The present disclosure is generally related to medical instrument sterilization devices and more particularly is related to a fabric sterilization tote apparatus and related methods.
Proper sterilization and storage of medical instruments is one of the foundations of modern medical care. Without properly sterilized medical instruments, medical procedures are highly susceptible to spreading disease and causing infections. Accordingly, it is crucial for medical instruments to be sterilized successfully after each time they are used and stored in such a way to preserve their sterilized state until they are used in a subsequent medical procedure.
There are varying techniques in the medical industry on how to properly handle medical instruments during and after a sterilization process. For sterilization, one widely used technique is to use an autoclave to subject the instruments to a high-pressure and high-temperature environment, which acts to eliminate all unsterile contaminants. Other sterilization techniques may use chemicals such as ethylene oxide or hydrogen peroxide, steam and gas environments, dry heat environments, or microwave environments, among other techniques.
When an autoclave is used, the medical instruments are retained in sterilization trays throughout the duration of the sterilization process.
While the sterilization trays 10 are used successfully during the sterilization process, they are unable to keep the medical instruments sterilized until their next use, namely due to the apertures within the trays which create numerous open paths from the interior of the tray to the outside atmosphere. As such, the sterilization trays must be housed in some other structure to maintain the sterilized state of the medical instruments therein until they are used. There are a variety of devices in the industry that can achieve this task, but they generally fall into two main categories: (1) medical sterilization cases which house the sterilization trays during and after the autoclave process; and (2) sterile wraps which are applied to the sterilization trays immediately after they exit the autoclave.
Sterilization cases are recognized in the industry as being durable, reliable, and generally easy to use, but they are also well-known to be bulky and expensive. The sterilization cases must be large enough to hold the sterilization tray which means their overall dimensions are significantly larger than the sterilization tray itself, as is visible in
Sterilization wraps, on the other hand, are able to be closely folded around sterilization trays, so storage space is less of an issue. And, sterilization wraps are generally far less expensive to initially purchase than sterilization cases. However, sterilization wraps have many shortcomings. For one, they are intended to be disposable which is costly over a long period of time and disposing of them after one use is wasteful. Further, sterilization wraps must be folded properly around the sterilization trays to ensure the instruments remain sterilized. This folding must be carefully taught to sterilization technicians which requires substantial training. Even then, improper folding can still occur due to human error. In addition, sterilization wraps are not made from highly durable materials so they are susceptible to being torn or ripped, especially when being transported or positioned on a shelf. It is not uncommon in the industry for a sterilization wrap to be torn by the shelf it is being placed on. One final aspect of sterilization wraps is that they have a short life span for successfully keeping the sterilization tray sterile. While sterilization cases may be able to be stored for weeks, sterilization wraps may only be capable of being used successfully for a few days.
Thus, a heretofore unaddressed need exists in the industry to address the aforementioned deficiencies and inadequacies.
Embodiments of the present disclosure provide a fabric sterilization tote apparatus as well as related systems and methods thereof. Briefly described, in architecture, one embodiment of the apparatus, among others, can be implemented as follows. A flexible, bacteria-impenetrable material is formed into a closable container, the closable container having a base, at least four sidewalls, and a cover, wherein an interior area of the closable container is defined by the base, the at least four sidewalls, and the cover. A bacteria-impenetrable closure is positioned between the cover and at least one of the four sidewalls, wherein the bacteria-impenetrable closure controls a sealing of the interior area of the closable container from an exterior atmosphere.
The present disclosure can also be viewed as providing methods for sterilizing medical instruments and storing sterilized medical instruments thereafter. In this regard, one embodiment of such a method, among others, can be broadly summarized by the following steps: placing a medical instrument sterilization tray with the at least one medical instrument in a fabric sterilization tote apparatus, wherein the fabric sterilization tote apparatus comprises: a flexible, bacteria-impenetrable material formed into a closable container, the closable container having a base, at least four sidewalls, and a cover, wherein an interior area of the closable container is defined by the base, the at least four sidewalls, and the cover; and a bacteria-impenetrable closure positioned between the cover and at least one of the four sidewalls, wherein the bacteria-impenetrable closure controls a sealing of the interior area of the closable container from an exterior atmosphere; sterilizing the fabric sterilization tote apparatus with medical instrument sterilization tray and the at least one medical instrument in an autoclave; and removing the fabric sterilization tote apparatus with medical instrument sterilization tray and the at least one medical instrument from the autoclave, whereby the interior area of the closable container remains sterile.
The present disclosure can also be viewed as providing methods of manufacturing a fabric sterilization tote apparatus. In this regard, one embodiment of such a method, among others, can be broadly summarized by the following steps: forming a closable container from a flexible, bacteria-impenetrable material, wherein the closable container has a base, at least four sidewalls, and a cover, and wherein an interior area of the closable container is defined by the base, the at least four sidewalls, and the cover; and integrating a bacteria-impenetrable closure between the cover and at least one of the four sidewalls, thereby controlling a sanitized environment within the interior area by sealing the interior area of the closable container from an exterior atmosphere with the bacteria-impenetrable closure.
Other systems, methods, features, and advantages of the present disclosure will be or become apparent to one with skill in the art upon examination of the following drawings and detailed description. It is intended that all such additional systems, methods, features, and advantages be included within this description, be within the scope of the present disclosure, and be protected by the accompanying claims.
Many aspects of the disclosure can be better understood with reference to the following drawings. The components in the drawings are not necessarily to scale, emphasis instead being placed upon clearly illustrating the principles of the present disclosure. Moreover, in the drawings, like reference numerals designate corresponding parts throughout the several views.
The apparatus 100 may be used during a medical instrument sterilization process and thereafter to ensure that medical instruments are properly sterilized and remain sterile until they are used in a medical procedure. Relative to the Background of this disclosure, the apparatus 100 may be used to fully replace conventional medical sterilization cases and fully replace conventional medical sterilization wraps. The apparatus 100 may prove to be far more efficient than manually wrapping a medical instrument tray with a sterilization wrap and it may provide a more cost-effective solution than the conventional metal sterilization case. Accordingly, the apparatus 100 may overcome the shortcomings of both conventional devices and provide additional benefits within the field of medical sterilization.
The apparatus 100 may be formed from a flexible, bacteria-impenetrable material, such as a sterilizing paper, a non-woven fabric such as spun-melt-spun (SMS) polypropylene, or other flexible fabric or paper-like substrates that are bacteria-impenetrable. Unlike conventional sterilization wraps which are constructed as flat sheets that are folded around a sterilization tray, the flexible, bacteria-impenetrable material of the apparatus 100 may be formed into a closable container 110 capable of housing the sterilization tray 10 carrying medical instruments (as shown in
The closable container 110 may generally have a base 112, at least four sidewalls 114, and a cover 116, although different configurations are envisioned as well. The cover 116 may generally be positioned at a top side of the closable container 110, but covers 116 positioned on a vertical sidewall are also possible. The shape and dimensions of the closable container 110 may be selected to substantially match the sterilization tray 10 or trays which the apparatus 100 is intended to hold, leaving enough tolerance between the base 112, sidewalls 114, and cover 116 and the sterilization tray 10. The interior area 118 of the closable container 110 may be defined by the space that the base 112, the at least four sidewalls 114, and the cover 116 shape when the cover 116 has a closed position to form an area fully interior of the base 112, sidewalls 114, and cover 116. The cover 116 may form the full portion of a side of the closable container 110 or it may form a portion of a side of the closable container 110, as shown in
The bacteria-impenetrable closure 130 is positioned between the cover 116 and at least one of the four sidewalls 114 to allow the cover 116 to be secured in a closed position. As shown in
The bacteria-impenetrable closure 130 may be a bacteria-proof zipper which has teeth positioned along the edges of the cover 116 and the interior terminating ends of the edges 120 on the topside of the closable container 110. The zipper may include any number of sliders 132 which are capable of engaging and disengaging the teeth of the zipper. In one example, two sliders may be used, thereby allowing for the bacteria-impenetrable closure 130 to be closed from multiple directions.
As is shown by block 202, a medical instrument sterilization tray with the at least one medical instrument is placed within a fabric sterilization tote apparatus, wherein the fabric sterilization tote apparatus comprises: a flexible, bacteria-impenetrable material formed into a closable container, the closable container having a base, at least four sidewalls, and a cover, wherein an interior area of the closable container is defined by the base, the at least four sidewalls, and the cover; and a bacteria-impenetrable closure positioned between the cover and at least one of the four sidewalls, wherein the bacteria-impenetrable closure controls a sealing of the interior area of the closable container from an exterior atmosphere. The fabric sterilization tote apparatus with medical instrument sterilization tray and the at least one medical instrument is sterilized in an autoclave (block 204). The fabric sterilization tote apparatus with medical instrument sterilization tray and the at least one medical instrument is then removed from the autoclave, whereby the interior area of the closable container remains sterile (block 206). The interior area may remain sterile for a period of time long enough to allow the medical instruments to be used in a future medical procedure.
It is noted that the method may include any number of additional steps, processes, or functions, including any disclosed relative to any other figure of this disclosure. For example, prior to insertion into the autoclave, the cover of the closable container may be closed with the bacteria-impenetrable closure. In one example, this closure may consist of simply moving at least one slider of a zipper along teeth of the zipper, which is far more efficient and secure than the conventional folding process with conventional sterilization wraps. Accordingly, the cover of the closable container can be fully closed with the bacteria-impenetrable closure without any need to fold or tape the flexible, bacteria-impenetrable material. Since no folding of the flexible, bacteria-impenetrable material is required, the corners of the apparatus may be formed from a single layer of the flexible, bacteria-impenetrable material. The method may also include transporting the sterilized fabric sterilization tote apparatus with at least two handles formed by at least one reinforcing strap positioned across at least a portion of the base and at least two of the at least four sidewalls.
As is shown by block 302, a closable container is formed from a flexible, bacteria-impenetrable material, wherein the closable container has a base, at least four sidewalls, and a cover, and wherein an interior area of the closable container is defined by the base, the at least four sidewalls, and the cover. A bacteria-impenetrable closure is integrated between the cover and at least one of the four sidewalls, thereby controlling a sanitized environment within the interior area by sealing the interior area of the closable container from an exterior atmosphere with the bacteria-impenetrable closure (block 304). It is noted that the method may include any number of additional steps, processes, or functions, including any disclosed relative to any other figure of this disclosure. For example, the closable container may be reinforced with a reinforcing strap positioned across at least a portion of the base and at least two of the at least four sidewalls.
As noted previously, the apparatus 100 may offer a number of benefits over the conventional art within the medical sterilization industry, such as being more efficient than manually wrapping a medical instrument tray with a sterilization wrap and being more cost-effective than the conventional metal sterilization case. It is further noted that the apparatus 100 may be easier and more efficient to store in an instrument storage room or operating room than conventional sterilization cases and it may offer a longer sterilized shelf life than conventional sterilization wraps.
Another benefit of the apparatus 100 is it may reduce the risk of wet pack problems in sterilization. Wet packs is a phenomenon in the medical sterilization industry where moisture remains in an autoclave or the sterilized items themselves after the autoclave process. Wet packs can cause contamination issues because excessive moisture can act as a pathway for microorganisms. This can lead to re-contaminating the sterilized instruments. In others words, if the sterilized items are not properly dried then microorganisms may wick through the wrapping and deposit themselves on the sterile load. While wet packs can occur for a number of reasons, one reason is believed to be cooling issues with metal sterilization enclosures, namely between conventional metal sterilization cases and the metal sterilization trays which reside inside the sterilization cases. By eliminating the need for the conventional sterilization case through the use of the apparatus 100, it may be possible to lessen the prevalence of wet packs.
It should be emphasized that the above-described embodiments of the present disclosure, particularly, any “preferred” embodiments, are merely possible examples of implementations, merely set forth for a clear understanding of the principles of the disclosure. Many variations and modifications may be made to the above-described embodiment(s) of the disclosure without departing substantially from the spirit and principles of the disclosure. All such modifications and variations are intended to be included herein within the scope of this disclosure and the present disclosure and protected by the following claims.