Patent Description:
The subject matter disclosed herein relates to containers used for sterilizing medical instruments.

Endoscopes are challenging to sterilize for various reasons. For example, because pressure within a lumen decreases from the lumen's inlet as a function of length and diameter, the pressure drop must be overcome to ensure that sterilant passes through the entire lumen and reaches all surfaces of the lumen. Further, lumens may collect debris or be blocked by fluids, such as rinse water. Patent document <CIT> discloses a sterilization tray for instruments, patent document <CIT> discloses a method for radiochemical sterilization, and patent document <CIT> discloses a lumen sterilization device and method.

A dry booster is a device that may be connected to a lumen of an elongate medical device, such as an endoscope. When subject to a sterilization process in which pressure changes are implemented, pressure differentials between the inside of a dry booster at one end of the lumen and a vacuum chamber at the other end of a lumen help pass a sterilant through the lumen, which assists in sterilizing the lumen.

A sterilization tray is disclosed herein. The sterilization tray may be fabricated from a flexible and vapor-permeable sheet. Cutouts may be disposed through the sheet to define standoffs that are foldable away from the sheet. A first standoff may include a first contoured portion disposed therein. A score line may be disposed upon the sheet that extends between two edges of the first standoff. The tray may also include a second standoff that has a second contoured portion and a third contoured portion disposed therein. The third standoff may include a locking tab disposed on a free end of the third standoff. A positioning tab may also be disposed on the third standoff.

The sterilization tray may also be comprised of a top portion, a side portion, a bottom portion, a second score line, and a third score line. The second score line may distinguish the top portion from the side portion. The third score line may distinguish the bottom portion from the side portion. The top portion may include a slit. The third standoff may be disposed through the slit such that the locking tab engages the top portion.

The sterilization tray includes a dry booster. A first tube is connected to the dry booster and a second tube is connected to the dry booster. An adapter may be connected to the first tube and the second tube. The adapter may mate with a port on a control body of an endoscope.

The sterilization tray may be used to assist in sterilizing an endoscope according to the following methods and variations. The sterilization tray may be provided. Then, the first standoff may be folded away from the sheet and a first portion of the endoscope may be positioned upon the first standoff. Specifically, the first portion of the endoscope, which may be a control body of the endoscope, may be positioned upon the contoured portion of the first standoff. A second portion of the endoscope may also be positioned on the tray. Specifically, the second portion of the endoscope, which may be a portion of an insertion tube of the endoscope, may be disposed in contact with the second contoured portion and the third contoured portion of the second standoff. Next, the locking tab of the third standoff may be inserted through the slit to restrict movement of the top portion relative to the bottom portion. A dry booster is attached to the sterilization tray and the endoscope is attached to the dry booster.

While the specification concludes with claims, which particularly point out and distinctly claim the subject matter described herein, it is believed the subject matter will be better understood from the following description of certain examples taken in conjunction with the accompanying drawings, in which like reference numerals identify the same elements and in which:.

The following description sets forth certain illustrative examples of the claimed subject matter. Other examples, features, aspects, embodiments, and advantages of the technology should become apparent to those skilled in the art from the following description. Accordingly, the drawings and descriptions should be regarded as illustrative in nature.

Successful sterilization of an endoscope may require accounting for various challenges. Sterilization trays for endoscopes may be designed to increase the likelihood that an endoscope may be successfully sterilized during a sterilization procedure by addressing each of the following three sterilization challenges. First, endoscopes are cumbersome to handle. Second, endoscope tubes are typically made from polyurethane, which absorbs sterilants such as hydrogen peroxide. When one portion of an endoscope tube touches another portion of the endoscope tube, or any other material or object that absorbs sterilant, a so-called "mated surface" is formed, which effectively provides additional mass through which a sterilant must penetrate to achieve sterilization. Third, endoscopes include multiple long and narrow lumens that may restrict the flow of a sterilant therethrough.

Disclosed herein is a tray or container that may address the foregoing challenges to endoscope sterilization. Referring to <FIG>, tray <NUM> may be provided as a single component fabricated from a sheet <NUM> of a material that is preferably light weight and vapor permeable, particularly to gaseous sterilants, such as hydrogen peroxide. High density polyethylene is a suitable material. Sheet <NUM> may include a top portion <NUM>, a side portion <NUM>, and a bottom portion <NUM>. Various vent holes, e.g., holes <NUM>, <NUM>, and <NUM>, may be disposed though portions <NUM>, <NUM>, and <NUM>, respectively, to minimize weight and material use, and also to minimize restrictions to sterilant flow through and about tray <NUM>.

Various cutouts may be disposed through lid portion <NUM> to define edges of features or standoffs for maintaining a position of an endoscope that may include, e.g., a control body <NUM>, a light-guide connector body <NUM>, an insertion tube <NUM>, and an umbilical tube <NUM>. For example, bottom portion <NUM> may include a first standoff <NUM> and a second standoff <NUM> that may support control body <NUM>, and a third standoff <NUM> and a fourth standoff <NUM> that may support light-connector body <NUM>. Each standoff <NUM>, <NUM>, <NUM>, and <NUM> may have a contoured portion-respectively <NUM>, <NUM>, <NUM>, and <NUM>-that facilitates proper placement and orientation of bodies <NUM> and <NUM> upon the standoffs. Bottom portion <NUM> may also include a fifth standoff <NUM> and sixth standoff <NUM> that may support insertion tube <NUM> and umbilical tube <NUM>. Fifth standoff <NUM> and sixth standoff <NUM> may include one or more contoured portions to facilitate placement and orientation of insertion tubes <NUM> and umbilical tube <NUM>. For example, as shown, fifth standoff <NUM> includes a single contoured portion <NUM> whereas sixth standoff <NUM> includes three contoured portions <NUM>, <NUM>, and <NUM>. Referring to <FIG>, umbilical tube <NUM> is supported by contoured portions <NUM>, <NUM>, and <NUM>, and insertion tube <NUM> is supported by contoured portion <NUM>.

Additional standoffs, e.g., seventh standoff <NUM> and eighth standoff <NUM>, may be provided with additional or alternative functionality. In the embodiments reflected in the figures, seventh standoff <NUM> includes a pair of locking tabs <NUM> disposed on its free end (i.e., the end not connected to sheet <NUM>), and eighth standoff <NUM> includes a pair of locking tabs <NUM> disposed on its free end. As shown, a pair of locking tabs <NUM> is also included upon sixth standoff <NUM>. Locking tabs <NUM>, <NUM>, and <NUM> may mate with slits <NUM>, <NUM>, and <NUM>, which are disposed on top portion <NUM>. That is, standoffs <NUM>, <NUM> and <NUM> may be disposed through slits <NUM>, <NUM>, and <NUM> such that locking tabs <NUM>, <NUM>, and <NUM> may engage top portion <NUM>. The portion of each standoff containing the locking tabs may be wider than the slits such that resistance to motion of top portion <NUM> may be provided by the locking tabs. Thus, locking tabs <NUM>, <NUM>, and <NUM> may be used to restrict movement of top portion <NUM> relative to bottom portion <NUM>, such that tray <NUM> may be placed into a closed or assembled configuration, which is reflected in <FIG>. Standoffs <NUM> and <NUM> may further include positioning tabs <NUM> and <NUM>, respectively. Positioning tabs <NUM> and <NUM> may help avoid inserting standoffs <NUM> and <NUM> too far through slits <NUM> and <NUM>. Alternatively or additionally, positioning tabs <NUM> and <NUM> may be used to support a portion of an endoscope. For example, although not shown in the figures, positioning tab <NUM> may be used to support a portion of insertion tube <NUM> and positioning tab <NUM> may be used to support a portion of insertion tube <NUM> or umbilical tube <NUM>.

Referring to <FIG> and <FIG>, standoffs <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, and <NUM>, as well as their contoured portions, may be used to position an endoscope's control body <NUM> and light connector body <NUM>, as well as route insertion tube <NUM> and umbilical tube <NUM> into a configuration in which one portion of the endoscope does not contact any other portion of the endoscope. As seen, insertion tube <NUM> and umbilical tube <NUM> are maintained in a coiled configuration in which they do not contact each other. For example, standoff <NUM> maintains the position of umbilical tube <NUM> at two locations and the position of insertion tube <NUM> at one location. Further, standoff <NUM> may be used to space umbilical tube <NUM> from insertion tube <NUM> as best seen in <FIG>. Accordingly, tray <NUM> helps avoid the mated-surfaces problem described above caused by one portion of the endoscope contacting another portion of the endoscope.

The various features, e.g., vent holes and standoffs, may be formed by removing material (e.g., by laser cutting or stamping) from sheet <NUM>. Further, sheet <NUM> may be scored at locations to form score lines, e.g., score lines <NUM>, <NUM>, <NUM>, <NUM>, and <NUM>, to facilitate folding tray <NUM> out of its open or unassembled configuration of <FIG> and into its closed or assembled configuration of <FIG>. For example, score lines <NUM> and <NUM> may extend the width of sheet <NUM> and distinguish side portion <NUM> from top portion <NUM> and bottom portion <NUM>. Further for example, score lines <NUM>, <NUM>, and <NUM> may be disposed upon sheet <NUM> and extend between cutouts defining standoff <NUM>, standoff <NUM>, and positioning tab <NUM>.

The sterilization tray includes a dry booster. Dry boosters are described in <CIT> and <CIT>. In short, dry boosters are used to create a pressure differential between a so-called "booster" volume and the vacuum chamber of a sterilizer to assist in introducing and removing sterilant through a lumen, such as a lumen in insertion tube <NUM> or umbilical tube <NUM> that connects the booster volume and the vacuum chamber.

As shown in <FIG>, tray <NUM> is outfitted with a dry booster <NUM>. Dry booster <NUM> may have a channel formed thereon that may mate with the edges of a vent hole in top portion <NUM> such that dry booster <NUM> may be disposed therein. A first tube <NUM> and a second tube <NUM> are connected on one end to dry booster <NUM>. In other embodiments, dry booster <NUM> may include additional tubes, e.g., a third tube and a fourth tube. The other ends of tubes <NUM> and <NUM> (and any additional tubes) may be connected to an adapter <NUM>. Adapter <NUM> may be configured to mate with ports (not shown) on control body <NUM> of an endoscope. These ports may provide access to one or more lumens within insertion tube <NUM> and/or umbilical tube <NUM>. Accordingly, when adapter <NUM> is connected to ports on control body <NUM>, one or more lumens in tubes <NUM> and/or <NUM> are placed in fluid communication with an internal volume defined by dry booster <NUM>. As described in <CIT>, the lengths and diameters of tubes <NUM> and/or <NUM> (and/or any additional tubes) may be chosen to provide flow-restriction to sterilant passing therethrough to help ensure that proper amounts of sterilant pass through each lumen in the endoscope.

A manufacturer of tray <NUM> may assemble dry booster <NUM> therein before providing it to a user (e.g., healthcare provider). Alternatively, a manufacturer or tray <NUM> may provide tray <NUM> and dry booster <NUM> to a user who installs dry booster <NUM> into tray <NUM>.

A sterilization tray, e.g., tray <NUM>,with an endoscope disposed therein may be subject to a sterilization cycle within a vacuum chamber of a sterilizer, such as the STERRAD® System, STERRAD® NX System or STERRAD® 100NX System of Advanced Sterilization Products, Division of Ethicon US, LLC, a Johnson & Johnson company. The dry booster assists the sterilizer in sterilizing the endoscope. As pressure is lowered within the vacuum chamber, the pressure within the dry booster concomitantly drops, but lags behind the pressure in the vacuum chamber because of the time required to withdraw gas from the dry booster and through insertion tube <NUM>. Similarly, when pressure within the vacuum chamber is raised, the pressure within the dry booster concomitantly rises, but it lags behind the pressure in the vacuum chamber because of the time required to pass gas into the dry booster, through insertion tube <NUM>. Accordingly, when pressure within the vacuum chamber is raised by introducing a gaseous sterilant into the vacuum chamber, the lower pressure within the dry booster provides suction through the lumens of insertion tube <NUM>, which may assist sterilant penetrating throughout the lumens. Similarly, when pressure is lowered in the vacuum chamber, suction through the lumens may assist in flushing or removing any residual sterilant or moisture from the lumens.

A sterilization tray as disclosed herein may be used according to the following method and variations. First, a tray (e.g., tray <NUM>) may be provided. In some variations, the tray may be provided having the form of a sheet. A dry booster is assembled onto the tray, either by a manufacturer or user (e.g., healthcare provider), to form a tray having a dry booster. For example, dry booster <NUM> may be installed into a vent hole of top portion <NUM>. Third, the standoffs of bottom portion <NUM>, e.g., standoffs <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, and <NUM>, may be folded such that they extend away (e.g., transversely) from bottom portion <NUM>. In those embodiments that include score lines (e.g., score lines <NUM> and <NUM>), the standoffs may be folded about the score lines. Further, in those embodiments that include positioning tabs, e.g., positioning tabs <NUM> and <NUM>, the positioning tabs may be folded out of their respective standoffs. A first tube <NUM> and second tube <NUM> are connected to ports of an endoscope's control body <NUM> to place the endoscope's lumens in fluid communication with the inside of dry booster <NUM>. In some variations, this connection may be accomplished by using adapter <NUM>, which is connected to tubes <NUM> and <NUM> and is configured to mate to the ports. Fifth, an endoscope's control body <NUM> may be disposed upon at least two of the standoffs, e.g., standoffs <NUM> and <NUM>. Sixth, the endoscope's insertion tube <NUM> and umbilical tube <NUM> may be disposed in a coiled configuration using the standoffs, e.g., standoffs <NUM> and <NUM>. Seventh, insertion tube <NUM> and umbilical tube <NUM> may be checked for mated surfaces, e.g., to confirm that no portion of insertion tube <NUM> contacts any portion of umbilical tube <NUM>. Eighth, the tray may be folded out of its open or unassembled configuration (<FIG>) to its closed or assembled configuration (<FIG>) such that side portion <NUM> extends away (e.g., transversely) from bottom portion <NUM> and such that top portion <NUM> is spaced from but parallel to bottom portion <NUM>. In those embodiments including score lines, e.g., score lines <NUM> and <NUM>, the tray may be folded at these score lines. Ninth, locking tabs (e.g., tabs <NUM>, <NUM>, and <NUM>) may be passed through slits disposed through top portion <NUM> (e.g., slits <NUM>, <NUM>, and <NUM>). The standoffs containing these locking tabs may be bent to assist in passing the locking tabs through the slits. After the locking tabs have been passed through the slits, the standoffs may become unbent due to resilience of the tray material. Tenth, sterilization tray <NUM>, with the endoscope disposed therein, may be placed into a sealable and vapor permeable pouch made from, e.g., DuPont™ Tyvek®. Alternatively or additionally, sterilization tray <NUM> may be wrapped using a sterilization wrap, such as KIMBERLY-CLARK* KIMGUARD* Sterilization Wrap. Ninth, tray <NUM> with the endoscope disposed therein, may be placed into a vacuum chamber of a sterilizer. Eleventh, the tray with the endoscope disposed therein may be subject to a sterilization cycle. Twelfth, pressure in the vacuum chamber may be lowered. Thirteenth, a sterilant, e.g., hydrogen peroxide, may be introduced into the chamber. Fourteenth, the sterilant may be drawn through insertion tube <NUM> and into volume or chamber <NUM> assisted by a pressure differential between dry booster <NUM> and the vacuum chamber. Fifteenth, the vacuum chamber may be vented to raise the pressure and introduce another gas, e.g., air, therein. This gas may be drawn through insertion tube <NUM> and into dry booster <NUM> assisted by a pressure differential between dry booster <NUM> and the vacuum chamber, which may assist in flushing the sterilant from the lumen. Sixteenth, pressure in the vacuum chamber may be lowered. Gas within dry booster <NUM> may be drawn through insertion tube <NUM> and into the vacuum chamber, which may further assist in flushing the sterilant from the lumen. Seventeenth, tray <NUM> may be removed from the vacuum chamber of the sterilization system.

It should be understood that any of the examples and/or embodiments described herein may include various other features in addition to or in lieu of those described above. The teachings, expressions, embodiments, examples, etc. described herein should not be viewed in isolation relative to each other. Various suitable ways in which the teachings herein may be combined should be readily apparent to those of ordinary skill in the art in view of the teachings herein.

Claim 1:
An assembly comprising an endoscope and a sterilization tray (<NUM>), the sterilization tray comprising:
a flexible and vapor-permeable sheet (<NUM>),
wherein the tray (<NUM>) comprises a cutout disposed through the sheet, the cutout defining a first standoff (<NUM>) that is foldable away from the sheet (<NUM>),
wherein a first portion of the endoscope is configured to be positioned upon the first standoff when the first standoff is folded away from the sheet,
a first contoured portion (<NUM>) disposed through the first standoff (<NUM>),
characterized in that the assembly comprises a dry booster (<NUM>) defining an internal volume, such that the tray (<NUM>) is configured to create a pressure differential between the internal volume of the dry booster and a vacuum chamber of a steriliser.