Container for washing sterilization, transportation and sterile storage of articles

A container for washing, sterilization, transportation and sterile storage of articles for sterilization is provided. The container includes a sleeve and a frame adapted to receive articles for sterilization. The container includes at least one filtered opening to permit communication between the sterilization apparatus and the sterilization chamber for the communication of steam and air. In a first configuration, a front and rear wall of the frame engage the sleeve to create a sterilization chamber. The container may be stacked and stored in any orientation. In a second configuration, the frame rests or nests on top of the sleeve to permit access to and use of the sterilized articles. The container, may include one or a plurality of openings for communication between a sterilization apparatus and the sterilization chamber and one or more filters adjacent to the pluralities of openings.

FIELD OF THE INVENTION

The present invention relates to a container for washing, sterilization, transportation and sterile storage of articles, such as medical or dental instruments, including containers which permit the passage of air and steam for sterilization of instruments held within the container and maintain sterile conditions for storage of instruments after sterilization.

BACKGROUND

Existing sterilization containers typically comprise a lid and a tray. Instruments for sterilization or procedural cassettes containing a set of instruments are placed within the container for sterilization and sterile storage. Other containers may be placed in a sterilization pouch or wrapped in sterilization wrap for sterilization and sterile storage.

Containers which comprise a lid and a tray may require additional work area during use since the lid must be removed from the tray and the instruments are usually removed from the tray and placed on a counter or other work surface during use. The storage of such containers also may be limited as the containers may be difficult to stack or may be stacked only in one orientation. Most containers are comprised of metal, such as stainless steel, or are wrapped as described above and do not permit the contents of the containers to be viewed. Some sterilization containers do not have adequate openings to allow effective cleaning of the articles contained therein during, for example, a wash process in an automatic instrument washer.

SUMMARY

A container for washing, sterilization, transportation and sterile storage of articles for sterilization, such as medical or dental instruments, is provided. The container includes a sleeve and a frame adapted to receive articles for sterilization. The container may be placed in a sterilization apparatus such as an autoclave. The container includes at least one opening equipped with a microbial filter or tortuous paths to permit communication between the sterilization apparatus and the sterilization chamber for the communication of steam. At least one portion of the container is transparent or semi-transparent to allow visual identification of contents and assessment of sterility. In a first configuration, a front wall and rear wall of the frame engage the sleeve to create a sterilization chamber. The container may be stacked and stored in any orientation. In a second configuration, the frame rests or nests on top of the sleeve to permit access to and use of the sterilized articles. The container may include one or a plurality of openings for communication between a sterilization apparatus and the sterilization chamber and one or more filters adjacent to the pluralities of openings.

According to an embodiment of the present disclosure there is provided a container for washing, sterilization, transportation and sterile storage of articles. The container comprises a frame adapted to receive articles for sterilization, the frame having at least a front wall and a rear wall; a sleeve having a top panel, a bottom panel and first and second side panels, the top panel, bottom panel and two side panels defining a cavity for receiving the frame, the sleeve being engaged with the front and rear walls of the frame to define a sterilization chamber; and at least one opening to permit communication between a sterilization apparatus and the sterilization chamber.

According to another embodiment, there is provided a container for washing, sterilization, transportation and sterile storage of articles. The container comprises: a frame adapted to receive articles for sterilization, the frame having at least a front wall and a rear wall; a sleeve having a top panel, a bottom panel and first and second side panels, the top panel, bottom panel and two side panels defining a cavity for receiving the frame, the sleeve being sealably engaged with the front and rear walls of the frame to define a sterilization chamber; and at least one opening to permit communication between a sterilization apparatus and the sterilization chamber.

In some embodiments, the sleeve further comprises a first region, a second region disposed discretely from said first region, and a third region disposed discretely from said second region; a front interface configured between the first and second regions for engaging the front wall; and a rear interface configured between the second and third regions for engaging the rear wall.

In another embodiment, there is provided a method for washing and sterilization of articles. The method comprises: placing articles in a frame, the frame being adapted to receive articles for sterilization, the frame having at least a front wall and a rear wall; washing the frame and articles placed therein in a washing apparatus; inserting the washed frame and articles into a sleeve to form a container. The sleeve has a top panel, a bottom panel and first and second side panels. The top panel, bottom panel and two side panels define a cavity for receiving the frame. In some embodiments, the sleeve is sealably engaged with the front and rear walls of the frame to define a sterilization chamber. The container has at least one filtered opening to permit communication between a sterilization apparatus and the sterilization chamber. The method includes sterilizing the container and articles contained therein in a sterilization apparatus

While the invention will be described in conjunction with the illustrated embodiments, it will be understood that it is not intended to limit the invention to such embodiments. On the contrary, it is intended to cover all alternatives, modifications and equivalents as may be included within the spirit and scope of the invention as defined by the appended claims.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

In the following description, similar features in the drawings have been given identical reference numerals where appropriate. Terms such as “front” and “rear”, “top” and “bottom”, “first” and “second”, “right” and “left” may be used to identify opposing ends or different configurations of structures. Such terms are used for illustration purposes and are not intended to limit the present disclosure.

An embodiment of the present disclosure provides a container assembly which holds articles for sterilization such as medical and dental instruments. The components of the assembly may be placed in a washer apparatus to wash the instruments and remove debris prior to a sterilization process. One or more containers may be placed in a sterilization apparatus such as an autoclave or a cassette sterilization apparatus such as the STATIM™ for sterilization of the articles in the container. The container also allows for sterile storage and transport of instruments and provides improved access to instruments during use. The container comprises a sleeve, and a frame adapted to receive articles for sterilization. The sleeve has a top panel, a bottom panel and two side panels which define a cavity for receiving the frame. The sleeve and the frame are engaged to create a sterilization chamber. In one embodiment, the sleeve and the frame are sealably engaged. In another embodiment, tortuous paths are configured at the engagement between the frame and the sleeve. The container includes at least one opening to permit communication between a sterilization apparatus and the sterilization chamber, such as for the communication of steam. In one embodiment, the container includes a plurality of openings for communication between a sterilization apparatus and the sterilization chamber and one or more filters adjacent to the pluralities of openings.

In one embodiment, the container has two configurations. In a first configuration, the frame is housed within the sleeve and a front wall and rear wall of the frame engage the sleeve to create the sterilization chamber. In one embodiment, the front wall and rear wall are adapted to attach to opposing ends of a tray, cassette or basket configured to fit within a suitably sized sleeve of the container. In another embodiment, the frame comprises a front wall, a rear wall and first and second side walls which are adapted to receive articles for sterilization as described herein. The frame may be inserted or slid into the sleeve in order to assemble the container in the first configuration. In the first configuration, the container and articles contained therein may be sterilized and stored efficiently by standing and stacking multiple containers in any orientation. Sterile articles held within the container in the first configuration may remain in the container and transported to a point of use.

In a second configuration, the frame rests or nests on top of the sleeve to permit access to and use of the sterilized articles. After sterilization, or after a sterilized container is removed from storage, the sterile seal may be broken at the point of use, such as in the presence of a medical or dental patient, and the frame and articles contained therein may be removed from the sleeve. For example, the frame and articles contained therein may be removed from the sleeve by sliding the frame out of the sleeve. The frame is sized to rest atop either a top panel or bottom panel of sleeve. In one embodiment, the frame nests within or partially within the top panel or bottom panel of the sleeve. The second configuration permits use of the container and articles using a minimal area or footprint since the frame may rest on top of the sleeve and the sleeve need not be stored elsewhere.

After the articles or instruments are used, they may be returned to the frame and the frame and articles contained therein may be placed into the sleeve to assemble the container in the first configuration for transport, thus reducing the risk of infection due to exposure and minimizing the risk of instrument damage due to improper handling. The frame and articles contained therein may be removed from the sleeve and the components washed, such as in an automatic washer, without removing the articles from the frame. The sleeve and frame may be reassembled in the first configuration for sterilization of the articles in the frame and subsequent sterile storage.

In some embodiments, the sleeve or at least a portion of the sleeve comprises a transparent material to enable visibility of the articles held or stored in the container. In other embodiments, mechanisms are provided to indicate whether the container has undergone a sterilization cycle and remains in a sterile condition or whether it has been accessed.

FIGS. 1(a), (b) and (c)illustrate embodiments of a container10,1000according to the present disclosure. The container10,1000comprises a frame12and a sleeve16. The container10,1000is shown in a first configuration with the frame12contained within the sleeve16. The sleeve16and frame12engage to create a sterilization chamber18.

As shown inFIGS. 1(a)-(c)and2, the sleeve16comprises a top panel22, a bottom panel24, a first side panel26and a second side panel28. The top panel22, bottom panel24, first side panel26and second side panel28define a cavity30for receiving and housing the frame12. In one embodiment, the cavity30is generally rectangular in shape. The sleeve16may be constructed from one or more individual panels or constructed as one piece.

In one embodiment, the frame12includes at least a front wall32and a rear wall34which are adapted to receive or hold articles for sterilization. In one embodiment (not shown), the front wall32and rear wall34may be attached or affixed to an existing sterilization cassette or basket which is suitably sized and configured with openings for sterilization of instruments contained therein when inserted in a sleeve16. In another embodiment (not shown), the front wall32and rear wall34may be attached or affixed to an existing sterilization cassette which can be inserted in a suitably sized sleeve (not shown). In yet another embodiment, the frame12includes the front wall32, the rear wall34and a first side wall36and a second side wall38. The frame12is configured or adapted to receive articles for sterilization as described in further detail below.

As illustrated inFIGS. 3(a), 3(b) and 4(a), the frame12and sleeve16are sealably engaged to define the sterilization chamber18. In one embodiment, the frame12slides through a front end40of the sleeve16towards a rear end42of the sleeve16. A rear interface46at the rear end42of the sleeve16engages the rear wall34of the frame12. A front interface48at the front end40of the sleeve16engages the front wall32of the frame12. In one embodiment, the rear wall34of the frame12first sealably engages the rear interface46of the sleeve16and the front wall32of the frame12then engages the front interface48of the sleeve16as the frame12is slid into the sleeve16. In another embodiment, the front wall32of the frame12first engages the front interface48of the sleeve16and then the rear wall34of the frame12sealably engages the rear interface46of the sleeve16as the frame12is slid into the sleeve16.

The dimensions of the container10,1000and the sleeve and frame components may vary, as described below. In some embodiments, the sides of the container, and its frame and sleeve components, are longer than the width of the front and rear ends and the frame is inserted and extends lengthwise through the sleeve as illustrated inFIG. 1(a). In other embodiments, the sides of the container, and its frame and sleeve components, are shorter than the width of the front and rear ends and the frame is inserted and extends widthwise through the sleeve as illustrated inFIGS. 1(b) and (c).

The container10,1000may include a front seal50and a rear seal52at the respective front and rear interfaces48,46, or one or more tortuous paths at the front and rear interfaces48,46, or a combination of seals and tortuous path configurations. A tortuous path refers to a winding or turning path wherein turns in the path inhibit the entrance and travel of bacteria into the container10,1000and sterilization chamber18. A tortuous path may be created between the front wall32of the frame12and the front interface48of the sleeve16by providing, for example, a number of complementary protrusions and/or recesses in the mating surfaces of the front wall32and front interface48as illustrated in at leastFIG. 3(b). Similarly, a tortuous path may be created between the rear wall34of the frame12and the rear interface46of the sleeve16by providing, for example, a number of complementary protrusions and/or recesses in the mating surfaces of the rear wall34and rear interface46. One or a plurality of tortuous paths between the front wall32and front interface48and between the rear wall34and rear interface46inhibit the entrance of bacteria into the container10and sterilization chamber18.

In one embodiment, the container10,1000includes at least one opening for communication between a sterilization apparatus and the sterilization chamber18. In another embodiment, the container10,1000includes a plurality of openings, such as multiple openings in one of the panels of the sleeve16. In the embodiments shown inFIGS. 1(a)-(c)and2, the container10comprises a plurality of openings60in the top panel22and a plurality of openings62in the bottom panel24. The pluralities of openings60,62allow for communication between a sterilization apparatus and the sterilization chamber18as described in detail below. One or more filter assemblies70, also described in further detail below, may be provided adjacent to the plurality of openings60,62. In some embodiments, the pluralities of openings60may be in the side panel26and the pluralities of openings62may be in the side panel28.

To assemble one embodiment of the container10,1000in the first configuration for sterilization, articles are placed in the frame12and the frame12is inserted into the cavity30of the sleeve16. The frame12and sleeve16engage to create the sterilization chamber18. The container10,1000may be placed in a sterilization apparatus and cycles of steam for sterilization and air for drying of the articles within the container10pass through the filter assemblies70and the one or more pluralities of openings60,62. After sterilization, the container10may be removed from the sterilization apparatus and stored which provides for sterile storage of the articles in the container10,1000. In one embodiment, the container1000includes a rear handle1003which may be used along with a knob160provided on the front wall32of the frame12for carrying the container1000when the container is hot.

As shown inFIG. 2, the container10,1000may be freestanding in any orientation. Thus, one or more containers10,1000according to the present disclosure may be stacked and stored in various configurations. The container10,1000may stand or be stored on the bottom panel24as shown inFIG. 2(a). The container10,1000may stand or be stored on the top panel22as shown inFIG. 2(b). The container10,1000may stand or be stored on the first side panel26as shown inFIG. 2(c). The container10,1000may stand or be stored on the second side panel28as shown in FIG.2(d). The container10,1000may stand or be stored on the front end40of the sleeve16as shown inFIG. 2(e). The container10,1000may stand or be stored on the rear end42of the sleeve16as shown inFIG. 2(f). As illustrated inFIGS. 2(g) and 2(h)and described below, the container10,1000may be stacked while in storage or while in a sterilization chamber with a gap2001created between adjacent containers10,1000to facilitate air removal, condensate drainage and steam penetration during sterilization.

FIG. 4(a)illustrates an embodiment of a container10in a second configuration wherein the frame12is removed from and rests on top of the sleeve16.FIG. 4(a)illustrates the frame12resting on top of the top panel22of the sleeve16. Alternatively, the frame12may rest on the bottom panel24when the sleeve16is oriented to stand on the top panel22as shown inFIG. 2(b).FIGS. 4(b) and (c)illustrate a container1000in a second configuration wherein the frame12is removed from and rests on top of the sleeve1016. A groove or channel4005may be provided in the top panel22of the sleeve16, as shown inFIGS. 3(b), 4(b) and 4(c)to accommodate the front wall32of the frame12for the frame12to rest level with the sleeve16. Alternatively, the frame12may rest on the bottom panel24of the sleeve16, the bottom panel24having a similar groove4005

In the embodiment shown inFIG. 4(a), the frame12comprises a front wall32, a rear wall34, a first side wall36and a second side wall38. The frame12is adapted to receive articles such as medical or dental instruments for sterilization. As described further below, in some embodiments, the frame12includes members72to maintain the structure of the frame12. In some embodiments, the frame12includes one or more spacers74to receive articles for sterilization.

FIGS. 5(a) and (b)illustrate an embodiment of a sleeve16according to the present disclosure. The sleeve16is shown with the top panel22facing upwards inFIG. 5(a)and with the bottom panel24facing upwards inFIG. 5(b). In some embodiments, the sleeve16comprises a generally symmetrical construction as shown in the figures. While a symmetrical construction aids in the efficient storage and standing of containers, it will be appreciated that other external configurations or external dimensions of the sleeve16may be provided.

In one embodiment, the sleeve16comprises a transparent or semi-transparent plastic material. The sleeve16may be comprised of polyetherimide (PEI) or polyphenylsulfone (PPSU) or any other suitable material which may withstand multiple washing and sterilization cycles and which is transparent or semi-transparent, such as tempered glass or borosilicate glass. The transparent or semi-transparent material of the sleeve16allows the contents of the container10to be visibly identified without the use of labels. A transparent or semi-transparent sleeve16also allows the status or sterility of the contents be assessed without breaking the sterile seal of the container10. In one embodiment, one or more chemical indicators may be placed or held in the sterilization chamber18and may be viewed through the sleeve16to provide an indication of the sterilization processes experienced by the contents of the container10.

In one embodiment, the sleeve16comprises a first region80, a second region82which is disposed discretely from the first region80and a third region84which is disposed discretely from the second region82. For the purposes of illustration and discussion, the first region80is situated at the front end40of the sleeve16and the third region84is situated at the rear end42of the sleeve16. In one embodiment, the front interface48is provided in the sleeve16between the first and second regions80,82for engaging the front wall32of the frame12, and the rear interface46is provided between the second and third regions82,84for engaging the rear wall34of the frame12. In one embodiment, the container10includes a plurality of openings60in the top panel22of the sleeve16, a plurality of openings62in the bottom panel24of the sleeve16, or pluralities of openings60,62in both the top and bottom panels22,24.

In one embodiment, the outer dimensions of the sleeve16include a width of approximately 154 mm, a length of approximately 239 mm and a height of approximately 51 mm. In another embodiment, the width of the sleeve16may be approximately 77 mm such that two smaller-width sleeves may be stacked or rested on top of a larger width sleeve. In one embodiment, the outer dimensions of the second region82are smaller than the outer dimensions of the first and third regions80,84. However, it is evident that many alternatives, modifications and variations will be apparent to those skilled in the art in light of the present disclosure. In one embodiment, the thickness of the sleeve16in the second region82is substantially the same as the thickness of the sleeve16in the first region80and third region84.

As illustrated inFIGS. 5(a) and (b), in some embodiments the second region82of the sleeve16may be smaller in height and width than the first and third regions80,84of the sleeve16. In one embodiment, the second region82is centered laterally and vertically relative to the first and third regions80,84. Providing a smaller second region82of the sleeve16provides room for air and steam to reach the one or more pluralities of openings60,62when the containers10are stacked in a sterilization apparatus. The smaller outer dimensions of the second region82also allow space for one or more filter assemblies70adjacent to the pluralities of openings60,62. As described below, the third region84need not have the same outer dimensions as the first region80. Providing regions80,84with similar dimensions allows for containers10to be stacked and sit evenly on a surface. Further, providing a second region82which is smaller in height and width than the first and third regions80,84allows some flow of steam, air and condensate between containers10regardless of their placement in a sterilization apparatus.

FIGS. 6(a) and (b)illustrate longitudinal and lateral cross-sections of the sleeve16ofFIG. 5(a). In one embodiment, the top panel22and bottom panel24in the first region80are separated by a first distance “x”; the top panel22and bottom panel24in the second region82are separated by a second distance “y”; and the top panel22and bottom panel24in the third region84are separated by a third distance “z”. In one embodiment, the distances “x” and “z” are approximately equal.

Similarly, as shown inFIG. 6(b), in one embodiment the first side panel26and second side panel28in the first region80are separated by a first distance “a”; the first side panel26and second side panel28in the second region82are separated by a second distance “b”; and the first side panel26and second side panel28in the third region84are separated by a third distance “c”.

In one embodiment, the distance “x” is greater than the distance “y”, and the distance “a” is greater than the distance “b”, thereby forming the front interface48in the transition between the first and second regions80,82. In one embodiment, the front interface48is formed by a transition between the top panel22, bottom panel24and first and second side panels26,28of the first region80and the respective top panel22, bottom panel24and first and second side panels26,28of the second region82. In some embodiments, the front interface48comprises portions of the top panel22, bottom panel24and first and second side panels26,28between the first region80and the second region82which are disposed generally perpendicularly to and outwardly from the top panel22, bottom panel24and first and second side panels26,28of the second region82. As shown inFIGS. 6(a) and (b), in this embodiment, the front interface48has a stepped cross-section at the transitions between the top panels and bottom panels22,24(as shown) and also at the transitions between the respective first and second side panels26,28. In other embodiments, the portions of the top panel22, bottom panel24and first and second side panels26,28between the first region80and the second region82may be configured at different angles or may comprise a curved or curvilinear cross section. In some embodiments, the front interface48comprises equal portions or extensions of the top panel22, bottom panel24, first side panel26and second side panel28.

In another embodiment (not shown), the distances between the top and bottom panels22,24in the first, second and third regions80,82,84may be the same, and the distances between the side panels26,28in the first, second and third regions80,82,84may be the same. In this embodiment, the front interface48comprises portions of the top panel22, the bottom panel24, the first side panel26, the second side panel28, or combinations thereof, which extend inwardly towards the cavity30between the first and second regions80,82. In this embodiment, the distance “x” need not be greater than the distance “y” and the distance “a” need not be greater than the distance “b”. In one embodiment, the portions of the top panel22, the bottom panel24, the first side panel26, the second side panel28or combinations thereof, extend inwardly and generally perpendicularly from the top, bottom, and first and second side panels22,24,26,28. In another embodiment, the portions of the top panel22, the bottom panel24, the first side panel26, the second side panel28, or combinations thereof, may extend inwardly at different angles or may comprise a curved or curvilinear longitudinal cross section.

In another embodiment, the front interface48comprises a front panel (not shown) disposed transversely across the sleeve16between the first and second regions80,82. The front panel may be mounted to the interior of the sleeve16or to portions of the sleeve16which extend inwardly into the cavity30. The front panel includes an opening to allow a portion of the frame12to pass through the front panel to the cavity30of the sleeve16between the second and third regions82,84. A portion of the front wall32of the frame12remains in the first region80and engages the front panel. A front seal50may be placed between the front wall32and the front interface48.

FIGS. 7(a) and 7(b)illustrate one embodiment in which a first surface94of the front interface48faces towards the first region80for engagement with the front wall32of the frame12. The front interface48extends around the interior perimeter of the sleeve16between the first and second regions80,82. In one embodiment, the first surface94of the front interface48is approximately 2.4 mm wide. In other embodiments, multiple surfaces of the front interface48may face in one or more directions towards the first region80for engagement with the front wall32of the frame12.

In one embodiment, as seen inFIGS. 3, 6 and 7, the rear interface46is comprised of one or more portions of the top panel22, the bottom panel24, the first side panel26or the second side panel28, or combinations thereof, which extend inwardly towards the cavity30between the second and third regions82,84. In one embodiment, the portions of the top panel22, the bottom panel24, the first side panel26, the second side panel28or combinations thereof, extend inwardly and generally perpendicularly from the top, bottom, and first and second side panels22,24,26,28. In another embodiment, the portions of the top panel22, the bottom panel24, the first side panel26, the second side panel28or combinations thereof, extend inwardly at different angles or may comprise a curved or curvilinear longitudinal cross section.

In one embodiment, the rear interface46comprises a rear panel (not shown) disposed transversely across the sleeve16between the second and third regions82,84. The rear panel may be mounted to the interior of the sleeve16or to portions of the sleeve16which extend inwardly into the cavity30. The rear panel includes an opening to allow a portion of the rear wall34of the frame12to extend between the second and third regions82,84or to extend into the third region84. A portion of the rear wall34of the frame12remains in the second region82and engages the rear panel. A rear seal52may be placed between the rear wall34and the rear interface46.

In one embodiment, the rear interface46reduces the height and width of the cavity30of the sleeve16between the second and third regions82,84of the sleeve16indicated as height “e” inFIG. 6(a)and width “f” inFIG. 6(b). In one embodiment, the height “e” is approximately 15 mm and the width “f” is approximately 118 mm. As shown inFIG. 3, the height of the portion which extends from the bottom panel24may be greater than the height of the portion which extends from the top panel22. Alternatively, the height of portions which extend from the top panel22, the bottom panel24, the first side panel26and the second side panel28may be approximately equal as shown in.FIGS. 6(a) and (b)andFIGS. 7(a) and 7(b). When the frame12is inserted in the sleeve16, the rear interface46prevents the frame12from being inserted entirely through the second region82into the third region84. A portion of the rear wall34of the frame12may extend between the second and third regions82,84or into the third region84.

In one embodiment, as illustrated inFIGS. 7(a) and (b), a first surface98of the rear interface46faces towards the second region82for engagement with the rear wall34of the frame12. The rear interface46and first surface98extend around the interior perimeter of the sleeve16between the second and third regions82,84. In one embodiment, the first surface98of the rear interface46is approximately 138 mm wide. In other embodiments, multiple surfaces of the rear interface46may face in one or more directions towards the second region82for engagement with the front wall of the frame12.

As shown inFIG. 6, in one embodiment the rear end42of the sleeve16also includes a transition between the top panel22, bottom panel24and first and second side panels26,28of the third region84and the respective top panel22, bottom panel and first and second side panels26,28of the second region82, similar to transitions between panels in the first and second regions80,82for one embodiment of the sleeve16. In one embodiment, the distance “z” is equal to the distance “x” and the distance “c” is equal to the distance “a” in order to provide the third region84of the sleeve16with a size similar or symmetrical to the first region80. In other embodiments, the distance “z” between the top and bottom panel of the third region84is the same as the distance “y” between the top and bottom panel of the second region82; and the distance “c” between the side panels26,28of the third region84is the same as the distance “b” between the side panels26,28of the second region82.

As illustrated inFIGS. 7(a) and (b), the sleeve16may include one or more rails100disposed on an interior surface of the top panel22, the bottom panel24, the first and second side panels26,28, or combinations thereof, to guide the insertion and alignment of the frame12in the sleeve16. The one or more rails100also provide for some displacement between the frame12and the sleeve16. The one or more rails100may allow for the passage of air and steam during the sterilization process. The one or more rails100may separate the frame12from the one or more filter assemblies70.

FIG. 3(a)illustrates a longitudinal cross-section of a container10in accordance with the present disclosure and the engagement between the frame12and the sleeve16in one embodiment. The frame12is generally sized to pass through the first region80of the sleeve16and fit within the cavity30in the second region82of the sleeve16with the height and width of the frame12being less than the height and width of the cavity30in the second region82. When the frame12is slid or inserted into the sleeve16, a portion of the rear wall34of the frame12rests adjacent to or engages the rear interface46. The rear seal52may be disposed between the rear wall34of the frame12and the rear interface46. In one embodiment, the rear seal52is part of or is affixed to the rear wall34. In another embodiment, the rear seal52is affixed to or is part of the rear interface46of the sleeve16. The rear seal52may be comprised of seals on both the rear wall34and rear interface46. As shown inFIG. 7, a portion of the rear wall34of the frame12may extend between the second and third regions82,84or into the third region84of the sleeve16.

A portion of the front wall32of the frame12rests adjacent to or engages the front interface48. A portion of the front wall32of the frame12is sized larger than the front interface48such that the portion of the front wall32of the frame12does not pass through the front interface48into the cavity30in the second region82. The front seal50may be placed between the front wall32and the front interface48. In one embodiment, the front seal50is part of or affixed to the front wall32. In another embodiment, the front seal50is affixed to or, is part of the front interface48, or the front seal50may be comprised of seals on both the front wall32and front interface48.

FIG. 8illustrates a sleeve16with a filter assembly70in accordance with one embodiment of the present disclosure. The sleeve16is configured with a plurality of openings60in the top panel22. The sleeve16includes a base110for receiving the filter assembly70. In one embodiment, the base110is formed as part of the top panel22of the sleeve16and comprises a wall extending outwardly from the top panel22and around the plurality of openings60. The filter assembly70includes a filter layer112and a retainer114to hold the filter layer112within the assembly70and to the sleeve16.

One or more attachment mechanisms may be used to hold the retainer114and filter layer112in place in the base110. In one embodiment illustrated inFIGS. 5, 6 and 8, the retainer114includes one or more snap tabs116which mate with one or more corresponding slots118in the top panel22of the sleeve16as shown inFIG. 8. The snap tabs116may comprise a hooked end which flexes to allow the retainer114to be placed over and locked with the top panel22. The hooked end engages an interior surface of the top panel22to prevent the retainer114and filter layer112from becoming dislodged. In one embodiment, the retainer114is removed from the sleeve16by moving the hooked end of the snap tab116from within the cavity30of the sleeve16in order to free the snap tab116from the slot. A similar filter assembly70may be provided adjacent to the plurality of openings in the bottom panel24.

The retainer114includes a plurality of openings120corresponding in surface area to the plurality of openings60in the sleeve16in order to allow for communication of steam between the sterilization chamber18and the sterilization apparatus. In one embodiment, the retainer114, snap tabs116and slots118may be configured to ensure alignment of the openings120in the retainer114with the openings60in the top panel22when the filter assembly70is fit in place.

The retainer114is comprised of plastic material which provides some flex for the snap tabs116to engage slots118, such as the slots118in the top panel22or bottom panel24as described above. In one embodiment, the retainer114comprises a plastic material such as polyether ether ketone (PEEK). Since the retainer114may be readily replaced, it need not comprise a material which can withstand the same number and duration of sterilization cycles as the sleeve16. In one embodiment, the filter assembly70and retainer114include a filter seal122. The filter seal122may comprise a ring of sealing material adjacent to the retainer114and the sleeve16. In one embodiment, the filter seal122is comprised of silicone and may be formed with the retainer114as an overmoulding from an injection moulding process.

The filter layer112comprises a layer of material which is permeable to gas and steam which enter through the pluralities of openings120,60in the retainer114and top panel22, but blocks the entry of germs, bacteria and other contaminants. The filter layer112may comprise a semi-permanent filter made from material such as Polytetrafluoroethylene (PTFE) which may be used for numerous sterilization cycles. The filter layer112also may comprise disposable or single use filter material such as paper-based filters. In one embodiment (not shown) a filter assembly70is not provided and the pluralities of openings120may be configured to define one or more tortuous paths between the environment of the container and the sterilization chamber18to limit the entry of bacteria. In other embodiments, a combination of a filter assembly70and tortuous path configurations for the pluralities of openings120may be used.

The pluralities of openings60in the sleeve16and filter assembly70also may be configured in shapes and locations other than the circular and centered configuration shown in the figures. In one embodiment, one or more pluralities of openings60and filter assemblies70are provided in one or both of the first and second side panels26,28.

FIGS. 9(a) to (g)illustrate further embodiments of a sleeve1016in accordance with the present disclosure. In some embodiments, the sleeve1016includes one or more notches9003in one or both the top panel22and bottom panel24, in one or both of the first and third regions80,84. The notches9003may be of various shapes such as, but not limited to, a curved or concave shape as illustrated. The notches9003may be located adjacent the knob160and rear handle1003when the sleeve1016and frame12are assembled in the first configuration of the container1000to improve access to the knob160and rear handle1003. In some embodiments, the notches9003allow provide for additional draining of condensate during the sterilization process.

The sleeve1016includes a filter assembly1070similar to the filter assembly70described above, including a base1110formed as part of the top panel22of the sleeve1016and comprises a wall extending outwardly from the top panel22and around a plurality of openings1060in the sleeve1016. In one embodiment, the filter assembly1070includes a retainer1114and filter layer1112to hold the filter layer1112within the assembly1070and to the sleeve1016. In one embodiment, the retainer1114includes two pairs of snap tabs1116which mate with one or more corresponding vertical ribs9011in the sleeve1016. The pairs of snap tabs may be spaced apart such that a user typically must use two hands to unlatch the filter retainer1114, thus reducing the likelihood of a user accidentally removing the filter retainer1114and accidentally comprising load sterility.

In some embodiments, the filter assembly1070includes a plurality of tabs9005in the base1110of the filter assembly1070and corresponding tabs9007in the retainer1114as identified inFIGS. 9(a) and (d)to (g). In one embodiment, four tabs9005and four tabs9007are provided and spaced over side edges of the respective base1110and retainer1114. In one embodiment, once the filter layer1112is placed on the base1110, the retainer1114may be placed over the filter layer1112adjacent the first region80of the sleeve1016. As shown inFIG. 9(g), the tabs9007are of the retainer1114are accepted through corresponding slots in the base1110. As the retainer1114is moved towards the third region84, the tabs9007of the retainer1114slide under the corresponding tabs9005in the base1110to lock the filter layer1112and filter retainer1114in place. In some embodiments, one or more snaps9009on the filter retainer1114are stopped by one or more vertical ribs9011on the base1110. In order for the retainer1114to be removed, the retainer1114and snap9009are lifted to clear the rib9011and allow the retainer1114to be pulled forward for removal.

In one embodiment, as illustrated inFIG. 9(h), a surface of the base1110of the filter assembly1070has a slight gradient and a surface of the retainer1114has a corresponding complementary gradient, which is shown enlarged and exaggerated inFIG. 9(h). As the retainer1114is placed over the base1110and slid towards the third region84to lock the filter assembly1070, the filter layer1112is gradually pressed against the surface of the base1110in order to eliminate any gap for air and steam to pass through between the filter layer1112and the base1110.

In one embodiment, the sleeve1016includes one or more recesses9009in the front interface48of the sleeve1016for receiving projections9011provided in a front wall32of a frame1012. As shown inFIGS. 9(i) and 9(j), the projections9011may comprise one or more tongues extending laterally from the front wall1032of the frame1012towards the second region1082of the sleeve1016. The corresponding recesses9009engage with the projections9011to ensure proper alignment and engagement of the front wall32, front interface48and front seal50.

As described above with respect toFIGS. 3(a) and 3(b), the container10,1000may include a front seal50,1050and a rear seal52,1052at the respective front and rear interfaces48,46, or one or more tortuous paths at the front and rear interfaces48,46, or a combination of seals and tortuous path configurations to inhibit the entrance and travel of bacteria into the container10,1000and sterilization chamber18. In some embodiments, the sleeve1016includes a rib9013in the front interface48which projects slightly from the front interface48towards the first region80of the sleeve1016and defines a channel for receiving the front wall1032of the frame1012. Similarly, the sleeve1016may include a rib9015in the rear interface46which projects slightly from the rear interface46towards the second region82of the sleeve1016and defines a channel for receiving the rear wall1034of the frame1012. As illustrated inFIGS. 9(k), 9(l) and 9(m), the ribs9013,9015may configured in a stepped fashion or with other variations in the geometry and contour of the ribs9013,9015in order to create tortuous paths9019,9021at the interfaces between the frame12,1012and the sleeve16,1016.

The sleeve1016may be constructed from one or more individual panels or constructed as one piece. The sleeve1016may be provided in different sizes and may be moulded from one or more parts. In one embodiment, as illustrated inFIG. 9(n), a larger-sized sleeve is constructed from top and bottom portions of the same injection-moulded part. In another embodiment, a larger-sized sleeve is assembled from the components for two smaller sized sleeves, such as with two filter assemblies1070as illustrated inFIGS. 9(a) to (f).

FIGS. 10(a), (b)and11illustrate a first embodiment of a frame12in accordance with the present disclosure. As described above, in one embodiment, the frame12includes a front wall32and a rear wall34which are joined by first and second side walls36,38. The frame12is adapted to hold one or more articles for sterilization, such as medical or dental instruments. In one embodiment, the frame12includes one or more members72which extend laterally, longitudinally, or both laterally and longitudinally across the frame12. The members72may provide structural support for the frame12. The members72may be situated at the bottom of the walls of the frame12to provide support for the articles received in the frame12. In one embodiment, as seen for example inFIG. 10, the frame12may include one or more members72adjacent to a bottom portion of each of the front, rear and first and second side walls. The members72may comprise bottom portions72ato72dof the front, rear and first and second side walls extending horizontally within the interior of the frame12to add support or stability for the frame12. In some embodiments, the frame12is comprised of a plastic material such as polyphenylene sulfide (PPS) or polyether ether ketone (PEEK) or a metal material such as stainless steel.

In one embodiment, the frame12includes one or more spacers74which are adapted to receive instruments for washing and sterilization and to maintain space between the instruments to allow for the passage of water, steam and air around the instruments during the washing and sterilization processes. In one embodiment, the spacers74are molded as part of the frame12.

The frame12may include one or more handles, such as a handle132, mounted to the first side wall36and the second side wall38adjacent to the front wall32and a handle134mounted to the first side wall36and the second side wall38adjacent to the rear wall34. The handles132,134are pivotally attached to the side walls36,38. In one embodiment of the frame12, the handles132,134are snapped into place by flexing the handles132,134slightly so that pivot pins in the handles132,134enter corresponding pivot holes in the frame12. The handles132,134also may be comprised of a plastic material such as PPS. In one embodiment, the handles132,134are configured in a first position and are contained within an interior136of the frame12. The handles132,134may rest on or adjacent to one or more spacers74to retain or secure the instruments held or resting within the spacer74. When the frame12is not contained within the sleeve16, the handles132,134may be moved to a second position wherein the handles132,134extend outwardly from the frame12as illustrated inFIG. 4. The handles132,134may be used in the second position to move the frame12and instruments contained therein. Adjusting the handles132,134to the second position also allows for access to the instruments contained in the frame12.

The frame12also may include one or more openings135in one or both of the first and second side walls36,38. The openings135may be made within the frame12to allow colour coded buttons (not shown) to be inserted into the openings135to facilitate identification of instruments in the frame12. In some embodiments, the colour coded buttons are visible through the transparent or semi-transparent sleeve16of the container10.

As illustrated inFIG. 11, each of the front wall32and rear wall34comprises a number of components. In one embodiment, the front wall32includes a front base138and a front plate140. The front base138is adapted to receive the front seal50which is held between the front plate140and the front base138. In one embodiment, the front base138is formed as an integral part of the frame12. The front seal50may be comprised of a silicone material such as a 1/16″ thick layer of silicone. In one embodiment, the front seal50has a height and width slightly larger than the front base138so that a portion of the front seal50extends beyond the front base138and is exposed for engagement with the sleeve16. The front seal50may comprise a bulb seal which engages the front interface48and is further compressed as the rear wall34of the frame12engages the rear interface46of the sleeve16. In one embodiment, the front base138includes a front bracket142which is adapted to receive the front seal50and retain the front seal50for engagement with the front interface48. In one embodiment, the front bracket142comprises a wall extending transversely from the front base138and extending around a perimeter of the front base138. The front seal50is configured to be stretched around or retained by the front bracket142. In one embodiment, the front seal50has a rectangular or rounded rectangular hole144so that the front seal50may be placed over and rest on or around a corresponding rectangular or rounded rectangular front bracket142. The front plate140may be affixed to the front base138by one or more screws which mate with one or more threaded cavities in the front bracket142or the front base138.

FIG. 12illustrates a sectional view of a container10showing the frame12partially inserted in the sleeve16and showing a rear view of the front wall32. A portion of the front seal50is exposed for engagement with the first surface94of the front interface48when the frame12is fully inserted in the sleeve16. In one embodiment, the front plate140has a length and height approximately the same as the front seal50. When the frame12is fully inserted in the sleeve16, the front plate140provides support for, and biases the front seal50against, the front interface48. As shown inFIG. 12, the front seal50extends above and below the front base138of the front wall32. The front seal50also may extend beyond the first and second side walls36,38of the frame12.

As illustrated inFIGS. 10, 11, and 14, in one embodiment, the rear wall34includes a rear base146and a rear plate148. The rear base146includes a rear bracket150extending transversely from the rear base146and laterally across a portion of the rear base146. The rear bracket150is adapted to receive the rear seal52. In one embodiment, the rear bracket150comprises a wall extending transversely from the rear base146and extending around a perimeter of the rear base146. The rear seal52may be placed over or stretched around the rear bracket150. The rear bracket150also may include means for receiving and engaging the rear plate148. The rear plate148may be affixed to the rear base146and rear bracket150to hold the rear seal52. The rear plate148may be affixed to the rear base146through mechanical means, such as by a fastener, threaded fastener, machine screw or self-tapping screw. In another embodiment, the rear bracket150is formed from a section of the rear base146which extends outwardly transversely from the rear base146.

The rear seal52may be comprised of a silicone material such as a 1/16″ thick layer of silicone. In one embodiment, the rear seal52has a height and width the same size as or slightly smaller than the height and width of the rear base146. The rear seal52may comprise a bulb seal which engages the rear interface46and is further compressed as the rear wall34of the frame12engages the rear interface46of the sleeve16and as the front wall32of the frame12engages the front interface48of the sleeve16. The rear plate148has a height and width smaller than the height and width of the rear seal52so that a portion of the rear seal52is exposed for engagement with the sleeve16. In one embodiment, the rear seal52has a rectangular or rounded rectangular hole152so that the rear seal52may be stretched and placed over and rest on or around the rear bracket150.

FIG. 13illustrates another embodiment in which the rear wall34comprises a rear base146and a rear bracket151which is formed from and which extends transversely from the rear base146. The rear bracket151includes a first section151aadjacent to the rear base146and a second section150badjacent to the first section151a, with the second section151bhaving a height and width greater than the first section151a. As illustrated inFIG. 13, the rear seal52may be placed or stretched over the second section151band rest on or around the first section151aadjacent to the rear base146. The second section151bof the bracket151has a height and width smaller than the height and width of the rear seal52so that a portion of the rear seal52is exposed for engagement with the sleeve16.

In one embodiment of the container10as shown inFIGS. 13 and 14(b), a portion of the rear wall34of the frame12extends into the third region84of the sleeve16. This provides a lead-in to center the frame12and the rear seal52with the rear interface46. As shown inFIG. 14(b)a fillet radius of the rear plate148creates a cam action as the frame12is inserted in the sleeve16and guides the frame12upwards slightly to center the rear seal52against the rear interface46. In embodiments where the dimensions of the sleeve16, front interface48and rear interface46are symmetrical, the frame12may be inserted in the sleeve16with either the top panel22or the bottom panel24of the sleeve16facing upwards.

FIG. 13illustrates a sectional view of the frame12and rear wall34with the frame12partially inserted in the sleeve16. A portion of the rear seal52is exposed for engagement with a first surface98of the rear interface46when the frame12is fully inserted in the sleeve16.

FIGS. 14(a) and (b)provide close-up side sectional views of the container10and engagement between the front wall32and rear wall34and the sleeve16. As shown inFIG. 13(a), a portion of the front seal50engages a portion of the first surface94of the front interface48. As shown inFIG. 14(b), a portion of the rear seal52engages a portion of the first surface98of the rear interface46.

As shown inFIG. 11, in one embodiment the front wall32includes a knob160which may serve multiple functions. The knob160may include one or more tabs162which extend from the knob160in a plane parallel to the front wall32. When the frame12is inserted in the sleeve16, the knob160and tabs162may be turned or oriented to align with and extend into or through one or more slots164in the top panel22, the bottom panel24, or both the top and bottom panels22,24of the sleeve16. See, for example, the illustrations inFIGS. 1, 3 and 14. The engagement of the one or more tabs162with the one or more slots164in the sleeve16serves to lock the frame12in place in the sleeve16and maintains compression of front seal50and rear seal52to the respective front and rear interfaces48,46on sleeve16. The knob160may be turned to move the tabs162out of the slots164to allow for the removal of the frame12from the sleeve16.

As shown inFIG. 15, when the container10is arranged in the second configuration, the front wall32of the frame12may rest on the top panel22or on the bottom panel24of the first region80of the sleeve16. The knob160and the one or more tabs162may be turned or oriented to align with and extend into or through the slot164in the top panel22or the bottom panel24. The engagement between the tab162and slot164in the second configuration helps to prevent the frame12from moving when resting on top of the sleeve16.

In some embodiments, the container10includes a holder for a label or chemical indicator (not shown), such as the holder168shown on the front plate140of the frame12inFIG. 11. A chemical indicator may change color after undergoing a sterilization process and provides an indication of the treatment of container10. The holder168allows the chemical indicator to be removed and replaced after each sterilization cycle and use of the container10and instruments contained therein. In other embodiments, the holder168is adapted to retain a radio frequency identification (RFID) module that contains an autoclavable RFID tag for tracking of container contents.

In some embodiments, as shown inFIG. 25(a)and FIGS.26(a) to (d), the container10,210includes a holder169for retaining an indicator269. The holder169may be located on a portion of the frame12which is visible when the frame12is inserted in the sleeve16,216. When the frame12and sleeve16,216are in the first configuration, the indicator269is located in the holder169in the sterilization chamber18,218. The indicator269is thus exposed to the same conditions as, and provides an indication of, the state of the articles in the container10,210. The indicator269may comprise a chemical or biological based indicator and may provide a visual or other indication of the state and history of conditions to which the indicator269has been exposed. With the sleeve16,216or a portion of the sleeve16,216comprised of a transparent or semi-transparent material, the indicator269in the holder169of the frame12may be viewed to determine the sterilization status of the contents of the container10,210without breaking the sterile seal of the container10,210. In other embodiments, one or more holders169and indicators269may be configured in different areas of the frame12.

In other embodiments, the handles1132,1134and supports or spacers of the frame1012are configured to retain one or more chemical indicators1269. For example, as illustrated inFIGS. 26(e) and (f), a chemical indicator1269may be retained between the handle1132and the first support1071of the frame1012, which is described in further detail below. As the handle1132is lowered down over the instruments and support1071, the chemical indicator1269is also held in place. In some embodiments, serrated surfaces2601may be provided on one or both of the inner surface of handle1132and the top surface of the first support1071to secure the indicator1269. One or more chemical indicators1269may be secured between the first support1071and the handle1132and one or more chemical indicators1269may be secured between the spacer1074and the handle1134. Indicators2603may be provided on the handles1132,1134to signal the locations for placement of the chemical indicators1269. In these embodiments, different sized chemical indicators may be accommodated without requiring additional space or custom compartments within the container10,1000.

In some embodiments, the container10includes a tamper evident mechanism170. The tamper evident mechanism170may comprise a tamper evident latch172and shape memory compression spring174. The latch172may be comprised of PEEK and the compression spring174may be comprised of a nickel titanium alloy such as nitinol. The tamper evident mechanism170responds to elevated temperatures in a sterilization apparatus. The compression spring174expands as a result of the elevated temperatures and forces the latch172to move laterally or outwardly from the tamper evident mechanism170. In another embodiment, the shape memory compression spring can be replaced by a linear-motion thermal actuator.

FIGS. 16(a) to (e)illustrate a front view of the container10and show an example embodiment of the tamper evident mechanism170working in cooperation with the knob160. InFIG. 16(a), the frame12is inserted in the sleeve16but the knob160and tabs162are at a position wherein the tabs162do not extend beyond the frame12. As shown inFIG. 16(b), the knob160may be turned, for example rotated clockwise by 90 degrees, to align the tabs162of the knob160with the slots164in the sleeve16. In one embodiment, a symbol176such as an image of a deadbolt lock or the word “LOCK” is placed on the front of the front plate140. The symbol176is revealed when the knob160is turned to the locked position to provide feedback and a quick visual indication that the container10is in a locked position.FIG. 16(c)illustrates the container10after a sterilization process. The compression spring174is expanded due to the high temperatures experienced during the sterilization process and the latch172is pushed by the compression spring174and moved outwardly from the tamper evident mechanism170. In one embodiment, the knob160includes one or more recesses178which correspond in shape to the profile of the latch172. As the latch172extends out from the mechanism170, it engages the recess178of the knob160and prevents the knob160from being rotated. The mechanism170is configured such that the latch172may not be pulled out of the tamper evident mechanism170manually, the latch172is configured to extend from the mechanism170only in response to the temperatures of a sterilization process. Thus, as shown inFIG. 16(c), the status of the container10and articles contained therein is clearly indicated by the lock symbol176and the appearance of the latch172engaging the knob160.FIG. 16(d)illustrates the first step to open the container10. In one embodiment, the latch172retracts in response to the cam action of the profile of the knob160as the knob160is rotated to an “unlock” position. In another embodiment, the latch172first must be manipulated back into its original position in the mechanism170prior to rotation or movement of the knob160. The latter two-step process to unlock the container10provides protection against users accidentally turning the knob160. After the latch172is returned to the mechanism170, it is disengaged from the recess178of the knob160and the knob160may be turned as illustrated inFIG. 16(e). As the knob160is turned, for example turned 90 degrees in a counter-clockwise direction, the tabs162are removed from the slots164in the sleeve16. With the tabs162in positions which do not extend beyond the frame12, the frame12may be removed from the sleeve16.

FIGS. 17 to 20illustrate alternative embodiments of a container210which includes a frame12and a sleeve216. In the illustrated embodiments, the sleeve216and frame12sealably engage to create a sterilization chamber218. The sleeve216comprises a top panel222, a bottom panel224, a first side panel226and a second side panel228. The top panel222, bottom panel224, first side panel226and second side panel228define a cavity230for receiving and housing the frame12. In one embodiment, the cavity230is generally rectangular in shape.

In one embodiment, a rear interface246at a rear end242of the sleeve216engages the rear wall34of the frame12. A front interface248at a front end240of the sleeve216engages the front wall32of the frame12. The container210may include a front seal50and a rear seal52at the respective front and rear interfaces248,246, one or more tortuous paths (not shown) at the front and rear interfaces248,246, or a combination of seals and tortuous path configurations. The front and rear interfaces248,246may be formed as described above.

The container210includes at least one opening for communication of steam and air between a sterilization apparatus and the sterilization chamber218. In one embodiment, as illustrated inFIGS. 18and19, the sleeve216includes a plurality of openings260in the top panel222of the sleeve216, and a plurality of openings262in the bottom panel224of the sleeve216. An opening or a plurality of openings may be provided in one or both side panels226,228.

One or more filter assemblies70, comprising a retainer114and a filter layer112, as described above, may be provided adjacent to the pluralities of openings260,262in the container210. The filter assembly70(not shown inFIGS. 18 and 19) may be sized to correspond to the plurality of openings260in the sleeve216. The sleeve216includes a base264for receiving the filter assembly70. The base264comprises a wall extending outwardly from the top panel222and around the plurality of openings260. In one embodiment, the base264comprises a segment of aluminum tube which is formed and press-fit into a recessed portion of the top panel222of the sleeve216. A base264for receiving a filter assembly70also may be provided around the plurality of openings262in the bottom panel224, or around other openings provided in the sleeve216for the communication of steam and air.

One or more attachment mechanisms may be used to hold the retainer114and filter layer112of the filter assembly70in place in the base264. As described above, the retainer114includes one or more snap tabs116which mate with one or more corresponding slots in the top panel222of the sleeve216. The snap tabs116may comprise a hooked end which flexes to allow the retainer114to be placed over and locked with the top panel222. The hooked end engages an interior surface of the top panel222to prevent the retainer114and filter layer112from becoming dislodged. In one embodiment, the retainer114is removed from the sleeve216by moving the hooked end of the snap tab116from within the cavity230of the sleeve216in order to free the snap tab116from the slot.

The plurality of openings260in the sleeve216and the plurality of openings120in filter assembly70also may be configured in shapes and locations other than the circular and centered configuration shown in the figures. In one embodiment, one or more pluralities of openings260and filter assemblies70are provided in one or both of the first and second side panels226,228.

In one embodiment, the sleeve216comprises a first region280, a second region282which is disposed discretely from the first region280, and a third region284which is disposed discretely from the second region282. For the purposes of illustration and discussion, the first region280is situated at the front end240of the sleeve216and the third region284is situated at the rear end242of the sleeve216. In one embodiment, the front interface248is provided in the sleeve216between the first and second regions280,282for engaging the front wall32of the frame12and the rear interface246is provided between the second and third regions282,284for engaging the rear wall34of the frame12.

The second region282comprises a section292which is comprised of a metal material such as aluminum. In one embodiment, the section292comprises a portion of each of the top panel222, the bottom panel224, the first side panel226and the second side panel228being comprised of, metal. In one embodiment, the section292is relatively centered within the second region282. The metal section292stores heat during the sterilization phase of a sterilization process and then releases the stored thermal energy during the drying phase of the sterilization process to facilitate the drying of the contents in the sterilization chamber218.

As illustrated in further detail inFIGS. 19, 20(a) and20(b), the section292may be constructed separately and affixed to respective front and rear sections295,297of the second region282. In some embodiments, as illustrated, the section292is mechanically affixed to respective front and rear sections295,297of the second region282such as by fasteners, threaded fasteners, machine screws or self-tapping screws. In some embodiments, as illustrated, front and rear seals comprising medical adhesive sealant material, such as an epoxy material, are provided on the mating surfaces298of the front and rear sections295,297of the second region282. In some embodiments, additional front and rear seals (not shown) comprising gaskets or o-rings are provided between the front section295and a front portion300of the section292and between the rear section297and a rear portion302of the section292.

The first region280, third region284and the front and rear sections295,297of the second region282of the sleeve216may be comprised of polyetherimide (PEI) or polyphenylsulfone (PPSU) or any other suitable material which may withstand multiple washing and sterilization cycles and which is transparent or semi-transparent such as tempered glass or borosilicate glass. The section292of the second region282of the sleeve216may be comprised of metal such as aluminum or specifically, aluminum6063. The first region280and the front section295may be formed as one piece and the third region284and rear section297also may be formed as one piece. In one embodiment, the holder169of the indicator269is situated on the frame12so as to be visible through the front section295or rear section297of the second region282of the sleeve216to provide an indication of the sterilization process received by the contents of the container210.

FIGS. 21 to 24illustrate alternative embodiments of frames in accordance with the present disclosure.FIGS. 21 and 22illustrate a frame312which is adapted to receive a basket320. The frame312may also receive other cassettes containing instruments and articles for sterilization. In some embodiments, the frame312(not shown) comprises a front wall and a rear wall which are adapted to be affixed to the basket. In other embodiments, the frame312includes a front wall332, a rear wall334, a first side wall336and a second side wall338which are adapted to receive the basket320. In one embodiment, the frame312may include one or more members340a,340b,340c,340dadjacent to a bottom portion of each of the front, rear and first and second side walls332,334,336,338as illustrated inFIGS. 21(b)and22. The members340a,340b,340c,340dmay comprise bottom portions of the front, rear and first and second side walls extending horizontally within the interior of the frame312to add support or stability for the frame312. In other embodiments (not shown), the frame312is adapted to receive other instrument assemblies including but not limited to instrument cassettes and spacers or holders designed to receive particular medical or dental instruments, such as hinged instruments, lumens and dental implants. The front wall332and rear wall334may comprise a number of components and are configured as described above for engaging the front and rear interfaces48,248,46,246of the sleeve16,216.

The basket320comprises a front wall342, a rear wall344, a first side wall346and a second side wall348. The basket320may receive instruments or articles for sterilization. The basket320may include a plurality of openings in the front, rear and side walls342,344,346,348or the basket320may comprise a mesh structure as illustrated. In one embodiment, one of the first or second side walls336,338of the frame312includes at least one slot350which is adapted to receive a tab354extending from a corresponding side wall of the basket. In one embodiment, the basket320includes tabs354on the first and second side walls336,338which are adapted to be received by respective slots350in the side walls336,338of the frame312. The engagement of the tabs354and, slots350secures the basket320within the frame312. The basket320may be comprised of a material which may be flexed and mounted to fit within the frame312with the tabs354aligned within the slots350. In other embodiments (not shown), the basket320may include tabs which may be flexed and inserted into the slots350. In other embodiments, the basket320may be affixed to the frame312with clips (not shown), such as clips comprised of spring steel. In one embodiment, the basket320is comprised of a metal material such as stainless steel 304 or a plastic material such as polyphenylene sulfide (PPS) or polyether ether ketone (PEEK). A basket320comprised of a metal material also serves to store thermal energy during the sterilization phase of the sterilization process and facilitates drying of the articles in the container10during the drying phase of the sterilization process. In some embodiments, the frame312is comprised of a plastic material such as polyphenylene sulfide (PPS) or polyether ether ketone (PEEK).

FIGS. 23 and 24illustrate a frame412in accordance with another embodiment of the present disclosure. In some embodiments (not shown), the frame412comprises a front wall and a rear wall which are adapted to receive articles for sterilization. In other embodiments, the frame412includes a front wall432, a rear wall434, a first side wall436and a second side wall438which are adapted to receive one or more instruments (not shown) for sterilization. The frame412is comprised of a metal material such as stainless steel 304, which stores heat during a sterilization phase and releases stored thermal energy during a drying phase to facilitate the drying of the load at the end of the sterilization process.

As illustrated inFIGS. 23 and 24, the frame412comprises a front wall432, a rear wall434, a first side wall436and a second side wall438. The frame412is adapted to hold one or more articles for sterilization, such as medical or dental instruments. In one embodiment, the frame412includes one or more members440which extend laterally, longitudinally, or both laterally and longitudinally across the frame412. The members440may provide structural support for the frame412. The members440may be situated at the bottom of the walls of the frame412to provide support for the articles received in the frame412. In one embodiment, the frame412includes one or more members440adjacent to a bottom portion of each of the front, rear and first and second side walls. The members440may comprise bottom portions440a,440b,440c,440dof the front, rear and first and second side walls432,434,436,438extending horizontally within the interior of the frame412to add support or stability for the frame412.

As illustrated, the one or more members440may support one or more spacers442which are adapted to receive instruments for washing and sterilization and to maintain space between the instruments to allow for the passage of water, steam and air around the instruments during the washing and sterilization processes. The spacers442may comprise a silicone material. The spacers442may be mechanically affixed to the members440of the frame412.

The frame412may include one or more handles, such as a handle446mounted to the first side wall436and the second side wall438, adjacent to the front wall432and a handle448446mounted to the first side wall436and the second side wall438adjacent to the rear wall434. The handles446,448are mechanically and pivotally attached to the side walls436,438. In one embodiment, the handles446,448are pivotally attached permanently to the frame412using self-clinching fasteners or rivets. The handles446,448also may be comprised of stainless steel or plastic material such as polyphenylene sulfide (PPS) or polyether ether ketone (PEEK). In one embodiment, the handles446,448are configured in a first position and are contained within an interior450of the frame412. The handles446,448may rest on or adjacent to one or more spacers442to retain or secure the instruments held or resting within the spacer442. When the frame412is not contained within the sleeve16,216, the handles460,462may be moved to a second position wherein the handles446,448extend outwardly from the frame412. The handles446,448may be used in the second position to move the frame412and instruments contained therein. Adjusting the handles446,448to the second position also allows for access to the instruments contained in the frame412.

In some embodiments, the front wall432and rear wall434comprise a number of components and are configured as described above for engaging the front and rear interfaces48,248,46,246of the sleeve16,216. In some embodiments, the front wall432includes a front base460and a front plate462. The front base460is adapted to receive the front seal50which is held between the front plate462and the front base460. In one embodiment, the front seal50has a height and width slightly larger than the front base460so that a portion of the front seal50extends beyond the front base460and is exposed for engagement with the sleeve16,216. In one embodiment, the front base460includes a front bracket464which is adapted to receive the front seal50and retain the front seal50for engagement with the front interface48. The front base460and front bracket464may be comprised of stainless steel and may be spot-welded together and spot-welded to the frame412. The front seal50is configured to be stretched around or retained by the front bracket464. In one embodiment, the front seal50has a rectangular or rounded rectangular hole144so that the front seal50may be placed over and rest on or around a corresponding front bracket464. The front plate462may be comprised of PPS and may be affixed to the front base460by one or more screws which mate with one or more threaded cavities in the front bracket464or the front base460.

In one embodiment, the rear wall434includes a rear base480and a rear plate482. The rear base480includes a rear bracket484extending transversely from the rear base480and laterally across a portion of the rear base480. The rear bracket484is adapted to receive the rear seal52. The rear seal52may be placed over or stretched around the rear bracket484. The rear bracket484also may include means for receiving and engaging the rear plate482. The rear plate482may be affixed to the rear base480and rear bracket484to hold the rear seal52. The rear plate482may be comprised of sheet metal and may be affixed to the rear base480through mechanical means, such as by a fastener, threaded fastener, machine screw or self-tapping screw. In another embodiment, the rear bracket484is formed from a section of the rear base480which extends outwardly transversely from the rear base480. The rear seal52has a height and width the same size as or slightly smaller than the height and width of the rear base480. The rear plate482has a height and width smaller than the height and width of the rear seal52so that a portion of the rear seal52is exposed for engagement with the sleeve16,216. In one embodiment, the rear seal52has a rectangular or rounded rectangular hole152so that the rear seal52may be stretched and placed over and rest on or around the rear bracket484.

FIGS. 27 to 32illustrate alternative embodiments of frames according to the present disclosure which may be engaged with the sleeves described herein to create a container for sterilization and storage. In one embodiment, the frame1012includes a front wall1032and rear wall1034which are joined by first and second side walls1036,1038.

The front wall1032includes a front base1138and a front plate1140as illustrated inFIGS. 28 and 29. In some embodiments, the front seal1050is comprised of an o-ring in silicone material. The front seal1050is held within a channel in the front plate1140. When the front plate1140is mounted to the front base1138, at least a portion of the front seal50is exposed around the circumference of the front wall1032as shown inFIG. 27(b), for engagement with the sleeve16,1016, as described above. In some embodiments, the front plate1140is affixed to the front base1138by mechanical means such as by a fastener, threaded fastener, machine screw or self-tapping screws2801as shown inFIG. 28.

In one embodiment as illustrated inFIGS. 27(b),28and30, the rear wall1034includes a rear bracket1150which is adapted to receive the rear seal1052. In some embodiments, the rear seal1052comprises an o-ring in silicone material. The rear seal may be placed over the bracket1150and exposed when the frame1012and rear interface46of the sleeve16,1016are engaged, as described above. In some embodiments, the rear bracket1150includes a channel3001for receiving the rear seal1052. Various means may be provided to retain the rear seal52in the channel3001and to prevent the rear seal1052from becoming dislodged before the frame1012and sleeve16,1016are engaged, such as by indenting or angling one or more portions of the rear bracket1150inwardly towards the rear seal1052. In one embodiment, as shown inFIG. 30, the rear bracket1150and channel3001may include one or more small protrusions3003wherein the walls of the channel3001are indented slightly towards the rear seal1052. The width of the channel3001is effectively reduced at one or more points to hold the rear seal1052in place.

In some embodiments, the front and rear seals1050,1052may be provided on the respective front and rear interfaces,48,46of the sleeve16,1016. Providing the front and rear seals1050,1052on the frame12,1012allows for easier access to the seals for inspection and cleaning.

FIG. 31illustrates a top view of the front plate1140according to an embodiment of the present disclosure. The front plate1140includes one or more condensate drains3101to assist with draining condensate from the container10,1000, including condensate from the front wall1032. The drains3101may be provided at numerous locations on the front plate1140as shown in order to facilitate the draining of condensate in any orientation of the container10,1000as illustrated inFIGS. 2(a) to (h).

In one embodiment, the frame1012includes one or more supports, such as a first support1071and a second support1073to receive articles for sterilization. One or more spacers1074may be provided to maintain space between the instruments to allow for the passage of water, steam and air around the instruments during the washing and sterilization processes. Handles1132,1134may be provided and may be pivotally attached to the front and rear walls1032,1034. The handles1132,1134may rest on or adjacent the one or more supports1071,1073or spacers1074. In one embodiment, as illustrated in at leastFIGS. 27(a)and32, the second support1073is positioned in the frame1012behind the center line3201of the frame1012. The instrument3203rests on the supports in a stable fashion since the second support1073is positioned behind the center of gravity of the instrument. When a user depresses one end of the instrument3203, shown by the arrow3205inFIG. 32, the second support1073acts as a pivot and the instrument3203is raised above the first support1071and above the frame1012. The user may then pick up the instrument3203by the raised portion of the instrument handle. While the second support1073does not function to retain the instruments within the frame1012, it improves the ability of a user to retrieve an instrument from among instruments which may be densely packed in the frame1012. It will be appreciated that in some embodiments, the second support1073may be positioned differently with respect to the center line3201depending on the instruments to be support by the frame1012.

In another embodiment, the frame1012may be comprised of multiple existing frames which are modified and joined together, as illustrated inFIG. 33. In this embodiment, the rear wall1034of the one frame1012amay be mechanically fixed to the front base1138of a second frame1012b. A front plate1140and front seal1050are provided for the first frame1012aand a rear bracket1150and rear seal1052are provided for the second frame1012b, as described above. It will be appreciated that frames1012of various dimensions may be provided and two or more frames may be fixed together with a front plate1140and front seal1050provided for the first frame and a rear bracket1150and rear seal1052are provided for the last frame. For example, three smaller sized frames may be combined and inserted into a larger sized sleeve to create the sterilization container. Alternatively, two medium sized frames may be combined and inserted into a larger sized sleeve to create the sterilization container. Thus, flexibility is provided in the configuration of the frame, and contents which may be placed in the frame and container for sterilization. In some embodiments, one or more frames may be adapted to support a basket, such as but not limited to basket320as described above. The frame1012may also receive other cassettes containing instruments and articles for sterilization. Thus, the frame1012may support a combination of one or more supports, racks, baskets, and/or cassettes for receiving instruments prior to the frame being engaged with a sleeve16,1016.

It will be appreciated that various configurations of containers for washing, sterilization, transportation and sterile storage of articles may be provided by combining the various sleeves16,216,1016and frames12,212,312,412,1012and that portions of the sleeves16,216,1016and frames12,212,312,412,1012may be comprised of metal, plastic and glass materials as described herein.

Thus, it is apparent that there has been provided in accordance with the invention a container for washing, sterilization, transportation and sterile storage of articles that fully satisfy the objects, aims and advantages set forth above. While the invention has been described in conjunction with illustrated embodiments thereof, it is evident that many alternatives, modifications and variations will be apparent to those skilled in the art in light of the foregoing description. Accordingly, it is intended to embrace all such alternatives, modifications and variations as fall within the spirit and broad scope of the invention.