Patent Description:
Often times, an Automated Endoscope Re-processor (AER) is used to dry the reprocessed endoscopes. However, endoscopes have channels with small internal diameters. There may be residual moisture within those channels, even after AER drying, that may provide an environment in which micro-organisms can quickly multiply and potentially be a source to transmit infection to a patient when an endoscopy is performed on that patient.

After endoscope reprocessing, an endoscope is generally disposed within a clean tray and a clean 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.

Before the reprocessed endoscope is disposed within the tray, if the tray has been previously used and has been contaminated, it must be cleaned to prevent the tray from contaminating the reprocessed endoscope. Trays can be cleaned in a cart washer, where fluid, chemicals and/or heat are applied to the tray in order to wash the tray. However, during tray washing, fluid can accumulate in the tray, making it harder for the tray to dry. If moisture remains in the tray after an endoscope is disposed in the tray, the moisture can increase the likelihood of contaminants developing in the tray and/or the endoscope. Also, depending on the configuration of the tray, it may not be compatible with the cart washer and must instead be cleaned manually. Further, when trays are loaded into the cart washer, often, the trays do not securely engage with the cart washer.

<CIT> discloses an instrument storage tray is provided that is compartmentalized for the storage of instruments of various sizes and for the storage of instruments of given configurations. The tray has slots at the wall junctions and legs extending from the wall junctions configured for insertion of the legs of one tray in to the slots of another tray so that a plurality of trays may be transported at one time.

<CIT> discloses a vacuum storage system for storing an article, comprising a sealable outer chamber and a sealable inner chamber. The sealable outer chamber has an evacuation valve for connection to a suction device for evacuation of said outer chamber. The sealable inner chamber is adapted to receive said article, and has a one-way valve in communication with the outer chamber. The one-way valve is adapted to open upon the application of suction to the outer chamber, enabling evacuation of said inner chamber, but to close upon discontinuation of said suction.

<CIT> discloses a tray for steam sterilization of the endoscope which is used for placing the endoscope thereon in storing the endoscope in a steam sterilizer. The tray has a plurality of bottom holes passing steam therethrough which is bored at the bottom surface and a leg extending downward from the rear surface of the tray.

Thus, there is a need to develop a new tray, systems and methods where apertures are disposed on at least a portion of a tray to facilitate drainage of fluid that is captured within the tray during washing. There is also a need to develop a tray and a cart that are compatible with each other, and where the tray maintains a secure engagement with the cart. It would also be beneficial to provide a tray that can be used during the final stages of endoscope reprocessing so that the endoscope can remain in the tray after reprocessing and then transported and stored in the same tray.

New devices, systems and methods are provided to facilitate drainage of fluids from an endoscope tray when the tray is washed in a cart. The invention as defined in independent claim <NUM> relates to an endoscope tray comprising an interior for storage of an endoscope, the interior having an upstanding element having a top surface; a plurality of apertures disposed on at least a portion of the top surface of the upstanding element to facilitate drainage of fluids. The tray further comprises an interior bottom surface also having the plurality of apertures disposed thereon; a sidewall and a rim disposed about the interior of the tray; and a lid comprising at least one valve and configured to engage the rim, wherein the at least one valve is an exhaust valve and a release valve.

A system for storage of an endoscope is also provided. The invention as defined in independent claim <NUM> relates to a system comprising a tray comprising an interior for storage of the endoscope. The interior has an upstanding element having a top surface. A plurality of apertures are disposed on at least a portion of the top surface of the upstanding element to facilitate drainage of fluids. A sidewall and a rim are disposed about the interior of the tray. A lid is configured to engage the rim, and a liner is configured to engage the rim of the tray. The lid comprises at least one valve comprising an exhaust valve and a release valve to seal the lid with the tray.

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.

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, 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.

In some embodiments, a tray is provided that is cart washer compatible and that is chemical and heat resistant. In some embodiments, the tray is configured for engagement with cart washer compatible trays and lids. The tray is designed to minimize pooling of fluid within the tray to facilitate drying during a final phase of a reprocessing cycle. In some embodiments, the tray is contoured to allow an endoscope to be retained more securely within an interior of the tray than if the endoscope was retained in a standard tray, thereby minimizing components of the endoscope from being damaged. For example, a light guide connector of the endoscope is heavy and can cause impact damage if it comes into contact with a patient insertion tube of a distal end of an endoscope.

In some embodiments, dimensions of the tray can be sufficient to accommodate substantially all sizes of flexible medical endoscopes in a coiled state without undue stress being applied to the flexible portions of the endoscope. However, the tray can also be sufficiently small to permit it to be easily carried by a person. In some embodiments, the tray is constructed and dimensioned to provide support for the endoscope coiled in a stress-free state.

In some embodiments, the tray is rigid and re-usable and comprises a base having planar and non-planar portions and surrounding sidewalls upstanding therefrom, the tray being formed of a semi-rigid material capable of withstanding repeated disinfection and dimensioned to provide support for a flexible medical endoscope coiled in a stress-free state.

In some embodiments, a shaped tray is provided that is cart washer compatible, has apertures (e.g., perforations) to allow improved automated cleaning, prevents pooling of a fluid in an interior of the tray and improves drying at the end of a cart washer cycle. In some embodiments, the tray is designed to prevent contact of sensitive areas of an endoscope from coming into contact with each other during storage and transportation which prevents damage to the endoscope.

In some embodiments, a lid is provided that engages with the tray and is also cart washer compatible. In some embodiments, the lid does not include apertures. In some embodiments, the lid is self-sealing on an upper surface of the tray. The lid can seal onto the tray by the natural vacuum created when the lid and tray mate. The lid comprises at least one valve comprising an exhaust valve and a release valve to seal the lid with the tray. An exhaust valve allows displacement of trapped air, and a release valve allows pressure to equalize so that the lid can be removed from the tray.

In some embodiments, a shaped base liner is provided configured to engage with an interior of the tray. In some embodiments, the liner contours the interior of the tray and creates a contact engagement. In some embodiments, the tray can engage with a mating surface of a cart to support the tray and secure it to a cart during transportation. In some embodiments, the tray improves storage and transport decontamination.

Referring to <FIG>, an endoscope tray <NUM> is provided. The tray is configured to store a flexible medical endoscope <NUM> and to facilitate drainage of fluids that are captured within the tray during tray washing. In some embodiments, the tray is rigid and reusable. In some embodiments, the tray can be formed of a semi-rigid material capable of withstanding repeated disinfection and dimensioned to provide support for the endoscope coiled in a stress-free state. According to the invention, the tray comprises a lid comprising at least one valve which is an exhaust valve and a release valve to seal the lid with the tray. The lid is not shown in <FIG>.

The tray comprises an interior <NUM> for storage of the endoscope. The interior defines an inner surface <NUM> that forms a base or bottom surface <NUM> that includes an upstanding element <NUM>. The upstanding element is configured to embrace and protect coils <NUM> of the endoscope without undue stress being applied to the endoscope when stored in the tray. In some embodiments, the interior comprises at least two upstanding elements spaced apart from each other to provide contour and support to at least a portion of the endoscope coiled between all or a portion of the at least two upstanding elements, as shown in <FIG>.

The interior can define more than one or two upstanding elements. For example, the interior can define <NUM>, <NUM>, <NUM> or <NUM> upstanding elements. In some embodiments, at least a portion of the upstanding element can include a curved portion or a side wall <NUM> and a straight portion or a side wall <NUM>. In some embodiments, each of the side walls of the upstanding element/elements have no apertures.

The upstanding element includes a top surface <NUM>. The top surface includes a plurality of apertures <NUM> disposed on at least a portion of the top surface of the upstanding element to facilitate drainage of fluids. The apertures can be variously configured and can be circular holes, indents, slits, and/or cutout shapes. In some embodiments, the apertures can be in discrete positions on the top surface, on edges of the top surface, or can be randomly positioned on the top surface.

The top surface can include from <NUM> to about <NUM>, from <NUM> to about <NUM>, from <NUM> to about <NUM>, from <NUM> to about <NUM>, from <NUM> to about <NUM>, from <NUM> to about <NUM>, from <NUM> to about <NUM>, from <NUM> to about <NUM>, from <NUM> to about <NUM>, from <NUM> to about <NUM>, or from <NUM> to about <NUM> apertures on the top surface of the upstanding element. In some embodiments, the top surface can include from about <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM> to about <NUM> apertures on the top surface. The apertures are positioned to allow air flow into the tray, as shown in <FIG>, and allow drainage of fluid and/or moisture from the reprocessed endoscope to be removed from the tray. This is also for trays that are stored in rows and/or are stacked in a cart.

The apertures can have a certain size. For example, the apertures can be from about <NUM> millimeter (mm) to about <NUM>, from about <NUM> to about <NUM>, from about <NUM> to about <NUM>, from about <NUM> to about <NUM>, and/or from about <NUM> to about <NUM>. In some embodiments, the apertures can be the same size or different sizes. The apertures can be a certain shape, such as, for example, circular, oval, disc, star, rectangular, square, triangular, freeform, semicircular, octagonal, pentagonal, cross, ring, crescent, hexagonal and/or quatrefoil shaped. In some embodiments, the apertures can be the same or different shapes.

The base or bottom surface of the tray, as described above, includes a plurality of apertures disposed thereon. As shown in <FIG> and <FIG>, the apertures can be sealed apertures <NUM>. In some embodiments, the sealed apertures can be punctured manually if a user wishes to drain a tray more quickly.

The base or bottom surface of the tray includes surrounding sidewalls <NUM> upstanding therefrom. The sidewalls extend about the interior and have no apertures. In some embodiments, the sidewalls are continuous and are monolithic with the base or bottom surface of the tray. In some embodiments, the base or bottom surface includes planar portions <NUM> and non-planar portions such as the upstanding elements, as described above and shown in <FIG>. The tray can also include non-planar portions <NUM> on a portion of the exterior sidewalls or exterior on the base of the tray, as shown in <FIG>.

The tray includes a rim <NUM>. In some embodiments, the rim includes the plurality of apertures, and the top surface of the at least two upstanding elements align with the rim on a same plane. As shown in <FIG>, the tray can also include a peripheral lip <NUM> disposed at least partially around the surrounding sidewalls and extending outwardly therefrom. The tray includes a bottom <NUM>, as shown in <FIG>. In some embodiments, the bottom of the tray is configured to engage with at least a portion of a cover, as described herein.

As shown in <FIG>, which is a non-claimed embodiment, the tray alternatively does not include an upstanding element, and the plurality of apertures are disposed on at least a portion of the bottom surface to facilitate drainage of fluids. In some embodiments, the bottom surface of the tray and/or the rim can include the plurality of apertures.

It will be understood that in some embodiments, the all apertures extend completely through the tray to maximize drainage and air flow. In some embodiments, some of the apertures do not extend completely through the tray and there may be a mix of apertures extending completely through and those that do not extend completely through the tray.

The tray 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 tray 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. The tray can also be made from steel, aluminum, paper, bamboo, cork, glass, hemp or any combination thereof.

In some embodiments, the tray can have a certain length, width and height. In some embodiments, the length of the tray can be from about <NUM> to <NUM> (<NUM> to about <NUM> inches), the width can be from about <NUM> to <NUM> (<NUM> to about <NUM> inches) and the height can be from about <NUM> to <NUM> (<NUM> to about <NUM> inches). In some embodiments, the length of the tray can be from about <NUM>, <NUM>, <NUM>, <NUM>, <NUM>. <NUM>, <NUM>, <NUM>, <NUM> to about <NUM> (<NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM> to about <NUM> inches), the width of the tray can be from about <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM> to about <NUM> (<NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM> to about <NUM> inches), and the height of the tray can be from about <NUM>, <NUM>, <NUM>, <NUM>, <NUM> to about <NUM> (<NUM>, <NUM>, <NUM>, <NUM>, <NUM> to about <NUM> inches).

The components of the tray, 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 tray as described herein may be constructed of a suitable biocompatible material to impart various desirable characteristics, such as rigidity, and resilience.

Components of the tray 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), plastic (e.g., polycarbonates), ABS, MABS, or the like or combinations thereof.

Referring to <FIG>, an endoscope storage system <NUM> is provided. The system comprises tray <NUM>, as described above. The system of the invention comprises a rigid lid <NUM> configured to engage with the rim of the tray to seal the tray closed, as shown in <FIG>. In some embodiments, the lid can self-seal with the rim of the tray by a natural vacuum created when the lid is mated with the tray. The lid comprises at least one valve comprising an exhaust valve and a release valve to seal the lid with the tray. In some embodiments, the lid comprises at least one valve <NUM> to facilitate sealing the tray closed. In some embodiments, the at least one valve can have similar features to the one-way valve found and described in <CIT>, assigned to Cantel (UK) Limited.

According to the invention, the at least one valve is an exhaust valve and a release valve to seal the lid with the tray, as shown in <FIG>. In some embodiments, the at least one valve is a non-return valve/one-way valve, as shown in <FIG>. When the lid is engaged with the tray, the at least one valve communicates with airspace within the interior of the tray.

In some embodiments, the at least one valve includes a valve that allows fluid (liquid or gas) to flow through it in only one direction thereby preventing any backward flow. Conventional one-way valves can be used that are provided in the lid that allow fluid (liquid or gas) to flow through it in only one direction thereby preventing any backward flow. The one-way valve can be controlled by the pressure applied to the valve and will open when the pressure inside and the pressure outside of the valve are different. This can be placed on after the moisture or fluid is removed by the apertures.

In some embodiments, the at least one valve comprises an outlet <NUM> configured to release air flowing from the interior of the tray, an inlet <NUM> to allow air from the interior to enter the at least one valve when suction is applied, and a seal <NUM> that allows only air to enter the inlet for release out of the outlet, as shown in <FIG>. 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 interior of the tray.

In some embodiments, the at least one valve can be a pressure valve or a degassing valve, as shown in <FIG>, a duckbill valve, as shown in <FIG>, a flap valve, as shown in <FIG>, a valve comprising a single slit diaphragm, as shown in <FIG> or a valve comprising a double or cross shaped slit diaphragm, as shown in <FIG>.

In some embodiments, the at least one valve is a controlling device for the passage of suction in one direction and is controlled by the suction applied to the at least one valve by a suction device (not shown), such as a vacuum. For example, the at least one valve will be closed when no suction is provided, however, when suction is provided, the suction will force the at least one valve to open, thereby releasing air from the interior of the tray. It is to be understood that the at least one valve is a valve that allows the passage of air in one direction and that the at least one valve will open when the pressure or suction outside of the interior is less than the pressure inside of the interior. The at least one valve will close when pressure difference between the outside of the tray and the interior is not significantly different. The pressure difference, in some embodiments, will aid in removing moisture or fluid from the endoscope.

In some embodiments, the at least one valve can be positioned within or on the lid in a few ways. For example, the at least one valve can be centrally attached to the lid or it can be attached to an edge of the lid. In some embodiments, the at least one valve is monolithically formed with the lid or is attached to the lid by an adhesive, a friction fitting and/or tape.

In some embodiments, the system includes a liner <NUM>. The liner is configured to engage with the interior of the tray and the endoscope, as shown in <FIG>. In some embodiments, the liner engages contours of the interior and rim of the tray. In some embodiments, the liner is similar to the liner found and described in <CIT>, assigned to Cantel (UK) Limited. The liner can be disposable and can be substantially impermeable to fluids.

In some embodiments, the tray interior and portions of the exterior of the tray can be engaged by the liner. The liner can be made of a flexibly deformable material substantially impermeable to fluids.

In some embodiments, the disposable liner contacts the bottom surface of the tray and at least partially encloses the reprocessed endoscope. In some embodiments, the liner is a disposable single use liner that may be sterile or unsterile.

In some embodiments, the disposable liner is configured to temporarily line the entirety of the interior compartment of the tray and prevents the endoscope from having direct contact with the interior of the tray. In some embodiments, the liner prevents moisture from the reprocessed endoscope from contacting the tray and when the tray is used repeatedly, it prevents or reduces contamination from one endoscope to the next endoscope.

The tray whether it is lined or not lined can be temporarily covered with a disposable cover <NUM>, as shown in <FIG>, <FIG> and <FIG>. In some embodiments, the disposable cover at least partially encloses or encloses the reprocessed endoscope and the tray. In some embodiments, the cover is a disposable single use cover that may be sterile or unsterile. In some embodiments, the cover can be similar to the cover found and described in <CIT>, assigned to Cantel (UK) Limited.

The cover for the endoscope storage tray can comprise a flexibly deformable sheet material substantially impermeable to fluids, the flexibly deformable sheet material configured to be temporarily secured to the endoscope storage tray so as to cover at least an interior of the endoscope storage tray. The cover can engage with the rim and/or the lip of the tray to temporarily secure the cover to the tray.

In some embodiments, the cover can be in a sheet (<FIG> and <FIG>) or a bag/pouch configuration (<FIG>). For example, when the cover is in a bag/pouch configuration, the cover can be a reversible pouch, as shown in <FIG>. The reversable bag/pouch is configured to entirely enclose the tray. In some embodiments, the reversible bag/pouch can have a clean/green colored side <NUM> and a biohazard/red side <NUM>. The clean/green side can have indicia <NUM> in the form of a word, words and/or symbols. For example, the indicia can be the word "CLEAN". In some embodiments, the biohazard/red side can have indicia <NUM> in the form of a word, words and/or symbols. For example, the indicia can be the word "BIOHAZARD". When the tray is inserted/engaged into a cart, as described below, and the clean/green side is facing upward, this can indicate to a user that the endoscope is clean and ready for use. When the tray is inserted/engaged into the cart and the biohazard/red side is facing upward, this can indicate to a user that the endoscope is contaminated, should not be used and that the endoscope needs to be reprocessed. In some embodiments, the reversible bag/pouch can have a clear/transparent viewing window <NUM> in the center of each side of the bag/pouch. In some embodiments, the reversible bag/pouch can be sealed by a zipper.

In some embodiments, the cover engages and partially encloses the tray with an elastic portion <NUM>, as shown in <FIG>. In some embodiments, the sheet or bag configuration 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, the cover can be temporarily secured to the rim of the tray, and/or the bottom of the tray.

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. A red color, in some embodiments, could indicate that the tray should not be used and the endoscope should be cleaned. Alternative colors can be selected such as blue, pink, yellow, orange, brown or black to indicate the status of the endoscope. 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.

The system includes a cart <NUM>, as shown in <FIG>. The cart is configured to assist in the transportation and/or storage of one or more of the trays that store one or more endoscopes. It is to be understood that the cart is defined as a mobile storage unit. However, a cabinet which is defined as a static or stationary storage unit can alternatively be used. The cart can also be an endoscope washing and/or drying cart. The cart includes a housing <NUM>. The housing includes a first side panel <NUM> and a second side panel <NUM>, as shown in <FIG>. The first and the second side panels are in a parallel configuration relative to each other and are spaced apart at a certain distance, such as, for example, a distance that is greater than the width of the trays. Each of the side panels include a first support <NUM>, a second support <NUM>, a rail <NUM> and a base <NUM>. The first and the second support are in a parallel configuration relative to each other and the rail and the base are in a parallel configuration relative to each other.

The rail extends from a first end <NUM> to a second end <NUM>. The first end fixedly engages with the first support by an engagement means <NUM>, such as a bracket, screw, adhesive and/or soldering. In some embodiments, the first end and the first support are manufactured fused together and are monolithic. The first end and the first support, in some embodiments, form a <NUM>-degree angle where they engage. The second end fixedly engages with the second support by engagement means <NUM>. In some embodiments, the second end and the second support are manufactured fused together and are monolithic. The second end and the second support form a <NUM>-degree angle where they engage. The base extends between a proximal end <NUM> and a distal end <NUM>, and includes an upper surface <NUM> and a lower surface <NUM>. The base fixedly engages with an end <NUM> of the first support at the upper surface and toward the proximal end. The base and the end of the first support can form a <NUM>-degree angle where they engage. The base fixedly engages with an end <NUM> of the second support at the upper surface and toward the distal end. The base and the end of the second support can form a <NUM>-degree angle where they engage. The base and end <NUM> of the first support and end <NUM> of the second support can fixedly engage via engagement means, similar to those described above with regard to engagement means <NUM>. A first brace <NUM> and a second brace <NUM> fixedly engage the bases.

In some embodiments, each rail of each of the side panels collectively form a runner assembly <NUM>. The runner assembly is configured for engaging with the tray and allows for the movement of the tray in a forward and backward direction once removably mounted on the runner assembly. Each rail includes an inner side <NUM> that includes a slot <NUM>. A bearing <NUM> can be positioned within the slot to facilitate retractable movement of an arm <NUM>. In some embodiments, the bearing and the arm movably engage relative to each other.

As shown in <FIG>, the cart includes a mating surface, such as a frame <NUM>. The frame can be variously configured, as shown in <FIG>, <FIG>, <FIG> and <FIG>. The frame is configured to mate with a corresponding mating surface <NUM> of the tray (<FIG>) to removably hold the endoscope tray in the cart. The tray removably engages the frame, and the cart allows the tray containing the endoscope to be transported to a patient for use. In some embodiments, the mating surface of the tray corresponds to a particular frame (e.g., mating surface) of the cart and the frame (e.g., mating surface) of the cart corresponds to a particular mating surface of the tray.

In some embodiments, the mating surface of the tray can be at least a portion of the sidewalls of the tray, the peripheral lip and/or the rim of the tray. The mating surface of the tray and the frame (e.g., mating surface) of the cart can also temporarily lock. For example, the mating surface of the tray can include one or more recesses <NUM> that mates with one or more projections <NUM> on the frame, as shown in <FIG>, <FIG> and <FIG>. Alternatively, the mating surface of the tray can include one or more projections <NUM> that mates with one or more recesses <NUM> on the frame, as shown in <FIG>. In some embodiments, the tray and the frame can be in locked engagement through one or more grooves, teeth, indents, tongues, peaks, valleys, ribs, flanges, dimples, slots, or a combination thereof disposed on the mating surface of the tray and the frame. The locked engagement can include, but is not limited to a friction fit, pressure it, or male/female engagement.

The frame can be fixedly or removably engaged with the runner assembly. In some embodiments, the frame can be variously configured. For example, the frame can be in a basket configuration as shown in <FIG>, where the mating surface of the tray is the peripheral lip and side wall; a solid mount with bracketed edges configuration as shown in <FIG>, where the mating surface of the tray are portions of the peripheral lip and the tray has a locked engagement with the frame projections; a railed configuration as shown in <FIG>, where the mating surface of the tray are portions of the peripheral lip and the tray has a locked engagement with the rail projections; and a low profile solid mount as shown in <FIG> where the mating surface of the tray are the sidewalls and the peripheral lip.

The cart can be configured to utilize all of the frames of <FIG> in a single cart. In some embodiments, one or all of the frame embodiments can be in a stacked configuration within the cart, as shown in <FIG>. One or more trays can also be stacked in the cart and disposed with lids, covers and/or liners.

The frames can include pockets <NUM> that are configured for portions of the tray to nest within. The perimeter of the tray, in some embodiments, is smaller than the perimeter of the frame so that the tray nests within the frame, as shown in <FIG>. When the perimeter of the tray is smaller than the perimeter of the frame, there is no tray rim or lip overhang. The perimeter of the tray, in some embodiments, is larger than the perimeter of the frame so that the tray nests within the frame, as shown in <FIG>. When the perimeter of the tray is larger than the perimeter of the frame, the rim or lip of the tray will overhang relative to the frame.

The system can alternatively include a cart <NUM>, as shown in <FIG>. The cart is configured for storage and/or transportation of the trays. The cart comprises a housing <NUM>. The housing includes opposing side walls <NUM>, <NUM> and top and bottom walls <NUM>, <NUM>. The cart can be in a rectangular configuration. An interior <NUM> of the housing comprises one or a plurality of slots <NUM>, each configured to slidably receive the tray. The slots are transverse relative to the opposing side walls. Each slot is defined by ledges <NUM>, <NUM> that are in parallel orientation relative to each other. The cart can comprise one or more slots, such as <NUM> to about <NUM> slots.

In some embodiments, the bottom wall includes an exterior surface <NUM> that attaches to a plurality of wheels <NUM>, such as caster wheels. The cart can include <NUM> or more wheels disposed at corners of the exterior surface. The cart can be washed and can be heat and chemical resistant.

The tray can be configured to nest in a specific row in the cart. In this way, a tray cannot be used in a different cart or a different row in the cart. Therefore, a tray that does not have apertures on the bottom surface of the tray, on at least a portion of the top surface of one or more of the upstanding elements, and/or on the rim of the tray would not be able to be used in that cart. Further, specific trays and specific carts can be tailored for specific endoscope suites in a medical facility and can be tailored for patient specific use.

It is to be understood that the tray engaged with the lid, liner and/or the cover and disposed with the cart for storage and/or transportation can reduce the number of receptacles used for endoscope reprocessing and delivery.

The cart can be made from various materials, including, but not limited to metals, such as for example, stainless steel alloys, commercially pure titanium, titanium alloys, Grade <NUM> titanium, cobalt-chrome alloys, or combinations thereof. In some embodiments, the cart can be made from thermoplastic materials and/or the materials described above with regard to the tray. In some embodiments, the cart are configured to be heat and chemical resistant.

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.

A method of using an endoscope storage tray is disclosed. The method comprises placing an endoscope within an endoscope tray, the endoscope tray comprising an interior for storage of the endoscope, the interior having an upstanding element having a top surface, and a plurality of apertures disposed on at least a portion of the top surface of the upstanding element to facilitate drainage of fluids. It is to be understood that the tray is tray <NUM> described above with regard to <FIG>.

In some embodiments, the interior comprises at least two upstanding elements spaced apart from each other to provide support for a flexible medical endoscope coiled between all or a portion of the at least two upstanding elements. In some embodiments, the upstanding elements contour portions of the endoscope. In some embodiments, a rigid lid engages the tray. In some embodiments, a disposable liner engages with the interior of the tray.

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 tray combined together to be used with the cart. The kit may include the tray in a first compartment. A second compartment may include the cover. A third compartment may include the liner. A fourth compartment may include the lid. A fifth compartment may include cleaning solutions, gloves and other procedural supplies for performing cleaning of the endoscope, 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 tray (<NUM>) comprising an interior (<NUM>) for storage of an endoscope, the interior (<NUM>) having an upstanding element (<NUM>) having a top surface (<NUM>); a plurality of apertures (<NUM>) disposed on at least a portion of the top surface (<NUM>) of the upstanding element (<NUM>) to facilitate drainage of fluids; the interior having a bottom surface (<NUM>) also having the plurality of apertures (<NUM>) disposed thereon; a sidewall (<NUM>) and a rim disposed about the interior (<NUM>) of the tray; and a lid (<NUM>) comprising at least one valve (<NUM>) and configured to engage the rim, wherein the at least one valve (<NUM>) is an exhaust valve and a release valve.