Patent Description:
Personnel in the Central Service Room (CSR) or the Sterile Processing Department (SPD) of hospitals are commonly charged with the responsibility of packaging surgical supplies to ensure that the sterility of the packaged contents is maintained from sterilization to the point of reuse. Several activities are involved in the task of sterile supply delivery to the operating room and other units.

Much of the surgical instruments and supplies used in the operating room are reusable. These supplies typically include such things as clamps, scalpel blade handles, retractors, forceps, scissors, surgeon's towels, basins, and the like. All of these supplies must be collected after each procedure, decontaminated, placed in a sterilization packaging system, and sterilized before they can be used again in another procedure. The sterilization packaging systems used must be of the size and shape to accommodate the items to be sterilized and must be compatible with and withstand the physical conditions of the sterilization process.

Typical means of sterilizing instruments include, among others, autoclaving with steam, exposure to ethylene oxide gas, and exposure to hydrogen peroxide plasma, as is done with the STERRAD® Sterilization System from Advanced Sterilization Products, Irvine, Calif. After the package and its contents have been sterilized, the sterilization package typically is stored until it is needed for a surgical procedure.

Common sterilization packaging systems include sealable pouches, sterilization wraps, and rigid containers. Although each of these systems has some advantage compared to other systems, each of these typical packaging systems also has drawbacks. As an example, using a sterilization wrap to package items to be sterilized in a certain prescribed manner will permit the entry of sterilizing vapor/gas or other medium to sterilize the contents of the wrapped package while denying the ingress of contaminants such as bacteria and other infection causing materials or their vehicles after sterilization. As such, sterilization wraps generally provide a consistent barrier against the ingress of contaminants. However, during storage and transfer to the operating room, the wrapped package may be handled several different times; each time the wrapped package is handled, there is a potential that the sterile nature of the package contents can be compromised, e.g., by a tear, cut, or other breach of the wrapping material.

As another example, sterilization containers - such as, e.g., a metal box and a rigid top or lid that closes the metal box - also can permit the entry of sterilizing medium while denying the ingress of contaminants after sterilization. Unlike sterilization wraps, rigid sterilization containers usually avoid tears, cuts, and the like that can compromise the sterilized contents of the container. However, typical rigid sterilization containers are complex packaging systems, including several parts that must be precisely assembled to prevent compromising the contents of the container after sterilization. Further, some parts of the sterilization container assembly are prone to warping, denting, and breakage, as well as mismatching, loss, and/or other damage. Thus, even if the parts of the container can be assembled, damaged parts can prevent proper assembly of the sterilization container and thereby allow the ingress of contaminants after sterilization.

Consequently, there is a need for a sterilization packaging system that overcomes the shortcomings of known packaging systems. In particular, a sterilization packaging system that reduces the number of packaging components and the number of steps required to assemble the sterilization packaging system while minimizing the costs of and the material required for the sterilization packaging system would be beneficial. Additionally, a sterilization packaging system that provides a consistent barrier against the ingress of contaminants while avoiding post-sterilization breaches of the packaging system would be advantageous. Moreover, a sterilization packaging system that increases confidence that a sterilized package has not been breached also would be useful.

<CIT> and <CIT> are related to sterile packaging solutions for medical instruments.

The disclosure provides sterilization packaging systems with features for sealing a volume against an ingress of contaminants. Such features include a sealing assembly, where the sealing assembly includes a sheet of sterilization material and a clamp for sealing the sheet of sterilization material against a container to seal the volume of the container from contaminants. The features further include a sterilization wrap and a lid for sealing a volume defined by the sterilization wrap and a frame. The present disclosure also provides a sealing assembly including a sheet of sterilization material and a clamp having open position and clamped positions. The clamp is configured to extend about a perimeter of a container, the sheet of sterilization material is disposed between the container and the clamp when the clamp is in the clamped position to seal a volume of the container, and the clamp is held in the clamped position by a latch. Additional aspects and advantages of the disclosure will be set forth in part in the following description, may be apparent from the description, or may be learned through practice of the invention.

In one aspect, the present subject matter is directed to a sterilization packaging system. The sterilization packaging system includes a frame, a sterilization wrap, and a lid. The frame defines a vertical direction and may include a plurality of vertical members extending along the vertical direction and a plurality of horizontal members extending perpendicular to the vertical direction. Each vertical member and horizontal member of the frame may have an inner side and an outer side. The sterilization wrap may include a first portion positioned adjacent the inner side of each vertical member and each horizontal member to define a volume and an opening to access the volume. Further, the sterilization wrap may be disposed between the lid and the frame. Moreover, the lid may be provided to seal the volume against an ingress of contaminants. In certain embodiments, the sterilization wrap is disposable. It should be understood that the sterilization packaging system may be further configured with any of the additional features as described herein.

In some embodiments, the frame is constructed from a rigid material. In another embodiment, the vertical members and the horizontal members of the frame may define a plurality of windows. As such, the sterilization wrap may be visible through the windows.

In another embodiment, the sterilization wrap of the sterilization packaging assembly may include a second portion. The second portion may be positioned across the opening defined by the sterilization wrap and the frame to cover the opening. In some embodiments, the lid is positioned in contact with the second portion of the sterilization wrap to seal the volume. In still other embodiments, the sterilization wrap may be folded over to define the second portion of the sterilization wrap. When the sterilization wrap is folded, a fold may be defined between the second portion and the first portion of the sterilization wrap.

In another embodiment, the lid may comprise a lip defined along a perimeter of the lid. The lid also may include a flange adjacent the lip, and the flange may define a recess. A gasket may be positioned in the recess to seal the volume from contaminants. In some embodiments, the gasket may be an inflatable gasket. Alternatively or additionally, a portion of the sterilization wrap is disposed between the gasket and a flange of the frame. In still other embodiments, a depression may be defined along the lip defined by the perimeter of the lid. The depression may be configured such that a second sterilization packaging system may be stacked on top of the lid.

In yet another embodiment, the lid comprises a plurality of ribs. As such, the ribs may, for example, support a sterilization packaging system stacked on top of the lid or may provide rigidity to the lid.

In still other embodiments, the sterilization packaging system may include a sterility gauge for signaling whether the volume is sealed against contaminants. More specifically, the sterility gauge may comprise a binary visual signal.

In another embodiment, the lid is positioned adjacent a top portion of the frame to seal the volume against contaminants. In some embodiments, the lid may have a shape complementary to a shape defined by the top portion of the frame.

In another aspect, the present subject matter is directed to a sterilization packaging system including a frame defining a vertical direction. The frame includes a plurality of vertical members extending along the vertical direction and a plurality of horizontal members extending perpendicular to the vertical direction. Each vertical member and horizontal member has an inner side and an outer side. The sterilization packaging system further comprises a sterilization wrap. A first portion of the sterilization wrap is positioned adjacent the inner side of each vertical member and each horizontal member to define a volume and an opening to access the volume. The sterilization packaging system also includes a lid for sealing the volume against an ingress of contaminants and a sterility gauge for signaling whether the volume is sealed against contaminants. The sterility gauge is positioned on the lid.

It should be appreciated that the sterilization packaging system may be further configured with any of the additional features as described herein. For example, in some embodiments, the sterility gauge comprises a binary visual signal. Alternatively or additionally, a second portion of the sterilization wrap may be positioned across the opening to cover the opening. Further, the lid may be positioned in contact with the second portion of the sterilization wrap to seal the volume.

In yet another aspect, the present subject matter is directed to a sterilization packaging system that comprises a frame defining a vertical direction. The frame includes a plurality of vertical members extending along the vertical direction and a plurality of horizontal members extending perpendicular to the vertical direction. Each vertical member and horizontal member has an inner side and an outer side. The sterilization packaging system further comprises a sterilization wrap including a first portion and a second portion, and the first portion defines a volume. The sterilization packaging system also includes a lid for sealing the volume against an ingress of contaminants. The first portion of the sterilization wrap is positioned adjacent the inner side of each vertical member and each horizontal member to define the volume and an opening to access the volume. The second portion of the sterilization wrap is configured to be positioned across the opening to cover the opening, and the lid is configured to be positioned in contact with the second portion of the sterilization wrap to seal the volume. It should be understood that the sterilization packaging system may be further configured with any of the additional features as described herein.

These and other features, aspects, and advantages of the present disclosure will become better understood with reference to the following description and appended claims. The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate embodiments and, together with the description, serve to explain the principles of the invention.

A full and enabling disclosure including the best mode thereof, directed to one of ordinary skill in the art, is set forth in the specification, which makes reference to the appended figures, in which:.

Reference now will be made in detail to embodiments of the disclosure, one or more examples of which are illustrated in the drawings. Each example is provided by way of explanation, not limitation of the invention. Thus, it is intended that the present disclosure covers such modifications.

Described herein is a sterilization packaging system and components thereof suitable for use in a variety of procedures for containing, sterilizing, storing, and using sterilized items such as surgical supplies. While described in conjunction with its use in hospital and surgical room procedures, the present subject matter is intended for use wherever there is a need for sterilized materials. Consequently, the following description should not be considered a limitation as to the scope of use of the present subject matter.

<FIG> provides a perspective view of a sterilization container system as described above and as generally known in the art. In typical container systems, such as container system <NUM>, one or more items to be sterilized are placed in a container <NUM>, which generally is a rigid metal box. Container <NUM> may define one or more vents <NUM>. A lid or top <NUM> is placed on container <NUM> to seal container <NUM> for sterilization. As shown, lid <NUM> may define one or more vents <NUM>, and a gasket <NUM> may be positioned between lid <NUM> and container <NUM> to improve the seal between container <NUM> and lid <NUM>. Further, typical sterilization container system <NUM> includes several filter assemblies <NUM>, each filter assembly <NUM> having a filter <NUM>, a retention plate <NUM>, and multiple gaskets <NUM>. As shown, the filter assemblies <NUM> usually are positioned within container system <NUM> adjacent vents <NUM>, <NUM> defined by container <NUM> and lid <NUM>. As will be readily understood, sterilization container system <NUM> generally is a complex assembly, comprising a multitude of parts that can be lost, damaged, or improperly assembled. Lost parts require replacement, which increases the cost of container system <NUM>, and damaged or improperly assembled container systems <NUM> can lead to post-sterilization contamination of the items contained in container <NUM> by permitting the ingress of contaminants into the container system <NUM>.

<FIG> provides a perspective view of a sterilization wrap system <NUM> as described above and as generally known in the art. To wrap an item for sterilization, such as one or more surgical implements or other items requiring sterilization, the item is placed on top of sterilization wrap <NUM> in contact with an inner surface of sterilization wrap <NUM> such that the four corners of sterilization wrap <NUM> can be folded over the item one at a time to fully wrap the item and form a wrapped package. Sterilization wrap <NUM> must be of a size large enough to fully wrap the items to be sterilized. Usually, each fold of the sterilization wrap <NUM> folds over most of the item or items to be sterilized, and each subsequent fold overlaps the previous fold, leaving the item or items to be sterilized completely encompassed within the folds of sterilization wrap <NUM>. Further, a sealing mechanism <NUM>, such as one or more of an adhesive, tape, mechanical fastener, or the like, may be applied to sterilization wrap <NUM> to hold the folds of wrap <NUM> in place. After wrapping, an outer surface <NUM> of sterilization wrap <NUM> forms the resulting exterior surfaces of the wrapped item or package. Alternatively, the items to be sterilized may be placed in a tray that is then wrapped with sterilization wrap <NUM> such that outer surface <NUM> of wrap <NUM> is the exterior surface of the wrapped package. Because sterilization wrap <NUM> forms the outer surface of sterilization wrap system <NUM>, system <NUM> is prone to breaches such as, e.g., cuts, tears, or the like, which can lead to post-sterilization contamination of the wrapped items by permitting the ingress of contaminants into the wrapped package.

Referring now to <FIG>, perspective views are provided of a sterilization packaging system according to an exemplary embodiment of the present subject matter. In the depicted embodiment, sterilization packaging system <NUM> includes a container <NUM> for containing one or more items to be sterilized and a sealing assembly <NUM>, which seals container <NUM> from the ingress of contaminants such as, e.g., bacteria and other infection causing materials or their vehicles. Sealing assembly <NUM> includes a sheet <NUM> of sterilization material and clamp <NUM>. As shown in <FIG>, clamp <NUM> has an open position for assembling sterilization packaging system <NUM> and for retrieving when needed the sterilized items within container <NUM>, and as shown in <FIG>, clamp <NUM> has a closed or clamped position for sealing container <NUM> against the ingress of contaminants. Once sealed, the sealed sterilization package can then be transferred to sterilizing equipment and exposed to sterilization conditions as generally known in the art. Such sterilization conditions can include, e.g., steam, ethylene oxide, or hydrogen peroxide plasma sterilization conditions. Sterilization conditions are the conditions present during a particular sterilization methodology utilized that substantially or completely destroys bacteria and other infectious organisms in an industrial or medical product.

Referring now to <FIG>, sterilization packaging system <NUM> will be described in greater detail. Container <NUM> defines a vertical direction V, a longitudinal direction L, and a transverse direction T, which are orthogonal to one another. Container <NUM> further defines a volume <NUM> for containing items to be sterilized. More particularly, container <NUM> includes one or more vertical walls <NUM> extending along the vertical direction V and one or more horizontal walls <NUM> extending perpendicular to the vertical direction. The one or more vertical and horizontal walls <NUM>, <NUM> define volume <NUM>.

In some embodiments, such as the depicted exemplary embodiment, container <NUM> may be generally rectangular in shape, having four vertical walls <NUM> and one horizontal wall <NUM> defining volume <NUM>. In such embodiments, container <NUM> may define a first side <NUM> of sterilization packaging system <NUM> opposite a second side <NUM>, e.g., first side <NUM> is spaced apart from second side <NUM> along transverse direction T, and a third side <NUM> opposite a fourth side <NUM>, e.g., third side <NUM> is spaced apart from fourth side <NUM> along longitudinal direction L. Moreover, as shown, container <NUM> may include one or more handles <NUM>, e.g., for ease in transporting sterilization packaging system <NUM>. For example, one handle <NUM> may be attached or pivotally coupled to a vertical wall <NUM> at first side <NUM> of system <NUM> and another handle <NUM> may be attached or pivotally coupled to a vertical wall <NUM> at second side <NUM>, i.e., handles <NUM> may be attached or coupled on opposite sides of container <NUM>. Of course, container <NUM> also may have other shapes or configurations, e.g., container <NUM> may be generally round in shape, include walls at an angle to the vertical direction V, include any number of handles <NUM>, or may omit handles <NUM>.

Further, container <NUM> has a perimeter <NUM> defining an opening <NUM> through which the items to be sterilized are placed within volume <NUM> of container <NUM>. Perimeter <NUM> generally is defined by an uppermost portion of vertical walls <NUM>. As shown in <FIG>, perimeter <NUM> is defined vertically opposite horizontal wall <NUM>, i.e., in the illustrated embodiment, perimeter <NUM> is defined at the uppermost portion of vertical walls <NUM> and horizontal wall <NUM> is defined at the lowermost or bottommost portion of vertical walls <NUM>. Referring particularly to <FIG>, container <NUM> may define a groove <NUM> near perimeter <NUM>. For example, groove <NUM> may be defined in vertical walls <NUM> and may extend about container <NUM> at a constant distance from perimeter <NUM>.

As stated, sterilization packaging system <NUM> includes a sealing assembly <NUM> for sealing items within container <NUM>, the sealing assembly including a sheet <NUM> of sterilization material and clamp <NUM>. In exemplary embodiments of the present subject matter, sealing assembly <NUM> is disposable, i.e., both sheet <NUM> and clamp <NUM> may be disposed of after they are used to seal container <NUM>, while container <NUM> may be reused. In other embodiments, sheet <NUM> and/or clamp <NUM> may be reusable.

As depicted in <FIG> and <FIG>, sterilization material sheet <NUM> is disposed between clamp <NUM> and container <NUM>. More particularly, sheet <NUM> is positioned to extend across opening <NUM> of container <NUM> such that when clamp <NUM> is in the closed or clamped position on container <NUM>, with the sheet <NUM> of sterilization material between clamp <NUM> and container <NUM>, opening <NUM> is sealed closed to prevent the ingress of contaminants into volume <NUM>. Further, as illustrated in <FIG> and <FIG>, an excess <NUM> of material may extend from beneath clamp <NUM>, in a direction generally away from or outward from container <NUM>, such that the excess material <NUM> defines a perimeter <NUM> of sterilization material sheet <NUM>.

Sheet <NUM> can be made from a number of materials and, generally, may be made of a material from one of two main classes, reusables and disposables. Reusables are materials that, as the name suggests, can be reused, typically by washing or some other form of cleaning. Disposables, on the other hand, usually are one-use items that are discarded or recycled after their initial use. Generally, cloth, linen, or other woven materials fall into the reusable category while disposables normally include nonwoven materials made from either or both natural and synthetic fibers such as paper, fibrous polymeric nonwovens, and films, which are capable of passing sterilants and retarding transmission of bacteria and other contaminants.

Nonwoven sterilization materials present several advantages due to their barrier properties, economics, and consistent quality. The nonwoven materials can be made from a variety of processes including, but not limited to, air laying processes, wet laid processes, hydroentangling processes, spunbonding, meltblowing, staple fiber carding and bonding, and solution spinning. The fibers themselves can be made from a variety of both natural and synthetic materials including, but not limited to, cellulose, rayon, nylon, polyesters, polyolefins, and many other materials. The fibers may be relatively short, staple length fibers, typically less than three inches, or longer and substantially more continuous fibers such as are produced by spunbonding and meltblowing processes. Whatever materials are chosen, the resultant sterilization material <NUM> must be compatible with the particular sterilization technique being used and must also provide both strength and barrier properties to maintain the sterile nature of the contents of the sterilization package system <NUM> until use. In the illustrated exemplary embodiment, sheet <NUM> of sterilization material is a transparent breathable film, but in other embodiments, sheet <NUM> may be a translucent or opaque material, such as, e.g., a translucent breathable film, a SMS material (described below), or the like. For example, sheet <NUM> may be a sterilization wrap such as described in more detail below.

Referring still to <FIG> and <FIG>, in the illustrated embodiment, clamp <NUM> extends about perimeter <NUM> of container <NUM> when clamp <NUM> is in its closed or clamped position. Clamp <NUM> may be formed from a substantially rigid material, or in some embodiments, clamp <NUM> may be formed from a semi-rigid material such that clamp <NUM> can conform to perimeter <NUM> and/or the contours of container <NUM>, which can aid in sealing container <NUM> when clamp <NUM> is closed or clamped onto container <NUM>. Alternatively, clamp also may be formed from any other suitable material.

Clamp <NUM> is held in the closed or clamped position by a suitable securing mechanism, such as a latch <NUM>. Referring particularly to <FIG>, latch <NUM> comprises a first arm <NUM> defining a catch <NUM> and a second arm <NUM> defining a detent <NUM>. In the depicted embodiment, first arm <NUM> and second arm <NUM> are portions of clamp <NUM>, such that clamp <NUM> defines latch <NUM>, i.e., latch <NUM> is integral with clamp <NUM>. In other embodiments, latch <NUM> may be any suitable mechanism for holding or fastening clamp <NUM> in its closed or clamped position, e.g., latch <NUM> may be formed separately from clamp <NUM> and attached, coupled, or otherwise secured to clamp <NUM> to hold or fasten clamp <NUM> in the closed or clamped position.

As depicted in <FIG>, clamp <NUM> includes a hinge portion <NUM> opposite latch <NUM>. In the illustrated embodiment, second arm <NUM> of latch <NUM> pivots or hinges about hinge portion <NUM> to fasten detent <NUM> in catch <NUM> and thereby clamp or close clamp <NUM>. Similarly, when detent <NUM> is unfastened from catch <NUM>, second arm <NUM> pivots or hinges about hinge portion <NUM> to unclamp or open clamp <NUM>. In other embodiments, first arm <NUM> defining catch <NUM> may pivot or hinge about hinge portion <NUM>. In still other embodiments, clamp <NUM> may have other configurations for closing and opening to fasten and unfasten latch <NUM> or other securing mechanism for holding clamp <NUM> in place on container <NUM>.

As further illustrated in <FIG> and <FIG>, clamp <NUM> includes a vertical portion <NUM> extending along the vertical direction V. Vertical portion <NUM> is positioned adjacent one or more vertical walls <NUM> of the container <NUM>. Clamp <NUM> also includes a horizontal portion <NUM> that extends perpendicular to vertical portion <NUM>. As depicted in <FIG>, vertical portion <NUM> and horizontal portion <NUM> are arranged such that clamp <NUM> has a generally L-shaped cross-section. Of course, in other embodiments, clamp <NUM> may have other configurations, e.g., clamp <NUM> may include multiple vertical and horizontal portions <NUM>, <NUM> or, additionally or alternatively, may include one or more portions that are at an angle with respected to the vertical direction V.

In the illustrated embodiment of clamp <NUM>, for example, as shown in <FIG>, horizontal portion <NUM> defines an opening or window <NUM>. As shown, horizontal portion <NUM> extends about clamp <NUM> adjacent perimeter <NUM> of container <NUM>, and more particularly, horizontal portion <NUM> extends inward from vertical portion <NUM> such that horizontal portion is adjacent opening <NUM> and volume <NUM> of container <NUM>. However, horizontal portion <NUM> does not extend fully across opening <NUM>, i.e., the clamp <NUM> extends only partially across opening <NUM> defined by the container <NUM>, and a portion of sheet <NUM> of sterilization material is visible and/or accessible through window <NUM> defined by horizontal portion <NUM>.

In other embodiments, horizontal portion <NUM> may extend fully across opening <NUM>. That is, horizontal portion <NUM> may extend between a vertical portion <NUM> at first side <NUM> of sterilization packaging system <NUM>, a vertical portion <NUM> at second side <NUM>, a vertical portion <NUM> at third side <NUM>, and a vertical portion <NUM> at fourth side <NUM>. Accordingly, horizontal portion <NUM> may substantially cover opening <NUM>, e.g., to protect sheet <NUM> of sterilization material that extends across opening <NUM> from punctures, cuts, tears, or like. In such embodiments, horizontal portion <NUM> may define one or more apertures for permitting the ingress of sterilization fluid and the egress of, e.g., water or other fluid (while sheet <NUM> of sterilization material prevent the ingress of contaminants as discussed).

Referring particularly to <FIG>, exemplary clamp <NUM> also includes a protrusion <NUM> defined by vertical portion <NUM> of clamp <NUM>. Protrusion <NUM> generally extends inward toward container <NUM>. As illustrated in <FIG>, when clamp <NUM> is positioned on container <NUM>, protrusion <NUM> protrudes into groove <NUM> defined by container <NUM>. As such, protrusion <NUM> may help seal container <NUM> and/or may help keep clamp <NUM> in place with respect to container <NUM>.

As also illustrated in the exemplary embodiment of sterilization packaging system <NUM>, clamp <NUM> defines a depression <NUM>. Depression <NUM> generally is configured such that a second sterilization packaging system <NUM> may be stacked on top of clamp <NUM> of a first sterilization packaging system <NUM>, as shown in <FIG>. In the depicted embodiment, depression <NUM> substantially is a curved transition between vertical portion <NUM> and horizontal portion <NUM> of clamp <NUM>. Other shapes, configurations, or the like of depression <NUM> may be used as well.

It will be readily understood that sterilization packaging system <NUM> requires fewer packaging components than prior art packaging systems using rigid containers. Accordingly, the number of steps required to assemble sterilization packaging system <NUM>, as well the costs of and the material required for sterilization packaging system <NUM>, is reduced compared to known systems. Additionally, sealing assembly <NUM>, comprising sheet <NUM> of sterilization material and clamp <NUM>, provides a consistent barrier against the ingress of contaminants while avoiding post-sterilization breaches of the packaging system. Thus, sterilization packaging system <NUM> can increase confidence in the continued sterility of items packaged therein after the package has been sterilized and stored. Of course, sterilization packaging system <NUM> also may have other benefits and advantages.

Referring now to <FIG>, a perspective view is provided of a sterilization packaging system according to another exemplary embodiment of the present subject matter. In the depicted embodiment, sterilization packaging system <NUM> includes a frame <NUM>, a sterilization wrap <NUM>, and a top or lid <NUM>. Generally, sterilization wrap <NUM> lines frame <NUM> to define a volume <NUM> for containing items to be sterilized. Lid <NUM> is positioned on a top portion <NUM> of frame <NUM>, with sterilization wrap <NUM> disposed therebetween, to seal volume <NUM> from the ingress of contaminants such as, e.g., bacteria and other infection causing materials or their vehicles. Once sealed, the sealed sterilization package can then be transferred to sterilizing equipment and exposed to sterilization conditions as generally known in the art and as described elsewhere herein. A sterility gauge <NUM> also may be included to indicate whether the sterilized package has been breached.

Referring now to <FIG>, sterilization packaging system <NUM> will be described in greater detail. In the depicted embodiment, frame <NUM> defines a vertical direction V, a longitudinal direction L, and a transverse direction T, which are orthogonal to each other. Frame <NUM> includes a plurality of vertical members <NUM> extending along the vertical direction V and a plurality of horizontal members <NUM> extending perpendicular to the vertical direction V and vertical members <NUM>. Each vertical member <NUM> and horizontal member <NUM> has an inner side <NUM> and an outer side <NUM>. That is, inner side <NUM> is opposite outer side <NUM> such that each inner side <NUM> is oriented toward another inner side <NUM> and is positioned adjacent sterilization wrap <NUM> lining frame <NUM> to define volume <NUM>. Together, vertical members <NUM> and horizontal members <NUM> define a plurality of windows <NUM>, and sterilization wrap <NUM> is visible and/or accessible through windows <NUM>. As shown in <FIG>, frame <NUM> also includes a horizontal bottom panel <NUM> extending perpendicular to the vertical direction V and vertical members <NUM> and between horizontal members <NUM> at a bottom portion <NUM> of frame <NUM>. Bottom portion <NUM> is generally vertically opposite top portion <NUM> of frame <NUM>.

In some embodiments, frame <NUM> is constructed from a rigid material. In alternative embodiments, frame <NUM> is constructed from semi-rigid or other materials. In any event, frame <NUM> - having vertical members <NUM>, horizontal members <NUM>, and bottom panel <NUM> - provides structure to and/or strengthens sterilization wrap <NUM> to help prevent breaches of sterilization wrap <NUM> due to, e.g., cuts, tears, or the like.

In the depicted exemplary embodiment, frame <NUM> is generally rectangular in shape, having four vertical sides defined by vertical and horizontal members <NUM>, <NUM> and a horizontal bottom panel <NUM>. In such embodiments, frame <NUM> may define a first side <NUM> of sterilization packaging system <NUM> that is opposite a second side <NUM>, e.g., first side <NUM> is spaced apart from second side <NUM> along transverse direction T, and a third side <NUM> opposite a fourth side <NUM>, e.g., third side <NUM> is spaced apart from fourth side <NUM> along longitudinal direction L. Moreover, as shown in <FIG>, frame <NUM> may include one or more handles <NUM>, e.g., for ease in transporting sterilization packaging system <NUM>. For example, one handle <NUM> may be attached or pivotally coupled to a horizontal member <NUM> at first side <NUM> of system <NUM> and another handle <NUM> may be attached or pivotally coupled to a horizontal member <NUM> at second side <NUM>, i.e., handles <NUM> may be attached or coupled on opposite sides of frame <NUM>. Of course, frame <NUM> may have other shapes or configurations as well, e.g., frame <NUM> may be generally round in shape, include members at an angle to the vertical direction V, include any number of handles <NUM>, or may omit handles <NUM>.

As illustrated most clearly in <FIG> and <FIG>, sterilization wrap <NUM> may be shaped to closely match the shape enclosed by frame <NUM> and thereby line frame <NUM> to define volume <NUM>. In other embodiments, sterilization wrap <NUM> may be positioned within frame <NUM> to generally match the shape enclosed by frame <NUM>. In either case, a first portion <NUM> of sterilization wrap <NUM> is positioned adjacent inner side <NUM> of vertical and horizontal members <NUM>, <NUM> to define volume <NUM> and an opening <NUM> to access volume <NUM>. As shown in <FIG>, sterilization wrap <NUM> may be folded over to define a second portion <NUM> of sterilization wrap <NUM>. Second portion <NUM> is thereby positioned across opening <NUM> to cover opening <NUM>. Further, when sterilization wrap <NUM> is folded to define second portion <NUM>, a fold <NUM> is defined between second portion <NUM> and first portion <NUM> of sterilization wrap <NUM>. Moreover, in some embodiments, sterilization wrap <NUM> may include a tab <NUM> to assist in positioning sterilization wrap <NUM>, e.g., for use as a grip when folding over sterilization wrap <NUM> to position second portion <NUM> across opening <NUM>.

Like sheet <NUM> of sterilization material described above, sterilization wrap <NUM> can be made from a number of materials and, generally, may be a material from one of the two main classes, reusables and disposables, previously described. It has been found that polyolefin-based fibers and their resultant nonwovens are particularly well-suited for the production of sterilization wrap <NUM>. Polypropylene spunbonded nonwovens such as are produced by Halyard Health, Inc. of Alpharetta, Georgia, can be used to impart strength characteristics to sterilization wrap <NUM>. In some embodiments, sterilization wrap <NUM> may be made from laminates such as a laminate of spunbonded and meltblown or spunbonded, meltblown, spunbonded to impart both strength and barrier properties to sterilization wrap <NUM>.

A spunbonded-meltblown-spunbonded material is made from three separate layers that are laminated to one another. The method of making these layers is known and described in <CIT>. The material of Brock, et al. is a three layer laminate of spunbonded-meltblown-spunbonded layers that is also commonly referred to by the acronym "SMS. " The two outer layers of SMS are a spunbonded material made from extruded polyolefin fibers, or filaments, laid down in a random pattern and then bonded to one another. The inner layer is a meltblown layer also made from extruded polyolefin fibers generally of a smaller diameter than the fibers in the spunbonded layers. As a result, the meltblown layer provides increased barrier properties due to its fine fiber structure, which permits the sterilizing agent to pass through the fabric while preventing passage of bacteria and other contaminants. Conversely, the two outer spunbonded layers provide a greater portion of the strength factor in the overall laminate. The laminate may be prepared using an intermittent bond pattern that is preferably employed with the pattern being substantially regularly repeating over the surface of the laminate. The pattern is selected such that the bonds may occupy about <NUM>% to about <NUM>% of the surface area of the laminate. Desirably, the bonds may occupy about <NUM>% to about <NUM>% of the surface area of the laminate. In an exemplary embodiment, sterilization wrap <NUM> is made from a SMS material, but sterilization wrap <NUM> also may be made from other suitable materials.

As illustrated, sterilization packaging system <NUM> includes lid <NUM> for sealing volume <NUM> against an ingress of contaminants. Referring particularly in <FIG>, lid <NUM> is positioned at top portion <NUM> of frame <NUM> in contact with second portion <NUM> of sterilization wrap <NUM> to seal volume <NUM>. More specifically, lid <NUM> generally has a shape complementary to a shape defined by top portion <NUM> of frame <NUM> such that when lid <NUM> is positioned at top portion <NUM>, lid <NUM> seals volume <NUM> by preventing access to opening <NUM>. In exemplary embodiments of the present subject matter, sterilization wrap <NUM> is disposable, i.e., sterilization wrap <NUM> may be disposed of after it is used within sterilization packaging system <NUM>, while frame <NUM> and lid <NUM> may be reused. In other embodiments, as described above, sterilization wrap <NUM> also may be reusable.

Continuing with <FIG>, lid <NUM> comprises a lip <NUM> defined along a perimeter <NUM> of lid <NUM>. Lid <NUM> further includes a flange comprising a horizontal flange portion <NUM> adjacent lip <NUM> and a vertical flange portion <NUM> adjacent horizontal flange portion <NUM>. Horizontal and vertical flange portions <NUM>, <NUM> define a recess <NUM>. An inflatable gasket <NUM> is positioned in recess <NUM>. As also illustrated, horizontal member <NUM> of frame <NUM> defines a corresponding lip <NUM> and a flange comprising horizontal flange portion <NUM> and vertical flange portion <NUM>. In the depicted embodiment, horizontal flange portion <NUM> of the lid flange rests on vertical flange portion <NUM> of the frame flange, and vertical flange portion <NUM> of the lid flange rests on horizontal flange portion <NUM> of the frame flange. Thus, gasket <NUM> inflates within recess <NUM> between flange portions <NUM>, <NUM> of lid <NUM> and flange portions <NUM>, <NUM> of frame <NUM>. Once inflated, gasket <NUM> compresses sterilization wrap <NUM> between lid <NUM> and frame <NUM> to help seal volume <NUM> from contaminants. It will be readily understood that, in other embodiments, a suitable noninflatable gasket <NUM> may be used to help seal volume <NUM> from contaminants and/or other configurations of lid lip <NUM> and flange <NUM>, <NUM> and frame lip <NUM> and flange <NUM>, <NUM> may be used.

As further shown in the illustrated embodiment, lip <NUM> and horizontal flange portion <NUM> of lid <NUM> defines a depression <NUM> along perimeter <NUM> of lid <NUM>. Depression <NUM> generally is configured such that a second sterilization packaging system <NUM> may be stacked on top of lid <NUM> of a first sterilization packaging system <NUM>, as shown in <FIG>. In the depicted embodiment, depression <NUM> substantially is a linear transition between lip <NUM> and horizontal flange portion <NUM>. Lid <NUM> also includes a plurality of ribs <NUM>. In the illustrated exemplary embodiment, ribs <NUM> extend horizontally between third side <NUM> and fourth side <NUM> of sterilization packaging system <NUM>, i.e., generally between a portion of depression <NUM> defined along third side <NUM> and a portion of depression <NUM> defined along fourth side <NUM>. Ribs <NUM> may provide rigidity to lid <NUM> and/or may support a sterilization packaging system <NUM> stacked on top of lid <NUM>. Of course, in alternative embodiments, depression <NUM> and ribs <NUM> may have other shapes, configurations, or the like.

Moreover, lid <NUM> may include one or more gripping portions <NUM>, e.g., for ease in positioning lid <NUM> to seal volume <NUM>. For example, one gripping portion <NUM> may be attached to or defined by lid <NUM> at first side <NUM> of system <NUM> and another gripping portion <NUM> may be attached to or defined by lid <NUM> at second side <NUM>, i.e., gripping portions <NUM> may be attached to or defined on opposite sides of lid <NUM>. Of course, lid <NUM> may include any number of gripping portions <NUM>, which may be attached to or defined at any appropriate location of lid <NUM>, or in some embodiments, gripping portions <NUM> may be omitted.

Sterilization packaging system <NUM> further includes a sterility gauge <NUM> for signaling whether volume <NUM> is sealed against contaminants or has been breached. As such, in an exemplary embodiment, sterility gauge <NUM> comprises a binary visual signal, i.e., a signal having two outputs. For example, sterility gauge <NUM> may provide, as one of the two outputs of the binary signal, a green indicia in a viewport <NUM> of gauge <NUM> if sterilization packaging system <NUM> remains sterile, i.e., if the seal remains intact and volume <NUM> has not be breached post-sterilization. Sterility gauge <NUM> may provide, as the other of the two outputs of the binary signal, a red indicia in viewport <NUM> if system <NUM> is no longer sterile, i.e., if volume <NUM> has been breached since the sealed package was sterilized such that the package should not be used. Sterility gauge <NUM> also may be configured to provide the red indicia before the sealed package is sterilized and to provide the green indicia upon exposure to sterilization conditions; a subsequent breach of the package causes the signal to revert to the red indicia. As shown in, e.g., <FIG> and <FIG>, sterility gauge <NUM> may be positioned on lid <NUM>; for example, sterility gauge <NUM> may be positioned on lid <NUM> adjacent first side <NUM> or second side <NUM> of sterilization packaging system <NUM>. Other configurations and outputs of sterility gauge <NUM> may be used as well.

It will be readily understood that sterilization packaging system <NUM> helps prevent cuts, tears, and the like that are common breaches in known sterilization wrap packages. Accordingly, sterilization packaging system <NUM> utilizes the advantages of sterilization wraps, e.g., providing a consistent barrier against the ingress of contaminants, while substantially avoiding disadvantages such as, e.g., tears, cuts, or other breaches, particularly in areas such as corners and edges that are prone to such breaches. Moreover, features such as, e.g., sterility gauge <NUM> can increase confidence that a sterilized package has not been breached. Sterilization packaging system <NUM> also may have other benefits and advantages.

Claim 1:
A sterilization packaging system (<NUM>), comprising:
a frame (<NUM>) defining a vertical direction, the frame including a plurality of vertical members (<NUM>) extending along the vertical direction and a plurality of horizontal members (<NUM>) extending perpendicular to the vertical direction, each vertical member (<NUM>) and horizontal member (<NUM>) having an inner side (<NUM>) and an outer side (<NUM>);
a sterilization wrap (<NUM>), a first portion (<NUM>) of the sterilization wrap (<NUM>) positioned adjacent the inner side (<NUM>) of each vertical member (<NUM>) and each horizontal member (<NUM>) to define a volume (<NUM>) and an opening (<NUM>) to access the volume (<NUM>); and
a lid (<NUM>) for sealing the volume (<NUM>) against an ingress of contaminants, the lid (<NUM>) positioned on a top portion (<NUM>) of the frame (<NUM>), with the sterilization wrap (<NUM>) disposed between the lid (<NUM>) and the frame (<NUM>), wherein the lid (<NUM>) comprises a lip (<NUM>) defined along a perimeter (<NUM>) of the lid (<NUM>),
wherein the vertical members (<NUM>) and the horizontal members (<NUM>) define a plurality of windows (<NUM>), the sterilization wrap (<NUM>) accessible through the windows (<NUM>).