U.S. patent application number 10/818424 was filed with the patent office on 2005-10-06 for sterile cleaning kit.
This patent application is currently assigned to STERIS Inc.. Invention is credited to Giddens, Timothy L., Kaiser, Herbert J., Leary, James P., Maddock, Todd William, Newman, Jerry Leigh.
Application Number | 20050218032 10/818424 |
Document ID | / |
Family ID | 35053109 |
Filed Date | 2005-10-06 |
United States Patent
Application |
20050218032 |
Kind Code |
A1 |
Maddock, Todd William ; et
al. |
October 6, 2005 |
Sterile cleaning kit
Abstract
A kit for forming a sterile cleaning solution. The kit is
comprised of a container, a packet, a first flexible package and a
second flexible package. The container contains a liquid and has an
opening and a removable cap sealing the opening. The packet
contains a pre-measured amount of an active agent. The first
flexible package is dimensioned to enclose the container and the
packet. The second flexible package is dimensioned to enclose the
first flexible package, the container and the packet.
Inventors: |
Maddock, Todd William; (Bay
Village, OH) ; Giddens, Timothy L.; (Florissant,
MO) ; Newman, Jerry Leigh; (O'Fallon, MO) ;
Kaiser, Herbert J.; (Pontoon Beach, IL) ; Leary,
James P.; (Belleville, IL) |
Correspondence
Address: |
KUSNER & JAFFE
HIGHLAND PLACE SUITE 310
6151 WILSON MILLS ROAD
HIGHLAND HEIGHTS
OH
44143
US
|
Assignee: |
STERIS Inc.
|
Family ID: |
35053109 |
Appl. No.: |
10/818424 |
Filed: |
April 2, 2004 |
Current U.S.
Class: |
206/581 ;
206/223; 206/823 |
Current CPC
Class: |
B65D 81/32 20130101;
B65D 77/003 20130101; B65D 23/12 20130101 |
Class at
Publication: |
206/581 ;
206/223; 206/823 |
International
Class: |
B65D 069/00 |
Claims
Having described the invention, the following is claimed:
1. A kit for forming a sterile cleaning solution, comprising: a
container containing a liquid, said container having an opening and
a removable cap sealing said opening; a packet containing a
pre-measured amount of an active agent; a first flexible package
dimensioned to enclose said container and said packet; and a second
flexible package dimensioned to enclose said first flexible
package, said container and said packet.
2. The kit as defined in claim 1, wherein said packet is attached
to, yet removable from, the exterior of said container.
3. The kit as defined in claim 2, wherein said packet is attached
to said container by an adhesive.
4. The kit as defined in claim 1, wherein said packet has a finger
portion and said packet is openable at said finger portion.
5. The kit as defined in claim 4, wherein said finger portion has a
surface feature dimensioned to facilitate opening.
6. The kit as defined in claim 5, wherein said finger portion has a
flange and said surface feature is a notch in said flange.
7. The kit as defined in claim 1, wherein said opening is
dimensioned to receive said finger portion.
8. The kit as defined in claim 4, wherein said finger portion is
dimensioned to fit within said opening.
9. The kit as defined in claim 1, wherein said liquid is water.
10. The kit as defined in claim 9, wherein said liquid is sterile
water.
11. The kit as defined in claim 10, wherein said liquid is a
sterile grade of water that meets the specification of USP water
for injection.
12. The kit as defined in claim 1, wherein said active agent is a
disinfectant.
13. The kit as defined in claim 1, wherein said active agent is a
sterilant.
14. The kit as defined in claim 1, wherein said active agent is a
cleaner.
15. The kit as defined in claim 1, wherein said container is
comprised of a polymer.
16. The kit as defined in claim 1, wherein said first flexible
package is comprised of a first polymer.
17. The kit as defined in claim 16, wherein said first polymer is
clear.
18. The kit as defined in claim 16, wherein said flexible package
is comprised of single or multi-layered barrier material comprised
from a polymer.
19. The kit as defined in claim 1, wherein said second flexible
package is comprised of a second polymer.
20. The kit as defined in claim 19, wherein said second polymer is
clear.
21. The kit as defined in claim 19, wherein said second flexible
package is comprised of single or multi-layered barrier material
comprised from a polymer.
22. A kit for forming a sterile cleaning solution, comprising: a
first container containing a liquid carrier fluid, said container
having an opening and a removable cap; a second container
containing an active agent operable to form a cleaning solution
when mixed with said liquid carrier; and at least one flexible
package dimensioned to enclose said first and second containers and
maintain said container in a sterile condition.
23. A kit as defined in claim 22, wherein said second container is
a packet.
24. A kit as defined in claim 23, wherein said packet is attached
to said first container.
25. A kit as defined in claim 24, wherein said kit includes a
second flexible package dimensioned to enclose said at least one
flexible package.
26. A kit as defined in claim 25, wherein said active agent is a
liquid disfinfectant.
27. A kit as defined in claim 25, wherein said active agent is a
liquid sterilant.
28. A kit as defined in claim 25, wherein said flexible packages
are formed of a polymer material.
Description
FIELD OF THE INVENTION
[0001] The present invention relates generally to cleaning
solutions, and more particularly, to a self-contained kit for the
preparation of a sterile cleaning and/or disinfectant solution.
BACKGROUND OF THE INVENTION
[0002] Clean-rooms, operating rooms, and the like must be
periodically cleaned and disinfected with sterile solution to
maintain clean and sterile conditions therein. The sterile solution
is typically formed by mixing sterile water and a sterile
disinfecting or sterilant agent. Immediately prior to use, the
sterile solution may be mixed in the room in which the solution is
to be used. Conventional methods for forming a sterile cleaning
solution involve measuring and pouring predetermined amounts of a
disinfecting agent and water into a container such as a bucket.
[0003] A problem associated with such mixing procedures is the
potential exposure of a user to harsh and toxic chemicals. Another
problem is measuring the respective components accurately to obtain
a proper cleaning solution. Measuring of the respective components
improperly may reduce the effectiveness of the final sterile
cleaning solution, or result in increased costs due to overuse of
expensive materials. Another problem associated with the current
practice is the need to closely control and document the mixing
activity which adds time and labor to the process.
[0004] The present invention overcomes these and other problems and
provides a sterile cleaning kit containing a pre-measured volume of
sterile water or liquid and a pre-measured, sterile packet of
disinfectant or sterilant attached thereto.
SUMMARY OF THE INVENTION
[0005] In accordance with the present invention, there is provided
a kit for forming a sterile cleaning solution. The kit is comprised
of a container containing a sterile water or liquid. The container
also has an opening and a removable cap that seals the opening. A
sterile packet or other container containing a pre-measured amount
of an active agent such as disinfectant or sterilant, is attached
to the container. The container and attached packet or other
container are enclosed within a sealed flexible inner bag or
package. The inner bag or package is further enclosed within a
sealed flexible outer bag or package and the entire system is then
sterile.
[0006] In accordance with another aspect of the invention, there is
provided a sterile cleaning solution kit as described above, having
a packet that is configured such that a portion of the packet
defines a pour spout or finger portion. The pour spout or finger
portion is dimensioned to fit within an opening in the container to
allow for safe, efficient transfer of the disinfecting or
sterilizing agent to the container or an additional mixing bucket,
without exposure to the operator or loss of product during
transfer.
[0007] In accordance with another aspect of the present invention,
there is provided a kit for forming a sterile cleaning solution
comprising a first container containing a liquid carrier fluid. The
container has an opening and a removable cap. A second container
contains an active agent operable to form a cleaning solution when
mixed with the liquid carrier. At least one flexible package is
provided to enclose the first and second containers to maintain the
container in a sterile condition.
[0008] An advantage of the present invention is a self-contained
sterile kit for forming a sterile cleaning and/or disinfectant
solution.
[0009] Another advantage of the present invention is a kit as
defined above having a packet or other container that is
dimensioned to provide safe, efficient transfer of the disinfectant
or sterilizing agent into the original container for the sterile
water or an additional mixing bucket.
[0010] Another advantage of the present invention is a kit as
defined above that provides pre-measured amounts of sterile water
or liquid, and the disinfecting or sterilizing agent, and the
pre-measured components allowing for accurate formation of the
sterile cleaning solution.
[0011] Another advantage of the present invention is a kit as
defined above that reduces waste and associated costs from improper
mixing of components.
[0012] Another advantage of the present invention is a kit as
defined above that facilitates the effectiveness of the cleaning
solution.
[0013] Another advantage of the present invention is that a user
does not need to provide sterile water or liquid in areas which are
considered critical, thus providing a substantial savings and
convenience for the user.
[0014] Another advantage of the present invention is that a user
does not need to provide filtration for the components or the
finished blended disinfectant/sterilant solution, again providing a
considerable savings and convenience for the user.
[0015] These and other advantages will become apparent from the
following description of a preferred embodiment taken together with
the accompanying drawings and the appended claims.
BRIEF DESCRIPTION OF THE DRAWINGS
[0016] The invention may take physical form in certain parts and
arrangement of parts, a preferred embodiment of which will be
described in detail in the specification and illustrated in the
accompanying drawings which form a part hereof, and wherein:
[0017] FIG. 1 is an elevational view of a kit for forming a sterile
cleaning solution illustrating a preferred embodiment of the
present invention;
[0018] FIG. 2 is a partial sectional view taken along line 2-2 of
FIG. 1; and
[0019] FIG. 3 is a partially sectioned view of the kit for forming
a sterile cleaning solution shown in FIG. 1, illustrating use of
the kit for forming a sterile cleaning solution.
DETAILED DESCRIPTION OF A PREFERRED EMBODIMENT
[0020] Referring now to the drawings wherein the showings are for
the purposes of illustrating a preferred embodiment of the present
invention only and not for the purposes of limiting same, FIG. 1
shows a sterile solution kit 10 for creating (forming) a sterile
cleaning solution. Broadly stated, sterile solution kit 10 is
comprised of a container 20, a packet 40, an inner bag 60 and an
outer bag 70.
[0021] In the embodiment shown, container 20 is generally
cylindrical or rectangular in shape and has a closed bottom end 21
and an open upper end 23. Upper end 23 of container 20 is formed to
define a throat 32 and a handle 34. Container 20 is a rigid or
soft-sided container wherein throat 32 and handle 34 are integrally
formed. Bottom end 21 of container 20 defines a support surface 36.
Support surface 36 is formed to allow container 20 to be free
standing on a flat surface. An option may be to package a soft
sided container that has other features designed to make it stable
on a flat surface. Handle 34 is dimensioned to allow lifting,
carrying, positioning, and pouring of container 20.
[0022] Referring now to FIG. 2, upper end 23 of container 20
narrows to form throat 32. Throat 32 has exterior threads 28 as
shown in FIG. 2 and defines an opening 26. In the embodiment shown,
opening 26 is round. Opening 26 is sealed by cap 24. Cap 24
includes internal threads 25 dimensioned to matingly engage
exterior threads 28 on container 20.
[0023] Container 20 is dimensioned to contain a predetermined
amount of a sterile inactive liquid 22. In a preferred embodiment
of the invention, sterile inactive liquid 22 is water, and in a
more preferred embodiment of the invention, sterile inactive liquid
22 is sterile water and in an even more preferred embodiment of the
invention, sterile inactive liquid 22 is a sterile grade of water
that meets the specification of USP water for injection (WFI
water).
[0024] Packet 40 is best seen in FIG. 1. In a preferred embodiment,
packet 40 is generally rectangular in shape and includes an
elongated finger portion 50 that extends from one corner thereof.
Packet 40 is formed of two layers of flexible metallic foil that
are heat sealed around the perimeter thereof to form a packet
flange 44. Packet 40 defines an inner chamber 46 that is
dimensioned to receive a pre-measured amount of an active agent 48,
such as a disinfectant or sterilant. Another possible configuration
for packet 40, i.e., the container of the disinfectant or
sterilant, would be a rigid or soft sided bottle that is shaped to
be either separate or attached to the base bottle or container.
[0025] In a preferred embodiment, finger portion 50 is an extension
of a long side of packet 40, but it is recognized that finger
portion 50 could extend from any portion of packet 40 and finger
portion 50 could be folded parallel to the body of packet 40.
Finger portion 50 has a mesial portion 53, and a distal end 54.
Finger portion 50 defines an inner passageway 51. Inner passageway
51 is fluidly connected to inner chamber 46. Finger portion 50 is
configured to tear or otherwise be opened so that distal end 54 is
separated from mesial portion 53 along a tear line 55, shown as a
dashed line in FIG. 1. In a preferred embodiment, surface means
such as a notch 56 is formed in packet flange 44 to facilitate
removal of distal end 54 from mesial portion 53 along tear line 55,
as will be discussed below.
[0026] Referring now to FIG. 3, finger portion 50 is dimensioned to
fit through opening 26 and within throat 32 of container 20. Finger
portion 50 is dimensioned to provide means for efficient transfer
of liquid through opening 26 and throat 32 and into container
20.
[0027] In a preferred embodiment, packet 40 is attached to
container 20 by an adhesive at locations 42A and 42B as best seen
in FIG. 2. The adhesive is preferably a hot-melt adhesive. In the
embodiment shown the adhesive is configured in two, parallel
spaced-apart lines. It is contemplated that the adhesive could be
configured in a single patch, a line defining the perimeter of
packet 40, a series of dots across the back of packet 40 or some
other known means of attaching. It is also contemplated that packet
40 may be attached to container 20 by other means, such as, by way
of example and not limitation, adhesive tape across the exterior of
packet 40 and the surface of container 20, a surrounding label
band, and adhesive in any configuration or equivalents.
[0028] Inner bag 60 is a flexible package that is dimensioned to
receive container 20 and packet 40. In a preferred embodiment,
inner bag 60 is made of a clear polymeric material which is heat
sealed around the perimeter to form inner bag flange 62 as shown in
FIG. 1. Inner bag 60 may be comprised of a single or multilayered
barrier material comprised from a polymer or other application
specific materials.
[0029] Inner bag 60 is comprised of a material that has properties
appropriate to sterile containment. Such properties would be low
permeability to microorganism transfer, resistant to
handling/transit damage and sterilization process stability. Inner
bag 60 has a thickness that is easy to tear, cut, or peel open. In
a preferred embodiment, inner bag flange 62 of inner bag 60 is
formed such that it can be peeled open at inner bag top 64 of inner
bag 60. Alternatively, inner bag 60 may be formed of a polymeric
material oriented to facilitate tearing or opening.
[0030] Outer bag 70 is a sealed flexible package that is
dimensioned to be larger than inner bag 60 and is dimensioned to
receive inner bag 60, container 20, and packet 40. Outer bag 70 is
preferably formed of the same material as inner bag 60 to have the
same characteristics and properties as inner bag 60 as discussed
above. In a preferred embodiment, outer bag 70 is made of a clear
polymeric material which is heat sealed around the perimeter to
form outer bag flange 72 as shown in FIG. 1. Outer bag 70 may be
comprised of a single or multilayered barrier material comprised
from a polymer or other application specific materials. Outer bag
70 is comprised of a material that has properties appropriate to
sterile containment. Such properties would be low permeability to
microorganism transfer, resistant to handling/transit damage and
sterilization process stability. Outer bag 70 has a thickness that
is easy to tear, cut, or peel open. In a preferred embodiment,
outer bag flange 72 of outer bag 70 is formed such that it can be
peeled open at outer bag top 74 of outer bag top 70. Alternatively,
outer bag 70 may be formed of a polymeric material oriented to
facilitate tearing or opening. When open, outer bag top 74 would
allow the removal of inner bag 60.
[0031] The complete sterile solution kit 10 comprised of container
20, attached packet 40, inner bag 60, and outer bag 70 is
irradiated with gamma radiation for sterility. In an alternative
embodiment, the individual components of sterile solution kit 10
could be sterilized separately and then assembled in a sterile
environment.
[0032] Referring now to the operation and use of sterile solution
kit 10, it is recognized that procedures vary from facility to
facility and that sterile solution kit 10 would be used in
accordance with the procedures in effect at the facility to be
cleaned. The method of use of sterile solution kit 10 begins with
observing relevant entry procedures for the environment to be
cleaned.
[0033] In a preferred method of use, outer bag 70 is opened in a
location outside or away from the area to be cleaned. Outer bag 70
is opened at outer bag top 74 by separating outer bag flange 72.
After outer bag 70 is opened, inner bag 60 is removed from outer
bag 70. Following the removal of inner bag 60 from outer bag 70,
outer bag 70 is discarded. Once outer bag 70 is removed and
discarded, the remainder of sterile solution kit 10 comprising
container 20, attached packet 40, and inner bag 60 is transferred
to the area to be cleaned. Inner bag 60 is opened at inner bag
flange 62 or by some other suitable method. Container 20 and
attached packet 40 are removed from inner bag 60. Packet 40 is then
detached from container 20. Cap 24 is removed from container 20
thereby exposing opening 26. Cap 24 is retained for future use.
[0034] Grasping packet 40 at mesial portion 53 and distal end 54,
distal end 54 is separated from packet 40 along tear line 55. Once
separated from packet 40, distal end 54 is disposed of. Distal end
54 may be placed within inner bag 60 for disposal.
[0035] Removal of distal end 54 defines an opening 58, best seen in
FIG. 3.
[0036] Packet 40 is then maneuvered so that mesial portion 53 is
placed in opening 26 within throat 32, and the active agent 48
within packet 40 is poured into container 20. Packet 40 is then
disposed of within inner bag 60. Inner bag 60 is then sealed and
disposed of appropriately. Cap 24 is placed over opening 26 and
tightened on exterior threads 28 so that container 20 is sealed.
Formation of the sterile cleaning solution may then be completed by
appropriate agitation or mixing. Cap 24 can then be removed and the
resulting solution of sterile inactive liquid 22 and active agent
48 can be used as needed. Alternatively, the user may empty packet
40 and container 20 into a larger container or bucket to be mixed
and used with an application device such as a mop.
[0037] The present invention thus provides a pre-measured kit for
the formation of a cleaning solution to be used in clean rooms,
operating rooms, and the like.
[0038] Modifications and alterations will occur to others upon
their reading and understanding of the specification.
[0039] For example, container 20 may assume other shapes, and the
opening 26 in container 20 may be sealed by other means such as a
peel-away metallic foil or polymer cap. Further, packet 40 could
also made of other materials such as, by way of example and not
limitation, a polymeric film, a laminate structure comprised of
metallic foil and polymeric film, or a polymeric film coated with
metal. Likewise, packet 40 can be rigid or semi-flexible. It is
intended that all such modifications and alterations be included
insofar as they come within the scope of the invention as claimed
or the equivalents thereof.
* * * * *