclosed container, such as a pouch, which is
comprised of a gas impermeable sheet material 202 defining a
housing 204 to have articles to be sterilized (not shown). An
exemplary gas impermeable sheet material may be preferably
Mylar.TM. (polyester), metal foil, polymer film materials such as
polypropylene or polyethylene films. The gas impermeable sheet can
also be multilayer of film with or without lamination or coating.
The flexible container 200 of this invention further comprise a
first window 206, second window 208 and an opening 210. The first
and second windows 206 and 208 are comprised of gas permeable
materials, and preferably positioned at the opposite ends of the
pouch 200. Articles to be sterilized are placed into the container
200 through the opening 210. This opening 210 may be a resealable
opening for multiple use of the container 200 or may be a
non-resealable opening for a single use.
[0065] A sterilant source cartridge 212 may be sealably placed onto
the first gas permeable window 206 and secured using various
fastening mechanisms such as double-sided tape, snap-on connectors
or the like. As shown in FIG. 9B, the sterilant source cartridge
212 comprises a gas permeable bottom 216, a gas impermeable top 214
and peripheral side walls 213 defining a sterilant housing 215. For
shipping and safe handling purposes, another gas impermeable layer
217 may be removably placed on the layer 216. However, before
placing the cartridge onto the window 206, this impermeable layer
217 should be removed. In this embodiment, the gas permeable bottom
216 of the cartridge 212 is preferably sized and shaped to fit over
the window 206. Referring to FIG. 9A, when the cartridge 212 is
placed onto the gas permeable window 206, the bottom gas permeable
layer 216 faces towards the window 206 on the flexible container
200. Therefore, when a sterilant source in the cartridge 212
releases a sterilant vapor, the vapor diffuses via the bottom layer
216 and the window 206 into the container 200 having articles to be
sterilized.
[0066] As illustrated in FIG. 9C, a process monitoring cartridge
218 comprising the biological and chemical indicators 122 and 124
may be sealably placed onto the second gas permeable window 208, as
in the manner described for the sterilant cartridge 212. As shown
in FIG. 9C, the process monitoring cartridge 218 is comprised of a
gas permeable bottom 220, a gas permeable removable top 221 and a
body 222 comprising the biological and/or chemical indicators 122
and 124. In operation, the sterilant gas released from the
sterilant cartridge 212 diffuses into the container housing 204 (in
the direction of the arrows) and reaches at the monitoring
cartridge 218 through the gas permeable window 208. Similar to
previous embodiments, the flexible container 200 of the present
invention can be also used in the oven 132, the vacuum chamber 136
or a vacuum oven 140.
[0067] As illustrated in FIG. 9D, in a second alternative
embodiment, the sterilization system comprises a flexible enclosed
container 250. Similar to the pouch 200 of the previous embodiment,
the flexible container 250 also comprises a gas impermeable sheet
material 252 (such as those materials given above) defining a
container housing 254 and an opening 256 to place articles (not
shown) into the container 250. However, in this embodiment, the
container 250 comprises only one gas permeable window 258 on which
a process monitoring cartridge 259 is placed, and a sterilant
enclosure 260 attached to a gas permeable wall portion 262 of the
flexible container 250. In this embodiment, the sterilant enclosure
260 is preferably a flexible sterilant enclosure comprising a
sterilant housing 264 which is separated from the container housing
254 by the gas permeable wall portion 262. A sterilant source 266
may be placed into the housing 264 through an optional opening 268.
This optional opening 268 may be a resealable opening for multiple
use of the container 250 or may be a non-resealable opening for a
single use. Similar to the previous embodiment, in operation, the
sterilant gas released from the sterilant source 266 diffuses
through the gas permeable wall portion 262 into the container
housing 254, and reaches at the monitoring cartridge 259 (following
arrows in FIG. 9D) through the gas permeable window 258.
[0068] FIG. 10 illustrates a further embodiment of the invention. A
container 300, has an interior space 302, with an article 304 to be
sterilized therein. The container 300 may be a rigid container
formed of a material suitable for exposure to the sterilization
environment, such as a liquid crystal polymer, or may be flexible
such as a pouch. So as to protect the sterility or cleanliness of
the article 304 or articles, it must be impermeable to
microorganisms. The container 300 is shown with a lid 306, but any
means of placing the articles 304 into the container 300 and
closing them inside as is known in the container art either
presently, or during the life of this patent may be employed.
[0069] A source 308 of an antimicrobial agent 310 is provided. FIG.
10 shows the source 308 as a separate enclosure attached to the
container 300 but most typically the container 300 will be placed
into a sterilization chamber (not shown) which is filled with the
antimicrobial agent 310, such as a steam sterilizer, or hydrogen
peroxide/plasma sterilization chamber as is known in the art. The
source 308 is separated from the interior space 302 by a valve 312,
thereby allowing ingress of the antimicrobial agent while
preventing ingress of microorganisms when the sterilization is
completed. Alternatively and preferably, a semi-permeable barrier
may be employed.
[0070] An indicator 314 is in fluid communication with the interior
space 302 past a semi-permeable barrier 316 of a vapor permeable,
microorganism impermeable material. The indicator 314 is contained
within a housing 318 having a valve 320. The entire housing 318 may
be detachable from the container 300 or the indicator 314 may be
removable from the housing 318. Alternatively, the indicator 314
may connect directly to the container 300 through the barrier 316,
thus dispensing with the housing. Of course, a valve could
substitute for the barrier 316. Preferably, the indicator 314 is
exposed to the antimicrobial agent only through the interior space
302.
[0071] The container 300 may comprise the sterilization chamber for
purposes of sterilizing the articles 304. FIG. 10 shows the
container 300 having a pump 322 connected thereto through an
isolation valve 324. The pump 322 draws a vacuum on the interior
space 302 which can vaporize a liquid sterilant in fluid
communication with the interior space 302 by virtue of being
disposed therein or being connected thereto as shown with the
source 308. The container 300 may also be used for washing the
articles 304 and be provided with a valved fluid inlet 326. A drain
valve 328 is also shown. Valves 328 and 320 allow liquid to drain
from the container 300 and housing 318. Therefore, suitable fluids
for use in this invention include, but are not limited to: liquid,
mist, aerosol, gas or vapor. Additionally, the fluid can also
include the gas plasma.
[0072] FIG. 11 shows a container 340 having a partition 345 to
separate the container into two areas 350 and 355. Areas 350 and
355 are in fluid communication through an opening 360 on the
partition 345. Optionally, the opening 360 has a gas or vapor
permeable and microorganism impermeable barrier. Area 355 having a
lid 365 contains an article 370 to be sterilized or disinfected,
and area 350 having a lid 375 contains at least one indicator 380.
The indicator 380 can be a chemical indicator and/or a biological
indicator. Suitable biological indicators include a packaged
substrate containing microorganisms or a self-contained biological
indicator having growth medium to support the growth of the
microorganisms, or perhaps enzymes indicative of microorganisms.
Both lids 365 and 375 can be attached near the top of the partition
345. The mechanism to attach the lids 365 and 375 can be achieved
with many conventional means such as heat-seal or by hinging the
lid to the container. The lids can also be attached on other side
of the container. Preferably, at least a portion of the container,
perhaps including the lids is clear or translucent, such that the
user can view the article and/or the indicator in the container.
The container 340 further comprises at least one gas or vapor
permeable and microorganism impermeable window 385 or 390 into area
355. The container 340 does not have any window on the walls around
the area 350 except the window on the partition 360. The window 385
or 390 allows the antimicrobial agent to diffuse from outside of
the container 340 into the area 355 containing the article 370. The
antimicrobial agent then diffuses from the area 355 containing the
article 370 to the area 350 containing the indicator 380. The
antimicrobial agent has to diffuse from outside of the container
340 indirectly into the area 350 containing the indicator 380
through the area 355 containing the article 370. Therefore, the
antimicrobial agent diffuses into the container 340 through area
355 and contacts the article 370 before it diffuses into area 350
and contacts the indicator 380. With the gas or vapor permeable and
microorganisms impermeable barrier on the opening 360, the
indicator can be removed after the sterilization or disinfection
process by opening the lid 375 without the risk of contaminating
the article 370 in the area 355. If the partition does not have the
gas or vapor permeable and microorganisms impermeable barrier on
the opening 360, then the indicator 380 needs to be stored in the
container 340 with the article 370 until the user is ready to use
the article 370 in the container 340.
[0073] FIG. 12 shows a container 400 similar to the container 340
of FIG. 11 but with two removable lids 410 and 420. The area 430
has gas or vapor permeable and microorganism impermeable windows
440, 450, 460, 470, 480, 490 on all six sides of walls. Actually,
one gas or vapor permeable and microorganism impermeable window is
sufficient to diffuse the antimicrobial agent into the area 430.
Six windows can shorten the time required to diffuse the required
antimicrobial agent into the container 400.
[0074] FIG. 13 shows a container 500 with two partitions 505 and
510 which divide the container 500 into three compartments 515,
520, and 525. The compartment 515 is in fluid communication with
the compartment 520 through the port 530 on the partition 505, and
the compartment 525 is in fluid communication with the compartment
520 through the port 535 on the partition 510. Preferably, either
or both ports 530 and 535 have a gas or vapor permeable and
microorganism impermeable barrier. Compartment 515 contains the
antimicrobial source 540 which provides the antimicrobial agent,
compartment 520 has the devices 545 and 550 to be disinfected or
sterilized, and compartment 525 contains at least one indicator
555. The compartments 515, 520, and 525 can share a common lid or
have its own lid. The antimicrobial agent can be a gas or vapor
generated from a source of liquid or solid. The antimicrobial agent
can be steam, ethylene oxide, chlorine dioxide, hydrogen peroxide,
peracetic acid, performic acid, formaldehyde, glutaraldehyde, ozone
or other suitable vapor. Preferably, the antimicrobial agent
comprises hydrogen peroxide, and the antimicrobial source 540 is a
liquid comprising hydrogen peroxide or a solid which releases
hydrogen peroxide vapor. Preferably, the antimicrobial source 540
is packaged in a gas or vapor permeable and liquid impermeable
barrier which retains the antimicrobial source 540 and allows the
diffusion of the antimicrobial agent. The device 550 can be a
lumened device. The container further comprises a fan 560 and a
window 570 to enhance the flow of the antimicrobial agent from
compartment 515 through compartment 520 to compartment 525. The fan
560 can be operated by AC, DC or any other means. Preferably, the
fan 560 is a battery-operated and self-contained fan with a switch
to control the operation of the fan. The arrow 565 indicates the
direction which the fan blows. The fan 560 can be located at other
wall or in any of the compartments, as long as it can enhance the
flow of the antimicrobial agent from the source 540 through the
devices 545 and 550 to the indicator 555. More than one fan can be
used to facilitate the flow of the antimicrobial agent. Additional
fan(s) can also be used in the compartment 520 to help the uniform
distribution of the antimicrobial agent over the devices 545 and
550 in the compartment 520. The container 500 can be placed into a
heated and/or reduced-pressure environment to facilitate the
release of the antimicrobial agent from the antimicrobial source
540.
[0075] FIG. 14 shows a container 600 with partitions 605, 610, and
615 which separate the container into compartments 620, 625, 630,
and 635. Compartments 620, 625, 630, and 635 are in fluid
communication through the ports 640, 645, 650, and 655. Preferably,
the ports 640 645, 650, and 655 have gas or vapor permeable and
microorganism impermeable barrier. Compartments 620, 625, 630, and
635 contain an indicator 660, fan 665, antimicrobial source 670,
and devices 675 and 680 to be processed, respectively. The
compartments 620, 625, 630, and 635 can share a common lid or each
one can have its own lid. The fan 665 circulates the antimicrobial
agent from the antimicrobial source 670 through the devices 675 and
680, and then to the indicator 660. Unlike the container 500 of
FIG. 13, the antimicrobial agent in the container 600 can be
re-circulated and re-used. The container further comprises a heater
685 to help the circulation of the heated air in the container 600.
The heated air can enhance the efficacy and the release of the
antimicrobial agent from the antimicrobial source 670. More than
one fan can be used to facilitate the circulation of the
antimicrobial agent in the container 600, and to help the uniform
distribution of the antimicrobial agent over the devices 675 and
680 in the compartment 635.
[0076] FIG. 15 shows a container 700 which is similar to the
container 600 of FIG. 14 except a compartment 710 can be attached
and detached from the compartments 720, 730, and 740 to form a
separate container for storing sterilized instruments 745. Although
an airtight coupling has some desirability so as to more
efficiently contain the sterilant from release, the coupling of the
compartment 710 to the other compartments 720, 730 and 740 does not
need to be airtight. The parts can be snapped together, clipped
together, attached with VELCRO hook and loop closure or tape, or
any other conventional means. Optionally, the compartments 720,
730, and 740 can also be detached and attached to each other.
Preferably, each attachable/detachable compartment has its own lid.
In order to prevent the risk of contaminating the device 745 in the
compartment 710 after the sterilization or disinfection process,
communication ports 750 and 755 are covered with gas or vapor
permeable and microorganism impermeable barrier. The other ports
760, 765, 770, and 775 can be any openings with or without the gas
or vapor permeable and microorganism impermeable barrier.
[0077] FIG. 15A shows a sterilization system 1600 having an
attachable/detachable container 1602 for holding instruments 1604
to be sterilized. It comprises a series of baffles 1606 to form an
extended flow path 1608, beginning at an inlet port 1610 and ending
at an outlet port 1612. Each of the inlet and outlet ports 1610 and
1612 are covered by a vapor permeable, microorganism impermeable
barrier 1614, such as spun-bond polyethlene (e.g. Tyvek.TM.) or
other materials as may be known or become known which have a pore
size sufficiently small to prevent ingress of bacteria, viruses,
prions and other contaminating microorganisms yet large enough to
pass vapor phase sterilant gases. A sterilant source system 1616
comprises an enclosure housing a sterilant source 1618 and a
circulation assist, such as a fan 1620 and having an outlet port
1622 and inlet port 1624. The system inlet port 1624 mates with the
container outlet port 1612 and the system outlet port 1622 mates
with the container inlet port 1610 as in the previous embodiment.
The ports need not lie flush on the container 1602 or sterilant
source system 1616 as shown, but rather could be connected through
a conduit or tubing or the like. An indicator 1626 can be provided,
as well as dividers to create compartments 1628, 1630 and 1632 as
in the previous embodiment.
[0078] FIG. 15B illustrates an additional sterilization system 1700
comprising a container 1702 similar to the container 1602, with the
exception that an inlet port 1704 and outlet port 1706 each have
thereat a normally closed valve 1708 and 1710 respectively. The
valves 1708 and 1710 can be of any type which are normally closed,
as with a bias mechanism like a spring. The system 1700 further
comprises a sterilant source system 1712 similar to the sterilant
source system 1616. Preferably, normally closed valves 1714 and
1716 are provided on outlet port 1718 and inlet port 1720
respectively. When the container 1702 is attached to the sterilant
source system 1712, the valves 1708, 1710, 1714 and 1716 are open.
Preferably, the valves are adapted such that the action of
attaching the container 1702 opens the valves and the action of
detaching the container 1702 closes the valves.
[0079] FIG. 16 shows a container 800 which is similar to the
container 600 of FIG. 14 except there is an additional compartment
810 in the container 800 to contain one open end of the lumen
device 820. This additional compartment 810 allows portion of the
antimicrobial agent generated from the antimicrobial source 830 to
diffuse from the compartment 840 through the port 850 into the
compartment 810, and then through the lumen device 820 into the
compartment 860. This additional compartment 810 helps the
diffusion of the antimicrobial agent through the lumen device 820.
The port 870 which holds the lumen device 820 can be a holder with
an openable/closeable and/or controllable opening or any opening
equipped with compressible, inflatable, or expandable material. A
variety of holders or openings are described in the U.S. Pat. No.
6,083,458 which is incorporated herein by reference.
[0080] FIG. 17 shows a container 900 having compartments 910, 915,
920, and 925 with an indicator 930, a fan 935, an antimicrobial
source 940, and devices 945, 950, 955, 960, and 965 to be
sterilized or disinfected, respectively. All comers of the
container 900 are rounded to enhance the flow of the antimicrobial
agent. Dividers 966, 967, and 968 in the compartment 925 divide the
area 925 into smaller areas. All the areas are in fluid
communication through the circuitous path in the compartment 925.
The use of dividers can enhance the efficacy for the lumen device.
The dividers separate the devices, reduce the open space around the
lumen device, increase the percentage of cross-sectional area of
the lumen device to the open space around the lumen device, and
therefore enhance the flow of the antimicrobial agent through the
lumen devices to be processed. Additional fans 970, 975, 980, and
985 can also be placed in the container 900 to enhance the
circulation of the antimicrobial agent from the antimicrobial
source 940, through the devices 945, 950, 955, 960, and 965, the
indicator 930, the fan 935, and then back to the antimicrobial
source 940. Optionally, partitions 990 and 995 can be used in the
compartment 925 to enhance the flow of antimicrobial agent through
longer and/or smaller lumen device 965.
[0081] FIGS. 18A, 18B, and 18C show alternative configurations to
disinfect or sterilize devices with attachable and detachable
compartments. Compartment 1000 contains at least one fan 1010,
compartment 1020 contains the antimicrobial agent or source of
antimicrobial agent 1030, compartment 1040 contains at least one
device 1050 to be sterilized or disinfected, and compartment 1060
contains at least one indicator 1070. The arrow 1080 indicates the
flow of the antimicrobial agent from compartment 1020 through
compartment 1040 and to compartment 1060. Compartment 1040 has gas
or vapor permeable and microorganism impermeable material or
barrier 1085 in order to isolate the device 1050 from microorganism
when the compartments are detached. The barrier 1090 for other
compartments 1000, 1020, and 1060 does not necessary to be
microorganism impermeable barrier. It can be either microorganism
permeable or impermeable barrier. FIG. 18A shows two sets of
independent attachable and detachable compartments. Each set has
its own fan 1010, source of antimicrobial agent 1030, device 1050
to be processed, and indicator 1070. FIG. 18B shows a system with
two sets of compartments are attached together such that the
antimicrobial agent can be circulated within the system. FIG. 18C
shows a system with one compartment 1000 with fan, one compartment
1020 with source of antimicrobial agent, two compartments 1060 with
indicators and two compartments 1040 with devices. A system with
such attachable and detachable compartments can have many different
combinations as long as the antimicrobial agent can flow from the
source of antimicrobial agent to the device to be sterilized or
disinfected, and then to the indicator. More than one compartment
with the same content can be attached together. For example, two
compartments 1020 containing the source of antimicrobial can be
attached to each other to produce more antimicrobial agent to
circulate in the system. Also, two device compartments 1040 can be
attached together; therefore, more devices can be sterilized or
disinfected at the same time. Each compartment may have multiple
windows covered with the appropriate barrier. Each window may be
equipped with a shutter to close the unnecessary openings, or the
barrier can also be replaced with an end plate to ensure the flow
of the antimicrobial agent through the right directions. A heating
element can be incorporated into one or more of the attachable and
detachable compartments, it can also placed in a separated
attachable and detachable compartment. The heating element can also
be a heating oven. Valves can also be used to isolate the
compartments.
[0082] FIG. 19 shows a pouch 1100 made of gas or vapor impermeable
material having a gas or vapor permeable and microorganism
impermeable window 1105 for diffusing the antimicrobial agent from
outside of the pouch to inside of the pouch. The pouch 1100 has an
opening 11 10 for placing the device 1115 into the pouch, at least
one indicator 1120 for indicating the sterilization or disinfection
process, and peelable heat seals 1125 for sealing the pouch and
separating the indicator 1120 from the device 1115 in the pouch.
The indicator 1120 is sandwiched between two gas or vapor
impermeable barriers, therefore, the antimicrobial agent cannot
diffuse from outside of the pouch 1100 directly into the area 1130
containing the indicator 1120. The indicator 1120 can be a chemical
indicator and/or a biological indicator. Preferably, the area 1130
contains one chemical indicator and one biological indicator. The
chemical indicator 1120 can be a substrate printed with chemical
indicator. The chemical indicator can also be printed directly on
the inner layer of the pouch 1100. The biological indicator can be
a packaged strip contaminated with test microorganisms or a
self-contained biological indicator. The area 1130 is in fluid
communication with the area 1135 through the opening 1140 between
the heat seals. The antimicrobial agent needs to diffuse into the
area 1135 of the pouch 1100 through the window 1105 before it can
diffuse into the area 1130. Therefore, the device 1115 in the area
1135 contacts the antimicrobial agent before the indicator 1120 in
the area 1130 contacts the antimicrobial agent. The area 1135 can
have more than one gas or vapor permeable and microorganism
impermeable window, and the windows can be located on either one
side of the pouch or both sides of the pouch. At the end of the
sterilization or disinfection process, an additional heat seal can
be applied to the area 1145 to completely separate the area 1130
from the area 1135, such that the indicator 1120 can be removed
from the pouch 1100 without the risk of contaminating the device
1115 in the area 1135. Preferably, there is more than one indicator
in the area 1130. Therefore, at the end of the process, at least
one indicator can be removed from the area 1130 and still leaves at
least one indicator in the area 1130 to indicate the status of the
device 1115 in the pouch 1100.
[0083] FIG. 20 shows an alternative pouch 1200 similar to the pouch
1100 of FIG. 19. Pouch 1200 has multiple communication ports 1210
between the area 1220 containing the indicator 1230 and the area
1240 containing the device 1250 to be processed. Pouch 1200 also
has a larger oval shape of gas or vapor permeable and microorganism
impermeable window 1260 than the window 1105 on the pouch 1100 of
FIG. 19. The size and shape of the gas or vapor permeable window is
not critical, as long as the device 1250 in the area 1240 contacts
or exposes to the antimicrobial agent before the indicator 1230 in
the area 1220 contacts the antimicrobial agent.
[0084] FIG. 21 shows another alternative pouch 1300 similar to the
pouch 1100 of FIG. 19. The pouch 1300 has a communication port 1310
between the area 1320 having the indicator 1330 and the area 1340
having the device 1350 to be sterilized or disinfected. The
communication port is created with two partially overlapped heat
seals. Pouch 1300 has a gas or vapor permeable and microorganism
impermeable window 1360 for diffusing the antimicrobial agent into
the pouch 1300, and the size of the window is about one side of the
pouch which covers the area 1340.
[0085] FIG. 22 shows a section of pouch 1400 of a roll of pouch.
The pouch 1400 is made of gas or vapor impermeable material with
gas or vapor permeable and microorganism impermeable window 1410
for diffusing the antimicrobial agent into the pouch 1400. A
heat-sealed partition 1420 separates the pouch 1400 into areas 1430
and 1440. Areas 1430 and 1440 are in fluid communication through
openings between heat seals. Area 1430 contains the device to be
sterilized or disinfected, and area 1440 contains the indicator
1450. The indicator can be chemical indicator and/or biological
indicator. An optional partition 1460 can be used to separate the
indicators in the pouch 1400. Preferably, the indicator is the
chemical indicator printed on the inner layer of the pouch. During
the actual use, the user cuts an appropriate section of pouch from
the roll of the pouch, places the device into the pouch, and then
heat-seals the open ends of the pouch. The antimicrobial agent can
diffuse from the outside of the pouch 1400 through the window 1410
into the area 1430, and then diffuse from area 1430 through the
partition 1420 into the area 1440. The antimicrobial agent diffuses
and contacts the device in the area 1430 before it diffuses and
contacts the indicator 1450 in the area 1440. FIG. 23 shows a
section of pouch 1500 similar to the pouch 1400 of FIG. 22 but with
a larger gas or vapor permeable and microorganism impermeable
window 1510. The use of this pouch 1500 and the placements of the
indicator and devices are the same as the pouch 1400 described in
the FIG. 22.
[0086] It will be appreciated that, in all above embodiments, upon
completion of the disinfection or sterilization cycle the process
monitor cartridge can be advantageously removed from system to
determine chemical and biological efficacy of the sterilization
process. As opposed to prior art systems, however, the removal of
the biological and chemical indicators does not disturb the
sterilized state of the articles inside the sterilization
container. Since the gas permeable layer only allows the passage of
the sterilant vapor, removal of the cartridge from the sterilizing
container will not break the sealed status of the container.
[0087] Hence, although the foregoing description of the preferred
embodiment of the present invention has shown, described and
pointed out the fundamental novel features of the invention, it
will be understood that various omissions, substitutions, and
changes in the form of the detail of the apparatus and method as
illustrated as well as the uses thereof, may be made by those
skilled in the art, without departing from the spirit of the
present invention. Consequently, the scope of the present invention
should not be limited to the foregoing discussions, but should be
defined by the appended claims.
* * * * *