Patent Description:
Endoscopes are well-known in the art and are commonly used for numerous medical procedures. After each use, an endoscope will undergo reprocessing by cleaning, disinfection and/or sterilization to reduce or prevent contaminants from settling onto the endoscope, as well as to prevent the spread of disease, viruses, bacteria, and illness.

After endoscope reprocessing, an endoscope is generally disposed within a tray and a cover can be secured to the perimeter of the tray. The tray can then be loaded into a cart. The endoscope is then transported from a reprocessing room, where it is dried, and then transported back to a procedure room.

To decrease contaminants from settling on the exterior of the endoscope or in the internal channels of an endoscope, it is desirable to not only have a cover temporarily secured to the tray but also to have forced filtered air circulating within channels of the endoscope. However, with current endoscope transport carts, forced filtered air cannot be provided during transportation because the carts and/or trays cannot be connected to a forced filtered air source.

Even if a cart and/or a tray were compatible so that it could be connected to a forced filtered air source, the cover temporarily secured to the tray would detach from the tray as the interior pressure of the forced filtered air within the tray would partially or completely remove the cover from the tray. The partially or completely uncovered reprocessed endoscope would no longer be protected from the outside environment as contaminants could enter into the tray where the reprocessed endoscope is stored, and the endoscope would become contaminated. This could be detrimental to a patient if the endoscope was used in an endoscopic procedure. Prior art document <CIT> discloses a vacuum storage system for storing e.g. a flexible medical endoscope. The system has a sealable outer chamber including an evacuation valve for connection to a suction device for evacuation of the outer chamber. A sealable inner chamber is adapted to receive an article, and includes a single-way valve. The single-way valve is in communication with the outer chamber and opened based on application of suction to the outer chamber for enabling evacuation of the inner chamber and closed based on discontinuation of suction to the outer chamber. The inner chamber comprises a tray and a lid.

Prior art document <CIT> discloses a kit for storage and transport of medical device i.e. a flexible medical endoscope, after processing or usage in hospitals. The kit has a bowl defined by a base and side and end walls. The bowl has a fold line formed in the base and/or the walls to compress the bowl. A protective cover is fastened at the bowl in a detachable manner. A cover plate is formed to engage with the walls. A container is impermeable to oxygen and accommodates the bowl. The bowl has an inner recess defined by the base and the walls. A circumferential lip region is partially provided at the walls. The bowl and/or the cover plate are made of plastic material.

Thus, there is a need to develop new covers and methods that allow forced filtered air to be released from the tray, to reduce or inhibit the cover from being detached from the tray during transportation. There is also a need to develop a cover that reduces or inhibits contamination of the endoscope while forced filtered air is released from or into the tray.

New devices, systems and methods are provided that allow forced filtered air to be released from the tray, to reduce or inhibit the cover from being detached from the tray during transportation. A one-way valve is attached to the cover, the one-way valve is configured to release air that escapes from the endoscope when filtered air is forced through the channels of an endoscope and released into a compartment of the tray.

According to the invention as defined in independent claim <NUM>, an endoscope storage system comprises a cover for an endoscope storage tray. The cover comprising a flexibly deformable sheet material substantially impermeable to fluids. The flexibly deformable sheet material is configured to be temporarily secured to the tray so as to cover an endoscope storage compartment of the tray. The tray comprising an inlet. The flexibly deformable material is configured to partially enclose the tray. A one-way valve is attached to the flexibly deformable sheet material and is configured to release air flowing from the endoscope storage compartment of the tray to the cover. The one-way valve is controlled by a pressure applied thereto by a forced filtered air source which is attached to the inlet. A liner is configured to engage the endoscope storage compartment of the tray.

In some embodiments, an endoscope storage system is provided. The system comprises an endoscope storage tray having an endoscope storage compartment. A liner is configured to engage the endoscope storage compartment of the tray. A cover for the endoscope storage tray is provided comprising a flexibly deformable sheet material substantially impermeable to fluids. The flexibly deformable sheet material is configured to be temporarily secured to the tray so as to cover the endoscope storage compartment of the tray. A one-way valve is attached to the cover that is configured to release air flowing from the endoscope storage compartment of the tray to the cover.

A method of making a cover for an endoscope storage tray is provided. The method, which does not fall within the scope of the claimed subject-matter, comprises attaching a one-way valve to the cover, the cover comprising a flexibly deformable sheet material substantially impermeable to fluids, the flexibly deformable sheet material configured to be temporarily secured to the tray so as to cover an endoscope storage compartment of the tray, and the one-way valve configured to release air flowing from the endoscope storage compartment of the tray to the cover.

A method of using a cover for an endoscope tray is provided. The method, which does not fall within the scope of the claimed subject-matter, comprises temporarily securing a cover to an endoscope storage tray, the cover comprising a flexibly deformable sheet material substantially impermeable to fluids, the flexibly deformable sheet material configured to cover an endoscope storage compartment of the tray, the cover having a one-way valve attached thereto, the one-way valve configured to release air flowing from the endoscope storage compartment of the tray to the cover.

Additional features and advantages of various embodiments will be set forth in part in the description that follows, and in part will be apparent from the description, or may be learned by practice of various embodiments. The objectives and other advantages of various embodiments will be realized and attained by means of the elements and combinations particularly pointed out in the description and appended claims.

In part, other aspects, features, benefits and advantages of the embodiments will be apparent with regard to the following description, appended claims and accompanying drawings where:.

It is to be understood that the figures are not drawn to scale. Further, the relation between objects in a figure may not be to scale, and may in fact have a reverse relationship as to size. The figures are intended to bring understanding and clarity to the structure of each object shown, and thus, some features may be exaggerated in order to illustrate a specific feature of a structure.

For the purposes of this specification and appended claims, unless otherwise indicated, all numbers expressing quantities of ingredients, percentages or proportions of materials, reaction conditions, and other numerical values used in the specification and claims, are to be understood as being modified in all instances by the term "about. " Accordingly, unless indicated to the contrary, the numerical parameters set forth in the following specification and attached claims are approximations that may vary depending upon the desired properties sought to be obtained by the present invention. At the very least, and not as an attempt to limit the application of the doctrine of equivalents to the scope of the claims, each numerical parameter should at least be construed in light of the number of reported significant digits and by applying ordinary rounding techniques.

Notwithstanding the numerical ranges and parameters set forth herein, the broad scope of the invention are approximations, the numerical values set forth in the specific examples are reported as precisely as possible. Any numerical value, however, inherently contains certain errors necessarily resulting from the standard deviation found in their respective testing measurements. Moreover, all ranges disclosed herein are to be understood to encompass any and all subranges subsumed therein. For example, a range of "<NUM> to <NUM>" includes any and all subranges between (and including) the minimum value of <NUM> and the maximum value of <NUM>, that is, any and all subranges having a minimum value of equal to or greater than <NUM> and a maximum value of equal to or less than <NUM>, e.g., <NUM> to <NUM>.

Reference will now be made in detail to certain embodiments of the invention, examples of which are illustrated in the accompanying drawings. While the invention will be described in conjunction with the illustrated embodiments, it will be understood that they are not intended to limit the invention to those embodiments. On the contrary, the invention is intended to cover all alternatives, modifications, and equivalents that may be included within the invention as defined by the appended claims.

It is noted that, as used in this specification and the appended claims, the singular forms "a," "an," and "the," include plural referents unless expressly and unequivocally limited to one referent. Thus, for example, reference to "outlet" includes one, two, three or more outlets.

We refer now to the drawings wherein depicted elements are not necessarily shown to scale and wherein like or similar elements are designated by the same reference numeral through the several views.

Referring to the drawings in general, it will be understood that the illustrations are for the purpose of describing particular embodiments of the disclosure and are not intended to be limiting thereto.

While most of the terms used herein will be recognizable to those of ordinary skill in the art, it should be understood that when not explicitly defined, terms should be interpreted as adopting a meaning presently accepted by those of ordinary skill in the art.

A vented liner cover with a pressure valve is provided that allows air to escape from an interior of a tray. The vented liner cover maintains a pressure within the interior of the tray so that the cover does not detach from the tray. The cover comprises a one-way pressure valve that allows air to escape from the interior of the tray but prevents air from entering the interior of the tray, thereby preventing contaminants from entering into the tray. In some embodiments, the cover can be temporarily secured to a tray and the tray can be stored in a drying cabinet.

Referring to <FIG>, a cover <NUM> for a rigid endoscope storage tray <NUM> is provided. The cover is configured to facilitate release of air flowing from an endoscope storage compartment <NUM> of the tray to the cover when forced filtered air is supplied to working channels of a reprocessed endoscope <NUM> during tray transportation. In some embodiments, the cover is a disposable single use cover that may be sterile or unsterile. In some embodiments, the cover has some similar features to the cover found and described in <CIT>, assigned to Cantel (UK) Limited.

The cover comprises a flexibly deformable material <NUM> that is substantially impermeable to fluids so as to protect the endoscope from external fluids that can contaminate the endoscope. The flexibly deformable material is configured to be temporarily secured to the tray so as to cover the endoscope storage compartment of the tray. Flexibly deformable is defined relative to the rigid tray, where the material is capable of being movable, bendable and/or moldable such that the material can be reshaped, stretched and/or manipulated. Substantially impermeable is defined as a material that is almost entirely impenetrable to fluids, preventing most fluids from passing through the material.

According to the invention, the cover comprises a flexibly deformable sheet material substantially impermeable to fluids, as shown in <FIG>, and is configured to engage a rim <NUM>, an exterior sidewall <NUM>, a bottom <NUM>, and/or a bottom exterior surface <NUM> of the tray. The flexibly deformable material extends between a first end <NUM> to an opposing second end <NUM>, and includes a first edge <NUM> and an opposing second edge <NUM>, as shown in <FIG> and <FIG>. The flexibly deformable material defines an inner surface <NUM> and an outer surface <NUM> disposed within the boundaries of the ends and edges. The flexibly deformable sheet material can have a rectangular shape to correspond with the shape of the tray but other cover shapes are contemplated depending on tray shape. These shapes include oval, square, circular or the like.

In some embodiments, a plurality of folds, such as a first fold <NUM> and a second fold <NUM> are formed from a portion of the first edge and the second edge, respectively, as shown in <FIG>. The plurality of folds are configured to be temporarily secured to the rim of the tray. The first fold extends between a proximal end <NUM> and a distal end <NUM>. The proximal end of the first fold is attached to a portion of the first end at a junction point or a junction seam <NUM>, and the distal end of the first fold is attached to a portion of the second end at a junction point or a junction seam <NUM> so as to form the first fold. The second fold extends between a proximal end <NUM> and a distal end <NUM>. The proximal end of the second fold is attached to a portion of the first end at a junction point or a junction seam <NUM> and the distal end of the second fold is attached to a portion of the second end at a junction point or a junction seam <NUM> so as to form the second fold. In some embodiments, the plurality of folds can be secured to the rim of the tray via tension or an elastic band. In some embodiments, the plurality of folds can be secured to the rim of the tray by a removable adhesive.

According to the claimed invention, the flexibly deformable material is configured to be temporarily secured to the tray. In some embodiments, the flexibly deformable material comprises an elastic material <NUM> configured to be temporarily secured to the bottom exterior surface of the tray, as shown in <FIG>.

According to the present disclosure but not forming part of the claimed invention, the flexibly deformable material can entirely enclose the tray, as shown in <FIG>. In some examples, the flexibly deformable material comprises a zip seal <NUM> or adhesive seal to enclose the tray. According to the claimed invention, the flexibly deformable material is configured to partially enclose the tray.

A one-way valve <NUM> is attached to the cover. The one-way valve is configured to release air flowing from the endoscope storage compartment of the tray to the cover. The air is forced filtered air flowing from an air source <NUM> (<FIG>) that uses a HEPA filter. In some embodiments, the one-way valve is configured to fluidly couple the cover to the endoscope storage compartment of the tray. The one-way valve can be a pressure valve or a degassing valve, as shown in <FIG>, a duckbill valve, as shown in <FIG> or a flap valve, as shown in <FIG>. In some embodiments, the one-way valve can have similar features to the one-way valve found and described in <CIT>.

The one-way valve is a controlling device for the passage of the forced filtered air in one direction and is controlled by the pressure applied to the one-way valve by the forced filtered air source. For example, the one-way valve will be closed when no forced filtered air is provided, however, when forced filtered air is provided, the pressure from the forced filtered air will force the one-way valve to open, thereby releasing the forced filtered air from the endoscope storage compartment and out of the cover. Therefore, it is to be understood that the one-way valve is a valve that allows the passage of air in one direction and that the one-way valve will open when the pressure inside the endoscope storage compartment is greater than the pressure outside of the cover. According to the invention, the air flow from the forced filtered air will flow and open the one-way valve. This will prevent the cover from partially or completely uncovering the tray and therefore prevent contaminants from entering in or on the reprocessed endoscope.

The one-way valve comprises an outlet <NUM> configured to release air flowing from the endoscope storage compartment of the tray to the cover, as shown in <FIG>, an inlet <NUM> to allow air flowing from the endoscope storage compartment to enter the one-way valve, and a seal <NUM> that allows only air to enter the inlet for release out of the outlet. The seal is disposed between the inlet and the outlet and is a movable barrier configured to reduce or prevent contaminants from entering into the endoscope storage compartment of the tray.

The cover can include an opening <NUM> that is configured to receive the one-way valve. The opening can be larger, smaller or the same size as the one-way valve. In some embodiments, the opening and the one-way valve are circular shaped. The inlet or outlet can further or alternatively engage the inner surface or the outer surface of the flexibly deformable material. The one-way valve can be positioned within or on the cover in a few ways. For example, the one-way valve can be centrally attached to the flexibly deformable material or can be attached to the flexibly deformable material adjacent to one of the edges of the flexibly deformable material. In some embodiments, the one-way valve is attached to the cover by an adhesive, tape and/or Velcro®.

As shown in <FIG>, when a cover does not include a one-way valve (<FIG>), forced filtered air entering into the endoscope storage compartment of the tray would create an interior pressure that would detach the cover from the tray since the forced filtered would have no way of escaping out of the tray. Thus, the endoscope would no longer be protected from the outside environment and could be subjected to environmental contaminates. When a cover does include a one-way valve, as described herein (<FIG>), forced filtered air will be released from the endoscope storage compartment of the tray through the one-way valve, preventing the cover from detaching from the tray. In this way, the reprocessed endoscope maintains disinfection and is not subjected to external environmental factors.

In some embodiments, a pressure differential will exist between the endoscope storage compartment when forced filtered air is present and the outside environment surrounding the cover and tray. In some embodiments, the pressure differential can be from about <NUM> to about <NUM> pounds per square inch (PSI). In some embodiments, the pressure differential can be from about <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM> to about <NUM> pounds per square inch (PSI). In order to decrease the pressure differential, the one-way valve releases the forced filtered air from the inside of the endoscope storage compartment and out of the cover.

In some embodiments, the cover can be manufactured at a certain sheet thickness. In some embodiments, the sheet thickness of the cover can be from about <NUM> micrometers (µm) to about <NUM> millimeters (mm). In some embodiments, the sheet thickness of the cover can be from about <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM> to about <NUM>.

In some embodiments, the cover can have certain dimensions. In some embodiments, the dimensions of the cover are from about <NUM> inches to about <NUM> inches in length and from about <NUM> to about <NUM> inches in width. In some embodiments, the dimensions of the cover are from about <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM> to about <NUM> inches in length and from about <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM> to about <NUM> inches in width.

In some embodiments, the flexibly deformable sheet material is made from a high-density polythene (HDP). In some embodiments, the flexibly deformable sheet material can be made from other materials such as, for example, high-density polyethylene (HDPE), low-density polyethylene (LDPE), and/or linear low-density polyethylene (LLDPE).

The cover can be manufactured in different colors such as in a green or a clear color to indicate that the endoscope is clean and ready for use. Alternative colors can be selected such as blue, pink, yellow, red, orange, brown or black. In some embodiments, the cover can be reversible and a different color can be used on the inner surface than on the outer surface of the cover.

In some embodiments, the components of the one-way valve can be made from a material such as, for example, a polymeric material. The polymeric material can be thermoplastic and/or is a polycarbonate. For example, the one-way valve can be fabricated from materials such as machined or injection molded thermoplastics such as polyaryletherketone (PAEK) including polyetheretherketone (PEEK), polyetherketoneketone (PEKK) and polyetherketone (PEK), carbon-PEEK composites, PEEK-BaS04 polymeric rubbers, polyethylene terephthalate (PET), fabric, silicone, polyurethane, silicone-polyurethane copolymers, polymeric rubbers, polyolefin rubbers, semi-rigid and rigid materials, elastomers, rubbers, thermoplastic elastomers, thermoset elastomers, elastomeric composites, polyphenylene, polychloropene, polyamide, polyetherimide, polyethylene, epoxy, partially resorbable materials, totally resorbable materials, polyglycolide, polytyrosine carbonate, polycaprolactone, silicone based rubber, liquid silicone rubber, High Consistency Rubber, silicon, TPE, Polypropylene, Polycarbonate, ABS or any combination thereof.

In some embodiments, the one-way valve can be a certain diameter ranging from about <NUM> centimeters (cm) to about <NUM>. In some embodiments, the one-way valve can have a diameter of <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM> to about <NUM>.

The components of the one-way valve, individually or collectively, may also be fabricated from a heterogeneous material such as a combination of two or more of the above-described materials. The one-way valve as described herein may be constructed of a suitable biocompatible material to impart various desirable characteristics, such as flexibility, and resilience.

In some embodiments, components of the one-way valve can also be made from a suitable material such as for example, polyurethane, polyurea, polyether(amide), PEBA, thermoplastic elastomeric olefin, copolyester, styrenic thermoplastic elastomer, carbon fiber, glass fiber, ceramics, methacrylates, poly (N-isopropylacrylamide), PEO-PPO-PEO (pluronics), plastic (e.g., polycarbonates), ABS, MABS, or the like or combinations thereof.

In some embodiments, the seal may be formed from a suitable material, such as metal, polyurethane, polyurea, polyether(amide), PEBA, thermoplastic elastomeric olefin, copolyester, and styrenic thermoplastic elastomer, carbon fiber, glass fiber, ceramics, methacrylates, poly (N-isopropylacrylamide), rubber, plastic, or the like or combinations thereof or any of the materials as described herein.

In some embodiments, contaminants can include, but are not limited to, biological contaminants such as microorganisms including bacteria, viruses, yeasts, molds and parasites; air borne contaminants such as airborne microbes; and/or chemical contaminants. In some embodiments, bacterial can include, but is not limited to Escherichia coli, Klebsiella species, Enterobacter species, enterococci, Pseudomonas aeruginosa and Salmonella species.

Referring to <FIG>, an endoscope storage system <NUM> is provided. The system is configured to facilitate release of air flowing from the endoscope storage compartment of the tray to the cover when forced filtered air is supplied to working channels of a reprocessed endoscope or to the reprocessed endoscope during tray transportation. The reprocessed endoscopes can be obtained from automated endoscope reprocessors obtained from, for example, Medivators Inc. In some embodiments, the system is also configured for storing an endoscope after the endoscope has been decontaminated. The system comprises cover <NUM> including one-way valve <NUM>, as described above and a liner <NUM>, as shown in <FIG>. In some embodiments, the liner is configured to engage the endoscope storage compartment of the tray. The liner can contact the endoscope storage compartment of the tray and an endoscope. In some embodiments, the liner is similar to the liner found and described in <CIT>.

In some embodiments, the system further includes endoscope storage tray <NUM>, as described above. In some embodiments, the tray is a rigid, reusable tray. In some embodiments, the tray is similar to the tray described in <CIT>. The tray includes exterior sidewall <NUM>, opposing end walls <NUM>, and rim <NUM> that is curled over to form a lip portion <NUM>. Bottom <NUM> includes exterior bottom surface <NUM> and the bottom contacts the exterior side wall and the end walls. The endoscope storage compartment <NUM> of the tray comprises a planar base <NUM> and surrounding walls <NUM> upstanding therefrom, as shown in <FIG>. In some embodiments, the entire tray base can be planar or portions of the tray can be planar, while other portions of the tray can be non-planar or arched, defining upstanding elements <NUM>, as shown in <FIG>.

In some embodiments, the tray comprises an outlet <NUM>, as shown in <FIG>, <FIG> and <FIG> configured to engage a working channel <NUM> of the endoscope to receive forced filtered air. The forced filtered air can be supplied by an air source <NUM> that utilizes a HEPA filter that is attached to an inlet <NUM> defined by the tray. In some embodiments, the HEPA filter can be made from thin fibers of glass and can contain an amount of an activated carbon-based material. The forced filtered air can be either released into the endoscope storage compartment of the tray by the outlet or the forced filtered air can be released into tubes that are attached to the outlet. In some embodiments, the outlet and/or inlet can be formed from the side walls, end walls and/or the bottom of the tray.

In some embodiments, an outlet member, or a hook up block <NUM> is alternatively provided that is configured to engage one or more working channels of the endoscope to receive forced filtered air. A hook up block can be a member having one or more conduits and/or tubes that allow air/gas and/or fluids to travel to the desired location. The outlet member can include one or a plurality of tubes <NUM> configured to engage one or more working channels. The outlet member can be disposed directly into the endoscope storage compartment, as shown in <FIG> or it can be disposed within a basket <NUM> that is disposed within the endoscope storage compartment, as shown in <FIG>. Forced filtered air can then be received by the outlet member by the air source that uses a HEPA filter. In some embodiments, the basket provides touch-free endoscope handling to reduce cross-contamination while protecting the endoscope during transport to reduce endoscope damage.

In some embodiments, the system further comprises a cart <NUM> configured to store a plurality of endoscope storage trays, as shown in <FIG>. The cart can comprise an outlet <NUM> configured to engage a working channel of the endoscope to receive forced filtered air. The forced filtered air can then be supplied by the air source that uses a HEPA filter which is attached to an inlet <NUM> defined by the cart. The outlet and the inlet can be defined from walls <NUM> of the cart.

In some embodiments, the cart comprises one or more inlets and outlets. In some embodiments, the cart comprises <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM> or <NUM> inlets and outlets. In some embodiments, only <NUM> inlet and <NUM> outlet are defined by the cart and the forced filtered air is supplied to all of the plurality of endoscope storage trays by the <NUM> outlet and the <NUM> inlet. Alternatively, a plurality of outlets and inlets are defined by the cart such that each outlet and inlet supply forced filtered air to each individual endoscope storage tray, as shown in <FIG>. In some embodiments, the cart and/or the tray comprises an outlet.

In some embodiments, the cart comprises the outlet member or hookup block, <NUM>, that is configured to engage a working channel of the endoscope to receive forced filtered air. The outlet member will be attached to the filtered air source, similar to what is shown in <FIG>.

In some embodiments, the system further comprises a drying cabinet <NUM> to store a plurality of endoscope storage trays, as shown in <FIG>. The drying cabinet is similar to the drying cabinet found and described in International Publication No. <CIT>. The entire disclosure is herein incorporated by reference. In some embodiments, one or more endoscopes can be disposed within either an endoscope storage tray, within a basket, and/or within a basket that is disposed with an endoscope storage tray. While in the drying cabinet, the outlet member or hookup block <NUM> can be configured to engage a working channel of the endoscope to receive forced filtered air by the air source.

In some embodiments, the one-way valve is a pressure valve and comprises an inlet, an outlet and a seal. In some embodiments, the one-way valve is attached to the cover by adhesive, tape or Velcro®. It is to be understood that the cover is cover <NUM>, as described above.

In some embodiments, the flexibly deformable sheet material comprises a plurality of folds configured to be temporarily secured to a rim of the tray. In some embodiments, the flexibly deformable sheet material is configured to be temporarily secured to a bottom exterior surface of the tray. In some embodiments, the flexibly deformable sheet material comprises an elastic material configured to be temporarily secured to a bottom exterior surface of the tray.

In some embodiments, the flexibly deformable sheet material is configured to entirely enclose the tray. In some embodiments, the flexibly deformable sheet material is configured to partially enclose the tray. In some embodiments, the endoscope storage tray is a semi-rigid and reusable tray. It is to be understood that the cover is cover <NUM>, as described above.

It will be recognized by one of ordinary skill in the art that numerous steps in the manufacturing process may be optional or may be performed in a different sequence than specifically shown. The scope of the manufacturing process is not limited to the particular sequence and steps discussed herein, except as expressly recited in the claims.

In some embodiments, components of the system described above may be made by injection molding, compression molding, blow molding, thermoforming, die pressing, slip casting, electrochemical machining, laser cutting, water-jet machining, electrophoretic deposition, powder injection molding, sand casting, shell mold casting, plaster-mold casting, investment casting, vacuum casting, permanent-mold casting, slush casting, pressure casting, die casting, centrifugal casting, squeeze casting, rolling, forging, swaging, extrusion, shearing, spinning, or combinations thereof.

In some embodiments, the components of the system may be formed by 3D printing. The terms "three-dimensional printing system," "three-dimensional printer," and "printing," describe various solid freeform fabrication techniques for making three-dimensional articles or objects by selective deposition, jetting, fused deposition modeling, multi-jet modeling, and other additive manufacturing techniques now known in the art or that may be known in the future that use a build material or ink to fabricate three-dimensional objects.

Instructions in the form of schematics encompassing any of the embodiments disclosed herein may be given to a computer to be carried out by a 3D printer. In some embodiments, components of the system may be color coded to signify various properties.

Components of the system may be sterilizable. In various embodiments, one or more components of the system are sterilized by radiation in a terminal sterilization step in the final packaging. Terminal sterilization of a product provides greater assurance of sterility than from processes such as an aseptic process, which require individual product components to be sterilized separately and the final package assembled in a sterile environment.

Typically, in various embodiments, gamma radiation is used in the terminal sterilization step, which involves utilizing ionizing energy from gamma rays that penetrates deeply in the device. Gamma rays are highly effective in killing microorganisms, they leave no residues nor have sufficient energy to impart radioactivity to the device. Gamma rays can be employed when the device is in the package and gamma sterilization does not require high pressures or vacuum conditions, thus, package seals and other components are not stressed. In addition, gamma radiation eliminates the need for permeable packaging materials.

In various embodiments, electron beam (e-beam) radiation may be used to sterilize one or more components of the system. E-beam radiation comprises a form of ionizing energy, which is generally characterized by low penetration and high-dose rates. E-beam irradiation is similar to gamma processing in that it alters various chemical and molecular bonds on contact, including the reproductive cells of microorganisms. Beams produced for e-beam sterilization are concentrated, highly-charged streams of electrons generated by the acceleration and conversion of electricity.

Other methods may also be used to sterilize one or more components of the system, including, but not limited to, gas sterilization, such as, for example, with ethylene oxide or steam sterilization.

In various embodiments, a kit or system is provided that may include additional parts along with the cover combined together to be used with the tray. The kit may include the cover in a first compartment. A second compartment may include the tray. A third compartment may include a liner. A fourth compartment may include an additional cover. A fifth compartment may include gloves and other procedural supplies for maintaining sterility, as well as an instruction booklet or notification of a website where instructions for using the kit or system can be located. Each component of the system or kit may be separately packaged in a plastic pouch. A cover of the kit may include illustrations of the use of the cover and a clear plastic cover may be placed over the compartments to maintain sterility.

Claim 1:
An endoscope storage system, the system comprising a cover for an endoscope storage tray, the cover comprising a flexibly deformable sheet material substantially impermeable to fluids, the flexibly deformable sheet material configured to be temporarily secured to the tray so as to cover an endoscope storage compartment of the tray, the tray comprising an inlet, wherein the flexibly deformable material is configured to partially enclose the tray; a one-way valve attached to the flexibly deformable sheet material, the one-way valve configured to release air flowing from the endoscope storage compartment of the tray to the cover and is controlled by a pressure applied to the one-way valve by a forced filtered air source which is attached to the inlet; and
a liner configured to engage the endoscope storage compartment of the tray.