Patent Application
20050218032
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.
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.
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.
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.
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.
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.
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.
An advantage of the present invention is a self-contained sterile kit for forming a sterile cleaning and/or disinfectant solution.
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.
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.
Another advantage of the present invention is a kit as defined above that reduces waste and associated costs from improper mixing of components.
Another advantage of the present invention is a kit as defined above that facilitates the effectiveness of the cleaning solution.
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.
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.
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.
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:
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,
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.
Referring now to
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).
Packet 40 is best seen in
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
Referring now to
In a preferred embodiment, packet 40 is attached to container 20 by an adhesive at locations 42A and 42B as best seen in
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
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.
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
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.
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.
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.
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.
Removal of distal end 54 defines an opening 58, best seen in
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.
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.
Modifications and alterations will occur to others upon their reading and understanding of the specification.
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.
